Quality Assurance Guidance 

Document 

Conducting Technical Systems 

Audits of Ambient Air Monitoring 

Programs 
 

EPA-454/B-17-004 

November 2017 

This page intentionally left blank 

ii
 
 

 

 

EPA-454/B-17-004 

November 2017 

Quality Assurance Guidance Document
 

Conducting Technical Systems Audits of Ambient Air
 

Monitoring Programs
 

U.S. Environmental Protection Agency
 

Office of Air Quality Planning and Standards
 

Air Quality Assessment Division
 

RTP, NC 27711
 

November 2017
 

iii 
 

 

 

EPA-454/B-17-004 

November 2017 

Disclaimer 

The statements in this document, with the exception of referenced requirements, are intended solely as 

guidance. This document is not intended, nor can it be relied upon, to create any rights enforceable by 

any party in litigation with the United States. This guidance may be revised without public notice to 

reflect changes in EPA’s approach to implementing 40 CFR Parts 50, 53, and 58. 

Mention of commercial products or trade names should not be interpreted as endorsement. Some types 

of instruments currently in use may be described in text or in example figures or tables. Sometimes 

these products are given as a typical and perhaps well-known example of the general class of 

instruments. Other instruments in the class are available and may be fully acceptable. 

iv 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EPA-454/B-17-004 

November 2017 

Table of Contents
 

1.0 Introduction...............................................................................................2
 

Technical Systems Audit (TSA) ...................................................................................................... 2
 

CFR TSA Requirements.................................................................................................................. 2
 

Regulation and Guidance..............................................................................................................3
 

CFR Monitoring Requirements...................................................................................................... 4
 

PQAO Quality Assurance Project Plans (QAPP) ............................................................................ 4
 

Guidance Documents.................................................................................................................... 5
 

2.0 Technical Systems Audit Objectives ...........................................................7
 

Scope............................................................................................................................................. 7
 

Resources...................................................................................................................................... 8
 

2.2.1 Staffing .................................................................................................................................. 8
 

2.2.2 Funding.................................................................................................................................. 9
 

2.2.3 Time ...................................................................................................................................... 9
 

2.2.4	 Tools and Resources ............................................................................................................. 9
 

Air Quality System (AQS).................................................................................................10
 

Quarterly Data Reviews ..................................................................................................10
 

Field Equipment..............................................................................................................11
 

3.0 Roles and Responsibilities........................................................................12
 

EPA Regions.................................................................................................................................12
 

Office of Air Quality Planning and Standards (OAQPS)...............................................................12
 

Contractors .................................................................................................................................13
 

4.0 Pre-Audit Activities..................................................................................15
 

EPA Regional Office TSA Scheduling ...........................................................................................16
 

4.1.1	 Assigning the Audit Team ...................................................................................................16
 

TSA Planning................................................................................................................................18
 

4.2.1 Basic Information Gathering (Pre-Planning).......................................................................19
 

4.2.2 Initial Contact with the Monitoring Organization...............................................................21
 

4.2.3 Refining the Audit Strategy.................................................................................................23
 

4.2.4 Selecting Specific Field Sites to Inspect...............................................................................25
 

4.2.5	 Finalized Audit Itinerary......................................................................................................28
 

Quality System Document Review..............................................................................................30
 

v 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EPA-454/B-17-004 

November 2017 

4.3.1 Document Status.................................................................................................................30
 

4.3.2 Document Content..............................................................................................................32
 

4.3.3	 Important Note about QAPP Approvals..............................................................................34
 

Data Review ................................................................................................................................35
 

4.4.1 AQS Reports ........................................................................................................................36
 

4.4.2 Review Criteria....................................................................................................................38
 

4.4.3	 Additional QC Data Requests and Review ..........................................................................41
 

Questionnaire Response.............................................................................................................42
 

Preliminary Findings Summary ...................................................................................................42
 

Audit Team Communications and Planning................................................................................43
 

4.7.1 Team Meetings Prior to the On-Site TSA ............................................................................43
 

4.7.2 Daily Briefings During the On-Site TSA................................................................................44
 

5.0 On-Site Audit Activities............................................................................46
 

Entrance Briefing.........................................................................................................................48
 

TSA Questionnaire Review..........................................................................................................49
 

Auditing the Monitoring Organization........................................................................................50
 

5.3.1 Monitoring Headquarters...................................................................................................51
 

5.3.2 Maintenance and Repair Shop............................................................................................52
 

5.3.3	 Monitoring Data Review and Validation Group..................................................................53
 

Tracking Data History......................................................................................................54
 

Data Review Process.......................................................................................................55
 

5.3.4 Quality Assurance Group ....................................................................................................56
 

5.3.5	 Analytical Laboratories .......................................................................................................58
 

PM2.5/Low-Volume PM10 Gravimetric Laboratory ..........................................................61
 

Hi-Volume PM10 Gravimetric Laboratory........................................................................62
 

Lead (Pb) Analysis Laboratory.........................................................................................64
 

PM2.5 Chemical Speciation Laboratories.........................................................................65
 

Air Toxics Laboratories....................................................................................................66
 

5.3.6	 AQS Submittal Group ..........................................................................................................66
 

Standards Certification Records Review.....................................................................................67
 

Monitoring Site Inspections........................................................................................................68
 

5.5.1 Inside the Monitoring Station .............................................................................................70
 

5.5.2 Outside the Monitoring Station ..........................................................................................71
 

vi 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EPA-454/B-17-004 

November 2017 

Concluding the Audit...................................................................................................................71
 

5.6.1	 Exit Briefing .........................................................................................................................72
 

Exit Briefing Preparation.................................................................................................72
 

Conducting the Exit Briefing............................................................................................73
 

6.0 Report Development and Corrective Action Process ................................75
 

Unresolved Issues and Additional Analyses................................................................................75
 

TSA Report ..................................................................................................................................77
 

6.2.1	 Report Structure & Elements..............................................................................................78
 

Report Elements..............................................................................................................80
 

Ranking TSA Findings ......................................................................................................83
 

6.2.2	 Draft Findings Summary (Report) .......................................................................................84
 

EPA Regional Office.........................................................................................................85
 

Issuance of Draft Findings Summary...............................................................................87
 

6.2.3	 Final TSA Report..................................................................................................................87
 

Audited Organization Corrective Action Plans............................................................................89
 

6.3.1 Auditee Response ...............................................................................................................89
 

6.3.2 Auditor Review....................................................................................................................89
 

Corrective Action Follow-Up.......................................................................................................90
 

6.4.1 Tracking...............................................................................................................................90
 

6.4.2	 Follow-up Site Visit..............................................................................................................92
 

TSA Close-Out..............................................................................................................................92
 

6.5.1	 TSA Project File ...................................................................................................................93
 

TSA Information in AQS...............................................................................................................94
 

7.0 TSA Training.............................................................................................96
 

8.0 EPA Audit Communication .......................................................................97
 

Regional Management Elevation Points.....................................................................................97
 

Inter-Regional Elevation Points...................................................................................................98
 

OAQPS Elevation Points..............................................................................................................98
 

vii 
 

 

 

 

EPA-454/B-17-004 

November 2017 

Appendices 

Appendix A 

Technical Systems Audit Questionnaire ..................................................................................... 100
 

Appendix B 

Example Field Audit Logbook...................................................................................................... 101
 

Appendix C 

Low-Volume Weighing Laboratory Audit Checklist .................................................................... 102
 

Appendix D 

Laboratory Systems Review: Lead in Air
 

Audit Checklist ............................................................................................................................ 103
 

Appendix E 

Example Technical Systems Audit
 

Report Template ......................................................................................................................... 104
 

Appendix F 

Example Technical Systems Audit Close-Out Letter ................................................................... 105
 

Figures 

Figure 4.1 TSA Pre-Audit Activities Flow Chart ............................................................................ 15
 

Figure 5.1 TSA On-Site Activities Flow Chart ............................................................................... 47
 

Figure 6.1 TSA Report Development and Corrective Action Flow Chart ..................................... 75
 

Figure 6.2 Example Corrective Action Tracking Mechanism ....................................................... 95
 

Tables 

Table 5.1 Pollutants and Corresponding Reference Methods and Guidance Documents.......... 59
 

Table 6.1 Example Findings Categorization ................................................................................. 83
 

viii 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EPA-454/B-17-004 

November 2017 

Acronyms and Abbreviations
 

APTI Air Pollution Training Institute 

AMNP Annual monitoring network plan 

AMTIC Ambient Monitoring Technical Information Center 

AQI Air Quality Index 

AQS Air Quality System 

ASTM American Society for Testing and Materials 

CFR Code of Federal Regulations 

CL confidence limit 

CBSA core-based statistical area 

COC chain of custody 

CSN PM2.5 Chemical Speciation Network 

CV coefficient of variation 

CY calendar year 

DAS data acquisition system 

DASC Data Assessment Statistical Calculator 

DQA data quality assessment 

DQI data quality indicators 

DQOs data quality objectives 

EDO environmental data operation 

EPA Environmental Protection Agency 

FEM federal equivalent method 

FR flow rate 

FRM federal reference method 

FY fiscal year 

GC/MS gas chromatography mass spectrometry 

HPLC high performance liquid chromatography 

ICP inductively coupled plasma 

IMPROVE Interagency Monitoring of Protected Visual Environments 

ISA internal systems audit 

IT information technology 

LDL lower detectable limit 

LIMS laboratory information management systems 

MDL method detection limit 

MFC mass flow control 

MQOs measurement quality objectives 

MSA Metropolitan Statistical Area 

NAAQS National Ambient Air Quality Standards 

NATTS National Air Toxics Trends Sites 

NCore National Core Network 

NIST National Institute of Standards and Technology 

NPAP National Performance Audit Program 

NPEP National Performance Evaluation Program 

ix 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EPA-454/B-17-004 

November 2017 

Acronyms and Abbreviations (Continued) 

OAQPS Office of Air Quality Planning and Standards 

SORD Office of Research and Development 

PAMS Photochemical Assessment Monitoring Stations 

Pb lead 

PE performance evaluation 

PEP Performance Evaluation Program 

ppb parts per billion 

ppm parts per million 

PQAO primary quality assurance organization 

PT proficiency test 

QA quality assurance 

QA/QC quality assurance/quality control 

QAGD Quality Assurance Guidance Document 

QAM quality assurance manager 

QAO quality assurance officer 

QAPP quality assurance project plan 

QMP quality management plan 

RO Regional Office 

SLAMS state and local monitoring stations 

SOP standard operating procedure 

SPMS special purpose monitoring stations 

SRP standard reference photometer 

TAD technical assistance document 

TEOM tapered element oscillating microbalance 

TSA technical systems audit 

TSP total suspended particulate 

VOC volatile organic compound 

x 
 

 

 

 

 

 

 

 

 

 

EPA-454/B-17-004 

November 2017 

Acknowledgements 

This document is the result of the collaboration of the Technical Systems Audit Workgroup. The 

Technical Systems Audit Workgroup is a group of quality assurance and air monitoring technical experts 

from across all EPA Regions and EPA Headquarters who are involved in Technical Systems Audits for 

ambient air monitoring organizations that monitor for comparison to the National Ambient Air Quality 

Standards. The goal of the workgroup is to provide guidance, technical expertise, and tools to aid in the 

technical systems audit process. The members of the workgroup at the time of development of this 

document are as follows: 

Gregory Noah, US EPA OAQPS Bilal Qazzaz, US EPA Region 5
 

Michael Papp, US EPA OAQPS Chad McEvoy, US EPA Region 5
 

Robert Judge, US EPA Region 1 Kara Allen, US EPA Region 6
 

Alysha Thompson, US EPA Region 1 Trisha Curran, US EPA Region 6
 

Catherine Taylor, US EPA Region 1 James Regehr, US EPA Region 7
 

Chris St. Germain, US EPA Region 1 Leland Grooms, US EPA Region 7
 

Mustafa Mustafa, US EPA Region 2 Richard Payton, US EPA Region 8
 

Elizabeth Gaige, US EPA Region 3 Albion Carlson, US EPA Region 8
 

Kia Hence, US EPA Region 3 Joshua Rickard, US EPA Region 8
 

Loretta Hyden, US EPA Region 3 Ethan Brown, US EPA Region 8
 

Verena Joerger, US EPA Region 3 Gwen Yoshimura, US EPA Region 9
 

Laura Ackerman, US EPA Region 4 Mathew Plate, US EPA Region 9
 

Stephanie McCarthy, US EPA Region 4 Randall Chang, US EPA Region 9
 

Richard Guillot, US EPA Region 4 Michael Flagg, US EPA Region 9
 

Keith Harris, US EPA Region 4 Jennifer Williams, US EPA Region 9
 

Anthony Bedel, US EPA Region 4 Chris Hall, US EPA Region 10
 

Adam Zachary, US EPA Region 4 Doug Jager, US EPA Region 10
 

Scott Hamilton, US EPA Region 5
 

Names that appear in bold are the primary contacts for the TSA workgroup in each EPA Region. 

xi 
 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 1 of 105 

Preface 

Intent of Document 

The intent of this document is to provide guidance to assist auditors in implementing the Technical 

Systems Audit (TSA) requirements and to provide guidance and tools to aid in conducting TSAs of 

ambient air monitoring programs. While this document is geared primarily for federal auditors 

conducting TSAs of air monitoring programs required by CFR, the principles and tools provided in the 

document could be a framework for an auditor performing a TSA of any ambient air monitoring 

network. This document is intended to present “best practices” that, if implemented and followed, 

would result in an accurate and complete assessment of a monitoring organization’s ambient air 

monitoring program. 

This document makes use of internet links that provide the user with access to more detailed 

information on a particular subject. Due to the limitations of Adobe, full URL addresses must be 

provided for the links to function. Web links (URLs) to references are included as footnotes for the 

reader to follow for additional information. 

Document Review and Distribution 

The information in this guidance document was developed by the members of the TSA Workgroup, 

representing EPA Headquarters and the ten EPA Regional Offices, and has been subjected to a peer 

review by the workgroup. This TSA Quality Assurance Guidance Document (QAGD) has been signed and 

distributed by OAQPS Quality Assurance (QA) staff to promote consistency across EPA in understanding 

and conducting TSAs. This guidance document may be viewed on the Internet and downloaded from the 

EPA AMTIC Homepage1

. 

Recommendations for improvement are welcome, and comments should be directed to the Regional 

TSA Workgroup contact identified in bold in the Acknowledgements section. The TSA QAGD will be 

reviewed at least every 5 years by the TSA Workgroup and revised as needed. The TSA QAGD may 

require more frequent revision following significant rule changes and/or to keep pace with technological 

advances in monitoring methodology. Appendices that contain checklists or other audit tools may also 

require more frequent updates. 

1 https://www.epa.gov/amtic/amtic-quality-assurance 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 2 of 105 

1.0 Introduction 

Technical Systems Audit (TSA) 

A TSA is an on-site review and inspection of a monitoring organization’s ambient air monitoring program 

to assess its compliance with established regulations and guidance governing the collection, analysis, 

validation, and reporting of ambient air quality data. A TSA is also an opportunity to highlight areas 

within a monitoring organization where it has shown innovation and improvement, identify areas where 

programs can be strengthened, and to provide feedback to the organization. 

An effective TSA includes many components, such as document reviews, data reviews, interviews, 

observations, and site evaluations. Performance audits and other activities may also be included in a 

TSA, but the aforementioned components comprise the core of the TSA. Selecting audit staff with 

pertinent expertise, clearly defining roles and responsibilities, and providing sufficient resources, 

including both time and funding, are elements of the TSA process that promote the goal of completing 

high quality TSAs. This guidance document provides best practices to aid in conducting TSAs to assess 

the suitability and effectiveness of an ambient air monitoring quality system, to assess the quality of the 

data collected, and to identify strengths and areas for improvement within each program. 

CFR TSA Requirements 

TSAs are required under 40 Code of Federal Regulations (CFR) Part 58, Appendix A, § 2.5. Also, EPA 

Order CIO 2105.02 establishes policy and program requirements for an Agency-wide Quality System that 

include assessments to determine if data are “of sufficient quantity and adequate quality for their 

intended use.” 

More specifically, 40 CFR Part 58, Appendix A, § 2.5 states the following: 

Technical systems audits of each PQAO shall be conducted at least every 3 years by the 

appropriate EPA Regional Office and reported to the AQS. If a PQAO is made up of more than 

one monitoring organization, all monitoring organizations in the PQAO should be audited within 

6 years (two TSA cycles of the PQAO). As an example, if a state has five local monitoring 

organizations that are consolidated under one PQAO, all five local monitoring organizations 

should receive a technical systems audit within a 6-year period. Systems audit programs are 

described in reference 10 of this appendix. 

Reference 10 of the quote is the QA Handbook for Air Pollution Measurement Systems, Volume II 

Ambient Air Quality Monitoring Program (EPA-454/B-17-001, January 2017)3

, commonly known as the 

QA Handbook or “Redbook”. 

To summarize 40 CFR Part 58, Appendix A, §2.5, each EPA Regional Office must conduct a TSA of each 

PQAO within its region every three years, and each monitoring organization within each PQAO should 

be audited every six years. While the regulation does not require audits of the monitoring organizations 

2 https://www.epa.gov/sites/production/files/2013-10/documents/21050.pdf 3 https://www3.epa.gov/ttn/amtic/files/ambient/pm25/qa/Final%20Handbook%20Document%201_17.pdf 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 3 of 105 

within the PQAOs, it is strongly recommended that EPA conduct a TSA of each monitoring organization 

within a PQAO every six years. 

Note that there is no language limiting an EPA Regional Office from auditing more frequently. An EPA 

Regional Office may perform a TSA of any federally-funded air monitoring organization at any time. 

Regulation and Guidance 

When conducting a TSA, the auditors must have a firm understanding of ambient air monitoring, quality 

systems, and what direction is regulatory and what is considered guidance. Regulation may be defined 

as language specifically written in CFR, whereas guidance is language written in guidance documents or 

technical directives. Regulation may contain several terms which define how a regulation is to be 

followed. To aid in this distinction, the following terms are used consistently throughout CFR and the 

quality assurance guidance documents: 

shall, must - when the element is a requirement in 40 CFR or the Clean Air Act 

should - when the element is recommended. This term is used when extensive 

experience in monitoring provides a recommended procedure that would help 

establish or improve the quality of data or a procedure. The process that 

includes the term is not required, but if not followed, an alternate procedure 

should be developed that meets the intent of the guidance. 

may - when the element is optional or discretionary. The term also indicates that what 

is suggested may improve data quality, that it is important to consider, but it is 

not as important as those that have been suggested using the term “should”. 

In summary, CFR language that contains “shall” or “must” is a requirement that must be followed. CFR 

language that uses “should” or “may” are recommendations that are encouraged to help ensure the 

quality of the data, but they are not requirements. CFR citations using the term “should” are not 

requirements, but the organization is responsible for implementing a procedure that meets the intent of 

the citation. By definition, language in guidance documents is guidance and not a requirement. 

However, guidance documents are companion documents to the CFR and provide the best practices for 

implementation of a program. 

Examples of CFR language and interpretation: 

40 CFR Part 50, Appendix L § 10.14 – “The exposed filter containing the PM2.5 sample shall be reconditioned in the conditioning environment in accordance with the requirements specified in 

section 8.2 of this appendix.” 

This citation from CFR uses the term “shall” and is an example of a requirement that must be 

followed. 

40 CFR Part 58, Appendix E § 3 – “Particulate matter sites should not be located in an unpaved 

area unless there is vegetative ground cover year round, so that the impact of windblown dusts 

will be kept to a minimum.” 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 4 of 105 

This citation from CFR uses the term “should” which emphasizes that it is recommended to 

ensure data quality; however, it is not a requirement. 

CFR Monitoring Requirements 

CFR requirements provide the backbone for all ambient air monitoring networks collecting data for 

comparison to the NAAQS. The specific requirement for conducting TSAs is located in 40 CFR Part 58, 

Appendix A, § 2.5. 40 CFR Parts 50, 53, and 58 provide the formal regulatory requirements for 

implementing and maintaining ambient air monitoring programs and the related quality assurance 

requirements that shall be followed. 

A summary of the content in 40 CFR Parts 50, 53, and 58 is below. 

40 CFR Part 50 – Contains the primary and secondary National Ambient Air Quality Standards 

(NAAQS), Reference Methods for the NAAQS pollutants, and interpretations of the NAAQS. 

40 CFR Part 53 – Contains general provisions, testing procedures, comparability determinations, 

performance testing, and physical design characteristics for reference and equivalent ambient 

air monitoring methods. Much of Part 53 contains manufacturing specifications for vendors; 

however, configuration specifications for ambient monitoring are also included. Monitoring 

organizations must ensure that the configuration for each analyzer meets the requirements of 

Part 53. 

40 CFR Part 58 – Contains general provisions, monitoring network requirements, special 

purpose provisions, NAAQS comparability, data reporting, federal monitoring, and quality 

assurance for ambient air quality monitoring. 

Direction in 40 CFR Parts 50, 53, and 58 must be followed by the monitoring organizations. All audit staff 

members should be well versed in these CFR requirements before conducting a TSA. The CFR references 

listed above encompass the majority of the requirements for ambient air monitoring; however, other 

relevant CFR references may be applicable. The CFR requirements can be viewed and downloaded from 

the Internet4

. 

PQAO Quality Assurance Project Plans (QAPP) 

Each PQAO conducting ambient air monitoring for NAAQS compliance must develop a QAPP for each of 

its ambient air monitoring programs. The QAPP is an essential and required component of the quality 

system and is defined in 40 CFR Part 58, § 2.1.2. The section states: 

The QAPP is a formal document describing, in sufficient detail, the quality system that must be 

implemented to ensure that the results of work performed will satisfy the stated objectives. 

PQAOs must develop QAPPs that describe how the organization intends to control measurement 

uncertainty to an appropriate level in order to achieve the data quality objectives for the EDO 

(Environmental Data Operations). The quality assurance policy of the EPA requires every EDO to 

4 www.ecfr.gov 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 5 of 105 

have a written and approved QAPP prior to the start of the EDO. It is the responsibility of the 

PQAO/monitoring organization to adhere to this policy. The QAPP must be suitably documented 

in accordance with EPA requirements (reference 3 of this appendix) and include standard 

operating procedures for all EDOs either within the document or by appropriate reference. The 

QAPP must identify each PQAO operating monitors under the QAPP as well as generally identify 

the sites and monitors to which it is applicable either within the document or by appropriate 

reference. The QAPP submission and approval dates must be reported to AQS either by the 

monitoring organization or the EPA Region. 

The QAPPs must illustrate how a monitoring organization will meet all regulatory requirements 

described in 40 CFR Parts 50, 53 and 58. In addition, the monitoring organization should attempt to 

conform to the recommendations in the QA Handbook unless an alternative is proposed that produces 

data of acceptable quality (as described in the regulation and the QA Handbook). A QAPP may include 

requirements that are more stringent than regulatory requirements, but it cannot be less stringent. Each 

PQAO is responsible for developing the QAPPs and submitting them to an approving authority, which is 

typically the EPA RO. QAPPs should also be updated annually, but minimally every five years, to reflect 

regulatory and/or organizational changes within the monitoring organization, and approval dates must 

be reported to AQS. 

The QAPP is a written commitment between the approving authority and the monitoring organization 

that the plan will be implemented and followed in the monitoring organization. As such, the EPA QA 

staff must review the QAPPs during the TSA to determine if the monitoring organization has adhered to 

these commitments. 

Guidance Documents 

Guidance documents present best practices for methods, interpretation of regulatory language, data 

quality and defensibility recommendations, or other information for implementing or clarifying CFR. It is 

important to note that guidance does not overrule CFR requirements. Guidance documents should 

accurately reflect CFR requirements; however, it is good practice to verify guidance against CFR. If 

discrepancies are found between the two, the auditor must always follow CFR direction. Guidance 

documents may be written in the following forms including: 

• Quality Assurance Guidance Documents 

• Technical Assistance Documents 

• Technical Memoranda 

• Newsletters 

The QA Handbook for Air Pollution Measurement Systems, Volume II is a guidance document designed to 

ensure that the Ambient Air Quality Surveillance Program: (1) provides data of sufficient quality to meet 

the program’s objectives, and (2) is implemented consistently across the nation. The QA Handbook is a 

one-stop source of quality assurance/control, network, sampling, and data handling information. The QA 

Handbook also contains a list of other key guidance documents located within its Appendix B (Ambient 
 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 6 of 105 

Air Monitoring Quality Assurance Information and Web Addresses). These guidance documents provide 

additional detail and summarize CFR requirements. TSA staff should be familiar with these documents 

before conducting a TSA. 

The CFR is routinely revised over time as regulations are changed or sections are updated. In some 

cases, the CFR may change but related guidance documents may be delayed or not updated at all. 

Auditors must exercise caution when reviewing CFR or guidance documents to ensure the correct 

revisions are being referenced. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 7 of 105 

2.0 Technical Systems Audit Objectives 

The primary objective of a TSA is to assess the suitability and effectiveness of the quality system being 

implemented on behalf of EPA. For data collected for comparison to a NAAQS, the assessment of the 

quality system includes investigating whether such data meet the established regulations to be used for 

decision-making purposes. Decision makers require data that is of adequate quality, is defensible, and 

that can stand up to public and legal scrutiny. TSAs are also an opportunity for the monitoring 

organization and EPA to collaborate and address findings and vulnerabilities in the organization’s quality 

system and data. Cooperation between the monitoring organizations and EPA is an essential component 

in conducting a successful audit. This document provides guidance on how to conduct the TSA and 

includes tools for an auditor to use to assess various areas of the ambient air monitoring program. 

Because of limited time and resources, it is not reasonable to expect that a TSA will uncover and address 

every data quality issue, quality system weakness, or programmatic issue; however, a properly 

conducted TSA will provide a thorough overview of the data quality of the network and a gauge of the 

effectiveness of the quality system. If a TSA uncovers a weakness that results in the flagging or 

invalidation of significant amounts of data, the quality system is compromised. For example, a large 

amount of data from PM2.5 sampling is invalidated because method criteria are not followed. The quality 

system should document a data review process that ensures method criteria are met as well as 

provisions for training staff. If staff do not understand the method, and data review does not identify 

the problem, then there are significant weaknesses in the quality system. The TSA should identify these 

weaknesses and trigger a corrective action process to strengthen the organization’s quality system, 

thereby bolstering the quality and defensibility of the data. 

TSAs are required to be completed every three years for PQAOs and are recommended every six years 

for monitoring organizations within the PQAO; however, these audits are only one component of a 

much larger quality assurance system. Monitoring organizations, EPA Regional Offices, and EPA 

Headquarters (OAQPS) should be assessing the monitoring data against the regulations and methods on 

a routine basis to ensure enough quality data is collected for decision-making purposes. A TSA by itself 

every three or six years is not enough to ensure data quality. 

Scope 

A TSA should focus on the broad picture of the monitoring organization as a whole. While there may be 

many elements of a TSA, there should be a balance in assessing the quality of the monitoring data 

collected and reported by an organization. Monitoring organizations may have the following common 

functional areas that should be investigated during a TSA: 

• Monitoring Headquarters 

• Maintenance and Repair Shop 

• Monitoring Data Review and Validation Group 

• Quality Assurance Team 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 8 of 105 

• Analytical Laboratories 

• AQS Submittal Group 

• Ambient Air Monitoring Sites 

The areas listed above comprise the core of an ambient air monitoring network that should be included 

in a TSA. If too much time or resources are devoted to one pollutant or area of the organization, other 

important areas in the monitoring program may not be assessed properly, giving an incomplete picture 

of the quality of an organization’s data. An incomplete TSA has the potential to leave an organization’s 

monitoring data vulnerable. There may be situations where more emphasis in some areas may be 

needed to address current priorities; however, this should not be used as a rationale to omit other parts 

of the monitoring organization. A TSA is not solely a data review, document review, or a series of 

performance evaluations; rather, it is a conglomerate of activities that should verify that an organization 

has met its overall quality system requirements, as dictated by CFR and the organization’s QA 

documents (QMP, QAPP, SOPs), and has produced, and is producing, quality data. 

Resources 

TSAs are resource-intensive. Monitoring organizations differ in size and complexity, and each present 

unique challenges for auditors. Various types of resources are required to conduct an effective TSA 

regardless of complexity. A small local agency may require only a few months to prepare, audit, report 

and follow-up on corrective action, while a large organization may require much longer to complete. 

An important point when discussing resources and TSAs is that the audit is not complete when a final 

report is written. Follow-up and corrective action for an organization can take significantly more 

resources to complete than the preparatory work, on-site activities, and report generation. If resources 

are omitted for the follow-up, it is realistic to assume that corrective action within the organization may 

show minimal progress and the same findings will appear in the next audit with no significant progress. 

For this reason, the follow-up could arguably be the most important component of the audit process, 

and it should not be overlooked or understated. 

The TSA may be the only time the auditors routinely visit the physical location of the monitoring 

organization and have the opportunity to observe the actual practices that occur. For this reason, it is 

important to ensure that the auditors have every resource available on hand. Items listed and described 

in the following sections are required when conducting a TSA. The appendices of this document also 

contain example checklists and templates that may assist the audit team. 

2.2.1 Staffing 

Trained staff is a necessity to conduct an effective TSA. Staff participating in TSAs should have applicable 

program knowledge and technical knowledge of ambient air monitoring programs. For each TSA, a team 

of auditors is highly recommended that, as a group, contains the knowledge and skills needed to address 

the different areas of an organization and the monitoring network. Too few staff or staff without the 

appropriate expertise can result in an audit where data quality issues are overlooked. More information 

regarding staffing assignments and requirements for an audit are detailed in Section 4.2 of this QAGD. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 9 of 105 

2.2.2 Funding 

Funding is a key resource in conducting complete and effective TSAs. NAAQS monitoring programs 

within a PQAO that are operated for compliance purposes are required to be audited by 40 CFR Part 58 

Appendix A. While TSAs primarily focus on these NAAQS programs, PQAOs generally have other nonregulatory monitoring programs, such as air toxics or PM2.5 Chemical Speciation, that should be included 

in the TSA. The EPA Regional Office should provide funding to cover all NAAQS programs, at a minimum, 

and all non-regulatory programs should be included in the TSA if possible. Regional Offices should 

consider the size and scope of the organization when allocating funding for TSAs. Inadequate funding 

and resources can result in an audit that is conducted at a level where issues and trends within a PQAO 

are not identified, leading to potentially large issues at the organization in the future. It is important to 

have an overview of the PQAOs and the scope of the audit to be conducted prior to allocating funds for 

the TSAs. 

Very simply, if adequate funding is not available to provide equipment, transportation, and to keep the 

auditors on site for as much time as needed to audit the monitoring organization, the quality of the TSA 

will suffer and important components of the audit may be rushed or omitted, resulting in a poor or 

incomplete audit. Costs to consider may include: 

• Hotel reservations 

• Per diem 

• Airline flights 

• Rental cars 

• Fuel 

• Cameras 

• Computers 

• Field equipment (range finders, inclinometers, measuring tapes, etc) 

2.2.3 Time 

Time is a critical resource that must be considered for each audit independently. No two monitoring 

organizations are alike, therefore, each organization will require different amounts of time to complete 

an audit. When planning, it is essential to consider the size and scope of the organization that is being 

audited in order to determine what is required. 

It is also very important to understand that a TSA encompasses much more than the on-site audit itself. 

Weeks, up to months, may be devoted to the review of an organization and its monitoring data prior to 

arriving on-site. By the same token, upon completion of the on-site visit, more time will be required to 

review the audit notes, make decisions, and write a report. Finally, follow-up on corrective action can be 

difficult to project and can range from a couple months to over a year depending on the audit findings. A 

TSA is a much lengthier process than a week of travel on a calendar may seem to represent. 

2.2.4 Tools and Resources 

A variety of tools and resources are required to complete a TSA. AQS monitoring data, quarterly data 

reviews, and field equipment should be available to the auditors to assist in preparing for and 
 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 10 of 105 

conducting the TSAs. Each audit will require all or many of these tools to complete the various 

components of the audit. Without these tools and resources, the auditors will not be able to accurately 

assess all components of the monitoring organization. Some of the most common tools and resources 

that should be available to the audit team are described below, but depending on the monitoring 

organization, other resources may be required. 

Air Quality System (AQS) 

AQS is the electronic database maintained by OAQPS as a repository for all ambient air monitoring 

network metadata and monitoring data submitted by monitoring organizations. The data housed in AQS 

includes: 

• Monitoring data 

• Site metadata 

• Network metadata 

• QA/QC data 

• Data submission histories 

AQS is designed to receive uploaded transactions, organize data, and store information for various 

internal and external data assessments. AQS itself provides standard reports for extracting a variety of 

information from raw data to quality assurance reports. These reports can help the auditor organize and 

sort data efficiently in preparation for an audit. Several pertinent AQS standard reports are listed in 

Section 4.4.1 of this QAGD that are helpful in preparing for a TSA. 

Extracted raw data from AQS can also be a resource and used to generate valuable assessments of data 

for external analysis outside of the standard AQS reports. Data handling programs, such as those 

available on AMTIC5

, can be used to create reports to compile and filter data that AQS currently cannot 

report. The AQS reports and assessments of raw data should help highlight areas such as data 

completeness, timeliness of data submission, and precision and accuracy acceptability when preparing 

for TSAs. Furthermore, routine data assessment and analysis is essential to limit large amounts of data 

loss from quality issues. 

Quarterly Data Reviews 

According to Section 2.4.3 of the FY16-17 OAR National Program Manager Guidance6

, EPA Regional 

Office staff should already be reviewing AQS data quarterly. Auditors should have these reviews 

available as a resource for the TSA. These reports are a snapshot of the organization’s monitoring 

network and can identify problems which direct the focus of the TSA. Quarterly reviews can also limit 

the amount of data that could be impacted by quality issues and can help initiate corrective action 

before a TSA. As a warning, quarterly reviews will only include extracts and reports from data that 

5 https://www3.epa.gov/ttn/amtic/qareport.html 

6 https://www.epa.gov/planandbudget/national-program-manager-guidances 
 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 11 of 105 

resides in AQS, so many checks and/or datasets that are not required to be submitted to AQS will not be 

accessible for review. As a practice, it is unacceptable for data review to only occur every three years as 

a part of the TSA. Data review should be completed on a much more frequent basis. 

Field Equipment 

Auditing ambient air monitoring sites is a major component of any TSA, and it is important to have field 

equipment on-hand and properly maintained to support these activities. Assessing monitoring sites may 

require specialized measuring devices such as laser range finders and inclinometers for measuring 

distances and heights of obstructions. These devices, and others like them, require routine service to 

function properly and should be maintained so that they are ready for use at all times. Although not a 

core activity of the TSA, performance audits may be conducted in conjunction with the TSA. These types 

of audit equipment are more expensive, require a high level of expertise and training, and must be 

operated according to a set procedure and regulatory requirements. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 12 of 105 

3.0 Roles and Responsibilities 

EPA Regions 

The EPA Regions bear the majority of the TSA responsibilities and must have trained staff, resources, and 

expertise to conduct TSAs effectively and on schedule. Furthermore, the EPA Regional Offices are 

responsible for the oversight of all TSA corrective action activities and should have the resources to 

follow up with the monitoring organizations to complete these actions. In the event that significant 

findings arise in a TSA, the EPA Regions are also responsible for communicating these findings to 

OAQPS to determine what affect the issues will have on designation decisions. More information about 

elevating audit findings can be found in Section 8 of this QAGD. 

As a whole, EPA Regional Office responsibilities for TSAs generally will include: 

• Identifying PQAOs and monitoring organizations within the region 

• Setting a TSA schedule for the PQAOs and monitoring organizations within a PQAO 

• Conducting the TSAs 

• Completing and reviewing the TSA reports 

• Following up on corrective action 

• Submitting TSA audit and close-out dates to AQS 

• Informing OAQPS when audit findings could effect a significant amount of data 

Ideally, and as staffing allows, the audit staff who conduct TSAs will be independent from the 

program/monitoring staff who are responsible for the NAAQS regulatory determinations. The EPA QA 

staff should have extensive expertise in both quality assurance and ambient air monitoring. To augment 

the audit team, the QA staff may request for other groups within EPA to participate and play a role in 

the audit, such as database experts, programmers, or other technical experts. These groups have the 

responsibility to answer questions and support the QA staff as requested. 

The EPA QA staff will also have the primary role of ensuring that the corrective actions required to 

resolve issues found in a TSA are on track and are sufficient to address the audit findings. In 

coordination with the QA staff, program and grants staff from the Regional Office may also have a role 

in ensuring that corrective action is completed. Corrective action may require a concerted effort in some 

cases to affect change within an organization and these different groups together may be more effective 

towards that end. 

Office of Air Quality Planning and Standards (OAQPS) 

OAQPS’s role in the TSA process is to support the EPA Quality System by developing quality assurance 

policy in the CFR, promoting consistency by developing guidance, aiding in implementing the quality 

assurance policy, and acting as an arbiter for the EPA Regions in resolving issues related to data quality. 

OAQPS provides the backstop for the EPA Regions in supporting decisions made regionally, but OAQPS 

also ensures that a message and/or decision is consistently communicated to all regions. The EPA 

Regions have the responsibility to communicate any issues discovered in TSAs that may have an impact 
 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 13 of 105 

on NAAQS design values to OAQPS, and OAQPS has the responsibility to communicate these issues to 

the QA and policy staff to determine the impact on regulatory decision-making. 

Consistency is an important priority in OAQPS’s role in the TSA process. It is OAQPS’s goal that all 

monitoring organizations are treated equally and fairly during a TSA. OAQPS provides direction in the 

form of guidance and interpretation of CFR to help ensure that regional audit staff are using the same 

guidance to make decisions. Consistency in invalidating data, flagging data, or recognizing improvements 

or achievements in an organization is an important and essential component in conducting an effective 

and fair audit program. 

In accordance with 40 CFR Part 58, Appendix A, §1.2.3, EPA reserves the authority according to “use or 

not use” monitoring data when making regulatory decisions based on the assessment of data quality. 

Therefore, issues that are uncovered during TSAs that have the potential to impact NAAQS attainment 

or other important decisions should be discussed between OAQPS and the EPA Regions so that decisions 

are consistent across the nation. 

Contractors 

Contractors may be used in conducting TSAs according to the EPA Quality Manual for Environmental 

Programs (CIO 2105-P-01-0). Section 2.2.2.7 of the Quality Manual discusses discretionary functions 

that may be performed by non-EPA personnel. The citation is below: 

Discretionary functions that may be performed by either EPA personnel or non-EPA personnel 

include: 

Performing technical assessments of environmental data producing activities, both intramural 

and extramural (on-site and off-site) according to a specific plan approved by the QAM. 

Preparations for such assessments may include the acquisition or development of audit materials 

and standards. Results (findings) are summarized, substantiated, and presented to the QAM or 

authorized EPA representative. 

A determination of whether an authorized Agency representative should accompany a 

contractor’s personnel should be made on a case-by-case basis only after coordination between 

the responsible organization and contracting officer. Such coordination should include 

consideration of the purpose of the accompaniment and clear definition of the Agency 

representative’s role and responsibility during the contractor’s performance of the audit or 

technical assessment to avoid the appearance of a personal services relationship. 

First and foremost, if a contractor is used for a TSA, there must be a specific plan that is approved by the 

Quality Assurance Manager. Next, the manual indicates that “A determination of whether an authorized 

Agency representative should accompany a contractor’s personnel should be made on a case-by-case 

basis only after coordination between the responsible organization and contracting officer.” In all cases 

where contractors are used to assist in completing TSAs for NAAQS compliance, the contractor must be 

under the guidance of the EPA audit lead. 
 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 14 of 105 

EPA Regions are expected to have the expertise and resources in-house to conduct TSAs without the 

need for a contractor. However, contractors may be utilized to add a level of expertise that is missing 

from an EPA audit team, but they should not be used to lead the audit. If contractors are added to an 

audit team, the region retaining the contractors must ensure, prior to the audit, that there are no 

conflicts of interest. If a region uses a contractor to add a level of expertise that is missing within the EPA 

audit team, the region should shadow the contractors to gain expertise during the audit so that they 

may be able to perform that function independently in the future. 
 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 15 of 105 

4.0 Pre-Audit Activities 

EPA Regional Office staff will begin preparing for the on-site TSA three or more months in advance of 

the on-site visit. Preparations include such activities as scheduling the TSA, assigning staff members to 

participate in the TSA, and outreaching to the monitoring organization to confirm the TSA schedule and 

audit plans. However, in addition to travel plans, the audit team will spend many hours reviewing the 

monitoring organization’s network configuration, programs, and quality system documentation, in 

addition to reviewing and analyzing the organization’s data in AQS. This section describes in detail the 

pre-audit activities of the TSA process. The following flow chart (Figure 4.1) provides a visual summary of 

these pre-audit steps and the timelines that the audit team should follow, which will be discussed in 

more detail throughout this section. 

Figure 4.1 TSA Pre-Audit Activities Flow Chart 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 16 of 105 

EPA Regional Office TSA Scheduling 

As previously discussed in Section 1.2 of this QAGD, 40 CFR Part 58, Appendix A, § 2.5 requires TSAs of 

each PQAO to be conducted by the appropriate EPA Regional Office every three years. TSAs of the 

monitoring organizations operating under the oversight of a larger PQAO should be audited every 6 

years. Each EPA Regional Office has multiple PQAOs within its jurisdiction. However, the number of 

PQAOs, and subsequently, TSAs, varies by EPA Region; larger EPA Regions typically have more TSAs to 

conduct over the course of the 3-year or 6-year period. With that in mind, each EPA Regional Office will 

have a unique process regarding how it plans, prioritizes, schedules, and tracks the multiple TSAs it is 

required to perform. Each EPA Regional Office is encouraged to develop an SOP that describes and 

formalizes this process. 

For planning purposes, it is suggested that each EPA Regional Office prepare a schedule at the beginning 

of each fiscal year (FY), identifying those monitoring organizations requiring a TSA during the FY, and 

establishing the tentative dates/time frames as to when these audits may occur. For example, the 

schedule may specify the month of each audit, but leave the specific dates open for discussion and 

coordination between the Regional Office and the monitoring organization. Another approach may be 

that a specific week is tentatively selected for each TSA. Regardless of the scheduling method, it is 

recommended that the EPA Regional Office share the tentative FY schedule with the monitoring 

organizations as soon as it is formulated, so that all PQAOs have been given notice of their upcoming 

TSAs. 

4.1.1 Assigning the Audit Team 

At the time when the yearly EPA Regional Office TSA schedule is formulated, it is recommended that one 

QA staff member be assigned the role of lead auditor (project lead) for each TSA. The TSA lead auditor 

will be responsible for leading and managing the specific TSA (project) throughout its duration, from the 

initial, pre-audit planning stages through close-out of the TSA after all corrective action measures have 

been completed. As a best practice, the EPA Regional Office should rotate the assignments of audit lead, 

so that the same monitoring organization does not have the same lead auditor multiple TSAs in a row. 

The rotation of lead is recommended because it eliminates biases, as well as provides the opportunity 

for a “new set of eyes” to review the organization’s quality system. Similarly, the practice of lead 

rotation is a way of building the skill set and experience of the EPA RO QA staff – because each team 

member, over time, will be afforded the opportunity to audit each PQAO – and each PQAO has its own 

unique circumstances from which the auditor will learn and grow. 

Another important element in TSA planning includes assembling an audit team to support the lead 

auditor and assist with conducting the TSA. As stated previously in Section 2.2.1 of this QAGD, the best 

practice for conducting a TSA is to assemble a team of QA staff members, ideally a group with expertise 

in various facets of the monitoring program. Although TSAs are resource-intensive, the benefits of 

assigning an audit team to conduct the TSAs should outweigh the associated costs. Benefits of an audit 

team include the following: 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 17 of 105 

•	 Assembling a team of auditors will provide a larger knowledge base during the on-site TSA, 

which should result in a more thorough and accurate audit. 

•	 Allows for non-conformances to be witnessed, assessed, and documented by more than one 

EPA auditor. (Note: A non-conformance, in general terms, is a failure to comply with a required 

standard, such as a procedure formalized in an SOP.) 

•	 A team can cover more aspects of the monitoring program during the TSA in less time, which 

promotes efficiency. For example, if the audit team consists of 4 staff members, two members 

could audit field sites while the other 2 staff members simultaneously audit records in the 

central office. 

•	 Provides the opportunity for immediate collaboration on site, which results in more efficient 

and accurate assessments of non-conformances. 

o	 The inefficiencies associated with having to call and/or email another EPA staff member 

during a TSA, and potentially wait for a response, are minimized. 

o	 Similarly, with other staff members available for consultation, the lead auditor will 

spend less time researching subject areas that are not his/her strength, in order to 

determine if the non-conformances identified during the on-site audit are significant. 

•	 Safety measure. Auditors are not traveling long distances or visiting remote field locations alone. 

•	 The TSA itself becomes more manageable for the lead auditor because certain responsibilities 

can be delegated to other teammates. This, in turn, promotes a more focused and successful 

audit. 

•	 Allows the opportunity for a team member(s) to be designated as a scribe. 

o	 Provides the lead auditor more time to focus efforts on conducting the TSA and 

interviewing monitoring organization staff, as opposed to taking notes. 

o	 Usually results in more thorough documentation at the end of the TSA, which should 

help with report writing. 

•	 Allows for multiple EPA auditors to develop a knowledge base about the monitoring 

organization and its quality system, which can carry forward to the next audit (as well as 

potentially assist EPA staff with other job responsibilities). If only one auditor is familiar with an 

organization and that auditor leaves the Agency, then the knowledge gained during the previous 

TSA(s) is lost. 

•	 Provides for a better quality audit overall. For example, when 1 auditor attempts to cover all 

aspects of a TSA in a short amount of time, findings will be missed. This could have huge 

implications for both the audited organization and EPA, especially given the 3 to 6-year time 

period between audits. Therefore, having a second person present during the audit, at a 

minimum, will decrease the chance of missing significant findings. 

At a minimum, each TSA should be assigned 2 team members. For TSAs of large PQAOs – especially 

those organizations which serve as PQAO for multiple smaller organizations – audit teams of 3 or more 

QA staff members may be necessary. The ideal situation would be for audit teams to be evennumbered, so that all auditors could work in pairs. It is acceptable for an audit team of 2 members to 

separate during the TSA and perform certain inspections individually, in order to save time while on site. 

However, the best practice is to work in pairs as much as possible during the TSA. Each auditor will see 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 18 of 105 

things differently, and having two individuals available to observe procedures and review records will 

provide a more thorough assessment, as well as decrease the likelihood of missing significant findings. 

Working in pairs also provides the opportunity for one team member to lead and the other to scribe 

during each phase of the audit. 

Each Regional Office is encouraged to tentatively assign team members for each TSA when formulating 

the FY audit schedule; although, assigning team members to accompany the lead auditor can occur any 

time prior to the TSA. The complexity of the organization scheduled for the audit should be considered 

when assigning the audit team. For example, if the organization has an analytical laboratory for criteria 

lead analysis or NATTS, or if the organization operates a PM10 or PM2.5 gravimetric laboratory, an auditor 

with expertise in those laboratories should be assigned to the team, if possible. During scheduling, team 

members should be appointed with the understanding that assignments are subject to change. 

However, for planning purposes, the ideal situation would be for all staff assigned to a TSA – whether as 

audit lead or as a team member – to know those assignments in advance, so they can immediately mark 

their calendars and begin to plan accordingly. 

Thoroughly conducted TSAs can provide long-term benefits to both the EPA Regional Office and the 

monitoring organization. Although each TSA is different, as a general rule each lead auditor should be 

allowed at least 1 business week to conduct the TSA. Trade-offs between the number of staff 

conducting the TSA versus the amount of time needed to conduct the TSA may need to be considered 

when allocating resources. If the EPA Regional Office can assign only 2 staff members to conduct the 

TSA, those two staff members should be allowed a longer period of time to complete the necessary onsite inspections. 

TSA Planning 

The TSA is a multi-phase project. The first phase of the project involves conducting the TSA – which is 

accomplished through audit planning in the office, followed by the on-site investigation, and culminates 

with the generation of a TSA report. This phase of the project is completed solely by the EPA Regional 

Office audit team. The second phase of the project involves corrective actions – which will be completed 

by the monitoring organization (i.e., auditee). During the second phase of the project, it is the EPA 

Regional Office’s responsibility to remain engaged with the auditee and communicate regularly, in order 

to oversee and track the progress of the corrective actions. This communication and oversight should 

continue until the issues identified in the TSA report are successfully resolved, at which time the TSA 

itself is “closed out”. With that in mind, the TSA is a major undertaking that will take months to 

complete. 

The EPA staff member assigned to lead the TSA is charged with ensuring that the audit is conducted as 

efficiently and effectively as possible. Towards that end, the lead auditor must dedicate a significant 

amount of time to pre-audit planning activities, in order to formulate the specific audit itinerary, as well 

as determine who on the audit team will conduct specific tasks. The lead auditor is also the primary 

decision maker and point-of-contact for the overall project. To complete these responsibilities, the lead 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 19 of 105 

auditor manages the TSA, but also leads the audit team, providing guidance and delegating 

responsibilities as appropriate. 

Preparation for an individual TSA should begin at least three months prior to the on-site visit of the air 

monitoring organization. During the initial planning stages, the lead auditor should determine the 

approximate length of the on-site audit (i.e., number of days), which laboratories and/or facilities will be 

audited, as well as which specific monitoring stations will be inspected in the field. The size of the team 

and the number of days allotted are critical factors that must be taken into consideration when planning 

the individual TSA; previous audit findings should also be considered because on-site follow-up on 

some issues may be warranted. The following will describe the general process that occurs “behind the 

scenes” to formulate an efficient audit plan. Activities include: 

• Basic information gathering (pre-planning) 

• Contact and coordination efforts with the auditee 

• Formulating the specific audit plan 

• Audit plan submittal to auditee 

4.2.1 Basic Information Gathering (Pre-Planning) 

To begin planning the audit, the TSA lead auditor should first clarify the scope of the specific TSA by 

asking three basic questions: 

• What aspects of the monitoring program will be covered during the on-site visit? 

• What time period is under review? 

• What issues were identified during the last TSA? 

To answer these questions, the lead auditor should become familiar with the size and composition of 

the monitoring organization’s air monitoring network and facilities. The monitoring organization’s last 

EPA TSA report should also be reviewed. 

The time period under review for the TSA can be defined quickly. The previous EPA TSA report should 

identify the 3-year time period reviewed (e.g., calendar year (CY) 2011-2013). From that, the lead 

auditor can project forward to the next 3-year block of time (e.g., CY 2014-2016). If the previous TSA 

report did not clearly state the time period audited, the lead auditor can review data and records 

maintained in the TSA’s project file in order to determine the years covered. (Note: The time period 

under review should be clearly stated within the TSA report; see Section 6 of this QAGD for more 

information. Section 6 also contains information about project files.) Ideally, the TSA should cover the 

previous 3 calendar years in their entirety, such that the auditor can review 3 years of certified data (for 

criteria pollutants). However, depending on scheduling, if the TSA falls before May 1, then the 

monitoring organization may not have completed their certification process for the previous year’s data. 

TSAs can be conducted any time, so audits conducted early in the calendar year are acceptable – 

however, in these instances, the lead auditor must remain cognizant during the TSA that the monitoring 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 20 of 105 

organization’s final data validation and reporting processes may not be complete. If the audit is a followup audit, the time period under review may be limited to only 1 -2 years. 

Note: Follow-up audits are typically conducted when a TSA reveals major issues within an organization 

that result in the need for increased EPA oversight during the corrective action phase of the project. 

Planning for a follow-up audit adheres to the same principles as described in this section of the QAGD, 

except that the time period under review is reduced, and the focus-areas of the audit are driven primarily 

by the findings from the recent TSA. 

The monitoring organization’s Annual Monitoring Network Plan (AMNP) is a good document to 

reference regarding the composition of the monitoring network, and may contain much of the 

information needed for strategy planning. The organization’s website may contain charts or maps of the 

air monitoring network’s sites/locations. The website may also contain an organizational chart, which 

may highlight any district or regional offices that may need to be visited during the TSA. 

Focusing on the field component of the monitoring program, the auditor should identify the number and 

types of monitoring stations the organization operates, the specific pollutants monitored, as well as any 

special programs it may participate in. The auditor should be aware of which monitors are considered 

SLAMS or SPMS, as well as which monitors are designated as regulatory or non-regulatory. Examples of 

special programs to be cognizant of include NCORE, Near-Road, NATTS, UATMP, CSN/IMPROVE, and 

PAMS. However, the auditor should also be aware of the monitoring program’s centralized facilities. 

With that in mind, the auditor should determine whether or not the monitoring organization operates 

any of the following laboratories, and consider the physical location (i.e., address) of each when 

planning the audit. 

 PM2.5 and/or low-volume PM10 gravimetric laboratory 

 Hi-volume PM10 gravimetric laboratory 

 Lead laboratory 

 CSN laboratory 

 Toxics laboratory 

 PAMS laboratory 

 Instrument maintenance and repair facility (“shop”) 

 Testing/Standards/Certification facility (“QA lab/shop”) 

The lead auditor should also investigate whether or not the monitoring organization outsources any of 

its monitoring activities, such as laboratory services, when planning the TSA. Although the monitoring 

organization is asked questions about outsourcing in the TSA Questionnaire (see Appendix A of this 

QAGD), it is best to know the answers in advance for planning purposes. For example, if the monitoring 

organization’s laboratory services are fulfilled by the EPA’s National Contract Laboratory, and that 

laboratory is audited by EPA Headquarters (or its contractors), then the Regional Office auditors may not 

need to perform this audit directly. Instead, the lead auditor may be able to accompany the headquarter 

auditors/contractors and serve as a witness to their audit. At a minimum, the lead auditor should obtain 

copies of and read any previously-issued EPA audit reports of the contract lab, in order to become 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 21 of 105 

familiar with their operations and be aware of the documented areas of concern. Also, knowing in 

advance that the organization contracts its PM2.5 analyses to a laboratory in another state, for example, 

helps the auditor focus the audit plan: the gravimetric analysis of filters will not be directly assessed 

during the TSA, but the auditor knows time will have to be allotted to review the organization’s 

shipping/receiving activities, as well as its data validation procedures. It may also be prudent, in this 

instance, for the lead auditor to request copies of the contract laboratory’s QAPP and SOPs from the 

monitoring organization – in order to ensure that the monitoring organization has these documents in 

their possession and is well versed in their content. 

The previous TSA report is also a good document to review to provide insight into the organization’s 

structure and facilities, such as its laboratories, off-site shops/facilities, regional/district offices, and/or 

other local monitoring organizations operating within the PQAO. The previous TSA report can provide 

insight into former problem areas that the lead auditor may want to follow-up on while on site, in order 

to verify the success of the corrective action measures implemented. The previous TSA report can also 

identify areas that were not reviewed during the last audit, which may result in the need for the auditor 

to focus efforts on those specific areas during the current TSA. For example, if the previous TSA report 

indicated that the only field inspection conducted was that of a proposed location for a new monitoring 

site, then the lead auditor may decide that several air monitoring site inspections should be conducted 

during the current TSA. Another example: If the previous TSA report indicated that the air toxics 

network was not reviewed due to resource limitations, the lead auditor may decide to put more 

resources towards air toxics in the current TSA, so that that component of the monitoring organization’s 

network is not overlooked two TSAs in a row. Furthermore, the prior TSA report and corrective action 

follow-up will identify the findings that were not resolved and direct focus to these areas for the current 

TSA. 

After completing this basic research, the lead auditor should outreach to the monitoring organization to 

officially begin coordination efforts. 

4.2.2 Initial Contact with the Monitoring Organization 

In order to best facilitate coordination efforts for the on-site TSA, the lead auditor should establish 

communications with the monitoring organization (i.e., auditee) early in the planning process. The lead 

auditor should complete the basic information gathering described above first, in order to have a “rough 

draft” of the plan available to discuss with the organization’s contact. It will also give the lead auditor a 

rudimentary knowledge of the monitoring organization, which may help the auditor ask more informed 

questions during the initial discussion. 

The lead auditor should contact the appropriate individual at the monitoring organization (typically the 

monitoring network’s program manager or Quality Assurance Officer (QAO)) for this introductory call 

approximately 3 months (~90 calendar days) prior to the scheduled visit. It is recommended that the 

initial contact be made by telephone in order to more readily exchange information. During this 

conversation, the auditor should offer introductions about himself and the TSA process. The lead auditor 

should also use this opportunity to confirm that the dates initially selected to conduct the on-site TSA 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 22 of 105 

are agreeable to the auditee. If there are conflicts, the lead auditor should discuss these concerns and 

work out an alternate schedule. (The auditor will need to follow-up with EPA Regional Office 

management about this scheduling change after the call.) If the tentatively scheduled dates had not 

been previously shared with the monitoring organization, then this telephone call is needed to establish 

the specific dates for the on-site TSA. 

During the call, the lead auditor can learn whether there have been significant changes within the 

monitoring organization since the last TSA, such as key personnel changes, changes in physical addresses 

of specific facilities, or the outsourcing of any field or laboratory operations, among others. The lead 

auditor should inquire at this time about the appropriate points of contact for arranging air monitoring 

station inspections and laboratory audits. For example, the monitoring organization may prefer the 

individual site operators be contacted directly to schedule air monitoring station inspections. Similarly, 

laboratories may be located off-site and operated under a different management structure. 

The lead auditor should also request specific information or documents needed to complete audit 

preparation, if such information and documents are not readily available at the EPA Regional Office. 

Requests may include items such as: 

•	 A listing/map of field monitor locations (sites) 

•	 Organizational chart(s) 

•	 The organization’s QMP 

•	 All QAPPs relevant to the time period under review 

•	 All SOPs relevant to the time period under review 

•	 QAPPs and SOPs utilized by contractors who provide services for the organization 

•	 Copies of any waivers granted to the monitoring organization that should be taken into 

consideration 

Note: Some of this requested information may be available on the monitoring organization’s website – 

web-addresses or hyperlinks should be obtained, if the lead auditor doesn’t already have access. 

The conversation should also include a discussion about the TSA questionnaire that will be provided 

to the auditee following the phone call. The lead auditor should explain its purpose to the auditee, and 

a deadline for the return of the completed questionnaire should be established. At a minimum, the 

questionnaire should be returned to the lead auditor one month prior to the scheduled on-site visit. 

This is necessary in order to allow the lead auditor (and audit team) a sufficient amount of time to 

review the monitoring organization’s responses. 

Finally, the lead auditor should explain to the auditee that all of the information provided will be further 

reviewed in order to formulate a more specific audit itinerary. The refined audit plan will be provided 

to the auditee approximately one month prior to the on-site TSA. By sharing the specific audit plan in 

advance, the monitoring organization can review the itinerary and alert the auditor to any known 

conflicts. In this manner, the monitoring organization can also make arrangements to ensure necessary 

personnel are available on specific days to better facilitate the audit. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 23 of 105 

Following this conversation, the lead auditor should summarize the discussion in an email (or similar), 

recapping the scheduled date of the on-site audit and the date agreed upon for the return of the 

completed questionnaire. The lead auditor should document the request for specific documents (QAPPs, 

SOP, etc) in this email as well, requesting the monitoring organization submit them as soon as possible. 

The lead auditor should also attach the EPA Technical Systems Audit Questionnaire (see Appendix A of 

this QAGD) to the email. It is suggested that the lead auditor copy the audit team members on this 

correspondence, to facilitate information sharing, as well as keep the audit team informed of audit plan 

development. 

4.2.3 Refining the Audit Strategy 

After the lead auditor has completed basic information gathering and talked to the monitoring 

organization’s designated TSA contact to ask clarifying questions, the complexity of the monitoring 

network should be clear. At this point, the lead auditor can make decisions regarding which aspects of 

the program will be focused on during the TSA, based on the available resources. Generally speaking, 

the regulatory SLAMS monitors should be given highest priority when formulating the audit plan; 

however, the audit should cover as much of the monitoring network as reasonably possible. As stated 

previously, a minimum of 1 week should be allotted for each TSA, which may necessitate weekend 

travel in order to allow the audit team 5 full business days on-site. 

If management has not already assigned the audit team, the lead auditor should make a 

recommendation to management at this time regarding the assignment of team members to assist with 

the audit. Moreover, it is also at this time that the lead auditor may request to management an increase 

in resources (more time or people) because the basic information gathering has shown that the PQAO is 

more expansive or complex than originally thought at the time when the FY audit schedule was 

formulated. The lead auditor should identify to management which program area(s) or facilities cannot 

be audited without additional resources. It is especially important to alert management of any specific 

programs/areas that have not been reviewed for a number of TSAs. The additional resources requested 

may not be available, but the lead auditor should still ensure that management is informed. 

In order to maximize TSA coverage and efficiency during the time-frame that has been allotted to 

conduct the audit, the lead auditor may decide to divide the audit team into smaller groups. Consider 

the following scenarios as examples to illustrate this aspect of audit planning. 

 The lead auditor determines that the monitoring organization is a state PQAO with 16 field 

stations that monitor all criteria pollutants (except for lead) and air toxics. The network includes 

NATTS, NCORE, Near-Road, and PAMS stations. Sites are spread out across the state, such that 

drive times between sites will be formidable. However, all laboratory services are outsourced, 

so there are no analytical or gravimetric laboratories to inspect. The NATTS site is subject to an 

upcoming audit by EPA Headquarters (or its contractors). If the auditor is allowed 5 business 

days to conduct the TSA and the assigned audit team is only 2 members (i.e., the lead auditor 

and a partner), the lead auditor may determine that the air toxics, NATTS, and PAMS sites will 

not be reviewed during the TSA. However, if the lead auditor is allowed 5 business days to 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 24 of 105 

conduct this same audit and provided an audit team of 4 members, then the lead auditor can 

broaden the scope of the audit by formulating a different strategy. For example, the lead 

auditor can divide the audit team into 2 groups of two, with one team auditing the monitoring 

organization’s central office (headquarters) and the other team auditing field sites, including 

SLAMS and non-NATTS air toxic sites. 

 The lead auditor determines that the monitoring organization is a large state PQAO with 5 local 

organizations operating under its jurisdiction. Across this large PQAO network, all 6 criteria 

pollutants are monitored, as well as air toxics, and the organizations participate in NATTS, 

NCORE, and Near-Road programs. All laboratory services for particulates, including lead, are 

conducted in-house, but air toxics analytical services are outsourced. For this audit, the goal 

would be to assess the monitoring network directly maintained by the PQAO, but also to 

evaluate the monitoring organization’s effectiveness as lead PQAO for the multiple 

organizations. If the auditor is allowed 5 business days to conduct the TSA and the assigned 

audit team is only 2 members (i.e., the lead auditor and a partner), the lead auditor may 

determine that the monitoring network is generally too big to audit, given the allotted 

resources. The lead auditor may need to request two weeks to conduct the audit, which may 

still be inadequate. However, if the lead auditor is allowed 5 business days to conduct this same 

audit and provided an audit team of 6 members, then the lead auditor can formulate a different 

strategy that allows for multi-tasking. For example, the lead auditor can divide the audit team 

into 3 groups of two, and the smaller teams can then audit different facets of the program 

simultaneously throughout the business week. One team can audit field sites across the PQAO 

throughout the week, whereas the other two teams can audit the central office and the 

particulate laboratories. As a result, both SLAMS and toxics programs can be reviewed to some 

extent, and the lead auditor can assess the overall effectiveness of the organization as PQAO. 

 The lead auditor determines that the monitoring organization is a small local program which 

serves as its own PQAO. The monitoring network is comprised of 5 SLAMS monitoring stations 

which collect ozone and PM2.5 data. The PQAO participates in no special programs, and it 

outsources its PM2.5 gravimetric analyses to a contract laboratory in another state. In this 

scenario, the lead auditor clearly knows the TSA will cover only NAAQS pollutants. If the auditor 

is allowed 5 business days to conduct the TSA and the assigned audit team is 2 members (i.e., 

the lead auditor and a partner), the auditor can formulate a strategy that reasonably covers this 

entire monitoring network. In fact, after assessing travel times between field sites, the lead 

auditor may determine that only 3 or 4 business days are needed to complete the on-site TSA. 

After prioritizing which programs and facilities will be assessed during the on-site TSA, the lead auditor 

must then decide when and how the following activities will be accomplished, and by whom: 

•	 Entrance Briefing 

•	 Questionnaire Discussion with Auditee 

•	 Monitoring Station (Field) Site Inspections 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 25 of 105 

•	 Laboratory Inspections 

•	 Other Facility Inspections (such as the QA/Standards Lab and Maintenance/Repair shop) 

•	 Review of Standards’ Certification Records 

•	 Data Review 

•	 Exit Briefing 

When planning which days/times these activities will occur, the lead auditor will need to consider 

whether the listed activities will be conducted jointly by the entire audit team, or if certain activities can 

be performed separately by individual member(s) of the team. Towards that end, the lead auditor may 

delegate some activities/inspections to audit team members, ideally based upon their knowledge and 

expertise. For example, team members with expertise in laboratory operations should be assigned to 

audit the analytical and/or gravimetric laboratories. Similarly, team members with expertise in 

instrument operations may be assigned field site inspections, in order to ensure monitoring sites are 

appropriately plumbed and instruments operated in the correct manner. 

4.2.4 Selecting Specific Field Sites to Inspect 

If resources allow, the lead auditor’s goal should be to visit all monitoring stations in the monitoring 

organization’s network. However, if this is not possible, the lead auditor will need to select a percentage 

of sites to inspect that reasonably reflects the composition of the monitoring organization’s network. 

The number of sites to visit will ultimately be determined by the number of days allotted for the audit, 

the size of the audit team, and the physical distances between sites (i.e., travel time). Google MapsTM (or 

similar) can be used to estimate distances and drive times. 

When narrowing down site selection, the lead auditor (or delegated team member) should consider the 

following questions/factors, and prepare a list of targeted sites. The lead auditor may want to consult 

with the audit team when selecting these sites. Generally speaking, the highest priority sites are those 

used for NAAQS regulatory decision-making purposes. The following bullets are listed in the suggested 

order of priority. 

•	 Select sites such that field inspections will include at least one of each type of pollutant
 

monitored by the monitoring organization (particularly the NAAQS pollutants).
 

•	 Select SLAMS sites over SPMS. 

•	 Consider capturing a variety of geographic locations across the network. Avoid centralizing the 

field inspections to one primary location, such as those stations located in closest proximity to 

the organization’s headquarters. 

•	 Consider inspecting sites operated by different site operators. This is especially important when 

the monitoring organization is structured such that site operators are located in different 

district/regional offices which operate under a different management structure. 

•	 Review the previous TSA report to determine which sites were inspected during the last TSA. 

Select different sites from the last audit, unless the previous audit report identified significant 

issues at the site(s) that warrant a repeat visit(s). 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 26 of 105 

•	 Are there any potential planning actions or other decisions (e.g., designations, exceptional 

events) in the next three years that could rely on the data from a specific monitor? If so, it may 

be worth the lead auditor’s time to ensure there are no significant issues with the operations of 

the particular monitor/site. 

•	 Review the monitoring organization’s data in AQS. Do the reports generated raise any concerns 

about the data quality or operations at a specific site? If so, the lead auditor may want to 

consider visiting the specific site to investigate these issues more closely. (Note: The selection of 

site(s) based on AQS data review may not evolve until later in the planning process and, 

resultantly, necessitate subtle changes to the travel itinerary.) 

•	 Consider inspecting newly established sites, in order to verify they are in good working order at 

“start up” and meet 40 CFR Part 58, Appendix E requirements. 

•	 Review the most recent site photographs available, which may be found in the organization’s 

AMNP or possibly from photographs taken during NPAP audits (or similar). Do any sites appear 

to have potential violations of Appendix E siting criteria? If so, these sites may need to be visited 

on the ground in order to take measurements and confirm whether or not siting criteria is met. 

o	 The AMNP may contain precise measurements obtained by the monitoring organization 

during in-house Appendix E evaluations. 

o	 Google EarthTM (or similar) can also be used to view sites aerially and estimate 

measurements from trees and roads, etc. 

•	 Have any sites been granted an EPA waiver (e.g., for siting/Appendix E requirements)? If so, the 

lead auditor may want to visit the site(s) in order to determine if the exception (waiver) is still 

warranted. 

•	 Consider inspecting any site scheduled for shutdown, if possible, in order to evaluate and 

document the site’s final operating conditions. 

•	 Consider visiting the NCore, Near-Road, PAMS, and NATTS monitoring stations, if possible. 

After considering the factors above, the lead auditor should have compiled a list of multiple sites 

targeted for potential inspection. At this point, the lead auditor should review the site locations on a 

map and determine the most logical, efficient travel route, as well as estimate travel times between 

sites. The auditor must also factor in the time needed to complete the field inspections, once on site. 

The field inspection should include the monitoring station’s interior and exterior conditions (see Section 

5 of this QAGD for more information). For planning purposes, the lead auditor should allot 1 hour for 

each site inspection when planning the travel itinerary – at a minimum. More time is recommended per 

site, if possible. With this information in hand, the total amount of time needed to audit the targeted 

site list can be estimated. From this, the lead auditor may determine it is possible to visit all of the sites 

selected. However, the lead auditor may determine that it is not feasible to audit all of the targeted 

sites, given the resources allocated for the audit. In case of the latter, the site list must be further 

prioritized and reduced. 

The size of the audit team is also a critical factor when finalizing the number of sites to inspect. When 

considering team member safety, it is best for auditors to work in pairs and visit the field sites together. 

With that in mind, if the audit team size is limited to 2 people, then the lead auditor has two options to 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 27 of 105 

consider for conducting the field inspections (and, therefore, finalizing the number of sites to audit). 

First, the lead auditor and his/her teammate can travel to the monitoring stations together and conduct 

the site inspections as a team. Under this scenario (and considering the minimum ~1 hour allotted for 

each site), it is suggested that the lead auditor divide the field inspection activities in order to maximize 

coverage in the limited amount of time. For example, one team member can assess the shelter exterior 

and measure probe heights/distances to verify Appendix E siting criteria, while the other team member 

inspects the interior shelter conditions and equipment. The second option would be for the lead auditor 

to stay at the central office while the other team member conducts the site visits (or vice versa), 

provided that the individual auditor inspecting the field sites is accompanied by personnel from the 

monitoring organization. However, under this scenario, the lone auditor should be afforded more time 

at each individual site, so that the site inspections can be completed without haste. The lead auditor 

must consider these two scenarios when determining the number of sites that can be reasonably 

audited, given the amount of time available. Using either approach, the number of sites selected for 

field inspection will be kept to a minimum, because these same individuals remain responsible for 

completing all other facets of the TSA. 

If the audit team consists of more than 2 individuals, however, it may be possible to assign a smaller 

team to separate from the main team and focus all efforts on monitoring station inspections. In this 

manner, the “field team” can travel from site to site and inspect monitoring stations during each day of 

the on-site TSA. Under this scenario, a larger number of sites can be selected for inspection, which will 

provide the audit team a more well-rounded assessment of the organization’s monitoring network and 

field operations. If a field team is assembled that will travel separately throughout the duration of the 

on-site TSA, the lead auditor should appoint one member as “field lead,” responsible for ensuring 

communications with the TSA lead auditor. The lead auditor can delegate the planning of the separate 

travel itinerary to the field lead, if needed. When field inspections will be conducted separately from the 

main audit, additional efforts must be made in advance to coordinate times and availability of site 

operators to ensure site access/entry throughout the course of the week. 

After the selection of field sites has been finalized, the lead auditor (or delegate) should prepare an 

audit logbook to document the field inspections. Although any ledger-style logbook can be used to 

record the auditor’s observations in the field, a logbook prepared specifically for air monitoring site 

inspections, prompting the necessary checks and measurements (both interior and exterior), will ensure 

consistency during the inspections from site to site (and ultimately, from TSA to TSA). Appendix B of this 

QAGD contains an example template that could be used as the basis for a field inspection logbook. The 

auditor can print the template provided in Appendix B for each site selected for inspection. Or, the 

auditor could create a template similar to the one found in Appendix B. It is recommended that the 

auditor print AQS Monitor Description Reports (AMP 390) for each site selected for inspection, so that 

the auditor can verify the accuracy of GPS coordinates, measurements, and other details entered in AQS 

while on site. After printing these templates, it is recommended that the printouts be bound and pagenumbered to form a logbook. 
 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 28 of 105 

4.2.5 Finalized Audit Itinerary 

Once the lead auditor has completed initial planning and developed an itinerary for the TSA, the auditor 

should share that itinerary with the monitoring organization in advance of the on-site audit. It is 

recommended that the finalized audit itinerary be provided to the organization ~ 1 month prior to the 

on-site TSA. Having an agreed upon itinerary with the monitoring organization provides notice and also 

allows the agency to allocate proper time, personnel, and resources towards the upcoming audit. It is 

also recommended that the lead auditor submit the audit plan to the monitoring organization in writing 

– via email or in a more formal format. The following tables give examples of audit plans for two 

different monitoring organizations, for illustration purposes. 

Example 1: Local PQAO, Audit team of 2 

Date Activity Time 

Day 1 Entrance Briefing; 

Questionnaire Discussion; 

General Tour of Facilities; 

PM10 Gravimetric Laboratory 

9 am 

Estimate lab audit in the PM 

Day 2 Monitoring Site Visits: 

Sites ID #s A & B 

8:30am – 5:00 pm 

Day 3 Certification Records Review; 

Data Review 

8:30am – 5:00pm 

Day 4 Exit Briefing 9am 

Example 2: State PQAO, Audit team of 6, with 2 teams traveling separately. Two audit 

itineraries developed to reflect the activities of the two teams.
 

CENTRAL OFFICE ITINERARY – 4 staff members
 

(Note: Team will divide into 2 smaller teams and separate to audit the PM2.5 Laboratory)
 

Date Activity Time 

Day 1 Entrance Briefing; 

Questionnaire Discussion; 

General Tour of 

Facilities/Grounds 

8:30am – 5pm 

Day 2 Standards (QA) Laboratory; 

Maintenance/Repair Lab; 

PM2.5 Gravimetric 

Laboratory; 

Begin Certification Records 

Review 

8:30am – 5pm 

Estimate labs in the AM and 

records in the PM 
 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 29 of 105 

Day 3 Complete PM2.5 Gravimetric 

Lab; Complete Certification 

Records Review; Begin Data 

Review 

8:30am – 5pm 

Estimate labs/certs in the AM 

and data in the PM 

Day 4 Data Review 8:30am – 5pm 

Day 5 Exit Briefing 9am 

FIELD SITE INSPECTION ITINERARY – 2 staff members 

Date/Time Activity Location 

DAY 1 

6:00 AM - 12:00 PM Drive Work Station to Site 1 

12:00 - 1:00 PM LUNCH 

1:00 - 2:00 PM Site Evaluation Site 1 

2:00 - 4:00 PM Drive To vicinity of next site 

4 PM Hotel 

DAY 2 

8:00 - 9:00 AM Site Evaluation Site 2 

9:00 - 11:00 AM Drive 

11:00 AM - 12:00 PM Site Evaluation Site 3 

12:00 - 1:00 PM LUNCH 

1:00 - 3:00 PM Drive 

3:00 - 4:00 PM Site Evaluation Site 4 

4:00 - 5:30 PM Drive To vicinity of next site 

5:30 PM Hotel 

DAY 3 

7:00 - 8:00 AM Site Evaluation Site 5 

8:00 - 10:00 AM Drive 

10:00 - 11:00 AM Site Evaluation Site 6 

11:00 AM - 12:00 PM LUNCH 

12:00 - 3:00 PM Drive 

3:00 - 4:00 PM Site Evaluation Site 7 

4:00 PM Hotel 

Day 4 

7:00 AM - 9:30 AM Drive To Site 8 
 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 30 of 105 

9:30 - 10:30 AM Site Evaluation Site 8 

10:30 - 11:00 AM Drive 

11:00 AM - 12:00 PM Site Evaluation Site 9 

12:00 - 1:00 PM LUNCH 

1:00-4:00 PM Drive Return to work station 

The audit plan depicted in Example 1 shows a full day allotted for monitoring station inspections, but it 

is not as detailed as the field itinerary depicted in Example 2. In the first example, with only a two sites 

selected for inspection, the precise travel times may not need to be specified prior to the on-site TSA. 

Additionally, the monitoring organization staff may have suggestions regarding the most efficient travel 

routes, being more familiar with the area’s traffic patterns and geography. The travel route can be 

discussed with the monitoring organization prior to the on-site TSA, or it can be fine-tuned during the 

entrance briefing when audit logistics are final-reviewed. 

Quality System Document Review 

A quality system is the means by which an organization manages the quality of the monitoring 

information it produces in a systematic, organized manner. It provides a framework for planning, 

implementing, assessing, and reporting work performed by an organization, including carrying out 

required QA/QC activities, and improving work processes via the corrective action process. Pursuant to 

40 CFR Part 58, Appendix A, §2.1, all PQAOs must develop a quality system that is described and 

approved in quality management plans (QMPs) and quality assurance project plans (QAPPs) to ensure 

that the monitoring results provide data of adequate quality for the intended monitoring objectives. As 

stated in Section 2 of this QAGD, a primary objective of a TSA is to assess the suitability and 

effectiveness of the quality system being implemented by the monitoring organization on behalf of EPA. 

Although the CFR and the consensus-built data validation templates in Appendix D of the QA Handbook 

can be used as basic guides to assist the auditor, in order to truly assess the monitoring program’s 

quality system, the auditor must evaluate the organization against the specific policies and practices 

established within its quality documents. With that in mind, the auditor must be familiar with the 

contents of the documents in order to conduct a successful audit. 

4.3.1 Document Status 

During initial contact within the monitoring organization, the lead auditor should request copies of the 

monitoring organization’s active quality system documents (if these documents are not already available 

at the EPA Regional Office). If the monitoring organization maintains its quality documents on its 

website, the lead auditor should request a hyperlink(s) and/or a listing of the active SOPs, so that the 

auditor downloads the correct files. Upon receipt of the quality system documents, the lead auditor 

should check their status in order to determine whether they are current and approved. 

Monitoring organizations should review their quality system documents on an annual basis and 

document and track the reviews. QMPs and QAPPs should be revised every 5 years, minimally, or 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 31 of 105 

revised as soon as possible after significant changes occur (if before the expiration of the 5-year period). 

40 CFR Part 58, Appendix A, §2.1.2 states that QAPPs must include SOPs, either within the document or 

by appropriate reference. Similarly, the EPA document Requirements for Quality Assurance Project Plans 

(EPA QA/R-5) indicates that SOPs are part of the QAPP and states, “Current versions of all referenced 

documents must be attached to the QAPP itself or be placed on file with the appropriate EPA office and 

available for routine referencing.” As such, SOPs should, ideally, be revised every 5 years along with the 

QAPP. However, minimally, SOPs should be reviewed annually and revised when procedures change. 

The specific revision schedule for these quality system documents may be included in some EPA 

Region’s grant commitments. Therefore, the auditor should review the grant commitments in order to 

confirm the specific time frames for each document type. The revision of the documents must be 

completed in accordance with the grant requirements. 

The lead auditor should observe the revision dates stated on the quality documents in order to estimate 

whether or not they have been revised within the expected time frames. The QMP, QAPP, and SOPs 

should contain both a revision number and revision date, either on a cover page or within the document 

header. If documents are observed that appear to be more than 5 years dated, the lead auditor should 

earmark them for further discussion with the monitoring organization. 

Similarly, the lead auditor should determine the approval status of each document. As a best practice, 

each document should include an approval page, which contains the signatures of the individuals within 

the monitoring organization’s chain-of-command, and/or the EPA’s designated approving official, who 

have reviewed and approved the document. If the document does not contain a signature/approval 

page, the lead auditor should determine whether or not a separate approval letter was issued by the 

monitoring organization or EPA Regional Office to document that the QMP/QAPP/SOP had been 

reviewed and approved. If this information is not readily available, the lead auditor can request copies 

of approval letters for any documents in question from the monitoring organization during the on-site 

TSA. If any document appears to be “unapproved”, the lead auditor should earmark it for discussion 

with the monitoring organization. Similarly, any QAPP that is “conditionally approved” should also be 

earmarked for closer review and additional discussion with the monitoring organization. The QA policy 

of the EPA requires every environmental data operation (e.g., air monitoring project) to have a 

written and approved QAPP prior to the start of the project (see 40 CFR Part 58, Appendix A, §2.1.2). 

As such, unapproved or partially approved QAPPs are non-conformances that should be identified in 

the written TSA report, should the on-site investigation confirm the unapproved or conditionallyapproved document status. 

A final step during the document status review, specifically in regards to QAPPs, is to verify the 

status/approval dates of the documents supplied by the monitoring organization with the 

status/approval dates found in AQS. Any discrepancies between AQS and the documents should be 

noted for discussion and subsequent reconciliation. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 32 of 105 

4.3.2 Document Content 

The monitoring organization’s QMP should illustrate the quality system infrastructure that will be 

described in the monitoring organization’s QAPP. As such, the lead auditor should complete a cursory 

review of the QMP. However, the documents that will be most valuable to the audit team during the 

TSA are the monitoring organization’s QAPPs and SOPs – because those documents contain the specific, 

technical procedures that drive the air monitoring program’s daily operations. The monitoring 

organization’s QAPPs are like a contract – and the organization is held accountable to policies and 

procedures established therein. During the TSA, the lead auditor is charged with assessing whether or 

not the monitoring organization is implementing its QAPP, and its referenced SOPs, as written. With that 

in mind, the lead auditor’s goal should be to become well versed in those procedures prior to the on-site 

TSA, in order to effectively assess how those procedures are implemented on the ground. As a result of 

that goal, an important audit preparatory activity is prioritizing the review of the monitoring 

organization’s numerous quality documents, and then completing the content review – which may 

involve delegating some responsibilities to audit team members. The following describes this process. 

Ideally, all of the monitoring organization’s quality documents should be reviewed at some level prior to 

the on-site TSA. However, depending on the size and complexity of the organization’s network, the 

number of documents to review may be too great, given the time and resources allotted for the audit. 

At a minimum, the lead auditor should attempt a cursory review on all documents, while completing a 

more in-depth review on the higher priority documents. When prioritizing the document review, the 

lead auditor should consider the monitoring organization’s QAPPs as the highest priority documents. 

SOP review should occur after QAPP review. 

QAPPs should be reviewed closely by all audit team members, so that everyone on the audit team is well 

versed in the monitoring organization’s quality system requirements. It is important to review the 

QAPPs that cover the 3-year time period specific to TSA. For example, if the time period covered by the 

TSA is 2014-2016, then the lead auditor should review the QAPP(s) that was “in effect” during that 

specific time period. When reviewing the content of the QAPPs, recognizing the regulations and EPA 

guidance that were in effect during the specific 3-year time period is also of primary importance. If the 

auditor observes what appears to be a discrepancy between the organization’s procedures in 

comparison to regulatory requirements, the auditor should review the regulations that were in effect 

during the time period specific to the TSA in order to verify the discrepancy. For the 2014-2016 time 

period, for example, the auditor would need to be cognizant of two different sets of regulatory 

requirements, since 40 CFR Part 58 was revised in March 2016 (effective April 2016). As such, the lead 

auditor would expect to see revisions to the monitoring organization’s QA/QC requirements in mid2016, with implementation anticipated most likely by the 4th quarter of that year. 

It is important to note that monitoring organizations often submit the most recent versions of their 

quality documents to the lead auditor prior to the TSA; at times, the submission includes documents the 

organization has recently revised while preparing for the TSA. If the QAPP submitted to the auditor is a 

new version and not truly applicable to the time period of the TSA, the lead auditor should contact the 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 33 of 105 

monitoring organization and request they submit the previous (older) QAPP for review as well. If time 

allows, the auditor can review the newer QAPP, in order to ensure the revised procedures are 

acceptable and appropriately implement current regulatory requirements. 

After the QAPPs, the order of priority for the remaining quality documents (SOPs) depends on the 

composition and complexity of the monitoring organization’s network. Like with the QAPPs, monitoring 

organizations often revise SOPs immediately prior to a TSA, so it is important for the auditor to be aware 

of the effective dates of the documents. The goal should be to review all of the SOPs for the criteria 

pollutant monitors, at a minimum. The lead auditor may delegate the review of SOPs such that this goal 

is accomplished. However, if the number of documents is too great, given the size of the audit team, 

then the SOP review should be prioritized. The following is the recommended approach for prioritizing 

the review of the monitoring organization’s SOPs. 

•	 Ozone SOPs should be reviewed for all audits. 

•	 PM2.5 SOPs should be reviewed for all audits, including SOPs for the gravimetric laboratory (if 

operated in-house by the monitoring organization). 

•	 The data handling/validation SOP should be reviewed for all audits. If the monitoring 

organization doesn’t have a data handling/validation SOP, ask why during the on-site TSA. 

•	 Will the audit include an inspection of any laboratories (beyond PM2.5)? If so, the SOP(s) for 

those specific analytical (Pb or toxics) or gravimetric (PM10) procedures will need to be reviewed. 

•	 Will any specific data set be under scrutiny due to upcoming designations or similar actions? If 

so, the lead auditor may want to review the SOP(s) for that particular pollutant. 

•	 For the remaining documents, prioritize them by age (revision date). Older, active SOPs may be 

more pertinent to focus on, because of the chances that procedures are outdated or in need of 

improvement. 

•	 Review SOPs for new instrumentation or programs. For example, if the monitoring organization 

switched from intermittent to continuous PM2.5 samplers during the time period under review, it 

may be prudent to ensure the monitoring organization has started out on the right foot with the 

different technology. 

•	 Review the SOP for any monitor/methodology in which the EPA Regional Office is aware that the 

monitoring organization is struggling. The auditor can read these documents in order to offer 

assistance to the organization during the on-site TSA. 

After determining which documents need to be reviewed, the audit team members should begin 

studying the documents. The sooner the audit team starts this process, the more time available to read 

and examine them prior to the start of the on-site TSA. It is suggested that the audit team read the 

documents prior to reviewing the monitoring organization’s data in AQS; the SOPs should shed light on 

the coding that will be observed in the data sets, as well as the frequency of QC checks, calibrations, and 

maintenance activities. As a goal, each document should be closely read, in order for the audit team to 

become well versed in the monitoring organization’s procedures. At a minimum, though, each 

document should be given a cursory review. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 34 of 105 

When reviewing the monitoring organization’s QAPPs and SOPs, the auditor should look for the 

following: 

•	 Are the QAPPs/SOPs current and properly reflect the organization’s network? (For example, are 

the SOPs written for monitors actually deployed, as opposed to models that are no longer in 

use?) 

•	 Are there any QAPPs or SOPs missing, given the monitoring network composition and expected 

instrumentation? 

•	 Do the QAPPs and SOPs contain specific, technical details (i.e., more direction than simply “See 

the User Manual”)? 

Note: Although the majority of information found in vendor-developed user manuals 

may be appropriate to reference, many times the manuals provide more than one option 

for method implementation and are not specific to the organization implementing the 

method. Therefore, monitoring organizations are encouraged to utilize these methods, 

but edit them to make them specific to the organization. 

•	 Do QAPPs and SOPs correctly implement the monitoring regulations? 

Note: This is especially important for QAPPs and SOPs that are impacted by recent 

regulatory changes. Note the date of the SOP revision in comparison to the regulatory 

modification(s). Has the monitoring organization made necessary and appropriate 

modifications to its procedures and quality documents, in accordance with the 

new/revised regulatory requirements? 

•	 Do any stated SOP procedures contradict the QAPP, regulatory, or method requirements? 

•	 Do any procedures go against EPA guidance – if so, is justification provided within the
 

document?
 

•	 Are SOPs readable, so that site operators easily understand the process? 

The auditors should earmark any concerns noted during the document review for follow-up with the 

monitoring organization during the on-site TSA. 

4.3.3 Important Note about QAPP Approvals 

As stated previously in Section 4.3.1, the QA policy of the EPA requires every environmental data 

operation to have a written and approved QAPP prior to the start of the monitoring project. Generally 

speaking, the submittal and approval of the QAPP – and the SOPs it contains – constitutes an agreement 

between EPA and the monitoring organization. 

For most monitoring organizations, the QAPP will be submitted directly to the EPA Regional Office for 

review and approval prior to the start of the monitoring project. With that in mind, during pre-audit 

activities, the EPA staff assigned to the audit team may have previously reviewed the document when it 

was initially submitted for approval. If that submittal/approval was recent, the audit team may only 

need to conduct a cursory review of the document as a refresher. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 35 of 105 

However, some monitoring organizations are delegated the authority to self-approve their QAPPs. In 

these cases, the EPA Regional Office must receive a courtesy copy of the QAPP, but a staff member may 

not be assigned by Regional Office management to review and approve its content. However, in order to 

assess the effectiveness of the quality system being implemented on behalf of EPA, the lead auditor 

must assess the monitoring organization against the policies and procedures formalized in its QAPPs and 

SOPs. This is accomplished in two parts: first, through review of the monitoring organization’s quality 

system documentation during pre-audit activities; and second, through observation of the procedures 

and practices implemented by the organization during the on-site TSA. For the monitoring organizations 

that self-approve their QAPPs, the pre-audit activities for the EPA Regional Office auditor must include 

an in-depth review of the QAPP to ensure it meets EPA specifications. 40 CFR Part 58, Appendix A, §2.1.1 

states, “Where a PQAO or monitoring organization has been delegated authority to review and approve 

their QAPP...The QAPP will be reviewed by the EPA during systems audits or circumstances related to 

data quality.” With that in mind, the auditor should ensure that the QAPP, at a minimum, conforms to: 

1) all regulations; 

2) the validation templates (critical criteria, at a minimum); and, 

3)	 generally agrees with the QA Handbook and/or applicable methods (such as the QAGD 2.12) or 

provides an acceptable alternative. 

If the auditor determines that the QAPP is inadequate, this issue must be addressed with the 

monitoring organization during the on-site TSA and identified in the TSA report. In this situation, it is 

likely that other findings will be identified during the TSA that stem from the issues noted within the 

monitoring organization’s QAPP. 

Data Review 

During the TSA, the lead auditor is charged with performing an audit of data quality. An audit of data 

quality includes reviewing supporting documentation and records, maintained by the auditee and not 

available in AQS, in order to ensure the data reported to EPA is accurate, traceable, and defensible. 

While on site, the lead auditor will have limited time to complete the audit of data quality, which is 

typically a lengthy process. Therefore, in order to maximize efficiency during the on-site TSA, it is 

imperative for the lead auditor to evaluate the organization’s data in AQS, to the best extent possible, 

prior to arriving on site. During three years, a monitoring organization will generate a large quantity of 

ambient concentration and QA/QC data; it will not be possible for the audit team to verify the accuracy 

and integrity of all data points. With that in mind, during audit preparatory activities, the lead auditor is 

tasked with evaluating the organization’s data, and then selecting only a limited number of critical data 

points to scrutinize during the on-site TSA. Through this process, the lead auditor will evaluate whether 

or not the monitoring organization is validating its data in accordance with its QAPP/SOPs and EPA 

requirements. These few data points, then, will be used to generally surmise the quality of the overall 

data sets, through confirmation of the effectiveness of the organization’s quality system and its 

documentation and recordkeeping practices. When preparing for this phase of the TSA, the lead auditor 

may delegate the review of specific pollutant data sets, or specific AQS reports, to audit team members. 

Given the size of the monitoring organization’s network and the quantity of data produced, the 
 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 36 of 105 

delegation of data review activities may help make this particular TSA task more manageable and 

focused. 

Because time is a limiting factor while on-site, it is important for the lead auditor to select a reasonable 

number of data points to represent the different pollutant data sets, and select those points for scrutiny 

that will be most effective in challenging the monitoring organization’s quality system. To begin this 

process, the lead auditor (or delegate) should extract the organization’s data from AQS using a variety of 

standard reports that are available (see Section 4.4.1 below). Each report has a different purpose and 

will highlight during facets of the organization’s data. After the data has been queried, the auditor 

should look for recurring or systemic issues within the data sets, and highlight any issues or anomalies 

observed. The null value codes and AQS qualifier flags utilized by the monitoring organizations when 

reporting concentration data to AQS will “tell a story”, when used properly. By reading the null codes 

and flags in the AQS data, the auditor can generally surmise whether or not SOPs appear to be followed 

(which will be confirmed later during the on-site audit). The auditor will be able to see through the data 

coding, for example, an analyzer malfunction, followed by maintenance/repair activities by the site 

operator, followed by a recalibration of the analyzer before ambient data collection resumes. This would 

be the anticipated sequence of events following a malfunction (and, thus, should be specified in the 

organization’s SOP). Similarly, the codes for calibrations and QC checks should be visible in the data and 

spaced at the frequencies established in the SOPs. If the data coding illustrates unusual events, or 

anticipated codes are missing (such as those for the QC checks), the auditor may decide that further 

investigation into the associated data points is warranted. 

During data review, it is extremely important for the auditor to remain cognizant of the 3-year time 

period under review. Any issues uncovered in the data should be compared to the regulations and 

guidance which were in effect during the specific time period under review. For example, if EPA 

regulations recently changed (e.g., in 2016), but during the time period of the TSA (e.g., 2013-2015) the 

organization was successfully implementing previous regulations, then it is inappropriate to cite the new 

regulations as justification for a non-conformance (i.e., audit finding). Similarly, the auditor should be 

cognizant of the requirements established in the monitoring organization’s QAPPs and SOPs, and judge 

the organization’s performance based upon the specific quality documents that were effective during 

the TSA review period. 

4.4.1 AQS Reports 

The most common data assessment tools accessible to all EPA auditors – and the monitoring 

organizations – are the standard reports available for query in the AQS database. Of the numerous 

standard reports available in AQS, several are particularly helpful when preparing for and conducting 

TSAs. The auditor should select the appropriate AQS reports to pull, based upon the scope of the 

individual TSA. For example, if the TSA will focus only on regulatory NAAQS pollutants, the lead auditor 

may not need to pull reports for non-regulatory data, such as air toxics or non-FEM continuous 

particulate samplers. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 37 of 105 

The following list suggests common AQS reports that may be helpful to the audit team, providing a brief 

description of the report’s purpose and potential use. It is important to note that this list is not allinclusive, nor does it suggest that each report listed should be queried during TSA preparation. Other 

reports are available for review which may be beneficial to the audit team. Similarly, due to the 

structure and organization of some EPA Regional Offices, the staff who conduct TSAs may or may not be 

the same individuals who review and approve AMNPs or apply concurrence flags to data as a result of 

the annual data certification process. Therefore, some reports listed below may or may not have been 

previously reviewed by EPA staff members as part of other job responsibilities, and, therefore, may or 

may not need to be reviewed during the TSA. 

• AMP251 QA Raw Assessment Report 

This report lists the results (i.e., % difference) of each individual QC check performed for 

the pollutant of interest. It includes the results of performance evaluations, NPAP/PEP 

audits, lead audit strip analyses, and collocation assessments as well. 

• AMP256 QA Data Quality Indicator Report 

This report calculates summary statistics at both the monitor and PQAO levels for the 

QC checks performed by the organization. It is used to determine whether or not the 

organization is meeting the established data quality objectives for the criteria 

pollutants. 

• AMP350 Raw Data Report 

This report shows hourly ambient concentrations for the continuous analyzers and 

samplers in the monitoring network, as well as concentrations for the intermittent 

particulate matter samplers (i.e., 24-hour samples) collected by the organization. 

• AMP350MX Raw Data Max Values Report 

This report provides the highest concentration value for each day for the pollutant of 

interest. This report is helpful for reviewing 5-minute SO2 data, particularly for those 

organizations that report only the highest 5-minute average from each hour. (Compare 

to AMP 501 below.) 

• AMP390 Monitor Description Report 

This report lists descriptive information on the location and configuration of monitoring 

sites and monitors. Information includes geographic descriptions, probe configuration 

descriptions, and locations of other items that may have an impact on the data collected 

by the site (such as nearby streets and obstructions). 

• AMP430 Data Completeness Report 

This report calculates monthly and annual data completeness for each monitor in the 

specific pollutant network. 

• AMP480 Design Value Report 

This report calculates the design value for each site in the network for each criteria 

pollutant. From that, the auditor can determine the overall highest concentration sites 

in the network. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 38 of 105 

• AMP501 Extract Raw Data 

This extract produces a text file that contains the organization’s ambient concentration 

data in raw format. This extract may be helpful for reviewing SO2 5-minute data, 

particularly for those organizations that report 12, 5-minute blocks of data for each 

hour. 

• AMP503 Extract Sample Blank Data 

This extract produces a text file that contains the organization’s PM2.5 field or trip blank 

data, if the monitoring organization operates a manual (FRM) PM2.5 network. Field blank 

data is required to be reported to AQS in accordance with 40 CFR 58.16; however, the 

submittal of trip blank data to AQS is optional. Review the text file as is, or import into 

Excel, depending on its size, so that it can be more easily assessed. 

• AMP504 Extract QA Data 

This extract produces a text file that contains the organization’s QA/QC data in raw 

format. This extract is helpful for reviewing data from organizations with large 

monitoring networks. The text can be imported into Excel, in order to more easily sort 

and review the data; or, the data can be imported into a similar data assessment 

program that will sort the data, such as the 504 QA Data Assessment Tool (see Section 

4.4.2 below). 

• AMP600 Certification Evaluation and Concurrence Report 

This is the primary report generated by organizations during annual data certification. 

The report shows whether or not data quality objectives have been met for the criteria 

pollutants, provides dates for QAPP approvals, and illustrates other QA considerations. 

4.4.2 Review Criteria 

When querying a large PQAO over a 3-year time period, many of the AQS reports listed above will 

produce hundreds of pages of data results. After these reports have been obtained, or raw data 

extracted, the lead auditor (or delegate) should examine these large data sets, with a goal of producing 

a narrowed list of specific, individual data points that will be further evaluated during the on-site TSA. 

During this data review process, the lead auditor can utilize additional data assessment tools to mine the 

AQS data. For example, on the AMTIC website, a 504 QA Data Assessment Tool (Excel)7 is readily 

available to help EPA Regional Offices (and the monitoring organizations) evaluate the pollutant data 

sets. The 504 QA Assessment Tool processes AMP 504 extracts, quickly evaluating the text files for 

specific monitoring criteria. Other assessment tools readily available on AMTIC are box and whisker 

plots, which may assist the auditor in seeing trends or issues within data sets. 

Prior to beginning this phase of data review, the auditor should read the monitoring organization’s 

QAPPs and SOPs, particularly the data validation SOP(s) – as suggested in Section 4.3.2 of this QAGD. 

The monitoring organization’s QAPPs and SOPs should clarify the coding that will be observed in the AQS 

reports. As stated previously, the data points selected for review during the on-site TSA will be used to 

7 https://www3.epa.gov/ttn/amtic/qareport.html 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 39 of 105 

assess whether the data has been handled in accordance with the monitoring organization’s quality 

documents. These data points will also be used to verify whether or not the monitoring organization has 

sufficient documentation available on site to support the decisions made regarding its validity (i.e., 

whether the data point was reported, null coded, or flagged appropriately). With that in mind, it is 

important for the auditor to be familiar with requirements detailed in the organization’s SOPs, 

particularly those related to data validation. 

The following bullet list summarizes general criteria and/or issues the lead auditor should look for when 

examining the organization’s AQS data. It is important to note that this list is not all-inclusive. As a 

general guide, the data validation templates found in the QA Handbook itemize key criteria against 

which ambient air monitoring data should be validated; the auditor can refer to those templates for 

more extensive, pollutant-specific criteria. The auditor should also look for any unique criteria specified 

in the organization’s QAPPs and SOPs that may not be listed below. 

•	 Determine if the 75% data completeness requirement has been satisfied. 

•	 Assess whether or not 1-point QC checks meet the critical % difference acceptance criterion 

established per pollutant (e.g., 7% difference for ozone). 

•	 Determine whether 1-point QC checks have been conducted at the appropriate frequency (i.e., 

every 14 days, minimum), and within the concentration range specified in CFR. 

•	 Determine if the appropriate number of PEs have been conducted, and whether those audits 

have been conducted at the concentrations specified in CFR. 

•	 Assess whether or not flow rate verifications meet the critical % difference acceptance criteria 

(e.g., 4% of transfer standard, 5% of design flow for PM2.5). 

•	 Determine whether or not the flow rate verifications have been conducted at the appropriate 

frequency. 

•	 Determine whether semi-annual flow rate audits have been conducted at the appropriate 

frequency and meet the acceptance criterion. 

•	 Determine the highest concentration site for each pollutant. (Note: These particular monitors 

may need to be inspected on site during the TSA, especially if any regulatory actions are 

pending.) 

•	 Identify any sites that have incomplete design values. (Note: These monitors may not have been 

in operation throughout the entire 3-year time period under review; check start-up dates in AQS.) 

•	 Review 1-hour SO2 data against its associated 5-minute data. Verify that 5-minute SO2 data has 

not been reported during time periods when the hourly value has been invalidated. 

•	 Examine PM2.5 blank data for exceedances. (Note: Some organizations will report both field 

blank and trip blank concentration values to AQS, but the auditor may not be able to discern 

from the AMP 503 extract which blank is which. The acceptance criterion for field blanks is ≤±30 

μg; the criterion for trip blanks is ≤ ±15 μg.) 

•	 Examine ambient concentration data for adherence to SOPs, as well as for anomalies. Examples 

of what to look for include the following: 

a.	 Missing data (i.e., gaps in reported concentrations). 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 40 of 105 

b.	 Repeating concentration values, such as consistently negative concentrations over long 

periods of time. 

c.	 Unusual maximums concentration values. (For example, maximum ozone 

concentrations at midnight: could the data be the result of an automated span check 

that was erroneously reported as ambient data?) 

d.	 Consistency in application of null value codes and qualifier flags. 

e.	 Do the null value codes, through the “story” they convey when read, indicate that SOPs 

have been followed? 

The auditor should earmark data that does not meet these criteria, as well as any data that appears to 

be anomalous, miscoded, or potentially deviates from the organization’s SOPs. An important step to 

determine whether or not data has been correctly coded is to reconcile the AMP 350 report against the 

AMP 251 (or AMP 504). Using these reports, the auditor can surmise whether or not ambient data has 

been invalidated when 1-point QC checks (or flow rate verifications) have exceeded acceptance criteria. 

The AMP 350 will allow the auditor to observe whether or not the data appear to have been 

“bracketed” appropriately – meaning data have been invalidated back to the last acceptable 1-point QC 

check, as well as invalidated forward until corrective action has been successfully implemented. If valid 

QC checks have been reported to AQS that exceed acceptance criteria and the associated ambient 

data has not been invalidated, the auditor should earmark the example(s) for further review and 

discussion with the monitoring organization. 

Additionally, a few data points that do not appear to be anomalous or miscoded should be tagged for indepth review during the TSA (see Section 5.3.3.1 of this QAGD). For these specific data points that will 

be used for data audit trail tracking, it is suggested the auditor select a few data points at random from 

the pollutant data sets. Also, because part of the goal of the on-site data review is to ensure the 

organization’s documentation supports data validity, it is recommended that the lead auditor select at 

least a few data points that appear to be valid high concentration values for the pollutants of interest. 

For example, the maximum valid lead concentration reported at a monitoring site may be an ideal 

sample for in-depth review; the laboratory data package would need to be obtained and evaluated, in 

order to ensure calibration techniques (including dilutions) were performed in accordance with the 

method; and the field sampling records and calculations would need to be reviewed and confirmed as 

well. In this manner, the auditor can assess the effectiveness of the monitoring organization’s quality 

system, as well as ensure the reported high concentrations are valid. However, given the significant 

amount of time needed to track the audit trail for a single data point, the number of points selected for 

this particular activity during the TSA should be limited. 

After completing this preliminary data review, the amount of data earmarked should be compared to 

the amount of time allotted for data review activities on site. The lead auditor will then have to decide 

whether or not there is sufficient time to cover all of the selected data points, or if the number of data 

points selected will have to be further reduced due to limited resources (i.e., time). It is important to 

note that, for the data review activities that occur during the on-site TSA, the size of the audit team is 

not the critical factor. Instead, the factor that typically drives the speed of the data review activities on­
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 41 of 105 

site is the number of staff available at the monitoring organization to assist the auditor(s) with reviewing 

their in-house data, and whether or not the organization’s monitoring database(s), such as AirVisionTM, 

can be accessed in multiple locations within their facility (which would allow the audit team to break 

into smaller groups to cover different pollutants simultaneously). With that in mind, time should be 

considered the most important resource during this phase of the TSA, and the auditor should anticipate 

at least 15 minutes to review each individual data point. 

If the auditor determines that the quantity of data earmarked for on-site data review is greater than the 

time available at the monitoring organization, it is recommended that the lead auditor create an 

abridged list of data from those earmarked, in order to have a “top priority” list. From that, the lead 

auditor can maximize the time available on site by reviewing the most critical data points first. To create 

an abridged, “top priority” data review list, the lead auditor should re-review the discrepancies and 

concerns first earmarked in the data sets. Of those highlighted, the auditor should determine whether 

any issues appear to be recurring or systemic. Similarly, the lead auditor should assess which issues 

appear to be of the greatest concern regarding data validity. For example, if the auditor notes any issues 

that could result in significant data invalidation, those data points should be prioritized. Ultimately, the 

auditor should select from the highlighted data only a limited number of points that best represent the 

major concerns identified, and include a few select points that do not appear to be anomalous in any 

manner, but will be used for data tracking purposes. 

It is important that the lead auditor not discard those data points which were earmarked, but not finalselected as “top priority.” Instead, it is recommended that the auditor keep all of the earmarked data 

points on hand during the on-site TSA. If data review activities progress at a faster speed than 

anticipated, such that all top priority data points are reviewed and time still remains on site, the lead 

auditor can then select from the other tagged data points to utilize the time that remains. 

4.4.3 Additional QC Data Requests and Review 

There may be additional data the TSA lead auditor wants to request in advance because the QAPP/SOP 

review alludes to unique processes which warrant verification by the audit team. Moreover, some 

supplementary program data may not be available in AQS that would be valuable to review in advance. 

In order to obtain this data for review, it has to be requested directly from the auditee. Requesting this 

information up front allows the auditor to be better prepared and/or save time while on site. However, 

if the auditor is unable to review this data in advance of the audit, the information can be requested 

while on site and reviewed at that time. 

Examples of supplementary information and data that may be requested in advance includes the 

following: 

•	 Copies of audit reports, such as the internal systems audits, if applicable, or internal 

performance audits
 

•	 Third-party audit reports, such as performance or systems audit reports by the PQAO (if the 

monitoring organization is a local monitoring program) or a contractor 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 42 of 105 

•	 PM2.5 Lab Blank Data – Request if the monitoring organization operates an in-house gravimetric 

lab. Review the data for excursions >±15 μg. 

•	 Control charts maintained by the organization, particularly from the PM2.5 or PM10 weigh labs. 

Common control charts generated by gravimetric laboratories include those used for tracking 

check weight standards, lab blanks, duplicates, and laboratory temperature and relative 

humidity conditions. 

•	 Shelter temperature data for some sites or monitors. 

•	 PT reports/results for air toxics. 

Questionnaire Response 

The monitoring organization should submit its completed questionnaire to the lead auditor one 

month prior to the on-site TSA. Upon receipt of the completed questionnaire, the lead auditor should 

disseminate the document to the entire audit team for review. All audit team members should review 

the monitoring organization’s responses and earmark any areas of concern requiring additional 

discussion and/or on-site investigation during the TSA. 

Items to note in the questionnaire response include, but are not limited to, the following: 

•	 Review the responses in comparison to EPA regulatory requirements. Are discrepancies noted? 

•	 Review the responses in comparison to the monitoring organization’s QAPP and SOP
 

requirements. Are discrepancies noted?
 

•	 Observe if the response to any question is marked “No” when the anticipated answer is “Yes.” 

•	 Mark any sections that are left completely blank, or sections in which the given response is too 

ambiguous. 

Preliminary Findings Summary 

Activities described in Sections 4.3 - 4.5 of this QAGD may result in identification of preliminary findings. 

The lead auditor should review all notes and earmarked documents/data, in order to compile a 

summary list of the issues that will be investigated during the on-site TSA. 

It is suggested that the lead auditor assemble the audit team prior to the on-site TSA to discuss their 

notes and earmarked documents/data as well. Such discussion can illuminate recurring themes or 

systemic issues within the organization that may not be apparent when focusing on one auditor’s notes 

alone. The team discussion, in turn, will help the lead auditor prioritize the most significant areas of 

concern identified through these pre-audit activities. The audit team should also discuss their notes and 

concerns regarding the completed questionnaire responses. The lead auditor should take the team’s 

concerns into consideration when prioritizing which responses will be discussed in person during the 

formal questionnaire discussion, and which responses may be left to verify through facility inspections 

and/or records/data review activities. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 43 of 105 

Audit Team Communications and Planning 

Effective communication and planning among the audit team is paramount; it should be frequent during 

the planning stages of the TSA, and ongoing throughout the duration of the on-site TSA audit. The lead 

auditor is responsible for coordinating and planning the communication protocol between audit 

members, audit teams (if working separately), and other EPA regional stakeholders. Some EPA Regional 

Offices are organized such that staff who conduct TSAs are located in different divisions from other Air 

program staff. In these situations, the lead auditor should contact their Regional Office partners when 

preparing for the upcoming TSA. This outreach can provide notice of the upcoming audit, as well as 

serve as a forum to exchange information about the monitoring organization, discussing any specific 

areas of concern that should be investigated during the TSA. For some TSAs, the monitoring organization 

audited may share CBSAs/MSAs with monitoring organizations located in different states or EPA 

Regions. Under some circumstances, it may be appropriate to outreach to the other EPA Region(s) to 

inform them of the upcoming audit. 

Audit team meetings are useful to enhance communication and promote good audit planning during 

pre-audit activities, as well as during the on-site TSA. The best practice is to implement at least two 

planning meetings during TSA preparation: one at the start of the project, to discuss team assignments 

and logistics; and the other immediately prior to the start of the on-site TSA, to finalize logistics and 

discuss the team’s preliminary findings (as described in Section 4.6 above). Once on-site, briefings 

among the audit team members and with the monitoring organization are essential. Briefings with the 

monitoring organization should include both an entrance and exit briefing, which are discussed in detail 

in Section 5 of this QAGD. Briefings amongst the audit team members, however, should occur daily, and 

are described below. 

4.7.1 Team Meetings Prior to the On-Site TSA 

As stated previously, the lead auditor is responsible for coordinating and planning the communication 

protocol between audit members. At the start of the TSA planning process, it is recommended that the 

lead auditor assemble the audit team in order to discuss the upcoming TSA. The lead auditor should 

ensure all team members have the correct date(s) scheduled for the on-site TSA and have received 

copies of the documents needed for review. It is suggested that the team create a medium to share 

documents, records, and data pertaining to the TSA; a shared folder on a Local Air Network drive can 

serve this purpose, or use of an approved, secured, web-based file-sharing program. During this 

preliminary meeting, the audit team can discuss the monitoring organization and formulate a tentative 

plan on how to most efficiently complete the audit. At this time, the lead auditor should delegate 

responsibilities to specific team members. For example, the lead auditor should designate a team 

member(s) as a scribe, who will be responsible for extensive note-taking during the on-site audit, 

especially during staff interviews when the lead auditor may be involved in lengthy and complex 

discussions. If the lead auditor intends to divide the audit team into smaller teams in order to make the 

on-site TSA more manageable, then he/she should appoint one individual in each team as the primary 

contact (or “lead”). For example, the “field team” described in Section 4.2.4 of this QAGD should have a 

designated lead; similarly, audits of laboratories conducted separately should have a lead as well. By 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 44 of 105 

making these assignments in advance, all members of the audit team have a better understanding of 

their roles and responsibilities while preparing for the upcoming audit. It is suggested that the lead 

auditor also use this time to tentatively schedule follow-up meetings with team members. As the 

specific audit itinerary is finalized, those schedule(s) will need to be shared not only with the monitoring 

organization (as discussed in Section 4.2.5), but also with the audit team members. Travel authorizations 

will need to be completed, as well as reservations for hotels and transportation. 

It is suggested that approximately one week prior to the on-site TSA, the lead auditor reassemble the 

audit team for a final planning meeting. During this time, the lead auditor should discuss results of the 

pre-audit document and data review activities (as described in Section 4.6), and go over the final audit 

logistics. The lead auditor should also ensure that all team members have gathered the necessary audit 

tools needed for the TSA, such as laser range finders, compasses, GPS units, cameras, and logbooks. As a 

best practice, all team members should carry individual logbooks (bound and page-numbered), created 

specifically for the audit and uniquely labeled to reference the audit. These logbooks act as supporting 

documentation for the audit and can be given to the TSA lead auditor upon completion of the field 

investigation to assist with the post-site visit activities described in Section 6 of this QAGD. The logbooks 

and documentation collected during the audit will play an integral part in the development of the TSA 

audit report. When teams are traveling separately, it is also important to designate someone as a scribe 

within the smaller team to ensure that all relevant observations and discussions are captured regarding 

the field/laboratory investigations. Logbooks, audit notes, and other supporting documentation should 

be retained for inclusion or reference in writing the audit report. These records should also be included 

in the final project file, after the TSA is closed-out (see Section 6.5.1 of this QAGD). 

4.7.2 Daily Briefings During the On-Site TSA 

Effective and frequent communication between audit team members is vital during the on-site TSA. As 

stated previously, depending on the scope and extent of the audit, audit team members may divide the 

activities among the team to ensure all aspects of the audit are sufficiently covered. If the team is 

separated, there must be a communication plan between the lead auditor and the primary contact(s) of 

the smaller team(s) to ensure that findings and developments are communicated and discussed. This 

communication may be in the form of meetings, telephone calls, texts, or emails. Ideally, when the onsite TSA is in progress, the lead auditor should be updated daily by all team members, as well as by the 

smaller team leads. It is especially important to share significant findings to allow all team members 

time to discuss the implications and consequences of the identified findings, and decide each day 

whether further investigation into specific findings is needed. 

At the completion of each work day, the lead auditor should assemble team members for a daily 

briefing. If possible, team members in remote locations should call in to the daily briefing. During this 

team meeting, all findings from the day should be summarized, discussed, and categorized according to 

severity (see Section 6 of this QAGD). The daily briefing is very important because the recollection of the 

auditors will be the best immediately following the day’s events. The daily team meeting can also be 

used to plan the next day’s activities, especially if any priorities have changed due to the nature of the 

day’s findings. The lead auditor can also use these daily briefings to build a list of major findings, which 
 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 45 of 105 

can later provide topics for the exit briefing. Compiling the significant findings daily will save time at the 

conclusion of the on-site audit, and help prepare the audit team for a smooth, well organized exit 

briefing. 

It is essential that there is good communication between audit team members so that a consistent 

message is delivered to the monitoring organization staff at all times during the on-site TSA. Auditors 

should never provide conflicting information to the monitoring organization, which could send mixed 

messages and cause confusion. The audit team must communicate in one voice. 
 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 46 of 105 

5.0 On-Site Audit Activities 

Although the audit team has already spent many hours reviewing documents and data prior to traveling 

to the monitoring organization, generally speaking, the TSA “begins” when the audit team arrives onsite for the face-to-face interaction with the monitoring organization. The audit team should be well 

organized through the preparatory process and each team member should have a clearly defined role in 

the audit. From the onset, it is essential that each member understand his or her responsibility on-site 

to efficiently move through the audit process since time is limited at the monitoring organization. The 

lead auditor is responsible for keeping the audit on schedule and routinely collecting the observations 

from the group. 

The on-site component of the TSA is a multi-day event that investigates the ambient air monitoring 

process including: sampling and monitoring, data collection, quality system functionality, quality 

document (QAPPs, SOPs) implementation, data review, and data submission to AQS. An important 

component to the success of the TSA is communication and planning between audit team members 

and monitoring organization staff during the audit itself. Section 2.1 of this QAGD defines the scope of 

the functional areas within a monitoring organization that should be examined during a TSA. Monitoring 

organizations may have all or several of these areas, and the audit team should already have a planned 

approach to inspect these areas prior to arriving on-site. The on-site audit should begin at the 

monitoring headquarters where many of these areas – such as the monitoring data review group, 

quality assurance team, and AQS submittal group – reside. Audit team members will visit other facilities, 

such as the analytical laboratories and ambient air monitoring stations in the field, over the course of 

the audit. The team’s schedule on-site should be flexible to allow for additional investigation if needed. 

During the audit, several meetings should occur to keep the audit team members and the monitoring 

staff informed about the audit progress. Routine meetings and communication will keep the audit on 

schedule and will assist in presenting clear audit findings to the monitoring organization. 

Monitoring organizations can be relatively complex. However, several important activities should occur 

during each TSA to consistently and efficiently cover the same material in each organization from audit 

to audit. No monitoring organization should be treated differently than another, and no bias should be 

reflected in the audit process. The audit activities described in this section are essential to the TSA 

process, should cover the functional areas of the monitoring organization defined in the scope, and 

provide the communication necessary for the audit participants. The functional areas are reiterated 

below. 

• Monitoring Headquarters 

• Maintenance and Repair Shop 

• Monitoring Data Review and Validation Group 

• Quality Assurance Team 

• Analytical Laboratories 

• AQS submittal Group 

• Ambient Air Monitoring Sites 
 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 47 of 105 

These functional areas, at a minimum, should be inspected during the on-site TSA. Monitoring 

organizations may have other areas that warrant inspection as well, and these additional areas should 

be identified in the TSA planning process. At the conclusion of each day, the audit team members should 

meet to discuss their progress with regard to completion of these necessary inspections; see Section 4.7 

of this QAGD for more information regarding the audit team’s daily briefings. This section will describe 

these core activities in detail and provide best practices for the audit team to follow. Figure 5.1 below 

shows a diagram of a typical TSA which includes the aforementioned activities. 

Figure 5.1 TSA On-Site Activities Flow Chart 

Figure 5.1 illustrates the basic flow of TSA activities that may occur at a small to mid-sized monitoring 

organization. The audit begins with a briefing to kick-off the TSA and ends in the same manner to 

present the audit findings. All of the functional areas of this example organization are covered in the 

TSA, and the order and timing have been determined during pre-audit planning. Note that during this 

example TSA, the audit team splits into two teams to efficiently use time and expertise to investigate 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 48 of 105 

these areas. No two audits will be the same, but using the example above as a guide will help promote 

consistency across EPA Regional Offices and auditors. 

As discussed in Section 4.4 of this QAGD, the auditor must always remain cognizant of the requirements 

established in the monitoring organization’s QAPPs and SOPs, and judge the organization’s performance 

based upon the specific quality documents that were in effect during the TSA review period. 

Entrance Briefing 

The on-site audit should begin with an entrance briefing to introduce the audit team, and inform the 

monitoring organization staff about what to expect during the on-site audit process. This briefing is an 

opportunity for audit staff to meet monitoring organization staff and set the stage for the activities that 

follow. The entrance briefing is best conducted face-to-face at the beginning of the audit. A face-to-face 

meeting promotes participation, engages the participants, and encourages efficiency. The entrance 

briefing may be conducted via teleconference prior to arrival on-site if necessary; however, this is not 

recommended. The briefing should be short, typically no longer than an hour, and should focus on 

overall objectives of the audit. Ideally, the entrance briefing should be the first order of business after 

arriving on-site at the organization’s central office. The entrance briefing should be conducted with the 

organization’s air monitoring director or other senior staff designee, monitoring managers, supervisors, 

QA staff, and any other monitoring staff who will be engaged with the auditors during the audit. All staff 

present should introduce themselves and provide a brief description of their particular role(s) and 

responsibilities. 

The entrance briefing should set the tone for the audit and serve as an open forum where the audit 

team and monitoring organization staff can comfortably ask questions and exchange information. It is 

important to discuss the audit itinerary and logistics to ensure that all plans are still viable and that 

pertinent staff are available for the field, laboratory, and facilities visits. Contact information should be 

shared/confirmed during the entrance briefing as well. If any unforeseen conflicts or problems regarding 

the audit schedule have arisen, modifications to the itinerary should be made during the entrance 

interview. If the pre-audit activities identified areas where the audit team may want to focus additional 

attention, it is important to ensure the appropriate contacts who can discuss those issues will be 

available during the audit. The projected time and location for the exit briefing should also be discussed 

during this meeting; it is important to schedule the exit briefing so that senior management will have 

opportunity to attend. This may not possible in all cases, but it is a priority in closing out the on-site 

phase of the audit. The audit team should make arrangements for a conference call line for the exit 

briefing, if necessary. 

The lead auditor should discuss the overall TSA process with the organization, especially its purpose, 

regulatory basis, and goals. The auditor should remind the monitoring organization staff that a TSA is a 

conglomerate of activities intended to assess whether the organization has operated the network in 

compliance with regulatory requirements, has a functioning quality system, and as a result, has 

produced quality monitoring data that is sufficient for decision-making purposes. The TSA is also an 

opportunity for the auditor to offer suggestions for improvements, and potentially assist the 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 49 of 105 

organization in discovering ways to implement needed enhancements. Explaining these objectives at the 

beginning of the TSA is especially important for newer monitoring organization staff where the TSA may 

be their first. The auditor should also explain the different phases and timelines of the TSA process, 

including audit preparation, TSA report generation, and post-audit follow-up activities. 

TSA Questionnaire Review 

The TSA Questionnaire is an important tool that helps EPA audit staff walk through important checks 

during the on-site TSA. The audit team should have received the completed TSA Questionnaire from the 

monitoring organization prior to arriving on-site and completed a comprehensive review of the 

documented responses. Specific areas of interest, based upon the monitoring organization’s responses 

(see Section 4.5) should be identified, and the audit team should be prepared to address those 

preliminary concerns during the TSA. 

The TSA Questionnaire meeting can occur at any time during the audit. Some auditors may choose to 

discuss the TSA Questionnaire immediately following the entrance briefing, so that all responses are 

clarified at the beginning. The auditor can then use the days that follow to verify those responses. On 

the other hand, the auditor may choose to discuss the questionnaire at a later time, after he/she has 

had an opportunity to visit some/all of the organization’s facilities and/or review records. Regardless of 

when this discussion takes place, it is important for the auditor to use the time on-site to verify the 

organization’s responses. Ideally, this meeting should occur on-site with the organization’s monitoring 

staff, but a conference call or webinar could be acceptable if resources are not available. Conducting the 

meeting at the organization is the best practice because the organization can easily provide 

documentation to support their answers on the questionnaire. Face-to-face meetings also facilitate 

better interaction between the two parties and tend to be more productive. The meeting may be 

conducted with the same personnel who attended the entrance briefing, but should include monitoring 

staff who contributed to the responses on the TSA Questionnaire. Conducting this meeting with only the 

monitoring manager and/or QA Officer present should be discouraged. While the monitoring manager 

and/or QA Officer may know what should be occurring within the program, it is the auditor’s role to 

verify that the TSA Questionnaire reflects the actual practices in the organization. To develop a more 

accurate understanding of the activities in the organization, it is strongly recommended that staff who 

perform the specific activities documented in the TSA Questionnaire participate in these discussions. 

The best practice would be to work through the TSA Questionnaire by section and meet with only the 

monitoring staff who work in those particular areas. 

Confirmation of the TSA Questionnaire responses may be determined during the TSA Questionnaire 

meeting or during the other parts of the audit such as interviews of staff, observations of procedures, or 

visits to the various organizational departments or sections. Given the length of the TSA Questionnaire 

and the amount of time needed for the monitoring organization staff to document their responses, 

some organizations may check the “yes” or “no” columns without providing detail, or leave sections 

completely blank. Similarly, given the amount of information to review during the TSA, the auditor may 

inadvertently overlook questions where the organization responded “yes”. The auditor should confirm 

the responses of the organization during the on-site TSA. The auditor should ask monitoring 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 50 of 105 

organization staff directly about any questions that do not contain supporting detail or have been left 

blank. If the organization answered “no” to any questions, the auditor should discuss the responses if 

supporting documentation does not justify the “no”. For any response on the questionnaire that is not 

addressed and/or verified during the TSA, the auditor should clearly document in the audit notes that 

he/she did not verify the organization’s response(s) for that particular item. The TSA Questionnaire is a 

record generated during the audit and may be included with the final TSA report. As such, it should be 

accurate in its content. 

Auditing the Monitoring Organization 

Each ambient air monitoring organization is unique and will contain different functional areas within the 

organization. A functional area may be defined as a group of staff tasked with a specific objective or 

responsibility within the monitoring organization. Most of these objectives and responsibilities are 

common to all ambient air monitoring organizations, therefore, the areas should be similar even if the 

groups use different names. The common groups and their general activities and responsibilities that an 

audit team may encounter within an ambient air monitoring organization are: 

•	 Monitoring Headquarters – Organization management and site operators conduct day-to-day 

oversight and operation of the network 

•	 Maintenance and Repair Shop – Maintenance and support staff perform routine monitor or site 

maintenance activities. 

•	 Monitoring Data Review and Validation Group – Data reviewers assess monitoring data from 

the network. 

•	 Quality Assurance Team – Auditors and support staff conduct QA activities and manage the 

quality system. 

•	 Analytical Laboratories – Laboratory analysts perform analyses of ambient air samples. 

•	 AQS Submittal Group – Data handling staff creates and uploads data transactions to the AQS 

database. 

Some functions may also be performed within the same group. For example, the Monitoring Data Group 

may review monitoring data and also handle AQS submittals. It is important to note that some 

organizations house these groups in one centralized headquarters, while other organizations spread 

these groups out across different locations, separate from the organization’s headquarters. It is 

imperative that the audit team have a clear understanding of the organizational structure before 

arriving on-site. Accordingly, the audit plan prepared by the lead auditor should have identified the 

groups and their locations prior to the on-site visit, so that audit team members know who will go where 

and when. 
 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 51 of 105 

Inspecting the monitoring organization’s facilities provides the auditor with a better understanding of 

how the organization functions on a day-to-day basis. Monitoring organization staff typically escort 

auditors to each area or facility, and while doing so should be encouraged to talk about that particular 

area or group and the processes that occur there. Typically, an audit tour includes visits to the 

organization’s primary office spaces (where key monitoring personnel work), as well as to records 

rooms, storage areas (e.g., long-term particulate filter storage), warehouses, sample shipping and 

receiving areas, technical repair/maintenance facilities (“shops”), quality assurance facilities 

(“QA/Standards labs”), and analytical laboratories. When visiting each facility, the auditor should: 

• Determine if there is adequate space to conduct the work 

• Investigate if there is adequate storage to support the operations 

• Identify what equipment is stored in each facility 

• Determine what records are stored on site and ensure the records are tracked and secured. 

Wholesale changes of the facility itself may not result from the audit because of cost and competing 

priorities within the monitoring organization, but it is important to note any observed deficiencies to 

assist in future planning. 

Additional monitoring staff may be present during these facility inspections and should be engaged in 

the audit discussions, when applicable. The auditor should review each area to ensure that it is 

maintained in a manner consistent with its function, as described in the organization’s QAPP and SOPs. 

While visiting each facility, the auditor should check to see if staff members have ready-access to the 

organization’s quality documents. Technical discussions with the monitoring staff at each facility can 

alert the auditor to potential quality system issues. If the auditor observes an inconsistency in practice 

within a particular facility, it could indicate staff are not following their QAPP/SOPs or have not been 

properly trained. Similarly, if an auditor asks questions that staff cannot answer, it could also signal a 

weakness in the organization’s quality system. 

The following subsections provide summaries about these general groups that are common among 

monitoring organizations. The subsections highlight some important areas of interest for the audit team 

within these groups, but do not represent the full scope of what should be audited. 

5.3.1 Monitoring Headquarters 

The monitoring headquarters is typically the “main office” of the monitoring organization. The 

monitoring staff and often the senior management reside at this location. The monitoring headquarters 

may contain the offices for the monitoring staff, records rooms, storage areas, computer network 

locations, and shipping and receiving areas, among others. 

Interviews of the monitoring staff should be conducted at the monitoring headquarters. Staffing levels 

are an important component of any monitoring organization and play an important role in the success of 

the organization and in the quality of the data. The auditor should examine schedules to see how many 

sites are being operated per staff member, which sites are run by whom, and other logistical concerns to 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 52 of 105 

understand how the network is operated. If an organization is stretched too thin the quality of data will 

suffer. The audit team should identify these instances and document them during the audit. Interviews 

with the monitoring staff will also give an auditor insight on how well the staff knows SOPs, QAPPs, and 

other components of the quality system. The monitoring organization is bound to follow all applicable 

CFR regulations. In addition, the QAPP documents the framework and requirements for the quality 

system of a monitoring organization, which is contractual in nature between the monitoring 

organization and EPA. If, through the interview process, a monitoring staff member is unaware of CFR 

regulation or correct procedures or requirements in the QAPP, this illustrates a potential weakness in 

the quality system and a potential for non-conformance to these requirements. 

A training program and training documentation are commonly located at the monitoring headquarters 

and are an important indicator of quality system implementation and organization sustainability. As 

regulations and quality documents change, a monitoring organization must train its staff accordingly. A 

robust training program is the foundation of a good monitoring organization and this should be 

described in the QAPP. The audit team should examine the training curriculum that is required for new 

hires and for existing staff to see if it meets the QAPP description and is adequate. There should be an 

established curriculum for new hires and a continuous training program for existing staff. There should 

also be information that documents the training for all staff members. This is an important aspect of the 

monitoring group as a whole and the audit should allow time to focus on this requirement. 

The majority of data acquisition is usually found at the monitoring organization’s headquarters. The data 

acquisition systems employed by a monitoring organization may differ dramatically from organization to 

organization. Configurations of these systems are complex and include many details. The configuration 

should allow the system to collect data that is required for AQS submittals, as well as allow the QA and 

data review groups to assess the raw and QC data. Instrument performance (diagnostic) data may be 

included in the configuration to aid in troubleshooting remotely as well. In many cases, data channels 

are configured to make automated calculations that should be verified during the audit. Data security is 

an important issue and the system must be protected against unauthorized access or manipulation. 

Data acquisition systems should always be configured in such a way that there is redundancy in data 

capture in case of system failure. Moreover, the entire system should always be archived off-site, to 

prevent data loss in event of catastrophe. The monitoring data is the culmination of all of the monitoring 

work, and its integrity should be protected. An audit team member should have technical knowledge of 

data acquisition systems to ensure that the data acquisition system is functioning properly and is 

capturing and processing the required data accurately. 

5.3.2 Maintenance and Repair Shop 

The maintenance and repair shop contains the staff and resources to maintain, repair, and store the 

monitoring equipment, parts, and standards required to keep the monitoring equipment in good 

working order. This shop typically contains workbenches and storage areas that are utilized with relative 

frequency to maintain the monitoring equipment. The shop should be well-organized and arranged in a 

manner to promote efficiency and quality workmanship. The maintenance and repair shop is an 

important part of the organization as a whole since good maintenance and quick repairs minimize 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 53 of 105 

monitoring down-time and promotes a higher level of data completeness and data quality. The audit 

team should ensure that the space, equipment, and staff are adequate for maintaining the equipment 

necessary for supporting the monitoring program. 

Documentation is a priority in the maintenance and repair shop. All activities that occur in the shop 

must be documented so that there is a record, present and historic, for all equipment involved in the 

collection of monitoring data. This includes calibration standards, gas standards, field analyzers, 

samplers, and testing equipment. If the shop uses a piece of equipment that produces a measurement, 

there should be documentation on file that describes its traceability to a standard of higher authority. 

Documentation for these standards is typically a certificate or a test summary that shows the equipment 

has been tested and has passed the acceptance criteria. A certification may only be valid for a 

prescribed time period. The audit team should investigate equipment records and may choose to copy 

documentation of interest as part of the audit file. 

Each piece of field equipment should also have a uniquely identifiable logbook or record that 

accompanies it in the shop and into the field. The maintenance, repair, and field staff should make 

entries into this logbook to record the maintenance or service that is performed on a monitor. This 

logbook serves to inform the site operator and the shop technician of the status and history of the unit 

and can also aid in troubleshooting. The logbook should contain records involving general maintenance 

and repairs, but could also include calibrations, QC checks, and field observations. The audit team 

should review the logbooks to ensure that a proper accounting of the history of the monitor is 

documented. 

The maintenance and repair shop typically contains spare monitors and storage space for spare 

equipment and replacement parts. The audit team should inventory the spare equipment and parts to 

determine if there is an adequate stock to support the monitoring network. If the stock is not adequate, 

the organization risks lengthy downtimes and poor data completeness. The audit team should also take 

note of the age of the equipment and the FRM/FEM status of the equipment. A monitoring organization 

should be phasing out older technology and investing in newer technology that is appropriate for the 

ambient concentrations observed in the network. For example, if concentrations have fallen to levels 

that are at or near the detection levels of older generation monitors, the monitoring organization should 

be investing in equipment with higher sensitivity. It is also important to note that older models of 

analyzers and samplers may not be supported with service or spare parts by the manufacturer after a 

period of time or after a newer model is released. If a monitoring organization operates unsupported 

equipment in the network this may result in lost data and possible completeness issues. It is important 

for the audit team to promote the use of reliable and sustainable monitoring equipment. 

5.3.3 Monitoring Data Review and Validation Group 

Review and validation of the monitoring data is a central focus of the ambient air monitoring 

organization. Therefore, the audit of data quality must be a central focus of the TSA. A monitoring 

organization may have volumes of documentation that should illustrate the quality of the monitoring 
 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 54 of 105 

data and support that it meets the monitoring requirements. The QA Handbook defines data review 

below: 

“Data validation is a routine process designed to ensure that reported values meet the quality goals of 

the environmental data operations. Data validation is further defined as examination and provision of 

objective evidence that the particular requirements for a specific intended use are fulfilled.” 

The Monitoring Data Review and Validation Group, or data review group, is responsible for reviewing 

data using the monitoring organization’s QAPP. The group should also have a data review SOP that 

describes, in detail, the data review process that is to be followed. This group should contain staff who 

are well versed in the QAPP requirements, the data review SOP, and the regulations. They should also 

be proficient with software and tools to perform various data assessments. Some data review 

responsibilities may be shared by the Quality Assurance Group depending on the organizational 

structure or the distribution of responsibilities. 

Each monitoring program retains an archive of monitoring data records from its monitoring network. 

This data includes raw data, QC data, calibration data, diagnostic data, and other supporting data. The 

data collected should be sufficient to assess program MQOs and to document the history of the data 

point, thereby demonstrating its quality. The audit team should devote significant resources during the 

TSA to monitoring data review and determining its quality and defensibility. 

Monitoring records may be electronic or hand-written. Electronic records from data acquisition systems 

are typically designed to contain all pertinent records for the user. However, hand-written records, such 

as logbooks, that are generated and maintained by the monitoring organization tend to be more 

informal. The audit team should review these types of records to ensure that they have the following 

characteristics. The records should be: 

•	 Maintained - Consistent with the organization’s QAPPs and SOPs 

•	 Current – Reflects the current operations of the organization 

•	 Legible – Clear and readable entries 

•	 Complete – Contains all pertinent information and meets the minimum requirements with 

no data gaps 

•	 Defensible – Entries made in indelible ink; no white-out or pencil 

•	 Signed - Contains proper signatures/initials, dates 

•	 Accessible - Easily retrieved for reference or review 

Tracking Data History 

Tracking a monitoring organization’s data is an important component of the audit because it can reveal 

systematic issues in the data collection process, quality system, and identify weaknesses in the data 

review process. Because of time limitations, the audit team cannot trace the history of each data point 

collected by the monitoring organization; however, the pre-audit activities described in Section 4.4 

should have identified a list of data points of interest for investigation. The audit team should 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 55 of 105 

methodically trace the history of these data points to confirm that all steps in the collection process pass 

QC checks, calibration requirements, traceability requirements, and collection requirements. For 

example, the general flow of tracking the history of an SO2 data point may be: 

1) Monitor is an approved FRM/FEM 

2) Sample residence time has been met 

3) SO2 calibration gases are in certification 

4) The monitor has been calibrated 

5) Calibrator MFC has been calibrated/certified 

6) Electronic data records and strip charts confirm correct calibration 

7) The calibration was documented correctly 

8) Particulate filters in the sample train were changed according to the maintenance schedule 

9) Sample line and probe were cleaned according to the maintenance schedule 

10) QC checks, before and after the collection date, passed acceptance criteria 

11) Electronic data records and strip charts confirm correct QC checks 

12) Logbook shows normal analyzer operation 

13) Raw data from the organization matches the measurement in AQS (were adjustments made 

to the data following collection?) 

14) Relevant data codes or flags are represented in the data, if applicable 

Depending on the organization, the above steps may be different; however, most of these steps should 

be included in a monitoring organization’s data collection process. The audit team should be able to 

follow the data collection path and examine documentation for each step in the process. The auditor 

should document the findings and note the areas where the data history could not be followed or 

confirmed. 

Data Review Process 

The audit team should have already reviewed monitoring data retrieved from AQS and should be 

prepared to discuss relevant findings with the data review group. The data review group should have an 

approved data review procedure in place and a prescribed timeframe specified to routinely review data. 

Different techniques or tools may be used by the monitoring organization to assess the monitoring data 

to investigate anomalies, outliers, or other data that may be suspect. Tools such as data acquisition 

features, control charts, or spreadsheets may be employed in the organization’s review process. 

Through the audit planning phase, the auditors should have a grasp of the methodology used by the 

data review group. 

The audit team should look for evidence on-site that the organization has reviewed and validated data 

in accordance with its QAPPs and SOPs. Common evidence to look for during an audit are hardcopy data 

review packages with signatures and dates, electronic spreadsheets with electronic signatures and 

dates, or functionality within a data acquisition system that can be signed electronically. Data validation 

will always require supporting documentation to detail and justify a change or to support the data as it 

was recorded. Common supporting documentation that may be reviewed include: 
 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 56 of 105 

•	 Minute data (electronic or paper strip chart records) 

− Helps illustrate data validity, as well as show graphically issues that hourly averages will 

mask
 

− Shows the stability of QA/QC checks
 

− Can confirm concentrations
 

• Calibration records or spreadsheets 

• Logbook entries 

• Maintenance records or spreadsheets 

• QC check records or spreadsheets 

• Performance audit reports 

• Corrective action reports 

The audit team should review the supporting documentation to determine if the data has been handled 

appropriately. Is there enough detail in the records that can easily recreate events and justify null value 

codes or data qualifiers? If the supporting documentation does not detail the timeline of data collection 

accurately or it does not exist, the defensibility or validity of the data may be compromised. 

Other data may also be reviewed as discussed in Section 4.4.3 of this QAGD, including PM2.5 QC data 

(e.g. lab blank data, room temperature and humidity data, balance checks), analytical laboratory data 

(e.g. CCV, calibration curves, media blanks), and monitoring shelter temperature data. These data may 

be reviewed by the data review group or a different group within the organization. Often, laboratory 

data is reviewed by a separate group with specialized processes and expertise. It is important for the 

auditor to determine who has the responsibility of reviewing all the data collected in a monitoring 

organization and include it in the audit. 

5.3.4 Quality Assurance Group 

Each monitoring organization should have an independent group that is responsible for ensuring that 

the quality system defined in the monitoring organization’s QAPP is implemented and is functioning 

correctly. A core concept in any quality system is to continually assess a program or operation to 

improve the process and ensure that requirements are consistently being met. This group assesses the 

program through a variety of quality assurance and quality control activities, including quality document 

development (QMP, QAPPs, SOPs), internal systems audits, performance audits, corrective action 

assessment, and QC data review. The audit team must ensure that the QA Group is functioning 

effectively and is enforcing the prescribed requirements in the monitoring organization’s QAPP. 

One of the most important aspects of the QA group that the audit team must investigate is its 

independence. 40 CFR Part 58, Appendix A, § 2.2 discusses the role of the QA group and its 

independence in the following way: 

“The quality assurance management function must have sufficient technical expertise and management 

authority to conduct independent oversight and assure the implementation of the organization's quality 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 57 of 105 

system relative to the ambient air quality monitoring program and should be organizationally 

independent of environmental data generation activities.” 

The quality assurance group should be independent so that it may oversee the quality system and make 

decisions without bias. The audit team should ensure that the quality assurance staff, or those who 

conduct quality assurance activities, are not the same staff who are engaged in the day-to-day 

monitoring or sampling activities. 

One of the QA group’s responsibilities is the development of the quality documents including the QMP, 

QAPP, and SOPs. All of these documents typically originate in the QA group and should be maintained by 

this group as well. Prior to the audit, the audit team should have reviewed these documents in 

preparation for the on-site audit. The approved documents should be on file with the QA group. During 

the audit, the auditors should determine if the quality documents are up-to-date with the current 

equipment and procedures. These documents should also be controlled, meaning that the documents 

distributed throughout the network are the current versions and not editable. Out-dated versions of the 

quality documents that are found in the organization can result in data that does not meet the current 

QC requirements and can cause confusion or inconsistency in management processes or equipment 

operation. For example, a regulation change results in a QC check for a pollutant being changed from 10 

ppb to 5 ppb, and the organization’s QAPP and related SOPs are revised to reflect the change. If the old 

QAPPs and SOPs are not removed and replaced with the new documents, there is a risk that operators 

in the field will continue using the old check requirements, which could put data at risk of invalidation or 

flagging. If the quality documents are out of date, not being followed, or do not exist, the audit team 

must investigate why. If the quality documents are neglected, the auditors should investigate further to 

determine whether adequate resources have been given to the QA group or if the necessary expertise is 

missing. 

A primary role of the QA group is to perform audits of the monitoring organization. Annual performance 

audits and internal systems audits (ISA) are the two most common types of audits that are typically 

conducted by the QA group. Direction for performing the annual performance audits is provided in 40 

CFR Part 58, Appendix A § 3.1.2. ISAs are not specifically required by CFR, but they should be included in 

the QAPP as part of a robust quality system. In assessing the annual performance audits, the audit team 

would have observed the number and results of the audits in AQS during the planning phase of the TSA. 

While on-site, the audit team should review the annual performance audit documentation and the 

procedures that were followed. The documentation should match what was found in AQS, and the 

methodology for the audit must be consistent with the CFR direction and the monitoring organization’s 

QAPP. If ISA s are conducted by the QA Group, they should be reviewed during the audit. These audits 

vary in scope, but as a best practice, they should cover the majority of the ambient air monitoring 

program of the monitoring organization. The ISAs are useful in providing the audit team with an 

overview of how the monitoring organization and the quality system functions and how well the 

organization implements corrective action. The audit team should investigate the ISA procedures and 

reports and identify shortcomings and recommend improvements. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 58 of 105 

Another important responsibility of the QA group is corrective action oversight. An ineffective corrective 

action process is an indicator of a weak quality system and may result in poor data quality. Findings in 

audits, failed QC checks, or lost data, for example, should trigger corrective action. The QA group is 

responsible for developing a corrective action program and ensuring that corrective action has been 

implemented and has been successful in correcting problems that were identified. The audit team 

should investigate first-hand how this process functions on-site. Documentation should exist that 

describes the problem, shows action taken, and provides evidence that the action has been successful. 

The auditors should spend enough time with the corrective action process to ensure that the process is 

functioning effectively. If there is no, or limited, corrective action, the same deficiencies will continue 

long-term and affect data quality. 

The QA group may also have the responsibility of reviewing data from the monitoring network. Data 

review may be completed by several groups in different ways, but the QA group is responsible for 

monitoring QC checks and assessing their impact on the routine monitoring data. These reviews may be 

completed using spreadsheets, control charts, or other means. Minimally, the QC data should be 

reviewed monthly, but weekly or even daily is recommended to reduce the amount of data that may be 

affected by a quality issue. The audit team should ensure that the QC review is occurring in a timely 

manner. Also, the audit team should ensure that the correct data qualification or data invalidation 

decisions are being made. 

5.3.5 Analytical Laboratories 

An analytical laboratory audit can be a complex and in-depth process. There may be numerous analytical 

methods employed by a laboratory to provide analytical support for the different air pollutants. This 

section offers general guidance for the NAAQS and other monitoring programs that may be encountered 

during the TSA. 

During the pre-audit phase, the audit team identified the laboratories that exist in an organization and 

developed a plan to audit them. There are a variety of analytical methods and analytical equipment that 

may be used in a laboratory. Because of the complexity of laboratory audits, it is essential that the audit 

team contain at least one member with technical knowledge and expertise in the specific laboratory 

operation/method under review. When auditing each of the methods, the audit team should engage 

with the analyst as they perform the analytical method, observing and questioning the analyst 

throughout the process. It is also important to listen to the analyst as he/she describes the process to 

determine if what is being done in the laboratory corresponds with the method and the SOP. If the audit 

team lacks expertise in analytical laboratories, they may investigate hiring a contractor to conduct the 

laboratory portion of the audit. If the use of a contractor is necessary, the audit team should observe 

the contractor during the audit with the intent of gaining the expertise necessary to conduct the 

laboratory audit in the future. 

It is critical that the auditor ensure that the laboratory is, and has been, following the applicable CFR 

federal reference and/or equivalent methods required for the analyses. However, some air analytical 

methods, such as those used to analyze air toxics pollutants, have no CFR requirements and are guided 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 59 of 105 

by a Technical Assistance Document (TAD). In either case, the monitoring organization must commit to 

following an applicable method of analysis in their QAPP for each analyte. The language in the QAPP 

binds the monitoring organization to the referenced method. The monitoring organization may also 

have specific language in their grant requirements, and those stipulations must be referenced and 

adhered to as well. The auditor must be aware of these commitments and verify they are being met 

during the TSA. 

EPA typically develops guidance documents to assist the monitoring organization in the implementation 

and quality assurance of a specific method. It is strongly recommended and is considered best practice 

to follow the guidance. Regardless of guidance, the CFR federal reference methods must always be 

followed and are not negotiable. 

Laboratories within an ambient air monitoring organization that may be audited during the TSA include: 

• PM2.5 and/or Low-Volume PM10 Gravimetric Laboratories 

• Hi-Volume PM10 Gravimetric Laboratory 

• Lead (Pb) Laboratory 

• PM2.5 Chemical Speciation Laboratories 

• Air Toxics Laboratories 

Table 5.1, Pollutants and Corresponding Reference Methods and Guidance Documents, lists the 

pollutant/analyte and reference information regarding the specified method and EPA guidance that has 

been developed to support the reference method. It is strongly recommended that the audit team 

member charged with investigating the laboratory(s) be familiar with these methods and guidance and 

have some experience in a laboratory environment. 

Table 5.1 Pollutants and Corresponding Reference Methods and Guidance Documents 

Pollutant CFR Reference 

Method1 

Guidance Document Guidance Document Web Links 

PM2.5 mass 40 CFR Part 50, 

Appendix L QAGD 2.12 https://www3.epa.gov/ttn/amtic/file s/ambient/pm25/qa/m212.pdf 

PM10 (lowvolume) 40 CFR Part 50, 

Appendix L QAGD 2.12 https://www3.epa.gov/ttn/amtic/file s/ambient/pm25/qa/m212.pdf 

PM10 (highvolume) 40 CFR Part 50, 

Appendix J QAGD 2.11 https://www3.epa.gov/ttn/amtic/file s/ambient/qaqc/m211.pdf 

Pb (lowvolume) 40 CFR Part 50, 

Appendix Q 

Generic ICPMS FEM SOP Pb 

PM10 

https://www3.epa.gov/ttn/amtic/file 

s/ambient/pb/EQL-0512-202.pdf 

Pb (highvolume) 40 CFR Part 50, 

Appendix G Generic ICPMS FEM SOP Pb TSP https://www3.epa.gov/ttn/amtic/file s/ambient/pb/EQL-0512-201.pdf 

PM2.5 

Chemical 

Speciation 

None Laboratory Standard Operating 

Procedures (SOPs) 

https://www3.epa.gov/ttn/amtic/spe 

csop.html 
 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 60 of 105 

PAMS None Under development Under development 

Air Toxics None Technical Assistance Document https://www3.epa.gov/ttn/amtic/file 

for the National Air Toxics s/ambient/airtox/nattsTADRevision2 

Trends Stations Program _508Compliant.pdf 

VOC None VOC – TO-15 Determination Of https://www3.epa.gov/ttn/amtic/file 

VOCs In Air Collected In 

Specially-Prepared Canisters 

And Analyzed By Gas 

Chromatography/Mass 

Spectrometry (GC/MS) 

Carbonyls – TO-11A 

s/ambient/airtox/to-15r.pdf 

Carbonyls None Determination of Formaldehyde https://www3.epa.gov/ttn/amtic/file 

in Ambient Air Using Adsorbent 

Cartridge Followed by High 

Performance Liquid 

Chromatography (HPLC) 

[Active Sampling Methodology] 

Metals – IO-3.5 Determination 

s/ambient/airtox/to-11ar.pdf 

Metals None of Metals in Ambient Particulate https://www3.epa.gov/ttn/amtic/file 

Matter Using Inductively 

Coupled Plasma/Mass 

Spectrometry (ICP/MS) 

PAH – TO-13A Determination of 

s/ambient/inorganic/mthd-3-5.pdf 

PAH None Polycyclic Aromatic https://www3.epa.gov/ttn/amtic/file 

Hydrocarbons (PAHs) in Ambient 

Air Using Gas Chromatography 

/Mass Spectrometry (GC/MS) 

s/ambient/airtox/to-13arr.pdf 

1 – CFR methods may be found at www.ecfr.gov 

The following sections summarize, in limited detail, each of these laboratories. The intent of the 

summaries is to provide the auditor with a general overview of a laboratory’s function, the types of 

equipment that may be observed, and important points of interest in the laboratory. 

Every sample that is collected and transported requires a chain-of-custody. The chain-of-custody 

provides the legal documentation of the life of the sample and provides a trail tracking its custody over 

the duration of the sample. For example, a sample may be collected in the field by an operator, brought 

to a shipper, received at a laboratory, and finally analyzed at a laboratory. The chain-of-custody tracks 

and documents this process. Typical information required on a chain-of-custody includes: 
 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 61 of 105 

• Sample collection location 

• Sample collection date and time 

• Sample matrix/media 

• Sampler/Site operator 

• Sampler/Site operator contact information 

• Sample relinquished to contact, date and time 

• Laboratory name 

• Laboratory contact information 

• Sample analysis requested 

• Sample condition 

• Additional instructions 

• Sample returned to laboratory contact, date and time 

For each laboratory, the audit team should pull several chain-of-custodies at random to determine if: 

• they are completed in accordance with the organization’s QAPPs and SOPs; 

• they are complete (e.g. signatures, times); 

• they adequately track sample custody; 

• they are legible; 

• they are completed in indelible ink; 

• strikethroughs are initialed and dated with the correct entry; and, 

• they are easily accessible. 

Chain-of-custodies that do not meet the criteria above, at a minimum, place the samples’ integrity and 

defensibility at risk. The audit team should carefully examine these documents to ensure that they can 

stand up to legal scrutiny if necessary. 

PM2.5/Low-Volume PM10 Gravimetric Laboratory 

The PM2.5 gravimetric laboratory includes the necessary space for an analyst(s) to receive, inspect, 

equilibrate, weigh, and ship low-volume Teflon© filters. 40 CFR Part 50, Appendix L contains the federal 

reference method that the PM2.5 weighing laboratory must follow, and the Quality Assurance Guidance 

Document 2.12 is the technical guidance for the method. The technical memorandum “Clarification on 

Use of PM2.5 Field and Laboratory Requirements for Low Volume PM10 Monitoring to Support PM10 

NAAQS8

” requires all low-volume PM10 laboratories supporting NAAQS sites to follow 40 CFR Part 50, 

Appendix L as well. 

Generally, work in a low-volume PM laboratory is divided between two phases: pre-sampling and postsampling. Pre-sampling includes the activities that precede the filter being shipped to the field and being 

placed in the sampler, while the post-sampling activities begin after the filter is received from the field. 

The following is a brief description of both phases of activity. 

8 https://www3.epa.gov/ttn/amtic/files/policy/pm10-low-vol.pdf 
 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 62 of 105 

Pre-sampling: 

1. Filters are received from EPA and examined for integrity. 

2. Filters are logged into the laboratory data management system. 

3. Filters are equilibrated and pre-weighed according to SOPs. 

4.	 Filters are loaded into sampling cassettes and shipped to field offices along with accompanying 

COC requirements and documentation. 

Post-sampling: 

1. Filters are received in the laboratory facility, checked for integrity, and logged in. 

2. Filters are kept in cold storage until ready for weighing. 

3.	 When ready for weighing, filters are brought into the weighing facility and equilibrated for at 

least 24 hours. 

4.	 Filters are post-weighed according to SOPs, and data are entered into the data management 

system where a concentration is calculated. 

5. After weighing, filters are stored in archive for 5 years, with the first year under cold storage. 

Because of the small amounts of particulate collected on the filters, the laboratory should be 

constructed and maintained as a “semi-clean room”. This means that the laboratory operates with many 

protocols generally seen in clean rooms, but some clean room protocols are relaxed. These laboratories 

will contain microbalances that are capable of weighing to the microgram, which require specialized 

equipment and conditions. One of the most important requirements of a gravimetric laboratory is 

climate control. To weigh the small amounts of particulate collected on the filters, the effects of relative 

humidity and temperature on the filters and the weighing equipment must be controlled. In the same 

manner, static electricity will affect the filter weights on the balances and must be controlled. Quality 

control procedures and weighing equipment may require certifications or calibrations at various points 

throughout the year. Because of these QC steps, equipment, and requirements in the filter weighing 

method, the gravimetric laboratory will have a large amount of documentation that the lab is, and has 

been, following the method. The audit team should plan enough time to track the data through the 

laboratory using these records. 

In auditing this lab, the audit team should select staff members who have expertise in low-volume PM 

labs. 40 CFR Part 50, Appendix L, the 2.12 guidance document, and Appendix C of this QAGD provide 

more detail regarding the method and illustrate the entire scope of the laboratory operations. 

Hi-Volume PM10 Gravimetric Laboratory 

The high-volume PM10 gravimetric laboratory resembles the low-volume PM2.5 laboratory, but many of 

the lab design parameters and acceptance criteria are less stringent than the “semi-clean room” 

requirements specified for PM2.5. As in low-volume weighing labs, the laboratory provides space for a 

gravimetric analyst(s) to receive, inspect, equilibrate, weigh, and ship high-volume filters. These filters 
 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 63 of 105 

may be glass or quartz fiber. 40 CFR Part 50, Appendix J contains the federal reference method for highvolume PM10 filter weighing, and the Quality Assurance Document 2.11 supports the method. 

Work in a high-volume PM10 laboratory is divided into pre-sampling and post-sampling activities as in 

low-volume PM labs. The following is a brief description of both phases of activity. 

Pre-sampling: 

1.	 Filters are received from EPA and examined for integrity. 

2.	 Filters are logged into the laboratory data management system. 

3.	 Filters are equilibrated and pre-weighed according to SOPs. 

4.	 Filters are loaded into envelopes or sample transport modules and shipped to field offices along 

with accompanying COC requirements and documentation. 

Post-sampling: 

1.	 Filters are received in the laboratory facility, checked for integrity, and logged in. 

2.	 Filters are placed into a conditioning chamber until ready for weighing; equilibration is for a 

minimum of 24 hours. 

3.	 Filters are post-weighed according to SOPs, and data are entered into the data entry system, 

where a concentration is calculated. 

4.	 After weighing, filters are stored in archive. 

The high-volume PM10 laboratory includes all areas and equipment needed to complete the steps above 

according to regulations and guidance. The laboratory should be clean and well organized. Climate 

control tolerances are less stringent in the high-volume PM10 laboratory; however, temperature and 

relative humidity are still controlled so that the particulate collected on the filters can be measured 

without the influence of water vapor. Static electricity could affect the filter weights on the balances, 

but to a lesser degree than in low-volume gravimetric laboratories. High-volume glass fiber or quartz 

filters are delicate in nature and lack the filter-support rings that are common on low-volume Teflon 

filters. Additionally, the analyst typically handles these larger filters with gloved hands, as opposed to 

using Teflon forceps. The analyst should exercise care in handling these filters in order to avoid loss of 

particulate; auditors should make efforts to observe the filter handling techniques of the analyst during 

the TSA. Quality control procedures and weighing equipment require certifications or calibrations at 

various points throughout the year. Because of these QC steps, equipment, and requirements in the 

filter weighing method, the gravimetric laboratory will have a large amount of documentation that the 

lab is, and has been, following the method. The audit team should plan enough time to review these 

records. 

As a best practice, the PM10 high-volume and low-volume gravimetric laboratories should not occupy 

the same space. However, it can be done, if necessary, if care is exercised to limit the potential for 

contamination. If both labs share the same space, it is highly recommended that each activity – high and 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 64 of 105 

low-volume filter weighing – be conducted in different areas of the weighing room and, ideally, on 

different days. Sharing of equipment should be discouraged. 

In auditing this lab, the audit team should select staff members who have expertise in high-volume PM 

labs. 40 CFR Part 50, Appendix J and the 2.11 guidance document contain more detail regarding the 

method and provide the entire scope of the laboratory operations. 

Lead (Pb) Analysis Laboratory 

The Pb analysis laboratory includes the facility that provides the space and equipment for an analyst(s) 

to receive and analyze filters used for Pb sampling in the monitoring network. Pb can be sampled using 

two different methods, high or low-volume sampling. High-volume sampling requires the use of glass 

fiber filters and low-volume sampling requires the use of Teflon© filters. An FRM analytical method is 

available for each collection method (high and low-volume) and several FEM analytical methods are 

available for use as well. If an organization chooses to develop an FEM, then ORD must approve the 

method before use. A listing of all approved FEM Pb methods is located on AMTIC9

. The auditors should 

already know which method is being used through the audit preparation process and should verify its 

use and correct implementation in the lab. The low-volume Pb FRM is located in 40 CFR Part 50, 

Appendix Q, and the high-volume FRM is located in 40 CFR Part 50, Appendix G. There are generic ICPMS FEM SOPs provided as guidance for both Pb in TSP and Pb in PM10. Links to these SOPs can be found 

in Table 5.1. 

All Pb methods typically have a filter digestion and digestate analysis component. However, there are 

many ways to conduct these processes and many instruments that may be involved in the analysis. For 

this reason, it is of utmost importance to have an audit team member who is experienced in a 

laboratory environment and who understands multiple analytical methods and types of 

instrumentation. 

The Pb analysis laboratory contains instrumentation, standards, data collection systems, and 

preparatory areas to perform the analytical method chosen by the monitoring organization. Regardless 

of method, best laboratory practices should be used at all times during the preparation and analysis of 

the filters. All methods will have QC steps or checks that the auditor must review, and the QC checks 

may be different depending on the method. The auditor should consult the FRM/FEM method and the 

QAPP to determine which QC checks should be investigated. The instrumentation used to analyze Pb 

samples, such as an ICP-MS, generates a large amount of data including calibration curves, QC checks, 

and chromatograms. Again, it is important for the audit team to include a chemist who understands 

these types of data packages and can assess this information quickly. 

Appendix D of this QAGD contains a Laboratory Systems Review checklist for Pb in Air developed to aid 

the auditor in performing an audit of a Pb laboratory. As described above, Pb laboratories have the 

option to conduct analyses using the FRM, an FEM, or develop and implement their own FEM through 

9 https://www3.epa.gov/ttn/amtic/files/ambient/criteria/AMTIC%20List%20Dec%202016-2.pdf 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 65 of 105 

ORD’s approval process. The differences in each of these methods can make Pb laboratory audits 

difficult since it would require an auditor to have knowledge of all published methods. The checklist 

does not include specific QC criteria or detailed procedural steps that will be unique to each method. 

However, commonalities exist in all of the methods, and laboratory best practices are consistent 

throughout the methods. The checklist provides a compilation of these method consistencies that the 

auditor can use to assist in auditing the laboratory. To use the checklist effectively, the auditor must be 

familiar with the requirements of the specific FRM or FEM that is currently in use in the laboratory and 

supplement the checklist with its specific method criteria. Using the checklist in conjunction with the 

laboratory’s approved analytical method and quality system requirements will assist the auditor in 

effectively auditing the Pb laboratory to ensure it is operating effectively and producing quality data. 

PM2.5 Chemical Speciation Laboratories 

PM2.5 chemical speciation laboratories generally support the PM2.5 chemical speciation network and 

analyze for an array of cations, anions, carbon species, trace elements, and semi-volatile organic 

particles. These analytes are collected on different types of media and analyzed using different methods 

such as ion chromatography, X-ray fluorescence, and gas chromatography/mass spectroscopy. Most 

monitoring organizations use the PM2.5 CSN contract laboratories; however, a few monitoring 

organizations have chosen to conduct these analyses in-house. The PM2.5 chemical speciation 

laboratories are audited every three years by OAQPS (or its contractors) as part of the national QA 

oversight responsibilities. Regional audit teams are encouraged to audit the PM2.5 chemical speciation 

labs during the TSA if the audit team has the resources and expertise. Audit materials that are used 

nationally are available through OAQPS if the audit team chooses to include this lab. Also, audit team 

members are encouraged to accompany the national auditors if possible. 

Many laboratories that support the PM2.5 CSN network have posted SOPs online that monitoring 

organizations may use as reference or as an audit template. There are no FRM or FEM methods 

specified for PM2.5 chemical speciation laboratories. However, monitoring organizations that choose to 

perform the analyses in-house must have their own approved SOPs and QAPP for their specific program. 

The audit team should use these documents to conduct the TSA. As suggested with other laboratories 

that employ complex analytical methods, the audit team should include a team member that 

understands the methods, best laboratory practices, specific QC, and can review the data from the 

various instrumentation used in the analysis. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 66 of 105 

Air Toxics Laboratories 

Air toxics laboratories support the NATTS, PAMS, UATMP, and community scale studies. Air toxics 

monitoring typically involves analysis for VOCs, carbonyls, PAHs, and metals. VOCs and carbonyls are the 

only compounds that are required in the PAMS program that may require an analytical laboratory. The 

methods for air toxics sampling and analysis are dictated in the NATTS TAD, which are based on EPA TO 

and IO methods. NATTS labs are required to follow the TAD, while other toxics programs are encouraged 

to comply with the NATTS TAD. These analytical methods are listed above in Table 5.1. 

Air toxics laboratories that support the NATTS and PAMS programs are audited by OAQPS (or its 

contractors) as part of national QA oversight. The air toxics TSAs typically do not occur at the same time 

as the regional TSAs of the PQAOs. Regional auditors are invited to participate in these audits if 

resources allow. During years where audits are not performed by OAQPS (or its contactors), regional 

audit teams are encouraged to include these labs in their TSAs if possible. Air toxics labs that do not 

support the NATTS program are not audited through the NATTS program. In the audit planning activities, 

the audit team should have identified if the toxics laboratory is part of the national audit program or if it 

needs to be included in the TSA. 

NATTS laboratories are required by the NATTS program to have EPA-approved QAPPs and SOPs that are 

based on the NATTS TAD and its included methods. The audit team should be aware that the NATTS TAD 

is a performance-based document, but it has some specific requirements that must be followed. For the 

performance requirements, the auditor should be prepared to review data and processes that verify 

that the laboratory is meeting the requirements. Because of the complexity of the methods, it is 

essential that a skilled chemist is included on the audit team who is well acquainted with the NATTS 

TAD, its QC requirements, and understands the concept of performance-based requirements. 

5.3.6 AQS Submittal Group 

Every monitoring organization must submit its ambient monitoring data to the AQS. Ambient monitoring 

data includes: 

• Monitoring data (measurements) 

• Quality control data 

• Site metadata 

• Network metadata 

Each monitoring organization typically has a group dedicated to generating and uploading the data 

transactions to AQS. This process can be relatively complicated and the staff should have the necessary 

skills and training to accomplish this task. Pre-audit review should have verified that the monitoring data 

is being submitted completely and in a timely manner. Additionally, the audit team should have 

reviewed the data to ensure that it has been coded or flagged appropriately. 
 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 67 of 105 

Along with the measurements from the analyzers and samplers, site and network metadata must be 

submitted and maintained in AQS. This information includes information from the sites themselves and 

the equipment operating at the sites. AQS requires the use of codes and other specific AQS parameters 

for the data. Some examples of this metadata are: 

• Network affiliation 

• Parameter codes 

• Monitor types 

• Unit codes 

• Ozone seasons 

• Site addresses 

• Site names 

• GPS coordinates 

• Collection frequencies 

• NAAQS exclusion codes 

This monitoring metadata is used for various types of assessments and the audit team should verify that 

that this data is correct in AQS. Issues discovered during the planning phase of the audit should be 

discussed during the visit to the AQS Data Submittal Group. While some of the metadata review can 

take place during the audit planning phase, the actual verification of equipment must occur on-site. 

Reviewing AQS codes and site configurations can be an arduous task and should be completed by an 

audit team member that possesses knowledge and experience using AQS. 

The audit team should also ensure that the AQS submittal staff has the appropriate supporting materials 

and information from the monitoring and QA staff to properly code the data for upload to the AQS. The 

AQS staff should have records that corroborate data qualifiers and null codes, and the audit team should 

review these records to ensure that the coding is correct. Additionally, the audit team should compare 

the monitoring organization’s records to the AQS reports to ensure consistency. It is essential that the 

data and any qualifiers in AQS accurately reflect the supporting documentation on-site. 

Standards Certification Records Review 

In support of the network’s quality system, monitoring organizations use various types of precision 

equipment and standards to perform QC checks, calibrations, and certifications. Each piece of 

equipment or standard used in the network must have certification documentation that demonstrates 

its traceability back to a reference standard of higher authority, such as a NIST or a primary standard. 

The equipment used in the network must compare to the reference standard within acceptance criteria 

documented in the QAPP and/or CFR. The monitoring equipment and standards include, but are not 

limited to, gaseous standards, photometers, calibrators, MFCs, flow standards, manometers, orifices, 

and other equipment. Each of these devices must have specific certification documentation that the 

audit team should examine. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 68 of 105 

The audit team should review certification records for all standards in use by the organization during the 

3-year audit period. Each standard used in the network should be traceable, and the standard must have 

been in certification throughout the three-year time period. If the organization has an in-house 

certification program in the maintenance and repair shop, the audit team should ensure that this 

equipment has also been calibrated against standards of higher authority or accuracy. For example, a 

flow meter used in the field for QC checks with an accuracy of 0.3 LPM should be calibrated or certified 

using a certified device with higher accuracy, such as 0.1 LPM. For small organizations, the audit team 

may be able to review all standards certifications, while only a representative subset may be examined 

for a large organization. For large organizations with district or local offices, the audit team should 

request documents from these locations during the on-site audit. 

The audit team should verify that the certification records contain the following information: 

• Dates and environmental conditions at the time of certification 

• Device receipt condition (in tolerance/out of tolerance) 

• Device returned condition (in tolerance/unable to meet tolerances) 

• Statement of traceability 

• Standard(s) used to conduct certification 

• Calibration method performed 

• Calibration interval/expiration 

• Contact information of certifying authority 

Typically, the information above is standard in a vendor certification; however, in-house certification 

program certificates should be closely scrutinized to ensure this information is documented. If the 

information listed above is not included in the certificates, the audit team should note these findings. 

Monitoring Site Inspections 

Monitoring data collection begins in the field. Therefore, data quality depends on good field practices. 

During a TSA, it is essential that the audit team visits and inspects the organization’s air monitoring 

stations. While on site, the auditor should inspect both the exterior and interior of the monitoring 

station. Routine operations, site housekeeping, safety, quality control activities, documentation, and 

siting criteria are areas that should be reviewed. 

Safety is always the top concern when auditing monitoring sites. Two auditors are recommended to 

efficiently and safely inspect monitoring sites. Using a second auditor to record measurements and 

identify potential hazards is the best practice when the inspection requires an auditor to work on a 

rooftop or ladder taking measurements, tracing sampling lines, or other activities where safety may be a 

concern. Also, no two auditors have the same level of expertise on all aspects of monitoring; therefore, 

a combination of auditors can conduct a more thorough and complete audit. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs

Revision 0

Date: 11/2017

Page 69 of 105

The size of the network and resources allotted for the TSA may dictate how many monitoring sites can

be visited. While it may be possible to visit all monitoring sites in a small organization, it may not be

possible to visit all sites in a larger organization. The audit team should, at a minimum, select enough

monitoring sites to observe all sampler types that are operated in an organization, and select sites that

are maintained by different site operators and/or via different management structures. This approach

will help the auditor to determine if the standard operating procedures are being consistently followed

and to acquire general information on the maintenance of the monitoring sites from operator to

operator.

Accurate data is contingent upon instruments (monitors, samplers) that are properly calibrated,

operated, and maintained by a trained and conscientious site operator. The site operator is responsible

for the collection and handling of manual air samples (particulates, toxics) and the operation of

continuous air monitors. The site operator is also responsible for conducting routine QC checks,

conducting varying degrees of maintenance, and implementing corrective action. Proper documentation

of these activities and the resulting data is essential. Therefore, the audit team should reserve time onsite to interact directly with the site operator to discuss the above activities, as well as to inspect the

field sites, equipment, and available documentation. The audit team should also attempt to observe the

site operator’s sample handling techniques and any other routine activities at the monitoring site. Oneon-one interaction with the site operator is desired during these activities, without the involvement 

from supervisors or other management, to encourage candid feedback.

The organization’s QAPPs and SOPs should detail field procedures and specify the acceptance criteria for

instrument QC checks. Section 4 discusses the importance of reviewing the organization’s QAPPs and

SOPs prior to conducting the TSA. Reviewing these documents prior to the on-site audit will alert the

auditor to any potential issues that may need to be inspected or clarified during the on-site TSA. In the 

absence of an in-depth review of the quality documents, technical discussions with the site operator(s) 

and review of documents and data in the field can alert the auditor to potential quality system issues (or

issues with quality systems documents). For example, if the auditor observes an inconsistency with field

practice(s) across a network, it could indicate the site operators are not following their QAPP/SOPs or 

have not been properly trained. Similarly, if an auditor asks the site operator what their QAPP/SOP says

about a particular procedure or requirement and he/she does not know the answer, then it could be a

sign that the site operator is not being trained or isn’t using the quality documents. It could also be a

sign that the quality documents need revision, because they lack critical information to help the site

operator do an adequate job.

Additionally, the auditor should discuss issues raised during the TSA Questionnaire meeting with field

staff to further clarify the responses received on the questionnaire. This can provide insight into how

consistently the organization is operating.

While not a core component of the TSA, some audit teams may choose to conduct performance audits

on air monitoring instruments during the site visit, such as sampler flow rate, barometric pressure, and
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 70 of 105 

temperature checks. The auditors may also examine PM2.5 PEP, Pb-PEP, and NPAP data to gauge 

instrument performance. 

5.5.1 Inside the Monitoring Station 

Inside the monitoring station is where the majority of the ambient monitoring work occurs, and most 

continuous analyzers and support equipment will be found inside the station. The construction of a 

monitoring station can range from a stand-alone shelter to a room inside of a larger building, such as a 

school. Monitoring sites can also have varying amounts of equipment, from a single particulate sampler 

to an NCore site measuring all NAAQS pollutants. Nevertheless, all monitoring sites include common 

items and are operated in a similar fashion. An experienced auditor can enter any monitoring station 

and quickly recognize what is being monitored and the methods that are employed. A novice auditor 

may need assistance in understanding the methodologies. Common audit activities or items to inspect 

and document inside an air monitoring station could include: 

•	 Sample lines and manifold material (appropriate probe material for pollutant of interest) 

•	 Sample lines and manifold condition (clean, condensation-free) 

•	 Manifold designs (properly functioning blower, no uncapped calibration lines or ports) 

•	 Housekeeping (clean, organized) 

•	 Potential sources of sample/measurement contamination (gasoline-powered weed-trimmers, 

dust, cigarette smoke) 

•	 Properly labeled chemicals in secure containers 

•	 Safety issues (electrical issues, compressed gases unsecured, etc) 

•	 Availability of safety equipment and first-aid kits 

•	 Appropriate sampling equipment (FRM/FEM status) 

•	 Examination of maintenance records (samplers, monitors, support equipment, station) 

•	 Examination of an analyzer using a specific monitor checklist (if available) 

•	 Cylinder certification dates (in certification, certification document available) 

•	 Calibrator certification dates (in certification, certification document available) 

•	 Other standards certification dates (in certification, certification document available) 

•	 Monitoring and support equipment age (analyzers, samplers, calibrators, data loggers) 

•	 Residence time calculations for sample paths 

•	 Documentation (logbooks, spreadsheets, bench sheets) 

•	 SOPs and user manuals 

•	 Availability of maintenance supplies (o-rings, scrubber refills, common replacement parts) and 

tools 

While inside the site, the audit team should work with the site operator to access the data acquisition 

system and retrieve monitoring data and chart measurements over a specified period. This exercise 

demonstrates that the site operator has the expertise to access the monitoring data and assess the 

operation of the equipment at the site. The site operator should also be able to easily move through the 

menus of the instruments to access diagnostic data. During the audit planning phase in Section 4.4.3, 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 71 of 105 

the audit team may have identified datasets for inspection that are not accessible using AQS, such as 

shelter temperature and calibration data. The monitoring site inspection provides an opportunity for the 

audit team to see these data and collection methods. If the site operator cannot operate the data 

acquisition system or is unfamiliar with basic operations, this is an indicator that site operator has not 

been properly trained. 

The age of monitoring equipment at the site (including analyzers, samplers, calibrators, and data 

loggers) is important to highlight. EPA monitoring cost estimates include an amortization schedule of 

seven years for the replacement of monitoring and sampling equipment. It is very important to ensure 

that the equipment used on-site is technologically capable of performing the tasks intended, as well as 

being currently supported by the vendor. Older equipment, while still being functional, may not have 

the ability to deliver the required precision at current concentration levels or integrate properly with 

modern data logging systems. Monitors operating at a higher range may not be appropriate for areas 

where trace concentrations are regularly observed. Older monitors that are no longer supported by the 

vendor may result in excessive downtime if parts and support are not readily available. Because of these 

potential issues, the age and capability of monitoring equipment on-site is paramount to a successful 

monitoring program. 

5.5.2 Outside the Monitoring Station 

External influences at a monitoring location, such as vegetative growth and nearby sources, can have an 

impact on the quality of data collected at a site. With regard to the station’s surroundings, the site visit 

presents the best opportunity to confirm that monitors/samplers are sited in accordance with 40 CFR 

58, Appendix E. A checklist can be found in Appendix B of this QAGD to assist the auditor with verifying 

site conformance to the Appendix E requirements. Common audit activities or items to inspect outside 

an air monitoring station could include the following. 

• Particulate samplers and their operation (setting up or collecting samples) 

• Sampling probes and rain shields (acceptable material and construction) 

• Obstructions around the site (buildings, food trucks, walls, parapets) 

• Impact of trees (10 meters from the drip line, primary wind direction) 

• External sampler maintenance (sampler cabinets, inlets, separators) 

• Emission sources (restaurants, exhausts, chimneys, gas stations, etc) 

• Distance from roadways 

• Paving or lack thereof (grass, gravel, concrete, etc.) 

• Inspection of grounds (safety issues) 

• Grounds maintenance (is vegetative growth an issue?) 

• Security 

Concluding the Audit 

After the on-site investigation has been completed, the audit team must begin the process of concluding 

the audit. For all practical purposes, the exit briefing is typically the end of the investigative phase of the 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 72 of 105 

TSA. The exit briefing brings all of the staff together to hear and discuss the results of the audit. This 

briefing is the culmination of all of the preparatory work and the on-site activities, and it is the most 

anticipated event of the audit. The audit team must make the proper preparations and deliver the 

results in an unbiased and understandable manner for all in attendance. The following sections describe 

the preparatory activities and provide direction in conducting the exit briefing. 

5.6.1 Exit Briefing 

The exit briefing is one of the most important and potentially stressful activities during the TSA. It is at 

this point that the audit team formally communicates the audit results to the monitoring organization. 

The exit briefing should be conducted as quickly as possible following the audit, preferably immediately 

following the TSA itself and on-site with the monitoring organization’s staff. 

Exit Briefing Preparation 

In preparation for the exit briefing, the audit team should meet to compile all final information. The 

audit team should have been conducting daily briefings during the TSA as described in Section 4.7.2 of 

this QAGD. The final daily briefing before the exit briefing should only include reviewing the last day’s 

information and drawing final conclusions regarding the overall results of the audit. However, if daily 

meetings have not occurred, then the meeting prior to the exit briefing will be of higher importance 

since it will be the only opportunity for the audit team to talk at length, compare notes, and discuss all 

findings and their implications. In addition, without daily briefings, preparation for the exit briefing may 

be lengthy and all audit results may not be captured completely or accurately. In short, daily briefings 

shorten the preparatory time for the exit briefing and will help the audit team be better prepared. 

The audit team should compare observed non-conformances and deficiencies during the audit process 

including: the organization’s quality documents, results of interviews and discussions with key 

personnel, records review, and data quality issues. Significant issues should be categorized based on 

severity (e.g., finding, concern, observation, as discussed in Section 6 of this QAGD), and the audit team 

should look for systemic issues or “themes” within the findings. The audit team should also collaborate 

on potential recommendations to address the identified issues to prepare for questions from the 

monitoring organization’s management. It is vitally important for the audit team to be prepared for the 

exit briefing with the organization’s senior management and to be ready to answer questions. The audit 

team should have supporting information on hand to support all findings including regulatory citations, 

method requirements, and scientific rationale. The lead auditor should assemble this information and 

prepare a briefing sheet or speaking notes for the upcoming meeting. The lead auditor should arrange 

the speaking points in a logical manner that will help the information flow and be easier for the 

organization’s senior management to digest. All findings should be presented in a professional manner 

that is accurate, clear, and constructive. 

In addition to non-conformances, the audit team should identify and list areas where the monitoring 

organization has excelled or where progress has been demonstrated. These kinds of observations help 

paint a more complete picture of an organization, rather than focusing solely on the deficiencies. 
 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 73 of 105 

However, the auditors must exercise caution when issuing commendations. Commending an 

organization should not be used to balance out non-conformances or overshadow obvious data quality 

or quality system issues. All deficiencies and commendations should be factual and without bias. Section 

6 contains examples of commendations. 

Conducting the Exit Briefing 

The TSA exit briefing should be conducted at the monitoring organization’s main office, if possible. At a 

minimum, the audit team, monitoring organization staff, and their senior management should be in 

attendance. The exit briefing should include the following elements: 

• Introductions of staff in attendance 

• Presentation of audit results 

• Discussion of the TSA report process 

• Discussion of the required Corrective Action Plan and follow-up process 

• Closing dialogue to address questions and comments from the monitoring organization. 

The exit briefing may vary in length depending on the results of the audit and the interaction with the 

organization staff, but the lead auditor should attempt to keep the exit briefing under an hour and a 

half. The audit scribe should plan to take notes throughout the exit briefing so that the lead auditor may 

focus on delivering the findings and answering questions from the monitoring staff. In the event that the 

organization’s key monitoring personnel or senior management officials are unable to attend the exit 

briefing, a follow-up conference call should be offered during the meeting and scheduled to occur after 

the audit team returns to the Regional Office. It is imperative that such a discussion occur as soon as 

possible following the on-site investigation, so that the monitoring organization is made aware of the 

audit findings and can begin necessary corrective action measures. 

The lead auditor should conduct the meeting and direct the presentation of audit results during the exit 

briefing. The primary focus of the exit briefing will be the discussion of the audit findings and areas of 

needed improvement. The lead auditor should guide this dialogue, asking audit team members to 

augment the discussion when appropriate. There should be no dissension during the briefing within the 

audit team, and the audit team should be unified in presenting the results of the audit. The tone should 

be professional and courteous; however, the team should be prepared to defend the audit results and 

have supporting material on-hand. Exit briefings have the potential to be contentious, and it is 

important for the audit team to listen and not become reactionary. Audit team responses must be 

rooted in facts and avoid opinions that can cause confusion. 

As discussed above, the lead auditor should also offer commendations during the exit briefing. The lead 

auditor should discuss improvements since the last TSA, outstanding accomplishments that deserve 

special recognition, and procedures that the organization implements that are especially innovative or 

efficient. 
 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 74 of 105 

The exit briefing also serves as an opportunity for the monitoring organization’s staff to ask questions, 

request clarification, and present any additional evidence that may refute a finding. For example, if a 

critical piece of information was missing on the first day of the audit, but staff found the misplaced 

document/record later in the week, that information can be presented to the auditors during the exit 

briefing. Similarly, the exit briefing provides an opportunity for the monitoring organization staff to 

address inaccuracies in the findings. For example, a calibration line may have been identified as 

uncapped allowing shelter air into a sample train. The site technician may dispute this by informing the 

audit team that the line was connected to a monitor that was not currently in operation. In these 

situations, the monitoring organization may need to present additional information or data that will 

negate the finding. In some cases, the monitoring organization may ask the audit team to revisit a site or 

laboratory, in order to ensure all information-gathering was accurate and complete. 

The audit investigation will sometimes uncover issues that necessitate additional review which may not 

be feasible during the limited time on site. With this in mind, the auditor may have to request that the 

monitoring organization submit additional documents, records, or data for review after the completion 

of the exit briefing. In this event, the request should be discussed during the exit briefing. The auditor 

should ask that the information be provided as soon as possible, but ideally within one week 

following the site visit. Moreover, the auditor should clearly explain the rationale behind the 

information request during the exit briefing. This explanation is important so that monitoring personnel 

present, as well as the senior management, understand the request and recognize that additional 

findings may result from it. Therefore, the exit briefing, under this scenario, may not be a complete 

account of all findings, which will necessitate a follow-up conference call after the requested 

information has been received and assessed (see Section 6.0 of this QAGD). 
 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 75 of 105 

6.0 Report Development and Corrective Action Process 

Generally speaking, the audit “ends” once the on-site investigation concludes. However, the TSA process 

continues after the on-site investigation phase is completed. The activities that follow the on-site 

investigation involve preparing the written TSA report to document the audit findings, and then working 

with the monitoring organization at length to ensure identified issues are successfully resolved. This 

section of the TSA QAGD provides more details regarding the events that should occur following the 

completion of the on-site investigation. 

The report development and corrective action process is one of the most important components of the 

TSA. This section defines the steps and the timeline that the audit team should follow to ensure that an 

accurate report is written and timely follow-up is completed. The following flow chart in Figure 6.1 

provides a summary of these activities and the timelines that the audit team should follow in this 

process. 

Figure 6.1 TSA Report Development and Corrective Action Flow Chart 

Unresolved Issues and Additional Analyses 

Although the time and effort spent planning for the TSA (i.e., pre-audit activities) should cut down on 

any additional review needed after the field investigation concludes, there may be times when 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 76 of 105 

additional analyses or follow-ups are warranted. Issues may arise during the on-site investigation such 

that the audit team may need additional resources in order to make a determination regarding a specific 

finding. For example, some audit findings may require consultation with OAQPS, especially if they could 

result in the flagging or invalidation of a significant amount of data. Additionally, the auditor may need 

to consult with other EPA staff or OAQPS directly to discuss the interpretation of a regulation before 

deciding how to frame a finding. Although contacting other EPA staff or OAQPS while still on-site during 

the field investigation is preferred – so that the organization can immediately know the outcome – these 

conversations may not be possible until after the audit team has returned to the Regional Office. 

As discussed in Section 5 of this QAGD, observations during the on-site investigation may uncover issues 

that need additional review. The auditor may not have time to complete these additional reviews while 

on site. For example, the audit team may request specific data to analyze (such as raw temperature and 

humidity data from a gravimetric laboratory), if procedures observed during the audit warrant its 

examination. Or, the audit team may observe an unexpected procedure in the field and, subsequently, 

request to review the SOP for that procedure (especially if that document was not provided to the 

auditor beforehand). Conversely, there may be instances where post-audit review is necessary because 

the monitoring organization itself was unable to provide requested information during the field 

investigation due to limited staffing, time, or other reasons (such as an ineffective records management 

system). Under scenarios such as these, continued analyses and discussions following the exit briefing 

may be necessary. 

Any information requested to be submitted post-audit should be discussed with the monitoring 

organization during the exit briefing (see Section 5). The exit briefing is the time to clearly outline any 

missing information and establish a deadline for submittal. Following the exit briefing, requesting new 

information, beyond what was discussed during the exit briefing, should be kept to a minimum. The 

auditor’s goal is to provide the monitoring organization a draft findings summary (i.e., written audit 

feedback – see Section 6.2.2 below) within 30 days of the completion of the on-site investigation. A 

completed list of audit findings – along with any resulting conclusions – cannot be drafted for a written 

report if information-gathering is ongoing. With that in mind, the recommended best practice is to limit 

requesting any additional documents, records, or data to one week following the completion of the 

exit briefing. It is important to remember that the audited organization has also expended time and 

resources in preparation for the audit (e.g., documenting the TSA questionnaire, gathering and 

submitting QAPPs and SOPs to the Regional Office, and so forth), as well as participating in the on-site 

investigation. Post-audit information gathering by the lead auditor should conclude as promptly as 

possible, in order to facilitate the timely completion of the TSA report, as well as to allow the audited 

organization to resume its normal business routine. 

However, there are certain situations where the auditor may need to request additional information 

beyond the recommended one-week follow-up period. For example, if the audited organization submits 

the wrong information, or the submitted information is not summarized in the manner originally 

requested by EPA, then the auditor may request the monitoring organization resubmit – which will delay 

resolution of the outstanding issue(s). Or, on the other hand, if the information submitted by the 

monitoring organization clearly indicates a more serious operational problem, then the auditor may 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 77 of 105 

have to request additional clarifying information or data in order to better understand the magnitude of 

the situation. Regional Office upper management may need to be notified and become involved under 

these scenarios, or when/if a monitoring organization is not cooperating in a forthright manner. 

However, these example scenarios should be infrequent; extending the TSA beyond the on-site 

investigation should not be the routine practice. (See Section 8 of this QAGD for more information on 

elevation points.) 

After the lead auditor has received and assessed all requested material, communication is needed with 

the monitoring organization in order to relay the results of the follow-up analysis. The best practice 

approach is to conduct a conference call with the organization’s senior management and monitoring 

staff in order to discuss any new findings and their implications. However, if no new findings resulted 

from the analysis, the lead auditor should still inform the organization that no new issues resulted from 

the information review – either via telephone or written communication (such as email). Similarly, if an 

issue was discussed during the exit briefing that required input from OAQPS, the auditor should followup with the audited organization after the necessary input from Headquarters has been obtained. It is 

important that any “loose ends” be resolved promptly, so that needed corrective actions can begin. 

TSA Report 

The purpose of the TSA is to help the monitoring organization improve its ambient air monitoring 

program by identifying vulnerabilities that weaken the organization’s quality system and/or the 

defensibility of its data. The TSA report serves to formally document the audit process and findings. The 

audit report should be composed in a concise, easy-to-read manner that focuses on objective evidence. 

Effective communications throughout the TSA process should lead to a written TSA report that contains 

no surprises, which in turn fosters a partnership between the organization and the auditor in the 

months that follow. 

It is important to remember that the written TSA report can be reviewed not only by the organization’s 

technical monitoring staff and program manager, but also by the organization’s director, other higher 

ranking departmental or cabinet officials, as well as by the community at large. With that in mind, the 

lead auditor should consider the TSA report’s audience when framing findings and providing supporting 

evidence and discussion. Ambient air monitoring regulations are complicated; the monitoring 

procedures, technical and intricate. The written TSA report should present these complex topics in a 

manner such that any reader can easily interpret the information and understand its significance. The 

lead auditor (and audit team) should keep the following directives from the EPA Communications 

Stylebook10 in mind when preparing the audit report: 

 Use plain language – which is communication the audience can understand the first time they 

read or hear the information being presented. 

 Use active voice as much as possible. The two different ways of using verbs are known as 

voices. When the verb is active, the subject of the verb is doing the action – so the voice is 

10 https://www.epa.gov/stylebook 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 78 of 105 

active. When the verb is passive, the subject undergoes the action, rather than doing it. Passive 

is formed with tenses of the “be” verb, along with the past participle of the main verb. Active 

voice is more interesting to read than passive voice, and is more likely to keep the reader 

engaged. Sentences are often more concise when using active voice. 

 Write in third person. Although second person should be used for most Agency 

communications, the EPA Communications Stylebook indicates that technical documents, such 

as a TSA report, are best presented in third person. The Stylebook also states that topics which 

might involve strong negative reactions, or might be considered too personal, are better written 

in third person as well. 

The lead auditor should keep these writing guidelines in mind when preparing the TSA report. The 

report should be written and formatted such that the reader can easily identify and understand the 

areas where improvement within the organization is needed. Important findings and recommendations 

may be lost if the audit report is too technical or verbose. 

It is also important to note that, just like the TSA itself cannot thoroughly delve into every single 

component of the organization’s monitoring network, the TSA report will not capture every discussion 

point, observation, or technical support recommendation offered during the on-site investigation. 

Instead, the TSA report focuses on the most significant findings, technical and/or systemic, that indicate 

non-compliance with regulatory requirements, or jeopardize the organization’s data quality or 

defensibility. Because the report serves to focus on these “big picture” issues, the lead auditor is 

afforded some discretion – based on professional judgment, experience, and through collaboration with 

the audit team – regarding whether to include minor observations in the final written report. 

The pre-audit and on-site TSA activities often generate many pages of notes, checklists, and 

photographs. To begin writing the report, the lead auditor should first assemble and organize all of the 

team’s notes and records, which may be in hardcopy and/or electronic formats. It is recommended that 

the lead auditor utilize the first week following the on-site investigation to start drafting the TSA 

report, while findings and observations are still fresh in the audit team notes, and before additional 

work assignments shift the lead auditor’s focus. The full report may take a few weeks to complete, 

especially if additional analyses and communications post-site visit are warranted. Therefore, it is 

recommended that management set the completion of the TSA report as a high priority and afford the 

lead auditor the time necessary to complete the assignment. 

6.2.1 Report Structure & Elements 

EPA Regional Offices may have different writing styles and layouts for their official correspondence. 

Some Regional Offices may compose TSA reports with detailed narrative that chronicles the general 

observations of the audit, and provides visual imagery (i.e., vivid descriptions of objects) regarding each 

field site and facility visited, whereas others may omit observations and imagery unless they are related 

to an issue found on site. However, regardless of style, it is imperative that the TSA report be formatted 

in a manner that clearly highlights the audit findings. The monitoring organization must be able to 

quickly and easily identify the major issues requiring corrective action within the body of the TSA report. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 79 of 105 

Therefore, the recommended best practice approach is to compose a succinct report that centers the 

reader’s attention to those issues requiring corrective actions, omitting imagery and details that do not 

benefit the overall discussion. Appendix E of this QAGD provides an example template for writing a TSA 

report. 

Note: It is important that all TSA reports produced by an individual EPA Regional Office use the same 

format and structure, and contain the same essential elements. Under no circumstances should the 

auditor craft a unique TSA report for each organization audited. 

Although the writing styles themselves may vary, in order to maintain consistency across the EPA 

Regions, the following elements must be included in all EPA TSA reports: 

•	 Title & Approval Page – Contains the audit title, as well as the name and signature of the 

individual who authorizes the report (mostly likely a designated Regional Offices approving 

official or manager). The name and signature of the lead auditor should also be included on the 

title page. 

•	 Executive Summary – An abstract, geared towards senior management, which summarizes the 

most significant audit findings and explains the overall implications. Senior management officials 

may not be fluent in the complex, technical aspects of the ambient air monitoring program; 

therefore, a summary that concisely explains the big picture issues is an especially important 

component of the TSA report. The abstract describes the significant findings in only a few 

paragraphs. Typically, an executive summary is 1-2 pages in length, maximum. 

•	 Introduction – Should state when and where the audit occurred, list the audit team members, 

audited participants, and field sites and/or facilities visited. The Introduction should also provide 

a summary of the audit preparation activities (such as a listing of the AQS reports and quality 

system documents reviewed prior to the on-site audit). 

•	 Findings and Recommendations – Itemizes the issues noted during the audit. For each nonconformance observed, the report should state the finding, provide a brief discussion of the 

finding, and follow it with a recommended solution/action to address the finding. (See Section 

6.2.1.1 for more information.) 

•	 Conclusions – Recaps the most significant TSA issues, particularly those that appear to be 

systemic within the organization, and discusses the consequences. More detailed than the 

Executive Summary, the Conclusions section typically contains more technical information, 

details, and/or specific examples. It highlights the most significant issues and clearly identifies 

those findings that must be corrected in order for the organization to be in compliance with 

regulations, or produce data sets that can be used for regulatory decision-making purposes. 

Provides the targeted due date for the organization’s written response to the TSA report and 

anticipated Corrective Action Plan. 

Other elements that may be included in the written TSA report include a cover page, Table of Contents, 

commendations, and appendices. A Table of Contents is especially beneficial when the audit report is 

lengthy; it allows the reader to quickly locate specific sections of the report. Some Regional Offices may 

include the TSA questionnaire, as completed by the audited organization, as an appendix. A Corrective 
 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 80 of 105 

Action Plan template, or Auditing Finding Tracking Form, may also be included in the appendix of the 

report (see Section 6.4 of this QAGD for more information). Other items that may be included in the 

appendices include audit checklists, photographs, and data analysis charts/graphs, among others. The 

body of the TSA report can include commendations, where applicable; or, if the organization has made 

numerous improvements since the last TSA, the report can have a separate section to highlight those 

achievements. A Commendations section can also provide recognition for innovative processes or 

emphasize procedures the audited organization does exceptionally well. However, commendations in 

the written audit report should not be used to offset or diminish the severity of the findings. 

Photographs can be beneficial in the Example Commendations written TSA report, in order to more 

The agency has made numerous changes and enhancements to its clearly illustrate a finding or 

ambient air monitoring program in the past three years. These observation. If used, the images 

improvements should enhance the agency’s long-term data should be of sufficient clarity and 

capture, as well as bolster data quality. Examples of the detail to support the stated issue. It is 

improvements include the following: important to remember that 

photographs taken during the on-site •	 All field instruments have been replaced; 

investigation serve as evidence and •	 Data acquisition software has been upgraded; 

•	 Polling capabilities have been upgraded from analog to will need to be logged in accordance 

digital; and, with the Regional Office’s standard 

• Equipment has been purchased for purposes of	 operating procedures for field 

implementing internal performance audits.	 activities. Typically, documentation of 

who took the photo, when, and 

where needs to be chronicled. 

Recommended procedures are outlined in the following EPA document: Digital Camera Guidance for 

EPA Civil Inspections and Investigations, U.S. EPA Office of Compliance, July 2006.11 However, 

photographs are not required in the TSA report. 

As a recommended best practice, the audit report should use a “Page X of Y” numbering format. 

Report Elements 

Core elements within each TSA report should be similar across the EPA Regional Offices, even if report 

formats differ. Therefore, in order to maintain national consistency, the TSA report will include the 

following information, at a minimum: 

•	 Audit report title, document control number, and/or any other unique identifying information; 

•	 Name of the organization preparing the report; 

•	 Names of audit team members, specifying the lead auditor; 

•	 Name, title, and signature of the individual authorizing the report; 

•	 Date of the audit; 

•	 Name of the audited organization; 

11 https://www.epa.gov/sites/production/files/2013-09/documents/digitalcameraguide.pdf 
 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 81 of 105 

•	 Names and/or titles of audited participants; 

•	 Location(s) audited; 

•	 Audit purpose (i.e., reference to 40 CFR Part 58, Appendix A, §2.5); 

•	 Specific programs or parameters audited; 

•	 Specific programs or parameters that were not covered by the TSA; 

•	 Explanation of finding categories/rankings (i.e., define terminology); 

•	 Identification of audit findings; 

•	 Supporting evidence and discussion of findings, including relevant regulatory or QAPP/SOP 

citations; 

•	 Corrective action recommendations (see below); and, 

•	 Request for the organization’s Corrective Action Plan. 

Note: If a document control number (or similar) is used as a unique identifier for the specific TSA project, 

it is recommended that the number be located within the header or footer of each page of the TSA 

report. 

Many of the items listed above can be included in the audit report’s Introduction section. With regards 

to programs and/or parameters that were not audited, it is important to add a disclaimer in the written 

report to better inform the reader as to the extent of the audit investigation. Although it is generally 

understood that a TSA cannot realistically cover all facets of an organization’s monitoring program, it 

helps to clarify which specific portions of the program were excluded from review. For example, a 

statement such as the following could be added to the report: 

“Due to time and resource constraints, this TSA focused on the field measurements used to 

demonstrate compliance with the National Ambient Air Quality Standards (NAAQS). As such, this 

TSA did not focus on meteorological measurements or air toxics field sampling and data 

collection techniques.” 

Such a disclaimer can also be helpful to future EPA auditors. For instance, during pre-audit planning 

activities, the auditor will see which programs/components were not reviewed when reading the 

previous TSA report, and can then use that information to determine whether or not to make those 

specific elements a priority during the upcoming TSA. Similarly, the Introduction should include a listing 

of the documents reviewed in preparation for the audit (e.g., QMP, QAPP, SOPs, AMNP, internal audit 

reports, etc), as well as data analyzed and reports queried. This listing documents information reviewed 

by the Region which may or may not be discussed in the audit findings – and as such, may be helpful to 

future auditors when assessing the scope of the previous TSA. This information may also be helpful to 

the monitoring organization, in order for management and staff to better understand the extent of the 

preparatory review. The summary of preparatory activities also gives credit to the lead auditor and audit 

team for the many hours of study that went into the TSA that otherwise may not be recognized. 

It is important to reiterate that audit reports should be focused on findings and recommendations 

related to the monitoring organization’s quality system. As such, the report should not contain 

information that will be included in other EPA correspondence. For example, concerns related to the 

review of the monitoring organization’s Annual Monitoring Network Plan should not be included in the 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 82 of 105 

written TSA report, since the Regional Office should issue separate letter(s) to the monitoring 

organization regarding the network design. Additionally, TSA reports should not be used to estimate 

design values for the monitoring organization’s CBSAs/MSAs, as this information will be communicated 

to the monitoring organization through other means. 

Ultimately, the TSA report should contain language that guides the monitoring organization towards the 

development of an effective Corrective Action Plan. Although the audited organization is charged with 

determining the root causes of issues identified during the TSA and solutions that will work best within 

their unique structure and network, the lead auditor should establish the EPA’s minimum expectation 

for corrective action within the written TSA report. Towards that end, the auditor should follow the 

discussion of each itemized finding with a recommended action to address the finding. For example, if 

quality system documentation is identified as outdated and in need of revision, the lead auditor could 

recommend that the organization develop and submit to EPA a prioritized timeline for revising the 

documents, at a minimum. In this manner, the organization must still determine the core reason(s) why 

the documents are outdated and, with that, develop a plan that will result in both the timely revision of 

the documents and a mechanism to ensure the documents stay up-to-date in the future. However, by 

recommending in the TSA report that the monitoring organization prioritize the document reviews and 

submit a revision schedule, the lead auditor is providing the audited organization with an indication of 

EPA’s minimum expectation towards addressing that specific finding. The monitoring organization can 

then use that recommendation as a springboard for developing a more comprehensive corrective action 

strategy. 

In some cases, the TSA findings impact data quality and/or 

demonstrate ambient data is not acceptable for use in 

regulatory decision making. As a consequence of those 

findings, concentration data must be appropriately flagged 

or invalidated in the EPA AQS database. In this event, the 

recommendations in the TSA report should include 

directives towards necessary data modifications in AQS, in 

addition to establishing a minimum expected action(s) to 

resolve the underlying issue. In many cases, data are 

impacted by a localized or short-term issue identified by the 

EPA auditor, which only affects a small amount of data. The 

appropriate AQS data handling convention for these issues 

is typically straightforward and does not impact the 

monitor’s data completeness. However, the needed AQS 

edits should still be specified in the TSA report, in order to 

ensure that those specific modifications are included in the 

organization’s Corrective Action Plan, and resultantly 

tracked and completed (see Section 6.4). On the other 

hand, the consequences of some TSA findings may include 

invalidating a significant portion of data, which could then impact the designation process. Under these 

circumstances, the TSA report should clearly and directly state that the impacted data must be 

Example Finding and 

Recommendation Involving ShortTerm Data Loss 

Finding: A through-the-probe calibration 

line was left uncapped in the shelter after 

the site calibrator was removed for 

maintenance. As a result, the analyzer 

sampled ambient air diluted with shelter 

air. 

Recommendation: Data must be 

invalidated back to the date/time the 

calibrator was removed from the site. In 

addition, the agency must cap the 

calibration line anytime the calibrator is 

removed; this requirement should be 

specified in the agency’s SOP. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 83 of 105 

invalidated. It is important to note that some monitoring organizations may not make large-scale edits 

in AQS, due to institutional roadblocks or other agendas, without explicit language in the written TSA 

report stating such action is required. Therefore, in order to provide the organization with the support 

and justification it needs to make significant modifications to its program or data, the audit report must 

state the necessary and/or minimum expectation for corrective action. 

Ranking TSA Findings 

Issues identified in an official TSA Report as “findings” can serve as a catalyst to promote change within 

the audited organization, especially when identified shortcomings represent a departure from 

regulatory requirements that jeopardize the validity of the organization’s data. The organization’s 

technical staff and monitoring program manager are often aware of the needed improvements within 

the network, but may be unable to address deficiencies due of a lack of resources or other institutional 

roadblocks. In that regard, the written TSA report can sometimes serve as the tool the organization’s 

monitoring staff have needed to leverage senior management’s support and, resultantly, acquire the 

resources necessary to improve their program. 

To provide a better understanding of the magnitude of the technical issues uncovered during the TSA, 

the findings should be categorized. Ranking the findings in the TSA report will draw attention to the 

most serious deficiencies and explain their import. Upon receipt of the audit report, it is often tempting 

for a monitoring organization to complete the quickest or easiest corrective actions first, which may or 

may not address the most significant audit findings. Therefore, by ranking the findings in the TSA report 

itself, the categorization will assist the audited organization in prioritizing its corrective action plan. 

Ideally, the most severe non-conformances should be corrected first, with less serious findings 

addressed afterwards. 

Commonly used tiers for categorizing findings – from most severe to least severe – include: Major 

Findings, Minor Findings, Concerns, and Observations. Other terminology may be employed. However, 

regardless of the naming convention, it is important that the TSA report define the terms used to tier 

the findings, so that the reader can clearly understand their meaning and significance. 

Table 6.1 provides one example of how to categorize audit findings, as well as provides a definition for 

each term used. 

Table 6.1 Example Findings Categorization 

Nonconformance with or absence of a specified requirement 

Finding: (regulatory, QMP, QAPP, SOP, etc.) or guidance deviation which 

could significantly impact data quality. 

Practices with the potential detrimental effect on the ambient air
 

Concern:
 monitoring program’s operational effectiveness or the quality of 

sampling or measurement results. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 84 of 105 

An infrequent deviation, error, or omission which does not impact
 

Observation:
 the output of the quality of the work product, but may impact the 

record for future reference. 

In addition to defining the tiers used to rank the findings, it is also important to clearly distinguish in the 

TSA report which categories require corrective actions. Using the example in Table 6.1 above, those 

issues ranked as “Findings” or “Concerns” would require corrective actions by the audited organization; 

“Observations,” on the other hand, would warrant consideration by the organization, but not require 

corrective action. 

6.2.2 Draft Findings Summary (Report) 

Ideally, the audited organization should formulate a Corrective Action Plan and begin implementing 

needed improvements immediately following the completion of the EPA’s on-site investigation. 

However, some monitoring organizations prefer to postpone corrective actions until they have received 

a formal document from EPA that enumerates the issues identified during the audit. The preparation of 

the official TSA report, peer-reviewed and routed through management, usually takes longer than a 

month to complete. Therefore, in order to expedite the corrective action process, the Regional Office 

should provide written audit feedback (i.e., a draft findings summary) to the monitoring organization 

prior to the completion of the finalized TSA report. The goal is to share the written audit feedback with 

the monitoring organization within thirty (30) calendar days following the conclusion of the field 

investigation. 

There are a variety of ways the EPA Regional Office can provide written audit feedback to the 

monitoring organization. Each Regional Office has the flexibility to choose which method of 

correspondence is most practical and works best for the monitoring organizations within their 

jurisdiction. Selecting one of the following three methods for drafting the findings summary is 

recommended: 

•	 An Excel spreadsheet, which categorizes the findings and ranks them from most to least severe; 

•	 A formal briefing sheet, which captures the discussion from the exit briefing and identifies the 

significant findings; or, 

•	 A draft report (Microsoft WordTM document) that contains a draft watermark (or similar draft 

identifier) that indicates the report is not finalized. 

Of these three methods, a formal briefing sheet is the quickest to prepare, but also contains the least 

amount of information regarding the overall TSA findings. An Excel spreadsheet containing all of the 

findings would most likely take longer to prepare than a briefing sheet – but it would likely omit 

pertinent discussion to support or clarify the listed findings. A draft report in Microsoft Word allows for 

the greatest detail and provides the majority of the written report to the monitoring organization. The 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 85 of 105 

draft report would be the most transparent document to share with the audited organization; however, 

it will take the most amount of time to prepare. 

EPA Regional Office 

All monitoring organizations within the Regional Office’s jurisdiction should be aware of the Region’s 

TSA reporting process, including the mechanism used to relay the draft findings summary (e.g., Excel 

spreadsheet, briefing sheet, or full report with draft watermark) and the appropriate comment process. 

To ensure the audited organization knows what to expect, the process should be reiterated during the 

TSA exit briefing. 

Following completion of the on-site investigation, the TSA lead auditor should: 

•	 prepare the draft audit findings summary; 

•	 provide it to the audit team for review; 

•	 route it through management; and, 

•	 submit it to the monitoring organization within ~30 calendar days from completion of the field 

investigation. 

Given the numerous steps in this draft process, the 30-day window is a goal, not a requirement. 

6.2.2.1.1 Internal Technical Review 

Once the findings summary has been drafted, the lead auditor should share the draft document with the 

audit team (or at least one member of the team) for technical review and feedback. Internal peer review 

is a good way to ensure that the individual team member(s) concur with the technical facets of the 

summary, including: 

•	 the findings enumerated are factual; 

•	 the findings are fair and accurately depicted; 

•	 the supporting discussion and technical evidence is correct and appropriate; 

•	 the categorization/ranking of the findings is appropriate; and, 

•	 there are no major omissions within the draft. 

Peer review is a useful tool to ensure the lead auditor has successfully conveyed the observations made 

by the audit team members. The lead auditor will often rely on the notes taken by teammates when 

composing the written findings. There may be times when the lead auditor incorrectly interprets a 

teammate’s notes; therefore, the peer review process serves as a way to make sure the written 

composition is accurate. 

Note: It is acceptable for audit team members to compose language regarding their individual findings 

and provide those to the lead auditor for inclusion in the draft document and/or final report. The TSA 

report is not required to be written solely by the lead auditor. 

Peer review is also a useful tool to ensure consistency throughout all audit reports produced within the 

Regional Office. For example, if the lead auditor designates an issue as a “Finding” in the audit report, 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 86 of 105 

yet on a separate TSA the same issue was deemed a “Concern” by a fellow auditor, this discrepancy 

warrants discussion and reconciliation amongst the audit team. In this regard, maintaining a master 

spreadsheet that tracks “Findings, Concerns, and Observations” (or similar terminology) may be useful 

within the Regional Office, in order to ensure consistency from audit to audit. If the lead auditor found 

evidence that elevated the “Concern” to the level of a “Finding”, it is important that the written 

discussion of that issue convey the additional, critical information, so that the designation of “Finding” is 

justified. 

A peer reviewer should also determine if supporting evidence and citations are correct, or if more 

appropriate references could be added to better convey the intended message. It is important to 

consider the 3-year time period which was audited, and ensure that any quotes from regulations, EPA 

guidance, or the organization’s quality system documents appropriately reflect the time period under 

review. For example, if EPA guidance recently changed (e.g., the EPA 2.12 QAGD in 2016), but during the 

time period of the TSA (e.g., 2013-2015) the organization was successfully implementing previouslyissued guidance (e.g., the 1998 2.12 QAGD), it is inappropriate to cite the newer guidance as justification 

for an audit finding. Instead, the newer guidance may be used to direct the organization towards 

implementing change and making improvements moving forward, but should not be held against them 

as a “finding” in the TSA report. 

Finally, a TSA report should contain no surprises. The lead auditor should not include issues in the draft 

findings summary or finalized TSA report that were not discussed with the organization previously. If the 

peer reviewer determines a finding has been included that was not discussed with the organization, the 

discrepancy should be brought to the attention of the lead auditor. A follow-up conference call with the 

audited organization may be necessary to correct this oversight, if the issue warrants inclusion in the 

report. 

6.2.2.1.2 Internal Administrative Review 

Administrative review of the written correspondence ensures that the document is clear of grammatical, 

mechanical, and spelling mistakes, and is formatted appropriately. This type of review also ensures that 

the technical content makes sense from a layman’s perspective. In some cases, a reviewer other than a 

team member may be needed for this particular step. As stated earlier in Section 6.2, both the draft 

findings summary and the finalized TSA report may be reviewed by individuals who are not directly 

involved with the technical facets of an organization’s ambient air monitoring program. Therefore, the 

complex information documented in both the draft and final TSA report should be presented in a 

manner that is technically accurate, yet easy to understand. 

Once these edits have been completed, the document should be reviewed and approved for submittal 

to the organization by the appropriate Regional Office manager or designated approving official. The 

manager or designated approving official may recommend additional edits to the document prior to 

signing. For example, revisions may be needed to correct any typographical issues missed during the 

first levels of review, or perhaps to change the tone of a particular finding. In writing, tone is subjective 

and often dependent on the individual reader; however, the use of active voice and third person helps 

minimize issues with tone (see the EPA Communications Stylebook). If editing for tone, it is important 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 87 of 105 

that the audit finding retain the technical facts of the issue. It is imperative that edits by individuals 

independent from the audit team not jeopardize the technical accuracy of the report or dilute the 

findings in a manner that negates their significance. The auditor’s findings and observations are facts; 

in upholding quality assurance principles, the findings should remain independent from outside 

influences or other agendas. 

Issuance of Draft Findings Summary 

Once the findings summary has been internally reviewed and approved, the draft is issued to the 

audited organization. The written findings summary should include a cover letter on organizational 

letterhead, signed by the designated approving official. 

This step in the process allows the audited organization an opportunity to preview the official report to 

come, and in that regard, to “fact check” the written information. If the organization observes an 

incorrect statement or datum within the draft, then the organization should provide corrections and/or 

edits to the lead auditor. Helpful edits the monitoring organization can provide include factual 

corrections such as staff names/titles, spellings, site names, and other typographical/minor errors made 

by the audit team. The audited organization should be allowed 15 calendar days for this review process. 

The cover letter that accompanies the findings summary should reiterate the fact that the draft is being 

provided for fact-check purposes only; the 15-day review period is not the appropriate forum to contest 

or negotiate audit findings. The cover letter should state that the audited organization can submit 

corrections to the lead auditor; however, should no corrections be received within 15 calendar days, it 

will be assumed that the draft document is acceptable to the monitoring organization in its present 

form. 

The issuance of this draft findings summary also facilitates corrective action measures. Monitoring 

organizations can develop or formulate necessary actions upon receipt of the draft document, if they 

have not already begun to do so. 

6.2.3 Final TSA Report 

The final TSA report should be issued to the monitoring organization as soon as possible following the 

receipt of the draft comments, but no later than 30 calendar days afterwards. The final report should 

include a cover letter on organizational letterhead, signed by the designated approving official. 

If the Regional Office provides an Excel spreadsheet or briefing sheet to serve as the draft findings 

summary, then the lead auditor should begin crafting the final TSA report immediately following its 

completion. Upon receipt and review of the monitoring organization’s written corrections or edits, the 

lead auditor should ensure that necessary corrections are incorporated into the final report, as 

appropriate. After the report is written, it should be routed through internal technical and 

administrative review, as discussed in Sections 6.2.2.1.1 and 6.2.2.1.2. Once these reviews have been 

completed, the final report should be reviewed and approved by the designated approving official, and 

submitted in its final form to the monitoring organization. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 88 of 105 

If the Regional Office provides a Example “Note” in Final TSA Report fully composed report 

Finding: The probe cap at the ACME monitoring site was stainless steel. (watermarked as draft) as the 

draft findings summary, then Discussion: Studies have been conducted to determine the suitability of preparation of the final TSA materials for use in ambient air monitoring sampling trains. Pursuant to 

40 CFR Part 58, Appendix E, Section 9(a), for those analyzers which report after receipt of 

measure reactive gases, such as ozone, only inert materials – borosilicate comments is largely simplified. 

glass, Teflon, or their equivalent – are allowed in the sampling train (from If the monitoring organization 

the inlet probe to the back of the analyzer). The probe cap utilized at the submits written corrections 

ACME monitoring site is part of the sampling train. EPA auditors observed and/or edits concerning the this probe cap was made of steel, which does not meet Appendix E 

requirements. draft, then the lead auditor 

should review and incorporate 

Recommendation: The cap at this site must be replaced immediately. them into the final TSA report, 

EPA acknowledges that the monitoring organization replaced the probe as appropriate, and simply 

cap on August 10, 2016, as documented in their response to the draft reprocess the report. A final 

audit report (in a letter dated December 8, 2016). administrative review may be 

necessary, if the edits were 

substantial, to ensure the 

newly composed language is 

free of typographical or grammatical errors. However, if the monitoring organization does not submit 

any corrections or edits to the draft, then the lead auditor can remove the draft watermark (or similar 

draft identifier), and update the dates/signatures within the document. It will then be ready for 

submittal to the monitoring organization. 

There may be times when the audited organization submits evidence that corrective action measures 

were completed after the on-site TSA concluded, but prior to the receipt of the draft findings summary. 

This evidence is usually submitted at the time when the audited organization provides factual 

corrections to the draft audit findings summary. In the event this occurs, the final TSA report should 

retain the original finding in its original form (minus any typographical errors noted in the draft). The 

opportunity for the monitoring organization to provide factual corrections to the draft report does not 

serve as a medium to erase audit findings from the final report. The TSA report documents the “as 

found” status of the monitoring organization at the time of the investigation, and should not be altered 

to reflect improvements that occurred after the fact. The lead auditor can, however, add a “Note” in the 

report that acknowledges that the organization implemented a corrective action measure for a 

particular finding after the on-site investigation concluded, but prior to the issuance of the final TSA 

report. It is recommended that this “Note” follow the recommendation that accompanied the finding 

(see the text box insert above for an example). 

Ultimately, the final TSA report should be prepared and submitted to the monitoring organization 

directly following receipt of the monitoring organization’s written corrections – which should equate to 

approximately 75 calendar days from the on-site investigation, if targeted timeframes have been 

maintained. Copies of the final TSA report should be sent to the monitoring organization’s director or 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 89 of 105 

his/her designee, as well as to the monitoring program manager. The cover letter should indicate the 

report is being distributed in its final form and draw attention to the next step of the TSA process: the 

organization’s official response to the report, which includes their anticipated schedule for corrective 

action implementation. 

Audited Organization Corrective Action Plans 

6.3.1 Auditee Response 

The audited organization should submit its official response and anticipated Corrective Action Plan to 

the EPA Regional Office within 30 calendar days of receipt of the final TSA report. In some EPA Regions, 

the audited organization is provided a specific template to use for documenting the Corrective Action 

Plan. On the other hand, some Regions allow the organization flexibility to develop its own unique 

Corrective Action Plan in any format, provided that the plan is clear and presents a timeline for 

implementation. 

In some cases, needed corrective actions may be easily implemented, with the identified issues resolved 

before the on-site TSA concludes, or shortly thereafter. Upon receipt of the draft findings summary, the 

audited organization is provided written notification of issues identified during the TSA, which should 

also contain recommendations that minimally guide the course of action. Including the review time of 

the draft findings summary, the organization has approximately two months in advance to consider the 

audit team’s findings and formulate its corrective action plan by the time the final TSA report is 

received. 

6.3.2 Auditor Review 

The lead auditor (or designated audit team member) will review the organization’s submitted response 

and Corrective Action Plan. Overall, the audit team member looks for corrective action measures and 

anticipated timelines that appear reasonable and meet minimum expectations. Although it may be 

easiest for the organization to address issues with “quick fixes” first, ideally, the organization should give 

priority to the most severe findings, since those findings often represent departures from regulatory 

requirements. It’s important to note that EPA’s role in judging the effectiveness of some solutions may 

be limited, depending on the monitoring experience and/or technical knowledge of the audit team with 

regard to the parameter(s) under review. It may be necessary to consult with technical experts outside 

the EPA Region or at OAQPS in order to determine if a resolution will be adequate and/or effective. 

Each Regional Office has flexibility in how it responds to the submitted response and Corrective Action 

Plan. Some Regional Offices may not directly approve or disapprove a Corrective Action Plan, but rather 

“accept” the plan overall with the expectation that the organization will report to the Regional Office 

the success (or not) of the implemented corrective actions, and that the organization will amend 

targeted timelines if corrective actions are delayed. With regard to the latter, communication of the 

amendment with the lead auditor is necessary, along with some form of written documentation (such as 

an email or letter from the audited organization). However, some Regional Offices may provide a 

written response to each finding's proposed corrective actions indicating that: 1) the proposed measure 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 90 of 105 

is approved, or 2) the proposed corrective action does not adequately address the root cause of the 

finding and, therefore, another solution(s) is needed. 

It is during this step in the process where the audited organization may formally contest an audit finding 

in writing and/or debate whether or not it will implement a recommended action stated within the 

report (such as invalidating data as a consequence of an audit finding). If this situation occurs, the lead 

auditor should work with the audit team and Regional Office management to determine the appropriate 

course of action. OAQPS may need to be involved in order to mediate a resolution with the audited 

organization. The outcome of the review should be included in a formal response to the audited 

organization. 

Corrective Action Follow-Up 

Once the Corrective Action Plan has been accepted or approved, the next step of the process becomes 

the tracking of completed action items. Dialog must be maintained with the monitoring organization 

regarding actions taken to address TSA findings. Issues should be addressed in a timely manner, with the 

understanding that systemic issues within a monitoring organization may take a longer amount of time 

to rectify. In fact, issues that involve staffing, or any significant restructuring of the organization’s quality 

system, may take months for the organization to successfully complete. Continued communications and 

routine follow-up on corrective action progress shows the audited organization that the Regional Office 

is vested in the organization. It is recommended that the lead auditor (or designated audit team 

member) conduct a follow-up phone call approximately 45 calendar days following receipt of the 

monitoring organization’s corrective action plan to receive a status/progress update. Any issues with 

implementing the corrective action plan can be discussed during this call. Other follow-up calls may be 

necessary following this first check-in, depending on the number and severity of findings in the TSA 

report. A schedule for conducting additional follow-up calls can be developed, if needed. 

6.4.1 Tracking 

The monitoring organization’s Corrective Action Plan should contain targeted due dates for the 

completion of each corrective action item. On the key dates when action items are scheduled to be 

completed, the monitoring organization should submit documentation to the lead auditor attesting to 

the resolution of the issue(s), as well as provide supporting evidence. The lead auditor (or designated 

team member) is responsible for tracking the completion of all action items in accordance with the 

schedule (timeline) developed by the monitoring organization. Given the extent of the audit findings, 

this phase of the TSA may take many months to complete. With that in mind, a strategy to manage this 

phase of the project should be developed by the EPA Regional Office. Any mechanism to internally track 

the status of action items is acceptable, provided that it guarantees that all items are accounted for and 

successfully remedied. 

There are numerous ways the completion of individual corrective action measures can be tracked. The 

recommended approach is to use a templated form that the audited organization documents upon the 

completion of each action item. See Figure 6.2 for an example of an audit finding tracking form. If using 

a form such as this one, the audited organization is responsible for all necessary documentation. A 

notable feature on the form is that it requires the signature of a reviewer from the audited organization 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 91 of 105 

that attests that the corrective action was successfully completed. The form is sent to the lead auditor 

upon its completion. Using this approach, the audited organization is responsible for completing one 

form for each finding itemized in the TSA report; the lead auditor, then, is responsible for accounting 

that a form for each auditing finding is received. If tracking corrective action items in this manner, it is 

important to note that the individual forms for each finding will need to be maintained and entered into 

the TSA Project File, once the TSA has been closed out (see Section 6.5.1 of this QAGD). 

In addition to tracking the receipt of audit finding tracking forms, the lead auditor is also responsible for 

evaluating the forms to determine whether the corrective action measures completed are acceptable, 

which may include evaluating supporting evidence provided by the auditee. In some cases, a specific 

deliverable may have been requested in the TSA report to illustrate successful completion of an action 

item, such as photographs and measurements demonstrating that Appendix E siting issues have been 

resolved, or specific AQS reports that illustrate recommended data flagging has been completed. 

Consultation with the audit team may be necessary when evaluating the documentation and supporting 

evidence provided by the monitoring organization, in order to determine whether or not a corrective 

action measure is adequate and effective. If the lead auditor (or designated audit team member) is 

satisfied with the corrective action measure taken, then the auditor should sign the audit form to close 

the loop on the specific finding. 

Although use of the audit tracking form is recommended, other tracking mechanisms are allowed. For 

example, the Regional Office may choose to develop a unique electronic spreadsheet or database that is 

used for tracking TSA corrective action measures. If using such a tool, the lead auditor is still charged 

with maintaining the documentation and records supplied by the auditee that demonstrate the 

corrective actions have been completed and were successful. On the other hand, if the Regional Office 

used a spreadsheet to initially provide the draft findings summary to the audited organization, the 

Regional Office may use that same spreadsheet – with additional columns added – to track the status of 

corrective actions. Under this scenario, the lead auditor is most likely charged with documenting the 

spreadsheet directly as the audited organization submits evidence that corrective action measures have 

been completed. Or, the Regional Office may elect to have the audited organization document the 

spreadsheet. If this option is employed, the lead auditor will need to determine how frequently the 

spreadsheet should be submitted to the Regional Office in order to receive status updates, or determine 

if the spreadsheet is only submitted once – when all corrective actions have been finalized. If the latter, 

then routine conference calls should be scheduled and/or status reports required in order to keep the 

auditor abreast of the organization’s progress. However, even using this approach, the auditor is still 

charged with maintaining copies of any additional records and supporting evidence the monitoring 

organization submits along with the spreadsheet. When all action items have been completed and the 

TSA is closed out, the spreadsheet and supporting records will need to be archived in the TSA Project 

File. 

While tracking corrective action measures, if expected documentation is not received by its anticipated 

due date, the lead auditor should contact the organization to inquire about its status. If the organization 

has had a delay, the lead auditor should request a written statement from the organization to explain 

the issue and establish a revised timeframe for submittal. The auditor should maintain copies of this 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 92 of 105 

correspondence, which serves as a record that documents the organization’s progress and the Regional 

Office’s follow-up. As the audited organization works through correcting the identified audit findings, 

conference calls with the organization’s senior management may become necessary, especially if 

repeated delays are reported or if the organization’s completed corrective action(s) does not meet 

minimum expectations. In these instances, EPA Regional Office upper management may need to 

become involved as well. See Section 8 of this QAGD for more information. 

6.4.2 Follow-up Site Visit 

If the TSA findings were especially significant, if there was a marked lack of responsiveness in completing 

corrective action, or if the organization itself requested assistance from EPA in the implementation of 

specific corrective action measures, follow-up site visits may be needed. A follow-up visit provides the 

auditor an opportunity to assess, in person, the progress the monitoring organization has made towards 

correcting issues. In many cases, judging the effectiveness of a corrective action measure can be best 

accomplished on site, as opposed to simply reading documentation that describes the resolution. While 

on site, the auditor can also offer additional technical advice or recommendations in order to help 

facilitate continued improvements. The follow-up visit provides the auditor the opportunity to help the 

organization alter its course of action, if the auditor determines the modification is inappropriate or 

deficient in some manner. In this regard, the follow-up visit facilitates improvements sooner, rather than 

later. Most importantly, the follow-up visit affords the auditor the opportunity for continued face-toface interaction with the monitoring organization. It is recommended that this follow-up site visit be 

documented in the manner by which the Regional Office deems most appropriate. Documentation could 

be in the form of a follow-up memorandum or email to the monitoring organization that acknowledges 

the visit and provides a brief summary of the activities completed. A more formal letter can be 

developed, if preferred. This documentation should be included in the TSA Project File, upon completion 

of the TSA. 

It is important to note that some recommended corrective actions (especially those that involve 

personnel or funding modifications) simply may not occur, due to institutional roadblocks within the 

monitoring organization or other reasons. In this event, the lead auditor should document the lack of 

corrective action (via email or internal memo to RO management, etc) in order to complete the internal 

tracking record. This documentation will illustrate the lead auditor’s commitment to tracking all audit 

findings, and will also serve as a means to inform RO management that an impasse has occurred. In 

these instances, the TSA will not be closed out in AQS and the monitoring organization will not receive 

a close-out letter from the Regional Office. Additionally, the finding(s) and recommendation(s) should 

be documented again in the monitoring organization’s next TSA report, emphasizing that the issue(s) 

was unresolved from the previous TSA. 

TSA Close-Out 

As stated earlier in this QAGD, TSAs are a mechanism for EPA to help monitoring organizations improve 

their ambient air monitoring programs. Although state and local air monitoring organizations are 

encouraged to provide solutions to issues identified as part of a TSA, EPA Regions and OAQPS may be 

needed to provide suggestions and guidance on options that bring the monitoring programs into 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 93 of 105 

compliance with federal regulations. As EPA and the monitoring organization collaborate on corrective 

action measures, the progress towards close-out of audit findings should be tracked and documented. 

This process may take many months to complete, depending on the extent of the audit findings. 

It is important that the lead auditor compile all records for the project file that are to be archived, 

including those records that demonstrate EPA has followed-up on the success of corrective action 

measures (or lack thereof). Once the lead auditor has the necessary paperwork to show that all 

identified TSA findings have been satisfactorily addressed (e.g., all requisite Audit Finding Response 

forms have been received and approved), the Regional Office should issue an official “close out” letter 

to the audited organization. Ideally, the close-out letter should be on organizational letterhead, signed 

by the designated approving official. The letter can be brief, and should clearly state that the 

organization has provided the necessary documentation to illustrate that required corrective action 

measures were successfully implemented; with that, the TSA is considered officially “closed.” Appendix 

F of this QAGD contains an example close-out letter. 

Along with the completion of this final correspondence, close-out information should also be entered 

into AQS to document the completion of the TSA. See Section 6.6 of this QAGD. However, if the TSA 

does not officially “close out” – meaning that the organization does not complete all the necessary 

corrective actions prior to the beginning of its next TSA cycle – an official close-out letter will not be 

generated and a close-out date will not be entered into AQS. 

6.5.1 TSA Project File 

Maintaining records and documents from the TSA is an important process for which the lead auditor is 

responsible. Each Regional Office has rules and policies regarding records retention; RO management 

should ensure that TSA documentation is filed and archived in a manner that adheres to Agency policies, 

and that each auditor is aware of the requirements. As such, each Regional Office is encouraged to 

document its TSA records management procedures in a SOP. Additionally, each Regional Office is 

encouraged to create a checklist that itemizes the documents and records from the TSA that should be 

maintained and archived. Records retained can be in electronic or hardcopy format, or a combination of 

both. 

After the TSA has been “closed out”, the lead auditor should gather all pertinent documents and records 

and place them collectively in a file that serves as the final repository for all information related to the 

specific TSA. Examples of records to maintain and archive may include, but not be limited to, the 

following: 

•	 a copy of the audit plan; 

•	 logbooks documented by the audit team during the on-site investigation; 

•	 pertinent AQS records or other documents that were investigated and resulted in significant 

audit findings; 

•	 photographs taken during the on-site investigation that relate to audit findings documented in 

the TSA report; 

•	 a copy of the draft findings summary and cover letter; 

•	 a copy of the final, signed TSA report and cover letter; 
 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 94 of 105 

•	 a copy of the questionnaire response documented by the monitoring organization; 

•	 a copy of the organization’s responses to both the draft findings summary and the final TSA 

report; 

•	 the monitoring organization’s corrective action plan; 

•	 audit finding tracking forms and/or the tracking spreadsheet; and, 

•	 a copy of the signed close-out letter. 

TSA Information in AQS 

The written TSA report serves as official documentation to demonstrate that the requirements of 40 CFR 

Part 58, Appendix A, §2.5 have been fulfilled – for both EPA and the audited organization. 

CFR-required TSAs must be reported to AQS. In 2013, an AQS entry screen was developed to allow the 

reporting of five TSA-related parameters: 1) the monitoring organization audited, 2) the auditing 

organization, 3) the audit begin date, 4) the audit end date, and 5) the close-out date. The audit begin 

date should be the date the on-site investigation begins. The audit end date should be the date the draft 

findings summary (report) is issued to the monitoring organization. The close-out date is defined as the 

date when all corrective actions identified in the audit report are completed and a close-out letter is 

issued, as discussed in Section 6.5 above. For those TSAs with outstanding issues that are not resolved 

before the onset of the next TSA cycle for the monitoring organization, the close-out date should be 

left blank in AQS. 

The lead auditor is responsible for ensuring that information regarding the TSA is successfully uploaded 

into AQS. It is recommended that the lead auditor (or delegate) enter the audit begin and end dates 

when the draft TSA report is first issued to the monitoring organization. The close-out date should be 

entered into AQS in conjunction with the issuance of the close-out letter, as the last step prior to 

archiving the completed TSA project file. 
 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 95 of 105 

Figure 6.2 Example Corrective Action Tracking Mechanism 
 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 96 of 105 

7.0 TSA Training 

While there is currently no standardized training required to conduct a TSA, each Region should have its 

own curriculum to train auditors. This should initially include training on the CFR regulations, QA 

Handbook, guidance documents, hands-on experience with monitoring equipment and procedures, and 

new auditors shadowing senior staff. Shadowing senior audit staff allows the new auditor to follow the 

process and observe the interaction between the monitoring organization and auditor. Training may be 

aided by a walk-through using in-house developed TSA checklists. Often, the best training originates 

from case studies and experience acquired during real TSAs. New auditors should not lead an audit until 

they have working knowledge of the monitoring and quality system requirements and several months of 

experience shadowing or participating in TSAs. 

In Regions with limited technical or quality system experience, it would be beneficial to take advantage 

of any cross-training or shadowing with other Regions. A wide array of technical expertise exists within 

the EPA Regions as a whole. Some Regions have been working on data analysis tools or best practices 

that can be shared and added to the guidance document. Other Regions have auditors who were prior 

air monitoring site operators or technicians. New lead auditors should reach out and take advantage of 

other EPA regional experience, OAQPS expertise, and the TSA workgroup members. 

There have been ongoing efforts to facilitate hands-on training with specific equipment and developing 

pollutant-specific checklists. For example, the Met One beta attenuation monitor (BAM) 1020 training 

has been offered by vendor personnel for each Region, and specific checklists have been developed by 

OAQPS to aid in auditing this monitor. There is interest/support in developing similar training and 

checklists for other equipment as well. If possible, proficiency training provides an excellent opportunity 

for new staff to learn and gain experience with monitoring equipment. All auditors should participate in 

TSA, RO/OAQPS Monitoring, and QA conference calls for more information as it becomes available. 

Training opportunities in the future include OAQPS-facilitated training with Regional expertise, a TSA 

Workshop or TSA discussions at the National Ambient Air Monitoring Conferences, QA workshops, and 

updated APTI training courses. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 97 of 105 

8.0 EPA Audit Communication 

While communication between the audit team and the audit team’s immediate supervisor(s) is generally 

anticipated to flow freely throughout the course of planning, performing, and writing the TSA report, 

there are points where elevation to upper management within the Region, to other Regions, or to 

OAQPS are more discrete. This section highlights some areas and situations where this elevation may 

occur. As a note, each Region may have different management communication policies, and this section 

is presented as a best practice for addressing specific concerns resulting from TSAs. 

Regional Management Elevation Points 

For purposes of this section, regional management refers to EPA management above the audit team’s 

immediate supervisor. The number of levels of management that may be involved depends on the how 

the Region is structured and the potential impact of the TSA. 

At the beginning of the fiscal year, EPA Regions should inform upper management of what organizations 

will be audited that year. This information will assist in planning the coming year’s priorities and in 

directing the necessary funding and resources for the audits. Two to three months prior to each on-site 

visit, the audit team’s immediate supervisor should inform upper management of the upcoming TSA. 

This may be followed a few weeks before the on-site visit by a short write-up emailed to upper 

management, stating the specific dates of the on-site TSA. 

Communication between the EPA audit team and the EPA Regional Office may be minimal during the 

on-site portion of the TSA. However, it is common for the audit team to reach out to other EPA experts 

(including OAQPS) during the on-site audit to answer technical questions or to request clarification on 

regulatory requirements. The EPA audit team will inform EPA Regional Office management (i.e., 

immediate supervisor(s) at a minimum) of any significant findings prior to communicating preliminary 

findings with the monitoring organization. By doing this, Regional Office management will be informed 

before the audit results are formally presented to the monitoring organization and can be better 

prepared to address questions or concerns that may result following the exit briefing. During the TSA 

exit briefing, EPA management (i.e., immediate supervisor(s) at a minimum) should participate via 

phone or in person. 

Upper management within the relevant EPA Regional Office may be informed of findings at a number of 

different stages, depending on the sensitivity or potential implications of findings, and management 

interest. Elevation may consist of a discussion between supervisor(s) and upper management, a formal 

briefing, or by emailing a summary and list of findings to upper management and offering a meeting to 

discuss further. 

Upper management may also need to be involved in the corrective action process between the EPA 

Region and the monitoring organization. If a monitoring organization shows no progress or limited 

progress during the TSA follow-up activities, the issue should be elevated to upper management for 

resolution. Upper management may be able to offer solutions or facilitate change quicker and more 

effectively than the audit team or the immediate supervisor. 
 

 

 

 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 98 of 105 

Points at which the audit team and supervisors should consider whether elevation is appropriate: 

•	 Upon receipt of the monitoring organization’s comments on the draft report 

•	 When fully-drafted findings are available, either as part of, or separate from, a completed draft 

TSA report 

•	 Prior to sending the draft report to the monitoring organization 

•	 Prior to sending the final report to the monitoring organization 

•	 Upon receipt of the corrective action plan 

•	 During the corrective action process 

•	 When there are delays in receiving the Corrective Action Plan 

•	 When there are delays in implementing the Corrective Action Plan 

•	 When there is a lack of communication from the monitoring organization 

•	 When there is refusal to reconsider corrective actions that have been identified as ineffective 

These elevation points may be different for each EPA Region depending on management and structure. 

The intent of identifying these different points is to allow for flexibility in handling communication of 

audit results. Instances when upper management involvement is specifically desired include findings 

that could result in significant amounts of data invalidation, or those with data implications for other 

EPA Regions. 

Inter-Regional Elevation Points 

Other EPA Regions will be contacted after issuing the final report if they are directly affected by the 

findings, such as in instances where two regions share an MSA and the TSA findings result in data 

invalidation and revised design values. Upper management should inform the other affected region(s), 

and the audit team may be requested to contact their staff-level counterparts. 

Other EPA Regions may also be contacted to share perspectives and provide input on how certain 

situations might be addressed. Questions or topics for discussion may be shared on national EPA calls, 

such as the monthly QA or RO/OAQPS Monitoring Calls, or during TSA Workgroup calls. 

OAQPS Elevation Points 

OAQPS may be contacted for clarification or guidance in interpreting CFR and national guidance 

documentation during the on-site audit or as the audit team drafts the TSA report. The audit team 

should feel free to contact OAQPS to gain knowledge on what precedents have been set in handling TSA 

findings in order to promote consistency across the regions. The region should elevate important audit 

findings to OAQPS that could result in: 

•	 significant data invalidation affecting NAAQS attainment decisions, 

• large amount of data qualification/flagging,
 

• or show serious deficiencies in the quality system.
 

It is especially important to report TSA results that may impact attainment decisions for the NAAQS. 

OAQPS is responsible for calculating design values for the NAAQS monitoring network using data in AQS. 
 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 99 of 105 

If audit findings demonstrate that data in AQS does not meet data quality requirements, action must be 

taken to correct the dataset through the use of flags or null codes as appropriate for the data quality 

issue. For this reason, it is imperative that these types of issues are raised to OAQPS so that only data of 

acceptable quality are used for NAAQS decision-making purposes. If large amounts of data are 

recommended for invalidation or flagged as a result of a TSA, the EPA Region should also communicate 

how much data is affected and when the data will be changed in AQS. 
 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 100 of 105 

Appendix A 

Technical Systems Audit Questionnaire 

The following questionnaire incorporates the requirements of the 40 CFR ambient air 

monitoring requirements and relevant EPA guidance and is intended to be used as a tool in 

conducting the TSA of an ambient air monitoring organization. This questionnaire is available 

on EPA’s AMTIC website as a fillable Word document and also as an Excel document. Both 

versions contain the same content and the user may choose to use either format. The 

questionnaire may be edited for specific regional use. 

Note: The criteria documented in this questionnaire was current as of the published date of this 

document. Users should verify that the criteria have not been updated in the CFR or other 

guidance documents, such as the QA Handbook, before use. If discrepancies exist, please 

inform the author(s) of this document to recommend revision of this appendix. 
Appendix A 

Technical Systems 

Audit 

Pre-Audit Questionnaire 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contents 

1. General.................................................................................................................................................. 4
 

a. Program Organization....................................................................................................................... 5
 

a.1 Organizational Chart ....................................................................................................................... 5
 

a.2 Key Position Staffing........................................................................................................................ 6
 

b. Facilities ................................................................................................................................................ 7
 

c. General Documentation Policies...........................................................................................................8
 

d. Training ................................................................................................................................................. 9
 

d.1 Training Plan ................................................................................................................................... 9
 

d.2 Training Events................................................................................................................................ 9
 

e. Oversight of Contractors and Supplies ...............................................................................................10
 

e.1 Contractors....................................................................................................................................10
 

e.2 Supplies.........................................................................................................................................10
 

2. Quality Management ..........................................................................................................................11
 

a. Status of Quality Assurance Program .............................................................................................11
 

a.1 QA Activities..................................................................................................................................11
 

a.2 QC Acceptance Criteria .................................................................................................................12
 

b. Internal Performance Evaluation (PE) Audits .................................................................................13
 

b.1 Internal Audit Questions...............................................................................................................13
 

b.2 Internal Audit Procedures.............................................................................................................13
 

b.3 Certification of Audit Standards....................................................................................................13
 

b.4 Audit Equipment ...........................................................................................................................14
 

b.5 Audit Acceptance Criteria .............................................................................................................14
 

c. Planning Documents Including QMP, QAPP, & SOP .......................................................................15
 

c.1 QMP Questions .............................................................................................................................15
 

c.2 QAPP Questions.............................................................................................................................15
 

c.3 SOP Questions ...............................................................................................................................16
 

d. Corrective Action ............................................................................................................................17
 

e. Quality Improvement......................................................................................................................17
 

f. External Performance Audits ..........................................................................................................18
 

3. Network Management........................................................................................................................19
 

a. Network Design...............................................................................................................................19
 

b. Siting................................................................................................................................................19
 

1 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b.1 Site Evaluations.............................................................................................................................19
 

b.2 Site Non-Conformance..................................................................................................................20
 

c. Waivers ...........................................................................................................................................20
 

c.1 Waiver Questions ..........................................................................................................................20
 

c.2 Waiver Types .................................................................................................................................20
 

d. Documentation ...............................................................................................................................21
 

4. Field Operations..................................................................................................................................22
 

a. Field Support...................................................................................................................................22
 

b. Instrument Acceptance...................................................................................................................23
 

b.1 Instrumentation............................................................................................................................23
 

b.2 Instrument Needs .........................................................................................................................23
 

c. Calibration.......................................................................................................................................23
 

c.1 Calibration Frequency and Methods.............................................................................................23
 

c.2 Calibration Questions....................................................................................................................24
 

d. Certification.....................................................................................................................................24
 

d.1 Flow Devices .................................................................................................................................24
 

d.2 Certification Questions .................................................................................................................25
 

d.3 Ozone Traceability Diagram..........................................................................................................26
 

d.3 Calibrator Certification..................................................................................................................27
 

e. Repair ..............................................................................................................................................28
 

f. Record Keeping ...............................................................................................................................29
 

5. Laboratory Operations............................................................................................................................30
 

a. Routine Operation ..........................................................................................................................30
 

a.1 Methods........................................................................................................................................30
 

a.2 Quality System ..............................................................................................................................31
 

b. Laboratory Quality Control .............................................................................................................32
 

b.1 Standards ......................................................................................................................................32
 

b.2 Laboratory Temperature and Relative Humidity..........................................................................32
 

c. Laboratory Preventive Maintenance ..............................................................................................33
 

d. Laboratory Record Keeping.............................................................................................................34
 

e. Laboratory Data Acquisition and Handling .....................................................................................36
 

f. Filter Questions...............................................................................................................................38
 

e. Metals & Other Analyses ................................................................................................................39
 

2 
 

 

 

 

 

 

 

 

 

 

 

 

 

e.1 Laboratory QA/QC.........................................................................................................................39
 

e.2 Chemicals......................................................................................................................................40
 

e.3 Pb ..................................................................................................................................................41
 

6. Data & Data Management..................................................................................................................42
 

a. Data Handling..................................................................................................................................42
 

b. Software Documentation................................................................................................................44
 

c. Data Validation and Correction.......................................................................................................45
 

d.	 Data Processing...............................................................................................................................45
 

d.1 Reports..........................................................................................................................................45
 

d.2 Data Submission............................................................................................................................46
 

e.	 Internal Reporting...........................................................................................................................47
 

e.1 Reports..........................................................................................................................................47
 

e.2 Responsibilities .............................................................................................................................47
 

3 
 

 

1. General 

Monitoring Organization/Agency/PQAO Audited 

Address: 

Street 

City, State, Zip Code 

Date of Technical Systems Audit: Click or tap to enter a date. 

This section of the questionnaire completed by: Click or tap here to enter name. 

Key Individuals (e.g., Agency Director, Ambient Air Monitoring Network Manager, QA Manager, etc.): 

Title/Position Name 

Click or tap here to enter text. Click or tap here to enter text. 

4 
a. Program Organization 

a.1 Organizational Chart 

Upload an organizational chart, or attach to the form: 

5 
 

 

 

 

 

 

 

 

a.2 Key Position Staffing 

Enter the number of personnel available to each of the following program areas, and any vacancies, if 

applicable. 

Program Area Number of People 

(Primary) 

Number of People 

(Backup) 

Vacancies 

Network Management (site setup, 

siting, ANP, etc.) 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Field Operation (QC checks, site 

visits, site maintenance, etc.) 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Quality management (audits, QA 

documentation, certifications etc.) 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Data and Data Management (data 

review, validation and acquisition 

system, AQS, etc.) 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Technical support (equipment repair 

and maintenance) 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Comment on the need for additional personnel, if applicable. 

Click or tap here to enter text. 

6 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

b. Facilities 

Identify the principal facilities where the agency conducts work related to air monitoring. Do not include 

monitoring stations, but do include facilities where work is performed by contractors or other 

organizations. 

Ambient Air Monitoring 

Function 

Facility Location Comment on any significant changes to be 

implemented within the next one to two 

years. 

Instrument repair Click or tap here to enter 

text. 

Click or tap here to enter text. 

Certification of Standards 

(e.g. gases, flow transfers, 

MFCs) 

Click or tap here to enter 

text. 

Click or tap here to enter text. 

PM filter weighing Click or tap here to enter 

text. 

Click or tap here to enter text. 

Pb analysis Click or tap here to enter 

text. 

Click or tap here to enter text. 

Data verification and 

processing 

Click or tap here to enter 

text. 

Click or tap here to enter text. 

General office space Click or tap here to enter 

text. 

Click or tap here to enter text. 

General lab/work space Click or tap here to enter 

text. 

Click or tap here to enter text. 

Storage space, short and 

long term 

Click or tap here to enter 

text. 

Click or tap here to enter text. 

Air Toxics Click or tap here to enter 

text. 

Click or tap here to enter text. 

Indicate below any facilities that should be upgraded or any needs for additional physical space 

(laboratory, office, storage, etc.) 

Click or tap here to enter text. 

7 
 

 

c. General Documentation Policies 

Complete the following table. 

Question Yes No Comment 

Does the agency have a documented records 

management plan? 

☐ ☐ Click or tap here to enter 

text. 

• If yes, does this include electronic records? ☐ ☐ Click or tap here to enter 

text. 

Does the agency have a method to track files 

considered official records and their media type (i.e. 

paper, electronic)? 

☐ ☐ Click or tap here to enter 

text. 

Does the agency have a schedule for retention and 

disposition of records? 

☐ ☐ Click or tap here to enter 

text. 

Are records kept for at least three years? ☐ ☐ Click or tap here to enter 

text. 

Who is responsible for the storage and retrieval of records? Click or tap here to enter 

text. 

What security measures are utilized to protect records? Click or tap here to enter 

text. 

Where/when does the agency rely on electronic files as primary records? Click or tap here to enter 

text. 

What is the system for storage, retrieval and backup of the electronic 

files? 

Click or tap here to enter 

text. 

8 
 

 

d. Training 

d.1 Training Plan 

Complete the following table. 

Question Yes No Comment 

Does the agency have a training plan? ☐ ☐ Click or tap here to enter 

text. 

Where is it documented? Click or tap here to enter 

text. 

Does it make use of seminars, courses, EPAsponsored college level courses, etc.? 

☐ ☐ Click or tap here to enter 

text. 

Are personnel cross-trained for other ambient 

air monitoring duties? 

☐ ☐ Click or tap here to enter 

text. 

Are training funds specifically designated in the 

annual budget? 

☐ ☐ Click or tap here to enter 

text. 

Does the training plan include: Yes No Comment 

Training requirements by position? ☐ ☐ Click or tap here to enter 

text. 

Frequency of training? ☐ ☐ Click or tap here to enter 

text. 

Training for contract personnel? ☐ ☐ Click or tap here to enter 

text. 

A list of core QA-related courses? ☐ ☐ Click or tap here to enter 

text. 

d.2 Training Events 

Indicate below the most training events since the last TSA and identify the personnel who participated in 

them. 

Event Dates Participant(s) 

Click or tap here to enter text. Click or tap to 

enter a date. 

Click or tap here to enter 

text. 

9 
 

 

 

 

 

e. Oversight of Contractors and Supplies 

e.1 Contractors 

Complete the following table. If your agency does not use contract personnel, proceed to section e.2 

Supplies. 

Contractors Yes No Comment 

Who is responsible for oversight of contract 

personnel? 

☐ ☐ Click or tap here to enter 

text. 

Are contractors providing a service (e.g., PM2.5 lab) 

audited? How often? Who is the contractor? 

☐ ☐ Click or tap here to enter 

text. 

What steps are taken to ensure contract personnel 

meet training and experience criteria? 

☐ ☐ Click or tap here to enter 

text. 

Are contractor Quality Documents reviewed before 

procuring a service? 

☐ ☐ Click or tap here to enter 

text. 

How often are contracts reviewed and /or 

renewed? 

☐ ☐ Click or tap here to enter 

text. 

e.2 Supplies 

Complete the following table. 

Suppliers Yes No Comment 

Have specifications been established for 

consumable supplies and/or for equipment? 

☐ ☐ Click or tap here to enter 

text. 

What supplies and equipment have established specifications? Click or tap here to enter 

text. 

Is equipment from suppliers open for bid? ☐ ☐ Click or tap here to enter 

text. 

10 
 

 

 

 

 

 

2. Quality Management 

This section of the questionnaire completed by: Click or tap here to enter name. 

Key Individuals: 

Title/Position Name 

Click or tap here to enter text. Click or tap here to enter text. 

a. Status of Quality Assurance Program 

a.1 QA Activities 

Complete the following table. 

Question Yes No Comment 

Does the agency perform all QA activities 

with internal personnel (i.e., developing 

QMPs/QAPPs/SOPs and DQOs, 

performing systems audits, assessments 

and performance evaluations, corrective 

actions, validating data, QA reporting, 

etc.)? If no, in the comment field, indicate 

who is responsible and which QA 

activities are performed. 

☐ ☐ Click or tap here to enter text. 

If the agency has contracts or similar agreements in place 

with either another agency or contractor to perform audits 

or calibrations, please name the organization and briefly 

describe the type of agreement. 

Click or tap here to enter text. 

Does the agency perform all QC activities 

with internal personnel (i.e., 

zero/span/one-point QC checks, 

calibrations, flowrate, temperature, 

pressure and humidity checks, 

certifying/recertifying standards, lab and 

field blanks, data collection, balance 

checks, leak checks, etc.)? 

☐ ☐ Click or tap here to enter text. 

11 
 

 

 

 

a.2 QC Acceptance Criteria 

Complete the following tables. 

Question Yes/No Location Comment 

Has the agency established and 

documented criteria to define agency 

acceptable QC results? 

Choose 

an item. 

Choose an 

item. 

Click or tap here to enter text. 

Pollutant Does the agency adhere to 

the critical QC acceptance 

criteria for criteria 

pollutants1 and 

meteorological 

measurements1? 

QC Acceptance 

Criteria 

(if other than 

validation 

templates1

) 

Action or 

Warning Limits 

Corrective 

Action 

Choose an 

item. 

Choose an item. Click or tap here to 

enter text. 

Click or tap here 

to enter text. 

Click or tap 

here to enter 

text. 

1 QA Handbook Volume II, Appendix D Validation Templates; Handbook for Air Pollution Measurement Systems, 

Appendix C Validation Templates; Quality Assurance Handbook for Air Pollution Measurement Systems: Volume IV: 

Meteorological Measurements Version 2.0 

12 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b. Internal Performance Evaluation (PE) Audits 

b.1 Internal Audit Questions 

Complete the following table. 

Question Yes No Response 

Does the agency maintain a laboratory to 

support quality assurance activities? 

☐ ☐ Click or tap here to enter text. 

Has the agency documented and 

implemented specific audit SOPs 

separate from monitoring SOPs? 

☐ ☐ Click or tap here to enter text. 

Are the QA personnel organizationally 

independent from the personnel 

responsible for generating environmental 

data? (40 CFR Part 58 Appendix A Section 

2.2) If no, please explain in the comment 

field. 

☐ ☐ Click or tap here to enter text. 

Are annual performance evaluations 

(audits) conducted by technician(s) other 

than the routine site operator(s)? (40 CFR 

Part 58 Appendix A Section 3.1.2) If no, 

please explain in the comment field. 

☐ ☐ Click or tap here to enter text. 

Does the agency have identifiable 

auditing equipment and standards 

(specifically intended for sole use) for 

audits? 

☐ ☐ Click or tap here to enter text. 

Are audit equipment and standards ever 

used to support routine calibration and 

QC checks required for monitoring 

network operations? If yes, please 

explain in the comment field. 

☐ ☐ Click or tap here to enter text. 

b.2 Internal Audit Procedures 

If the agency does not have a performance audit SOP (included as an attachment), please describe the 

performance audit procedure for each type of pollutant. 

Pollutant Performance Audit Procedure 

Choose an item. Click or tap here to enter text. 

b.3 Certification of Audit Standards 

Use the table below to provide information on certification of audit standards (ex. Flowmeters, gas 

standards, etc.) currently being used. 

Vendor Audit Standard Certification Certification 

Frequency 

Click or tap here to Click or tap here to Choose an item. Choose an item. 

enter text. enter text. 

13 
 

 

 

 

 

 

 

 

 

 

Complete the following table. 

Question Yes No Comment 

Does the agency have a separate certified 

source of zero air for performance audits? 

☐ ☐ Click or tap here to enter text. 

Does the agency have procedures for 

auditing and/or validating performance of 

meteorological monitoring? 

☐ ☐ Click or tap here to enter text. 

b.4 Audit Equipment 

Use the table provided below to list the agency’s audit equipment and age of audit equipment. 

Manufacturer Make and Model Number Purchase Year or Year Acquired 

Click or tap here to enter text. Click or tap here to enter text. Choose an item. 

b.5 Audit Acceptance Criteria 

Complete the following tables. 

Question Yes/No Location Comment 

Has the agency established and 

documented criteria to define agency 

acceptable audit results? If yes, 

comment where (page number, 

section, etc.) 

Choose 

an 

item. 

Choose an item. Click or tap here to 

enter text. 

Pollutant Does the agency adhere to 

the audit acceptance 

criteria for criteria 

pollutants and 

meteorological 

measurements1

? 

PE Audit 

Acceptance 

Criteria (if other 

than validation 

templates1

) 

Do the audit 

levels (gaseous 

PE audits only) 

meet 40 CFR Part 

58 Appendix A 

Section 3.1.2.1 

criteria? 

Corrective Action 

Choose 

an item. 

Choose an item. Click or tap here 

to enter text. 

Choose an item. Click or tap here 

to enter text. 

14 
 

 

 

 

 

c. Planning Documents Including QMP, QAPP, & SOP 

c.1 QMP Questions 

Complete the following table. 

Question Response 

Does the agency have an approved quality management plan (QMP)? Choose an 

item. 

• If yes, who approves the QMP (EPA, self-approval, PQAO, etc.)? Click or tap 

here to enter 

text. 

• Is the QMP multi-media, or air-specific? Choose an 

item. 

• Does the agency have any QMP revisions still pending EPA approval? Choose an 

item. 

• Has the QMP been approved by EPA within the last 5 years? Choose an 

item. 

• What is the approval date of the QMP? Click or tap 

to enter a 

date. 

c.2 QAPP Questions 

Complete the following table. 

Question Response 

Does the agency have an EPA-approved quality assurance project plan 

(QAPP)? 

Choose an item. 

• If no, has the agency been delegated self-approval? Choose an item. 

How often does the air monitoring agency review QAPPs? Click or tap here to enter 

text. 

Does the agency have any QAPP revisions still pending EPA approval? Choose an item. 

How does the agency verify that the QAPP is fully implemented? Click or tap here to enter 

text. 

How are staff notified and trained when a QAPP is revised? Click or tap here to enter 

text. 

What personnel regularly receive updates? Click or tap here to enter 

text. 

Does the agency have any missing QAPPs that need to be developed? Choose an item. 

• If yes, list any missing QAPPs. Click or tap here to enter 

text. 

15 
 

 

 

 

 

 

 

 

 

List all QAPPs. 

QAPP Title Approval 

Date 

Pollutants Status 

Click or tap here to enter text. Click or tap to 

enter a date. 

Click or tap 

here to 

enter text. 

Choose an item. 

c.3 SOP Questions 

Complete the following tables. 

Question Response 

Are all standard operating procedures (SOPs) complete, or are some in 

development? 

Choose an item. 

Are any monitoring SOPs needed? Choose an item. 

• If yes, list the SOPs that need to be developed. Click or tap here to enter 

text. 

Are SOPs available to all field operations personnel? Choose an item. 

Are SOPs for “episodic monitoring” prepared and available to field 

personnel? Refer to QA Handbook Vol. II, Section 6.0. 

Choose an item. 

Are SOPs based on the framework contained in Guidance for Preparing 

Standard Operating Procedures (SOPs) (EPA QA/G-6)? 

Choose an item. 

Does the agency have SOPs specific to data handling and data 

validation? 

Choose an item. 

Who approves SOPs? Click or tap here to enter 

text. 

How often are SOPs reviewed and updated? Click or tap here to enter 

text. 

How are staff notified and trained when a SOP is revised? Click or tap here to enter 

text. 

List all SOPs. 

SOP Title Approval 

Date 

Pollutants Status 

Click or tap here to enter text. Click or tap 

to enter a 

date. 

Click or tap 

here to 

enter text. 

Choose an item. 

16 
 

 

 

 

 

 

 

 

d. Corrective Action 

Question Response 

Does the agency have an operational, documented, and comprehensive 

corrective action program in place? 

Choose an item. 

• As a part of the QAPP? Choose an item. 

• As a separate, or part of a, SOP? Choose an item. 

Does the agency have established and documented corrective action 

limits for QA and QC activities? 

Choose an item. 

Are corrective action procedures based on results of the following that 

have exceeded established limits? 

Click or tap here to enter 

text. 

• 1-Point QC checks Choose an item. 

• Calibrations and zero/span checks Choose an item. 

• Flow rate verifications Choose an item. 

• Performance evaluations (gaseous audits and semi-annual flow 

rate audits) 

Choose an item. 

• Precision goals (collocated PM2.5 and PM10) Choose an item. 

• Bias goals Choose an item. 

• NPAP audits Choose an item. 

• PEP audits Choose an item. 

• Completeness goals Choose an item. 

• Data audits Choose an item. 

• Technical Systems Audits Choose an item. 

How is responsibility for implementing corrective actions assigned? Click or tap here to enter 

text. 

How does the agency follow up after corrective actions are 

implemented? 

Click or tap here to enter 

text. 

Briefly describe recent examples of the ways in which the above 

corrective action system was employed to remove problems. 

Click or tap here to enter 

text. 

e. Quality Improvement 

Question Response 

What actions were taken to improve the quality system 

since the last TSA? 

Click or tap here to enter text. 

Since the last TSA, do your control charts indicate that the 

overall data quality for each pollutant is steady or 

improving? 

Click or tap here to enter text. 

What was the cause when goals for measurement 

uncertainty per 40 CFR Part 58 Appendix A were not met? 

Click or tap here to enter text. 

Have all deficiencies indicated on the previous TSA report 

been corrected? If no, please list and explain. 

Click or tap here to enter text. 

What are your agency’s plans for quality improvement? Click or tap here to enter text. 

17 
 

 

 

 

 

 

 

 

 

 

f. External Performance Audits 

Question Response Comment 

Does your agency participate in the following 

external performance audits? If the agency does not 

participate, please explain why. 

Click or tap here to enter text. 

• NPAP Choose an 

item. 

Click or tap here to enter text. 

• PM2.5 Choose an 

item. 

Click or tap here to enter text. 

• PEP Choose an 

item. 

Click or tap here to enter text. 

• Pb-PEP Choose an 

item. 

Click or tap here to enter text. 

• Pb Strip Audit Choose an 

item. 

Click or tap here to enter text. 

• Ambient Air Protocol Gas 

Verification Program 

(AA_PGVP) 

Choose an 

item. 

Click or tap here to enter text. 

• Round Robin metal PT Choose an 

item. 

Click or tap here to enter text. 

List other performance audit participation. Click or tap here to enter text. 

Who performs NPAP and PEP audits? Click or tap here to enter text. 

18 
 

 

 

 

 

 

 

3. Network Management 

This section of the questionnaire completed by: Click or tap here to enter name. 

Key Individuals: 

Title/Position Name 

Click or tap here to enter text. Click or tap here to enter text. 

a. Network Design 

For monitoring organizations and agencies that do not submit the annual network plan required by 40 

CFR 58.10, please complete the table below. For those that do submit an annual network plan, proceed 

to section b. 

Site Name AQS Site ID # Pollutants Monitored Proposed Changes 

Click or tap here to 

enter text. 

Click or tap here to 

enter text. 

Click or tap here to enter 

text. 

Click or tap here to enter 

text. 

b. Siting 

b.1 Site Evaluations 

Complete the following table. 

Question Yes No Comment 

Does the current level of monitoring effort, 

station placement, instrumentation, etc., meet 

requirements imposed by current grant 

conditions? 

☐ ☐ Click or tap here to enter 

text. 

Are there any issues? ☐ ☐ Click or tap here to enter 

text. 

How often are site evaluations for 40 CFR Part 58 

Appendix E criteria conducted? 

Frequency: Click or tap here to enter 

text. 

Date of last 

review: 

Click or tap to enter a date. 

19 
 

 

 

 

 

 

 

 

 

 

 

 

b.2 Site Non-Conformance 

Please list any monitors with siting non-conformances, the AQS ID numbers for those monitors, the type 

of non-conformance and the reason(s) for the non-conformance. If none of your agency’s monitors have 

siting non-conformances, proceed to section c. Waivers. 

Monitor AQS Site ID # Type of NonConformance Reason(s) for NonConformance 

Choose an item. Click or tap here to Choose an item. Click or tap here to 

enter text. enter text. 

c. Waivers 

c.1 Waiver Questions 

Complete the following table. 

Question Yes No Comment 

Does your agency have any waivers? ☐ ☐ Click or tap here to enter 

text. 

Does your agency plan to request any waivers? 

If yes, identify waivers in the Comment section. 

☐ ☐ Click or tap here to enter 

text. 

Has your agency obtained necessary waiver 

provisions to operate equipment which does 

not meet the effective reference and 

equivalency requirements? 

☐ ☐ Click or tap here to enter 

text. 

Do any sites vary from the required frequency in 

40 CFR Part 58.12? 

☐ ☐ Click or tap here to enter 

text. 

Do any collocated PM2.5 sites exceed the 

distance requirements in 40 CFR Part 58 Section 

3.2.3.4 (c)? Waiver allowances can found in 40 

CFR Part 58, Section 3.2.3.4 (c) 

☐ ☐ Click or tap here to enter 

text. 

c.2 Waiver Types 

Indicate any waivers requested or granted by the Regional Office, and provide waiver documentation. If 

your agency does not have any waivers, proceed to section d. Documentation 

Waiver Type Reason 

Choose an item. Click or tap here to enter text. 

20 
 

 

d. Documentation 

Complete the following table. 

Question Yes No Comment 

Are hard copy or electronic site information files 

retained by the agency for all air monitoring stations 

within the network? 

☐ ☐ Click or tap here to 

enter text. 

Does each station have the required information including: 

AQS Site ID Number? ☐ ☐ Click or tap here to 

enter text. 

Photographs of the four cardinal compass points? ☐ ☐ Click or tap here to 

enter text. 

Startup and shutdown dates? ☐ ☐ Click or tap here to 

enter text. 

Documentation of instrumentation? ☐ ☐ Click or tap here to 

enter text. 

Who has custody of the current network documents Name: Click or 

tap here to enter 

text. 

Click or tap here to 

enter text. 

Title:Click or tap 

here to enter 

text. 

Click or tap here to 

enter text. 

21 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4. Field Operations 

This section of the questionnaire completed by: Click or tap here to enter name. 

Key Individuals (e.g., Field Manager, Field Supervisor, Field QA Manager, etc.): 

Title/Position Name 

Click or tap here to enter text. Click or tap here to enter text. 

a. Field Support 

Complete the following table. 

Question Yes No Comment 

On average, how often are most of your stations visited 

by a field operator? 

Click or tap here to enter text. 

Is this visit frequency consistent for all air 

monitoring data collecting organizations 

within your agency? 

☐ ☐ Click or tap here to enter text. 

On average, how many stations does a single operator 

have responsibility for? 

Click or tap here to enter text. 

How many sites (SLAMS/NCORE/SPM) have sampling 

manifold? 

Click or tap here to enter text. 

Do the sample inlets and/or manifolds 

meet the requirements for through-theprobe audits? 

☐ ☐ Click or tap here to enter text. 

Briefly describe the most common manifold type Click or tap here to enter text. 

How often are manifolds cleaned? Click or tap here to enter text. 

Is there a conditioning period for the 

manifold cleaning? 

☐ ☐ Click or tap here to enter text. 

Are manifolds equipped with a blower? ☐ ☐ Click or tap here to enter text. 

Is there sufficient air flow through the 

manifold/sampling lines at all times? 

☐ ☐ Click or tap here to enter text. 

How is the air flow through the manifold/sampling line 

monitored? 

Click or tap here to enter text. 

What is the average residence time? Click or tap here to enter text. 

How often is the residence time calculated? Click or tap here to enter text. 

Sampling lines: 

1) What material is used for instrument sampling 

lines? 

Click or tap here to enter text. 

2) How often are sampling lines changed? Click or tap here to enter text. 

Do you utilize uninterruptable power 

supplies or backup power sources at your 

sites? 

☐ ☐ Click or tap here to enter text. 

What instruments or devices are protected? Click or tap here to enter text. 

22 
 

 

 

 

 

b. Instrument Acceptance 

b.1 Instrumentation 

Please list the instruments in your inventory. 

Pollutant Number of Make and Models Reference or 

Instruments Equivalent Number 

Choose an item. Click or tap here to Click or tap here to Click or tap here to 

enter text. enter text. enter text. 

b.2 Instrument Needs 

Please list your instrument needs in order of priority. 

Click or tap here to enter text. 

c. Calibration 

c.1 Calibration Frequency and Methods 

Please indicate the frequency and method of multi point calibrations. 

Pollutant Frequency Calibration Method: 

Back of Instrument 

Calibration Method: 

Through the Probe 

Choose an item. Click or tap here to 

enter text. 

☐ ☐

23 
 

 

 

 

 

 

 

 

 

 

 

c.2 Calibration Questions 

Please complete the following table. 

Question Yes No Comment 

How are field calibration procedures documented and 

how are the results recorded? 

Click or tap here to enter text. 

Are calibrations performed in keeping 

with the guidance in Vol. II of the QA 

Handbook? 

☐ ☐ Click or tap here to enter text. 

Are calibration procedures consistent 

with the operational requirements of 

Appendices to 40 CFR Part 50 or to 

analyzer operation/instruction manuals? 

☐ ☐ If no, why not? Click or tap here to enter 

text. 

Have changes been made to calibration 

methods based on manufacturer’s 

suggestions for a particular instrument? 

☐ ☐ Click or tap here to enter text. 

Do standards used for calibrations meet 

the requirements of appendices to 40 CFR 

50 (EPA reference methods) and Appendix 

A to 40 CFR 58 (traceability of materials to 

NIST, SRMs or CRMs)? 

☐ ☐ Comment on deviations. Click or tap here to 

enter text. 

Are all flow-measurement devices NISTtraceable? 

☐ ☐ Click or tap here to enter text. 

d. Certification 

d.1 Flow Devices 

Please list the authoritative standards used for each type of flow measurement, and indicate the 

certification frequency of standards to maintain field material/device credibility. 

Flow Device Serial Number Primary Standard Certification 

Frequency 

Use (calibration, 

audit, or spare) 

Choose an item. Click or tap here 

to enter text. 

Click or tap here 

to enter text. 

Click or tap here 

to enter text. 

Choose an item. 

24 
 

 

 

 

 

 

 

 

 

 

d.2 Certification Questions 

Please complete the following table. 

Question Yes No Comment 

How are certifications performed? (internally, by a vendor, 

or third party?) 

Click or tap here to enter text. 

Where do field operations personnel obtain gas 

standards? 

Click or tap here to enter text. 

How are the gas standards verified after receipt? Click or tap here to enter text. 

What equipment is used to perform calibrations (e.g., 

dilution devices) 

Click or tap here to enter text. 

Do the dilution air flow control and 

measurement devices conform to CFR 

requirements? 

☐ ☐ Click or tap here to enter text. 

What traceability is used? Click or tap here to enter text. 

Is calibration equipment maintained at 

each station? 

☐ ☐ Click or tap here to enter text. 

How is the functional integrity of this equipment 

documented? 

Click or tap here to enter text. 

Who has responsibility for maintaining field calibration 

standards? 

Click or tap here to enter text. 

*Please provide copies of certifications of all standards currently in use from your master and/or 

satellite certification logbooks (i.e., chemical, gas, flow, and zero air standards). 

25 
 

d.3 Ozone Traceability Diagram 

*Please provide a flow diagram establishing traceability from the SRP (Level 1) to the ozone transfer 

standards used in your network. 

26
 
 

 

d.3 Calibrator Certification 

Please list the authoritative standards and frequency of each type of dilution, permeation and ozone 

calibrator and indicate certification frequency. 

Calibrator Primary Standard Frequency of 

Certification/Calibration 

Choose an item. Click or tap here to enter text. Click or tap here to enter text. 

27 
 

 

 

 

 

 

 

 

 

 

 

 

e. Repair 

Complete the following table. 

Question Yes No Comment 

Who is responsible for performing preventive 

maintenance? 

Click or tap here to enter text. 

Is special training provided to them for 

performing preventive maintenance? 

Briefly comment on background or 

courses. 

☐ ☐ Click or tap here to enter text. 

What is the preventive maintenance schedule for each 

type of field instrumentation? 

Click or tap here to enter text. 

If preventive maintenance is MINOR, it is performed at 

(check one or more) 

☐Field Station ☐Headquarters Facilities ☐Manufacturer 

☐PQAO 

Click or tap here to enter text. 

If preventive maintenance is MAJOR, it is performed at 

(check one or more) 

☐Field Station ☐Headquarters Facilities ☐Manufacturer 

☐PQAO 

Click or tap here to enter text. 

Does the agency have service contracts 

or agreements in place with instrument 

manufacturers? Indicate in the 

Comment section or attach additional 

pages to show which instrumentation is 

covered. 

☐ ☐ Click or tap here to enter text. 

Comment briefly on the adequacy and 

availability of the supply of spare parts, 

tools, and manuals available to the field 

operator to perform any necessary 

maintenance activities. Do you feel that 

this is adequate to prevent any 

significant data loss? 

☐ ☐ Click or tap here to enter text. 

Is the agency currently experiencing any 

recurring problem with equipment or 

manufacturer(s)? If so, please identify 

the equipment or manufacturer, and 

comment on steps taken to remedy the 

problem. 

☐ ☐ Click or tap here to enter text. 

28 
 

 

 

 

 

 

 

 

f. Record Keeping 

Complete the following table. 

Question Yes No Comment 

What type of station logbooks are maintained at each 

monitoring station? (maintenance logs, calibration logs, 

personal logs, etc.) 

Click or tap here to enter text. 

What information is included in the station logbooks? Click or tap here to enter text. 

Who reviews and verifies the logbooks for adequacy of 

station performance? 

Click or tap here to enter text. 

How is control of logbook maintained? Click or tap here to enter text. 

Where is the completed logbook archived? Click or tap here to enter text. 

What other records are used? (Use drop-down menu 

below). Comment on the use and storage of these 

documents. 

Click or tap here to enter text. 

Choose an item. Click or tap here to enter text. 

Are calibration records (or calibration 

constants) available to field operators? 

☐ ☐ Click or tap here to enter text. 

*Please attach an example field calibration record sheet. 

29 
 

 

 

 

 

 

 

 

5. Laboratory Operations 

This section of the questionnaire completed by: Click or tap here to enter name. 

Laboratory Name: 

Laboratory Name 

Laboratory Address: 

Laboratory Address 

Key Individuals (e.g., Laboratory Manager, Laboratory Supervisor, Laboratory QA Manager, etc.): 

Title/Position Name 

Click or tap here to enter text. Click or tap here to enter text. 

a. Routine Operation 

a.1 Methods 

In the table below, identify which of the following analyses are performed in the laboratory and state 

the method used to conduct the analyses. 

Pollutant Method 

Choose an item. Click or tap here to enter text. 

Please describe areas where there have been difficulties meeting the regulatory requirements for any of 

the above methods. 

Click or tap here to enter text. 

30 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a.2 Quality System 

Complete the following table. 

Question Yes No Comment 

Are procedures for the methods listed in 

section a.1 included in the agency’s QA 

Project Plan? 

☐ ☐ Click or tap here to enter text. 

Have the laboratory SOPs been reviewed 

and approved? If yes, in the comment 

section, indicate by who (EPA, PQAO, 

etc.)? 

☐ ☐ Click or tap here to enter text. 

Are SOPs easily and readily accessible for 

use and reference within the laboratory? 

If not, where are the documents stored? 

☐ ☐ Click or tap here to enter text. 

Does the lab have sufficient 

instrumentation to conduct the analyses? 

☐ ☐ Click or tap here to enter text. 

Are separate facilities maintained for 

weighing the different sample types? 

(e.g., hi-volume vs low-volume), or is one 

weighing room utilized for all samples? 

Describe. 

☐ ☐ Click or tap here to enter text. 

Does your laboratory hold certifications? 

(EPA, NIST, State, NELAC, or other) 

☐ ☐ Click or tap here to enter text. 

Does your laboratory operate under a 

Quality Assurance Manual or equivalent 

document? 

☐ ☐ Click or tap here to enter text. 

Does your laboratory participate in 

performance evaluation programs? 

☐ ☐ Click or tap here to enter text. 

Does your laboratory have a corrective 

action process for non-conforming work? 

☐ ☐ Click or tap here to enter text. 

Does your laboratory have a laboratory 

staff person assigned the role of Quality 

Assurance Officer? 

☐ ☐ Click or tap here to enter text. 

Please describe needs for laboratory instrumentation. 

Click or tap here to enter text. 

31 
 

 

 

 

 

 

 

 

b. Laboratory Quality Control 

b.1 Standards 

Please identify the equipment and standards used in support of the gravimetric laboratory, including any 

quality assurance standards (such as additional weight sets or portable RH/temperature probes). 

Device Pollutant Brand (Make) Model (Class) Calibration/Certification 

Expiration Date 

Choose an 

item. 

Choose an 

item. 

Click or tap 

here to enter 

text. 

Click or tap here 

to enter text. 

Click or tap to enter a 

date. 

*Please have calibration/certification records available for all laboratory standards. 

b.2 Laboratory Temperature and Relative Humidity 

Complete the following table. 

Question Yes No Comment 

What is the accuracy specification and recording time 

(e.g., 5 min. averaging time) of the temperature sensor 

(logger) used in the gravimetric laboratory? 

Click or tap here to enter text. 

What is the accuracy specification and recording time 

(e.g., 5 min. averaging time) of the RH sensor (logger) 

used in the gravimetric laboratory? 

Click or tap here to enter text. 

What is the accuracy specification for any RH/temp audit 

device used in the laboratory, if applicable? 

Click or tap here to enter text. 

Does the laboratory utilize an IR gun to 

obtain sample shipment temperatures? 

☐ ☐ Click or tap here to enter text. 

• If yes, is the IR gun NISTtraceable? Provide the 

certification expiration date. 

☐ ☐ Click or tap here to enter text. 

If the laboratory does not utilize an IR gun, what device is 

used to obtain shipment temperature? Please describe its 

traceability and provide a certification expiration date. 

Click or tap here to enter text. 

32 
 

 

 

 

 

 

 

 

c. Laboratory Preventive Maintenance 

Complete the following table. 

Question Yes No Comment 

Is preventive maintenance performed on 

laboratory equipment? If so, who has the 

responsibility for performing preventive 

maintenance? 

☐ ☐ Click or tap here to enter text. 

If equipment maintenance is performed 

by laboratory staff, does the SOP detail 

the procedures to be followed? Provide 

the SOP title, date, and revision number 

where the procedures are found. 

☐ ☐ Click or tap here to enter text. 

Is a maintenance log maintained for the 

balance? 

☐ ☐ Click or tap here to enter text. 

Are service contracts in place for the 

balance? 

☐ ☐ Click or tap here to enter text. 

If utilizing a weighing room, are service 

contracts in place for the climate control 

unit/HVAC? 

☐ ☐ Click or tap here to enter text. 

Describe static control equipment utilized in the 

weighing room, if applicable. 

Click or tap here to enter text. 

Does the weighing room undergo routine 

cleaning activities? On what frequency? 

☐ ☐ Click or tap here to enter text. 

Briefly describe the weighing room cleaning procedure. Click or tap here to enter text. 

33 
 

 

 

 

 

 

 

 

 

 

 

 

d. Laboratory Record Keeping 

Complete the following table. 

Question Yes No Comment 

Are all samples that are received by the 

laboratory logged in? 

☐ ☐ Click or tap here to enter text. 

Discuss sample routing (or attach a copy of the latest 

SOP which covers this). Attach a flow chart on the next 

page, if possible. 

Click or tap here to enter text. 

For the following 4 questions, select the medium used to document various activities enlisted. If the 

medium is not listed, select “Other” and list the medium. If the information is not recorded, select 

“N/A”. 

• Environmental conditions, weighing session 

results, balance checks, and weight checks? 

Choose an item. 

• Serial numbers of filters prepared for the field? Choose an item. 

• Serial number of filters returning from the field 

for analysis? 

Choose an item. 

• General information about daily lab activities, 

preventive maintenance procedures, and/or 

other significant events in the laboratory that 

may impact data quality or the data record? 

Choose an item. 

How are data records from the laboratory archived? Click or tap here to enter text. 

• Where? Click or tap here to enter text. 

• Who has the responsibility? (identify 

person/position) 

Click or tap here to enter text. 

How long are records kept? Indicate the number of 

months/years. 

Click or tap here to enter text. 

Does the laboratory SOP contain 

procedures for sample chain-of-custody 

(COC)? 

☐ ☐ Click or tap here to enter text. 

• If yes, indicate the title, date, and revision 

number, and where it can be found. 

Click or tap here to enter text. 

What type of COC record accompanies the samples? Click or tap here to enter text. 

Does the laboratory maintain original 

COCs or copies? 

☐ ☐ Click or tap here to enter text. 

Where are COCs filed? Click or tap here to enter text. 

34 
*If possible, attach a sample routing flow chart: 

35 
 

 

 

 

 

 

 

 

 

e. Laboratory Data Acquisition and Handling 

Question Yes No Comment 

Identify those laboratory instruments (e.g., balances, 

temperature/RH loggers, etc.) which make use of 

computer interfaces directly to record data. 

Click or tap here to enter text. 

Are QC data results readily available to the 

analyst during a weigh session? 

☐ ☐ Click or tap here to enter text. 

Do RH/temperature loggers record values 

using paper chart records (chart wheels)? 

If yes, where are the paper charts 

maintained? Are they signed and dated? 

☐ ☐ Click or tap here to enter text. 

What is the laboratory’s capability with regards to data 

recovery? In case of problems, can the laboratory 

recapture data that may be lost in the event of 

computer failure? Discuss briefly. 

Click or tap here to enter text. 

Does the laboratory maintain an SOP that 

discusses how to use the laboratory’s data 

acquisition instrumentation? If yes, please 

provide the SOP title, date, and revision 

number. 

☐ ☐ Click or tap here to enter text. 

36 
 

*Please attach a flow chart/diagram which illustrates the transcriptions, verifications, validations, and 

reporting processes the data goes through before being released by the laboratory. 

37 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

f. Filter Questions 

Question Yes No Comment 

Does the agency use filters supplied by 

EPA? 

☐ ☐ Click or tap here to enter text. 

If the answer to the above question is No, 

do the filters utilized meet the 

specifications in 40 CFR Part 50? Who is 

the vendor? Be prepared to provide 

documentation to demonstrate 

acceptance testing results. 

☐ ☐ Click or tap here to enter text. 

Are unexposed filters visually inspected 

via strong light from a view box for 

pinholes and other imperfections? 

☐ ☐ Click or tap here to enter text. 

Are unexposed filters equilibrated in a 

controlled conditioning environment 

which meets or exceeds the requirements 

of 40 CFR Part 50? Describe the 

conditioning room/chamber. 

☐ ☐ Click or tap here to enter text. 

How long is the conditioning period? Click or tap here to enter text. 

Briefly describe how exposed filters are prepared for 

conditioning. 

Click or tap here to enter text. 

Are exposed filters reconditioned in the 

same conditioning environment as the 

unexposed filters? 

☐ ☐ Click or tap here to enter text. 

Are the temperature and relative humidity 

of the conditioning environment (i.e., 

weigh room or conditioning chamber) 

monitored? What is the resolution of the 

data collected (e.g., 1-minute, 5-minute, 

1-hour, etc.)? 

☐ ☐ Click or tap here to enter text. 

How often are balance checks performed? Click or tap here to enter text. 

Do the weights (mass reference standards) 

bracket the weights of the filters being 

utilized? What are the masses of the 

weight standards used? 

☐ ☐ Click or tap here to enter text. 

To what sensitivity are filter weights recorded? Click or tap here to enter text. 

Are filters packaged for protection to and 

from the laboratory? 

☐ ☐ Click or tap here to enter text. 

On average, what is the elapsed time in hours between 

the end of sampling and laboratory receipt? 

Click or tap here to enter text. 

In what medium are field measurements recorded (e.g., 

in a log book, on a filter form, or on standard forms)? 

Click or tap here to enter text. 

Briefly describe how and where exposed filters are 

stored after being weighed. 

Click or tap here to enter text. 

On what frequency are lab blanks utilized? Click or tap here to enter text. 

38 
 

 

 

 

 

 

 

 

 

 

 

 

Are chemical analyses performed on ☐ ☐ Click or tap here to enter text. 

filters? If yes, which? Where are these 

additional analyses performed? 

e. Metals & Other Analyses 

If your laboratory completes lead (Pb) and/or other metals analyses, please complete the tables in this 

section. 

e.1 Laboratory QA/QC 

Question Yes No Comment 

Are at least one duplicate, one blank, and 

one standard or spike included with a 

given analytical batch? 

☐ ☐ Click or tap here to enter text. 

Briefly describe the laboratory’s use of data derived 

from blank analyses. 

Click or tap here to enter text. 

Are criteria established to determine 

whether blank data are acceptable? 

☐ ☐ Click or tap here to enter text. 

How frequently and at what concentration ranges does 

the lab perform duplicate analyses? What constitutes an 

acceptable agreement? 

Click or tap here to enter text. 

Please describe how the lab uses data obtained from 

spiked samples, including the acceptance criteria (e.g., 

acceptable percent recovery). 

Click or tap here to enter text. 

Does the laboratory include samples of 

reference material within an analytical 

batch? If yes, indicate frequency, level, 

and material used. 

☐ ☐ Click or tap here to enter text. 

Are mid-range standards included in 

analytical batches? If yes, describe the 

frequency, level, and compound. 

☐ ☐ Click or tap here to enter text. 

Are criteria for real time quality control 

established that are based on the results 

obtained for the mid-range standards 

discussed above? If yes, briefly discuss 

them below or indicate the document in 

which they can be found. 

☐ ☐ Click or tap here to enter text. 

Are appropriate acceptance criteria for 

each type of analysis documented? 

☐ ☐ Click or tap here to enter text. 

39 
 

 

 

e.2 Chemicals 

Complete the following table. 

Question Yes No Comment 

Are all chemicals and solutions clearly 

marked with an indication of shelf life? 

☐ ☐ Click or tap here to enter text. 

Are chemicals removed and properly 

disposed of when the shelf life expires? 

☐ ☐ Click or tap here to enter text. 

Does the laboratory purchase standard 

solutions such as those for use with lead 

or other metals analyses? 

☐ ☐ Click or tap here to enter text. 

Are only ACS grade chemicals used by the 

laboratory? 

☐ ☐ Click or tap here to enter text. 

Comment on the traceability of chemicals used in the 

preparation of calibration standards. 

Click or tap here to enter text. 

40 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

e.3 Pb 

Question Response Comments 

Is Pb analysis performed by a 

contract laboratory? If yes, 

provide the laboratory name in 

the comment section. 

Choose an item. Click or tap here to enter text. 

What filter media is used for Pb 

analysis? 

Choose an item. Click or tap here to enter text. 

Are filter samples visually 

inspected for defects (e.g., 

pinholes, tears and non-uniform 

deposit)? 

Choose an item. Click or tap here to enter text. 

Are filters invalidated if defects 

are found? If no, why not? 

Choose an item. Click or tap here to enter text. 

Are tweezers used to handle 

filters? If yes, what material are 

the tweezers made of (ex. 

Teflon, plastic, metal, etc.)? 

Choose an item. Click or tap here to enter text. 

What extraction method is used 

for filters? 

Choose an item. Click or tap here to enter text. 

What reagents are used to clean glassware? Click or tap here to enter text. 

List standards used for analysis. Click or tap here to enter text. 

Are filter lot blanks analyzed for 

Pb content at a rate of 20 to 30 

random filters per batch of 500 

or greater? Only for filters not 

provided by EPA. 

Choose an item. Click or tap here to enter text. 

How often are MDLs determined? Click or tap here to enter text. 

How many replicates used for MDLs? Click or tap here to enter text. 

Are MDLs calculated in 

accordance with 40 CFR Part 

136, Appendix B? If not, why 

not? 

Choose an item. Click or tap here to enter text. 

Are waste HNO3, HCL, and 

solutions containing these 

reagents and/or Pb placed in 

labeled bottles and delivered to 

a commercial firm that 

specializes in removal of 

hazardous waste? 

Choose an item. Click or tap here to enter text. 

41 
 

 

 

 

 

 

 

 

 

 

 

6. Data & Data Management 

This section of the questionnaire completed by: Click or tap here to enter name. 

Key Individuals: 

Title/Position Name 

Click or tap here to enter text. Click or tap here to enter text. 

a. Data Handling 

Complete the following table. 

Question Yes No Comment 

Is there a procedure, description, or a chart 

which shows a complete data sequence 

from point of acquisition to point of 

submission of data to EPA? 

☐ ☐ Click or tap here to enter text. 

Are procedures for data handling (e.g., data 

reduction, review, etc.) documented? If yes, 

comment on where. 

☐ ☐ Click or tap here to enter text. 

In what media (e.g., flash drive, telemetry, wireless, 

etc.) and formats do data arrive at the data processing 

location? 

Click or tap here to enter text. 

How often are data received at the processing location 

from the field sites and laboratory? 

Click or tap here to enter text. 

Are there any activities being done before 

data is released to agency internal data 

processing? 

☐ ☐ Click or tap here to enter text. 

How are data entered to the computer system? (e.g., 

computerized transcription, manual entry, digitization 

of strip charts, or other)? 

Click or tap here to enter text. 

For manual data, is a double-key entry 

system used? 

☐ ☐ Click or tap here to enter text. 

42 
*Please provide a data flow diagram indicating the data flow within the reporting organization. 

43 
 

 

 

 

 

 

 

 

 

 

 

b. Software Documentation 

Complete the following table. 

Question Yes No Comment 

Does your agency use an AQS Manual? ☐ ☐ Click or tap here to enter text. 

Does the agency have information on the 

reporting of precision and accuracy data 

available? 

☐ ☐ Click or tap here to enter text. 

What software is used to prepare air 

monitoring data for release into the AQS 

and AirNow databases? Include the names 

of the software packages, vendor or 

author, revision numbers, and the revision 

dates of the software. 

☐ ☐ Click or tap here to enter text. 

What is the recovery capability in the 

event of a significant computer problem 

(i.e., how much time and data would be 

lost)? 

☐ ☐ Click or tap here to enter text. 

Has your agency tested the data 

processing software to ensure its 

performance of the intended function are 

consistent with the QA Handbook Volume 

II, Section 14.0? 

☐ ☐ Click or tap here to enter text. 

Does your agency document software 

tests? If yes, provide the documentation. 

☐ ☐ Click or tap here to enter text. 

44 
 

 

 

 

 

 

 

 

 

 

 

c. Data Validation and Correction 

Complete the following table. 

Question Yes No Comment 

Is there documentation in regards to data 

that has been identified as suspect and 

subsequently flagged? 

☐ ☐ Click or tap here to enter text. 

Please describe what action the data validator will take 

(e.g., flags, invalidate, etc.) if they find data with 

exceeded QC criteria. 

Click or tap here to enter text. 

Please describe how changes made to data that were 

submitted to AQS and AirNow are documented. 

Click or tap here to enter text. 

Who has signature authority for approving corrections? Name:Click or tap here to enter text. 

Program Function:Click or tap here to 

enter text. 

What criteria are used to determine a data point be 

deleted or invalidated? 

Click or tap here to enter text. 

What criteria are used to determine if data need to be 

reprocessed? 

Click or tap here to enter text. 

Are corrected data resubmitted to the 

issuing group/record generator for crosschecking prior to release? 

☐ ☐ Click or tap here to enter text. 

d. Data Processing 

d.1 Reports 

Complete the following table. 

Question Yes No Comment 

Does the agency generate data 

summary reports? 

☐ ☐ Click or tap here to enter text. 

Please list at least three reports routinely 

generated, including the information requested 

below. 

Click or tap here to enter text. 

Report Title Distribution Period Covered 

Click or tap here to enter text. Click or tap here to enter 

text. 

Click or tap here to enter text. 

45 
 

 

 

 

 

 

 

 

 

 

 

 

 

d.2 Data Submission 

Complete the following table. 

Question Yes No Comment 

How often are data submitted to AQS? Click or tap here to enter text. 

How often are data submitted to AirNow? Click or tap here to enter text. 

Briefly comment on difficulties the agency may have 

encountered in coding and submitting data following the 

AQS guidelines. 

Click or tap here to enter text. 

Does the agency retain a hard copy 

printout of submitted data from AQS? 

☐ ☐ Click or tap here to enter text. 

Are records kept by the agency for at least 

3 years in an orderly, accessible form? If 

yes, does this include: 

☐ ☐ Click or tap here to enter text. 

• Raw data ☐ ☐ Click or tap here to enter text. 

• Calculations ☐ ☐ Click or tap here to enter text. 

• QC data ☐ ☐ Click or tap here to enter text. 

• Reports: list which reports are 

used 

☐ ☐ Click or tap here to enter text. 

Has your agency submitted data (along 

with the appropriate calibration equations 

used) to the processing center? 

☐ ☐ Click or tap here to enter text. 

Are concentrations of PM10 corrected to 

EPA standard temperature and pressure 

conditions (i.e., 298 K, 760 mm Hg) before 

input to AQS? 

☐ ☐ Click or tap here to enter text. 

Are concentrations of PM2.5 and Pb 

reported to AQS under actual (volumetric) 

conditions? 

☐ ☐ Click or tap here to enter text. 

Are audits on data reduction procedures 

performed on a routine basis? If yes, at 

what frequency? 

☐ ☐ Click or tap here to enter text. 

Are data precision and accuracy checked 

each time they are calculated, recorded, 

or transcribed to ensure that incorrect 

values are not submitted to EPA? 

☐ ☐ Click or tap here to enter text. 

46 
 

 

 

 

 

 

 

 

 

 

e. Internal Reporting 

e.1 Reports 

What internal reports are prepared and submitted as a result of the audits required under 40 CFR Part 

58, Appendix A? 

Report Title Frequency 

Click or tap here to enter text. Click or tap here to enter text. 

What internal reports are prepared and submitted as a result of precision checks also required under 40 

CFR Part 58, Appendix A? 

Report Title Frequency 

Click or tap here to enter text. Click or tap here to enter text. 

Question Yes No Comment 

Do either the audit or precision check 

reports indicated include a discussion of 

corrective actions initiated based on audit 

or precision check results? 

☐ ☐ Click or tap here to enter text. 

e.2 Responsibilities 

Who has the responsibility for the calculation and preparation of data summaries? To whom are such 

summaries delivered? 

Name Title Type of Report Recipient 

Click or tap here to Click or tap here to Click or tap here to Click or tap here to 

enter text. enter text. enter text. enter text. 

Identify the individuals within the agency responsible for reviewing and releasing the data. 

Name Program Function 

Click or tap here to enter text. Click or tap here to enter text. 

Question Yes No Comment 

Does your agency report to the Air Quality 

Index (AQI)? 

☐ ☐ Click or tap here to enter text. 

Is data certification signed by a senior 

officer of your agency? 

☐ ☐ Click or tap here to enter text. 

47 
 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 101 of 105 

Appendix B 

Example Field Audit Logbook 

The following example of a field audit logbook consists of a series of tables and checklists to 

assist an auditor in investigating ambient air monitoring sites. The contents are as follows: 

• Monitoring site evaluation form 

• Site drawing form 

• Comment page 

• Photograph log 

This logbook may be edited for specific regional use. 

Note: The siting criteria documented in this template was current as of the published date of 

this document. Users should verify that the criteria have not been updated in the CFR or other 

guidance documents before use. If discrepancies exist, please inform the author(s) of this 

document to recommend revision of this appendix. 
 

 

 

 

 

LOGBOOK: Air Monitoring Site Evaluations
 

Technical Systems Audit 

Agency Name: ___________________________________
 

Audit Date: _____________________________________
 

Lead Auditor: ______________________________________________
 

Audit Team
 

Print Name / Signature / Initials
 

1: (Team Lead) _____________________________________________________________________________
 

2:_____________________________________________________________________________________
 

3:_____________________________________________________________________________________
 

4:_____________________________________________________________________________________
 

5:_____________________________________________________________________________________
 

Page 1 of 9 
 

 

Site Name
 

(AQS ID:
 

xx-xxx-xxxx)
 

Insert AMP 390 

Report for specific site
 

Page 2 of 9
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

MONITORING SITE EVALUATION FORM (MSEF) (Page 1/5) 

Local Site Name: _________________________________ Initials: ____________ Date: ___________________ 

EPA auditor should document in the Site Logbook – the time / date / purpose of visit / EPA representatives present [Y/N] Completed 

Arrival Time: __________ Departure Time: __________ Primary Operator: ____________________________ 

Observer(s): ___________________________________________________________________________ 

NETWORK(s): [□Criteria / □NCore / □Near Road / □IMPROVE / □CASTNet / □NATTS / □PAMS / □Toxics] 

SITE 

[Y/N]-Security Fence [Y/N]-Razor/Barb Wire [Y / N / NA] Grass/Shrubs Cut [Y / N / NA] Bare Soil Area 

[Y/N] Vandalism – [□Inside / □Outside] Date: ________________________ [Y/N] Police Report Filed 

Issues: ____________________________________________________________________________________________________________________________ 

SHELTER - Interior
 

Arrival Temperature: __________°C (from data logger) Operator Site Visits: _________ per [week | month | ___________]
 

[Y/N] Leaking Roof [Damaged: □Ceiling / □Floor / □Walls] [Y/N] Clean / Neat [Y/N] Fire Extinguisher
 

[Y/N] Insect / Wildlife Issues [Y/N] Thermometer (min/max) [Y/N] Gasoline (inside shelter)
 

Issues: __________________________________________________________________________________
 

MONITOR(s): Location: Exterior Samplers [□Roof / □Ground / □ Not Present]
 

Monitor(s) Manufacturer Model Serial Number 

MET: [□Sonic / □Analog] - [□WS / □WD / □Temp / □RH / Other: _______Make: _____________________] □ Not Present
	

CALIBRATOR(s): □ Not Present [Y/N] Are QA/QC Check Gases Vented Outside Shelter?
 

QA/QC Make Model Serial Number Certification 

Date 

Expiration 

Date 

Page 3 of 9 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MSEF (Page 2/5): Local Site Name: _________________________ Initials: __________ Date: _______________ 

Is any analyzer sampling shelter air through its calibration line? [Y/N] If yes, photo, document and notify agency mgr. 

All Gas Standards Pass thru all Filters during: [Y/N] Calibrations [Y/N] Precision Checks [Y/N] Audits 

Issues: ____________________________________________________________________________________________________________________________ 

CYLINDER GAS STANDARDS: □ Not Present 

VENDOR: (PSI Reading < 200, tank is empty and should not be in service) 

QA 

/QC Gas Standard PSI Reading 

Expiration 

Date 

Standard 

Concentration Serial Number 

Issues: ____________________________________________________________________________________________________________________________ 

SUPPORTING INSTRUMENTATION: Internal
 

[Y/N] Temperature Sensor [Y/N] Uninterruptable Power Supply [Y/N] On-Site Computer
 

Zero Air System: Commercial System (Make / Model): _______________________________________________________
 

Cartridge System: [□Silica Gel [□Pink / □Blue] / □Charcoal / □Purafil / □Hopcalite / Other: ____________]
	

[Y/N] Needs Service Last Service Date: _______________ Condition: ____________________________
 

Issues: _____________________________________________________________________________________________________________________ 

Data Logger: [□8816 /□ 8832 / □8872 / Other: ______________________________________________________] 

Instrument(s) to Logger: [□Analog / □Digital / □Mixed] Communications: [□Cell Modem / □DSL / □Dial up] 

Strip Chart: [□Electronic / □Paper / □Both / □No Access] [Y/N] Operator Proficiency [Y/N] Time Accurate 

(Examine on chart: last calibration / precision check / audit – look for stability, concentration level, comments, etc.) 

Issues: _____________________________________________________________________________________________________________________ 

Probe Line(s): [□Replaced / □Cleaned] – Frequency: ___________ Last Service Date: __________________ 

[Y/N] Clean [Y/N] Heated [Y/N] Insulated [Y/N] Moisture [Y/N] Retractable [Y/N] Old / Unused Lines 

[Y/N] Lo Flo Manifold -> [Y/N] Any Open Ports? –> How many analyzers using manifold? ________________ 

Issues: _____________________________________________________________________________________________________________________ 

RECORDS – At Site
 

Documents Available: [□Hardcopy / □Electronic] – [□QAPP(s) / □SOP(s) / □Instrument Manual(s)]
 

Issues: ____________________________________________________________________________________________________________________________ 

Logbooks: [□Hardcopy / □Electronic] - [□Site Log / □Instrument Log / Other(s): ________________________] 

(Entries well documented?): _______________________________________________________________________ 

Charts / Papers on Walls: What do they Track, Up-to-date? __________________________________________________ 

Page 4 of 9 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MSEF (Page 3/5): Local Site Name: _________________________ Initials: __________ Date: _______________ 

SHELTER – Exterior □ Not Present
	

Type: [□Freezer / □Wood Building / □Brick-Block / Other: ___________________________________]
 

[Y/N] Needs Maintenance (specify) [Y/N] Tied Down [Y/N] Electrically Grounded [Y/N] Roof Railing
 

Roof Access: [Stairs [Interior/Exterior] / Ladder [attached/removable] / □ Not Present] [Y/N] Loose Decking (Trip Hazard)
 

Issues: ____________________________________________________________________________________________________________________________
 

OUTDOOR SAMPLERS □ Not Present 

[Y/N] Locked [Y/N] Electrically Grounded [Y/N] Stabilized [Y/N] Clean Inside [Y/N] Head/Separator Clean 

Operator / Log: VSCC/WINS Clean Schedule: __________________ PM10 Head Clean Schedule: __________________ 

Issue(s): __________________________________________________________________________________________________________________________ 

COLLOCATED SAMPLERS: □ Not Present (39.4 inches = 1 meter) 

Pollutant Flow 

(Hi / Lo) 

Separation Distance 

(meters) 

Collocated monitors must be within 4 meters of each other and at least 2 meters apart for flow rates greater than 200 liters/min or at least 1 

meter apart for samplers having flow rates less than 200 liters/min to preclude airflow interference, unless a waiver is in place as approved by the 

Regional Administrator pursuant to section 3 of Appendix A. 

PROBE SYSTEM(s): External □ Not Present
	

Inlet Type: [□Single Line / □Dual Line / □Bell Type (CAS design)]
 

Funnel(s): [□Rain Shield / □Part of Probe] Funnel Material: [□Teflon® / □Glass / □Stainless Steel / Other: _________]
 

Probe Line(s): [□Teflon® / Other: _____________] Probe Fitting(s): [□Teflon® / Other: ___________ / □ Not Present]
 

Residence Time: (20 sec. max) 

Issue(s): __________________________________________________________________________________________________________________________ 

Pollutant(s) 

Inlet 

Height 

(meters) 

Inlet Location 

(Side of Shelter, Ground, Roof) 

Horizontal 

Distance 

(meters)

If Applicable 

Vertical 

Distance 

(meters)

If Applicable 

Monitoring SCALE 

AQS 

Annual 

Network 

Plan 

FOR Horizontal and Vertical Distances: Separation Distance = (1 meter for O3, CO, SO2, NO2) & (2 meters for PM, Pb) 

When probe is located on a rooftop, this separation distance is in reference to walls, parapets, or penthouses located on roof. 

Height of Roof: _________________meters Roofing Material: _______________________________________ 

Issues: ____________________________________________________________________________________________________________________________ 

Page 5 of 9 
 

 

 

 

 

 

 

 

 

MSEF (Page 4/5): Local Site Name: _________________________ Initials: __________ Date: _______________ 

OBSTRUCTION(s): Distance from sampler, probe to obstacle, such as a building, must be at least twice the height the obstacle 

protrudes above the sampler and probe. 

All distances in meters OD MUST be ≥ [2*(OH-IH)] 

Obstacle Distance(s) (OD) 

Sampler Inlet Height (IH)

Obstacle Height (OH) 

Probe Inlet Height (IH) 

Obstacle(s) Obstacle 

Height (OH) 

Sampler/Probe 

Inlet Height 

(IH) 

[2*(OH-IH)] Obstacle Distance 

(OD) 

Please identify each of these obstacles in the SITE DRAWING (next page)
 

TREE DRIPLINE(s): ____________inches = _________meters (nearest inlet to dripline) □ No Trees Present
	

(39.4 inches = 1 meter) ____________inches = _________meters (nearest inlet to dripline) □ Not Present 

____________inches = _________meters (nearest inlet to dripline) □ Not Present 

Should be greater than 20 meters from the dripline of tree(s) and must be 10 meters from the dripline when the tree(s) act as an obstruction. 

Issues: ____________________________________________________________________________________________________________________________ 

UNRESTRICTED AIR FLOW: _________° Estimated Degrees of Clearance 

Must have unrestricted airflow 270 degrees around the probe or sampler; 180 degrees if the probe is on the side of a building or a wall. 

10 meters 

20 meters 

Page 6 of 9 
 

 

 

 

 

 

 

MSEF (Page 5/5): Local Site Name: _________________________ Initials: __________ Date: _______________ 

SITE DRAWING - Please Indicate: (relevant distance / height measurements) 

□ Direction NORTH □ Monitoring Shelter □ Nearby Trees/Shrubs □ Possible Sources 

□ Primary Wind Dir □ Probe Position(s) □ Roadways □ Paved / Unpaved Areas 

□ Security Issues □ Exterior Samplers □ Buildings □ Nearby Construction 

□ Sloping Areas □ Met Tower □ Walls □ Flues, Vents, Boilers 

□ Railroad Tracks □ Security Fencing □ Other Obstructions □ Meat Cooking 

Page 7 of 9 
 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

_______________________________________________________________________________________ 

Local Site Name: ______________________________________ Initials: _________ Date: _________________ 

Additional Comments: 

Page 8 of 9
 
 

 

 

 

 

 

 

 

 

 

 

 

 

PHOTO LOG: Local Site Name: _________________________ Initials: _________ Date: _____________
 

Camera [□ EPA / □ Personal – Owner: ________________] Make/Model: ________________________________
 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: ___________________
 

Description: _____________________________________________________________________________________________
 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: __________________
 

Description: ____________________________________________________________________________________________
 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: ___________________
 

Description: _____________________________________________________________________________________________
 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: __________________
 

Description: ____________________________________________________________________________________________
 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: ___________________
 

Description: _____________________________________________________________________________________________
 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: __________________ 

Description: ____________________________________________________________________________________________ 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: ___________________ 

Description: _____________________________________________________________________________________________ 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: __________________ 

Description: ____________________________________________________________________________________________ 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: ___________________ 

Description: _____________________________________________________________________________________________ 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: __________________ 

Description: ____________________________________________________________________________________________ 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: ___________________ 

Description: _____________________________________________________________________________________________ 

Filename: _____________________ Date: _______________ Time: _______________ Photographer: __________________ 

Description: ____________________________________________________________________________________________ 

Page 9 of 9 
 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 102 of 105 

Appendix C 

Low-Volume Weighing Laboratory Audit Checklist 

The following checklist incorporates the requirements of the 40 CFR Part 58, the Appendix L 

method, and the guidance contained in Quality Assurance Guidance Document 2.12. This 

checklist is intended to be used as guide to aid auditors in auditing low-volume PM10 or PM2.5 

gravimetric laboratories. 

Note: The criteria documented in this template was current as of the published date of this 

document. Users should verify that the criteria have not been updated in the CFR or other 

guidance documents, such as the QAGD 2.12, before use. If discrepancies exist, please inform 

the author(s) of this document to recommend revision of this appendix. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LOW-VOLUME GRAVIMETRIC WEIGH LAB SYSTEMS REVIEW
	

Analyst: Audit Date: 

Location: Auditor: 

Response Audit Questions Comments 

Yes No N/A 

I. Routine Operations & Site Housekeeping 

What anti-static prevention device(s) is in place? 

Are polonium strips used to eliminate static? Are they 

purchased in advance? If so, how far in advance? 

How often are they replaced? What is the date stamped 

on the current strips? 

List any visible sources that may impact the weigh lab. 

Is the room access restricted? Is the equipment located 

inside the weigh room only that which is required for 

daily weighing operations? 

Is the weighing table stable so vibrations do not affect 

the balance? 

Is the balance checked to determine if it is in fact 

leveled? If so, at what frequency? Visually inspect 

balance to determine if level. 

What device (LIMS, datalogger, etc) is used to 

monitor temperature and RH readings? What is the 

resolution of data collected? What procedure is 

utilized to verify these readings and at what frequency? 

Is there an anteroom? Describe its condition. 

Is the balance grounded? 

Is the autocalibration feature on the microbalance on or 

off? 

What is being done to control drafts in the weigh 

room? Is the microbalance located so that it is not 

impacted by drafts? 

Is the balance certified annually by an outside source? 

When was the balance last certified? Where are the 

records of this maintained? Request copy of 

documentation. 

Is the balance left in the "On" position at all times? 

What is the readability and repeatability of the 

balance? 

1
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Is the datalogger calibrated/certified annually? When 

was the last certification? Where are the records 

maintained? Request copy. 

At what frequency are the temperature and humidity 

sensors certified by an outside source? When was the 

most recent certification? Where are these records 

maintained? Request copies of documentation. 

Is the temperature maintained at 20-23°C, with a 

temperature control range of ≤ 2°C over a 24-hour 

period? How is control demonstrated? 

Is the relative humidity maintained at 30-40%, with a 

standard deviation of ≤5% over a 24-hour period? 

How is control demonstrated? 

How and where is temperature & RH data review 

documented? Frequency? 

Are pre & post sampling RH differences calculated? 

Where is this documented? 

If the temperature or RH is found to be out of 

specification, what corrective action is taken? Are 

weigh sessions halted? 

Are maintenance/service contracts in place for climate 

control unit, sensors, and software in the lab? 

Is electronic data backed-up at a defined frequency? 

How long? Where is it stored? 

Print and review temperature and RH graphs for three 

prior weigh sessions (one for each year under review). 

Obtain the 24-hr means and SDs for temp and RH for 

those sessions. 

Are there two sets of weights being used: a primary set 

and a working set? Are they at least Class 2 weights? 

Do the weights bracket the weight of the filters being 

utilized? 

How frequently are the weights recertified by an 

outside source? Where is this documented? Request 

copies of documentation. 

2
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

What were the results of the most recent lot stability 

test? Request copy of documentation. 

Are all filters visually inspected for defects both pre 

and post-sampling? What technique is used to inspect 

the filters? What criteria would cause a filter to be 

rejected? Give examples. 

Describe the lot blank test procedure. 

Are all filters pre-conditioned prior to both the initial 

and final weighing sessions? How long is the 

conditioning period? Where are they conditioned? If 

on a metallic shelf, is it grounded? 

Is a logbook used to document environmental 

conditions, weighing sessions, balance checks, weight 

checks, lot blank stability test results, etc, as well as lab 

maintenance activities? If not, how and where is this 

information documented? Are entries signed and 

dated? 

Is there a separate location designated specifically for 

cooler packing/unpacking? If so, describe its location 

and condition. 

II. Sample Conditioning 

Where are new lots of filters stored once they are 

received from EPA? 

On what frequency and how is the weigh lab cleaned? 

Describe daily, monthly, & yearly cleaning regimes. 

Who is responsible for ensuring that all standards are 

certified at their required frequencies? How is this 

tracked? 

How are sample cassettes, including stainless steel 

backing screens, cleaned? At what frequency are they 

cleaned? Are they inspected for cracks or other 

damage? Do both halves fit tightly together when 

assembled? 

At what frequency are the working weights verified 

against the primary weights? Where is this 

documented? Request copies of documentation. 

3
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Are the filters conditioned in petri dishes or slides? Are 

the lids on the slides or are they slightly ajar? 

How is the conditioning period affected if the weigh 

room conditions are out of tolerance? 

III. Sample Weighing
	

Is one person designated to weigh all sample filters? Is 

there a back-up analyst? Does the same analyst weigh 

the same filters pre- and post-? 

Are filters sampled within 30 days of the initial (tare) 

weigh? How is this tracked? 

Are samples pre-assigned to a site? Or, is a site 

assigned after a filter is deployed? Elaborate on how 

filters are requested and distributed. 

How are filters prepared for field deployment (i.e., 

loaded into sample bags or a magazine)? Where does 

this activity occur? 

Are samples maintained in a secure area at all times 

after being delivered to the laboratory? 

How are filters packed for shipment back to the 

laboratory? What happens if a shipment (package 

and/or individual filters) is damaged in transit? 

Where are samples unloaded from the transport 

containers? Is this area clean and secure? 

Is the temperature of the cooler recorded at receipt in 

the laboratory? Is the temperature device NISTtraceable? Where is the temperature reading recorded? 

Describe the post sample weigh time limits (i.e., 10 

days/30 days) established for the lab and supporting 

rationale. 

If samples are refrigerated, is the temperature of the 

refrigerator monitored? How is this accomplished? Is 

the monitoring equipment verified/certified? 

4
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Is a LIMS systems used to record the weighing results? 

If not, describe how each weighing session is 

documented. 

Are anti-static, powder-free gloves and lab coats worn 

while handling sample filters? 

Are teflon forceps used to handle the sample filters? 

How are they cleaned and at what frequency? 

Are the same forceps used for handling the mass 

standards used in handling sample filters? 

How often are balance checks performed? What is the 

tolerance (μg) for balance checks? How and where is 

this documented? 

If balance checks do not agree within ±3 μg, what 

corrective action is taken? 

How often are lab blanks weighed? If the lab blanks 

are not within ±15 μg, what corrective action is taken? 

Are lab blanks used more than once? 

Are field blanks weighed with each session? Are final 

weigh results within ± 30 μg of the initial weigh? How 

is this tracked? What corrective action is taken when 

FBs are out of limits? 

Are duplicate filters weighed with each session? What 

is the acceptance limit (i.e., ± 15 μg)? Are sampled 

filters or blanks used? 

What happens if a weighed filter appears to be an 

outlier? How is it handled? 

How are re-weighs documented? 

Are trip blanks utilized? If so, at what frequency? 

What is the acceptance limits for trip blanks (i.e., ± 15 

μg)? 

5
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Are chain of custody (COC) forms submitted by the 

field technician for each sample? Are they signed by 

all parties within the chain? Where are they 

maintained? Who reviews the COC forms? 

IV. Data Handling 

Who does the lab analyst notify when discrepancies are 

found and/or corrective actions are needed? 

During the data review process, does the reviewer 

differentiate between critical and non-critical criteria 

when flagging data? Describe this process. 

After the final weighing has been completed, how are 

samples stored, and for what period of time are they 

retained? 

Following each manual weigh session, is the weighing 

(batch) audited? If so, who does the audit? What 

percentage of filters are reweighed? What limits are 

used to determine good agreement? 

Are concentrations verified to ensure data entry & 

computations are correct? How many samples are 

reviewed per batch? Describe the verification 

procedure that is utilized. 

Once filter weighing is complete, is a report listing the 

sample concentrations generated for QA review? Does 

it list any void/flagged sample(s) and the reason for 

invalidating the sample(s)? Who is responsible for 

generating this report? How is responsbile for 

reviewing it? 

During the data review process, are sampler 

maintenance results, precision checks, and audit results 

reviewed to determine if any samples should be 

invalidated or flagged based on the results of these 

activities? 

Are control charts used? If so, detail the types of 

control charts developed & how they are maintained. 

At what frequency are the charts reviewed & by 

whom? Where are these charts located? 

How are field flags/notes linked to the filter data? 

How are these notes communicated to the data 

reviewer? 

6
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

How are corrective actions addressed? Are forms filled 

out for corrective actions? Who reviews them in the 

data validation chain? If corrections are made to data 

as a result of corrective actions, how is this 

documented & verified? Who is responsible for followup? 

Are internal performance & systems audits of the 

weigh lab and supporting equipment (loggers, 

balances, etc) performed? Who conducts these audits? 

Describe the review process and how the results are 

documented. How are staff notified of the audit 

results? Where are the audit reports filed? 

Describe in detail the training the lab analyst has 

received. Who trained the analyst? Which courses 

have been taken? Has the analyst been trained on both 

QC operation of the lab, as well as data 

verification/validation procedures? 

Does this weigh lab gravimetrically analyze samples 

collected for PM10 and/or lead? If yes, then describe 

any notable differences in procedures for the PM10 

and/or lead samples. 

V. Other 

Are the filter, summary data, and interval data 

downloaded from the instrument for each sample run? 

Where is this data stored? Is the data reviewed as part 

of the QA audit process? 

Does the laboratory operate under an approved QMP, 

QAPP, and SOP? What are the approval dates for the 

current revisions? 

What is the size of the particulate matter network for 

which this weigh lab is in operation? Describe the 

number of samplers and their operational frequency. 

Approximate number of samples weighed per 

month/year. 

Are exceptional events or impacts from nearby sources 

documented? Where? 

Once the data has been audited, are null codes and any 

qualifiers applied to the sample reviewed? If so, who is 

responsible for applying the codes/flags? Is this prior 

to the data being uploaded to AQS? 

7
 
 

 

 

Describe in detail the training the back-up weigh lab 

analyst has received. How often do they weigh filters? 

Additional Comments on Audit: 

Auditor's Signature: 

8
 
 

 

 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 103 of 105 

Appendix D 

Laboratory Systems Review: Lead in Air 

Audit Checklist 

The following audit checklist is designed to aid the auditor in performing an audit of a Pb 

laboratory. To use the checklist effectively, the auditor must be familiar with the requirements 

of the specific FRM or FEM that is currently in use in the laboratory and supplement this 

checklist with its specific method criteria. The checklist does not include specific QC criteria or 

detailed procedural steps that will be unique to each method. The checklist includes 

commonalities that exist in all of the Pb methods, as well as laboratory best practices. This is a 

compilation of these method consistencies that the auditor can use to assist in auditing the 

laboratory. This checklist should be tailored to the needs of the specific Pb analytical method 

implemented in the laboratory under audit. 

Note: The criteria documented in this template was current as of the published date of this 

document. Users should verify that the criteria have not been updated in the CFR or other 

guidance documents before use. If discrepancies exist, please inform the author(s) of this 

document to recommend revision of this appendix. 
_______________________________________________________ 

LABORATORY SYSTEMS REVIEW: Lead in Air 

Laboratory: 

Air Monitoring 

Agency: 

Reference or Equivalent Method : 

Audit Questions Response 

 I. Document Control 

a) Is there an official, documented Operating 

Procedure (SOP) for this method? Is this a controlled 

document? Describe how it is controlled. 

b) Who is responsible for the updates to the SOP? At 

what frequency is the SOP updated? Describe the 

review process. 

c) Are changes allowed to the SOP outside of a review 

cycle? Describe this process and how the changes are 

documented and staff are notified of any pertinent 

changes. 

d) Do changes to the SOP ever require updates of the 

Laboratory Information Management System(LIMS)? 

If so what is the procedure for LIMS updates?

e) How are SOP updates communicated to staff? 

f) When SOPs are updated for air analysis is the Air 

Monitoring Unit notified of the changes? 

 II. Training and Demonstrations of Competency 

a) Are all analyst involved with Lead in air sample 

preparation and analysis properly trained? Review 

available training records 
 

b) Are Initial and Continuing Demonstrations of 

Competency (DOC) required for each analyst? 

Describe the DOC process. 

c) Who maintains records of acceptable competency 

demonstrations? Ask to review these records. 

d) Are Method Detection Limit (MDL) Studies 

performed? At what frequency? Describe the MDL 

determination procedure. Ask to review records of 

MDL studies performed for the audit time period. 

e) Are Linear Dynamic Range (LDR) studies 

performed? At what frequency? Describe the 

procedure. 

f) Who maintains documentation of LDR studies? Ask 

to review records of studies performed during the audit 

time period. 

g) What is the Reporting Limit for Lead in Air? How is 

the reporting Limit determined? 

 III. Sample Receiving, Sample Log-in and Sample Custody 

a) Describe how samples are received by the laboratory 

(Are they shipped, are they in folders or envelopes, 

who receives them, etc.) 

b) Are samples received as a group (all samples 

collected for one month) or are individual samples 

submitted? 

c) Is a COC form submitted for each sample? 

(Request copies of COC form for review)
d) Are samples logged in as received? If not where are 

samples stored prior to sample log-in? Following 

sample log-in, where are samples stored? 

e) Describe the sample storage location (are there any 

sources of potential contamination). 

f) Is access restricted to the custody , storage and 

analytical labs? How is it restricted? 

g) Following sample preparation, where are the 

extracts stored? Where are the unused portions of the 

filters stored? 

IV. Sample Preparation 

a) Describe the sample preparation location, are there 

any sources of contamination present, is there 

sufficient room to perform all activities? 

b) Preparation of the filter requires a strip to be cut 

from the 8 X 10 filter. What size filter strip is used for 

preparation? Ask for a demonstration of the cutting 

procedure. 

c) Are instruments (cutters, cutting boards, etc. ) 

cleaned in between fitters? Describe this procedure. 

d) What type of glassware/labware is used for sample 

extraction? Is it acid washed? Is it certified clean by 

the vendor (if so is there a certificate available) How is 

cleanliness of the labware determined? 

e) What ancillary equipment is utilized for sample prep 

(Hotblock, Hotplate, Ultrasonic Bath) Describe the 

condition of the equipment and any checks utilized to 

verify proper operations. 

f) Describe the sample preparation procedure. 

g) Are duplicate samples prepared? Describe this 

process. 
h) Are blank filters prepared and assessed for 

background concentration? What level of background 

is acceptable? Is this value used in the determination of 

the final lead concentrations reported? 

i) Are matrix spikes prepared? Describe spike 

preparation procedures. At what frequency are spikes 

prepared? 

j) Is a quality control check sample from a second 

source prepared? Is there a COA provided for the 

QCS? (Request copy(s) for review) At what frequency 

is the QCS prepared/analyzed? 

V. Standards Preparation 

a) Are stock standards prepared in-house or purchased 

as certified standards from a vendor? If purchased is a 

Certificate of Analysis provided? (Request copies of 

CoAs for review). How/where are CoAs maintained? 

b) How are expiration dates of the stock standards 

established? Are stock standards ever utilized outside 

of the expiration date. If so, describe the process for 

verifying the standards and how this is documented. 

c) At what frequency are working and/or calibration 

standards prepared? How are expiration dates for these 

standards established? 

d) How is the traceability of the standard preparation 

documented? (logbooks, controlled prep forms, LIMS). 

Request copies of standard prep records for review. 

e) Are all standards prepared in a matrix comparable to 

the matrix of the samples following extraction? 
f) Are air displacement pipettes utilized for preparing 

standards? Are they certified? At what frequency? Ask 

to review certification records.

 VI. Audit Strips 

a) Are audit test strips spiked at 30-100% and 200-300 

% of the lead NAAQS, analyzed? Are these strips 

prepared in-house or provided by an EPA contract 

laboratory? At what levels of the NAAQS are the strips 

analyzed((if prepared in house)? 

b) Describe the preparation of the audit strips if 

prepared in -house. Review documentation of audit 

strip preparation. Are standards and reagents 

independent of the calibration standards utilized in the 

preparation procedure? 

c) At what frequency are the strips analyzed? Are 

dilutions required to produce results for audit strips 

within the calibration curve? 

d) How are the results of the audit strips reported to the 

air monitoring unit (Spreadsheet, Sample Report)? In 

what units are the results reported?Is the true value for 

the audit strips reported with the results? 

e) What criteria must be met for the audit strip results 

to be considered acceptable? If the criteria is not met, 

what corrective action is performed? 

 VII. Instrument Calibration/Quality Control 

a) What instrumentation is utilized for analysis 

(Make/Model)? Is the instrument capable of meeting 

the method requirements? 

b) How often is the instrument calibrated? How many 

standards are used to calibrate the instrument?
c) What is the requirement for the correlation 

coefficient ? What curve fit is used? 

d) Is an initial check standard analyzed to verify the 

calibration stability is ±5%? Describe what corrective 

action is taken if the calibration stability check exceeds 

acceptance criteria. Is the standard prepared from the 

same source as the calibration standards? 

e) Are continuing calibration standards analyzed? At 

what frequency? At what level(s) ? What is the 

acceptance criteria? Describe what corrective actions 

are taken if the criteria is not met. Are the continuing 

check standards prepared from the same source as the 

calibration standards? 

f) Describe the type(s) of blanks utilized in the 

analysis. What is the acceptance criteria for each type 

of blank? What corrective action is performed if blanks 

exceeded the acceptance criteria? 

g) If duplicates are prepared and analyzed, what is the 

acceptance criteria for duplicate analyses? What 

corrective action is performed in the event the 

duplicate results do not meet this criteria? 

h) Describe how matrix spikes are assessed? What are 

the acceptance criteria? 

i) Are dilutions performed for samples that exceed the 

calibration? If dilutions are performed, is a dilution 

check standard included in the analytical batch. What 

criteria is utilized to assess dilutions?

 VIII. Lab Data Review 

a) Following analysis, who is responsible for review 

and uploading data into the LIMS system. Describe 

this process. How is the review documented? 

b) Is the data reviewed by a secondary reviewer? What 

does the secondary review process entail? How is this 

process documented. 
c) If corrections to data are required as a result of 

secondary review, who makes the corrections and how 

is this documented? 

c) Is data ever qualified? Who determines the 

appropriate qualifiers? Are the qualifications reviewed 

as part of the review process? 

d) Does a list of qualifiers and their definition 

accompany the data? 

e) Are the results of method QC reported with the 

sample results? 

f) Is an assessment of measurement uncertainty 

provide with the final results? 

g) What units are the results reported in? 

h) How are final reports generated and disseminated to 

the sample submitter? 

Additional Comments on Audit: 
 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 104 of 105 

Appendix E 

Example Technical Systems Audit 

Report Template 

The following Technical Systems Audit report template is designed to include the desired 

elements that each Technical Systems Audit report should include, and serves as an aid for 

Regional auditors to use in preparing the TSA report. This template may be edited for specific 

regional use. 
 

2017 Technical Systems Audit Report – Draft or 

Final 

Agency Name: 

Agency Location: 

Project Date: 

Project Leader: NAME 

ADDRESS 

PROJECT ID: ____ Draft OR Final Report Page 1 of 9 
 

Approvals: 

Project Leader: 

NAME Date 

Section 

Approving Official: 

NAME, TITLE Date 

Section 

PROJECT ID: ____ Draft OR Final Report Page 2 of 9 
 

 

 

 

 

 

 

Table of Contents
 

1.0 Executive Summary ........................................................................................................... 4
 

2.0 Introduction........................................................................................................................ 5
 

3.0 Commendations.................................................................................................................. 6
 

4.0	 Findings and Recommendations....................................................................................... 6
 

4.1 FIELD OPERATIONS.......................................................................................................7
 

4.2 LABORATORY OPERATIONS .........................................................................................7
 

4.3 RECORDS MANAGEMENT .............................................................................................8
 

4.4 DATA MANAGEMENT.....................................................................................................8
 

4.5 QUALITY ASSURANCE....................................................................................................9
 

5.0 Conclusions......................................................................................................................... 9
 

Appendix A: Response – Technical Systems Audit Questionnaire..............................10 

PROJECT ID: ____ Draft OR Final Report	 Page 3 of 9 
 

1.0 Executive Summary 

Enter language here, followed by page break 

PROJECT ID: ____ Draft OR Final Report Page 4 of 9
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2.0 Introduction 

On __________, 2017, EPA Region _____ personnel conducted a TSA of the ______________ 

ambient air monitoring program. The audit team included ________ (lead auditor), and 

_________. 

Pursuant to 40 CFR Part 58, Appendix A, §2.5, TSAs of each Primary Quality Assurance 

Organization (PQAO) are required to be conducted every three years; monitoring organizations 

within a PQAO should be audited within 6 years (2 TSA cycles). _________ operates its ambient 

air monitoring program under the _________________ PQAO, utilizing the quality assurance 

project plans (QAPPs) and standard operating procedures (SOPs) established by ____. The 

purpose of this TSA was to assess ______’s compliance with established regulations governing 

the collection, analysis, validation, and reporting of ambient air quality data. Data reviewed as part 

of this TSA included that generated during the 2014-2016 calendar years. Data was queried from 

EPA’s Air Quality System (AQS) database prior to the on-site audit. SESD’s Ambient Air 

Monitoring Technical Systems Audit Form (i.e., questionnaire) was completed by _____ staff prior 

to the on-site audit and is included as Appendix A of this report. 

The audit included a review of data, recordkeeping, documentation, and support facilities housed 

at the _____ office complex, located at ___________, (City, State). The _______ (PM10/PM2.5 

gravimetric, or toxics/analytical) laboratory was audited as well. _#_ air monitoring stations were 

inspected during the audit. The sites visited are listed below. 

Common Site Name AQS Identification 

NAME XX-XXX-XXXX 

NAME XX-XXX-XXXX 

During the audit, the following personnel were interviewed. 

• NAME, Title 

• NAME, Title 

The following AQS reports were reviewed in preparation for this TSA. 

• AMP 251: QA Raw Assessment Report (2014-2016) 

• AMP 256: QA Data Quality Indicator Report (2014-2016) 

• AMP 350: Raw Data Report (2014-2016) 

• AMP 350MX: Raw Data Max Values Report (2014-2016) 

• AMP 360: Raw Data Qualifier Report (2014-2016) 

• AMP 380: Site Description Report (2014-2016) 

PROJECT ID: ____ Draft OR Final Report Page 5 of 9 
 

 

 

 

 

 

 

 

 

 

 

• AMP 390: Monitor Description Report (2014-2016) 

• AMP 430: Data Completeness Report (2014-2016) 

• AMP 480: Design Value Report (2016) 

• AMP 503: Extract Sample Blank Data (2014-2016) 

• AMP 504: Extract QA Data (2014-2016) 

• AMP 600: Certification Evaluation and Concurrence (2014-2016) 

Additionally, the following quality documents were reviewed. 

• NAME, Control Number, Revision Number, Date 

• NAME, Control Number, Revision Number, Date 

• NAME, Control Number, Revision Number, Date 

3.0 Commendations 

Enter text here 

4.0 Findings and Recommendations 

The observations from this TSA were compared to EPA regulations, technical policies and 

guidance, and the monitoring organization’s quality system documentation. 

Quality system deviations found through this TSA are classified into three categories: Findings, 

Concerns, and Observations. These quality system deviations are defined as follows: 

Finding: 

Departure from or absence of a specified requirement (regulatory, QMP, 

QAPP, SOP, etc.) or guidance deviation which could significantly impact 

data quality. 

Concern: 

Practices thought to have potential detrimental effect on the ambient air 

monitoring program’s operational effectiveness or the quality of sampling or 

measurement results. 

Observation: 

An infrequent deviation, error, or omission which does not impact the output 

of the quality of the work product, but may impact the record for future 

reference. 

PROJECT ID: ____ Draft OR Final Report Page 6 of 9 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

For each of these categories, corrective action recommendations are provided. Corrective actions 

are required for all quality system deviations ranked as Findings or Concerns. Depending on the 

severity of the deviation, a specific data deliverable(s) may be requested to show that the corrective 

action recommendation has been successfully implemented. In these cases, the TSA report will 

specify the deliverable(s) that will be required for AQS and/or submitted to EPA. Observations 

do not require corrective actions. 

4.1 FIELD OPERATIONS 

4.1.1 Finding: 

Discussion: 

Recommendation: 

4.1.2 Concern: 

Discussion: 

Recommendation: 

4.1.3 Observation: 

Discussion: 

Recommendation: 

4.2 LABORATORY OPERATIONS 

4.2.1 Finding: 

Discussion: 

Recommendation: 

4.2.2 Concern: 

Discussion: 

Recommendation: 

4.2.3 Observation: 

PROJECT ID: ____ Draft OR Final Report Page 7 of 9 
 

 

 

 

 

 

 

 

 

 

 

Discussion: 

Recommendation: 

4.3	 RECORDS MANAGEMENT 

4.3.1	 Finding: 

Discussion: 

Recommendation: 

4.3.2	 Concern: 

Discussion: 

Recommendation: 

4.3.3	 Observation: 

Discussion: 

Recommendation: 

4.4	 DATA MANAGEMENT 

4.4.1 Finding: 

Discussion: 

Recommendation: 

4.4.2	 Concern: 

Discussion: 

Recommendation: 

4.4.3	 Observation: 

Discussion: 

PROJECT ID: ____ Draft OR Final Report	 Page 8 of 9 
 

 

 

 

 

 

 

Recommendation: 

4.5	 QUALITY ASSURANCE 

4.5.1	 Finding: 

Discussion: 

Recommendation: 

4.5.2	 Concern: 

Discussion: 

Recommendation: 

4.5.3	 Observation: 

Discussion: 

Recommendation: 

5.0	 Conclusions 

Enter text here 

_____ must develop a corrective action plan and timeline to address the findings and concerns 

identified in Section 4 of this report and respond back to EPA within 30 days of receipt of the final 

TSA report. Please note that the corrective actions do not have to be completed by this date, only 

a plan to address the findings and concerns. Observations do not require corrective action and, 

therefore, do not need to be addressed. If _____ anticipates that the development of the corrective 

action plan will not be completed within 30 days after the receipt of the final TSA report, please 

contact EPA to request an extension. 

Page Break, then attach Appendix A 

PROJECT ID: ____ Draft OR Final Report	 Page 9 of 9 
 

 

 

 

Conducting TSAs 

Revision 0 

Date: 11/2017 

Page 105 of 105 

Appendix F 

Example Technical Systems Audit Close-Out Letter 

The following Technical Systems Audit Close-Out letter is designed to include the desired 

elements that each TSA Close-Out letter may include, and serves as an aid for Regional auditors 

to use in closing out the TSA. This template may be edited for specific regional use. 
 

 

 

 

 

 

 

 

 

 

 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
 

August 1, 2017 

Mr. John Smith, Director 

ACME Agency 

200 North Monitoring Street 

Anywhere, US 12345 

Project ID: 01-1234 

Dear Mr. Smith: 

On May 20, 2016, a corrective action plan (CAP) was submitted by the ACME Agency to the EPA 

Region X, which addressed the findings identified in the ACME 2016 Technical Systems Audit (TSA). 

During this past year, ACME has implemented corrective action measures as described in the 2016 

CAP, providing EPA with both verbal and written progress updates at routine intervals. As of July 28, 

2017, all issues identified in the 2016 TSA report have been successfully resolved by your agency. 

I appreciate your agency’s participation in the TSA, as well as the diligence of your staff to address the 

issues that were identified. EPA has finalized this TSA in the EPA Air Quality System (AQS) 

database, entering the date of this letter as the official close-out date. If you have any questions or 

concerns about this correspondence, please contact Joe Auditor of my staff at (123) 456-7890. 

Sincerely, 

Jane Supervisor, Chief 

Air Protection Branch 
 

United States Office of Air Quality Planning and Standards Publication No. EPA-454/B-17-004 

Environmental Protection Air Quality Assessment Division November 2017 

Agency Research Triangle Park, NC