United States EPA 454/R-01-011

Environmental Protection Office of Air Quality 

Agency Planning and Standard 

Research Triangle Park, NC 27711 Office of Air and Radiation

Quality Management Plan

For the PM Supersites 

Program
ii

Foreword

The following document is a Quality Management Plan (QMP) for the environmental data operations of 

the PM Supersites Research Monitoring Program. The Office of Air Quality Planning and Standards 

(OAQPS) staff developed this QMP to outline the roles of organizations involved in the Supersites 

Particle Monitoring Program.

This QMP was generated using the EPA Quality Assurance (QA) regulations and guidance as described 

in EPA QA/R-2, EPA Requirements for Quality Management Plans and the accompanying document, 

EPA QA/G-2, Guidance for Developing, Reviewing and Implementing Quality Management Plans. All 

pertinent elements of the QMP regulations and guidance are addressed in this document. 
iii

Acknowledgments

This QMP is the product of the EPA Office of Air Quality Planning and Standards. The following 

individuals are acknowledged for their contributions.

Principle Authors

Dennis Mikel, OAQPS-EMAD-MQAG, Research Triangle Park, North Carolina

Michael Papp, OAQPS-EMAD-MQAG, Research Triangle Park, North Carolina

Dr. Les Hook, Oak Ridge National Laboratory, Oak Ridge, Tennessee

Dr. Sigurd Christensen, Oak Ridge National Laboratory, Oak Ridge, Tennessee

 

Reviewers

Office of Air Quality Planning and Standards

JoAnn Rice, Dr. Richard Scheffe, Dr. Marc Pitchford, Joe Elkins, Michael Jones

Office of Research and Development 

Dr. Paul Solomon, Las Vegas, Nevada

Parsons Corporation

David Bush

National Oceanic and Atmospheric Administration

Jeffrey West

College of Engineering, Center for Environmental Research and Technology 

Dennis Fitz, David Gemmill

Comments and questions can be directed to:

Dennis Mikel, OAQPS, RTP, NC mikel.dennisk@epa.gov
iv

Acronyms and Abbreviations

AIRS Aerometric Information Retrieval System

APTI Air Pollution Training Institute

ASTM American Society for Testing and Materials

CAA Clean Air Act

CFR Code of Federal Regulations

DQA data quality assessment

DQOs data quality objectives

EDO Environmental Data Operation

EMAD Emissions, Monitoring, and Analysis Division

EPA Environmental Protection Agency

FIPS Federal Information Processing Standards

IMPROVE Interagency Monitoring of Protected Visual Environments

LAN local area network

LIMS Laboratory Information Management System

MQAG Monitoring and Quality Assurance Group 

MQOs measurement quality objectives

MSR management system review

NAAQS National Ambient Air Quality Standards

NAMS national air monitoring station

NAREL National Air and Radiation Environmental Laboratory

NARSTO formerly North American Research and Stratospheric Transport of Ozone

OAQPS Office of Air Quality Planning and Standards

PC personal computer

PE performance evaluation

QA/QC quality assurance/quality control

QA quality assurance

QAC quality assurance coordinator

QAFR quality assurance final report 

QAO quality assurance officer

QAPP quality assurance project plan

QS quality staff

QSSC NARSTO Quality Systems Science Center

QMP quality management plan

R&IE Radiation and Indoor Air

SLAMS state and local monitoring stations

SOP standard operating procedure

TSA technical system audit
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Number

 2.1

 2.2

 3.1

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Tables

Description

QAPP Elements Applicable to Various Programs

Types of Assessments

Core Ambient Air Training Courses

Assessment Schedule 

Page No.

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Figures

Number Description Section Page

 1.1

 1.2

1.3

 1.4

 1.5

 6.1

 Overview of the National Fine Particle Program

Phase I and II Supersites

Supersites Project Management Overview

 Flow diagram illustrating major program stages and review

Supersites implementation general structure

Data Flow Diagram

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Quality Management Plan Identification and Approval
Table of Contents

Section Page Revision Date

Foreword

Acknowledgments

Acronyms and Abbreviations

Tables

Figures

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1. Management and Organization

1.1Supersites Program Background

 1.2 Roles and Responsibilities

 1.3 Principle EPA Coordinators

 1.4 Research Groups

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2. Quality System and Description

 2.1 Supersites QA Applications

 2.2 Quality Management Plan

 2.3 Data Quality Objectives

 2.4 Quality Assurance Project Plans

 2.5 Standard Operating Procedures

 2.6 Assessments 

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3. Personnel Qualifications and Training

 3.1 Personal Qualification

 3.2 Training 

 3.3 Certification

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4. Procurement of Items and Services

 4.1 Sources of Funds

 4.2 Procurement of Items 

 4.3 Procurement of Services

 4.4 Assistance Agreements

 4.5 EPA Exclusive Versus Discretionary Functions

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5. Records and Documentation

 5.1 Documents Hierarchy and Process

 5.2 Document Responsibilities

 5.3 Deposition and Storage of Documents and Records 

 5.4 Deposition of Reports

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6. Computer Software and Hardware

 6.1 Computer Systems Description 1/3

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7. Planning and Implementation of Work Process

 7.1 Project Goals and Objectives

 7.2 Initial Planning and Conceptualization

 7.3 Key Planning Personnel

 7.4 Other Planning Activities

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8. Implementation of Work

8.1 Implementation Roles 1/2

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 9. Data Quality Assessments 

9.1 Program Assessment Techniques

 9.2 Reports to Management

 9.3 Planning, Training and Authority

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 10.1 Quality Improvement Process

 10.2 Quality Improvement Assurance

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 Glossary 1/4 1 08/08/01

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Appendix A - Procurement Policy Notice 1/11 1 08/08/01
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1.0 Management and Organization

The purpose of this section is to document the overall policy, scope, applicability, and 

management responsibilities of the “Supersites” Program’s quality system. The section will 

provide a brief description of the Supersites Program and the organization and management of 

the programs as it relates to the quality assurance aspects.

1.1 Supersites Program Background 

The Clean Air Act (CAA) requires EPA to revise or update the air quality standards based on 

review of the latest scientific information on known and potential human health effects 

associated with Particulate Matter (PM) levels found in the ambient air. In fulfilling this 

obligation, the EPA reviewed the air quality criteria, National Ambient Air Quality Standards 

(NAAQS) for PM and epidemiological evidence that shows an association between ambient 

concentrations of PM and a range of serious health effects. Based on the results of its review, the 

EPA revised and promulgated 

new primary standards for the 

fine fraction of PM (i.e., particles 

with aerodynamic diameters less 

than or equal to [a nominal] 2.5 

:m, referred to as PM2.5) and the 

regulatory requirements for 

monitoring the chemical 

composition of these particles. In 

response to this promulgation, 

EPA has instituted a PM2.5

network.

Figure 1.1 illustrates the overall 

national fine particle network. 

The network is divided into three 

tiers. The base is composed of the mass sampling network, for which the mass fine particulate 

data is collected for comparison to the national ambient air quality standards (NAAQS). The 

second tier, the Speciation Trends Network (STN) is intended to monitor and gather data on the 

chemical makeup of fine particles. These STN samplers will be placed at various national air 

monitoring stations (NAMS) and State and local air monitoring stations 

(SLAMS) across the Nation. The top tier, the “Supersites” Program is a grant based research 

program “designed to conduct special, detailed chemical and physical characterization studies in 

geographic areas with a range of characteristic PM2.5 source-receptor and health risk situations1” 

This series of analytes is very similar to those measured within the Interagency Monitoring of 

 8 Enhanced Airsheds

 ~50 Trends 

(Mass & Components)

 ~50 Sites 

(Coordinated With SS)

 ~150 IMPROVE

 ~200 Sites (Sips)

 850 Required

 ~1050 FRM

 (Compare to

 NAAQS)

 ~ 200 

 Continuous Mass Sampling

Routine

Speciation

SS

 ~15 Daily Sites

Figure 1.1 Overview of the National Fine Particle Network
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Protected Visual Environments (IMPROVE) program. In addition, several STN monitors will be 

placed at IMPROVE locations (or visa versa) in order to ascertain whether there are statistical 

and chemical links between these two national networks. 

The goals of the Supersites Program took shape at a public PM Measurements Research 

Workshop held in Chapel Hill, N.C. on July 22 and 23, 1998. To commence the PM Supersites 

Program, EPA selected two initial sites: Atlanta GA and Fresno CA. These sites, henceforth 

referred to as Phase I Supersites, were non-competitively selected by virtue of ongoing and 

planned research activities, which align with those of the PM Supersites Program, and 

characteristics of the two airsheds. Six additional sites, and the Fresno Phase I site, henceforth 

referred to as Phase II Supersites, were competitively selected cooperative agreements awarded 

in January 2000. Figure 1.2 identifies both phase II Supersites and I. the Supersites will address 

objectives in three major areas:

1) SIPs.... Support development of State Implementation Plans (SIP’s) through improved 

understanding of source-receptor relationships leading to improved design, implementation, 

and tracking of control strategy effectiveness in the overall PM program; 

2) health effects and exposure.....development of monitoring data and samples to support 

health and exposure studies to reduce uncertainty in National Ambient Air Quality 

Standards setting and to enable improved health risk assessments; and 

Figure 1.2 Phase I and II Supersites

Phase I

Phase II

Both Phases

Fresno

Los Angeles 

New York

Atlanta

Houston

St. Louis

Pittsburgh

Baltimore
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3)methods testing.... comparison and evaluation of emerging sampling methods with 

routine techniques to enable a smooth transition to advanced methods. 

Additional background information on the Supersites program can be found on the Ambient 

Monitoring and Technology Website (AMTIC) , (http://www.epa.gov/ttn/amtic/Supersites.html).

1.2 Roles and Responsibilities

 Program Management, Organization and Review

Figure 1.3 provides an overview of program management that will establish the communications 

and accountability essential for program planning, coordination and implementation. 

Figure 1.3 Supersites Project Management Overview

Project Organization

Supersites Coordination Committee

{Sponsors (Supersites and relevant studies)}

EPA (OAQPS, ORD); NOAA; DOE

State/Locals; Industry

Science Oversight

NAS 

FP Subcommittee

(CASAC)

EPA Steering Committee

EPA staff (OAR, NERL, NHEERL)

Participating Research Groups and Contractors

Data

Management

Field 

Measurements

Data

Analysis QA

 Executive Leads

EPA OAR and ORD AA delegates

Principal EPA Technical Coordinators

OAR designate

ORD designate (s)

Freq .

Ext. Research Coordination

CENR; NARSTO/HEI;

NAS/CASAC

Planning
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Executive Leads

OAQPS and Office of Research and Development (ORD) will share in the overall administration 

and management of the program. The Assistant Administrators of both Offices and their 

designates will be accountable for all program objectives, including the integration of science 

research sponsored and conducted by EPA with the Supersites program. 

Supersites Coordination Committee

The Coordination Committee will extend beyond EPA to sponsors of related programs in other 

Federal agencies, industry and State and local agencies. The role of this Committee is to provide 

a forum for coordination and leveraging of resources by establishing and maintaining a dialogue 

among the members collectively who share similar needs and interests. In addition, the 

Coordination Committee would provide a valuable resource in reviewing Supersites plans and 

assessing progress.

Figure 1.4 Flow Diagram Illustrating Major Program Stages and Review

Science Oversight

The Supersites represent an important component to foster greater integration across several 

science research programs. The National Academy of Sciences Committee on Research 

Priorities for Airborne Particulate Matter clearly has expressed a desire to see comprehensive 

science planning. The Technical Subcommittee on Fine Particle Monitoring of the Clean Air 

Scientific Advisory Committee (CASAC) (hereafter referred to as the Subcommittee) is 
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reviewing the Supersites Program and will provide advice and consultation. Program execution 

involves a sequence of activities starting with conceptualization, design and planning, and 

measurement deployment, with necessary reviews and assessments that feed back into program 

design. The proposed role of the Subcommittee within this sequence of events is shown 

schematically in Figure 1.4. Each of the major stages is also outlined briefly below.

Following Subcommittee review in 1998, EPA established formal internal and external planning 

and design teams. Internally, EPA established a planning team composed of atmospheric 

science, regulatory and health effects and exposure specialists. In parallel, invitations were 

mailed to other Federal and State/local agencies and private industries active in relevant research 

to participate in a broader External Coordination Workgroup. EPA staff will be responsible for 

developing program plans and working with the external committee at a partnership level by 

providing early drafts and conducting meetings on an as needed basis. The design approach was 

based on developing a measurements strategy responsive to key questions (science and 

regulatory) and scientific hypotheses, taking advantage of the PM Measurements Workshop 

Report. EPA will be responsible for establishing and managing all administrative tasks related to 

program funding. 

External Research Coordination

 The active work with the External Coordination Committee is one of several steps taken to 

optimize measurement resources across different organizations. The Subcommittee will be 

requested to review more detailed plans as part of the decision approval process. 

Accordingly, the Supersites program will be responsive to advice generated by other venues 

explicitly dealing with larger science integration issues.

EPA Steering Committee

Figure 1.5 provides a more detailed view of the program described in Figure 1.3 starting with the 

EPA Steering Committee. The EPA Steering committee is made up of program managers and 

science leads in OAQPS, NHEERL and NERL. This committee takes the advice and 

recommendations from the various stakeholder groups and provides internal EPA technical 

direction for the Supersites program technical coordinators. The Steering Committee builds 

consensus within EPA on technical direction and helps establish/prioritize resources to 

implement the program.
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1.3 Principal EPA Technical Coordinators

Internal EPA project management and technical coordinator teams that include regulatory, 

atmospheric sciences, health effects and exposure specialists will deal with resource 

management, communications, and technical issues. The principal coordinators are responsible 

for ensuring the implementation of the program. The specific duties of the coordinators as they 

relate to the development and implementation of the quality system are described below.

1.3.1 EPA Program Manager – R. Scheffe

Dr. Richard Scheffe has oversight of the entire Supersites program. Dr. Scheffe interacts at all 

levels of the Supersites Program. His duties include: 

• implementing and overseeing the EPA policy throughout this program ;

• communicating the goals of the program with the technical leads of the program;

• interacting directly with the Supersites Principal Investigators (PIs);

• communicating the progress of the program with management. 

1.3.2 EPA Project Officer - M. Jones

Mr. Jones is responsible for monitoring performance and ensuring compliance with agreement 

terms and conditions for each Supersites Project. His primary duties include: 

< review and approve progress reports and other deliverables;

< maintain all programmatic, fiscal, technical deliverable, and communication records; 

< review and approve/ recommend approval (as appropriate) requests for changes to budget, 

schedule, work plan, and key personnel;

< conduct site visit(s) for each project (programmatic / fiscal / technical).

1.3.3 EPA Technical Leads - P. Solomon and M. Pitchford

Drs. Solomon and Pitchford are the technical coordinators for the Supersites program. As such, 

they work closely with the PIs of the Supersites program. They are responsible for the technical 

aspects of this program. As such, their responsibilities are: 

< coordinate with the PI the types of instruments at each Supersites;

< coordinate meetings between PIs and EPA personnel;

< provide technical guidance to the PIs and the other technical leads. 
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1.3.4 Quality Assurance Coordinator - D. Mikel

Mr. Mikel will oversee the quality assurance aspects of the Supersites Program. His primary 

responsibility is to ensure that a quality system is in place for each Supersites. Additional 

responsibilities include:

< implementing and overseeing the OAQPS QA policy throughout this program ;

< assisting in solving QA-related problems at any level of the program; 

< ensuring that an approved QAPP is in place for all environmental data operations associated 

with the program. 

< work with the Project QA manager to ensure that technical systems audits, audits of data 

quality, and data quality; assessments occur within the appropriate schedule and conducting 

or participating in these audits;

< coordinate the QA Supersites Tele-conference group. 

The QA Coordinator (QAC) has the authority to carry out these responsibilities and to bring to the 

attention of the project officer, program manager or technical leaders any issues related to these 

responsibilities.

Figure 1.5 Supersites Implementation General Structure 

J. Bachmann (OAQPS)

R. Scheffe (OAQPS)

J. Vandenberg (NHEERL)

J. Vickery (NERL)

EPA Technical Leads:

P. Solomon (NERL)

M. Pitchford (OAQPS)

EPA Project Officer:

M. Jones (OAQPS)

Data Management:

Les Hook (DOE/ORNL)

Sigurd Christensen 

(DOE/ORNL)

Quality Assurance:

Dennis Mikel (OAQPS)

Los Angeles CA

C. Sioutas -TL

D. Bush - QA

Fresno CA

J. Watson -TL

D. Fitz - QA

St Louis MO

J. Turner -TL

J. Watson - QA

Houston TX

D. Allen -TL

G. McCaughey - QA

Baltimore MD

J. Ondov - TL

P. Hopke - QA

Pittsburgh PA

S. Pandis - TL

B. Wittig - QA

New York NY

K. Demerjian - TL

V. Mohnen - QA

EPA

Collaborators

EPA Steering

 Committee

Principal EPA Technical

 Coordinators

Research Groups
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1.3.5 Data Management - L. Hook and S. Christensen

Drs. Christensen and Hook are responsible for working with all of the Supersites data managers 

and ensuring that they archive the data in the NARSTO Permanent Data Archive. Due to the 

nature of the data collected, EPA’s Aerometric Information Retrieval System (AIRS) does not 

have neither capability nor the temporal flexibility to house the data from the Supersites. Section 

6 will highlight the details of this archive. In addition, their responsibilities include: 

< leading the data management working group; 

< leading the technical discussions of efforts to develop consistent metadata (e.g., variable 

naming, units, methods, and flags); 

< ensuring that all data that are entered into the NARSTO archive have been quality assured;

< attending annual Supersites meetings and updating the Supersites community on data 

management issues. 

1.4 Research Groups

Each Supersites is made up of a number of research scientists performing the environmental data 

collection activities as described in the Supersites specific grant proposal. Figure 1.5 identifies the 

technical leads, PIs and the QA Manager (QAM) for each Supersites. Both these individuals 

provide a focal point for the coordination of the research activities at the Supersites

Research Group Principle Investigators

The PIs responsibilities include:

< ensuring research scientists fulfill their obligations for development of QAPPs for their 

research environmental data operations;

< ensuring communication between the research group and the EPA technical QAC;

< assisting the research group QA lead in coordinating QA activities;

< approving and implementing the Supersites QAPP for which he/she is responsible.

Research Group QA Manager

The Research Group QAMs will have primary responsibility to ensure that a quality system is 

developed and implemented for the Supersites he/she is responsible. The QAM’s responsibilities 

include:
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< developing and approving the Supersites QAPP for which he/she is responsible prior to 

implementing environmental data operations;

< ensuring research scientists are aware of their obligations for development and 

implementation of QAPPs for there research environmental data operations;

< establishing communications with the QAC and reporting progress on QA activities;

< providing internal technical systems audits and assessments of researchers efforts; 

< ensuring that all Standard Operating Procedures (SOPs) are reviewed and finalized before the 

start of the program. 

References

1. Allbritton, D. and D. Greenbaum. 1998. Atmospheric Observations: Helping Build the 

Scientific Basis for Decisions Related to Airborne Particulate Matter. Report of the PM 

Measurement Research Workshop, Chapel Hill, North Carolina, 22-23-July. Prepared by 

Health Effects Institute and the Aeronomy Laboratory of the National Oceanic and 

Atmospheric Administration. Health Effects Institute, Cambridge, MA. 

http://www.al.noaa.gov/wwwhd/pubdocs/PMMRW.pdf
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2.0 Quality System Description

A quality system is defined as a structured and documented management system describing the 

policies, objectives, principals, organizational authority, responsibilities, accountability, and 

implementation of an organization for ensuring quality in its work processes, products (items), 

and services. The quality system provides the framework for planning, implementing, and 

assessing work performed by the organization and for carrying out required QA and QC. This 

section will describe the quality system applications used by the organization to implement 

effective quality assurance activities.

2.1 Supersites QA Application

In order to meet its stated mission using environmental data, the Supersites PI must implement a 

QA program that assures that the data can be used for its intended purpose. The following 

elements will assist in the assurance of data quality and will be described in the following 

sections.

• QA management plans;

• Management systems reviews;

• Data quality objectives process;

• QA project plans;

• Standard operating procedures;

• Data quality assessments.

Various reviews to determine the successful application of QA in Supersites will be discussed in 

Section 9 and 10.

2.2 Quality Management Plans

The Quality Management Plan (QMP) is part of the mandatory Agency-wide policy requires that 

all organizations performing work for EPA develop and operate management processes and 

structures for assuring that data or information collected are of the needed and expected quality 

for their intended use. The QMP describes the quality system in terms of the organizational 

structure, functional responsibilities of management and staff, lines of authority, and required 

interfaces for those planning, implementing, and assessing activities involving the Supersites 

Environmental Data Operation (EDO). This document represents the QMP for the Supersites 

program. The QMP will reside on the Air Monitoring Technology Information Center (AMTIC) 

web site for easy access to all Supersites cooperators. A hardcopy will also be filed with the 

OAQPS Document Control Manager. Approval for the QMP will include the OAQPS QA 

Manager, Mr. Joe Elkins and the Supersites QAC Mr. Dennis Mikel. 
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2.3 Data Quality Objectives (DQOs)

Data quality objectives (DQOs) are qualitative and quantitative statements derived from the DQO 

process that clarify project technical and quality objectives, define the appropriate type of data, 

and specify tolerable levels of potential decision errors that will be used as the basis for 

establishing the quality and quantity of data needed to support decisions. 

As described in section 1, the Supersites will address objectives in three major areas:

< SIPs.: support development of State Implementation Plans through improved understanding 

of source-receptor relationships leading to improved design, implementation, and tracking of 

control strategy effectiveness in the overall PM program; 

< health effects and exposure: development of monitoring data and samples to support health 

and exposure studies to reduce uncertainty in National Ambient Air Quality Standards setting 

and to enable improved health risk assessments; and 

< methods testing: comparison and evaluation of emerging sampling methods with routine 

techniques to enable a smooth transition to advanced methods. 

The goals of each Supersites are described on the AMTIC Supersites web page 

(http://www.epa.gov/ttn/amtic/ssprojec.html.). In addition, each Supersites contains a number of 

sub-objectives which are carried out by various research organizations participating in the 

Supersites. OAQPS identifies the types of projects occurring in the Supersites Program as 

category 3 (see section 2.1.4). Category 3 projects do not require a formal DQO process but do 

require a determination of the quality of data needed for decision making. The quality of data will 

be defined in the QAPPs that are submitted for each Supersites project. 

2.4 QAPPs

The QAPP is a formal document describing in comprehensive detail the necessary QA/QC, and 

other technical activities that must be implemented to ensure that the results of work performed 

will satisfy the stated performance criteria (DQOs). 

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

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

Research Groups participating in the Supersites Program to adhere to this policy. The technical 

lead and QA lead identified for each Research Group are responsible for assuring adherence to 

this EPA QA Policy and for approving the respective Supersites QAPP. 

Each Supersite will produce one QAPP, incorporating all sub-projects. Due to the number of subprojects in each Supersite the QAC will not review and approve SOPs. The research group QA 

lead will be responsible for assuring that SOPs are developed for each sub-project in accordance 

with the approved QAPP.
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QAPPs are secured in a file by the grant ID number with the EPA Project Officer.

2.4.1 Categories of QA Project Plans

OAQPS will utilize a four-tiered project category approach to its QA Program in order to 

effectively focus QA. This approach was originally developed by the U.S. EPA, Air and Energy 

Engineering Research Laboratory (AEERL) and published by the EPA Risk Reduction 

Engineering Laboratory, Cincinnati, Ohio (EPA/600/9-89/087). Category I involves the most 

stringent QA approach, whereas Category IV is the least stringent. The following definition of 

the categories are quoted from the document listed above:

Category I Projects

Projects include EDOs that directly support rulemaking, enforcement, regulatory, or

 policy decisions. They also include research projects of significant national interest, such as 

those typically monitored by the Administrator. Category I projects require the most detailed 

and rigorous QA and QC for legal and scientific defensibility. Category I projects are typically 

stand-alone; that is, the results from such projects are sufficient to make the needed decision 

without input from other projects.

Category II Projects

Projects include EDOs that complement other projects in support of rulemaking regulatory, or 

policy decisions. Such projects are of sufficient scope and substance that their results could be 

combined with those from other projects of similar scope to provide necessary information for 

decisions. Category II projects may also include certain high visibility projects as defined by 

EPA management

Category III Projects

Projects include EDOs performed as interim steps in a larger group of operations. Such

 projects include those producing results that are used to evaluate and select options for interim 

decisions or to perform feasibility studies or preliminary assessments of unexplored areas for 

possible future work.
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Category IV Projects

Projects involving EDOs to study basic phenomena or issues, including proof of concepts, 

screening for particular analytical species, etc. Such projects generally do not require 

extensive detailed QA/QC activities and documentation. The number of elements required 

for each category is reduced as one proceeds from category I to IV as illustrated in Table 

2-1.

OAQPS has designated the Supersites program as a category 3 project. The statement of 

the category will be placed on the QAPP signature and approval page, which will include 

signatures of the QAPP preparer, Task Lead, QA Lead and the QAC.

Table 2-1 QAPP Elements Applicable to Various Categories 

QAPP Element Category 

Applicability

Project Management

A1 Title and Approval Sheet

A2 Table of Contents

A3 Distribution List

A4 Project/Task Organization

A5 Problem Definition/Background

A6 Project/Task Description

A7 Quality Objectives and Criteria for Measurement Data

A9 Special Training Requirements/Certification

A10 Documentation and Records

Measurement and Data Acquisition

B1 Sample Process Design

B2 Sampling Methods Requirements

B3 Sample Handling and Custody Requirements

B4 Analytical Methods Requirements

B5 Quality Control Requirements

B7 Instrument Calibration and Frequency

B8 Inspection/Acceptance Requirements for Supplies and 

Consumables

B9 Data Acquisition Requirements

B10 Data Management

Assessment and Oversight

C1 Assessments and Response Actions

C2 Reports to Management

Data Validity and Usability

D1 Data Review, Validation, and Verification Requirements

D2 Validation and Verification Methods

D3 Reconciliation and User Requirements

I, II, III, IV

I, II, III

I, II, 

I, II, III

I, II, III

I, II, III, IV

I, II, III, IV

I

I, II, III

I, II, III, IV

I, II, III, 

I, II, III

I, II, III, IV

I, II, III, IV

I, II, III

I, II

I, II, III

I, II

I, II, III

I, II, III

I, II, III

I, II

I, II, III
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2.4.2 QAPP Review and Approval

QAPPs are reviewed and approved in accordance with EPA QA/R5, Requirements for 

Quality Assurance Project Plans for Environmental Data Operations. Copies of this 

document are available from the EPA Quality Staff (QS) Web site 

(http://www.epa.gov/quality1/). EPA Quality Staff encompasses all EPA staff that proves 

Quality Assurance for the agency. This includes Headquarters, OAQPS, Office of 

Research and Development (ORD) and the Regional Offices. 

This document identifies and defines the elements that must be addressed in all formal 

QAPPs. The NARSTO QAPP model1 was used as the template of all QAPPs for this 

program. This was a decision made by the Supersites QA Work Group, since many of the 

scientists were familiar with the format and had used the NARSTO format previously. 

The NARSTO QAPP format is similar to the EPA QA format, but is organized differently. 

All required sections of the EPA QA format are represented in the NARSTO format.

Review of the QAPP must include QAPP preparer, Research Group Task Lead and QA 

Lead and the QAC. Mr. Dennis Mikel, the QAC for the Supersites Program, will review 

and approve each QAPP for the required elements and the soundness of the QA/QC. The 

QAC will attempt to review QAPPs within 30 working days of submission. The QAC 

will provide written comments on each element. Through the QAPP review process, the 

QAC will determine whether the QAPP can be approved, and if not, will identify those 

elements requiring revision. If the QAPP requires revision, it will be sent back to the 

author. The revisions, which may be included in the QAPP or as an addendum, must be 

reviewed and approved by the QAC. All QAPP reviews are secured in a file by the grant 

ID number with the EPA Project Officer.

Conditional Approvals

OAQPS does not encourage the use of conditional approvals; therefore, QAPPs may be 

conditionally approved only by the QAC. Conditional approval is defined as a QAPP that 

demonstrates that a quality system is in place and operational and that critical elements of 

the QAPP are provided in enough detail to allow the reviewer to determine that the data 

collected under the QAPP will be documented and of sufficient quality to meet the 

program data quality objectives.

QAPP Revision 

Any revisions required to the original QAPP can be included in a second or subsequent 

revision or an addendum. However, sometimes the scope of a project can change which 

may have the potential to affect the quality of the data. If these changes affect the 

collection of environmental data, an addendum to the approved QAPP must be submitted 
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that describes the changes and the appropriate QA/QC techniques necessary to meet the 

DQOs. The QAC must approve the changes.

QAPP Archive

Upon completion of the Supersites Program, QAPPs will be filed with the OAQPS 

Document Control Officer (DCO) who will identify the document with a unique document 

control number (see section 5). All original copies of the QAPPs and any subsequent 

revisions will be secured by the DCO. 

2.5 Standard Operating Procedures (SOPs)

Standard operating procedures (SOPs) are written documents that detail the method for an 

operation, analysis, or action with thoroughly prescribed techniques and steps. SOPs are 

protocols for all routine activities, especially those that are involved in the EDOs, which 

generally involve repetitious operations performed in a consistent manner. 

SOPs should ensure consistent conformance with organizational practices, serve as 

training aids, provide ready reference and documentation of procedures, reduce work 

effort, reduce error occurrences in data, and improve data comparability, credibility, and 

defensibility. They should be sufficiently clear and written in a step-by-step format to be 

readily understood by a person knowledgeable in the general concept of the procedure. 

Guidance for SOP development can be found in QS document entitled Guidance for the 

Preparation of Standard Operating Procedures (SOPs) EPA QA/G-6. Copies of this 

document are available at the QS Website (http://www.epa.gov/quality1/qa_docs.html).

SOPs must be written prior to the start of an EDO. The Research group QA Manager will 

be responsible for ensuring SOPs are developed. SOPs for data collection methods must 

be included in QAPPs either by reference, by inclusion of the actual method or be attached 

as an appendix. In general, approval of SOPs occurs during the approval of the QAPP. 

Any change in a SOP during the EDO should be documented and filed by the research 

lead. SOPs will be reviewed during Technical Systems Audits (TSAs).
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2.6 Assessments

There are several assessments tools that will be implemented by the QA system. Please 

see Chapter 9.1 for details. Assessments will be performed as the program begins and on 

a periodic basis after January 2001. Table 2-2 lists the types of assessments, assessor and 

assessment frequency. 

 Table 2-2 Assessments

Assessment Type Assessor Frequency

Technical Systems Audits Project Level QA Managers At the beginning of the project

Performance Audits Project Level QA Manager At the beginning of the project/annually 

after the first year

Network Review EPA- OAQPS-QA Coordinator At the beginning of the program 

Performance Evaluations EPA -ORIA-NAREL Lab Throughout the life of the program 

QAPP Review and Approval EPA - OAQPS-QA Coordinator Before projects begin

Data Quality Assessment Project Level QA Managers After data collection phase

Reference

1. NARSTO Quality Planning Handbook, November 23, 1999, Oak Ridge National 

Laboratory, http://cdiac.esd.ornl.gov/programs/NARSTO
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3.0 Personal Qualifications and Training 

This section will discuss the process put in place to provide training for the Supersites 

program. This chapter will outline the process involved and training available for air 

monitoring professionals. 

The process of training the personnel whom will be the involved in the Supersites program 

will vary. The Supersites projects will be employing many research and well-known 

methods. For instance, Federal Reference Method PM2.5 instrument will be employed at 

many locations. With these, State and Local agency professionals will be operating the 

instruments. For the research type of instruments, interns and graduate students from 

various colleges and universities will be operating the monitors. It is the responsibility of 

each Supersites project PI and QAM to provide training for all personnel involved in their 

projects. OAQPS provides numerous satellite classes and on-your-own courses that are 

free to air monitoring individuals. All persons working on this program are encouraged to 

take these courses. 

3.1 Personal Qualifications

Each Supersites program will make every effort to provide training to all who participate 

in this program. Personnel assigned to the Supersites Program should meet the 

educational, work experience, responsibility, personal attributes, and training requirements 

for their positions. Although OAQPS can provide training to all agencies, it cannot 

require the Supersites projects or any contractors to send their staff to EPA training 

courses. During the TSAs, the QAM for each project or its contractor will review records 

on personnel qualifications and training. All agencies should maintain these records in 

personnel files and will be accessible for review during audit activities. 

3.2 Training

Appropriate training is made available to persons supporting the Supersites program, 

commensurate with their duties. Such training may consist of classroom lectures, 

workshops, tele-conferences, and on-the-job training. 

Over the last 2 years, a number of courses have been developed in cooperation with EPA 

for personnel involved with ambient air monitoring and quality assurance aspects. Formal 

QA/QC training is offered through the following organizations:

< Air Pollution Training Institute (APTI) http://www.epa.gov/oar/oaq.apti.html

< Air & Waste Management Association (AWMA) http://awma.org/epr.htm
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< American Society for Quality Control (ASQC) 

http://www.asqc.org/products/educat.html

< EPA Institute

< EPA Quality Staff (QS), http://www.epa.gov/quality1/

The courses mentioned below are open to all air monitoring personnel. EPA strongly 

encourages all state and local agencies and contractors to take these courses. Table 3.1 

presents a sequence of core ambient air monitoring and QA courses for ambient air 

monitoring staff, and QA managers. The suggested course sequences assume little or no 

experience in QA/QC or air monitoring. Persons having experience in the subject matter 

described in the courses would select courses according to their appropriate experience 

level. 

Table 3.1 Core Ambient Air Training Courses

Sequence Course Title (SI = self instructional) Source

1* Air Pollution Control Orientation Course (Revised), SI:422 APTI

2* Principles and Practices of Air Pollution Control, 452 APTI

3* Orientation to Quality Assurance Management QS

4* Introduction to Ambient Air Monitoring (Under Revision), SI:434 APTI

5* General Quality Assurance Considerations for Ambient Air Monitoring (Under 

Revision), SI:471

APTI

6* Quality Assurance for Air Pollution Measurement Systems (Under Revision), 470 APTI

7* Data Quality Objectives Workshop QS

8* Quality Assurance Project Plan QS

9 Atmospheric Sampling (Under Revision), 435 APTI

10 Analytical Methods for Air Quality Standards, 464 APTI

11 Chain-of-Custody Procedures for Samples and Data, SI:443 APTI

* Data Quality Assessment QS

* Management Systems Review QS

* Beginning Environmental Statistical Techniques (Revised), SI:473A APTI

* Introduction to Environmental Statistics, SI:473B APTI

* Statistics for Effective Decision Making ASQC

AIRS Training OAQPS

* Courses recommended for QA Managers
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3.3 Certification

No certificates are required for this program. 
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4.0 Extramural Agreements and Procurement of Items and 

Services

OAQPS must ensure that the items and services it acquires are procured within EPA 

regulations, are delivered in a timely fashion, and are within the required specifications. 

The following sections will provide general information on OAQPS procurement 

procedures and provide personnel involved in the Supersites Program with the a 

description of the requirements

4.1 Source of Funds

4.1.1 State Assistance Grants: Many SLAMS and NAMS will support the Supersites 

Program by operation of ancillary sites in the SLAMS/NAMS network. The source of 

funds is Section103 and eventually Section 105 State Assistance Grants (STAG). Every 

year, funds will be allocated to the State and local air monitoring organizations to operate 

the PM2.5 Federal Reference and Speciation Program. Funds are allocated to the EPA 

Regions who then allocate them to the State, local or Tribal agencies. These agencies then 

follow their own procurement policies to get the monitoring accomplished.

 A portion of the STAG funds are allocated back to OAQPS for two activities

1 National speciation monitor contract- OAQPS set up a national contract to facilitate 

the purchase of speciation monitors

2 Analytical laboratory contract- OAQPS set up a national contract to perform all the 

filter preparation and analyses and reporting activities. 

Each year OAQPS will submit a request for the appropriate allocation of funds for these 

activities based on the number of monitors being implemented (or planned) for that fiscal 

year.

4.1.2 OAQPS Internal funds: Each year OAQPS plans the activities it will pursue in the 

upcoming fiscal year. The OAQPS speciation monitoring and QA leads will work with 

various work groups and cooperators to prioritize the use of the environmental program 

management (EPM) funds. These funds may be used to purchase capital equipment or for 

contracting.

OAQPS, through the Memorandum of Agreement with the Office of Radiation and Indoor 

Air lab will provide contract funds to these labs. The use/ allocation of the funds will be 

negotiated during fiscal year planning. 
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4.2 Procurement of Items

In EPA, only contracting officers (COs) are authorized to procure items and services, 

unless it is an impress fund transaction approved by the CO prior to the originators 

purchase of the item. The Federal Government is not bound by any commitments made 

by other than authorized personnel.

Requests for purchases begin at the yearly planning stages of the Speciation Program for 

the EPM funds. Purchases by contractors must be identified in the project scope of work 

for such purchases. All items should be identified and specifications that meet the 

government's minimum needs should be detailed. These specifications will be referred to 

during the procurement process and will assure that the OAQPS requestor receives the 

proper item and reduces the chances of purchase delays or incorrect purchases because of 

inadequate product specifications. 

4.3 Procurement of Services

Two types of mechanisms are primarily used to procure services, contracts and assistance 

agreements (grants, cooperative agreements, etc.). As mentioned in section 4.1, COs are 

the only individuals who can obligate funds. 

When procuring services, one should follow the same basic procedure used for the 

procurement of items. There are certain activities that are of a policy- and decisionmaking nature that should remain the sole authority of EPA. The CMD should be 

contacted during the initial planning of the PR to discuss specific requirements for the 

procurement.

The Project Officer (PO) states the service that will be delivered, measures the quality of 

the service, and accepts the service. When a level-of-effort contract is the vehicle used in 

procuring services, the work assignment manager (WAM) provides the technical expertise 

for the work assignment and assumes responsibility for the QA requirements assigned to 

the PO. Two major tools to ensure that adequate service is provided are a well-defined 

statement of work (SOW) and a QAPP that includes reviews (audits).

The QAM or DQAO assists in this activity by providing knowledge and guidance on the 

QA requirements and aspects of any potential project. The QAM or DQAO will also 

approve the QA review form that is discussed in the next section.

4.3.1 Contracts: Contracts are used when the government derives sole benefit from a 

particular product or service. Contracts can be specific and can require a degree of leadtime for development. Depending upon the scope of the service, QA attributes can be 

developed that must be adhered to under the terms and agreements of the contract. Any 
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EPA initiated contracts are required to use some type of QA form to determine if the 

contract will require EDO and therefore requires a QMP, a QAPP assessments and reports. 

After the form is completed it must be reviewed by the (WAM/PO) and a QA officer. The 

form must be kept in the official contract file. 

The Federal Acquisition Regulations, Title 48 of the Code of Federal Regulations, was 

recently amended to address contract quality systems requirements on a government-wide 

basis. The new FAR clause at 52.246-11, Higher-Level Quality Requirement, allows a 

Federal agency to select a voluntary consensus standard as the basis for its quality 

requirements for contracts and allows tailoring of the standard to more effectively address 

specific needs or purposes. Based on this FAR clause, EPA has selected ANSI/ASQC E4, 

Specifications and Guidelines for Quality Systems for Environmental Data Collection and 

Environmental Technology Programs, as the basis for its environmental quality 

requirements and has tailored this standard to ensure that contractors demonstrate 

conformance to this national standard. The background and application of the new 

procurement policy as it relates to QA is included in Appendix A must be followed.

Due to these changes, 48 CFR 1546, a quality regulation that applies only to EPA, will be 

removed from the Code of Federal Regulations. The tailoring language allowed by 52 

CFR 246-11 and pertinent requirements in 48 CFR 1546 will be included in the EPA 

Directive 1900, Contracts Management Manual. This procurement policy notice is being 

issued to ensure an orderly transition from 48 CFR 1546 to EPA Directive 1900 and 

contains tailoring language allowed by 52 CFR 246-11. It is in effect until the revisions to 

Directive 1900 are completed

Whenever the government enters into a contract, it is entitled to receive quality service. In 

order to define and measure this quality, the WAM/PO must develop a SOW that will 

accurately define the minimum acceptable requirements for the service or product. 

Methods used to determine quality (audits, quarterly interviews, random inspections, etc.) 

should be explained prior to project implementation so that the supplier will understand 

how quality will be assessed. 

Part of the procurement process of certain types of large contracts include the use of a 

technical evaluation panel (TEP). When this form of contracting mechanism is used to 

solicit contracts in which a significant percent of the cost (> 25%) includes EDO, the TEP 

must include a QA representative, if possible, a representative from the group/branch 

processing the contract. Part of the TEP responsibilities will include rating each potential 

contractor against a standard set of criteria. A portion of these criteria can include various 

assessments such as on-site audits and the analysis of performance evaluation materials. 

Prior to the solicitation for bid, it must be determined what proportion of the TEP rating 

will be allocated to QA assessments. It is suggested that a minimum of 5% of the overall 

TEP rating be allocated to QA. 
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Depending upon the type of contract used to acquire a service, different types of QA 

methods for determining the quality of product or output may be used. However, in all 

cases, documentation is essential. POs/WAMS are responsible for documenting quality 

on a regular basis. EPA personnel must be aware of the "personal services" type of work 

characterized by an employer-employee relationship between government and contractor 

employees. These contracts are illegal in EPA. Personal services conflicts arise when 

government employees assume the right to instruct, supervise, or control a contractor's 

employee in how he or she performs work. It is the contractor's right to hire and 

terminate, to assign, and to organize and implement tasks as the contracting organization 

deems appropriate. OAQPS may tell the contractor what to do within the terms and 

agreements of the contract, but not how to do it. 

4.4 Assistance Agreements

Assistance agreements are used when both parties (EPA and the group providing the 

service) derive benefit out of the service. This usually occurs with grants or cooperative 

agreements where universities or states derive benefits from participating in EDOs. QA 

requirements are developed for all assistance agreements that include EDOs. OAQPS 

follows guidelines developed in the EPA Assistance Administration Manual (EPA-5700). 

Assistance agreement SOWs are usually developed jointly. However, once the SOW is 

completed, the parties must also agree on the quality standards for assuring the product or 

service. It is the responsibility of the WAM/PO to be knowledgeable of the EPA QA 

policy and to represent these standards during the development of the projects SOW. 

Special conditions are usually included in assistance agreements. The PO will list the 

conditions to which project participants must adhere. One of these conditions relates to 

QAPPs. Any assistance agreement that includes EDOs must include the following 

statement:

A quality assurance project plan must be submitted within 90 days of this 

agreement and/or 30 days prior to commencement of any EDOs. 

Implementation dates will be adjusted based upon the above conditions. 

Costs associated with data collection are not allowable costs until the quality 

assurance project plan is submitted, nor will costs be reimbursed until the 

quality assurance program plan is approved.

4.5 EPA Exclusive Versus Discretionary Functions

The following information comes directly from EPA Quality Manual for Environmental 

Programs 5360.

Many quality system activities involving environmental data operations are inherently 

governmental functions and must be performed only by EPA personnel or by personnel explicitly 
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authorized by EPA based on statute, regulation, or by the terms of an extramural agreement. Such 

representatives may include other governmental personnel and with specific authorization, 

contractor personnel. When quality management tasks are performed by a contractor, the contract 

must be appropriately managed and must remain under the control of the authorized EPA 

contracting representatives. EPA cannot use cooperative agreements or grants to provide quality 

management activities such as QA and QC services for EPA because it is an inappropriate use of 

financial assistance (Office of General Counsel memorandum, August 2, 1994). 

This section describes the quality management tasks necessary to comply with the Order and 

identifies those tasks that may be performed by non-government personnel under appropriate 

management controls.

Two types of quality management functions are described:

C Exclusively EPA Functions - inherently governmental work which must be performed 

only by responsible EPA officials, including the QA Managers (QAMs), or authorized 

EPA representatives. 

C Discretionary Functions - activities that may be performed either by EPA personnel or by 

non-EPA personnel under the specific technical direction of and performance monitoring 

by the QA Manager or other responsible EPA or Government official under an approved 

contract, work assignment, delivery order, task order, etc.

In the situations involving the other associated functions, there may be instances involving 

sensitive contracting services, advisory and assistance services, and vulnerable contracting 

practices as defined by the Federal Acquisition Regulations, Office of Federal Procurement Policy 

(OFPP), and the EPA Contracts Management Manual (EPA Order 1900). Such situations are 

identified by italicized text in the following sections. In addition, management approval of 

services contracts as defined by OFPP Letter 93-1 must be obtained for many of the associated 

tasks.

Technical direction or other instructions to an extramural organization, relating to performance of 

an extramural agreement, shall be provided only by authorized EPA or other Government 

representatives in accordance with the terms of the applicable extramural agreement. Only 

authorized EPA or other Government representatives are to provide direction or instructions to an 

extramural organization providing quality systems support for environmental programs. This is to 

avoid such actions as:

C the providing of directions or instructions that are inconsistent with the terms of an 

extramural agreement,

C unauthorized access to confidential business information (CBI), or
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C unauthorized access to information that may allow an extramural organization to gain an 

unfair competitive advantage. 

4.5.1 Mandatory Quality Management Tasks and Descriptions: This section describes the 

activities and tasks integral to an effective quality system. These tasks are required to implement 

EPA Order 5360.1 CHG 1. 

 Manage and Coordinate the Quality System

Exclusively EPA functions that must be performed by EPA QA personnel include:

C managing the day-to-day implementation of the mandatory quality system. 

C acting as liaison between the organization and the QS on matters of QA policy.

C coordinating with senior management the development of and preparation of the 

organization's Quality Management Plan.

C coordinating with senior management changes to the Quality System as needed to assure 

its continued effectiveness and assisting in reporting the results annually to management 

and to QS in the QA Annual Report and Work Plan.

C managing organization resources designated for the quality system. 

C maintaining records of pertinent quality system activities performed by the organization.

Review and Approve Procurement and Financial Assistance Documents for QA Requirements

Exclusively EPA functions that must be performed by EPA QA personnel include:

C reviewing procurement and financial assistance documents (e.g., statements of work, 

scopes of work, applications for assistance, funding requests, and purchase requests) to 

confirm any need for QA requirements, providing any necessary special language or 

conditions for such QA requirements, and approving by signature the appropriate Quality 

Assurance Review Form.

C participating directly or indirectly in the solicitation or agreement review process to advise 

the Project Officer on the suitability of the offer or quality system or quality 

assurance/quality control (QA/QC) approach for the particular project. 

C reviewing work assignments, delivery orders, and task orders to certify that appropriate 

QA/QC requirements have been established and that the necessary instructions are being 

communicated to the contractor to carry out the required QA/QC tasks. Approving by 

signature appropriate Quality Assurance Review Form (EPA Order 1900, Chapter 2).
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Review and Approve QA Planning Documents

Exclusively EPA functions that must be performed by EPA QA personnel or their authorized 

EPA representative include:

C reviewing Quality Assurance Project Plans (QAPPs) for all projects, work assignments, 

delivery orders, task orders, grants, cooperative agreements, and interagency agreements 

involving data acquisition, data generation, and/or measurement activities that are 

performed on behalf of EPA.

C approving all QAPPs for implementation in all applicable projects, work assignments, 

delivery orders, task orders, grants, cooperative agreements, and interagency agreements 

performed on behalf of EPA.

C coordinating the correction of deficient QAPPs with the Project Officer and his/her 

management. 

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

include:

C reviewing, at the specific technical direction of the QAM, QA Project Plans and other QArelated planning documents, such as sampling and analysis plans, Data Quality 

Objectives (DQO) specifications, etc., and providing specific substantiated 

recommendations to the QAM on the adequacy of the QA approach in meeting the 

criteria provided by the QAM. (The reviews should identify specific technical 

deficiencies in the planning documents.)

Track and Report Quality System Deliverables

Exclusively EPA functions that must be performed by EPA QA personnel or their authorized 

EPA representative include:

C tracking critical quality system deliverables for the organization and make periodic reports 

to senior management on the status of reporting actions and deliverables. 

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

include:

C compiling/logging administrative and management information including turnaround 

times to correct deficient QAPPs, responses to audits (e.g., responses and corrective 

actions), and quality reviews of final reports.

Manage Contractor Support Work Assignments, Delivery Orders, and Task Orders
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Exclusively EPA functions that must be performed by EPA QA personnel include:

C serving as the Contracting Officer Representative (for example, Project Officer, Work 

Assignment Manager, or Delivery Order Project Officer) for specific QA support 

contracts, work assignments, delivery orders, and task orders.

Plan and Conduct Management Assessments

Exclusively EPA functions that must be performed by EPA QA personnel include:

C planning, directing, and conducting assessments of the effectiveness of the quality system 

being applied to environmental data operations and reporting results to senior 

management. Such assessments may be conducted using the Management Systems 

Review (MSR) process.

C coordinating with senior management any revision of the quality system as necessary 

based on the findings of the assessment. 

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

include:

C providing technical support to the EPA QAM in the planning phase of management 

assessments. (Such activities are limited to the assembly and compilation of background 

information and data, guidance documents, technical reports, etc., available in the public 

domain, for use by EPA in designing the assessment goals and specifications.)

 Plan and Conduct Technical Assessments

Exclusively EPA functions that must be performed by EPA QA personnel or their authorized 

EPA representative include:

C planning and directing with the responsible EPA project officials the implementation of 

periodic technical assessments of ongoing environmental data operations to provide 

information to management to assure that technical and quality objectives are being met 

and that the needs of the customer are being satisfied. Such assessments may include 

technical systems audits, surveillance, performance evaluations, and data quality 

assessments.

C determining conclusions and necessary corrective actions (if any) based on the findings of 

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

include:

C 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.

Prepare and Present QA Training Materials and Courses

Exclusively EPA functions that must be performed by EPA QA personnel or their authorized 

EPA representative include:

C developing and presenting detailed guidance and training for QA/QC activities based on 

interpretation of Agency-wide requirements and guidance. 

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

include:

C providing or coordinating quality-related training for the organization in special skill 

areas identified by the Agency and not generally available to the organization.

C providing allowable technical and/or logistical assistance in preparing and presenting 

quality-related technical training (within the Agency’s implementation of special 

management and control measures and the constraints of potential for conflict of interest, 

of revealing confidential business information, or of appearing to be interpreting or 

representing Agency policy).

Review and Approve Final Reports for Quality Documentation

Exclusively EPA functions that must be performed by EPA QA personnel or their authorized 

EPA representative include:
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C establishing criteria for the acceptability of quality documentation in the organization's 

published papers and reports; that is, defining what is required for an adequate discussion 

of the quality of the project results and the usability of the information reported.

C approving for publication those papers and reports that meet the defined criteria.

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

include:

C conducting a substantiated technical review of all reports produced by the organization 

using the qualitative and quantitative specifications obtained from the DQO process or 

other criteria provided by EPA. This quality review complements the peer review 

process. 

4.5.2 Non-Mandatory Quality Management Tasks and Descriptions: This section describes 

other activities and tasks integral to an effective quality system. They are not explicitly required 

to implement EPA Order 5360.1 CHG 1, but if implemented, they must be implemented as 

described below.
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5. 0 Records and Documentation

The responsibility of record keeping falls upon OAQPS, ORD and the individual Supersites 

Projects and their contractors. For this program, there are number of documents and records that 

need to be retained. A document, from a record management perspective, is a volume that 

contains information, which describes, defines, specifies reports, certifies, or provides data or 

results pertaining to environmental programs. As defined in the Federal Records Act of 1950 and 

the Paperwork Reduction Act of 1995 (now 44 U.S.C. 3101-3107), records are: "...books, papers, 

maps, photographs, machine readable materials, or other documentary materials, regardless of 

physical form or characteristics, made or received by an agency of the United States Government 

under Federal Law or in connection with the transaction of public business and preserved or 

appropriate for preservation by that agency or its legitimate successor as evidence of the 

organization, functions, policies, decisions, procedures, operations, or other activities of the 

Government or because of the informational value of data in them...” EPA-OAQPS and ORD 

will adhere to this guideline. Section 5.1will illustrates the process that will be implemented for 

storing documents and records. Since many agencies are involved, their documentation storage 

capabilities and processes will differ; however, at a minimum, all documents and records for this 

program will be securely stored. For more information on document control and storage, please 

see the individual agency QAPPs. 

5.1 Document Hierarchy and Process

This section will outline the hierarchy of the documentation and illustrate the review process for

the major documents created for this program. 

5.1.1 Hierarchy: The Clean Air Act (CAA) and EPA Order 5360.1, July 1998 are the 

overarching documents for this program. As such, all authority to create programs and allocate 

funds is given in these documents. EPA Order 5360.1 gives the EPA authority to require all 

agencies that accept federal funds to create QMPs, QAPPs and Network Plans. OAQPS has the 

authority to require, review, comment and withhold funds if these requirements are not met. The 

order of hierarchy follows: 

< The Code of Federal Regulation, through the CAA and Order 5360.1 are the 

overarching authority.

< The QMP encompasses the entire program. All agencies, OAQPS, ORD and the 

individual Supersites projects will adhere to the requirements and guidelines in the 

QMP. The QMP discusses the roles of each agency. 

< The QAPPs for individual agencies will govern that agency. The agency must adhere 

to the statements made in their QAPP. 

< The Network Plan will outline how the network will be implemented and document 

the location of each sampler with all ancillary data. 
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5.1.2 Document Creation and Review Process

5.1.2.1 QMP

The QMP for this program was generated by OAQPS-EMAD-MQAG. It has the overarching 

authority over all QAPPs, Network Plan and all other ancillary documents. This document has 

undergone thorough review by OAQPS, ORD, and the Supersites Project PIs and QA Managers. 

5.1.2.2 QAPPs

The individual Supersites PIs and QA Managers to describe their process of assuring the quality 

of the data write the QAPPs. OAQPS reserves the authority to review, make comments and 

approve the individual QAPPs. 

5.1.2.3 Network Plan

OAQPS requests that all Supersites project take electronic photographs of each site in the cardinal 

directions. These will be forwarded to OAQPS with all other siting data. OAQPS will create 

electronic resources that will include the following:

< Electronic photos of the sampler in place;

< Electronic photos of the area in all cardinal directions;

< Maps of the area showing local sources (if known);

< Coordinates of the location generated by Geographic Positioning Systems. The 

standard is +/- 10 meters.

This data will be compiled and placed in an accessible electronic database and distributed and 

stored by OAQPS. Any parties that wish to review the network will be able to obtain this data 

expeditiously.

5.1.2.4 Other Documents

The responsibility of all other documents is detailed in the next section. 

5.2 Documentation Responsibilities

5.2.1 OAQPS –EMAD

 This division has oversight of the Supersites. As such, the documents that must be controlled and 

stored are under the jurisdiction of the Project Officer, who has the responsibility of storing and 

archiving all records that pertain to the requisition and deposition of contracts.
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5.2.2 Supersites 

Principle Investigators- the PIs are responsible for the oversight of the field and laboratory 

documents and implementation of the QAPP. As such, he/she is responsible for the storage of all 

records and documents generated by the labs or field. 

Quality Assurance Managers - The QA Managers are responsible for the archiving of all QA 

related documents created during any assessments by the manager or contractor in accordance 

with the QAPP. 

Individual Investigators - The individual research investigators are responsible for the oversight 

of the their instrument documentation. All calibration or maintenance data, notes, field 

information is their responsibility. As such, he/she is responsible for the storage of all records 

and documents generated by their field operations in accordance with their SOPs.

5.3 Deposition and Storage of Documents and Records

This section will address the deposition, storage accessibility, and protection of documents and 

records. It is noted that the persons filling the roles mentioned above are responsible for the 

documents and record that they generate. These agencies will take full responsibility for the 

deposition of these records. Please note that all records and documents will be made available 

for review and scrutiny upon request for up to 5 years after the data were generated. 

5.3.1 Field notebooks

Notebooks will be utilized for recording results of field audits. Dates, times, field conditions, 

temperature, pressure and flow rates will be recorded. Each investigator will archive all field 

logs. Any computer-generated logs will be downloaded to their headquarters. 

5.3.2 Lab Notebooks

Notebooks will also be issued for the laboratory. These notebooks should be uniquely numbered 

and associated with the Supersites program. One notebook will be available for general 

comments/notes; others will be associated with, the temperature and humidity recording 

instruments, the refrigerator, calibration equipment/standards, and the analytical balances and all 

instruments used for this program. Laboratory notebooks review and archiving are the 

responsibility of the individual investigators or researchers. All logs must be maintained for at 

least 5 years after the data are generated.
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5.3.3 Chain of Custody Forms

Original Chain of Custody forms will be archived by the individual investigators. 

5.3.4 Other Documents

All other documents must be stored according to their QAPP. 

5.3.5 Electronic data collection

In order to reduce the potential for data entry errors, automated systems will be utilized where 

appropriate and will record the same information that is found on data entry forms, such as the 

output of the Fine Particle Federal Reference Method or Speciation samplers. Safe and secure 

handling and storage of electronic information must be assured through good data administrative 

practices, including periodic data backups, as described in their QAPP.

5.4 Deposition of Reports

5.4.1 Data Reporting Package/Archiving and Retrieval

All the information, electronic and written, will be retained for 5 years from the date the grantee 

submits its final expenditure report unless otherwise noted in the funding agreement. However, if

any litigation, claim, negotiation, audit or other action involving the records has been started 

before the expiration of the 5-year period, the records will be retained until completion of the 

action and resolution of all issues which arise from it, or until the end of the regular 5-year period, 

whichever is later. For example, any data collected in calendar year 2001 (1/1/01 - 12/31/01) 

will be retained until, at a minimum, January 1, 2006, unless the information is used for litigation 

purposes.
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6.0 Computer Software and Hardware

There is an increasing dependence upon computers and computer related hardware in the 

collection of environmental data. Indeed, all environmental programs within and outside of the 

EPA use computers extensively to collect, store, validate and analyze environmental data. This 

section will outline briefly what computer systems will be employed throughout the Supersites 

program. This chapter will also describe the roles and responsibilities for system hardware and 

software. 

6.1 Computer System Descriptions

6.1.1 EPA-OAQPS

 The QMP and Network Plan will be archived in Research Triangle Park, North Carolina. All 

communications and hardcopy information will also be housed at the EPA facility in Research 

Triangle Park, North Carolina. The QMP, final Supersites QAPPs will be posted on the EPAOAQPS website, AMTIC. 

6.1.2 Supersites

 Individual Supersites will develop, operate, and maintain their computer systems as outlined in 

their individual site’s QAPP or data management plan.

6.1.3 NARSTO

 While participating in the flow of information from Supersites projects to the NARSTO 

Permanent Data Archive, NARSTO will employ three computer systems. Supersites data and 

metadata will be entered into, stored, and processed by the Data and Information Sharing Tool 

(DIST), an FTP site, and the NARSTO Quality Systems Science Center processing system. 

Please see Figure 6-1. 

Data and Information Sharing Tool (DIST): DIST is a web-based index and clearinghouse of 

atmospheric measurement and chemistry data and metadata, made available by the NARSTO 

program. The DIST enables small groups of investigators to share project data in a secure 

environment and also provides data from numerous sources to the at-large research community. 

The data available through DIST may include measurement data, model outputs, images, and 

other information of interest to the atmospheric research community. Data are indexed using 

consistent metadata categories to support searching by fields such as project, location, date, 

keyword, and investigator. Data providers can easily enter metadata and add links to their data in 

this Web-based tool. The DIST is a key component in the flow of data from projects to the 

NARSTO Permanent Data Archive (PDA) with output capabilities that facilitate metadata and 

data archiving. The DIST can be accessed at http://cdiac.esd.ornl.gov/programs/NARSTO/ . 
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The overall DIST system is robust in design and efficient in implementation. Users will find a 

convenient interface, similar to many existing web-based products, that includes a file manager 

and good help files. The system is implemented using Internet standards, including XML, and 

supports international metadata standards, including FGDC and Z39.50. DIST is based on 

commercial off-the-shelf software with many value-added improvements and is part of the ORNL 

Mercury Consortium, a group of independent data projects that work together to share 

improvements and reduce individual costs.

Supersites FTP site: The Supersites shared-access FTP site has two areas for accessing data files. 

One area is publicly accessible as an anonymous login site (ftp://narsto.esd.ornl.gov) and the 

other is an internal area with login and password limited access to directories for each Supersites 

project and working group. System administrators will distribute login names and passwords, 

create subdirectories and move files as directed by site users, and maintain and periodically 

backup the site. Appropriate security and access disclaimers are distributed to users and posted 

on the site.

Quality Systems Science Center processing system: This system accepts Supersites data provided 

in the Data Exchange Standard format, checks the format, calculates summary statistics, 

assembles documentation, and transmits the data to the NARSTO Permanent Data Archive 

(PDA). The Data Exchange Standard is documented in the NARSTO Data Management 

Handbook (http://cdiac.esd.ornl.gov/programs/NARSTO/narsto.html#qsmp), and also in Excel 97 

templates designed to support creating these files. Files with related data are grouped into data 

sets for processing and archiving. A QSSC “Read and Verify” code reads the files in each data 

set, reproduces each file with an added section containing summary statistics for data in the file, 

produces files helpful in documenting the data set for archiving, verifies conformity to key 

provisions of the Data Exchange Standard, and produces a QA report indicating any deviations 

from the Standard that were found. If deviations were found, this QA report is sent back to the 

data originator so issues can be resolved. When the data set is complete and ready, 

documentation is assembled, and the data set is sent to the PDA for archiving.

NARSTO Permanent Data Archive (PDA): The PDA is maintained at the Langley Distributed 

Active Archive Center (DAAC) and operated by the NASA Langley Research Center, Hampton, 

Virginia. NARSTO data are maintained as part of their permanent data collection and are 

available to the public at no charge through a convenient Internet ordering system 

(http://eosweb.larc.nasa.gov/ ).
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Figure 6-1. Data Flow Diagram

Principal

Investigator

Project Data

Coordinator

NARSTO QSSC

Data Processing System

Data

Collection

System

Data

Project

Data

System

Project

FTP

Site

FTP

Site

NARSTO

Permanent Data

Archive

D

I

S

T3

D

I

S

T3

Data Set Metadata

Data Set Metadata

Data Set Documentation

Data Files in

DES1 or

other format

Data Files in

DES format 2

Data Files in DES format 2

Supersites Data Flow

1 NARSTO Data Exchange Standard Format

2 Special formats permitted

3 Data and Information Sharing Tool
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7.0 Planning and Implementation of Work Process

7.1 Project Goals and Objectives

This section outlines planning and implementation procedures that were employed in the 

Supersites program. This program has several diverse agencies that are interacting at several 

levels. Therefore, to ensure that the work is being performed and that the quality of the data is 

acceptable, clear communication must be employed for this program. The following sections 

outline how this is accomplished. 

 7.1.1 Program Objectives

The program addresses the objectives in three major areas:

< SIPs: support development of State Implementation Plans (SIPs) through improved 

understanding of source-receptor relationships leading to improved design, 

implementation, and tracking of control strategy effectiveness in the overall PM 

program;

< health effects and exposure: development of monitoring data and samples to support 

health and exposure studies to reduce uncertainty in National Ambient Air Quality 

Standards setting and to enable improved health risk assessments; and 

< methods testing: comparison and evaluation of emerging sampling methods with 

routine techniques to enable a smooth transition to advanced methods.

These objectives are broad in scope and presented the challenge of developing specific data

quality objectives within a National program responsive to many disciplines. Based on the

original funding rationale, each of the Supersites study areas provided some support for

implementation questions. Some of the sites added objectives related to research on health,

exposure, and methods testing. Thus, while some aspects of the program were common to all

locations, others, including duration, measurement frequency, and indicators measured may vary

with specific objectives at differing locations. The Measurements Workshop Report (see Chapter 

1 reference) provided numerous examples of overlapping data needs across diverse science 

disciplines that typically exhibit very limited interaction. A simple example includes the daily 

collection of chemically speciated data that assist both air quality model evaluations and exposure 

studies. Clearly, windows of opportunity exist for optimizing the use of environmental data to 

respond effectively to seemingly disparate objectives. An organized approach to building specific 

study objectives must be followed to ensure needs are met and resources optimized. Targeted 

program objectives were developed by:

< starting from test hypotheses and questions that are generated by an integrated program 

planning team;
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< utilizing site/time based objectives where certain locations and study periods are 

optimized for specific topic areas; e.g.: specific airsheds optimized for source receptor 

and air quality model evaluation of specific airsheds optimized to support 

epidemiological and exposure studies;

< emphasizing methods testing early, then transitioning to other objectives within a single 

airshed; including discrete or intensive sampling periods optimized to address specific 

test hypotheses; 

< requiring all investigators to follow existing quality assurance protocols in the 

development of QAPPs which includes requirements for developing DQOs. Optimizing 

objectives by location or time does not preclude some level of support at all locations to 

SIPs, health effects and exposure studies and methods testing, given the multiple uses of 

similar data.

7.1.2 Program Principles

EPA staff adhered to the following organizational and guiding principles derived from

the PM Measurements Workshop Report (Chapter 1 reference) in developing an overarching 

strategy for implementing the program:

• be designed as a “learning” rather than a “measurement” program; 

• provide consistent and comparable, but not necessarily identical, measurements across the 

sites and the nation; be an investment that leverages the largest possible number of other 

governmental and private investments; 

• have analysis and evaluation built in from the start;

• organize the measurements approach by asking; what are the major questions and hypotheses; 

what should be measured; where and when should the measurements.

The Supersites program must be flexible to adjust to and accommodate the unique needs of

different research disciplines by planning across scientific disciplines (health effects, exposure 

and atmospheric science measurement needs) and regulatory agencies. Results must be developed 

in a timely manner to assist development of SIPs which are required as early as 2005, and review 

of the PM standard which is to be completed in 2002 and again in 2007. Therefore, program 

deployment is following a dual track staging with an initial establishment of two sites in 1999 and 

a gradual full site deployment accomplished in 2002. The rationale for this dual track deployment 

is to test technical and organizational elements of the program early in order to aid the 

optimization of the full program, and allow adequate planning and design so that the full program 

can provide the most relevant support for a mix of regulatory and research based needs.

Program planning and design to date consisted of the planning meeting, and report writing by the 

steering committee and attendees related to the PM Measurements Workshop, along with internal 

EPA meetings involving regulatory, atmospheric sciences, health effects and exposure specialists. 

More formal planning and design with a coordination group started the beginning of 1999. EPA 

staff recommended the establishment of two initial sites located in Atlanta, Georgia and 
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Fresno/Bakersfield, California in mid-1999, which operated from 2 years or longer. Initial 

objectives for these sites was oriented toward source-receptor characterizations and testing nonroutine monitoring methods and establishing logistical procedures, including assessment of 

resource needs, that will benefit subsequent deployment in other locations. 

Preliminary feedback from the initial sites (Atlanta and Fresno) was factored into subsequent 

design of the full program, which benefited from more integrated planning among science 

disciplines and regulatory groups. Selection of remaining site locations was completed in the last 

calendar quarter, 1999 so that local agencies and universities could take into account the 

availability of Supersites in deploying their chemical speciation network. EPA staff recommends 

the deployment of the remaining six sites commencing in mid-2000. 

7.2 Initial Planning and Conceptualization

The development of this plan was discussed in the introduction above.

7.2.1 Program Planning and Design

Following Subcommittee review scheduled for November 30, 1998, EPA established

formal internal and external planning and design teams. Internally, EPA established a planning 

team composed of atmospheric science, regulatory and health effects and exposure specialists. In

parallel, invitations were mailed to other Federal and State/local agencies and private industries 

active in relevant research to participate in a broader External Coordination Workgroup. EPA 

staff were responsible for developing more detailed program plans and working with the external 

committee at a partnership level by providing early drafts and conducting meetings on an as 

needed basis. The design approach was based on developing a measurements strategy responsive 

to key questions (science and regulatory) and scientific hypotheses, taking advantage of the PM 

Measurements Workshop Report. EPA also was responsible for establishing and managing all

administrative tasks related to program funding. The active work with the External Coordination 

Committee is one of several steps (see Section 7) taken to optimize measurement resources across 

different organizations. The Subcommittee requested to review more detailed plans as part of the 

decision approval process.

7.2.2 Program Execution

EPA manages program resources that result in funding vehicles to research groups and

contractors that conduct much of the work. The actual work is being performed principally by

university and other non-profit research groups with support as needed by contractor

organizations. EPA assigned Technical Coordinators to the program to work closely with Project 

PIs. The limited number of Supersites locations demanded that a thoughtful and objective 

selection process be established. The initial assumptions underlying selections included the ability 

to capture unique airsheds in populated areas roughly defined through a combination of air 

chemistry, source distribution and geographical/meteorological characteristics. The following
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selection criteria, which again draw on the PM Workshop Report, guided the selection of study

areas. 

< High concentrations of PM in unique and prototypical “airsheds”: known or 

expected “high” concentration areas that will approach or exceed the PM NAAQS and 

affect substantial exposure to populations (serves SIPs and health effects and exposure). 

In the aggregate, these airsheds should reflect locations with varying meteorological, 

source composition and atmospheric properties, to allow for more comprehensive 

stressing of sampling methods, more sound statistical design for exposure/health 

research, and capture areas for varying dominance/mix of sources/atmospheric processes, 

including concentration regimes that approach the standard.

< Existence of ongoing/planned advanced monitoring: availability of existing advanced 

field studies with an established expert monitoring support infrastructure to increase the 

chance of success, and leverage environmental measurement resources (serves 

predominantly SIPs). However, “under-served” locations lacking a historically strong 

support infrastructure would benefit from advanced measurements, and test the ability to 

start up a sophisticated measurement program. When viewed in the aggregate as a group 

of airsheds, a desirable balance of well-served, complemented with historically “underserved” locations provide potential rewards toward expansion of widespread 

measurement capability.

< Ongoing and planned health effects and exposure research studies: Studies that 

benefit from Supersites measurements and foster greater coordination between 

measurements, atmospheric scientists and health and exposure science communities. EPA 

staff recommended that two sites in 1999 located in Atlanta, GA and Fresno/Bakersfield, 

CA be established. Both of these locations are likely to exhibit high PM levels, are 

associated with planned or ongoing major field sampling programs with expert technical 

personnel, and represent diverse airsheds (e.g., east versus west; predominant high sulfate 

versus high nitrate; predominant summer versus winter episodes). Moreover, it was 

imperative that the initial sites offer a high success probability to increase the usefulness 

of data early in the program.

These early needs included testing and intercomparisons of emerging sampling methods to 

expedite application to other areas, data to support EPA’s review of the PM standard and to 

elucidate source-receptor relationships for SIPs. Atlanta and Fresno provided excellent 

opportunities for conducting health effects and exposure research studies in the near and long 

term. Furthermore, both locations served as models for coordinating across university groups, 

industry and State/local agencies.
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7.3 Key Planning Personnel

7.3.1 Program Manager

The Program Manager has the responsibility to make the final decision on the implementation of 

the program. He has the following responsibilities:

< meet with the expert panel or/or CASAC to review the progress of the program; 

< direct OAQPS personnel listed below; 

< review the progress of the program and assure that it is moving forward as recommended 

by the expert panel. 

7.3.2 Program Officer

The Program Officer is the person who performs the following planning activities: 

< identify program schedules;

< writes the level of effort proposals; 

< oversees the implementation of program from a technical perspective.

7.3.3 Quality Assurance Coordinator

The QAC is responsible for the QA planning for the program. He is responsible for: 

< overseeing the overall QA for the program;

< assess any data obtained from sources outside of the EPA that did not use approved 

QAPPs;

7.4 Other Planning Activities 

The following activities will facilitate the success of the program. 

7.4.1 Communication

OAQPS has the overall responsibility for the Supersites program. As such, the agency must 

assure that each agency within the program receives the goods, services and technical knowledge 

to perform their duties. In addition, all parties must be made aware of events and deadlines. Part 

of this is clear communication amongst all agencies. The following methods will be used to 

impart information to ensure proper planning. 
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7.4.2 Tele-communications

Tele-conferencing is an extremely useful tool to impart information and ensure that the planning 

process is moving forward. Drs. Les Hook and Sigurd Christensen lead the tele-conference 

working group for the data processing issues. This working group consists of OAQPS, NARSTO 

and Supersites data base managers. Drs. Hook and Christensen have guided this working group 

by informing the group concerning the development of the NARSTO data archiving process, data 

formatting, and metadata issues. 

In addition, a working group formed in spring of 2000 to bring together the quality system for the 

Supersites program. This QA working group is led by Mr. Dennis Mikel, who is the Supersites 

QAC. The QA workgroup consists of OAQPS and ORIA and Supersites QA managers. 

Dr. Joellen Lewtes, EPA ORD in Seattle, Washington leads the Organic Analysis Workgroup that 

has been overseeing the issues related to Organic Carbon research and analysis.

Dr. Peter McMurray, led the Supersites Size Distribution Committee, which summarized and 

compared the different measurements for particles and aerosols. 

7.4.3 Internet

EPA supports and maintains the AMTIC web site on the Word Wide Web. The address for the 

Supersite Program is http://www.epa.gov/ttn/amtic/ssprojec.html. Guidance, special 

announcements and related documents are posted on this website. These documents can be 

downloaded from the File Transfer Protocol (FTP) areas of the web site. In addition, the EPA 

and all of the agencies involved in this program have electronic mail (email) capabilities, by 

which information can be transmitted and all affected parties can be informed of meetings and 

special events. 
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8.0 Implementation of Work

Each Supersites group will develop a QAPP as described in Section 2.4.2 of this QMP. Since 

each Supersites group has developed their own QAPPs, ultimately each agency is responsible for 

the implementation of their program. This section will outline the individuals in each agency that 

will be required to implement the work. 

8.1 Implementation Roles

8.1.1 Principal Investigator

The PIs are responsible for all work to be performed. This includes: 

< ensuring that work is being performed according the approved QAPP;

< development and implementation of procedures;

< development of special or “critical” techniques that might deviate from the normal good 

laboratory practices; and

< ensuring that quality assured data are transferred to the NARSTO QSSC in a timely 

manner.

8.1.2 Quality Assurance Managers

The QAMs oversee through internal TSAs and review of data, that procedures are being followed 

as specified by the project QAPP and SOPs. In addition, the QA managers must also: 

< identify operations needing SOP’s;

< help prepare the procedures by writing and revising the QAPP;

< review and approve SOP’s before they are implemented;

< provide new tools to the monitoring or laboratory staff that may enhance or increase the 

productivity of the operation; 

< work with the PI in approving changes to procedures; 

< revise the QAPP to remove obsolete techniques and keep up-to-date procedures available 

to field and laboratory staff;

< verify that changes made in the field, through TSAs, are performed as prescribed in the 

QAPP and SOP’s; 

< perform (or through a contractor) TSA and DQA. 
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8.1.3 Individual Investigators

The investigators oversee their particular project or instrument. Any contractors or students 

working with or for them must follow the specified SOPs and QAPPs. In addition, the 

investigators must also: 

< prepare the procedures and SOPs for their instrument;

< review and approve procedures before they are implemented;

< provide training to their students or contractors before the instruments are operated; 

< work with the PI and QA manager in approving changes to procedures; 

< validate collected data and work with Data Manager to process data for site data system 

and archiving; and

< actively engage other researchers in analyzing data. 

8.1.4 Data Manager

The Data Manager works with the project team to facilitate the data management, review, analysis, 

and archiving process. In addition, the Data Managers must also:

< design, develop, and maintain a site data system suitable for site data acquisition, 

validation, and analysis activities;

< assist investigators in collecting data and metadata, quality assuring data, formatting data 

files, and providing data sets to the NARSTO QSSC for archiving; and

< participate in Supersites Data Management Working Group activities.
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9.0 Data Quality Assessments

This section describes the quality-related activities necessary to support the Supersites program for 

acquisition, validation, assessment, and reporting. 

9.1 Program Assessment Techniques

Assessment is an all-inclusive term used to denote any of the following: TSAs, performance 

audits, data quality assessments(DQAs), performance evaluations, Network Reviews and QAPP 

reviews. Definitions for each of these activities can be found in the Glossary. Table 10.1 provides 

information on the assessment type, assessor and frequency.

 Table 9.1 Assessment Schedule

Assessment Type Assessor Frequency

Technical Systems Audits Project Level QA Managers At the beginning of the project

Performance Audits Project Level QA Manager At the beginning of the project/annually

after the first year

Network Review EPA- OAQPS-QA Coordinator At the beginning of the program 

Performance Evaluations EPA -ORIA-NAREL Lab Throughout the life of the program 

QAPP Review and Approval EPA - OAQPS-QA Coordinator Before projects begin

Data Quality Assessment Project Level QA Managers After data collection phase

9.1.1 Technical System Audit

The individual project QA managers for each project or their contractors will perform the TSAs. 

QA mangers must not be involved in the routine data collection or analysis program. The results 

of the audits will be submitted to the QA manager who will review the results and institute 

corrective action if needed. The TSA results will then be incorporated into the QA final report 

(QAFR) that will be submitted to OAQPS. 

9.1.2 Performance Audits

Individual project QA managers for each project or their contractors will perform performance 

audits. The audits should commence at the beginning of the program in order to detect any 

problems with the instruments. Any deviations from the Measurement Quality Objectives (MQOs) 

as stated in the project QAPP will be reported to the project QA manager. Corrective actions will 

be performed as stated in the QAPP. Performance audits for the criteria pollutants are performed 

annually. The results will then be incorporated into the QA final report (QAFR) that will be 

submitted to OAQPS. 
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9.1.3 Network Review

The EPA-EMAD-MQAG office will perform the network assessment in the first year of the Phase 

II project. The EPA QAC will request that all project QA managers or PIs submit electronic 

photographs to the MQAG. These pictures will be compiled to create the Network Plan. Maps 

will be generated through Geographic Information Systems (GIS) programs and will be saved to 

computer hard drives. 

9.1.4 Performance Evaluations

EMAD-MQAG is the lead agency for Performance Evaluations (PEs). The MQAG will be 

working with the Office of Indoor Air (ORIA) National Air and Radiation Environmental 

Laboratory (NAREL). NAREL will submit PEs to a majority of the laboratories during the first 

year of the study. The results from the PEs will then be submitted to MQAG-QAC who will share 

this information with the QA managers of each Supersite. This information will be included in the 

QAFRs.

9.1.5 QAPP Review and Approval

EMAD-MQAG is the agency that will review and approval all QAPP. These will be submitted to 

the MQAG office with enough time for a thorough review prior to project start. Comments will be 

sent back to the submitting project for clarification and re-submission. When MQAG QA 

personnel are satisfied with the QAPP, then final approval will be determined. Data collected prior 

to QAPP approval must be flagged accordingly.

9.1.6 Data Quality Assessment

Each project QA manager is tasked with writing a QAFR for their individual project. The QAFR 

will consist of the results of the performance and technical systems audits. In addition, the QA 

Managers will include their assessment of the data collected as stated in their QAPPs. Precision, 

Bias and accuracy data will be presented as stated in the QAPPs. The equations used in the 

QAPPs will be utilized to access the data sets. This will be submitted within two years after the 

end of the project to EMAD-MQAG. The QAFR will evaluate the data using the MQOs that are 

stated in the QAPP. EMAD-MQAG will create a final program QAFR that will summarize the 

quality of the Supersites experiments. 

9. 2 Reports to Management

As stated in Section 9.1, each of the QA managers is required to submit a QAFR for each project. 

The QAFR will evaluate the data using the MQOs that are stated in the QAPP. EMAD-MQAG 

will create a final program QAFR that will summarize the quality of the Supersites experiments. 
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9.3 Planning, Training and Authority 

The following sections will discuss process of planning, training and the authority of those whom 

will be performing assessments. 

9.3.1 Planning

The QMP is the first step towards having an effective planning process. This QMP will outline 

how assessors for this program will plan, schedule and implement assessments. At the beginning 

of the year, those who have been assigned to perform assessments will set out their tentative 

schedule for assessments. This schedule will first be submitted to the PIs and QA managers, who 

can modify schedule. After management approval, the schedule is submitted (by email) to the 

agencies that will be assessed. Usually, one month before the assessment, the agency to be 

assessed is notified by telephone of the exact dates and times. At this time, the assessment form 

(TSA forms) is submitted to the agency to be assessed (in writing or via email). This allows the 

agency the time to review the forms and gather the information needed to be presented to the 

assessors. This has a two-fold objective: it allows those to be assessed knowledge of what will be 

required and it can minimize the time that assessors are in the field and that managers and 

scientists are away from their other duties. 

9.3.2 Training

Training is essential to assessors in two ways: the assessor needs to understand the process by 

which data are generated, without this knowledge the assessment may be inadequate, and in order 

to communicate clearly with the agency that is being assessed, the assessor must be competent. 

Training fills these needs. A part of training that is not seen or documented is the fact that those 

chosen for assessment should have experience in the field in which they are assessing. Although 

most QA criteria and theory are universal, understanding the process by being experienced in 

working in that field is essential. It is the responsibility of the QA manger of each individual 

Supersites project to provide training for the assessment team. If the project decides to hire a 

contractor to perform assessments, the project PI and QA manager should have the confidence that 

this contractor can fulfil their duties as described in the QAPP and this QMP.

9.3.3 Authority

All personnel that are chosen to conduct assessments to this program have the authority to do so 

through the EPA. OAQPS has the overall responsibility and authority over this program. It 

delegates this authority to perform assessments to all agencies/contractors that perform such duties. 

All personnel in this capacity have the right and responsibility to:
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• identify problems;

• Identify and cite noteworthy practices that may be shared with others to improve the quality of 

their operations;

• propose recommendations for resolving quality problems;

• independently confirm implementation and effectiveness of solutions; 

• report these finding to the Supersites PI or QA manager.

Reports of assessments are discussed in section 9.2. 

9.3.4 Disputes

Occasionally, findings in an assessment report may be disputed by the researcher/investigator 

assessed. Any disputes that are announced should first be handled by the Supersites PI or QA 

manager. If this fails to satisfy the situation, then OAQPS has the final authority to make a 

decision concerning a dispute.
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10.0 Quality Improvement

This section will outline planning and implementation procedures that will be employed for 

improving the quality of the program. OAQPS and the QA managers from each Supersite have the 

responsibility to improve the quality of the program over an unspecified period of time. There can 

be no set dates on when this improvement can or will occur, however, OAQPS and the Supersites 

QA managers will make every effort to improve the system during the life of the Supersites 

program. 

10.1 Quality Improvement Process 

This section will outline the process flow of the quality improvement paradigm. 

10.1.1 Assessment

The assessments that are planned for the Supersites program are detailed in section 9.1 of this 

QMP. Once the assessment agency has completed an assessment, a report will be sent to the QA 

manager of the Supersites, who will review the results. Depending on the assessment report and 

the assessment scheme detailed in the QAPP, action may be deemed necessary and an assessment 

loop will be initiated. 

10.1.2 Assessment Report

The assessment report will state the who, what, where and when of the assessment. The report will 

highlight the findings of the assessment. The QA manager will contact investigator where findings 

may be outside of the MQOs or requirements of the QAPP. 

10.1.3 Response

The investigator has the right to respond in writing, or email. All responses will be reviewed by 

the assessor, QA manager and PI and will respond in kind. If any disputes arise from the 

assessment this will be dealt as detailed in section 9.3.4 of this QMP. In addition, the EPA has 

electronic mail (email) capabilities, by which information can be transmitted and all affected 

parties can be informed of meetings and special events. 

10.1.4 Final Assessment Report

The final assessment report (QAFR) will be sent to OAQPS and the assessed agency. This report 

will highlight the findings of the assessment and recommendations. 
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10.1.5 Review, Compilation and Analysis

Once OAQPS has received the final assessment reports from all of the Supersites, the EMAD 

QAC will compile the information and analyze the data. Any disputes concerning the assessments 

will be finalized at that time. The QAC will check the assessment reports to for outstanding issues 

raised by the reports. If any have not been resolved, then the QAC may recommend flagging of 

the data for a particular parameter. 

10.1.6 OAQPS-QAFR

The QAFR will be the final report. The report will highlight the major findings of the Supersites 

assessment and recommendations will be made in this report. In addition, the results from the 

NAREL PE will also be included into the QAFR.

10.2 Quality Improvement Assurance

The OAQPS-QAFR and the QAFRs from each Supersite will assess the quality of the Supersites 

data set. Once the QAFRs are issued, the report will be sent to NARSTO for archive into the 

Supersites data area. Deficiencies that are not addressed will be noted in the reports. Any 

university, government or public researcher will be advised to read the QAFRs before they use the 

data in any analysis. This assures that the researchers understand the limitations of the data that 

they will use and should act responsibly in presenting their results to the scientific community.
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GLOSSARY OF QUALITY ASSURANCE AND RELATED TERMS

Activity — An all-inclusive term describing a specific set of operations of related tasks to be performed, 

either serially or in parallel (e.g., research and development, field sampling, analytical operations, 

equipment fabrication), that, in total, result in a product or service.

Assessment — The evaluation process used to measure the performance or effectiveness of a system and its 

elements. As used here, assessment is an all-inclusive term used to denote any of the following: audit, 

performance evaluation (PE), management systems review (MSR), peer review, inspection, or surveillance.

Audit (quality) — A systematic and independent examination to determine whether quality activities and 

related results comply with planned arrangements and whether these arrangements are implemented 

effectively and are suitable to achieve objectives. 

Audit of Data Quality (ADQ) — A qualitative and quantitative evaluation of the documentation and 

procedures associated with environmental measurements to verify that the resulting data are of acceptable 

quality.

Certification — The process of testing and evaluation against specifications designed to document, verify, 

and recognize the competence of a person, organization, or other entity to perform a function or service, 

usually for a specified time. 

Collocated samples — Two or more portions collected at the same point in time and space so as to be 

considered identical. These samples are also known as field replicates and should be identified as such.

Computer program — A sequence of instructions suitable for processing by a computer. Processing may 

include the use of an assembler, a compiler, an interpreter, or a translator to prepare the program for 

execution. A computer program may be stored on magnetic media and referred to as “software,” or it may 

be stored permanently on computer chips, referred to as “firmware.” Computer programs covered in a 

QAPP are those used for design analysis, data acquisition, data reduction, data storage (databases), 

operation or control, and database or document control registers when used as the controlled source of 

quality information.

Corrective action — Any measures taken to rectify conditions adverse to quality and, where possible, to 

preclude their recurrence.

Data Quality Assessment (DQA) — The scientific and statistical evaluation of data to determine if data 

obtained from environmental operations are of the right type, quality, and quantity to support their intended 

use. The five steps of the DQA Process include: 1) reviewing the DQOs and sampling design, 2) 

conducting a preliminary data review, 3) selecting the statistical test, 4) verifying the assumptions of the 

statistical test, and 5) drawing conclusions from the data.

Data Quality Objectives (DQOs) — The qualitative and quantitative statements derived from the DQO 

Process that clarify study’s technical and quality objectives, define the appropriate type of data, and specify 

tolerable levels of potential decision errors that will be used as the basis for establishing the quality and 

quantity of data needed to support decisions.

Data reduction — The process of transforming the number of data items by arithmetic or statistical 

calculations, standard curves, and concentration factors, and collating them into a more useful form. Data 

reduction is irreversible and generally results in a reduced data set and an associated loss of detail. 

Design — The specifications, drawings, design criteria, and performance requirements. Also, the result of 

deliberate planning, analysis, mathematical manipulations, and design processes.
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Document — Any written or pictorial information describing, defining, specifying, reporting, or certifying 

activities, requirements, procedures, or results.

Environmental data — Any parameters or pieces of information collected or produced from 

measurements, analyses, or models of environmental processes, conditions, and effects of pollutants on 

human health and the ecology, including results from laboratory analyses or from experimental systems 

representing such processes and conditions.

Financial assistance — The process by which funds are provided by one organization (usually 

governmental) to another organization for the purpose of performing work or furnishing services or items. 

Financial assistance mechanisms include grants, cooperative agreements, and governmental interagency 

agreements.

Finding — An assessment conclusion that identifies a condition having a significant effect on an item or 

activity. An assessment finding may be positive or negative, and is normally accompanied by specific 

examples of the observed condition.

Independent assessment — An assessment performed by a qualified individual, group, or organization that 

is not a part of the organization directly performing and accountable for the work being assessed.

Inspection — The examination or measurement of an item or activity to verify conformance to specific 

requirements.

Management — Those individuals directly responsible and accountable for planning, implementing, and 

assessing work.

Management system— A structured, nontechnical system describing the policies, objectives, principles, 

organizational authority, responsibilities, accountability, and implementation plan of an organization for 

conducting work and producing items and services.

NARSTO Program — NARSTO is a public/private alliance, whose membership spans 

government, the utilities, industry, and academe throughout Mexico, the United States, and 

Canada. The NARSTO mission is to plan, coordinate, and facilitate comprehensive, long-term, 

policy-relevant scientific research and assessment of primary and secondary pollutant species 

emitted, formed, transformed, and transported in the troposphere over the North American 

continent. Member organizations support the mission through participation in workshops and 

meetings, financial support, or contribution of in-kind resources. Atmospheric research and 

assessment initiatives that support the mission may request to become NARSTO Technical 

Programs. Technical Programs agree to follow certain quality assurance and data management 

guidelines and send their data to the NARSTO Permanent Data Archive.

NARSTO QSSC — The NARSTO Quality Systems Science Center (QSSC) at the Oak Ridge 

National Laboratory assists NARSTO projects by consulting, reviewing quality system planning 

documents, and advising about data management issues. The QSSC is responsible for archiving 

data at the NARSTO Permanent Data Archive.

Organization — A company, corporation, firm, enterprise, or institution, or part thereof, whether 

incorporated or not, public or private, that has its own functions and administration.
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Organization structure — The responsibilities, authorities, and relationships, arranged in a pattern, 

through which an organization performs its functions.

Procedure — A specified way to perform an activity.

Process — A set of interrelated resources and activities that transforms inputs into outputs. Examples of 

processes include analysis, design, data collection, operation, fabrication, and calculation.

Project — An organized set of activities within a program.

Quality — The totality of features and characteristics of a product or service that bears on its ability to meet 

the stated or implied needs and expectations of the user.

Quality Assurance (QA) — An integrated system of management activities involving planning, 

implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service is 

of the type and quality needed and expected by the client.

Quality Assurance Project Plan (QAPP) — A formal document describing in comprehensive detail the 

necessary quality assurance (QA), quality control (QC), and other technical activities that must be 

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

The QAPP components are divided into four classes: 1) Project Management, 2) Measurement/Data 

Acquisition, 3) Assessment/Oversight, and 4) Data Validation and Usability. Guidance and requirements 

on preparation of QAPPs can be found in EPA QA/R-5 and QA/G-5.

Quality Control (QC) — The overall system of technical activities that measures the attributes and 

performance of a process, item, or service against defined standards to verify that they meet the stated 

requirements established by the customer; operational techniques and activities that are used to fulfill 

requirements for quality. The system of activities and checks used to ensure that measurement systems are 

maintained within prescribed limits, providing protection against “out of control” conditions and ensuring 

the results are of acceptable quality.

Quality improvement — A management program for improving the quality of operations. Such 

management programs generally entail a formal mechanism for encouraging worker recommendations with 

timely management evaluation and feedback or implementation.

Quality management — That aspect of the overall management system of the organization that determines 

and implements the quality policy. Quality management includes strategic planning, allocation of 

resources, and other systematic activities (e.g., planning, implementation, and assessment) pertaining to the 

quality system.

Quality Management Plan (QMP) — A formal document that describes the quality system in terms of the 

organization’s structure, the functional responsibilities of management and staff, the lines of authority, and 

the required interfaces for those planning, implementing, and assessing all activities conducted.

Quality system — A structured and documented management system describing the policies, objectives, 

principles, organizational authority, responsibilities, accountability, and implementation plan of an 

organization for ensuring quality in its work processes, products (items), and services. The quality system 

provides the framework for planning, implementing, and assessing work performed by the organization and 

for carrying out required quality assurance (QA) and quality control (QC).

Requirement — A formal statement of a need and the expected manner in which it is to be met. 
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Round-robin study — A method validation study involving a predetermined number of laboratories or 

analysts, all analyzing the same sample(s) by the same method. In a round-robin study, all results are 

compared and used to develop summary statistics such as interlaboratory precision and method bias or 

recovery efficiency. 

Self-assessment — The assessments of work conducted by individuals, groups, or organizations directly 

responsible for overseeing and/or performing the work.

Specification — A document stating requirements and referring to or including drawings or other relevant 

documents. Specifications should indicate the means and criteria for determining conformance.

Standard Operating Procedure (SOP) — A written document that details the method for an operation, 

analysis, or action with thoroughly prescribed techniques and steps and that is officially approved as the 

method for performing certain routine or repetitive tasks.

Technical review— A documented critical review of work that has been performed within the state of the 

art. The review is accomplished by one or more qualified reviewers who are independent of those who 

performed the work but are collectively equivalent in technical expertise to those who performed the 

original work. The review is an in-depth analysis and evaluation of documents, activities, material, data, or 

items that require technical verification or validation for applicability, correctness, adequacy, completeness, 

and assurance that established requirements have been satisfied.

Technical Systems Audit (TSA) — A thorough, systematic, on-site qualitative audit of facilities, 

equipment, personnel, training, procedures, record keeping, data validation, data management, and 

reporting aspects of a system.

Vendor — Any individual or organization furnishing items or services or performing work according to a 

procurement document or a financial assistance agreement. An all-inclusive term used in place of any of 

the following: seller, contractor, subcontractor, fabricator, or consultant.

Verification — Confirmation by examination and provision of objective evidence that specified 

requirements have been fulfilled. In design and development, verification concerns the process of 

examining a result of a given activity to determine conformance to the stated requirements for that activity. 
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Contact List

The following list is a compilation of contacts for the Supersites Program

Contact Agency Phone Number Email

Rich Scheffe OAQPS-EMAD-MQAG 919-541-4650 scheffe.rich@epa.gov

Dennis Mikel EPA-NARSTO 919-541-5511 mikel.dennisk@epa.gov

Jeffrey West NOAA (NARSTO) 919-541-4635 west.jeffreyepa.gov

Michael Clark ORIA-NAREL 334-270-7069 clark.michael@epa.gov

Paul Solomon ORD-Las Vegas 702-798-2280 solomon.paul@epa.gov

Marc Pitchford OAQPS-EMAD-Las Vegas 702-798-0432 marcp@dri.edu

Michael Jones OAQPS-EMAD-MQAG 919-541-0528 jones.mike@epa.gov

 Les Hook DOE (NARSTO) 865-241-4846 Hookla@ornl.gov

Sigurd Christensen DOE (NARSTO) 865-574-7394 swc@ornl.gov

John Ondov University of Maryland 301-405-1859 jondov@wam.umd.edu

John Watson Desert Research Institute 775-674-7046 Johw@dri.edu

David Allen University of Texas 512-475-7842 Allen@che.utexas.edu

Constantinos Sioutas University of California 213-740-0603 Sioutas@almaak.usc.edu

Ken Demerjian University of Albany 518-437-8705 Kld@asrc.cestm.albany.edu

Spyros Pandis Carnegie Mellon University 412-268-3531 Spyros@andrew.cmu.edu

Jay Turner Washington University 314-935-5480 Jrturner@seas.wustl.edu
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Appendix A

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Appendix A - Procurement Policy Notice

For Contracting Officer’s Representatives
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Appendix A

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Procurement Policy Notice

For Contracting Officer’s Representatives

1. Background

The Federal Acquisition Regulations, Title 48 of the Code of Federal Regulations, was recently 

amended to address contract quality systems requirements on a government-wide basis. The new 

FAR clause at 52.246-11, Higher-Level Quality Requirement, allows a Federal agency to select a 

voluntary consensus standard as the basis for its quality requirements for contracts and allows 

tailoring of the standard to more effectively address specific needs or purposes. Based on this 

FAR clause, EPA has selected ANSI/ASQC E4, Specifications and Guidelines for Quality 

Systems for Environmental Data Collection and Environmental Technology Programs, as the 

basis for its environmental quality requirements and has tailored this standard to ensure that 

contractors demonstrate conformance to this national standard. 

Due to these changes, 48 CFR 1546, a quality regulation that applies only to EPA, will be 

removed from the Code of Federal Regulations. The tailoring language allowed by 52 CFR 246-

11 and pertinent requirements in 48 CFR 1546 will be included in the EPA Directive 1900, 

Contracts Management Manual. This procurement policy notice is being issued to ensure an 

orderly transition from 48 CFR 1546 to EPA Directive 1900 and contains tailoring language 

allowed by 52 CFR 246-11. It is in effect until the revisions to Directive 1900 are completed.

2. Application

This procurement policy notice applies to all Contracting Officer’s Representatives, that is, all 

Project Officers, Deputy Project Officers, Regional Project Officers, Zone Project Officers, 

Delivery Order Project Officers, Work Assignment Managers, and Task Order Managers. 

This procurement policy notice applies to all solicitations; task orders, work assignments, and 

other statements of work for contracts (including simplified procurement acquisitions) that 

involve environmentally related measurements (i.e., the collection and use of environmental 

data1 and the design, construction, and operation of environmental technologies). Examples of 

environmentally related measurements are contained in Attachment 1. 

 

1

Environmental data are defined as any measurements or information that describe environmental 

processes, location, or conditions; ecological or health effects and consequences; or the performance of 

environmental technology. For EPA, environmental data include information collected directly from measurements, 

produced from models, and compiled from other sources such as data bases or the literature.
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3. General Requirements

Although this procurement policy notice applies solely to contracts, EPA requires that all 

recipients of funds (i.e., contractors, grantees, etc.) for work involving environmentally-related 

measurements comply with the American National Standard ANSI/ASQC E4-1994, 

Specifications and Guidelines for Quality Systems for Environmental Data Collection and 

Environmental Technology Programs. To demonstrate conformance to this standard, EPA 

requires all recipients submit two types of documentation: 

1. Documentation of the organization quality system (usually called a Quality 

Management Plan), and/or

2. Documentation of the application of quality assurance (QA) and quality control 

activities to a project-specific effort (usually called a Quality Assurance Project 

Plan).

Use of existing quality system documentation, such as documentation that a company is ISO 

9000 certified, may be acceptable alternatives. 

For small contracts, these two documents may be combined into a single document that describes 

the organization’s quality system and the application of this system to the work performed under 

the contract. This can only be done with permission of the EPA QA Manager who will identify 

which elements should be addressed in this combined document.

Some contracts may cover activities of a program that are to be conducted at multiple locations 

or over a long period of time; for example, a large monitoring program that uses the same 

methodology at different locations. In this case, a Programmatic Quality Assurance Project Plan 

may be used to describe, in a single document, the general, common activities that are not site- or 

time-specific but are applied throughout the program. Project-specific information is then added 

to the approved Programmatic Quality Assurance Project Plan on a project-specific basis. 

4. Directions for Pre-Award and Post-Award Activities

STEP 1. After consultation with the QA Manager (or the appropriate QA personnel2), 

complete the QA Review Form (as described in Section 2.5 of the Contracts 

Management Manual) and obtain the concurrence signature of the QA Manager. 

 

2Appropriate QA personnel are defined in each EPA organization’s Agency-approved Quality Management 

Plan. For simplicity, the use of the term QA Manager will refer to both the QA Manager and other approved QA 

personnel.
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If QA requirements are not applicable to the procurement (indicated on the QA 

Review Form), the remaining Steps do not apply.

STEP 2. With the assistance of the QA Manager, determine what quality standards apply. 

Generally, ANSI/ASQC E4-1994 applies to the majority of EPA’s work; 

however, standards other than ANSI/ASQC E4-1994 may also apply. 

STEP 3. If ANSI/ASQC E4-1994 applies, identify (with the assistance of the QA 

Manager) whether the contract work will consist of:

A. A single project, 

B. Multiple projects with different activities, or

C. Multiple projects with similar activities.

A If the contract work consists of a single project, you must require one of the 

following:

1.Before Award: A Quality Management Plan

After Award: A Quality Assurance Project Plan for the contract

 (Note: These are the default requirements.)

2. Before Award: QA Manager-specified documentation3

 After Award: A Quality Management Plan and a Quality 

Assurance Project Plan for the contract

3. Before Award: QA Manager-specified documentation3

 After Award: A Joint Quality Management Plan/Quality 

Assurance Project Plan for the contract

4. Before Award: A Joint Quality Management Plan Quality 

Assurance Project Plan for the contract

After Award: None

 

3QA Manager-specified documentation is defined in an EPA organization’s Agency approved Quality 

Management Plan. This documentation must be consistent with Agency requirements defined in EPA Order 5360 

(May 2000).
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B. If the contract work consists of multiple projects with different activities, 

you must require one of the following:

1. Before Award: A Quality Management Plan

 After Award: A Quality Assurance Project Plan for each 

applicable project

(Note: These are the default requirements.)

2. Before Award: QA Manager-specified documentation3

 After Award: A Quality Management Plan and a Quality 

Assurance Project Plan for each applicable project

C. If the contract work consists of multiple projects with similar activities, 

you must require one of the following:

1. Before Award: A Quality Management Plan

 After Award: A Quality Assurance Project Plan for each 

applicable project

(Note: These are the default requirements.)

2. Before Award: A Quality Management Plan

 After Award: A Programmatic Quality Assurance Project Plan for 

the program (contract) and a project-specific 

supplement to the Programmatic Quality Assurance 

Project Plan for each applicable project

3. Before Award: A Quality Management Plan and a Programmatic 

Quality Assurance Project Plan for the program 

(contract)

 After Award: A project-specific supplement to the Programmatic 

Quality Assurance Project Plan for each applicable 

project

For each of the three cases (single project, multiple projects with different 

activities, or multiple projects with similar activities), the default requirements are 

listed as the first option (1). These requirements should be used unless the QA 

Manager concurs otherwise. 

STEP 4. For each type of documentation identified in STEP 4, identify (with the assistance 

of the QA Manager) whether the documentation should be prepared in accordance 
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with the standard EPA requirements [i.e., EPA Requirements for Quality 

Management Plans (QA/R-2) and EPA Requirements for Quality Assurance 

Project Plans (QA/R-5)] or whether other EPA-approved equivalent requirements 

will be used. The standard EPA requirements should be used unless the QA 

Manager concurs otherwise.

STEP 5. If additional standards apply besides ANSI/ASQC E4-1994, identify (with the 

assistance of the QA Manager) what documentation is required to determine 

conformance to these standards. 

STEP 6. Provide the Contracting Officer with a list of documentation required before and 

after award (from cases A, B, and C in STEP 3) and if applicable, a list of any 

equivalent requirements to be used (STEP 4), and the Title, Numbering, Date, and 

any documentation required to demonstrate conformance for any additional 

standards (STEP 5). 

The information that must be submitted to the Contracting Officer is contained in 

Attachment 2. It is recommended that you complete this form and provide it to 

the Contracting Officer with the QA Review Form (STEP 1).

STEP 7. After award of the contract, if the work consists of multiple projects (cases B and 

C in STEP 3), complete a QA Review Form and Section 3 of Attachment 2 for 

each statement of work (e.g., work assignment, delivery order, task order). 

Include in each applicable statement of work the requirement to submit the quality 

documentation needed after contract award. For example, if a project-specific 

supplement to the Programmatic Quality Assurance Project Plan is required for 

the project described in the statement of work, you must incorporate the 

requirement to develop this document into the statement of work.
Project: Speciation QMP

Appendix A

Revision No:1.0

Date: 9/13/01

5.0 Example of Activities involving Environmentally-Related Measurements

The following are some examples that involve environmentally-related measurements:

C Activities that collect data to establish/determine the states/conditions of 

environmental or ecological systems and the health of human populations; 

C Activities that collect data to establish the ambient conditions in air, water, sediments, 

and soil in terms of physical, chemical, radiological, or biological characteristics;

C Activities that collect data to establish/categorize radioactive, hazardous, toxic, and 

mixed wastes in the environment and to establish their relationships with and/or 

impact on human health and ecological systems;

C Activities that monitor and quantify the waste and effluent discharges to the 

environment from processes and operations (e.g., energy generation, metallurgical 

processes, chemicals production), during either normal or upset conditions (i.e., 

operating conditions that cause pollutant or contaminant discharges); 

C Activities that use environmental data to develop environmental technology for 

pollution prevention, pollution control, waste treatment, storage, and disposal, and 

waste remediation;

C Activities that use environmental data in mapping environmental process and 

conditions, and/or human health risk data, etc. (e.g., geological information system);

C Activities that generate data from the evaluation of environmental technology used 

for pollution prevention; pollution control; waste treatment, storage, and disposal; and 

waste remediation;

C Activities that generate/collect data to support enforcement and/or compliance 

monitoring efforts;

C Activities that collect/generate data for the evaluation and/or demonstration of 

environmental technology (e.g., treatability and pilot studies); 

C Activities that investigate and collect data to determine chemical, biological, physical, 

or radioactive constituents in environmental and ecological systems, and their 
Project: Speciation QMP

Appendix A

Revision No:1.0

Date: 9/13/01

behavior and associated interfaces in those systems, including exposure assessment, 

transport, and fate; 

C Activities that collect and/or generate data from the development and evaluation of 

methods for use in the collection, analysis, and use of environmental data;

C Activities that involve the development, evaluation, and use of computers or 

mathematical models (and their input data) to characterize environmental processes or 

conditions;

. C Activities that use secondary data (i.e., environmental data that were collected for 

other purposes or obtained from other sources, including literature, industry surveys, 

compilations from computerized data bases and information systems) for the 

development and/or evaluation of computerized or mathematical models of 

environmental processes and conditions, and collect/generate data from the process; 

and 

C Activities that collect and/or use environmental data for monitoring/addressing 

concerns over the occupational health and safety of personnel in EPA facilities (e.g., 

indoor air quality measurements) and in the field (e.g., chemical dosimetry, radiation 

dosimetry).
Project: Speciation QMP

Appendix A

Revision No:1.0

Date:08/08/01 

6.0 Contracts Clause and Tailoring Language Form

Use this form to provide direction to the Contracting Officer on the quality assurance 

activities that are required in your solicitation and contract.

1. List any additional quality standards besides Specifications and Guidelines for 

Quality Systems for Environmental Data Collection and Environmental 

Technology Programs (ANSI/ASQC E-4)

Title: _________________________

Numbering: _________________________

Date: _________________________

Documentation required to determine conformance: 

__________________________

________________________________________________________

2. a. Check all required documentation required before award of contract: 

Documentation Specifications

9 Quality Management Plan EPA Requirements for Quality Management 

Plans (QA/R-2) [dated ______]4

9 Joint Quality Management 

Plan/Quality Assurance 

Project Plan

EPA Requirements for Quality Management 

Plans (QA/R-2) [dated ______] and EPA 

Requirements for Quality Assurance Project 

Plans (QA/R-5) [dated ____]

9 Programmatic Quality 

Assurance Project Plan

EPA Requirements for Quality Management 

Plans (QA/R-2) [dated ____] and EPA 

Requirements for Quality Assurance Project 

Plans (QA/R-5) [dated ____]

9 Other Equivalent: 

 

[Insert specification]

 

b. If the standard specifications do not apply, identify equivalent 

specifications: 

3. a. Select all documentation required after award of contract either at time of 

award or upon issuance of a statement of work:

 

4Note: we will fill in this date once the Federal Register Notice is published.
Project: Speciation QMP

Appendix A

Revision No:1.0

Date:08/08/01 

Documentation Specifications Due After

9 Quality Management Plan EPA Requirements for Quality 

Management Plans (QA/R-2) 

[dated ]

Award of 

contract

9 Joint Quality Management 

Plan/Quality Assurance 

Project Plan

EPA Requirements for Quality 

Management Plans (QA/R-2) 

[dated ] and EPA 

Requirements for Quality 

Assurance Project Plans (QA/R-5)

[dated ____]

Award of 

contract

9 Contract Quality 

Assurance Project Plan

EPA Requirements for Quality 

Assurance Project Plans (QA/R-5) 

[dated ]

Award of 

contract

9 Programmatic Quality 

Assurance Project Plan

EPA Requirements for Quality 

Management Plans (QA/R-2)

[dated ] and EPA 

Requirements for Quality 

Assurance Project Plans (QA/R-5) 

[dated ]

Award of 

contract

9 Quality Assurance Project 

Plan for each applicable 

project

EPA Requirements for Quality 

Assurance Project Plans (QA/R-5) 

[dated ]

Issuance of 

statement of 

work

9 Project-specific 

supplement to 

Programmatic Quality 

Assurance Project Plan

EPA Requirements for Quality 

Assurance Project Plans (QA/R-5) 

[dated ]

Issuance of 

statement of 

work

9 Other Equivalent:

 

[Insert specification]

 

[Select one] 

9 award of 

 contract 

9 issuance of 

 statement of

 work
Project: Speciation QMP

Appendix A

Revision No:1.0

Date:08/08/01 

b. If the standard specifications do not apply, identify equivalent 

specifications. 

. 
TECHNICAL REPORT DATA

(Please read Instructions on reverse before completing)

1. REPORT NO.

 EPA-454/R01-011

2. 3. RECIPIENT'S ACCESSION NO.

5. REPORT DATE

 09/01

4. TITLE AND SUBTITLE

Quality Management Plan for the PM Supersites Program

 

6. PERFORMING ORGANIZATION CODE

7. AUTHOR(S)

 Dennis Mikel, Michael Papp, Les Hook, Sigurd Christensen

 

8. PERFORMING ORGANIZATION REPORT 

NO.

9. PERFORMING ORGANIZATION NAME AND ADDRESS 10. PROGRAM ELEMENT NO.

 U.S. Environmental Protection Agency

 Office of Air Quality Planning and Standards

 Research Triangle Park, NC 27711

11. CONTRACT/GRANT NO.

 

12. SPONSORING AGENCY NAME AND ADDRESS 13. TYPE OF REPORT AND PERIOD COVERED

 Director

 Office of Air Quality Planning and Standards

 Office of Air and Radiation

 U.S. Environmental Protection Agency

 Research Triangle Park, NC 27711

14. SPONSORING AGENCY CODE

EPA/200/04

15. SUPPLEMENTARY NOTES

16. ABSTRACT

The Quality Management Plan outlines the management structure for the Particle Matter Supersites Program. 

The guidance document gives details on how the Supersites Program will be implemented. The Supersites 

program is a multi-year research program that draws upon EPA OAQPS and Office of Indoor Air and 

university research groups throughout the country. This Plan outlines each agency’s responsibilities and 

authority. 

. KEY WORDS AND DOCUMENT ANALYSIS

a. DESCRIPTORS b. IDENTIFIERS/OPEN ENDED TERMS c. COSATI 

Field/Group

Air Quality Monitoring

Quality Assurance 

Air Pollution Control

19. SECURITY CLASS (Report)

 Unclassified

21. NO. OF 

PAGES

18. DISTRIBUTION STATEMENT

 Release Unlimited

20. SECURITY CLASS (Page)

 Unclassified

22. PRICE