16 

## CHAPTER 2 QUALITY MANAGEMENT SYSTEM

2.1 PRINCIPAL COMPONENTS OF TH E QUALTY MANAGEMENT SYSTEM

The Quality Management System consists of staff, defined functions, tools, and quality assurance (QA) procedures. These components ar e used to ensure that environmental data generated by ADEQ, or its contra ctors/consultants, are of appropr iate quality for their intended purpose. The ADEQ QA/QC Unit has determined th at the following twelve essential elements comprise an effective QA System:



##  Stating of ADEQ QA Goals and Policy (identified in ADEQ’s QMP );



##  Adhering to applicable ADEQ QA requi rements and criteria (EPA Orders, regulations, and guidelines);



##  Defining ADEQ’s QA organi zational structure;



##  Describing ADEQ Programs and activitie s covered by the QA requirements;



##  Outlining the roles and responsibilitie s of those involved with ADEQ QA functions;



##  Utilizing QA tools and procedures;



##  Identifying resource allocations;



##  Establishing a communications pr ocess (internal and external);



##  Affording QA training opportunities;



##  Dictating documentation and record keeping requirements;



##  Implementing review and evaluation procedures to ensure continuous improvement;



##  Defining key QA terminology.

2.2 PRINCIPAL TOOLS OF THE QUALITY MANAGEMENT SYSTEM

ADEQ uses a graded approach to the Quality Management Plan, as does EPA. The graded approach recognizes that differe nt projects, depending on size or complexity, may require a greater or lesser degree of formal planning. Th e successful implementation of ADEQ’s Quality Management Program requires a consistent and graded approach for QA practices commensurate with the intended uses of the data. ADEQ’s QMP requires that a variety of tools and procedures be utilized for planning, implementing, and eval uating the Quality Manage ment System. ADEQ Managers and staff members will be informed of the availability and use of these tools through ADEQ sponsored training.

The QA/QC Unit presently functions with the guidance and support of a Steering Committee, made up of designated QA/QC representatives from each of the three Program Divisions and one17 QA/QC Unit Supervisor, who serves as the co mmittee chair. The QA/QC Unit Supervisor

resides in the Administra tive Services Division, speci fically the Business and General/Laboratory Services sect ion. This section performs no environmental data collection activities and thereby preserves autonomy and independence. The QA/QC Unit, in conjunction with the Steering Committee, is responsible fo r establishing, implementing, and evaluating the details of the QMP.

The QA planning and implementation tools include a Quality Management Plan ( QMP ), establishment of Data Quality Objectives ( DQOs ), Quality Assurance Program Plans ( QAPrP s), Quality Assurance Project Plans ( QAPjPs ), Standard Operating Procedures ( SOPs ,) and Sampling and Analysis Plans (SAP s) or Field Sampling Plans (FSPs ). ADEQ’s Program staff, or their contractors, create these plans with t echnical assistance, as necessary, from ADEQ’s QA/QC Unit.

The QA evaluation and assessment tools comp rising ADEQ’s Quality Management System include Management System Reviews (MSRs), Technical System Audits ( TSAs ), Performance Evaluation (PE) Studies, and Data Quality Assessments (DQAs). These are either arranged for, or performed by, ADEQ’s QA/QC Unit.

All environmental data collecti on activities conducted by, or on behalf of, EPA Region IX must be addressed in a Quality Assurance Project Pl an (QAPjP). These details are discussed in

Section 2.2.4.

These elements explicitly require clear Data Quality Objectives (DQOs) for each planned data collection activity, and also require that data assessments be conduc ted to evaluate the validity of the results. Every field investigation should be constructed in accordance with an approved ADEQ QAPjP, or other planning document, suitable for the task. The planning document shall ensure that DQOs will be met. Arizona Statutes require that the ADHS Office of Laboratory Licensure be responsible for licensing all labs generating data for regulatory use by ADEQ

described in detail in section 4.2.2.

2.2.1 Quality Management Plan (QMP)

ADEQ’s QMP describes the policies, procedures, and systems governing Agency data collection

activities. It serves as the umbrella documen t for all QA/QC operations. Future revisions and updates to this QMP will be prep ared at least annually, and at any other time that significant changes occur within ADEQ’s operational structur e. The QA/QC Unit will lead this process to gain concurrence from all ADEQ Leadersh ip as well as the Region IX EPA QA/QC representatives. Revisions and/ or updates will be completed and prepared for submission to EPA in as expeditious a manner as possible under th e particular circumstances for each revision.

2.2.2 Quality Assurance Program Plans (QAPrP)

A Quality Assurance Program Plan is a planning document instituted at the level between the QMP and a QAPjP. This document is used to descri be details that are specific to a Program, or Division, when the QMP is too general to encomp ass the unique circumstances for all Programs.18 It is appropriate to reference Program specific regulations and guidance documents in a Program Plan that are utilized for defining data quality objectives such as Soil Remediation Levels (SRLs) and Water Quality Standards (WQSs). A QAPrP can encompass a entire Di vision or it can be specific for individual sections or Programs. The appropriate level of planning will be determined within the Divisions. For some Progra ms a QAPrP may be suffici ent to be utilized in lieu of a QAPjP. The Programs will provide a copy of their QAPrPs to the QA/QC Unit for approval, general oversight, and management of the Agency wide Quality System. QAPrPs may

also need to be sent to Re gion IX QA office for approval.

2.2.3 Data Quality Objectives (DQO)

ADEQ is committed to sound science during the ge neration of environmental data that are technically appropriate for thei r intended use. Environmental data collected should be of adequate quality and quantity to support intended regulatory d ecisions, and when necessary be legally defensible. Data Quality Objectives (DQO) are used in the planning phase of all Agency data collection activities in the capacity that defined objectives shall be identified before sampling goes forward. The Guidance for the Data Quality Objectives Process, EPA QA/G-4 is used, as appropriate, for the development of DQOs by the Agency. In many situations, regulatory criteria and action limits are the basis for environmental decisions. In these situations, the appropriate planning document should stat e (i.e. QAPrP, QAPjP, FSP, or SAP) that regulatory limits are the driving force for Data Quality Objectives, and that the formal EPA DQO process is not extensively utilized. Alt hough DQOs are a required element of any Quality Assurance Project Plan (QAPjP), these data objectives can be identified with regulatory limits and/or action limits that are already in existen ce, and do not necessarily need to be derived. ADEQ Programs should discuss within their QAPrP circumstances and situations for projects when the DQO process will be utilized.

Each Program within ADEQ is responsible for establishing DQOs fo r projects where ADEQ takes the lead role in gathering environmental data or for those proj ects where ADEQ provides oversight. ADEQ’s QA/QC Unit will provide techni cal assistance, if needed, to determine the appropriateness of the DQO process gi ven the intended use of the data.

The development of data quality objectives ( DQOs) is outlined in QA/R-5. For many projects, DQOs may be a simple statement of why data are being collected and what data outputs will be considered significant. For other projects, the co mplete statistical hypothesis testing approach as described in Agency Guidance QA/G-4, Guidance for the Data Quality Objectives Process may be appropriate.

Data Quality Objectives are intended to accomplish the following



##  Clarify the project objectives;



##  Define the most appropriate types of data to collect;



##  Determine the most appropriate conditions under which to collect the data;



##  Specify the level of uncertainty that is acceptable as the basis for establishing the19 quantity and quality of data needed.

2.2.4 Quality Assurance Project Plans (QAPjP)

All QAPjP’s should be develope d as specified in EPA QA/R-5 , EPA Requirements for Quality Assurance Project Plans for Environmental Data Operations . ADEQ requires that all twentyfour elements be addressed before ADEQ’ s QA/QC Unit may submit a QAPjP to EPA on ADEQ’s behalf. These elements consist of the following:

Group A 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 A8 Special Training Requirements/Certification

A9 Documentation and Records

Group B Measurement/Data Acquisition B1 Sampling Process Design B2 Sampling Methods Requirements B3 Sample Handling and Custody Requirements B4 Analytical Methods Requirements B5 Quality Control Requirements B6 Instrument/Equipment Testing, Inspection, and Maintenance Requirements B7 Instrument Calibration and Frequency B8 Inspection/Acceptance Requireme nts for Supplies and Consumables B9 Data Acquisition Requirements B10 Data Management

Group C Assessment/Oversight C1 Assessments and Response Actions C2 Reports to Management

Group D Data Validation and Usability D1 Data Review, Validation and Verification Requirements D2 Validation and Verification Requirements D3 Reconciliation with User Requirements

The QAPjP dictates the policies and proce dures, project organizat ion and objectives, QA requirements, and QC activities designed to achieve the desired type and quality of environmental data necessary to support project objectives. In ADEQ a QAPjP is utilized for collection and analyses of data to su pport long term and large scale projects.20 For those activities funded by EPA, there are ad ditional influences from the federal level on QAPjP preparation. ADEQ Program Plans identi fy projects requiring QAP jPs and the detail required within that planning document. Some Programs utilize abbreviated QAPjPs in the form of “fill in the blank” documents, although these s hortened documents still need to be completed prior to sampling activities. Ot her Programs within ADEQ, such as Tank Programs, rely heavily on Guidance Documents for the planning proces s and do not require formal QAPjPs as such. Short-term projects and one-time events (e .g., emergency response) do not require QAPjPs as long as the sampling protocols and objectives are addressed in th e Program QAPrP. Whether or not a project is funded by EPA, planning documents suitable for the task are required. These planning documents, in the form of a QAPjP or an alternative document, are an expected part of the Quality System. The detail within the doc uments, and the circumstances under which each form is appropriate, will be described in the Program specific documents. A QAPjP, or the equivalent planning document, must be approve d by appropriate delegated autonomous Division personnel or by the QA/QC Unit. Additionally, a ll contractors for ADEQ must meet the quality assurance and Program requireme nts established by ADEQ QMP.

2.2.5 Quality Assurance (QA) Status Reports

QA Status Reports are a tool used for doc umentation and communica tion of QA activities. Although all Programs do not make use of QA St atus Reports, some of the Programs may require these reports, and when utilized they w ill be described in the appropriate QAPrP. Each plan for environmental data collection should incl ude a section discussing the frequency, content, and format of the required QA status report(s). These factors will be determined by the relevant ADEQ Program Project/Case Manager. Status re ports will be placed in the project file by ADEQ’s Project/Case Manager and will be used to he lp track project progress. Each status report should address, at a minimum, the following elements:



##  Status of the project;



##  Changes that occurred in project acti vities (sampling, QC control measures, analytical methods);



##  Results of performance and system audits as they apply;



##  Any corrective actions taken;



##  Any project organizational changes;



##  Results of the assessment of data quality indicators; precision, accuracy, completeness, comparability, representativeness, and sensitivity.

For some Programs, rules or policies supersede these status reports. The policies or rules establish requirements similar to status repor ts, and can function as an alternative. The alternative should be referenced in the plan, and may if necessary, discuss elements in addition to

those listed above.

2.2.6 Standard Operating Procedures (SOP)21 The use of standard operating procedures (SOPs) in ADEQ serves as one mechanism to ensure comparability across Programs and individual envi ronmental data collection projects. SOPs must be incorporated, either in full or by reference, in the QAPjPs or QAPrPs.

ADEQ uses a variety of SOPs, some are EPA developed documents such as Laboratory Documentation Requirements for Data Evaluation R9QA/004.2 August, 2001 , and others have been developed by ADEQ. SOPs developed by ADEQ are peer reviewe d. ADEQ’s QA/QC Unit is available for assistance in both SOP developm ent and review. ADEQ has a number of general SOPs that are maintained within the QA/QC Unit. These SOPs are available for reference and can be incorporated into QAPjPs or QAPrPs. SOPs can also be modified to develop specific SOPs for a variety of Programs. SOPs for th e water sample collection from Public Water Systems are maintained on ADEQ’s website. Some other examples of ADEQ’s general SOPs

are:



##  Collection of Composite Soil Samples for Compliance Purpose;



##  Groundwater Monitoring Well Sampling;



##  Water Sampling from Groundwater Treatment Systems;



##  Soil Vapor Sampling Guidance;



##  Soil Vapor Sampling for Remediation Systems.

2.2.7 Technical Systems Audit ( TSA )

All ADEQ Programs that employ environmental samp le collection and analyses are subject to a TSA. TSAs are a principal tool of ADEQ’s qua lity system and are defined more thoroughly in

Section 9.2.2.

2.2.8 Management System Reviews (MSR)

Management System Reviews (MSRs) will be performed periodically within ADEQ for all Programs. Further details on MSRs are provided in Section 9.2.1.

2.2.9 Corrective Actions

In the normal case, deficiencies are identified, and corrective actions are initi ated, as a result of a review or audit. However, there are cases wh en deficiencies are iden tified during normal work routines, outside a review or audit. In thes e cases a corrective action memo is generated to document and communicate the deficiency. The me mo, at a minimum, explains the problem and documents procedural changes and actions that wi ll correct the problem and minimize the chance for repeat problems and deficiencies. In some situations, no corrective action is required; however, it is necessary to document the occurrence. For these situations, the corrective actions

can be referred to as non-conformances.

2.3 OPTIONAL PRACTICES FOR THE CONTROL OF DATA COLLECTION

2.3.1 Field Audits22 These are "real-time" observation, review, and critical appraisal of field sampling activities.

Field audits consist of an on- site visit to the sampling lo cation; observation of sampling practices; review of project records and sampling SOPs; and, documentation of findings. The primary intention of such audits is to ascertain whether the QAPjP specified practices are being

followed.

When sampling is being performed by ADEQ personne l, or ADEQ contractors, the lead auditor must be an ADEQ employee. In these circum stances, audits may be requested through the ADEQ QA/QC Unit, and are performed by non-proj ect personnel to avoid the appearance of

bias.

All field auditing activities will result in the production of a written report. Usually, the draft findings report should be prepared by the Lead Auditor within 30 days of the observation phase of the audit, although it may need to be prepared more quickly in some cases. Whether internal or external, the Auditor should send the report to the ADEQ Project/Case Manager for review. For external audits, the ADEQ Project /Case Manager will pass the audit report onto the auditee for comments. Final repor ts generated by the Audit Team are to be completed within a reasonable and appropriate time. Copies of the Fi nal Report will be stored in the Project file and with the auditor. Additional copies will be distributed as appropriate.

2.3.2 Laboratory Audits

These are audits of laboratory operations. Such audits may be "real-time" (i.e., performed while project samples are under analysis ) or performed after analysis is completed. Laboratory audits

will consist of an on-site visit to the laborat ory, observation of analytical practices when possible, review of project records and labor atory SOPs, and documentation of findings. A laboratory audit is conducted to determine and document whether laboratory practices and analytical procedures used are consistent with QAPjP requirements and laboratory tasking

instructions.

When analyses are being performed by ADEQ cont ractors, the lead auditor must be an ADEQ employee. In these circumstances, audits may be requested through the ADEQ QA/QC Unit, and are performed by non-project personne l to avoid the appearance of bias. All laboratory auditing activities will result in th e production of a written repor t. A draft of this report is due within 7 calendar days of the completion of the observ ation phase of the audit, or a mutually agreed upon alternative. The draf t will be sent for comments to the ADEQ Project/Case Manager responsible for the activity observed prior to completion of the report. Written comments must be supplied by the ADE Q Project/Case Manager to the ADEQ QA/QC Unit within 7 calendar days of th e receipt of the draft, or a mu tually agreed upon alternative. Final reports generated by the ADEQ QA/QC Unit are to be completed within 30 calendar days of receipt of comments by the ADEQ Project/C ase Manager, or a mutually agreed upon alternative. Copies of the Fina l Report will be stored in the Project’s file a nd also with the ADEQ QA/QC Unit. Additional copies wi ll be distributed as appropriate.23 

## CHAPTER 3 PERSONNEL QUALIFICATIONS AND

TRAINING

3.1 POLICY FOR QUALITY ASSURANC E (QA) RELATED TRAINING

The purpose of this Chapter is to explain the pr ocesses used by ADEQ to ensure that staff and managers working in environmental Programs are trained and qualified to perform their required QA responsibilities. This includes Project/Cas e Managers, field personn el, ADEQ QA/QC staff, data processors, and the individual s who supervise these personnel.

3.1.1 Responsibilities

ADEQ’s Program Unit Managers are responsible fo r ensuring that each staff member involved with collecting or analyzing environmental data has the necessary technical, quality assurance, and project management training re quired for his or her assigned tasks and functions. Section Managers are also responsible for ensuring that technical staff maintains the necessary level of proficiency to effectively m eet ADEQ’s QA/QC responsibilitie s. ADEQ’s QA/QC Unit will serve as the Agency resource for arranging for, and assisting in, defini ng QA/QC training needs on a regular basis to update Program staff with developing QA/QC issues.

Maintaining staff proficiency in critical tec hnical disciplines (e.g., environmental engineers, geologists, hydrologists, hydrogeologists, chemists, and micr obiologists) is assumed to be

determined within the hiring process.

3.1.2 Identification of Training Needs

Core training will be coordinated through the QA /QC Unit in conjunction with various Division supervisory personnel. Intermediate and adva nced skill training will be arranged when the appropriate Agency staff identify the need. The QA/QA unit, in conjunction with Program management, will identify continuing professi onal training requirements and address those requirements utilizing external re sources for the latest technologi cal advances and evolution in industry standards.

3.1.3 Implementation of Training Requirements

ADEQ staff are encouraged by supervisors to draw upon their educational background, experience, technical training, and on-the-job training to enhance th eir understanding and performance of QA-related procedures.

ADEQ’s QA/QC Unit is developing a training progr am that will offer, or arrange for through a third-party vendor, the following courses on a sche dule and frequency suited to meet the needs of ADEQ’s staff with QA responsibilities:

 An Orientation to Quality Assurance Management

 Establishing Data Quality Objectives24  Preparing Quality Assurance Project Plans

 How to Perform a Preliminary Data Review

The goal is to offer no less than three of the f our courses during the year. The classes will be open to anyone responsible for QA functions. ADEQ’s QA/QC Unit will also schedule impromptu QA training designed to address specific QA needs of Program staff.

It is a goal that ADEQ Program staff responsib le for QA functions (as identified by Program management) should complete the above courses w ithin two years from their employment date. In addition, they will be encourag ed to attend meetings and seminars , and to take formal training, in accordance with ADEQ’s training policy, to en hance their understanding of Program specific QA requirements within the Programs they work.

3.1.4 Documentation of Training

ADEQ’s QA Unit will maintain a record of all QA training taken by staff and managers responsible for environmental data generation. ADEQ’s Leadership Team will provide resources for QA training for ADEQ Program staff. This training will be provided, through internal training and/or external sources, to staff at all levels to ensure that QA requirements and responsibilities are understood and implemented at al l stages of projects. Some of the training required to support ADEQ’s Quality Management System will come from EPA.25 

## CHAPTER 4 PROCUREMENT OF ITEMS AND SERVICES

ADEQ procures items such as sampling equipment, instrumentation, field equipment, laboratory services, and consulting servic es. All items and services relating to environmental data collection and generatio n are obtained through the procurem ent process. The ADEQ public procurement process is guided by the Arizona Pr ocurement Code (Arizona Revised Statutes 41- 2501 et seq., and administrative rules and regul ations A.A.C. R2-7-101 et seq.). This procurement code has modeled itself on the Model Procurement Code as provided by the American Bar Association. The procurement pro cess is also governed by State statutes and rules, and depending on the circumstances of the pr ocurement, may involve the approval of other agencies within the State. Whenever appropr iate, requirements for equipment and services specific to individual Programs shou ld be detailed in QAPrPs or QAPjPs. Procurement activities may range from general and scientific supplies to highly sophisticated scie ntific instrumentation and services which directly affect the quality of environmental measurements.

4.1 ITEMS

Within ADEQ, identified equipment needs are submitted to management who prioritize, rank, and approve items for proposed procurement. This process allows ADEQ to identify particular equipment needs, relative to other needs, in orde r to facilitate quality in measurement processes. Specific monitoring, sampling, and analytical eq uipment are procured only after quality requirements have been discu ssed among procurement officials, Program personnel, and when appropriate, ADEQ’s QA/QC Unit. The Contracts and Procurement Section requires that items meet the approved specifications. The criteria for selection of the specific items are outlined prior to approval of the equipment.

4.1.1 EQUIPMENT MAINTENANCE

ADEQ field personnel are responsible for main tenance of their own field equipment and instrumentation. ADEQ has either service contract s or in-house capabiliti es for the repair and maintenance of field equipment and instrumentat ion. Schedules for preventive and/or corrective

maintenance are determined and carried out thro ugh service contracts or in-house capabilities.

4.2 SERVICES

Project managers work with the ADEQ Contracts and Procurement Section to incorporate quality control within the specific scope of work for each task assignment. Quality assurance for service

contracts is based on contractor performance measures which in clude, but are not limited to, the ability of the contractor to adhere to the cont ract terms and conditions, and the ability of the contractor to complete the work in accord ance with the ADEQ approved QAPjP, SAP, and/or other work plan. Services (laboratory, consul ting, drilling, etc.) that are procured through ADEQ's procurement process are contracted in accordance with the standard terms and

conditions of the Uniform Commerc ial Code as adopted by the Stat e of Arizona. The standard terms and conditions, at a mini mum, include the following:

 Contract interpretation;26  Contract administra tion and operation;

 Costs and payments;

 Contract changes;

 Risk and liability;

 Warranties;

 State contractual remedies;

 Contract termination.

The Project/Case Manager from the applicab le ADEQ Program can utilize the ADEQ QA/QC Unit in finding services appropriate for his or her needs. Prior to procurement of services, it is important that the data quality objectives and measurement quality objectives of the specific project, as they relate to analytical requirements, can be achieved by the laboratory. The laboratory needs to submit a current Quality Assurance Manual (or similar documentation) for

review before the contract is awarded

.

4.2.1 CONTRACTS WITH EXTERNAL PARTIES

ADEQ conducts and oversees assessment (site characterization), reme diation, and removal

activities at solid and hazardous wa ste sites in Arizona. For some of these activities, ADEQ may contract directly for environmentally re lated measurements or data generation.

ADEQ’s General Laboratory Services Contract goes out to bid every 3-5 year s. This contract is for General Laboratory Services for a variety of analyses and methodologies and can be awarded

to one or more laboratories. This process is a collaboration of ADEQ’s Procurement Section, the QA/QC Unit, and/or QA/QC Steerin g Committee. All Divisions can utilize this contract for analyses within their Divisions.

The Monitoring Assistance Program (MAP) is a Program mandated by Ariz ona Revised Statutes 49-360, for which ADEQ contracts with vendors to ta ke samples and perform necessary analyses for approximately 900 small drinking water systems within the State of Arizona. This contract goes out to bid through the Drinking Water Sec tion and is awarded on an annual basis.

For services procured outside of the general laboratory services contract, and the MAP contract, the Programs are responsible for ensuring that the contractors meet the quality assurance requirements as outlined in the Program specific QAPrP. It is necessary, at a minimum, to obtain a Quality Assurance Manual from any contracting laboratory prior to commencement of

work. Other areas where contra ctors and subcontractors are util ized include: ambient surface water analyses for chemical and microbiol ogical indices, air quality analyses, etc.

For contractors performing sampling, the contract ors must develop their own QAPrP or QAPjP.

In some instances where contractors are handlin g extensive sampling and data management at multiple levels, it may even be appropriate for the contracting organization to have an overall Quality Management System documented in a QMP.27 4.2.2 Laboratory Licensure Requirements

In addition to the requirements of the Arizona Procurement Code (A.R.S. 41-2501 et. seq.) and

the Arizona Administrative Code (A.A.C. R2-7-101 et. seq.), Ariz ona Revised Statutes require

that the ADHS Office of Laborator y Licensure license environmental laboratories engaged in compliance testing.

Compliance testing has been defined by Arizona State Law pursuant to A.R.S. 36-495(1) as any:

“Laboratory analysis of any matter, pollutant, contaminant, hazardous substance or other substance subject to regulation pursuant to: (a) Title 49 or rules adopted or enforced by the department of environmental quality for the purpose of determining compliance with title 49. (b) Federal environmental statutes or regulations administered or enforced by the United States environmental protection agency relating to the safe drinking water act (42 United States Code sections 300f through 300j), the clean air act (42 United States Code sections 7401 through 7642), the clean water act (33 United States Code sections 1251 through 1376), the resource conservation and recovery act (42 United States Code sections 6921 through 6939B), the comprehensive environmental response, compensation, and liability act (42 United States Code sections 9601 through 9657) and the toxic substance control act (42 United States Code sections 2601 through 2654) as they relate only to the regulation of polychlorinated biphenyls and asbestos.”

Samples analyzed for regulatory or enforcem ent decisions by non-ADHS licensed laboratories are considered unacceptable for compliance purpose s, as statutorily mandated, and should be rejected unless no other options are available. As testing requiremen ts evolve with the

introduction of new contaminants of concer n, there may be unique cases when an ADHS certified laboratory is not available for the me thods required or capable of achieving the required

limits. For instances when a method is not ce rtified by ADHS, or no ADHS laboratories are available, an exception can be made. All other re sources should be exhausted before this option

is utilized. These instances should be comm unicated to the QA/QC Unit to track overall regulatory issues and develop solu tions in coordination with ADHS.

Upon application for an environm ental laboratory licen se ADHS shall issue the license if, after investigation, ADHS determines that the applica tion conforms with the standards established by

ADHS.28 The ADHS Director shall prescribe rules prov iding for minimum standards of proficiency, methodology, quality assurance, operation, and sa fety for environmental laboratories and may prescribe standards for personnel education, training, and experience to meet Federal environmental statutes or regula tion. The ADHS Director may also allow reciprocity with other states, and prescribe the manner and form in whic h compliance testing results are reported. The rules shall be developed in cooperation with the Director of the Department of Environmental Quality and shall be consistent with Title 49 (Section 49-101 et seq.).

Unless exempted by A.R.S. 36-495.02, no person may operate or maintain an environmental laboratory without a license issued by th e ADHS pursuant to A.R.S. 36-495.03 through 36-

495.14.

4.3 THE ROLE OF THE ADEQ QA/QC UNIT IN THE PROCUREMENT PROCESS

ADEQ’s QA/QC Unit will assist the Procurement S ection in the development of the Request for Proposal (RFP), or Invitation for Bid (IFB), for th e General Laboratory Serv ices Contract which will occur approximately every 3-5 years. The QA/QC unit will provide input on minimum Quality Control requirements for Contract Labora tories as well as items to be included in submittal for QA/QC evaluation.

ADEQ’s QA/QC Unit will advise the Drinking Water section on minimum QA/QC standards for

laboratories contracted for the Monitoring Assistance Program.

When appropriate, ADEQ’s QA/QC Unit or its dele gate should review a laboratory’s Quality Assurance Manual, or its equiva lent, before the formal execution of any agreement or related action with the organization.

The QA/QC Unit will confer with ADHS on the good st anding of laboratories that are contracted with, or submitting compliance data to, ADEQ.

4.4 THE ROLE OF ADEQ PROJECT/CAS E MANAGERS IN THE PROCUREMENT

PROCESS

ADEQ Program Personnel should define the quality of performance and specifications required of services, instruments, and reagents. The responsibility for monitoring contract pe rformance within ADEQ’s Quality Management System lies with the Programs and ADEQ’s Proc urement Section. All contracts are managed in

accordance with the Stat e procurement code.

4.5 AGREEMENTS WITH GOVERNMENTAL ENTITIES

ADEQ also utilizes governmental agreements w ith EPA and other Federal, State, and local agencies. A.R.S. 41-2501 exempts governmental agreements from the Arizona Procurement Code. Agreements between ADEQ and other stat e agencies, or universities, to provide or

receive a service are authorized under A.R.S. 35-148. Agreem ents between ADEQ and another29 State Agency, political sub-divi sion, or other governments to sh are joint authority (authority possessed by both parties) are author ized by A.R.S. 11-951 through 11-952.

In the event that a governmental agreement scope of work would include environmentally related measurements or data generation, the ADEQ QA/QC Steering Committee’s role would be substantially the same as it is for the General La boratory Services Contra ct. Procurement’s role

would include coordination with the ADEQ QA/QC Unit Manager or his or her designee, the ADEQ Project/Case Manager, and the outside politic al subdivision, and then final negotiation of the governmental agreement.

4.5.1 ADHS and State Laborat ory Services (SLS)

The ADHS provides support for ADEQ as neces sary for laboratory services, method development, risk assessments, development of some regulatory limits, and expert testimony.30 

## CHAPTER 5 DOCUMENTATION AND RECORDS

MANAGEMENT

Maintaining important quality assurance (QA) doc uments and records is a continuous process at ADEQ. This process serves as a vehicle for id entifying quality-related documents and records requiring management control. Moreover, this pr ocess serves to assure that QA documents and records are accessible, and prot ected from damage and deterior ation during storage. Finally, ADEQ’s Records Management Process ensures co mpliance with all statutory and contractual requirements for records involving environmen tal Programs. ADEQ Records Management System also provides adequate preservation of key records necessary to support the mission of ADEQ.

5.1 DEFINITION OF PUBLIC RECORDS

"Records" as defined in ARS § 41-1350, “means all books, papers, maps, photographs or other documentary materials, regardless of physical form or characteristics, incl uding prints or copies of such items produced or reproduced on film or electronic media, made or received by any governmental agency in pursuance of law or in connection with the tr ansaction of public business and preserved or appropriate for preser vation by the agency or its legitimate successor as evidence of the organization, functions, policies, decisions, pr ocedures, operations or other activities of the government, or because of the inform ational and historical value of data contained therein. Library or museum material made or acquired solely for reference or exhibition purposes, extra copies of documents pr eserved only for convenience of reference and stocks of publications or documents intended for sa le or distribution to in terested persons are not

included within the definition of re cords as used in this chapter.”

5.2 EXCLUSIONS FROM THE DEFINITION OF PUBLIC RECORDS

ARS § 49-205 indicates that:

A. Any records, reports or information obtaine d from any person under th is chapter, including records, reports or information obtained or prepared by the Direct or or a department employee, shall be available to the public, except that:

1. Income tax returns are confidential;

2. Drinking water system security vulnerabili ty assessments that are submitted to the

United States Environmental Protection Agency, pursuant to Public Law 107-188, are exempt from disclosure under this chapter and Title 39, Chapter 1;

3. Other information, or a particular part of the information, shall be considered

confidential on either:

(a) A showing, satisfactory to the Director, by an y person that the information, or a particular part of the information, if made public, woul d divulge the trade secrets of the person.31 (b) A determination by the Attorney General that disclosure of the information or a particular part of the information would be detrimental to an ongoing criminal investigation or to an ongoing or contemplated civil enforcement actio n under this chapter in superior court.

B. Notwithstanding subsection A of this section, th e following information shall be available to the public:

1. The name and address of any permit applicant or permittee;

2. The chemical constituents, concentrations and amounts of any pollutant discharge;

3. The existence or level of a concentration of a pollutant in drinking water or in the

environment.

C. Notwithstanding subsection A of this section, and in addition to the information prescribed by subsection B of this section, the following information that is obtained by the department and that relates to discharges au thorized by a permit issued under the Program adopted pursuant to section 49-203, subsection A, paragraph 2 shal l be made available to the public by the department:

1. Information required to be submitted in a permit application;

2. The frequency of the discharge;

3. The temperature and pH level of the discharge;

4. Other water quality charact eristics that are required to be reported under the permit.

D. Notwithstanding subsection A of this section, th e Director may disclose any records, reports or information obtained from any person under th is chapter, including records, reports or information obtained by the Director or department employees, to:

1. Other state employees concerned with admini stering this chapter or if the records, reports or information is relevant to any administrative or judicial proceeding under this chapter;

2. Employees of the United States Envi ronmental Protection Agency if such information is necessary or required to ad minister and implement or comply with the Clean Water Act, the Safe Drinking Water Act, Comprehensive Environmental Response Compensation and Liability Act ( CERCLA) or provisions and regulations relating to those acts.32 Materials excluded from the defini tion of public records include reference material, extra copies of articles, periodicals, reports, documents, blank forms, extra copies of documents preserved for convenience of reference, studies , vendor catalogs, and similar ma terials that are needed for convenience or reference, but are no t part of the official file. Su ch items should be destroyed as soon as they are no longer needed and accord ing to an approved retention schedule. Other materials excluded from the definition of p ublic records, but maintained in confidential files, include draft documents, such as electronic and marked up copy drafts.

5.3 CONFIDENTIAL DOCUMENTS

Some documents collected, received, or genera ted may, by nature and content, be documents which require special handling procedures. Do cuments of this category may be, but are not limited to, enforcement sensitive/enforcement c onfidential, attorney client, or confidential business information (CBI). Confidential documen ts are handled in accordance with state law and ADEQ policy. Only ADEQ staff are allowed to see documents classified as enforcement

confidential. Confidential documents shall be maintained separately from other QA documents. Only those ADEQ staff, and others , who have been trained and aut horized can access CBI files.

In most cases criminal sanctions exist for una uthorized disclosure of CBI. Nothing in the requirements put forward in this QMP shall be construed to supers ede any existing requirements for handling enforcement sensi tive or confidential documents.

5.4 ROUTINE QUALITY ASSURANC E AND RECORDS MANAGEMENT

The ADEQ Records Management Process addres ses the system employed by the Agency for handling documents. This plan outlines the role s and responsibilities fo r management and staff concerning chain of custody proced ures and records management.

ADEQ document control procedures require that documents generated, or obtained, by Agency personnel be accounted for when a project is co mpleted. ADEQ’s Records Management System dictates the procedures for checking-in and check ing-out files for ADEQ sta ff, external clients, and the public.

For reasons of file integrity, th e files must be reviewed in th e presence of the Custodian of Records or his or her designee. No file can be certified as an original co py if it is reviewed by anyone without a staff member fr om the Custodian of Records be ing present. The chain of custody for all Agency files must be carefully gu arded in order to have the greatest degree of integrity regarding Agency files.

ADEQ creates and maintains a unique identificati on code for each investigation or project. ADEQ Records Center is able to use the iden tification codes, and th eir cross referencing capabilities, to identify the cont ents and location of the investig ation/project files. All custody tags, custody records, field notes, or analyt ical records are labeled with ADEQ generated identification codes. Each file is required to have an identification code, date, the Agency Project/Case Manager’s initials or signature, a nd where appropriate the ADEQ Index and PCA to

indicate the source of th e funding for the project. Data pack ages generated by laboratories which33 are requested by Project/Case Managers, and submitted to the ADEQ QA/QC Unit Supervisor, will be maintained by the ADEQ QA/QC Unit.

The QA/QC Unit is responsible for maintaining a directory of QA/QC documents within the Agency, this includes the QMP

, QAPrPs

, QAPjPs , FSPs, SAPs, SOPs , and other related QA/QC documents. Duplicates of many of these documen ts are stored electronically within the QA/QC Unit. Original QA documents are organized by pr oject or site. These documents, along with other records generated, are stor ed in the applicable Program offices within ADEQ or in the Central Records Management Office. The records will be centrally managed via the records management system, but physically may reside in th e Program files, project file, or in the records review area. Regardless of phys ical location of a file, records and documents associated with a given project are the responsibility of the Division Program that has primary responsibility for that project. Hard copies of s ite or project specific information su ch as sample field sheets, chain of custody records, laboratory no tes, and instrument/equipment r eadings shall be maintained in the official project file. Th e ADEQ Project/Case Manager is re sponsible for assuring that all field and analytical identification codes referencing the project are maintained in the project file. Correspondence that is material to the project a nd is generated on the network shall be printed and maintained in the app licable project file.

The ADEQ Director represents the final custodian of that information. Projects involving the generation of environmental data shall include, at a minimum, the Quality Assurance Project Plan (QAPjPs) and final labor atory reports. For projects not funded by EPA some project planning documents other than a QAPjP may be acceptable providing that the objectives are clear and the documentation is likely to produce data of known quality and appropriate for its intended use. QAPjPs submitted to ADEQ are peer reviewed by the respective Project/Case Manager, and approved by desi gnated Program staff. The ap proval process is based upon guidelines set forth by the QA Steer ing Committee. The process for QAPjP review is spelled out in corresponding QA Program Plans. Approved c opies, with the approving signatures, are retained by the Program’s Project/Case Manage r and the ADEQ QA/QC Unit Supervisor, or his or her designee. The QAPjP and the final analytical reports will be stored together, thereby allowing a subsequent analyzer (the ADEQ QA/QC Unit Superv isor or designated Program staff), or investigator, to unde rstand the full context of the data produced and the conclusions

reached.

The ADEQ QA/QC Steering Committee, in conjunc tion with EPA Region IX where appropriate, ensures that all Quality Management Plans and Quality Assurance Project Plans are current.

Should one of these documents become outda ted, the ADEQ QA/QC Unit Supervisor and EPA Region IX, in conjunction with the ADEQ Projec t/Case Manager, shall de termine the status of the plan and initiate appropriate action. The Division Program and the ADEQ QA/QC Unit Supervisor shall be responsible for maintaini ng copies of ADEQ revised/approved QAPrPs and QAPjPs for five years after completion of the project.

ADEQ management will assure that the objectives of the Records Management Process are achieved. These objectives include the following:



##  Prevent the creation of unnecessa ry records in any media;34 

##  Promote the continuous development of f iling systems and structures that allow for the efficient organization, maintena nce, and retrieval of records;



##  Ensure that records of continuing value are preserved, but that valueless or noncurrent information is disposed of or tr ansferred to storage in a timely manner in accordance with ADEQ and/or ADHS r ecords retention requirements;



##  Ensure that the acquisition and use of a ll direct paper to microform systems and equipment, or electronic digital imaging, are technically feasib le, cost-effective, and most importantly, satisfy Program needs;



##  Preserve and protect information that is vital to the essentia l functions or mission of the organization. Preserve and protect in formation that is e ssential to the legal rights and interests of indivi dual citizens and the government.

5.5 IN-HOUSE QUALITY ASSU RANCE GUIDANCE DOCUMENTS

Quality guidance documents developed in-house are peer reviewed by ADEQ’s QA/QC Unit and the appropriate Divisional Program. Most of the in-house quality guidance documents are formatted as SOPs covering specific environmenta l monitoring activities such as field inspection, sample collection/handling, analytical protocols, and data evaluation as mentioned in section 2.2.6. Also, the ADEQ QA/QC Unit maintains on ADE Q’s website, SOPs for the collection of water samples from Arizona public water syst ems that will be submitted to ADHS certified laboratories for analysis of volatile organi c compounds (VOCs), synthetic organic compounds (SOCs), and inorganic compounds (IOCs). These SOPs have been peer reviewed and approved by EPA, and the ADHS State Laboratory, for ADEQ use.

Other in-house quality assurance guidance doc uments include policies. The ADEQ QA/QC Steering Committee drafts quality assurance and analytical polic ies to express the Agency’s position when interpreting analytical data gene rated by laboratories using EPA methods which may have multiple procedural interpretations. One such Agency wide policy is ADEQ Policy # 0154.000 Addressing Spikes and matrix effects.

5.5.1 Requirements for Field Documentation

Documentation of field activities establishes pro cedures, identifies written records, enhances and facilitates sample tracking, standardizes data entries, and identifies and establishes authenticity of the sample data collected. Proper documentation helps to ensure that all essential and required information is consistently acquired and preserved. Timely, correct, and complete documentation establishes the chain-of-custody, a requirement for data intended to provide evidence in court proceedings. Ex act procedures vary from Program to Program and are detailed within individual Program documents.

Field records shall be generated and stored as specified in project sp ecific QAPjPs, SOPs, or guidance for handling field records.

5.6 MAINTAINING DOCUMENT INTEGRITY35 Following all required ADEQ documented policie s and actions regarding Records Management, the file clerk, and all other ADEQ staff, with access to potentially sensitive documents and records (i.e., audit reports and performance eval uation reports) will take special care to preserve the integrity of these doc uments. If sensitive documents are to be used at a work station, due care will be used in order to maintain the integrity of the data.36 

## CHAPTER 6 INFORMATION TEC HNOLOGY (IT) AND DATA

MANAGEMENT

Data management serves a critical function in both preserving information and making that information available. Data management necessa rily encompasses a variety of activities related to planning environmental monitoring, collecting samples from different media, laboratory and in-situ analysis of samples, organizing and stor ing resulting data, analyz ing and interpreting data, disseminating data, and communicating the m onitoring results and knowledge gained. The way ADEQ manages data has evolved substa ntially in the past decade primarily due to Internet availability (e.g., opportunities in electronic government), increased emphasis on enterprise architecture, and the need for better security of e nvironmental data. Also, ADEQ strives to comply with all EPA standards and re gulations, as appropriate, pertaining to hardware, software, database system deve lopment, and data reporting.

This section summarizes the department’s in formation management practices and related information technology topics. Additional aspect s of project management, such as planning, data gathering, and evaluation by ADEQ Programs, are addressed in the QAPrPs or other project planning documents as appropriate.

6.1 MANAGEMENT PRACTICES FO R ENVIRONMENTAL DATA

An important Agency goal is to continue to improve the way data are generated, compiled, stored, and disseminated across each of the ADEQ Divisions (Air, Waste, Water, and Administrative Services). The manner data are managed is governed by the Agency mission, Program business needs (e.g., permitting, compliance, assessments), and specific data collection project/Program objectives. Additional activities that influence data management approaches include EPA reporting requirements, quality assurance, cost control, and security. Information management systems are typically evaluated for return on investment, risk management, and total cost of ownership. This has led ADEQ to adopt an Oracle-based enterprise architecture that offers common services and c onsolidated purchases as a foundation for all our major database applications that include, but are not limited to, AZURITE (the Agency’s enterprise database application fo r managing data related to the functions of licensing/permitting, inspections, compliance, and remediation), Air Assessment Ambient Database ( AAAD),Water Quality Database , Safe Drinking Water Information System (SDWIS), Surface Water Quality System, Groundwater Qual ity System, Drywell System, Water Permits and Certifications System, Engineering Review System, and Global Positioning System Data Post-processing.

6.1.1 Database Development:

Data models are employed when developing database systems to serve as a bridge between those collecting the data and the information processing systems that support those using the data. Data models are basically conceptual schemas that map data relationships, focusing on those

relations that matter most to the business. ADEQ utilizes a standard System Development Lifecycle Methodology for information projects, a nd a rapid application development method, as37 appropriate. Generally, the methods used incl ude an analysis and documentation of user requirements, followed by system design specifica tions. ADEQ uses the Oracle Designer tool to document requirements and system design. ADEQ coding standards are published and implemented, ensuring consistency and maintainabil ity of source code. A project team approach is utilized, which includes end user involve ment throughout the proj ect lifecycle. User documentation, including on-line help, is provided with each database system as resources permit.

6.1.1.2 Systems development planning

The State of Arizona utilizes a standard In formation Technology (IT) project planning and justification process. The G overnment Information Technology Agency (GITA) reviews and approves Project Investment Justif ications (PIJs) for IT projects with a combined developmental and infrastructure cost great er than $25,000. PIJ approval must be received before budget monies can be allocated to an IT project. The central IT organization wo rks in unison with the Program IT specialists to plan, prioritize, and implement Agency IT projects.

6.1.2 Data Quality and Data Integrity:

Data integrity and data quality are related in the fact that both are needed to ensure that the data are sufficient for their intended use. For the purpose of this document data quality relates to the process used to collect, analyze, verify, and validate environmental results. Data integrity relates to the input, storage, maintenance, and retrieval of those results.

6.1.2.1 Data Quality:

Before environmental data are entered into a ny database, and released for production, producers of the data shall use a standard Quality Assura nce procedure to verify that they meet the requirements of their intended use. QAPrPs will de scribe the level of QA/QC necessary for their Programs and should include references to how data quality is determin ed with regards to precision, accuracy, representa tiveness, comparability, comp leteness and sensitivity.

Regardless of the data entry method, manual entry or electronic file transfer, data entry personnel should verify that the data meet the above criteria prior to input into the database. Questionable data may be entered and maintained in a da tabase if they are a ppropriately documented, qualified, or flagged.

6.1.2.2 Data Integrity:

The data integrity process begins once the data are ready for input into the databases. Data integrity addresses the vulnerability of the sy stem to unauthorized access, data manipulation, theft, and environmental damage.

These threats are mitigated by implementing a strong internal database QA/QC process. This includes a security process, further detailed in Section 6.8, that re cognizes database users through logons and assigned database roles. The pro cess begins through ADEQ’s AZURITE database that maintains ADEQ’s centralized core data such as:38 

##  PERSON (Individual users of the database, including tracking information);



##  PLACE (The sites and facilities that ADEQ regulates or tracks);



##  CUSTOMER (individuals, or ganizations, and businesses that ADEQ regulates or interacts with);



##  LTF (Licensing Time Frames).

Daily verification is performed on PLACE, CUSTOM ER, and LTF core data to assure that data entry standards are followed, that location info rmation is provided, and that a duplicate record does not exist before validating a new record as pa rt of ADEQ core data. Any record that is not complete, or does not meet data entry standards, will be returned to the originating Program for correction, and the use of that data will be restricted until corrected.

Presenting data in an understand able and useful format is a key component in ensuring data integrity. Agency projects will be presented in a way that is suitable for the intended audience. The following guidelines are implemented by ADEQ, to the extent applicable, useful, and possible in designing effective a pproaches to Agency projects:

1. Establish a context for presenting data using one or many of the following techniques: displaying data in a geogra phic context, combining the new data source with existing collections of mon itored data, or aggregating the data collected to demonstrate a trend or ongoi ng view of the environmental conditions. ADEQ will present the data in ways that make that data relevant and useful;

2. Format data for easy interpretation so data are portrayed with the intended message and not misused. ADEQ will make every effort to ensure that data will always be presented in a format that is easy to understand and not subject to misinterpretation. This includes no t separating data from corresponding documentation, qualifiers, or flags that may indicate the usability of the data;

3. Be responsive to the users of the data by staying abreast of ch anging user needs, Agency IT projects are designed to include ways for users to provide feedback on the projects.

Metadata are additional information related to the primary results that are being presented, commonly known as data about the data. This supporting information ca n significantly impact the usability of the primary data and should always be considere d. Specifically, metadata include positional/location data, field measurements, temperatures, quality control data, data qualifiers, meteorological data, facility inform ation, and site conditions. The st orage of metadata is specific to each of the databases maintained at ADEQ. E ach database, and the Programs associated with the database, are delineated in relevant Program documents and detailed in the Program’s QAPrP. It is important to note that metadata often provide substantial information relating to

environmental results and should not be separated from those resu lts if it changes the meaning, or usability, of the data in any way.39 Audits and Testing are required for all databa ses and systems. A ll IT projects involving development of systems for tracki ng of environmental data will be thoroughly tested to ensure that they meet the requirements in the written f unctional specifications. Independent audits of these systems will be conducted by the QA/QC Unit. The central IT organization has a test server environment that is in place, and is utilized regularly to te st Agency applications prior to being released into production.

6.1.3 Establishing back up and archiving procedures :

Department Programs will coordinate with the O ffice of Information and Technology to establish standard procedures for data b ackup and archiving, system failure, and recovery. Data sets will be archived to provide a histor ical record of data over the lif etime of the project. Current procedures involve daily full or incremental backups of all critical Agency data that are stored on site at ADEQ. Weekly and monthly back up of all critical data are kept in perpetuity and stored off site at ADEQ’s Disaster Recovery location in Tucson. Should a catastrophic event occur that renders our Phoenix computer equipment unusab le; ADEQ will be able to operate using the equipment and data located in Tucson.

6.2 INFORMATION MANAGEMENT PLAN

ADEQ has an information management plan that documents its approach to data collection, storage, retrieval, delivery, and communication. ADEQ also has procedur es for data quality control and security, which may be inco rporated, as appropriate, into QAPrPs. The information management plan includes the following elements:



##  Data Owners Data are owned by the Programs . This information plan provides the primary contact information of the individual and Program that has overall information management respons ibility and authority for Agency IT projects;



##  Description of the Data Flow Process The plan explains the key points in the information data flow and collection proce ss. This can be il lustrated by a flow chart, or diagram, depicting key information components;



##  Description of the Data Collection Methods The plan summarizes data

measurement and collection methods. It also describes any emerging measurement technologies used, and/or how existing systems of environmental monitoring will be augmented/up-graded to provide the proposed data;



##  Description of the Data St orage and Retrieval System ADEQ’s standard relational database platform is Oracle. ADEQ utilizes Oracle tools, including Designer and Developer, for application development. ADEQ also uses Microsoft Project for planning and tracki ng projects to completion. The plan

describes the hardware and software t echnologies that will be used for data management and processing systems. It specifies the componen ts of the project

architecture and also describes the arch ival components or st orage requirements. The plan addresses data management responsibilities among stakeholders and40 contractors to ensure data documen tation and data standardization.

6.3 ELECTRONIC DATA INTERCHANGE (EDI) AND NODE

Arizona Department of Environmental Quality (ADEQ) collects and manages compliance, measurement, and statistical data for a number of environmental Program s within the State of Arizona. The data are managed and reported both internally and external ly to other state and federal agencies. Typically, the electronic data interchange (EDI) is performed using rigid data

formats that are difficult to ma intain and managed using propriet ary methods. The rigidity and closed nature of the interchange make it very difficult to add new data formats, communicate with new data partners, or improve the overall process. The purpose of ADEQ’s Node is to eliminate the proprietary exchange formats a nd more easily facilitate the exchange of

information between the Environmental Protec tion Agency (EPA), and other participating organizations, by developing a Web Service base d gateway that supports the EPA XML message formats. ADEQ currently has a fully comp liant production Node, and has successfully exchanged data with EPA's Facility Registry System. Additional data flows are planned to exchange data with EPA's RCRA Info and AQS sy stems. In addition, the Node can be used internally and for non-EPA partner exchanges.

6.4 LEVELS OF DOCUMENTATION FO R ENVIRONMENTAL PROJECTS

Documentation is important because it helps users make informed decisions regarding the use of environmental data, provides consistency and IT project memory over time, and allows the data to be shared and used for a variety of purposes and in a variety of computing environments. ADEQ has developed the following four kinds of documentation requirements for environmental IT project data systems:

1. Data System Documentation : Documents critical information about the IT project, including project purpose and scope, user requirements, IT PIJ, and the IT project plan;

2. Data Set Documentation : Provides clear informati on about what data are collected and how to access and use them;

3. Data Element Documentation : Provides full definitions and specifications for

each element collected and ma intained in a data set;

4. Database System Documentation : Describes electronic and hard copy documentation of system design and implementation.

6.5 COMPUTER HARDWARE/SOFTWARE REQUIREMENTS

ADEQ managers and staff will comply with all ADEQ hardware and software standards, which are maintained by the Office of Informati on and Technology. These standards address compatibility, hardware, operating systems, co mmunication, database management, user and printer interface, application development, and applications.41 ADEQ will procure hardware and software that c onforms to Agency wide and EPA information management architecture. In some cases, ADEQ will procure and configure hardware, or develop application software thr ough vendors that are not on the statewide contract. All such purchases will be evaluated to ensure that they comply with ADEQ standards as outlined in the Agency’s software and hardware standards. Prior to any purchases, ADEQ’s Chief Information Officer, or designee, will evaluate software and hardware to determine their performance capabilities, impact of implementation upon ADE Q, and its compatibility with EPA reporting requirements.

6.6 SYSTEM DEVELOPMENT

All ADEQ system development, enhancement, and modernization efforts will comply with Agency standards. The standards include a sy stematic and comprehensive dialogue between the data providers, data/system users, and system de velopers. The majority of the dialogue occurs prior to the design of the system in order to ensure extensive and successful user participation, and a systematic approach to the design. Syst ems will be designed and built to integrate with core Agency data in such a manner that re-use of code, and its associat ed cost savings, is

maximized.

All software systems shall be operated and mainta ined in accordance with written specifications and/or the owner’s manual. All software system s will be subjected to acceptance testing by end users prior to being placed in to a production environment.

For the proper implementation and maintenance of the technology infrastructure, ADEQ’s Office of Information and Technology:



##  Maintains an inventory of the computer system(s) hardware and written operating procedures for routine maintenance operations;



##  Documents data management systems in use, including functional and design specifications and requirements;



##  Maintains Standard Operating Procedur es which describe routine operation, maintenance, and testing to ensure that both the hardware and software in use are accurately performing their intended functions.

These documents will be readily available in the areas where these procedures will be performed. Changes in any part of the operating procedures shall be properly authorized, reviewed, and accepted in writing by the designated responsible person.

6.7 DATA STANDARDS

To take full advantage of both ADEQ’s and EP A’s growing technology, data standards, and resources, there must be an increased empha sis on improving the compatibility of data among computer systems. In addition to the policies a nd standards contained in the CFR, federal data policies and standards that are currently followed, including those which ADEQ is attempting to implement, include:42 

##  Chemical Abstract Service Registry Number Data Sta ndard, EPA Order 2180.1, June 26, 1987;



##  Data Standards for the Electronic Transmission of Laboratory Measurement Results, EPA Order 2180.2, December 10, 1987;



##  The Minimum Set of Data Elements for Ground Water Quality, Policy Order 74500.IA, September 11, 1989;



##  Facility Identification Data Standard, U.S. EPA Office of Administration and Resources Management, Information Manage ment and Services Division, April 9,

1990.



##  Policy on Electronic Reporting, U.S. EPA Office of Ad ministration and Resources Management, July 30, 1990;



##  Site Location Identification Policy a nd Responsibilities, Region III, Order 5361.5, September 14, 1988;



##  ADEQ Locational Data Polic y, 0034.001 (see Appendix J);



##  Locational Data Policy, IRM Policy Manual, Chapter 13, April 1991; and



##  Locational Data Policy Implementation Gu idance- Guide to the Policy, U.S. EPA Office of Information and Resources Management, March, 1992.



##  Cross Media Electronic Reporting, Final Rule, October 13, 2005.

6.8 INFORMATION SECURITY

It is important that ADEQ information resource s are protected from pot ential loss and misuse from a variety of accidental and deliberate causes. Failure to adequately protect database systems can affect the integrity of data, privacy of data sources, availability of data for use (e.g., for legal and enforcement purposes), and the very existence of data. ADEQ utilizes the following security procedures and protocols:



##  Network Operating Systems use log-in and password controls;



##  Internal rights to Agency data are granted by local management for their employees;



##  Maintaining a “chain-of-custody” for any data value created or changed in a database;



##  A firewall security system for Internet usage;



##  Remote access controls for employees and third parties include the use of log-in and password protection;



##  All UNIX, NetWare, and Remote Access Operating Systems comply with DOD C2 security standards;



##  The main computer room is physically secured to limit access to only critical IT personnel.43 

## CHAPTER 7 PLANNING

A primary goal of ADEQ’s Quality Management Sy stem is to promote effective planning for the collection, analyses, and processing of environmenta l data. Quality planning must occur at three levels to ensure that such data meet ADEQ’s programmatic quality goals. The three levels are:



##  Agency wide Requirements;



##  Program Specific Requirements;



##  Project Level Requirements.

7.1 AGENCYWIDE PLANNING

7.1.1 Internal Strategic Planning

The ADEQ Strategic Plan is the foundation upon which all Programmatic priorities, and corresponding environmentally rela ted data collection and use activ ities, are based. Using the projected annual budget for ADEQ from the vari ous funding sources including EPA and the State of Arizona, ADEQ’s Director and senior mana gers meet each fiscal year to discuss and set ADEQ priorities. These priorities are then re flected in ADEQ’s Strate gic Planning process, which establishes overall goals, direction, resource utilization, policies, and budget allocations. Yearly action plans, developed by each ADEQ Di vision, are tied to ADEQ’ s Strategic Plan and budget allocation process. Action plans further speci fy the types of environmentally-related data generation activities that will occur. The yearly action plans also delineate what decisions they are designed to support and the corresponding requi rements for quality assurance and quality control procedures.

7.1.2 Eternal Strategic Planning

Close coordination and planning ac ross organizations is essential to ensure that data are of sufficient quality to support decisi on-makers, or otherwise meet thei r intended use. Data Quality Objectives (DQOs) and other planning tools can be shared across Programs sites and governmental agencies, and private organizations, where appropriate.

7.1.3 External Data Coordination

Once the data have been collected, ADEQ must also coordinate the use of environmentally related data across numerous government agenci es, academic, and private organizations. ADEQ encourages data sharing whenever possible. However, data shar ing is only done when adequate data quality indicators (DQIs) ar e available so that the quality of data is sufficiently known to support the applicable decision(s).44 7.2 PROGRAM-SPECIFIC PLANNING

ADEQ Programs are functional areas of work authorized by Stat utory reference (e.g., National Ambient Air Quality Standards (NAAQS)or Dri nking Water Program) or by Agency direction (e.g. the Voluntary Remediation Program). A ny of ADEQ’s environmental Programs which generate environmental data are covered by the QMP , though it is acknowledged that not every Program or project requires the same level of quality assurance. Generally, Program managers (their grades and titles vary by Division) are responsible for Program level planning, which includes the responsibility to ensure that there is agreement between the customer and the data supplier as to expected data quality.

Establishing Data Quality Objectives (DQOs) wh en initiating a new proj ect, or incorporating major statutory changes, is a mandatory component of the ADEQ Quality Management System. The EPA Quality Assurance Division guidance document, Guidance for the Data Quality Objectives Process, EPA QA/G-4 is available to assist user s in developing these objectives, as are other resources within the ADEQ QA/QC Unit when the formal DQO processes is necessary. Predetermined DQO’s based on regula tory criteria and act ion levels within similar Programs are often available, and thus a formal DQO process is not necessary. DQOs at the project level may address sources of error (i.e., sampling design and s ite variability) that will accumulate and affect the interpretation of data for st atus and trends. Program-level DQOs have the ability to meet Division Program objectives. Data Quality Objectiv es are also used as performance criteria for assessments of data quality for their ade quacy in determining status and trends.

It is critical to consider th e QMP during the planning proce ss when modifying existing, or designing new, Programs. Although the QMP outlines the minimum QA requirements for ADEQ, it is likely that most of the Programs covered by the QMP will need more QA specificity when implementing their Programs. In these cases, supplemen tal QA components and procedures are developed and described by th e Program. If requested, the ADEQ QA/QC Unit

will serve as technical advisors in the devel opment of these components and procedures. All Programs covered by the QMP should review th eir programmatic requirements each year to determine if the QMP adequately covers their QA needs, and if not, incorporate supplemental procedures into the Program Plans

7.3 PROJECT-LEVEL PLANNING

A project is an organized set of activities within a Program. The Quality Assurance Project Plan (QAPjP) is the primary vehicle for ensuring that ther e is adequate data quality at the project level (see Chapter 2, Section 2.2 for a more comple te discussion of the QAPjP development and review process.) The ADEQ QMP refers to QA activities as a well-defined component of any project plan involving th e collection or use of environmental data.

The key to good quality planning at this level is to link the data collectio n, or analyses, to be performed directly to the environmental decision to be made. This is essential so that ADEQ

does not collect mounds of data for which there is no purpose. Achievin g this key component requires dialogue between the decisi on maker, contractor, and the data supplier. Again, the EPA45 Quality Assurance Division (QAD) document EPA QA/G-4, Guidance for the Data Quality Objective Process March, 2006 , as well as resources within the ADEQ QA/QC Unit, can be invaluable in establishing the desired data cert ainty requirements based on the decision to be made. The use of statistical methods to qua ntify data acceptability measures is highly recommended. Members of the QA Team in EP A Region IX can provide assistance with statistical applications. The ADEQ QA/QC Unit can assist ADEQ Programs by providing the appropriate references.

Planning documentation identifies ADEQ’s pe rsonnel responsible for ensuring that all components of a QAPjP are addressed appropriate ly. Project/Case Managers will normally be responsible for the development of these QA com ponents, which will adhere to the requirements of EPA QA/R-5, EPA Requirements for QA Project Plans. March, 2001 . QAPjPs are reviewed to ensure that all the required EPA and ADEQ el ements are appropriately addressed. The review process is conducted by the Division QA Representa tive, or appropriate de signee, and must be approved by appropriate delega ted autonomous Division personnel or by the QA/QC Unit.

When initiating a site-specific project, a preliminary plan is developed for accomplishing the required work. Through this process, specific individuals are made accountable for different aspects of the investigation.

The ADEQ planning process considerations include:



##  Identifying the regulations involved;



##  Defining the forensic requirements of the regulations;



##  Defining DQOs



##  Defining MQOs



##  Structuring communication between all th e parties involved in the project;



##  Defining the scope of the project to meet enforcement objectives;



##  Identifying and scheduling activities;



##  Identifying resources needed;



##  Identifying health and safety issues;



##  Questioning the validity of scientific models and methods proposed for use.

7.3.1 On-Site Monitoring

The determination to use on-site monitoring, and the specific type of monitoring to be conducted, is based upon the project objectives as defi ned by the QAPjP. Field screening information, combined with statistics, can be used to define the number and type of samples needed to meet the project objectives.

Monitoring for personal protection may include usi ng a specific instrument to screen the work area to determine the appropriate level of pers onal protection needed. These instruments can also be used for continuous monitoring while work is being performed.46 Quality control indicators used in on-site monitoring depend on the applicable regulations, the type of equipment, the nature of the material s monitored, and the monitoring objectives. Quality control parameters such as blanks, blank spikes , matrix spikes, field duplicates, surrogates, and calibration curve data (all QC parameters as they apply) shall be documented.

7.3.2 Sampling Events

The sampling activity shall be focused toward me eting the regulatory, technical, and analytical requirements defined during the planning phase . ADEQ sample collection activities are designed to answer questions such as:



##  How do the media compare to a regulatory threshold?



##  How do the media compare to other site media?



##  Is a specific component or condition present?



##  Are there trends or hot spots?

The sampling activity requires:



##  Coordinating field activities with laboratory activities;



##  Maintaining sample integrity;



##  Focusing on regulatory and Agency de fined data quality requirements.

7.3.2.1 Sample Scheduling

Communication with the laboratory prior to sampli ng is critical in achieving the stated Data Quality Objectives. Some sample events ar e unique and one time events, while others are routine and ongoing. Regardless, all laboratory sample scheduling ev ents need to be coordinated with the laboratories, at a minimum, several days prior to sampling. Communications should include, time frames, methods, matr ix types, required detection limits, and where appropriate, the purpose for testing to ensure the requirements of Federal or State stat utes under which ADEQ intends to regulate are fulfilled. The QA/QC Unit can facilitate finding appropriate laboratories, ensuring that DQOs and MQOs can be met, a nd that the laboratory meet minimum ADEQ Quality Control requirements.

7.4 ANALYTICAL REQUIREMENTS

Analysis involves the characteri zation of samples based on chemical and/or physical properties. Analyses result in generating raw data from either instrumental analysis, chemical analysis, or physical testing. The analytical methods used will be specific, sensi tive enough to answer the question posed by the Program objectives, and meet the data quality goals associated with those objectives.47 Measurement Quality Objectives (MQOs) are the project or program QC criteria defined for various Data Quality Indicators (DQIs). During the planning phase, these set pre-determined limits on the acceptability of the data in regard s to accuracy /bias, and precision, completeness and sensitivity.

ADEQ Project/Case Managers may consult with the ADEQ QA/QC Un it, or research a variety of published or written materials, to aid th em in selecting or developing measurement technologies. The ADEQ QA/QC Unit shall maintain a file of in-house procedures and practices used in the measurement process. Data Qu ality Objectives (DQOs), and ADEQ QA/QC Unit’s professional knowledge, are used to identif y appropriate analytical procedures.

DQI’s, as defined by EPA involve precision, acc uracy, representativeness, completeness, comparability, and sensitivity, also known as “PAR CC” parameters. It is expected that these indicators be used in data evaluation, but in ge neral, the criteria by which DQIs are evaluated are based on project data quality needs, ie, the MQOs.. The extent to which theses indicators will be utilized should be provided in a Program’s QAP rP. The extent to which program or project QC results meets MQOs determines whether data are acceptable for the intended use.

7.5 DATA TRANSLATION

Data translation involves transl ating raw data into useable information which can include qualitative identifications, quantitative determina tions, and/or statements of condition. This process can include arithmetic calculations, and/or statistical evaluations, of results from a sample or collection of samples.

7.6 DATA INTERPRETATION

The ADEQ Project/Case Manager will attempt to us e sample data to form an opinion about the characteristics of a data set. The ADEQ Pr oject/Case Manager will use quality control information to support conclusions or to iden tify limitations of the data. The ADEQ QA/QC Unit will be available to assist the ADEQ Proj ect/Case Manager in assessing QC data when actions have regulatory implications . For compliance testing, the acc eptable data (ie, data that meets the MQOs) will define the characteristics of the data set that will then be compared to regulatory requirements to determine compliance.

7.7 HEALTH AND SAFETY

Health and safety are an integral part of the ADEQ Quality Management System, because the management philosophy is that a safe workplace is essential for the long term success of the Quality Management System. ADEQ Management, with the assistance of the ADEQ Health and Safety Committee, has developed policies and procedures focused toward a safe working environment, and developed a Program that is ade quate to protect the health and safety of ADEQ staff. The ADEQ Health and Safety procedures implement applicable EPA and Office of Safety and Health Administration regula tions. The ADEQ Safety Committee conducts or contracts for specialized training Programs to meet the sa fety needs of ADEQ measurement activities.48 The ADEQ Health and Safety Environmental Management Program is the mechanism which ensures that appropriate issues are considered pr ior to the initiation of measurement activities. The ADEQ Health and Safety Environmental Ma nagement Program includes the following three key elements: 1. Training - Includes field a nd laboratory safety, first aid and CPR, supervisory safety, hazardous waste, a nd other pertinent training;

2. Audits, Inspections, Investigations, and Hazard Control - Includes planning reviews, associated reporting, and record keeping to identif y, prevent, and/or abate health and safety problems;

3. Occupational Medical Monitoring - Incl udes medical monitoring of staff who may be exposed to chemical, biological, ra diological, or other agents, or who may experience physical stress during their work.49 

## CHAPTER 8 IMPLEMENTATION OF QUALITY ASSURANCE

WORK PROCESSES

This Chapter of the QMP describes the processes used at ADEQ for facilitating the effective implementation of QA plans and procedures wh ich comprise ADEQ’s Quality System. Any changes to the QMP will be documented in revisions and will receive, at least, Agency Director level approval. As with the QA planning de scribed in Chapter 7, implementation of QA procedures takes place at the Agency, Program, and project levels.

8.1 AGENCYWIDE IMPLEMENTATION

ADEQ utilizes a tiered approach to ensure that environmental data are of sufficient quantity, and quality, for their intended purpose. Any revision s to the QMP will be processed in the same manner as was the original document. QMP revisions will be drafted by the ADEQ QA/QC Unit, and submitted to the QA/QC Steering Co mmittee for comment, with final approval by ADEQ’s Leadership Team. The ADEQ QA/QC Unit Supervisor, teamed with the QA/QC Steering Committee, will provide general over sight of implementation of the ADEQ Quality Management System and identify needs for revisions to the QMP. The ADEQ Programs will provide technical oversight for implementi ng environmental data operations through the development of Quality Assurance Program Plans (QAPrPs).

8.1.1 Divisional Quality Assurance Program Plans

QAPrPs will be developed within the individu al Programs. When requested, ADEQ’s QA/QC Unit will assist in development and implementa tion of environmental data operations according to approved planning documents. Additionall y, each QAPrP needs to identify those specific activities that will ensure the generation of quality data by:



##  Defining commonalities in operations, methods, and procedures used throughout the Program;



##  Covering elements of Program manage ment, data generation and acquisition, assessment and oversight, and da ta validation and usability;



##  Describing the level or degree of the Pr ogram quality system, and the different types of QA documents used by the Progr am, focusing on those elements that are not time or site specific;



##  Identifying those responsible and desc ribing the procedures for Program QA document preparation, review, and approval;



##  Discussing data quality objectives includi ng the identification of Program wide technical or regul atory criteria;



##  Attaching reference and supporting document s used throughout the Program, such as SOPs and regulatory lists.

Each ADEQ QAPrP should be reviewed on an annua l basis, and at minimu m, revised every five years or when significant changes in the busine ss operation occur, to en sure that the plans50 accurately reflect how business within the Prog ram is conducted. It is essential that the workflow outlined in the QAPrP is consistent with actual business conducted. The Programs will provide a copy of their QAPrP to the QA/ QC Unit and also to EPA Region IX for EPA Funded programs, for approval, general oversight, and management of the Agency wide Quality System.

8.2 PROGRAM LEVEL IMPLEMENTATION

8.2.1 Operating Policies and Procedures

Any ADEQ Program which generates, or uses, environmental data will document its QA policies and procedures, and will develop and/or use ap propriate policy and procedure manuals for its Programs. The ADEQ QA/QC Unit will provide suppor t and oversight in the generation of such documents. The EPA Quality Staff issues doc uments to provide information on satisfying Federal Regulations, for example, Guidance for Preparing Standard Operating Procedures, March, 2001 (QA-G6), this document should be referenced by ADEQ Programs when developing procedure manuals for administrativ e and technical QA operations. Implementation of these procedures will enable Program personnel to gain and document procedural knowledge about their operations, and will also serve as a training guide for new staff members.

The ADEQ QA/QC Unit Supervisor will work with the ADEQ Programs to ensure that operational QA policies and procedures develope d by the Programs are consistent with the ADEQ QMP . This responsibility includes defining procedures for appropriate routine, standardized, special, or critical operations, including the policies and procedures that address,

but are not limited to:



##  The identification of operations needing standardized procedures;



##  The process for preparation of pro cedures, including form, content, and applicability;



##  Determination of SOP adequacy, and consequent review and approval.

Any QA procedure manuals developed by the ADEQ QA/QC Unit will be made available to all personnel involved in Program implementation. If implementation of the Program is delegated or outsourced, these QA procedural manuals will be referenced in the Task/Work Assignment, Task/Delivery Order, or similar document consis tent with the ADEQ Procurement process. A Program using data generated by external source s must develop criteria and a process by which to evaluate the acceptability of the data supplied. The data quality assessment process described in Chapter 9.4 can be useful here.

8.3 PROJECT LEVEL IMPLEMENTATION

8.3.1 Quality Assurance Project Plan Implementation

All environmental data operations will be implem ented in accordance with an approved QAPjP or QAPrP. The ADEQ Project/Case Manager shoul d include identifiable QA milestones, and51 target dates, in the project timeline so that progress and completion of QA and QC activities can be effectively tracked. Any changes to the QAP jP will be documented as soon as possible in writing with an amendment to th e QAPjP. Amendments will be reviewed and approved by the ADEQ Project/Case Manager. It is critical to have a quick and efficient system for any QAPjP changes so the plan can be accurately used for its intended purpose, as a reference and guide throughout the project.

8.3.2 Standard Operating Procedures (SOPs)

Many repetitive procedures that are routinely used can be standardized and documented in writing as SOPs. SOPs can be prepared for r outinely conducted sampling, analytical, and quality control procedures. Once established, the SOPs can be cited in the QAPjPs, contract proposals, grant agreements, and other similar documents, t hus saving time and paper by avoiding the need to write out the specific pro cedures in each document. ADEQ SOPs relating to QA shall be maintained by the appropriate Program office with technical support provided by the QA/QC Unit, as appropriate. SOPs common to Programs can be found as attachments with URLs to their corresponding QAPrP. Tasks or functions that may be effectively addressed within a SOP

include:



##  Sampling network design;



##  Sampling site selection;



##  Sampling and analytical procedures;



##  Sample collection methods and devices, c ontainers, preservatives, holding times, handling and transportation methods;



##  Documentation and chain-of -custody procedures;



##  Calibration and maintenance of instruments and equipment;



##  Quality control procedures;



##  Data review, reduction, and validation;



##  Safety procedures;



##  Inspection and audit procedures.

ADEQ has established the following policies, pro cedures, and/or guidance for sample collection and analytical techniques. Thes e procedures, where relevant, appl y to all analytical data being generated for use by ADEQ. These procedures should be followed unless special exceptions have been requested and approve d, and/or deviations are outlined in a Program’s QAPrP. These
documents can be found in their entir ety as attachments to this QMP.



##  ADEQ Temperature/Preser vation Guidance Policy;



##  Substantive Policy 0154 Addressing Spike And Surrogate Recovery As They Relate To Matrix Effects In Water, Air, Sludge And Soil Matrices Policy ;



##  Substantive Policy 0170 Implementation Of EPA Met hod 5035 - Soil Preparation For EPA Method 8015B, 8021B and 8260B ;52 

##  Arizona Data Qualifiers.

The Arizona Data Qualifiers are revised peri odically with the consensus of the Arizona Environmental Laboratory Adviso ry Committee (ELAC). The most up to date version should be used when applying qualifiers to data a nd can be found on the ADHS and ADEQ websites.53 

## CHAPTER 9 QUALITY ASSESSMENT AND RESPONSE

This Chapter of the QMP describes how ADEQ will assess the effectiveness of its Quality Management System. ADEQ will use a variety of internal management and technical reviews, performance evaluations, and QA audits to ensu re that the procedur es in this QMP are implemented successfully. ADEQ will also utilize, as needed, independent reviews of the systems and procedures described in ADEQ’ s QMP by personnel from the EPA Region IX Quality Assurance Office. This chapter will al so describe ADEQ’s commitment to using the results of these evaluations to make any necessary operational adjustments to ADEQ’s data collection and analytical procedures, as well as to other aspects of the Quality Management System.

9.1 ANNUAL REVIEW OF THE QUALITY MANAGEMENT PLAN

The QA practices and procedures described in th e QMP will be assessed annually, and revised or updated by October 1 of each year by the ADEQ QA St eering Committee. As an integral part of the QA Steering Committee, ADEQ’s QA/QC Unit S upervisor is responsible for coordinating this assessment, arranging meetings of the QA St eering Committee to assist with the review, and for incorporating any recommended changes in to the QMP. Minor changes in the QMP proposed by the ADEQ Programs should be su bmitted in writing to the ADEQ QA/QC Unit Supervisor by June 30th of each year. Afte r approval by the QA/QC Steering committee, the QMP will be turned over to the Leadership Te am for updated signatures. A copy, for record keeping, will be sent to EPA Region IX. A major rewrite will take place every five y ears with approvals needed by ADEQ’s QA/QC Steering Committee, ADEQ’s Leadership Team , and final approval by EPA Region IX.

9.2 QUALITY AUDITS

ADEQ employs several QA assessment tools designe d to provide a better understanding of the components of, and basis for improving, the ADEQ Quality Management System. Internal (programmatic) and External QA audits are one of the principal tools for determining the effectiveness of the ADEQ QA/QC components. QA audit frequency and scheduling will vary with the type of review conducted. Specifics of frequency and type of review will be outlined in the individual Program QAPrPs. The following is a description of some of the evaluation tools:

9.2.1 Management System Reviews (MSRs)

An MSR is an independent assessment of a Program’s QA management practices and data collection procedures, and is generally perf ormed by the ADEQ QA/QC Unit with oversight privileges from the QA Steering Committee. The MSR will qualitatively assess a Program to determine if the ADEQ Quality Management System is adequate to ensure the quality of the Program’s data. MSRs address the effectivenes s of management controls in achieving and assuring data quality, the adequacy of resour ces and personnel devoted to QA functions, the effectiveness of training and assessments, and the applicability of data quality requirements.54 While MSRs can identify significant QA concerns and areas of needed improvement, they also point out noteworthy accomplishments.

ADEQ Program MSRs are generally conducted by an external party (typically the ADEQ QA/QC Unit) and focus on the Program's adherence to the approved Agency QMP, its Quality Assurance Program Plan, as well as the implemen tation of QA practices w ithin a single Program area. The ADEQ QA/QC Unit will attempt to c onduct an MSR for every major Agency Program (including the Northern and S outhern Regional Offices) once ev ery four years. The ADEQ QA/QC Unit’s MSRs focus on the overall struct ure and procedures for accomplishing the QA Program.

Most MSRs will examine the following elements:



##  An assessment of the overall effectiven ess of the QA management system, as measured by its adherence to the approved QMP;



##  Procedures for developing Data Quality Objectives (DQOs);



##  Procedures for developing and approving QAPrPs and QAPjPs;



##  The effectiveness of existing QAPrP guidance and QAPjPs;



##  Procedures for developing and approving SOPs;



##  Procedures, criteria, and schedul es for conducting QA audits;



##  Tracking systems for assuring that the QA Program is operating effectively, and

that corrective actions disclosed by QA audits have been taken;



##  Responsibilities and authorities of vari ous line managers, and QA personnel, for implementing the QA Program;



##  The degree of management support;



##  The level of financial and other reso urces committed to implementing the QA Program.

MSRs performed or arranged by the ADEQ QA/QC Unit will be conducted in accordance with

the Guidance on Assessing Quality Systems, March, 2003 , EPA QA/G-3. ADEQ may also make occasional use of independent, outside reviews of its quality assurance pr actices. When electing to use an outside source, the ADEQ QA/QC Un it Supervisor, in consultation with the QA Steering Committee and Division Director, will make arrangements for such a review by selecting an appropriate team of qualified reviewers (e.g. EP A Region IX). The goals and objectives of this type of review will be the sa me as if the assessment were conducted internally.

EPA QA Office has the authority and may, from time to time, audit ADEQ’s Quality System as part of its oversigh t responsibilities.

All MSRs will result in the producti on of a written report. A draft of this report is due within 30 days of the completion of the observation phase of the audit. The draft will be sent for comments to the Program’s senior management. Comments must be supplied by the Program’s55 senior management within 30 days of the receipt of the draft. Final reports are to be completed within 30 days of receipt of comments by the Program’s senior management

9.2.1.1 Review ADEQ Quality Assurance Programs

ADEQ’s QA/QC Unit, with oversight privileges from the QA Steering Committee, will conduct internal assessments of the individual ADEQ Qu ality Assurance Programs as described in the Agency QMP. All major data generating Progra ms within ADEQ will be reviewed every four years. These Programs include those listed in Chapter 1 of this document. These reviews will be authorized by the ADEQ Director and the result s of the evaluations will be transmitted to the ADEQ Division Director, in a wr itten memorandum, from the ADEQ QA Steering Committee. The reviews are intended to accomplish the following objectives:



##  Identify any data quality problems;



##  Identify benchmark practices that coul d be used in other Agency Programs;



##  Propose recommendations for resolving quality problems;



##  Confirm implementation and effectiveness of any recommended corrective

actions.

The reviewed Program will have 30 days to prepare a written response to the reviewer’s memorandum. If the evaluation report recomme nds corrective actions, the reviewed Program

should address these recommendations and incl ude a schedule for making any appropriate changes in its quality assurance procedures . These reviews will be used by the ADEQ Leadership team to gauge the effectiveness of the Agency QMP and of the Programs’ approaches to data quality management.

9.2.2 Technical Systems Audits (TSAs)

A Technical Systems Audit is conducted to assess the sampling and analytical quality control procedures used to generate environmenta l data. The ADEQ QA/QC Unit with oversight privileges from the QA Steering Committee will use TSAs to ev aluate laboratory and field procedures used by EPA, state pe rsonnel, and contractors. TSAs entail a comprehensive, on-site evaluation of the field equipment; sampling a nd analyses procedures ; documentation; data validation; and training procedures for coll ecting or processing environmental data. TSAs may be routinely planned by ADEQ’s QA/ QC Unit, specifically requested by ADEQ’s Project/Case Manager, or result from the findings of another audit or review. ADEQ’s QA/QC Unit Supervisor is responsible for assembling th e audit team. Results will be reported to the audited organization in the form of a written repo rt within 14 calendar days of the completion of the audit, or a mutually agr eed upon alternative. Written co mments by ADEQ’s Project/Case Manager must be supplied to ADEQ’s QA/QC Unit within 14 calendar days of receipt of the audit findings, or a mutually ag reed upon alternative. Copies of the TSA Audit Final Report will be stored in the project file and also with the ADEQ’s QA/QC Unit. Additional copies will be distributed as appropriate.

Both laboratory and field TSAs may be performed.56 9.2.2.1 Laboratory TSAs

TSAs will be conducted on the Arizona Department of Health Services State Laboratory, ADEQ contract laboratories, and cont ract laboratories of consulta nts and contractors who submit analytical data to ADEQ. TSAs may be conduc ted on other Federal agency laboratories that perform sample analysis under Interagency Agre ements with ADEQ. The primary goals of TSAs will be to review the laboratory organi zation, operation, and capabilities; determine the reliability of data; and note corrective action for any apparent deficiencies. Auditors for TSAs will be selected by the ADEQ QA Steering Committ ee based on their technical proficiency in the subject area. The designated auditors will be responsible for planning and conducting the audit, and reporting the findings to th e laboratory manager and to the ADEQ QA Steering Committee.

9.2.2.2 Field TSAs

Oversight of field operations is an important part of the quality assurance process, and the ADEQ QA/QC Unit, with oversight privileges fr om the QA Steering Committee, will conduct QA audits of field sampling activities, both for its own field operations, and on those contractors and other federal agencies that collect samples fo r Programs sponsored by EPA. ADEQ will specify frequency and procedures for conducting field TS As within specific Program areas. When QAPjPs are reviewed, and also during any MSRs or other QA audits, the ADEQ QA/QC Unit Supervisor will determine the necessity of field TSAs.

9.3 PERFORMANCE EVALUATIONS

Performance Evaluations (PEs) Samples are used to assess the ability of a laboratory, or field measurement system, to provide reliable data. PEs samples will be considered for laboratories providing analytical services, directly or indi rectly, for ADEQ and will be traceable, whenever possible, through the National Institute of St andards and Technology (NIST). The evaluation consists of providing a reference, "blind" or “double blind” sample , to the laboratory for analysis. A PE sample contains known concentrations of ch emical constituents, or pollutants, of interest and will normally be in the appropriate media (e .g., soil, water, air). The analytical results obtained by the laboratory are compared to the known concentrations of the chemical constituents contained in the PE sample(s), as a means of determin ing if the laboratory demonstrated its ability to properly identify, and quantify, pollutants w ithin established, or calculated, control limits.

PE samples will be scheduled at a frequency sp ecified by Program requirements, or on an asneeded basis depending on the laboratory and Pr ogram involved. Some national Programs, such as the Public Water Supply Supe rvision (PWSS) and National Po llutant Discharge Elimination System (NPDES) Programs, have regularly-sche duled PE studies in which participation is mandatory for designated laboratories. For the PWSS Program, PE evaluations are required twice a year for all laboratories w ho wish to be certified for drinking water analysis. In addition, PE samples of specific parameters may be obtaine d from the appropriate EPA Office of Research Development laboratory or prepared commercially.57 All PE studies performed for ADEQ, whether re quired on a regular basis or performed on a one time basis, will be coordinated through or reque sted from the ADEQ QA/QC Unit or designee. For external projects requiring PEs, the Task/W ork Assignment, Task/Delivery Order, or similar document needs to outline the specific details of the Performance Evaluation so the associated

costs can be included in the c ontractor proposal. The result s of PEs provide a means for assessing overall data integrity, and may be used as criteria fo r selecting candidates for on-site

evaluations.

9.4 DATA QUALITY EVALUATIONS

Data quality requirements and evaluation methods are addressed in the ADEQ QMP and also in specific QAPjPs. The QMP describes the met hods by which data quality evaluations will be conducted and utilized, and how these evaluatio ns relate to Data Quality Objectives.

9.4.1 Data Quality Assessments (DQAs)

A Data Quality Assessment (DQA) refers to the pr ocess used to determine whether the quality of a given data set is adequate fo r its intended use. DQAs can be performed on all, or selected projects and/or data generation pr ocesses. The purpose of this t ype of evaluation is to determine whether the data collected are acceptable to the decision-maker or end user. Assessments generally take place at one of two points in the data generation process. First, as data are generated, aspects of the project such as su rveillance of field and laboratory operations, consistency of the data with MQOs, successful ly completing performance evaluation sample studies, and so forth, can be used to arrive as an assessment of whether the data are valid and acceptable. Rejected or questionable data cannot be used by ADEQ in its decision making, except in limited circumstances, su ch as a rough site screening.

Once data have been examined and assessed, an d they are found to be of known and acceptable quality, then the results can be evaluated in the context of the Data Quality Objectives for the project. In some, but all, cases, this may invol ve a statistical evaluati on such as null hypothesis testing. In others in may invol ve a comparison to regulatory acti on levels. An assessment must

also be made as to whether there is a sufficien t quantity of data to s upport program or project decisions, and whether the original sampling desi gn was appropriate. In some cases, the data may suggest that additional data are required to achieve a higher statistical confidence level. This could be because too many data points were invalidated, that samples were not collected over a long enough time period, or that a vital sampling area not prev iously considered important, was missed. In other cases, an assessmen t might show that data of a different type are required, or that the sensitivity of the instrument used in the measurement was not adequate to meet project objectives. Thus, both types of asse ssments are vital to the successful completion of a project.

If necessary, ADEQ’s QA/QC Unit can review da ta generated by the ADHS State Laboratory, and by contract laboratories, for the various ADE Q Programs. These data review activities use checklists, standard operating pro cedures, and standardized qualif ication codes to indicate data quality. The use of checklists and SOPs help st andardize the data review process. The extent58 and level of verification for indi vidual data sets should clearl y be defined in the Program’s QAPrP and/or QAPjP.

9.4.2 Data Quality Audits

A related evaluation tool involving data review and assessment is th e data quality audit which is

used to evaluate the documentati on of the quality of data genera ted for a given project. This assessment primarily involves an evaluation of th e completeness of the documentation of field and analytical procedures and qua lity control results, and usually involves tracing the paper trail accompanying the data from sample collection and custody to analytical results and entry into a database. This technique is commonly used to verify the process i nvolved in entering data residing in large re gulatory databases.

Results of both DQAs and data quality audits can be used in a number of ways. First, they can be used in making recommendations for change s in the design and performance of data collection efforts, and in the use and documenta tion of QC procedures. Secondly, they can be used as a guide for the planning and acquisiti on of supplemental data for the project and potentially for other related pr ojects. Problems identified th rough DQAs may trigger the need for an MSR to determine management deficienci es, or a TSA to identify technical problems.59 

## CHAPTER 10 QUALITY IMPROVEMENT

The ADEQ Leadership Team actively supports quality improvement by encouraging the ADEQ

staff to:



##  Continually evaluate the effectiveness of current policies, procedures, and practices via discussions of the QA/QC Steering committee and subsequent leadership review;



##  Apply innovative approaches while main taining integrity and accuracy. Conduct regular management reviews to define and celebrate success while recognizing and eliminating undesirabl e processes or results.

The above goals are achieved by continually co mmitting resources to the Agency’s quality management efforts. Peer review and performanc e audits will enable th e constant evaluation of ADEQ Programs, projects, and individual staff performance. The ADEQ Quality Management System is designed to identify opportunities for improving the measurement process. Improvement can take the form of preventi ng quality problems from occurring by adjusting current work processes, or by seeking out bett er ways to do the work. The ADEQ Integrated Quality Management process seeks to prevent quality problems from occurring, recognize challenges early, and celebrate success.

Continual improvement is achieved through consis tent evaluations of Program, project, and individual performances. Regular oversight allows ADEQ to reshape Program protocols to reflect changing methods or procedures.

10.1 PROGRAM REVIEWS

It is the responsibility of line management to a ssure staff participation in all Program reviews and to review annually all QA activities of their st aff, to determine that SOPs are in place and to revise them if necessary, to en sure that QAPrPs are written and approved in advance of project start-up, and to ensure that data quality assessments are made. A ll deviations and discrepancies noted during any independent or self-assessment review will be corrected promptly. Recommendations for modifications to the QM P will be forwarded in writing to the ADEQ QA/QC Steering Committee for implementation and inclusion during regula r review sessions, as

described in section 9.2.1.60 10.2 PROJECT REVIEWS

It is the responsibility of Project/Case Managers to request project review s and/or QA audits and to identify where improvements can be made. This process is started during the determination of data quality objectives and is finalized during the assessment of data quality. All corrective actions required during the life cycle of the project are to be filed in the official project file or with the project’s final report. Project team debr iefing is a regular component of project closeout. All data collection and testing pr ocedures are to be scrutinized for consistency within industry best practices.

The evaluation can include the findings resulting from scientific scrutiny (new technologies) or analytical measurements. The team will prepare a written report of its findings, for Division Management and the Agency Leadership Team, along with recommendations for improvement. The Leadership Team may choose to solicit other recommendations for improvement from persons not directly involved with the project. The ADEQ Leadership Team will decide which recommendations to implement in future projects.61 

# TERMS AND DEFINITIONS

Acceptable Quality Level - a limit above which quality is considered satisfactory and below which it is not. In sampling inspection, the maximum percentage of defects or failures that can be considered satisfactory as an average.

Accuracy - the degree of agreement between an obser ved value and an accepted reference value; a data quality indicator

.

Activity - an all-inclusive term describing a specific set of operations or related tasks to be performed, either serially or in parallel (e.g., research and development, field sampling, analytical operations, equipment fabrication), th at in total result in a product or service.

Assessment - the evaluation process us ed to measure the performance or effectiveness of a system and its elements. In this document, assessm ent is an all-inclusive term used to denote any of the following: audit, performance evaluati on, management systems review, peer review, inspection or surveillance.

Audit - a planned and documented investigative ev aluation of an item or process to determine the adequacy and effectiveness, as well as comp liance with established pr ocedures, instructions, drawings, quality assurance project pl ans, and other applicable documents.

Audit of Data Quality - a qualitative and quantitative ev aluation of the documentation and procedures associated with envir onmental measurements to verify that the resulting data are of acceptable quality.

Bias - the systematic or persistent distortion of a measurement process which causes errors in one direction; a data quality indicator.

Characteristic - any property or attribute of a datum, item, process, or service that is distinct, describable, and measurable.

Comparability - the degree to which different methods, da ta sets and/or decisions agree or can be represented as similar; a data quality indicator

Completeness - the amount of valid data obtained co mpared to the planned amount, and usually expressed as a percentage; a data quality indicator.

Computer Program - a sequence of instructions suita ble 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 pr ogram may be stored on magnetic media, and be referred to as "software", or may be stored permanently on computer chips, and be referred to as "firmware". Computer programs covered by this document are those used for design analysis,62 data acquisition, data reduction, data storage (data bases), operation or control, and data base or document control registers when used as th e controlled source of quality information.

Contractor - any organization or indivi dual that contracts to furn ish services or items or perform work.

Corrective Action - measures taken to rectify cond itions adverse to quality and, where necessary, to preclude their recurrence.

Criteria - a standard on which judgment is based.

Customer - any individual or organi zation for whom items or services are furnished or work performed in response to defined requirements and expectations.

Data - facts or figures from which conclusions can be inferred.

Data Base - a collection of integrated data that ca n be used for a variety of applications.

Data of Known Quality - data are of known quality when the qualitative and quantitative components associated with their derivation are documented appropriately for their intended use

and such documentation is verifiable and defensible.

Data Quality Assessment (DQA) - a process for performing stat istical analysis to determine whether the quality of a data set is adequate for its intended use.

Data Quality Indicators - qualitative statistics and quantita tive descriptors that are used to interpret the degree of acceptability or utility of data to the user. The principal data quality indicators are bias, precision, accuracy, comparability, complete ness, representativeness, and sensitivity.

Data Quality Objectives (DQOs) - qualitative and quantitative st atements of the overall level of uncertainty that a decision-maker is willing to accept in results or decisions derived from environmental data. DQOs provide the statis tical framework for planning and managing environmental data operations consiste nt with the data user's needs.

Data Usability - the process of ensuring or determining whether the quality of the data produced

meets the intended use of the data.

Defensible - the ability to withstand any reasonable cha llenge related to the veracity of integrity of laboratory documents and derived data.

Design Review - a documented evaluation by a team, incl uding personnel other than the original designers, the responsible designers, the customer for the work or product being designed, and a quality assurance representative to determine if a proposed design will meet the established design criteria and perform as expected when implemented.63 Electronic Data Deliverable (EDD ) – an electronic file containi ng data sorted into specific fields for different data constituents. Designed to be uploaded into data bases for overall data management without additional manual input of data.

Engineered Environmental Systems - an all-inclusive term used to describe pollution control devices and systems, waste trea tment processes and storage facilities, and site remediation technologies and their components that may be u tilized to remove pollutants or contaminants from the environment. Examples include wet sc rubbers (air), soil washing (soil), granulated activated carbon unit (water), a nd filtration (air, water). Usually, this term will apply to hardware-based systems; however, it will also appl y to methods or techniques used for pollutant

reduction or containment of cont amination to prevent further m ovement of the contaminants, such as capping, solidification or vi trification, and bi ological treatment.

Environmental Conditions - the description of a physical medium (e.g., air, water, soil, sediment) or biological system expressed in terms of its physical, chemical, or biological

characteristics.

Environmental Data - any information or measurements resulting from field data collection activity, laboratory analyses or modeling invol ving the assessment of chemical, physical, or biological factors related to the environment, and that describe environmental processes or conditions, or the performance of en gineered environmental systems.

Environmental Data Operations - work performed to obtain, use, or report information pertaining to environmenta l processes and conditions.

Environmental Monitoring - the process of measuring or collecting environmental data.

Environmental Processes - manufactured or natural processes that produce discharges to or impact the ambient environment.

Environmental Programs - generally considered a regulator y activity that results from the implementation of an act of Congress or other legislative body (e.g., a st ate). The duration of a Program is usually legally seven years, (subjec t to renewal by the legislative body at various intervals), and is effectively c ontinuous. Measurements are usually the same from year to year and take place on a recurring basis, e.g., quarterly monitoring for water or air pollutants, site assessments for Superfund, etc. Although the locati ons, parameters, and nature of measurements may change, the overall goal, which is to compar e data to a regulatory standard, is generally constant. The Clean Water Act, Resource Conserva tion and Recovery Act, Clean Air Act, etc. are examples of Programs, although not all data generation activities funded under these laws would necessarily be considered Program data if they fall into the project category (see below). A Program requires a QMP , describing its QA System, a nd usually a Program QAPP (QA Program Plan) to describe in detail the process by which Program data are obtained. In this document, an environmental Program also refe rs to functional areas of work performed by groups or teams of people within the ADEQ organization.64 Environmental Project - is defined as a data gathering activit y that usually is of a finite length. Project data quality objectives are established during the planning phase and an assessment is made at the completion to determine whether th e data quality objectives were met. Projects may include monitoring, but the data collected are freq uently not intended for the use in enforcement of a regulatory standard. A tria l burn, testing a new technology, a one-time ecosystem assesment and a habitat inventory are but a few examples of environmental projects. An environmental project requires a Quality Assu rance Project Plan (QAPjP).

Environmentally Related Measurements - any measurement or information that describes environmental processes or conditions, or the perf ormance of engineered environmental systems. Thus, environmental data include all chemical, physical, or biological measurements relating to the environment; however, it does not include demographic or financial data. In addition,

environmental data includes both direct measur ements of environmental conditions and data

collected from other sources such as literature, industry surv eys, computerized databases, historical data, and mathematical models. Data from such sources are often called secondary

data.

External Oversight - a term used to convey related ac tivities performed for EPA by ADEQ; usually performed under contracts, grants, or co operative agreements. Used in reference to Quality Assurance Project Plans a nd the Quality Management Plan.

Financial Assistance - the process by which funds are provided by one organization (usually government) to another organization for the purpose of performing work or furnishing services

or items. Financial assistance mechanisms include grants, cooperative agreements, and government interagency agreements.

Graded Approach - the process of basing the level of app lication of managerial controls applied to an item or work according to the intended use of results and the degree of confidence needed in the quality of the results.

Hazardous Waste - any waste material that satisfies the definition of "hazardous waste" as given in 40 CFR Part 261, "Identifica tion and Listing of Hazardous Waste".

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 - an examination or measurement of an item or activity to verify conformance to specific requirements.

Internal Activities - a term used to describe the ac tivities performed by ADEQ employees; usually used in relationship to Quality Assurance Project Plans, the QMP, contracts, or grants.

Item - an all-inclusive term used in place of th e following: appurtenance, facility, sample assembly, component, equipment, material, modul e, part, product, structure, subassembly, subsystem, system, unit, documented concepts, or data.65 Leadership Team - that group of ADEQ Management asse mbled and under the direction of the ADEQ Director. The Leadership Team consists of the following members: ADEQ Director; ADEQ Deputy Director; Waste, Wate r, Air and Administrative Dire ctors; Northern and Southern Regional Directors; Communications O fficer; and ADEQ Administrative Council.

Management - those individuals di rectly responsible and accountable for planning, implementing, and assessing work.

Management System - a structured non-technical system describing the policies, objectives, principles, organizational authority, responsibilit ies, accountability, and implementation plan of an organization for conducting work and producing items and services.

Management System Review (MSR) - the qualitative assessment of a data collection operation and/or organization(s) to establish whether the prevailing qualit y management structure, policies, practices, and procedures are ade quate for ensuring that the type and quality of data needed are

obtained.

Measurement Quality Ob jectives (MQOs) - Performance or acceptance criteria for individual data quality indicators, usually including precision, bias, sensitivity, completeness, comparability, and representativeness.

Method - a body of procedures and techniques fo r performing an activity (e.g., sampling, chemical analysis, quantification) systematically presented in the order in which they are to be

executed.

Mixed Waste - hazardous waste material, as define d by 40 CFR part 261 (RCRA), mixed with

radioactive constituents.

Peer Review - a documented critical review of work characterized by the existence of potential uncertainty. The peer review is conducted by qua lified individuals (or organization) who are independent of those who performed the work, but are collectively equivalent in technical expertise (i.e., peers) to those who performed the original work. The peer review is conducted to

ensure that activities are tec hnically adequate, competently performed, properly documented, and satisfy established technical and quality requirements. The peer re view is an in-depth assessment of the assumptions, calculations, extrapol ations, alternate interpretations, methodology, acceptance criteria, and conclusions pertaining to specific work and of the documentation that supports them. Peer reviews provi de an evaluation of a subject where quan titative methods of analysis or measures of succe ss are unavailable or undefined, such as in research and development.

Performance Evaluation Audit - a type of audit in which the quantitative data generated in a measurement system are obtained independently a nd compared with routinely obtained data to evaluate the proficiency of an analyst or laboratory.66 Performance Evaluation Sample

- (PE) a sample, the composition of which is unknown to the analyst, is provided to test wh ether the analyst/laboratory can produce analytical results within the specified performance limits.

Procedure - a documented set of steps or actions that systematically specif ies or describes how an activity is to be performed.

Process - an orderly system of acti ons that are intended to achie ve a desired end or result. Examples of processes include analysis, desi gn, data collection, opera tion, fabrication, and

calculation.

Qualified Data - any data that have been reviewed and assessed as part of data validation, or data verification, operations.

Quality - the sum of features and properties/characteris tics of a process, item, or service that bears on its ability to meet the stated needs and expectations of the user.

Quality Assurance (QA) - an integrated system of mana gement 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 customer.

Quality Staff - the EPA Headquarters office within th e Office of Environmental Information that establishes and promulgates Quality Assura nce Policy for the Agency. Formerly the Quality Assurance Management Staff (QAMS).

Quality Assurance Project Plan (QAPjP) - a formal document describing in comprehensive detail the necessary QA, QC, and other manage rial and technical activ ities that must be implemented to ensure that the results of the wo rk performed will satisfy the stated performance (data quality) objectives.

Quality Assurance Program Plan (QAPrP) – a formal document that describes the QA system for environmental Programs such as the Clean Wate r Act or Clean Air Act that is usually based on environmental regulations. It contains details like a QA Proj ect Plan, but at a organization wide or Program level and can function as a QA Project Plan or it may contain broader spectrum procedures that require additional QA Project Plans with more specific details.

Quality Control (QC) - the overall system of technical activiti es 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.

Quality Improvement - a management Program for improving the quality of operations. Such management Programs generally entail a fo rmal mechanism for encouraging worker recommendations with timely management evaluation and feedback or implementation

Quality Management - that aspect of the overall manage ment system of the organization that determines and implements the quality policy. Quality management includes strategic planning,67 allocation of resources, and other systema tic 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 organizational structure, functional re sponsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, and assessing all QA

activities conducted.

Quality System - a structured and documented manage ment system describing the policies, objectives, principles, organizational author ity, responsibilities, accountability, and implementation plan of an organization for ensu ring quality in its work processes, products (items), and services. The quality system pr ovides the framework for planning, implementing, and assessing work performed by the organiza tion and for carrying out required QA and QC procedures.

Readiness Review - a systematic, documented review of the readiness for the startup or continued use of a facility, process, or activity. Readiness reviews are t ypically conducted before proceeding beyond project milestones and prior to initiation of a major phase of work.

Remediation - the process of reducing th e concentration of a contam inant (or contaminants) in air, water, or soil media to a level that poses an acceptable risk to human health.

Self-Assessment - an assessment of work conducted by in dividuals, groups, or organizations directly responsible for overse eing and/or performing the work.

Sensitivity - - The capability of the measuring instrument to discriminate between the analytical response (e.g., absorbance, volume, meter reading) and background. In a specialized sense, it has the same meaning as the detection limit.

Service - the category of economic activity that does not produce manufactured items. In environmental data operations or engineering projects, such ac tivities include design, inspection, laboratory and/or field analys is, repair, and installation.

Significant Condition - any state, status, incident, or situ ation of an environmental process or condition of an engineered environmental system in which the work being performed will be adversely affected in a manner sufficiently seri ous to require corrective action to satisfy quality objectives or specifications and safety requirements.

Software Life Cycle - the period of time that starts when a software product is conceived and ends when the software product is no longer available for routin e use. The software life cycle typically includes a requirements phase, a design phase, an implementation phase, a test phase, an installation and check-out phase, an opera tion and maintenance phase, and sometimes a retirement phase.

Standard Operating Procedure (SOP) - a written document that details the method for an operation, analysis, or action with thoroughly pres cribed techniques and steps, and that is officially approved as the method for perfor ming certain routine or repetitive tasks.68 Supplier - any individual or organi zation furnishing items or services or performing work according to a procurement document or financial assi stance agreement. This is an all-inclusive term used in place of any of the following: vendor , seller, contractor, subc ontractor, fabricator, or

consultant.

Surveillance - the act of monitoring or observing a pro cess or activity to verify conformance to specified requirements.

Technical Review - a documented critical review of work that has been performed. The review is accomplished by one or more qualified revi ewers who are independent of those who performed the work, but are collectively equiva lent in technical expertise to those who performed the original work. The reviews are an in-depth analysis and evaluation of documents, activities, material, data, or items that re quire technical verifica tion or validation for applicability, correctness, adequ acy, completeness, and assurance that established requirements

are satisfied.

Technical Systems Audit (TSA) - a thorough, systematic, on-site qua litative audit of facilities, equipment, personnel, training procedures, reco rd keeping, data validation, data management, and reporting aspects of a system.

Validation - an activity that demonstrates or confirms that a process, item, data set, or service satisfies the requirements defined by the user.

Verification - the act of authenticating or formally asse rting the truth that a process, item, data set, or service is, in fa ct, that which is claimed.69 

## APPENDICES

ADEQ Temperature/Preservation Guidance Policy

ADEQ Policy 0154 - Addressing Spike and Surrogate Recovery As They Relate to Matrix Effects in Water, Air, Sludge, and Soil Matrices

ADEQ Policy 0170 – Implementation of EPA Method 5035 - Soil Preparation for EPA Methods 8015B, 8021B, and 8260B

Arizona Data Qualifiers – Revision 3 (0 9/20/2007)Attachment J

PCWRL Quality Manual