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QUALITY ASSURANCE PROGRAM PLAN FOR

TECHNICAL ENFORCEMENT SUPPORT AT

HAZARDOUS WASTE SITES

ZONE III

PRC Environmental Management, Inc.

Revised January 1992

• 30221193

ililili Superfund

TABLE OF CONTENTS

Section £g£f.

1.0 APPROVALS 1

2.0 INTRODUCTION 1

2.1 BACKGROUND 1 2.2 PURPOSE 1 2.3 OBJECTIVES AND SCOPE ] 2.4 DEFINITION OF TERMS 2

3.0 QUALITY ASSURANCE POLICY 3

4.0 QUALITY ASSURANCE MANAGEMENT 4

4.1 ORGANIZATION 4 4.2 RESPONSIBILITIES AND AUTHORITY 6

4.2.1 Program QA Manager 6 4.2.2 Lead Regional QC Coordinator 6 4.2.3 Woric Assignment Manager QC Functions 7

4.3 INTERNAL CONTROL 7 4.4 REPORTS TO MANAGEMENT 9 4.5 PROGRAM QUALITY ASSURANCE PLAN 9 4.6 DOCUMENT REVISIONS 9 4.7 DOCUMENT CONTROL 10 4.8 SUBCONTRACTOR REQUIREMENTS 10

5.0 QA OF FACILITIES, EQUIPMENT, AND SUPPLIES , , 10

5.1 RESPONSIBILITIES 10 5.2 IDENTinCATION OF EQUIPMENT , 10 5.3 CALIBRATION, INSPECTION, AND TESTING 11 5.4 RECORDKEEPING 11

6.0 DATA GENERATION II

6.1 ENVIRONMENTAL MEASUREMENTS-SCOPE 11 6.2 LEVELS OF QUALITY CONTROL 12 6.3 WORK ASSIGNMENT AND OTHER ACTIVITY 6.4 QUALITY ASSURANCE PLANS 12

7.0 DATA REDUCTION AND VALIDATION 13

- 7,1. . - ^ R £ P . U J : 3 I I Q J ^ ^ I ^ 4 ^ ^ A M S E ^ ^^^^ - . . . ^_ . . ... ..„ «^„-..„...... .43 7.2 DATA VALIDATION , 14

8,0 DATA QUALITY ASSESSMENT 14

8.1 REPRESENTATIVENESS 14 8.2 COMPARABILITY , 14 8.3 COMPLETENESS 14

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TABLE OF CONTENTS (Continued)

Sgct'oq £ag£.

9,0 PEER REVIEW 15

9.1 REPORTS OF WORK 15

9.2 OUTSIDE CONSULTANTS 15

10,0 AUDITS 15

11,0 CORRECTIVE ACTIONS 17

LIST OF EXHIBITS

Exhibit Page

1 QUALITY ASSURANCE ORGANIZATION STRUCTURE 5

2 REPORT REVIEW CHECKLIST 8

3 - AUDIT REPORT 16

4 PRC WORK ASSIGNMENT CORRECTIVE ACTION REQUEST FORM 18

5 PRC QA CORRECTIVE ACTION STATUS FORM 21

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1.0 APPROVALS

This Quality Assurance Program Plan describes the quality assurance requirements pertinent to ail technical tasks in which documentation is developed or acquired In support of site investigations, compliance oversight design or evaluation of remedies, feasibility studies, and other technical activities to support enforcement action. It includes environmental measurements produced and analyzed in support of hazardous site evaluations or monitoring activities. This document i» controlled and may not be revised or reproduced without the express written consent of the PRC program QA manager,

2.0 INTRODUCTION

2.1 BACKGROUND

This quality assurance (QA) program is established for the U.S, EPA TES Program for Zone III (TES) to ensure that appropriate technical and procedural standards are met for all reports of work, data, and documentation, PRC requires all subcontractors to participate in this QA program.

2.2 PURPOSE

QA encompasses all actions taken in TES work assignments to ensure that the results and conclusions produced are accurate and reliable. An established QA philosophy and QA program are essential for consistent production of valid data and documentation in support of site investigations, remedial planning and review of remedial plans, enforcement case preparation, site monitoring, and other efforts that are assigned to PRC by EPA. The QA program also ensures that valid data are interpreted by capable personnel who are trained in appropriate scientific and engineering disciplines.

Quality control (QC) is the check system implemented within work assignment teams to ensure that quality work is performed.

This document describes explicit procedural methods of QA and provides written procedures and guidelines that facilitate attainment of congruent levels of QC on all work assignments by providing policy guidance for the development of work assignment specific QA project plans.

2.3 OBJECTIVES AND SCOPE

TTie objectives and scope of the QA program include:

• Provision for and scheduling of an independent review of all technical products to assure that documentation provides accurate and acceptable responses,

• Coordination of quality assurance and quality control (QA/QC) procedures which 7-.provide=adocumentable^-xonsistent«leyeliOf^quaIity'forenvironmental measurements,

-• ...Goordination.ofjQA project (work^assignment) plan development as-an-:integral part of the preparation and planning for all field work involving sampling and laboratory analysis, and the incorporation of QA provisions in the work plans for other work assignments. Plans are designed to ensure the adequacy of the technical product specified by EPA, both as to technical content and the document control procedures that ensure its security.

• Identification of QA/QC deficiencies and coordination of expeditious resolutions.

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• Assurance of systematic, timely revisions of QA/QC procedures as needed.

• Responsibility for documentation of all data collected, stored, reported, or used as scientifically valid, defensible, and of known, documented precision, accuracy, and origin, to ensure that data and/or information limitations are not exceeded in any use.

2.4 DEHNITION OF TERMS

Quality Assurance (OA) — An auditing and review function carried out by qualified technical QA personnel to ensure legal defensibility, accuracy, and validity of data, procedures, or documents and to assure consistent technical report standards.

Quality Control (OC) — Review and check processes to ensure that quality work is performed. The work assignment managers and the QC coordinators are responsible for QC.

Precision — Degree of mutual agreement among individual measurements made under prescribed conditions relative to the data from a single test procedure.

Accuracy — Degree of closeness of measurements in relation to the "true* quantitative value or absolute standard,

Defensibility -- Ability to document the origin, chain of custody, matrix of scientifically-acceptable operations performed, reduction, and transcription of data, so that their limitations, representativeness and applicability are known.

Representativeness -- Assurance that presented data are statistically sound and accurately show the physical or chemical state of the parameters tested/measured at a given time and place.

Completeness — The property of a database that relates to its ability to describe thoroughly, enumerate, or interpret environmental phenomena.

Chain of Custody -- Documentation that describes the physical control of a sample, measurement, or document.

Standard Operating Procedures (SOP) -- A written, sufficiently detailed set of instructions that facilitates the reproducible and/or cost-effective implementation of each of the elements of a work plan, QC, QA, administration, or procurement. Such SOPs are the translation of policy into operation. *

Quality Levels —

Level 1: This level requires special permission to be used on a project because it is below the normal EMI QA/QC requirements. If permitted, a Level 1 review requires the author of a work product to review the product, but does not require a separate review by another person. In most cases, the author would be a senior staff member of EMI, well experienced in the type of work to "be performed. An editorial review is not required but'hijhly desirable.

''Level 2: This level also requires special permission to'be used on a project. '''Basically,'the author of a work product is required to have it reviewed by another person or a member of the work team, usually a person experienced in the type of work performed. Again, an editorial review is highly desirable.

Level 3: This is the level EMI currently uses on all projects. It involves work product reviews by three people: an ER, TR, and QCC, ail of whom are outside the work team, QC review

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of calculations and analyses are part of routine engineering practice. However, documented QA reviews are also required in the case of such calculations and analyses. The various forms used to document QA reviews are described in Section 5 of this statement.

Level 4: This level requires the same reviews as required for Level 3, plus reviews of intermediate steps leading to the final work product. (In the case of calculations and analyses, thu Level 4 review requirements are the same as those for Level 3.) In addition, a special program must be prepared to show the planned reviews at the various stages or milestones. Again, QA forms used to document these reviews are explained in Section 5. Examples of this level of QA/QC are project-: of long duration without many intermediate deliverables or projects involving large volumes of dat i and potential litigation, such as PRP searches.

Level 5: This level requires that the discipline manager and discipline directors review tho qualifications of key staff assigned to the project at the authorization stage before work is started. The form used to document this participation is described in Section 5. The work product review requirements are the same as those for Level 4, Examples of this level of QA/QC are projects involving services for which our staff members have little or no previous experience and projects involving consultants or agencies of our caliber on behalf of parties facing our clients.

Level 6: For Level 6, a special QA/(JC program is required; it will usually involve the participation of outside specialists in some capacity to supplement EMI staff or to review the work performed. No special QA form is used, but a file memo is required for documentation purposes. Tlie other requirements for this level are the same as those of Level 5.

3.0 QUALITY ASSURANCE POLICY

The policy of the enforcement support program is to maintain an active QA program to provide the highest quality data and results to achieve the goals of each activity undertaken. To accomplish this goal, the following staff QA responsibilities are clearly defined:

• The program QA manager has technical and administrative responsibility for the overall QA program.

• The program QA manager has the authority to require implementation of action to document and correct any situation that creates an negative impact on the quality of data or documentation related to its intended and specified use.

• The program QA manager reports as necessary to the PRC group president. Dr. Tom Brisbin, and consults frequently with the program manager.

• The program QA manager refers all QA issues or disputes that cannot be resolved within the program to the PRC group president. Direct channels of communication are provided for this function.

• The QA program will be implemented in each of the three regions by the QCr coordinators and other senior technical staff,

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• All data must meet the following standards:

Environmental data will be collected using available SOPs if applicable, and approved for the intended use of the data (for example. Test Methods for Evaluating Solid Waste SW-846, NEIC sampling and chain-of-custody procedures, or current edition

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of Standard Methods, SOPs will be developed, if necessary, to serve special needs and will be attached to the Quality Assurance Project Plan, if required by EPA.

Work plans must be developed to define the scope of major activities.

Specific QC procedures must be developed for all major activities that produce or use environmental data.

Acceptance criteria for the quality of the data must be specified in writing before data are collected.

The program manager may give approval to waive requirements for a written QC procedure when standard operating procedures are specified by EPA and available for use.

The precision, accuracy, representativeness, and completeness of all data are defined and reported and documentation is maintained on file.

Data validation procedures will be documented, routinely reviewed, and revised (if necessary). All data will be validated according to specified regional criteria.

QA manager or designee will plan and implement regular and random audits of all technical operations.

A mechanism for identifying QA problems and expediting corrective actions will be maintained for all work assignment teams. The program QA manager will work with program management, regional QC coordinators and work assignment managers to develop, revise, and implement mechanisms as needed. These mechanisms are consistent with PRC EMI's company-wide QA/QC policies and procedures.

4.0 QUALITY ASSURANCE MANAGEMENT

4.1 ORGANIZATION

The PRC program QA manager is responsible for QA. The QA program depends on organizational independence. Accordingly, the program QA manager reports to the PRC group president, Tom Brisbin.

This plan complies with EPA requirements for QA program plans as described in QAMS-004/80, "Guidelines and Specifications for Preparing Quality Assurance Program Plans." Central to the QA program is the independence of the QA program team as shown in QA Organization Structure, Exhibit 1.

All subcontractors* QA program managers are responsible to the PRC QA manager and PRC ^TES programiimanager^f orahe :quality<ofiithe.iSubcontractors*^work,

-ThePRC^program^QA^manager^isresponsible-fopprovidingdirection and guidance to all PRC regional office staff, subcontractors' QA managers, and to each of the regional PRC QC coordinators, and for auditing or directing designees* auditing of all phases of the technical efforts within selected work assignments. Primary quality control, within the guidelines of the QA program plan; the generation of control and calibration data; documentable sample control and data management; and documentation of the sources of all information acquired are the responsibility of the work assignment teams, with direction and guidance from the regional QC coordinators,

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• NCTO EXHIBIT 1 - QUALITY ASSURANCE ORGANIZATION STRUCTURE

CO

Group Pr^ident ToniBfishin

kL

Subc^niMctor

Managers

PRC QA Manager Elolse Bean

PRC Regional QC Coordinators Ed Schuessler - Lead R. V Tony Gardrwr - Lead R. VI David Homer - Lead R. Vll

PRC TESProgrEun

Manager

EPA Headquarters Project Officer

009C11001CM QA-ORG.DRW 01/27/92

Management Authority & Communicatkxi QA Authority Direct Problem Resolution

4.2 RESPONSIBILITIES AND AUTHORITY

4.2.1 Program QA Manager

The program QA manager is responsible for the quality of all work performed by PRC in the TES program in all three regions. Generally, all QC work involving review of the work product will be performed in each of the PRC regional offices. She manages development and maintenance of a comprehensive QA program. She audits and/or reviews for all work performed and issues recommendations about quality to technical staff and management. The program QA manager's specific responsibilities include:

• Meeting regularly with the program manager and PRC regional QC coordinators,

• Developing and revising the QA program, as required,

• .. Supervising the QA responsibilities of the regional QC coordinators.

• Coordinating and auditing QA review of documentation, as required.

• Providing recommendations and orders, as required, for corrective action for all aspects of work that do not meet program standards.

• Identifying nonconformance situations to management, as needed.

• Providing guidance for work assignment team QC program development and correcting nonconformance situations.

• Interacting with EPA regional QA personnel about certification of laboratories and subcontractors, and coordinating QA and technical staff compliance with requirements, to the extent required under the contract in each region, with expert technical assistance used as needed.

• Ensuring compliance with orders and/or recommendations to work assignment team leaders regarding corrective action.

4.2.2 Lead Regional QC Coordinators

The lead regional QC coordinators are the regional managers assigned to each region. They are responsible for the quality of all work performed by PRC in their respective EPA regions under the TES program. They manage the QA program within their regions. They or their designees audit and/or review work performed and issue recommendations about quality to the regional technical staff and management. They regularly communicate with the program CA manager to discuss QA problems or resolutions. The lead regional QC coordinators* specific responsibilities include:

• 'Recommending any revisions to'the^QA program,

«• 'Supervising'the-QA^responsibilities-df^the other QC'COordinators in'their regions,

• Coordinating and auditing QA review of documentation, as required,

• Providing recommendations and orders, as required, for corrective action for all aspects of work that do not meet program standards,

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• Providing guidance for work assignment team QC program development and correcting nonconformance situations.

• Interacting with EPA QA personnel and the PRC program QA manager about certification of laboratories and subcontractors, and coordinating QA and technical staff compliance with requirements,

• Ensuring compliance with orders and/or recommendations to work assignment team leaders regarding corrective action.

4.2.3 Work Assignment Manager QC Functions

The work assignment managers are responsible to the regional lead QC coordinator, and through the lead QC coordinator to the program QA manager for monitoring and documentation of the quality of all work produced or generated by the work assignment teams. Specific responsibilities are:

• Preparing a QA project plan for those work assignments involving field data collection, for which one is required by EPA

• Ensuring that the team completes all QC requirements of the work plan, and this program plan,

• Maintaining and regularly reviewing all QC records, and forwarding copies to the QA Manager

• Assuring that all document control procedures are followed, according to the document control guidance

• Monitoring sample preservation, handling, and transport throughout the project,

• Approving all data and documentation before transmittal, through signing of transmittal letter by the work assignment manager or designee.

• Establishing and maintaining liaison between the work assignment team and the PRC regional QC coordinators

• Ensuring by personal observation that appropriate sampling, field testing, and field analysis procedures as specified in the work piao and QA project plan are followed and that correct QC checks are being made.

4.3 INTERNAL CONTROL

'«As4an 'integral ;part<.'of':the^QA:program,'«PRC°«has-^a-successful-^internal control program ^o • <^;prevent^dyerse3nnpact4o!theiirESi}rogtam^=W4ien^!a^e]i«erablosfor.^^

the-work.assignment^managerJs^responsible for:theinitiation of-an^independent-QC^review. ^The manager prepares a PRC Report Review Checklist (Exhibit 2) to be completed by the reviewers at each step of the QC review. The deliverable is first reviewed by a technical editor. Second, one or more senior technical staff members independent of the project team reviews the deliverable. Finally, the lead regional ( ^ coordinator or his designee reviews the deliverable.

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EXHIBIT 2 - REPORT REVIEW CHECKLIST

PRC EnvironoeBtai Management, Inc. QA/QC Level _Q_

Protect/Contract No. . . 1 rnUnt /Rnn t r a f t Typ« • TitU: D L P R O CbadOUt Initiktod Br: WA Mp'./T*ch. Monitor Project ManiKcn Editorial

Reriewer fTR): QC CoordiDktor fOCC^: Word ProceMiof (WPV.

lUm

Introduction SiU/Project

Vklidity of Dat» Uauaual Site Condition! Studied Pertinent

Supported Concluiioni JuitiQkble Recommendetioni Teblee ic Ficurei Cited ii Attached Complete Reference Lift Attached

Aooendicee Attached Clear U Readable Text Overall OrraniEation Technical Adeouacv/Accuracv Tech. Complete, All Altem. Coniidered Scope of Work Plan Obiectivei Covered Supporting Maieriala Ueed in Tech ReviewT Report Pormat Coneietencjr in

Appropriate

Prim Reeo

ER

A A

TR

TR

TR

TR

TR

ER

ER

Ai'A

ER

ER

TR

TR

TR TR

ER

ER

GR

See Re»D

\/A

/A

^I'A

\/A

MA

/A

N/A

M\

MA

MA

KQ

KQ

ac<?

* Worii product types: D for'datafa Reeponiiibilily: ER = Editorial Revi Beet UM QA4 to documuit detaUed

Deadline l i t Draft / / DateRae'd trem Sub / / Deadlina ER Rrriew; / /

Deadlina QCC Review: / /

Changee Not Rea'd

Chance* Chanfei Needed

aee, L for letter, P for plani R for re ewer; TR = Tech Revievor; QCC s commanti and lUt neeaiaary chaof«

Pinal Raviev Deadline / / Date Drafted / / Data Raviewed: / / Data

Reviewed: / / OaU Reviewed: / /

Draft or Final: No. of Pares: DaUvery Due DaU / / Author of Work Product:

SlEnature:

SImature:

Slnisture:

Speciitc CommenU er Reference to Form QA4 Attached

tort, O for other type. Circle one. Quaiity Control Coortlinator, A/A = as appropriate

,

All conunents resolved and chanc** mad* _ or not required „ : _ _ _ ^ ^ _ _ _ _ _ _ _ _ _ _ ^ _ ^ _ _ ^ _ _ _ _ ^ ^ _ _ ^ QCC Sicnatura DaU

Distribution: 1) Oiiginal and detailed comments abeets, if any, plus copy of final venion to project file ]) Copy of checklist tt detailed comments sheets, if any, plus hard copy of Cnal version to QA/QC file S) Copy to Tech Reviewer 4) Copy to QCC

D068:OA3-7:3/91 Form 0A3. Rev

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If corrective action is not required the QC coordinator signs the form so indicating and distributes copies of the checklist to the program QA manager, project file, QC coordinator, and technical reviewer. The QC coordinator has final authority for release of the work product. Release occurs when the QC coordinator signs the Report Review Checklist (Exhibit 2) indicating that corrective action is not required.

When corrective action is necessary, it is so noted on the checklist and the work product. Both are returned to the work assignment manager for further action. Upon completion of corrective action the work product is returned to the QC coordinator for final review. If the corrective action has been properly completed, the QC coordinator signs the checklist and distributes copies as stated. The work product is then sent to EPA.

4.4 REPORTS TO MANAGEMENT

The program QA manager prepares monthly reports to the PRC program manager, the PRC group president, and, upon request, to the EPA zone and regional project officers. These reports include:

• QA audit and other inspection results. • Instrument, equipment, or procedural problems that affect QA. • Past due corrective actions. • Objectives from the previous report that were achieved. • Objectives from the previous report that were not achieved. • Work planned for the next month. • Subcontractor performance issues, if any

4.5 PROGRAM QUALITY ASSURANCE PLAN

This program QA plan is applicable to the overall PRC TES program for Zone III. This plan specifies the QA objectives of the program and defines the procedures used to document those objectives. The program QA plan therefore enhances the validity of the data to be used for decision making and enforcement actions. It provides mechanisms to:

• Monitor and control the management of data and information to document validity,

• Document the precision, accuracy, and sensitivity of the sampling and analytical systems,

• Recognize deficiencies early and provide a mechanism for correction.

4.6 DOCUMENT REVISIONS

The QA program requires updating of all existing technical SOPs. Changes in these documents are made by issuing: (1) an entirely new'docuinent,'(2) replacement pages, (3) an errata sheet, 0^(4) wtitteh Irevisidns to' the 6ngin¥l iaocumeht7'^eapients"bTllocuiiient changes are

*responsible'toremove^airrevisea'pages''orsections'arid"replace''-them with revised copies,^Document preparers ensure that the QA manager and all other staff receive copies of the SOPs and the revision;; to them, EPA guidance updates are distributed by the PRC program manager through PRC*:; librarian and library.

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4.7 DOCUMENT CONTROL

All PRC staff are required to handle all work assignment documents according to the established PRC document control (handling) procedures. PRC has instituted document control procedures for the following types of documents:

• Regular work assignment documents • RCRA Cfil documenu • TSCA CBI documents

EPA has approved PRC's procedures for handling RCRA CBI and TSCA CBI under this contract. Each work assignment manager is responsible to follow the appropriate document handling procedures in compiling a work assignment file which consists of all pertinent documents and reports for that work assignment.

For each regional office, PRC has assigned a document control administrator (DCA) to manage the work assignment files. The overall responsibilities of the administrator are to ensure that established PRC procedures are followed, PRC has also assigned a document control officer (DCO) in each regional office to be responsible for all CBI documents,

A secure central file for each work assignment is maintained in each regional office,

4.8 SUBCONTRACTOR REQUIREMENTS

Team subcontractors must fulfill all contract requirements for QA, To properly assess the quality of subcontractors' environmental measurements and other support, a written QC plan must be in place and implemented by each team subcontractor. This plan is subject to audit by the PRC QA manager to assure adherence and adequacy.

5.0 QA OF FACILITIES, EQUIPMENT, AND SUPPLIES

5.1 RESPONSIBILITIES

The work assignment managers and the regional lead QC coordinators have primary responsibility for QC of supplies and equipment. Specification of quality of supplies and capability of equipment as it relates to QA objectives is included in the pertinent SOPs.

5.2 IDENTIFICATION OF EQUIPMENT

Field and laboratory equipment are uniquely identified. Each piece of non-disposable equipment has a unique PRC inventory tag. An inventory of equipment is maintained and updated regularly, at PRC's equipment warehouse in Addison, Illinois. The inventory provides the following -information:

•^ >iDescription-,of=Item'including:'Part'*Number and Manufacturer Quantity Unit (Size) Of Equipment Status Date of Update Inventory Number Cost

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Records of service and calibration are maintained at the warehouse for the appropriate pieces of non-disposable equipment.

5.3 CALIBRATION, INSPECTION, AND TESTING

Measuring and testing equipment is calibrated, adjusted, and maintained at prescribed intervals or, prior to use, kgainst standards provided by the manufacturer, or against certified equipment with known valid relationships to nationally recognized standards. Procedures for calibration, testing and maintenance are kept at the warehouse and with the equipment for reference.. For field equipment, calibration and testing instructions accompany the equipment.

The method and interval of calibration for each item is based on the type of equipment, stability characteristics, required accuracy, intended use, manufacturer's recommendation, and other conditions affecting measurement control. The method and interval of calibration are specified in the appropriate accompanying procedural documents.

5.4 RECORDKEEPING

Documentation is maintained and processed in an efficient manner to avoid unnecessary expense or delay when a record is needed. Sufficient records are prepared during the performance of the work assignment to furnish documentary evidence of the conduct and quality of the work.

The PRC document control procedures (refer to Section 4.7) provide adequate control, and security for all program-related information. Data/document control includes receipt from external or internal sources, preliminary secure storage, transmittal^ entry of identification data into the document control system, transfer to storage, chain of custody procedures for withdrawal from storage, and records of document status and custody. Retention includes receipt at storage areas, indexing and filing, storage and maintenance, and retrieval.

PRC document control room in each regional office and temporary work assignment team facilities in the field will provide a suitable environment that minimizes deterioration of or damage to documentation, and prevents loss. These facilities will have controlled access and provide protection from excess moisture and temperature extremes. Records are placed in folders or envelopes, or otherwise secured for storage in containers (such as locked room or locked steel file cabinets).

All storage systems allow for the prompt retrieval of information for reference or use outside the storage areas. Program records are accessible to EPA on demand.

6.0 DATA GENERATION

6.1 -?ENV.IRONMENTAL'MEASUREMENTS-SCOPE

The scope ofvQA extends toaHenvironmental measurements.-An environmental measurement is described as any physical observation, measurement, analysis, or any output of a predictive tool or model that is used to describe the chemical, biological, or physical status of the environment or an environmental process. Environmental measurements are of known, specified quality and are documented through QA procedures and records.

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6.2 LEVELS OF QUALITY CONTROL

All environmental measurements made in support of the EPA enforcement program are covered by a statement of the quality and limitations of the data. In general, such data fall into four general levels.

Level 1: This level requires special permission to be used on a project because it is below the normal EMI QA/QC requirements. If permitted, a Level 1 review requires the author of a work product to review the product, but does not require a separate review by another person. In most cases, the author would be a senior staff member of EMI, welt experienced in the type of work to be performed. An editorial review is not required but highly desirable.

Level 2: This level also requires special permission to be used on a project. Basically, the author of a work product is required to have it reviewed by another person or a member of the work team, usually a person experienced in the type of work performed. Again, an editorial review is highly desirable.

Level 3: This is the level EMI currently uses on all projects. It involves work product reviews by three people: an ER, TR, and QCC, all of whom are outside the work team. QC review of calculations and analyses are part of routine engineering practice. However, documented QA reviews are also required in the case of such calculations and analyses. The various forms used to document QA reviews are described in Section S of this statement.

Level 4: This level requires the same reviews as required for Level 3, plus reviews of intermediate steps leading to the final work product. (In the case of calculations and analyses, the Level 4 review requirements are the same as those for Level 3.) In addition, a special program must be prepared to show the planned reviews at the various stages or milestones. Again, QA forms used to document these reviews are explained in Section 5. Examples of this level of QA/QC are projects of long duration without many intermediate deliverables or projects involving large volumes of data and potential litigation, such as PRP searches.

Level 5: This level requires that the discipline manager and discipline directors review the qualifications of key staff assigned to the project at the authorization stage before work is started. The form used to document this participation is described in Section S, The work product review requirements are the same as those for Level 4, Examples of this level of QA/QC are projects involving services for which our staff members have little or no previous experience and projects involving consultants or agencies of our caliber on behalf of parties facing our clients.

Level 6: For Level 6, a special QA/QC program is required; it will usually involve the participation of outside specialists in some capacity to supplement EMI staff or to review the work performed. No special QA form is used, but a file memo is required for documentation purposes. The other requirements for this level are the same as those of Level 5,

6.3 WORK ASSIGNMENT AND OTHER ACTIVITY QUALITY ASSURANCE PLANS

^QAEproject^plans^for^work,assignments^and.other.^specified=work^activities4hat'involve .•;^jnp_Ungjtnd^aljr_sLs,.rif requiredJ[>y^EPA,^

in consultation with the regional lead QC-coordinators and the^program QA manager. Such plans support the scope of the work assignment plan by defining the QA objectives and QA/QC procedures that are used to meet those objectives. Such plans are approved by EPA before the field work begins and serve as documented understanding of the QA requirements of the work, QA project plans can be organized into the following sections and may contain the listed information:

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1,0 APPROVAL PAGE (Signature)

EPA Regional Project Officer EPA Regional QA Staff EPA Work Assignment Primary Contact

PRC Program QA Manager PRC Regional Manager PRC Regional QC Coordinator PRC Work Assignment Manager

2.0 TABLE OF CONTENTS

3.0 PROJECT (WORK ASSIGNMENT) DESCRIPTION

Purpose of Work Brief Description and Objectives

4.0 PROJECT (WORK ASSIGNMENT) ORGANIZATION

AND RESPONSIBILITIES

5,0 QA OBJECTIVES

6.0 SAMPLING PROCEDURES

7,0 SAMPLE CUSTODY

8.0 CALIBRATION PROCEDURES, REFERENCES AND FREQUENCY

9.0 ANALYTICAL PROCEDURES AND SYSTEMS CONTROL (if applicable)

10.0 DATA REDUCTION, VALIDATION AND REPORTING

11.0 INTERNAL QUALITY CONTROL CHECKS AND FREQUENCY

12.0 QUALITY ASSURANCE PERFORMANCE AND SYSTEMS AUDITS

13.0 QUALITY ASSURANCE REPORTS TO MANAGEMENT

14.0 PREVENTIVE MAINTENANCE PROCEDURES AND SCHEDULES

15.0 ROUTINE DATA ASSESSMENT PROCEDURES

16.0 CORRECTIVE ACTION

17.0 QA PLAN IMPLEMENTATION SCHEDULE

n.4i *DATA DEDUCTION AND -VALIDATION

7.1 REDUCTION AND TRANSFER

Data reduction and transfer are essential functions in summarizing information to support conclusions. It is essential that these processes are performedl accurately and, in the case of dati reduction, accepted statistical techniques are used. Data reduction includes computation of summary

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statistics, their standard errors, and confidence intervals or limits. Available EPA guidance should be followed by the work assignment manager in executing data reduction and transfer steps.

7.2 DATA VALIDATION

All data that are used to support enforcement program activities must be valid for the intended purpose(s). Such validation requires a trail of data and information handling practices and assessments to determine the attributes of the data base. The validity of a set of data is determined by comparison with a predetermined set of criteria, established by EPA, Data validation criteria will be specified in each EPA-required QA Project Plan.

8.0 DATA QUALFFY ASSESSMENT

Based upon planned data usage and available referenced material measurements and documentation, all environmental measurements are assessed for precision, accuracy, representativeness, comparability, and completeness.

Approved (JC methodology is used for data quality assessment. These procedures meet or exceed EPA guidelines (EPA 1979; EPA 600/4-79-019), In situations not covered in these references, suitable QC methodology is selected or developed and reviewed by the EPA regional QA/QC staff, PRC regional QC coordinators, and the PRC program QA manager, for acceptability.

8.1 REPRESENTATIVENESS

QA project plan procedures document that all samples collected accurately represent the media and environment. The approach includes a description of sampling methods and procedures, and preservation techniques used to ensure continued representativeness and sample integrity. Maximum sample holding period and sample storage requirements are defined. Sample collection frequency and site selection rationale are documented.

8.2 COMPARABILITY

QA project plan procedures provide guidance to assure the comparability of data. Such procedures include:

• Use of available SOPs and standard or accepted procedures • Appropriate reporting units • Standardized data format

8.3 COMPLETENESS

iThe quantity ofrdata neededio^meetproject objectives changes'with the statistical variability inherent.Jn^the?analy.tJi£^Ume^th<Mls.--Jaie.i[jA^piajecta^ sufficienttoachieve.thestatedobjectiv.es.

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9.0 PEER REVIEW

Peer review is a part of the procedure routinely used to assess work assignment managemen't and team performance,

9.1 REPORTS OF WORK

Peer review of all reports of work, data, and documentation generated or acquired by th(! work assignment teams is performed at two levels. Work plans and monthly progress reports are, at minimum, reviewed by the work assignment manager and regional manager before being submitted to EPA and the PRC program manager. All other deliverables, including those containing results and conclusions for site investigations or concepts for remedial action require a higher level of revie\ ' and all requirements of the Report Review Checklist (Exhibit 2) are utilized. In addition to review by the appropriate work assignment manager, review and approval by the technical editor, the technical reviewer(s) and the regional QC coordinator, are normally required. Problems at this stage; are resolved between the appropriate work assignment manager and these internal peer reviewers. After this internal peer review, the documentation may be subject to additional peer review at the discretion of the regional QC coordinator or the regional manager. Peer review is normally conducted by senior technical staff. The responsibility of the regional QC coordinator is to approve the documentation after assuring proper peer technical review.

9.2 OUTSIDE CONSULTANTS

It is the policy of PRC to use professional outside consultant technical review whenever all of the following are met

• It is in the best interest of the EPA and does not violate contract confidentiality or COI requirements.

• It is in the best interest of the TES program

• It is approved by the EPA Contracting Officer in the work plan

10.0 AUDITS

Audit procedures are routinely used by the QA program to assess and document performance of technical work. Audits are performed at scheduled intervals by the program QA manager, or designee, regional lead QC coordinators, or designees, and senior technical staff, as appropriate. A copy of the audit results (Exhibit 3 shows an example report) will be submitted to the program manager, regional manager and work assignment manager, and PRCs group president. These audits form one of the bases for corrective action requirements and constitute a permanent record of the conforitiance of activities to QA requirements. These results are available for EPA review, if necessary,

^ Audits-jiay include.inspections-for^herence.to4hejwoi^kj>jan,4iealthand.safety.j?roced4ir^s, activity performance-aind records, budget status,-QC data, calibrations, conformance to SOPs, or compliance with laws, regulations, policies, and procedures. An individual audit plan is developed to provide a basis for each audit, and may include one or all of the above items.

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EXHIBIT 3 - AUDIT REPORT

Work Assignment No.:. W,A, Manager. Region: Firm:

Date of Audit: Auditor PRC Regional Manager

Brief Description of Work Assignment

Audit Summary:

Corrective Action Required:

Remarks:

' Auditor Signature: *Date:.

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Most audits are performed by the QA manager or designees; however, technical specialists are employed as necessary. All auditors are independent of the activities audited. When an independent auditor or audit team Is required, selection is based on the activities to be audited and their complexity. The selection process considers technical expertise and experience in auditing.

A lead auditor serves as audit team leader. Lead auditor responsibilities include the selection and preparation of the team, coordination of the audit process, communications with the work assignment team or organization being audited, participation in the audit, coordination of the preparation and issuance of audit reports, and evaluation of audit responses.

Following completion of an audit, the auditor or audit team prepares and submits a post-audit report (see Exhibit 3 example form) to PRCs group president, program manager, regional manager, and work assignment manager. The PRC group president coordinates a management review of any deficiencies that are noted. He provides the program manager with additional corporate resources to correct such deficiencies, if necessary.

The auditor can, if necessary, issue a corrective action request (see Exhibit 4 example form) to identify specific corrective actions to be undertaken and completed on a schedule by the work assignment manager. Completion of corrective action is verified by the auditor or audit team. After acceptance and verification of all corrective actions, the corrective action request form will be used to close out the audit.

All activities and outputs from PRC or the team subcontractors may be the subject of a random audit pursuant to this QA program plan and carried out by PRC and/or EPA.

11.0 CORRECTIVE ACTIONS

An effective QA program requires rapid, effective, and thorough correction of QA problems. Effective action minimizes the possibility of questionable data or documentation. There are two types of corrective actions: immediate and long-term. Immediate corrective actions involve such things as the correction of procedures, repair of instrumentation that is working improperly, or correction of errors or deficiencies in documentation. Long-term corrective actions eliminate the sources of problems by correcting systematic errors in sampling or analysis, procedures that produce questionable results, and similar cause/effect relationships.

To provide a complete record of QA activities, all QA problems and corrective actions applied are documented. Historical records assist work assignment managers and program management in identifying long-term QA problems, and enable management to apply long-term corrective actions such as personnel training, replacement of instrumentation, improvement of procedures, etc,

A corrective action requires defined responsibilities for scheduling, performing, documenting, and assuring the effectiveness of the action. Many times the source of a nonsystematic problem is obvious and can be corrected immediately. Immediate corrective actions routinely made by technicians or professional staff are documented as standard operating procedures.

--^A-^orrective =aetion-request 'Action ^(s'ee^)fhibk'^^^xiimple^^)rtn)--is'-usetHto-=inh ^documentTall^corrective^actions. <The^action»may be =initiated'byreither'any QA/QC-program staff person who observes a major problem, or a designated QC auditor; each form is limited to a single problem. If more than one problem is involved, each problem is documented on a separate corrective action request form.

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EXHIBFT 4

PRC WORK ASSIGNMENT CORRECTIVE ACTION REQUEST FORM

Work Assignment Number Region: Site Location: Fi rm:

To (Work Assignment Manager):.

From (Reviewer):

Date:

Description of Problem:.

Corrective Action Requested:

The above corrective action must be completed by (Date)

Corrective Action Taken:

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EXHIBIT 4

(continued)

Work Assignment Manager (Subcontractor QA Manager) Acknowledgement of Receipt Correction Action Completed

•

(Date/Initial)

Reviewer

Corrective Action is/is not satisfactory

(Date/Initial)

QA/QC Coordinators

Corrective Action is/is not satisfactory

(Date/Initial)

cc: PRC TES Program Manager

PRC TES QA Program Manager

PRC Regional Coordinator

(E>ate/Initial)

Remarks

Remarks

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Copies of the corrective action request form are given to the program QA manager, the program manager, and regional manager (or subcontractor QA manager) who will discuss each problem jointly to:

• Determine when the problem arose,

• Assign responsibility for investigating and documenting the problem,

• Determine what specific corrective action is needed to eliminate the problem

• Set a time schedule and assign responsibility for implementation of the required corrective action,

• Determine whether notification of EPA is required,

• Verify and document that the corrective action has eliminated the problem,

A corrective action status form (see Exhibit 5 example form) is used to monitor the status of all corrective actions. Corrective action is not complete until the problem has been solved effectively and permanently, Foliow-up action to ensure that the problem remains corrected is an important step in the corrective action procedure.

The program QA manager has the authority to require environmental measurements that are compromised to be discontinued or limited until corrective action is complete and data quality is no longer questionable. The QA Manager also may order the re-analysis of samples or measurements occurring since the last documented evidence that the system was in control.

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QA Manager:

EXmBITS PRC QA CORRECTIVE ACTION STATUS FORM

Status as of (Date):

•

Correction Action No.

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• - i

Description of Action Required

•;r.

•- '

Date Initiated

_ •

— •

Date Due

- -

Date Resolved

• - 1

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