MODEL QUALITY ASSURANCE
          PROGRAM PLAN
               FOR

ENVIRONMENTAL MONITORING AGENCIES

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                            TABLE OF CONTENTS
                                                 STATE QA Plan
                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  2    of 14
 ITEM:
 1.0  QUALITY ASSURANCE PROGRAM PLAN IDENTIFICATION FORM
2.0  INTRODUCTION
PAGE


  3


  5
3.0 QUALITY ASSURANCE POLICY
4.0 QUALITY ASSURANCE MANAGEMENT

    4.1 Assignment of Responsibilities
    4.2 Communications/Reportings
    4.3 QA Program Review and Audit

5.0 GENERAL QUALITY ASSURANCE REQUIREMENTS FOR MONITORING
6.0 PERSONNEL QUALIFICATIONS
7.0 FACILITIES, EQUIPMENT, AND SERVICES
8.0 IMPLEMENTATION REQUIREMENTS AND SCHEDULE
 10


 11


 11


 12
    APPENDIX A     Interim Guidelines and Specifications for
                   Preparing Quality Assurance Project Plans.
 13
    APPENDIX B     (Regional Quality Assurance Monitoring Protocols)  14

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                                                 STATE QA Plan
                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  3   of 14
1.0 QUALITY ASSURANCE PROGRAM PLAN IDENTIFICATION FORM
Document Title:
Document Control Number:_


Organization Title:	


Address:
DIRECTOR:	PHONE NUMBER:


TITLE:
QA OFFICE:
ADDRESS:
PLAN COVERAGE:

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CONCURRENCES:
(1) NAME:
    TITLE:
                                                 STATE QA Plan
                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  4	of 14
                        (Quality Assurance Officer)
    SIGNATURE:
    DATE:
(2) NAME:
    TITLE:
    SIGNATURE:
    DATE:
APPROVAL:
    NAME:
    TITLE:
         (Agency Director)
    SIGNATURE:
DATE:
    NAME:
    TITLE:
         (Regional Administrator or designee)
    SIGNATURE:
  DATE:
    RA COMMENTS:

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                                                 STATE. QA Plan
                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  5   of 14
2.0 INTRODUCTION

    The	^_ is strongly
    committed to good science and aggressive quality assurance (QA)
    practices.  This commitment complements the U.S. Environmental
    Protection Agency's (EPA) own emphasis given to a comprehensive and
    coordinated QA program.

    The    ^     has already developed and integrated QA practices into
    monitoring and measurement activities within its purview.  These QA
    practices are specifically designed to generate and process data of
    known and appropriate quality in a cost-effective manner.

    The purpose of this document is to establish        -wide consistency
    in the application of these individual QA practices.  Further, it
    ensures that all monitoring and measurement activities funded by EPA
    will be conducted in accordance with EPA's monitoring and QA
    requirements.

    This document describes the _^	QA program
    plan.  Its objectives are ta clearly delinate the         QA policy
    and management structure which will be used to implement the QA
    strategy and the QA monitoring requirements necessary to document the
    reliability and validity of environmental data.

3.0 QUALITY ASSURANCE POLICY

    It is the policy of the	^___^	i	that there shall  be
    sufficient QA activities conducted within the         to ensure that
    all environmental data generated and processed will be scientifically
    valid, of known precision and accuracy,  of acceptable completeness,
    respresentativeness, and comparability and where appropriate, legally
    defensible.  This goal can be achieved by ensuring that adequate QA
    steps and procedures are used throughout  the entire monitoring
    process (from initial study planning through data usage).

    A.   Specifically it is the policy of	that;

         1.   All environmental  data generated will be of known and
              acceptable quality.   The data quality information developed
              with all environmental data will be documented and
              available.

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                                        STATE QA Plan
                                        Revision No. 01
                                        Date 3/1/82
                                        Page  6   of 14
2.   The intended use(s) of the data will be defined before the
     data collection effort begins* so that appropriate QA
     measures may be applied to ensure a level of data quality
     commensurate with the monitoring objectives.  The
     determination of this level of data quality shall also
     consider the prospective data needs of secondary users.
     The assigned level of data quality, specific QA activities,
     and data acceptance criteria will be explicitly described
     in each monitoring activity's QA project plan.

3.   Quality assurance activities will be designed in the most
     cost-effective fashion possible without compromising data
     quality objectives.

4.   All 	monitoring activities will ensure that
     acceptable QA requirements are included and implemented in
     all applicable external procurements funded by EPA.

5.   Each program which generates environmenal data will
     develop  QA project plan addressing the major elements
     contained in Appendices A and B and will ensure that
     adequate resources (both monetary and staff) are provided
     to support the QA effort, and will be responsible for
     implementing the plan.  The QA project plan will specify
     the mechanism by which timely corrective action can be
     taken when data quality under goes degradation.  The
     project plan will specify the detailed procedures required
     to assure quality data.

6.   The technical and administrative authority for all QA
     matters within the         will be assigned to the Quality
     Assurance Officer (QAO).The QAO will review, comment, and
     concur on all         QA project plans.  The QAO will be
     the focal point for interaction between EPA's Regional QA
     program, 	programs, and other environmental
     monitoring agencies in QA related matters.

7.   All applicable programs will adhere to the requirements and
     specifications stated in the QA program and in all QA
     project plans, (when they are developed.)

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                                                 STATE QA Plan
                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  7   of 14
4.0 QUALITY ASSURANCE MANAGEMENT

    In order to properly manage the QA activities of environmental
    monitoring programs within the        , all QA management
    responsibilities shall be assigned to the QAO.  The QAO will be under
    the administrative management direction and support of
    the      	.  Each applicable monitoring program
    will designate a person to serve as program Quality Control
    Coordinator (QCC).  The organizational structure is shown in Figure 1.

4.1 Assignment of Responsibilities


    A.   Responsibilities of the	QA Officer

         1.   The QAO will be the official contact for all QA matters of
              the	.

         2.   The QAO will be responsible for identifying and responding
              to QA needs, problems, and requests from within the  	.
              The QAO will provide technical QA assistance or obtain
              technical assistance from EPA's Regional Quality Assurance
              Management office (RQAMO) as necessary.  This will include
              assistance in preparing detailed QA plans, contract or
              other external procurement packages requiring QA measures,
              designing QA programs for new studies, etc.

         3.   The QAO will review and approve all         QA project
              plans and all the QA-related sections of procurement
              packages which includes or requires QA measures.

         4.   The QAO will work with the individual program managers and
              other 	 management to take appropriate corrective
              action when where and however needed.

         5.   The QAO will serve as liaison between EPA's Regional  QA
              program, 	programs, and other environmental
              monitoring agencies in QA related matters.

         6.   The QAO will prepare and submit QA reports to 	
              management and when appropriate, EPA RQAMO.

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                 i>iA!h yA Plan
                 Revfsion No. 01
                 Date 3/1/82
                 Page  8   of 14
Figure 1

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                                                        a nan
                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  9   of 14
    B.   Program Quality Control Coordinator

         1.   The QCC is responsible for ongoing identification and
              coordination of activities within their programs(s), which
              result in the generation and/or processing of environmental
              data.

         2.   The QCC will facilitate development and implementation of
              QA project plans for those activities with the assistance
              of the QAO.

         3.   The QCC will inform QAO of new legislation or regulations
              which affect the QA program.


4.2 Communication/Reporting

    A system for the dissemination of both written and oral communication
    relative to QA program status/needs will be developed and implemented
    to ensure that QA programs are effectively coordinated within
    the	purview.  The QAO and QCC.will have direct access to the
    program managers or laboratory directors on specific QA matters as
    problems arise.  The QAO will keep responsible management informed at
    all times of the performance of the data-production systems and of
    any program problems and heeds.  Responsible management will in turn
    adequately respond to identified program problems and needs
    (including resource aspects) and ensure their resolution.

    By October 1 of each year, the QAO will submit a QA status report
    to  	management and to EPA RQAMO.  These reports will contain
    at least the following types of information:

         A.   Status of QA plans.

         B.   Data quality assessments, to include:

              1.   Accuracy
              2.   Precision
              3.   Completeness
              4.   Representativeness
              5.   Comparability

         C.   Significant QA problems,  corrective actions, progress,
              plans and recommendations.

         D.   Results of performance audits.

         E.   Results of system audits.

         F.   Summary of QA-related training.

         G.   Other information specifically requested by 	
              management and EPA.

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                                                 STATE QA Plan
                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  10   of  14
4.3 QA Program Review and Audit

    The QA program will include periodic reviews and audits to ensure
    achievement of expressed QA objectives.  The nature and frequency of
    these reviews/audits will be determined on a project-specific basis.
    Generally, they shall include the following:

    A.   Review of Program and Project Plans

         As part of the QAO's responsibility for QA program overview, all
         existing programs, future program plans, study/project plans,
         experimental designs, and external procurements will be reviewed
         by the QAO for adequacy, and be modified as necessary.^  These
         reviews will ensure that acceptable QA/QC activities and
         requirements are included, that proper QA was considered at the
         project's inception, and that the project will be able to
         produce data of the required quality in a reliable and
         cost-effective manner.

    B»   External Reviews/Audits of Performance

         System and performance audits and inter-laboratory/inter-field
         comparision studies shall be conducted on each external  (e.g.,
         contractor laboratories) monitoring program within the
         as required by the QAO.  These audits will assess the adequacy
         of, and adherence to, the respective QA plans.

    C.   Internal Review/Audit of Performance

         The QAO will develop and implement a quarterly blind field spike
         and duplicate program when appropriate.  Corrective actions will
         be taken and the reports submitted to appropriate 	
         management.

    5.0 GENERAL QUALITY ASSURANCE REQUIREMENTS FOR MONITORING

    Adequate QA will be applied throughout the entire monitoring process
    to ensure that all environmental data generated and processed will be
    scientifically valid, defensible, of known qaulity, complete,
    representative and comparable.  The QA elements which will be
    incorporated into monitoring activities (both internal and externally
    procured) by all program offices are defined in Appendices A and B.
    Deviations from these QA monitoring requirements will be justified
    and documented.  The specific requirements and level(s) of effort
    applicable to these QA elements will be described in individual QA
    project plans which will be prepared for each monitoring activity.

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                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  11   of 14
    The QAO will review all QA project plans provide input, recommend
    changes, and approve final QA plans .  The QAO will maintain a
    current file of all approved QA plans for every environmental
    monitoring program.


6.0 PERSONNEL QUALIFICATIONS

    All QA personnel will have adequate education, training, and
    experience both in the area of their technical expertise and in
    quality assurance to meet their designated responsibilities.

    All other monitoring personnel will possess adequate experience and
    knowledge to perform satisfactorily all technical tasks assigned.
                 >v
7.0 FACILITIES, EQUIPMENT, AND SERVICES

    The QA program requires that all applicable   	 facilities,
    equipment and services will be capable of producing acceptable
    quality data in a efficient manner with minimum risk to personnel.
    Specifically, the	ensures provision of the following :

    (a)  acceptable facilities (e.g., lighting, ventilation, temperature,
         noise levels, etc.) in their laboratory.

    (b)  acceptable utility services (e.g., electricity and voltage
         control; purity, pressure, and supply of water and air; etc.) in
         their laboratory.

    (c)  acceptable general laboratory equipment (e.g., analytical
         instrumentation support, air conditioners, furnaces,  generators,
         refridgerators, incubators, laboratory hoods,  sinks,  counters
         etc.) in their laboratory.

    (d)  acceptable monitoring equipment used in the field.

    (e)  routine inspection and preventive maintenance will be performed
         for all facilities and equipment.

  " The above applies to any contractor receiving State/EPA funds for
    monitoring.

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                                                       w« r ian
                                                 Revision No. 01
                                                 Date 3/1/82
                                                 Page  12   of 14
8.0 IMPLEMENTATION REQUIREMENTS AND SCHEDULE

    Implementation of the _^__^	QA program requires that each major
    milestone be identified and scheduled for accomplishment.  Milestones
    include:
         Milestones                                        Dates

    1.   Designation of QA officer                         	

    2.   QA program plan approved by	             	
    3.   QA program plan approved by EPA Region
    4.   Preparation of QA project plan                    On-going

    5.   Prepare and submit QA program                     On-going
         status, report

    6.   Review and update of QA plan                      On-going

    7.   Participation in annual                           On-going
         performance or system audits.

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                                        STATE QA PI art
                                        Revision No. 01
                                        Date 3/1/82
                                        Page  13   of 14
                      APPENDIX A

Interim Guidelines and Specifications for Preparing Quality
Assurance Project Plans QAMS -005/80, December 29, 1980.

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     INTERIM GUIDELINES AND  SPECIFICATIONS  FOR

     PREPARING  QUALITY ASSURANCE  PROJECT PLANS
                    QAMS-005/80
Office of Monitoring Systems and Quality Assurance
        Office of Research and Development
  United  States  Environmental  Protection Agency
              Washington,  D.C.  20460
                December 29, 1980

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                             ACKNOWLEDGEMENTS

       This document has  been  prepared  by the Quality Assurance Manage-
ment  Staff of  the Office  of  Research  and  Development  in  cooperation
with Systems, Science  and Software of San Diego, California.  We grate-
fully  acknowledge  the assistance  of  Mr.  Darryl  von  Lehmden of  the
Environmental Monitoring  and  Systems  Laboratory  of  Research  Triangle
Park, North Carolina.   The assistance of the  Agency's Quality Assurance
Officers  in  reviewing  the  document and  providing  comments  during  its
generation is also gratefully acknowledged.
                                DISCLAIMER
       Mention of  trade names  or  commercial  products does  not  consti-
tute EPA endorsement or recommendation for use.

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                                 ABSTRACT

      The  Agency-wide quality  assurance policy  stipulates that  every
monitoring  and measurement  project must  have a  written  and  approved
Quality Assurance  (QA)  Project  Plan.   A QA Project  Plan  is  a  written
document, which presents,  in  specific  terms,  the  policies,  organization
(where applicable),  objectives,  functional  activities, and specific QA
and quality control  (QC)  activities designed to achieve  the data  qual-
ity goals  of  a specific project(s) or  continuing  operation(s).  The QA
Project Plan  is required  for each specific project or continuing  oper-
ation (or  group of similar projects or  continuing  operations).  The QA
Project  Plan  will  be  prepared  by  the  responsible  Program  Office,
Regional Office, Laboratory, contractor, grantee,  or other organization.

      This document  describes the  sixteen  elements which  must  be con-
sidered for  inclusion in  all Quality  Assurance Project  Plans,  and  es-
tablishes  criteria for  plan  preparation, review  and  approval.  All  QA
Project Plans  must describe procedures  which  will  be used  to  document
and report  precision, accuracy  and  completeness  of  environmental  mea-
surements.
                                    ii

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                                 CONTENTS
Section

       ABSTRACT
1.0    INTRODUCTION
2.0    DEFINITION, PURPOSE, AND SCOPE
       2.1   Definition
       2.2   Purpose
       2.3   Scope
3.0    PLAN PREPARATION AND
       RESPONSIBILITIES
       3.1   Document Control
       3.2   Elements of a QA Project Plan
       3.3   Responsibilities
4.0    PLAN REVIEW, APPROVAL AND
       DISTRIBUTION
5.0    PLAN CONTENT REQUIREMENTS
       5.1   Title Page
       5.2   Table of Contents
       5.3   Project Description
       5.4   Project Organization and
              Responsibility
       5.5   QA Objectives for Measurement
              Data in Terms of Precision,
              Accuracy, Completeness,
              Representativeness,  and
              Comparability
       5.6   Sampling Procedures
       5-7   Sample Custody
Pages
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                           CONTENTS (Continued)
Section
                                    Pages
Revision    Date
6.0
7.0
8.0
5.8   Calibration Procedures and
       Frequency
5.9   Analytical Procedures
5.10  Data Reduction, Validation
       and Reporting
5.11  Internal Quality Control
       Checks
5.12  Performance and System Audits
5.13  Preventive Maintenance
5.14  Specific Routine Procedures
       Used to Assess Data Precision,
       Accuracy and Completeness
5,15  Corrective Action
5.16  Quality Assurance Reports to
       Management
QUALITY ASSURANCE PROJECT PLANS
VERSUS PROJECT WORK PLANS
STANDARD OPERATING PROCEDURES
SUMMARY
REFERENCES
APPENDICES
^^^•M^








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       A  Glossary of Terms
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                                    iv

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                                                Section No. 	1_
                                                Revision No.      4
                                                Date: December 29, 1980
                                                Page      T   of    1
1.0   INTRODUCTION

      Environmental  Protection  Agency (EPA)  policy requires participa-
tion by all EPA  regional  offices,  program offices, EPA laboratories and
States in  a centrally-managed quality assurance  (QA)  program as stated
in  the  Administrator's Memorandum  of May  30,  1979.   This  requirement
applies to all  environmental  monitoring  and measurement efforts  man-
dated or  supported  by  EPA through  regulations,  grants,  contracts,  or
other formalized means not  currently covered  by  regulation.   The re-
sponsibility for developing, coordinating  and directing the  implementa-
tion of this  program has  been  delegated to  the  Office of Research and
Development (ORD), which  has  established the Quality  Assurance Manage-
ment Staff (QAMS) for this purpose.

      Each office  or laboratory generating data  has  the responsibility
to  implement minimum procedures which assure that  precision,  accuracy,
completeness,  and  representativeness of its data  are known  and  docu-
mented.  In addition, an  organization should  specify  the quality levels
which data must  meet  in  order to  be  acceptable.  To  ensure  that  this
responsibility is  met uniformly across  the Agency, each  EPA  Office  or
Laboratory must have  a written  QA  Project  Plan  covering each monitoring
or measurement activity within its purview.

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                                                Section No.       2
                                                Revision No.       4
                                                Date;  December 29. 1380'
                                                Page      1    of     2
2.0   DEFINITION, PURPOSE AND SCOPE

2.1   Definition

      QA  Project Plans  are  written documents,  one for  each specific
project or continuing operation  (or group of similar  projects  or con-
tinuing operations),  to be prepared  by  the responsible Program Office,
Regional  Office,  Laboratory,  Contractor,  Grantee,  or  other organiza-
tion.  The QA Project Plan  presents, in  specific  terms,  the policies,
organization,  objectives,  functional  activities,  and  specific QA and
quality control  (QC)  activities  designed  to  achieve  the  data  quality
goals  of   the  specific  project(s)  or  continuing  operation(s).   Other
terms useful in understanding this document are defined in Appendix A.

2.2   Purpose

      This  document  (1)  presents  guidelines  and   specifications  that
describe  the  16  essential  elements  of a  QA  Project Plan,  (2)   recom-
mends the format to  be  followed, and  (3) specifies how plans  will  be
reviewed and approved.

2.3   Scope

      The  mandatory   QA   program  covers  all  environmentally-related
measurements.  Environmentally-related measurements are defined as  all
field and  laboratory  investigations  that  generate  data.   These  include
(1) the measurement of chemical,  physical, or biological  parameters  in

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Section No.       2
Revision No*       4
Date:  December 29.  1980
Page       2    of    2
the environment,  (2)  the  determination  of the  presence or absence  of
pollutants  in  waste streams,  (3)  assessment of health and  ecological
effect studies,  (4)  conduct of clinical  and  epidemiological  investiga-
tions,  (5)  performance  of  engineering   and  process  evaluations,  (6)
study of  laboratory simulation of  environmental events, and  (7)  study
or  measurement on  pollutant transport  and  fate,  including  diffusion
models.  Each  project  within these activities must  have a written  and
approved QA Project Plan.

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                                                Section No. 	3
                                                Revision No.      4
                                                Date: December 29. 1980
                                                Page      1    of     3
3'.0   PLAN PREPARATION AND RESPONSIBILITIES
3.1   Document Control
      All  Quality Assurance  Project  Plans  must  be  prepared  using  a
document control  format consisting of  information  placed in  the upper
right-hand corner of each document page:
      •  Section Number
      •  Revision Number
      •  Date (of revision)
      •  Page
3.2   Elements of QA Project Plan
      Each of  the sixteen  items  listed below must  be  considered  for
inclusion in each QA Project Plan:
      (1)  Title page with provision for approval  signatures
      (2)  Table of contents
      (3)  Project description
      (4)  Project organization and responsibility
      (5)  QA objectives  for measurement  data in  terms of  precision,
           accuracy,  completeness, representativeness and comparability
      (6)  Sampling procedures

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Section No.	3
Revision No.        4
Date:  December 29, 1980
Page      2    of     3 '
       (7)  Sample custody
       (8)  Calibration procedures and frequency
       (9)  Analytical procedures
      (10)  Data reduction, validation and reporting
      (II)  Internal quality control checks and frequency
      (12)  Performance and system audits and frequency
      (13)  Preventive maintenance procedures and schedules
      (14)  Specific  routine  procedures  to be  used to  assess  data pre-
           cision,  accuracy  and  completeness  of specific measurement
           parameters involved
      (15)  Corrective action
      (16)  Quality assurance reports to management

      It  is Agency policy that  precision  and accuracy  of  data shall  be
assessed  on  all  monitoring and measurement projects.   Therefore, Item
14 must be described in all Quality Assurance Project Plans.

3.3   Responsibilities

      Intramural Projects  - Each  Project Officer  working  in  close co-
ordination with the QA  Officer is  responsible for the  preparation of a
written  QA  Project  Plan  for  each  intramural   project that  involves
environmental  measurements.   This  written  plan must be  separate from
any  general  plan  normally  prepared for  the  project (see  caveat pre-
sented in  Section 6).  The Project  Officer and the QA  Officer must en-
sure  that  each intramural  project plan contains  procedures to document
and report precision, accuracy and completeness of all data generated.

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                                                Section No. 	3
                                                Revision No.      4
                                                Date: December 29, 1980
                                                Page     3    of     3
     Extramural  Projects  - Each  Project Officer  working in  close co-
ordination  with  the  QA Officer  has  the responsibility  to see  that a
written QA  Project  PTan is prepared by  the extramural  organization for
each project  involving  environmental measurements.  The elements of the
QA  Project  Plan must be  separately  identified  from any  general  plan
normally prepared for the project (see  caveat  presented  in Section 6).
The Project Officer and the QA  Officer must ensure that each extramural
project  plan  contains  procedures  to  document  and report  precision,
accuracy and completeness of all data generated.

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                                                Section No.        *
                                                Revision No.      4
                                                Date: December 29, 1980'
                                                Page     1    of     1
4.0  PUN REVIEW, APPROVAL AND DISTRIBUTION

     Intramural Projects - Each  QA  Project Plan must be approved by the
Project officer's  immediate  supervisor and the  QA  Officer.   Completion
of reviews  and approvals  is shown by  signatures  on the title  page of
the plan.  Environmental measurements  may not be initiated  until the QA
Project  Plan  has  received  the  necessary  approvals,  unless  emergency
response is necessary.  A copy of  the approved QA  Project Plan  will be
distributed  by the  Project  Officer  to  each  person who has  a  major
responsibility for the quality of measurement data.

     Extramural Projects - Each  QA  Project Plan must be approved by the
funding organization's  Project  Officer  and the QA Officer.  In  addi-
tion, the  extramural  organization's Project  Manager  and  responsible QA
official must  review and approve  the  QA Project  Plan.  Completion of
reviews and  approvals  is shown  by  signatures on the title  page of the
plan.   Environmental  measurements   may not be initiated until  the  QA
Project  Plan  has  received  the  necessary  approvals.   A copy  of  the
approved QA Project  Plan  will be distributed  by the extramural  organi-
zation's Project Director to each  person who  has a major responsiblity
for the quality of the measurement  data.

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                                                Section No. 	5
                                                Revision No.      4
                                                Date: December 29, 1980'
                                                Page     1    of     18
5.0  PUN CONTENT REQUIREMENTS

     The sixteen  (16)  essential  elements  described in this section must
be considered  and addressed in  each  QA Project Plan.   If a particular
element  is  not relevant to  the project  under consideration,  a  brief
explanation of why  the element is not  relevant must  be included.   EPA-
approved reference,  equivalent or alternative methods  must  be used and
their corresponding Agency-approved guidelines  must  be applied wherever
they are available and applicable.

     It  is  Agency policy that  precision  and accuracy  of  data shall  be
assessed  routinely and  reported on  all  environmental monitoring  and
measurement data.   Therefore,  specific procedures to  assess  precision
and accuracy on a routine basis  during  the project must be described  in
each  QA Project  Plan.  Procedures  to  assess  data  quality  are  being
developed  by   QAMS  and  the  Environmental  Monitoring  Systems  Support
Laboratories.   Additional  guidance can be  obtained  from QA  handbooks
for air, water biological,  and  radiation  measurements  (References  1,  2,
3, 12, 17, and 18).

     The following  subsections  provide specific  guidance pertinent  to
each of  the 16 components  which must  be  considered  for inclusion  in
every QA Project Plan.

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Section No. .	5
Revision No.       4-
Date:  December 29. 1980
Page  • • • 2- • •   of   18"'
     5.1  Title page

          At the bottom  of the title page,, provisions  must be made for
          the signatures of  approving  personnel.  As a minimum,  the QA
          Project Plan must be approved by the following:

               A*  For intramural projects
                       !•  Project Officer's immediate supervisor
                       2.  QA Officer

               B.  For extramural projects
                       I.»  Organization's Project Manager
                       2.  Organization's responsible QA Official
                       3*  Funding organization's Project Officer
                       4.  Funding organization's QA Officer
     5.2  Table of Contents
          The QA  Project Plan Table  of Contents will  address each  of
          the following items:

            *  Introduction.
            *  A  serial  listing  of  each  of the  16 quality  assurance
               project plan components.
            »  A  listing of  any appendices  which  are required to  aug-
               ment the  Quality  Assurance  Project  Plan  as  presented
               (i.e.,  standard  operating procedures,  etc.).

-------
                                           Section No. 	5
                                           Revision No.      4
                                           Date: December 29. 1980"
                                           Page     3    of   18
     At  the end of  the Table  of  Contents,  list  the QAO  and all
     other  individuals  receiving official  copies of the QA Project
     Plan and any subsequent revisions.
5.3  Project Description

     Provide a  general description  of the project,  including  the
     experimental design.  This  description  may be brief  but must
     have sufficient detail  to  allow those individuals responsible
     for  review  and approval  of  the QA  Project  Plan to  perform
     their task.  Where appropriate, include the following:

       *  Flow diagrams, tables and charts.
       •  Dates anticipated for start and completion.
       •  Intended end use of acquired data.

5.4  Project Organization and Responsibility

     Include a table or chart showing  the  project  organization  and
     line authority.   List the key individuals,  including  the QAO,
     who  are  responsible  for  ensuring the  collection  of  valid
     measurement data  and  the  routine  assessment of  measurement
     systems for precision and accuracy.

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Section No.	5
Revision No.       4
Date:  December 29. 1980
Page      4    of   18  '
     5.5  QA  Objectives  for  Measurement  Data in  Terms of  Precision,
          Accuracy, Completeness, Representativeness, and Comparability
          For each major measurement  parameter,  including all pollutant
          measurement systems,  list  the  QA  objectives  for  precision,
          accuracy and  completeness.   These QA objectives will  be sum-
          marized in a table.  (See Table 1 for example of format.)

          All measurements must be made so  that results are  representa-
          tive of the media  (air,  water,  biota,  etc.)  and  conditions
          being measured.  Unless otherwise specified,  all data  must be
          calculated and reported in units  consistent with other organ-
          izations  reporting similar  data to allow  comparability  of
          data bases  among  organizations.  Definitions for  precision,
          accuracy and completeness  are provided  in Appendix A.

          Data quality  objectives  for accuracy  and  precision   estab-
          lished  for  each  measurement parameter  will  be based on  prior
          knowledge of the measurement system employed  and method  vali-
          dation  studies using  replicates,- spikes, standards, calibra-
          tions,   recovery  studies,  etc,  and   the  requirements  of  the
          specific project.
     5.6  Sampling Procedures

          For each  major  measurement parameter(s),  including  all pol-
          lutant  measurement systems,  provide a description of the sam-
          pling  procedures  to  be used.  Where  applicable, include the
          following:

-------
                                      Table  1


EXAMPLE OF  FORMAT TO SUMMARIZE PRECISION,  ACCURACY AND COMPLETENESS OBJECTIVES
Measurement Parameter
(Method)
N02
(Chenllunl nescent)
S02 (24 hr)
(Pararosanlllne)
•
t
•
Reference
EPA 650/4-75-011
February 1975
EPA 650/4-74-027
December 1973
•
•
•
Experimental Conditions
Atmospheric sample;
spiked with NO. as
needed
Synthetic atmosphere
•
•
•
Precision,
Std. Dey.
<±10X
<±20t
•
•
»
Accuracy
*5X
tl 6|
«
•
«
Completeness
901
90f
t
•
t
                                                                                                     •O O 70 UJ
                                                                                                     tu 0* (o n>
                                                                                                     03 rK O
                                                                                                       • • (/> —i.
                                                                                                         _i. o

                                                                                                       O O 3
                                                                                                     en
                                                                                                     00
§cf?
a- •
o>


ro
vo

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Section No*	5
Revision No.       4
Date:  December 29, 1980
Page     6     of   ~W~~
            •  Description of  techniques or  guidelines  used to  select
               sampling sites*

            »  Inclusion of specific sampling procedures to  be  used (by
               reference  in  the  case  of standard  procedures  and  by
               actual description  of  the entire  procedure  in  the  case
               of nonstandard procedures).

            *  Charts,   flow  diagrams  or  tables  delineating  sampling
               program operations.

            *  A description  of containers, procedures, reagents, etc.,
               used for sample  collection, preservation, transport,  and
               storage.

            *  Special   conditions   for  the  preparation  of  sampling
               equipment and containers  to avoid sample  contamination
               (e.g., containers for organics should be solvent-rinsed;
               containers  for trace metals should  be acid-rinsed).

            *  Sample preservation  methods and holding times.

            •  Time considerations  for shipping  samples  promptly to  the
               laboratory.

            *  Sample custody  or  chain-of-custody procedures   (to be
               described later  in this  document).

            »  Forms,  notebooks  and procedures  to be  used  to record
               sample history,  sampling  conditions  and  analyses  to be
               performed.
     5.7   Sample Custody


          Sample  custody  is  a  part of  any good  laboratory  or field

          operation.   Where samples may  be needed for  legal purposes,
          "chain-of-custody"  procedures,  as  defined  by the  Office of

          Enforcement, will  be used.  However,  as  a  minimum,  the fol-

          lowing sample  custody procedures will be addressed in the QA
          Project Plans:

-------
                                    Section No.	5
                                    Revision No.      4
                                    Date; December 29. 1980
                                    Page    7     of    18
A. Field Sampling Operations:

       •   Documentation  of procedures  for preparation  of
           reagents  or supplies  which  become an  integral
           part of the sample  (e.g., filters,  and absorbing
           reagents ) .

       •   Procedures  and  forms  for recording  the  exact
           location  and specific  considerations  associated
           with sample acquisition.

       •   Documentation  of  specific  sample  preservation
           method.

       •   Pre-prepared sample labels  containing  all  infor-
           mation necessary for  effective  sample tracking.
           Figure  1  illustrates  a  typical  sample  label
           applicable to this purpose.

       *   Standardized field  tracking  reporting forms  to
           establish sample custody in  the field prior  to
           shipment.  Figure 2 presents  a  typical sample  of
           a field tracking report form.
B. Laboratory Operations:

       •   Identification  of  responsible  party  to act  as
           sample  custodian  at   the   laboratory  facility
           authorized to  sign for  incoming field  samples,
           obtain  documents  of  shipment  (e.g.,  bill  of
           lading number  or mail  receipt),  and  verify the
           data entered onto the sample custody records.

       •   Provision  for  a  laboratory  sample custody  log
           consisting  of  serially numbered  standard  lab-
           tracking report sheets.  A  typical  sample  of  a
           standardized  lab-tracking  report form  is  shown
           in Figure 3.

-------
Section No. 	5
Revision No>       4_
Date:  December 29, 1980
Page     8.    of   1~
           (NAME OF SAMPLING ORGANIZATION)

      SAMPLE DESCRIPTION 	
PLANT:	
DATE:	
TIME:	
MEDIA:	
SAMPLE TYPE:.
      SAMPLED BY:.
     SAMPLE  ID NO.:
        LAB NO.
                               LOCATION:.
                               STATION:	
                               PRESERVATIVE:
               Figure 1.  Example of General Sample Label

-------
                                   Section No.  	5
                                   Revision No.      4
                                   Date;  December 29,  1980
                                   Page     9    of   18
W/O No.
FX3LD

FIELD SAMPLE CODE
(FSC)




















TRACKING REPORT:
1
BRIEF DESCRIPTION









,










_
LOC-SM
DATE





















F
TIME(s)



















Pa
-------
Section No.       5
Revision No.       4
Date:  December 29,  1980
Page     10    of   18
W/O *J.


Paga
LAB TRACKING REPORT: - -

. FRACTION
CODE








,











X



















PREP/ANAL
REQUIRED















(LOC-SN-FSC)
RESPONSIBLE
INDIVIDUAL














OATS
DELIVERED



























DATE
COMPLETED



















             Figure 3.  Sample of Lab-Tracking Report Form

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                                           Section No. 	5
                                           Revision No.       4
                                           Date: December 29.  1980
                                           Page    IT    of     18
                  Specification  of laboratory  sample  custody pro-
                  cedures  for  sample handling,  storage  and dis-
                  persement for analysis.
     Additional guidelines  useful  in establishing a sample custody

     procedure  are given  in  Section 2.0.6  of  Reference 2,  and

     Section 3.0.3 of Reference 3, and References 13 and 14.
5.8  Calibration Procedures and Frequency


     Include calibration procedures and information:
       •  For each major measurement  parameter,  including  all  pol-
          lutant  measurement  systems,  reference  the  applicable
          standard operating  procedure (SOP) or  provide a written
          description of the calibration procedure(s) to be used.

       •  List the frequency planned for recalibration.

       •  List  the  calibration  standards  to  be used  and  their
          sources(s), including traceability procedures.
5.9  Analytical Procedures


     For each  measurement parameter,  including all  pollutant  mea-

     surement systems, reference the  applicable  standard operating

     procedure (SOP)  or  provide a written description of  the  ana-

     lytical  procedure(s) to  be  used.   Officially  approved  EPA

     procedures will  be  used when  available.  For  convenience  in
     preparing the  QA Project  Plan,  Elements 6,  8 and  9 may  be

     combined (e.g., Sections 5.6, 5.8 and 5.9).

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Section No. 	5
Revision No.       4   _
Date:  December 29, 1980
Page    iz     Of   ig"~
    5.10  Data  Reduction,  Validation  and Reporting  -  For each  major

          measurement  parameter,   including  all  pollutant  measurement

          systems, briefly describe the following:
            *  The  data reduction  scheme  planned on  collected  data,
               including all.equations used to  calculate the concentra-
               tion or  value of  the measured  parameter and  reporting
               units.

            »  The  principal  criteria  that will  be used  to  validate
               data integrity during collection  and reporting of data.

            •  The methods used  to identify and  treat  outliers.

            *  The data flow or reporting scheme from collection of  raw
               data through  storage  of  validated  concentrations.    A
               flowchart will  usually be needed.

            *  Key individuals who will handle the data  in this  report-
               ing  scheme  (if  this  has  already  been  described  under
               project organization  and  responsibilities, it  need  not
               be repeated  here).
    5.11  Internal  Quality Control  Checks


          Describe  and/or reference all specific  internal  quality  con-

          trol  ("internal" refers  to  both  laboratory and field activi-
          ties)  methods to be  followed.   Examples of  items  to be  con-
          sidered include:


           • Replicates

           » Spiked samples

           * Split samples

           •> Control charts

-------
                                           Section No. 	5	
                                           Revision No.      4
                                           Date; December 29, 1980'
                                           Page    13    of   18
       •  Blanks
       •  Internal standards
       •  Zero and span gases
       •  Quality control samples
       •  Surrogate samples
       »  Calibration standards and devices
       *  Reagent checks

    Additional  information  and specific  guidance  can be  found  in
    References 17 and 18.

5.12 Performance and System Audits

     Each project plan  must describe  the  internal  and  external
     performance  and  systems  audits  which  will  be  required  to
     monitor the  capability  and  performance of the total  measure-
     ment system(s).

     The systems audit consists of evaluation  of all  components  of
     the measurement  systems to determine  their  proper  selection
     and use.   This audit  includes  a  careful  evaluation of  both
     field  and   laboratory  quality  control  procedures.    Systems
     audits   are  normally  performed  prior  to  or  shortly  after
     systems  are  operational;   however,   such audits  should  be
     performed on a  regularly  scheduled basis during the  lifetime
     of  the  project or continuing  operation.  The on-site  systems

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Section No. 	 5-
Revision No.       4
Date:  December 29, I960
Page     u   of   t~
          audit may  be a requirement  for formal  laboratory certifica-
          tion programs such  as  laboratories analyzing  public drinking
          water  systems.    Specific  references  pertinent  to  systems
          audits for formal  laboratory  certification  programs can  be
          found in References 19  and 20.

          After systems  are  operational  and generating data,  perfor-
          mance  audits are  conducted  periodically  to  determine  the
          accuracy  of the  total  measurement  system(s)  or  component
          parts thereof.  The plan should  include a schedule  for  con-
          ducting  performance audits for each  measurement  parameter,
          including  a performance  audit  for all  measurement  systems.
          As part of the performance audit process, laboratories may  be
          required to participate  in analysis of performance evaluation
          samples  related to  specific projects.   Project plans should
          also indicate,  where applicable,  scheduled  participation  in
          all other inter-laboratory performance evaluation  studies.

          In support  of performance audits,  the Environmental  Monitor-
          ing  Systems/Support  Laboratories  provide  necessary   audit
          materials and devices and technical  assistance.   Also,  these
          laboratories  conduct  regularly   scheduled   inter-laboratory
          performance tests  and provide  guidance  and assistance in the
          conduct  of systems  audits.   To make  arrangements for assis-
          tance in the  above areas, these  laboratories  should be con-
          tacted directly:

-------
                                            Section  No.	5
                                            Revision No.       4	
                                            Date:  December  29, 1980'
                                            Page     15   of    18
          Environmental Monitoring Systems Laboratory
          Research Triangle Park, NC  27711
          Attention:  Dr. Thomas R. Hauser, Director

          Environmental Monitoring and Support Laboratory
          26 W. St. Clair Street
          Cincinnati, OH  45268
          Attention:  Mr. Robert L. Booth, Director

          Environmental Monitoring Systems Laboratory
          P.O. Box 15027
          Las Vegas, NV  89114
          Attention:  Mr. Glen Schwitzer, Director
5.13  Preventive Maintenance


      The following  types  of preventive maintenance items should be
      considered and addressed in the QA Project Plan:
        •  A  schedule  of  important  preventive  maintenance  tasks
           that  must  be  carried  out to minimize  downtime of  the
           measurement systems.

        *  A  list  of any critical spare  parts that  should be  on
           hand to minimize downtime.
5.14  Specific Routine Procedures Used to Assess Data Precision,
      Accuracy and Completeness


      It is Agency policy  that precision and accuracy of  data must
      be routinely  assessed for  all  environmental  monitoring  and

      measurement data.   Therefore,  specific  procedures to  assess
      precision and accuracy on a routine basis on the project must
      be described in each  QA Project Plan.

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Section No. 	3
Revision No.       4
Date:  December 29, 1980
Page     is    of   18
          For each major  measurement parameter,  including all pollutant

          measurement  systems,  the  QA  Project  Plan  must  describe the

          routine procedures used to assess  the  precision,  accuracy and

          completeness  of  the  measurement   data.    These  procedures
          should include  the equations  to  calculate precision,  accuracy

          and completeness, and the  methods used to  gather  data for the

          precision and accuracy calculations.


          Statistical  procedures  applicable  to  environmental  projects

          are found in References 1,  2, 3, 12, 17,  and 18.   Examples of

          these procedures include:


            ••  Central tendency and  dispersion

                   -   Arithmetic mean
                   -   Range
                       Standard deviation
                       Relative standard deviation
                       Pooled standard deviation
                   -   Geometric mean

            »  Measures of variability

                   -   Accuracy
                   -   Bias
                   -   Precision;  within laboratory  and
                       between  laboratories

            »  Significance test

                       u-test
                   -   t-test
                   -   F-test
                       Chi-square  test

-------
                                            Section No. 	5
                                            Revision No.      4
                                            Date: December 29, 1980'
                                            Page    17    of   18
        •  Confidence limits

        *  Testing for outliers

      Recommended   guidelines  and   procedures   to  assess   data
      precision, accuracy and completeness are being developed.


5.15  Corrective Action


      Corrective action  procedures  must be described for  each pro-
      ject which include the following elements:
        ••  The predetermined  limits for  data acceptability  beyond
           which corrective action is required.

        •  Procedures for corrective action.

        *-For each  measurement  system,   identify  the  responsible
           individual for initiating the  corrective  action  and  also
           the individual responsible  for approving the  corrective
           action, if necessary.
      Corrective actions may also be initiated as a result  of  other

      QA activities,  including:


        (1)   Performance audits

        (2)   Systems  audits

        (3)   Laboratory/interfield comparison studies

        (4)   QA Program audits conducted by QAMS


      A  formal  corrective action  program  is  more  difficult  to

      define for these  QA  activities  in advance and may  be defined

      as the need  arises.

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Section No. 	5
Revision No.       4
Date:  December 29, 1980
Page     18    of    18
    5.16  Quality Assurance Reports to Management

          QA  Project  Plans  should  provide a  mechanism  for  periodic
          reporting to  management  on  the performance  of  measurement
          systems and  data quality.  As a minimum,, these reports  should
          include:

            »  Periodic  assessment  of measurement data  accuracy,  pre-
               cision  and completeness.
            *  Results of performance audits.
            »  Results of system audits»
            »  Significant QA problems and  recommended solutions.

         The  individual(s)  responsible  for  preparing  the  periodic
         reports  should  be identified.  The final  report  for each  pro-
         ject must include a  separate QA section  which  summarizes  data
         quality  information  contained in the periodic reports.

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                                                 Section No. 	6
                                                 Revision No.      4
                                                 Date; December 29. 1980'
                                                 Page     1    of     1
 6.0   QUALITY ASSURANCE PROJECT PLANS VERSUS PROJECT WORK PLANS

       This document provides guidance for  the  preparation  of QA Project
 Plans and  describes 16  components  which  must  be  included.   Histori-
 cally, most  project managers  have  routinely  included the  majority  of
 these 16 elements in their project work plans.   In practice* it is fre-
 quently difficult  to  separate  important  quality  assurance  and quality
 control  functions and to isolate these functions  from technical perfor-
 mance activities.  For those projects where this  is the  case,  it is not
 deemed necessary  to replicate  the narrative  in  the  Quality  Assurance
 Project Plan section.

       In instances  where  specific QA/QC  protocols are addressed  as  an
 integral part of the technical  work  plan,  it is only  necessary to cite
.the page number  and location in the work plan in  the specific subsec-
 tion designated for this  purpose.

       It must be stressed, however,  that whenever  this approach is used
 a "QA Project Plan locator page" must be  inserted  into the  project work
 plan  immediately  following the table of  contents.   This   locator  page
 must list each of the items required  for  the  QA Project Plan  and  state
 the section and pages in  the  project plan where the  item  is described.
 If a QA Project  Plan  item is  not  applicable to  the work plan  in  ques-
 tion,  the words "not applicable" should  be inserted next to the appro-
 priate component on the locator page and  the reason why this  component
 is not applicable  should  be briefly  stated  in the  appropriate subsec-
 tion in  the QA Project Plan proper.

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                                                Section No. 	7
                                                Revision No.      4
                                                Date: December 29, 1980
                                                Page      1    of     2
7.0  STANDARD OPERATING PROCEDURES

     A large number of  laboratory  and  field operations can be standard-
ized  and written  as  Standard  Operating Procedures  (SOP).   When  such
procedures are  applicable and available, they may  be incorporated  into
the QA Project Plan by reference.
                                                   \
     QA  Project  Plans  should provide  for  the review  of  all  activities
which  could  directly  or  indirectly  influence  data quality and  the
determination  of  those  operations  which  must  be  covered   by  SOP's.
Examples are:
     •   General network design
     •   Specific sampling site selection
     *   Sampling and analytical methodology
     •   Probes,  collection   devices,  storage  containers,  and  sample
         additives or preservatives
     •   Special precautions, such as  heat,  light,  reactivity, combust-
         ability, and holding times
     •   Federal reference, equivalent  or alternative test procedures
     •   Instrumentation selection  and  use
     •   Calibration and standardization
     •   Preventive and remedial maintenance
     •   Replicate sampling
     •   Blind  and spiked samples

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Section No. 	7
Revision No.       4
Date:  December 29, 1980
Page       2    of    2  '
     *   Colocated samplers
     •   QC procedures  such as  intralaboratory and  intrafield activi-
         ties* and interlaboratory and interfield activities
     •   Documentation
     *   Sample custody
     »   Transportation
     *   Safety
     *   Data handling procedures
     *   Service contracts
     •   Measurement of  precision,  accuracy, completeness,  representa-
         tiveness, and comparability
     »   Document control

-------
                                                Section No. 	8
                                                Revision No.~"5
                                                Date: December 29, 1980
                                                Page      1    of     1
8.0   SUMMARY

      Each  intramural  and extramural  project  that  involves  environ-
mental measurements  must have a  written  and approved  QA  Project Plan.
All  16 items  described  previously must  be considered and  addressed.
Where  an  item is  not relevant,   a  brief  explanation  of  why it  is  not
relevant  must be  included.   It  is  Agency policy  that  precision  and
accuracy  of  data  must  be  routinely assessed and   reported  on  all
environmental  monitoring  and measurement  data.   Therefore,  specific
procedures to  assess precision and  accuracy on a routine basis  during
the project must be described in each QA Project Plan.

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                                                 Section  No,  References
                                                 Revision No.       4
                                                 Date;  December  29,  1980
                                                 Page  ••• V    of     2
                                REFERENCES
 1-  Quality  Assurance  Handbook for Air  Pollution Measurement Systems.
     Volume I - Principles"!EPA-600/9-76-005, March 1976.

 Z.  Quality  Assurance  Handbook for Air  Pollution Measurement Systems.
     Volume II  - Ambient Air Specific  Methods.EPA-600/4-77-027a, May
     1977.

 3.  Quality  Assurance  Handbook for Air  Pollution Measurement Systems.
     Volume  III -  Stationary  Source  Specific  Methods.EPA-600/4-77-
     027b, August 1977.

 4.  Systems  Audit  Criteria and  Procedures for  Ambient  Air Monitoring
     Programs.  Currently  under development and  available  from address
     shown in Reference 1 after July 1, 1980.

 5.  Techniques  to  Evaluate Laboratory   Capability  to  Conduct  Stack
     Testing.

 6.  Performance Audit  Procedures for Ambient Air Monitoring Programs.
     Currently under development.

 7.  Appendix A -  Quality Assurance Requirements  for State  and Local
     Air Monitoring Stations (SLAMS).Federal  Register, Vol. 44,  No.
     92, pp. 27574-81, May 10, 1979.

 8.  Appendix  B -  Quality  Assurance  Requirements for  Prevention  of
     "Significant Deterioration^ (PSD)  Air  Monitoring,  Federal  Register.
     Vol. 44, No. 92, pp. 27582-84, May 10, 1979.

 9.  Appendix  E  -  Quality  Assurance   Requirements   for   Continuous
     Emission Monitoring Systems  (CEMST!To be  submitted as a proposed
     regulation to amend 40 CFR 60.

10.  Test  Methods  for  Evaluating   Solid  Waste  -  Physical/Chemical
     Methods.   EPA SU-846,  1980.

11.  Quality  Assurance   Guidelines  for   IERL-CI  Project   Officers.
     EPA-600/9-79-046.December 1979.

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Section No. References
Revision No.       4
Date:  December 29, 1980"
Page       2'   of    2
12.  Handbook for  Analytical  Quality  Control  in  Water  and  Wastewater
     Laboratories.  EPA-600/4-79-019, March 1979.

13.  NEIC  Policies  and  Procedures  Manual.   Office  of  Enforcement,
     EPA-330-9-78-001, May 1978.

14.  NPDES Compliance, Sampling and  Inspection  Manual.   Office of Water
     Enforcement, Compliance Branch, June 1977.

15*  Juran,  J.   M.  (ed),  Quality  Control  Handbook.   Second  Edition,
     McGraw Hill, New York, 1962.

16*  Juran,  J.   M.  and  F. M- Gryna,  Quality   Planning  and  Analysis.
     McGraw Hill, New York, 1970.

17.  Handbook   for   Analytical   Quality   Control   and   Radioactivity
     Analytical  Laboratories"!  EPA-600/7-77-088, August  1977.

18.  Manual  of  Analytical  Quality  Control for  Pesticides and  Related
     Compounds  in  Human and  Environmental Samples.EPA-600/1-79-008,
     January 1979.

19.  Procedure   for   the   Evaluation   of   Environmental   Monitoring
     LaboratorleTiEPA 600/4-78-017, March 1978.

20.  Manual  for  the Interim Certification  of Laboratories Involved  in
     Analyzing   Pub_Ttc_  Drinking   Water   Supplies   -   Criteria   and
     Procedures"EPA 600/8-78-008,  August 1978.

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                                                Section No.  Appendix  A
                                                Revision No.      4
                                                Date: December 29, 1980'
                                                Page     1    of    5
                                APPENDIX  A

                            GLOSSARY OF TERMS
AUDIT:
     A systematic  check  to determine  the  quality of operation  of  some
     functon or activity.  Audits  may be of two  basic  types:   (1)  per-
     formance audits  in which  quantitative data are  independently ob-
     tained for comparison with routinely  obtained  data in a  measure-
     ment  system,  or  (2)  system  audits  of a  qualitative nature  that
     consist of an on-site review of a laboratory's quality  assurance
     system  and  physical  facilities  for  sampling,  calibration,   and
     measurement.
DATA QUALITY:
     The totality of features and characteristics of  data  that  bears  on
     its ability  to satisfy  a  given purpose.   The  characteristics  of
     major importance  are accuracy, precision,  completeness,  represen-
     tativeness, and comparability.   These characteristics are  defined
     as follows:

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Section No. Appendix A
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       «   Accuracy - the degree  of agreement of  a measurement (or
           an average of measurements  of the same thing), X, with an
           accepted reference or true  value, T, usually expressed as
           the difference  between  the two  values,  X-T, or  the dif-
           ference  as  a percentage  of the reference  or  true value,
           100  (X-T)/T, and  sometimes  expressed as  a ratio,  X/T.
           Accuracy is a measure of the bias in a system.

       *   Precision -  a measure  of mutual  agreement  among  individ-
           ual measurements of the same  property, usually under pre-
           scribed  similar conditions.  Precision is  best expressed
           in terms of  the standard deviation.   Various  measures of
           precision  exist depending  upon  the  "prescribed  similar
           conditions."

       ••   Completeness -  a  measure  of the  amount  of valid  data
           obtained from a measurement system compared to  the amount
           that  was expected  to   be obtained  under  correct  normal
           conditions.

       *   Representativeness  - expresses the  degree  to which  data
           accurately and precisely  represent  a  characteristic  of  a
           population,  parameter  variations at a sampling point,  a
           process condition,  or an environmental  condition.

       *   Comparability - expresses the confidence with which  one
           data set can  be  compared to  another.
DATA VALIDATION


       A systematic process  for  reviewing a body  of data against  a

       set of  criteria  to  provide assurance that  the data are  ade-

       quate for  their  intended  use.   Data validation  consists  of

       data  editing,  screening,  checking,  auditing, verification,

       certification,  and review.

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                                                Section No.  Appendix A
                                                Revision No.      4
                                                Date: December 29. 1980
                                                Page      3    of    5   ~
ENVIRONMENTALLY RELATED MEASUREMENTS:

       A  term  used to describe essentially  all  field and laboratory
       investigations that  generate data  involving  (1)  the measure-
       ment  of chemical, physical,  or biological  parameters  in the
       environment,  (2) the determination  of the presence or absence
       of  criteria  or  priority  pollutants  in  waste streams,  (3)
       assessment  of  health and ecological effect  studies,  (4)  con-
       duct  of clinical  and epidemiological  investigations,  (5)  per-
       formance of engineering  and  process evaluations,  (6)  study of
       laboratory  simulation of environmental events, and  (7)  study
       or  measurement on   pollutant  transport  and  fate,  including
       diffusion models.
PERFORMANCE AUDITS:

       Procedures  used  to  determine  quantitatively the  accuracy  of
       the total measurement system or component parts thereof.
QUALITY ASSURANCE;

       The total  integrated  program for assuring  the  reliability  of
       monitoring and  measurement  data.   A  system for  integrating
       the  quality   planning,  quality   assessment,   and   quality
       improvement efforts to meet user requirements.

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Section No. Appendix  A
Revision No.       4
Date:  December 29. 1980
Page     4     of     5 ""
QUALITY ASSURANCE PROGRAM PLAN:

       An  orderly  assemblage  of management policies,  objectives,
       principles,  and  general  procedures  by  which  an  agency  or
       laboratory outlines  how it  intends  to produce  data  of known
       and accepted quality.
QUALITY ASSURANCE PROJECT PLAN;
                              i
       An orderly assembly of detailed  and specific procedures which
       delineates how  data of known and  accepted  quality data  is
       produced for  a  specific project.   (A given  agency  or labora-
       tory would have  only one quality assurance  program  plan,, but
       would have a  quality  assurance  project  plan for each  of its
       projects.)
QUALITY CONTROL;

       The  routine,  application  of  procedures  for  obtaining  pre-
       scribed standards of  performance in  the  monitoring and  mea-
       surement process-

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                                                Section No. Appendix A
                                                Revision No.      4
                                                Date: December 29, 1980
                                                Page     5    of    5
STANDARD OPERATING PROCEDURE (SOP);

       A written  document which  details  an  operation, analysis  or
       action whose  mechanisms are  thoroughly prescribed  and  which
       is  commonly  accepted  as  the method  for performing  certain
       routine or repetitive tasks.

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                                    STATE QA Plan
                                    Revision No. 01
                                    Date 3/1/82
                                    Page  14   of 14
                  APPENDIX B

Regional Quality Assurance Monitoring Protocals

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           Environmental Sampling and Quality Assurance Protocol


 It  is  the policy of Region 10 that  every study or activity involving
 environmental  data collection results  in data  of adequate statistical
 quantity and known precision  and accuracy.   To ensure  that this  is
 achieved,  a  sampling protocol should be followed and a study plan
 prepared.  The plan should describe the specific study details  and
 discuss  the  procedures  to  be  used to assure that the data is of  known  and
 sufficient quality to satisfy the study objectives.  The  following
 sampling protocol  and study plan development outline are  intended to be  a
 guide  for  EPA  staff and/or EPA contractors  conducting  environmental
^monitoring or  measurement  activities within Region  10.

     I.   Scope and purpose of the monitoring or measurement  activity.

         A.    Technical objectives.

         B.    Intended  use of data  and  associated levels  of  data quality
               required.

         C.    Time frames  and schedules.

         0.    Organization and responsibilities.

         E.    Reporting format (reports, samples  only,  etc.)

     II.  Preliminary activities.

         On  any detailed survey other than  those  requiring just one or
         two grab  samples  to  be collected,  the  following  activities
         should be  considered:

         A.    If necessary, conduct  a pre-survey  site visit  to obtain
              pertinent information  for conducting the sampling survey;
              such  as logistics problems, equipment needs, access to
              sample  location,  etc.

         B.   Develop a preliminary  plan of study which includes
              recommendations for any changes in the original objectives,
              survey timing, anticipated problems, etc.

         C.   If necessary, appropriate representatives of EPA and the
              sampling entity will meet to discuss the preliminary plan
              of study;  especially any changes   in objectives or survey
              timing.  At  that  time, any changes required will be agreed
              upon by all  parties.

    III.   Detailed plan  of  study.

         The  sampling entity must develop this  plan to  satisfy EPA
         analytical sampling and quality assurance requirements and
         Inform appropriate staff how the study is to be conducted.   The
         plan of study should:

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                           -2-
A.   Discuss the final agreed upon objectives  including  an
     objective which addresses possible  limitations of data use
     and level of data quality.
B.   Contain a brief explanation of past sample analysis results
     if known.
C.   Identify responsibilities for:
     1.   Conducting the survey.
     2.   Quality assurance activities.
     3.   Providing equipment.
     4.   Sample analysis.
     5.   Interpretation and analysis of results.
     6.   Scheduled report outputs.
0.   Include a description of activities associated with sample
     collection, including:
     1.   Discussion of parameters to be collected, sampling
          procedures, and methods employed.
     2.   Listing of equipment to be used.
     3.   Discussion of potential  sample collection problems
          that may be encountered.
     4.   Listing of sample containers used,  volumes of  samples
          to be collected,  and preservatives  to be used.
     5.   Discussion of field and  laboratory  analysis  to  be
          performed and rationale.
     6.   Listing of methodology or reference to a standard
          methodology for all  field and laboratory analysis
          including reporting units.
     7.   Discussion of documentation  to be used including  field
          data  forms,  analysis request forms, and  sample  routing
          forms if  appropriate.
     8.   Discussion of quality  assurance activities associated
         with  field and  laboratory monitoring or  measurement
          analysis,  including:

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                 -3-
 a)    Analytical  procedures.

      For  each  major qualitative and/or quantitative
      analysis, list or provide a description of the
      analytical  procedures  to be used.   Where
      applicable, analytical  procedures recognized by
      EPA  as  standard methods should  be used.

 b)    Calibration procedures  and frequency.

      For  each  qualitative and/or quantitative
      analysis, list or provide a description  of the
      calibration procedures  to be used.   List the
      frequency planned for scheduled recalibration.
      Where applicable, list  those calibration
      standards whose concentrations  or  values will  be
      established or compared to standards of  higher
      quality.  This process  is called traceability.
      List the  standards of higher quality that  will be
      used for  this  traceability.

 c)    Quality control checks.

      For  each  qualitative and/or  quantitative
      analysis, describe the  frequency and type(s) of
      operational  check(s) planned during routine
      sampling  and routine analysis,  the established
      control limits, and corrective  action to be
      initiated before  measurements are continued.

d)    Preventative maintenance  procedures.

      Include a schedule of important preventative
     maintenance  tasks  that must  be  carried out to
     minimize downtime  of the measurement systems.
     Where appropriate, list critical spare parts that
      should  be on hand  to minimize downtime due to
     parts failure.

e)   Precision and accuracy assessments.

     It is EPA's  policy that precision and accuracy of
     data shall be routinely assessed on all
     applicable environmental monitoring and
     measurement  data.   Describe  a procedure  to be
     used to routinely assess the precision and
     accuracy of environmental data.  Include in  this
     procedure the equations to calculate precision
     and accuracy and the activity planned to gather
     data for the precision and accuracy calculation.

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                                 -4-


                     Accuracy—The mechanism which will demonstrate
                     that the reported data are favorably comparable
                     to the true value(s).

                     Precision—The mechanism which will demonstrate
                     the reproducibility of the measurement process.

           9.   Identify how samples are to be transported.

           10.  Identify the chain-of-custody procedures to be used
                (if any).

 VI.  Analytical Methods.

      All field and laboratory environmental  measurements  shall  adhere
      to established EPA regulations,  guidelines,  and Regional
      standard operating laboratory procedures (SOP).   SOP's  shall  be
      detailed documents describing who does  what,  when, where,  how,
      and why in a stepwise manner. They shall  be  sufficiently
      complete and detailed to ensure  that data of  known precision  and
      accuracy are generated.   SOP's shall be prepared or  referenced
      for all routine tasks but are not required to be contained in
      the plan.

      Recommended EPA Laboratory procedures are described  in  the
      Federal Register,  NPDES  Amendments,  Dec.  1, 1976,  Vol.  41  No.
      232,  pp.  52780-86, "Guidelines Establishing Test Procedures for
      the Analysis of Pollutants",  or  the  most recent  update  which  is
      expected around January  1,  1980.   Also  refer  to  the  following
      references:

           Methods for Chemical Analysis of Water and  Wastes, March
           1979,  EPA-600/4-79-020.

           Handbook for  Analytical  Quality Control  in  Water and
           Wastewater Laboratories, EPA-600/4-79-019.

           Microbiological  Methods  for  Monitoring the  Environment,
           Water,  and Wastes,  EPA-600/8-78-017.

     Copies  of the above-referenced documents  can  be  obtained through
     the Region  10 Quality Assurance Management Office.   Address and
     telephone number are  as  follows:

           Mr. Barry Towns
           Regional  Quality Assurance Management Office
           U.S. EPA  M/S 345
           1200 6th Avenue
           Seattle,  WA   98101

          Telephone  (206) 442-1106

V.  Data Management  and Reporting Requirements.

     This section  addresses the management and reporting  requirements
     of environmental data from sample  collection  through laboratory

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                           -5-
analysis to the final deposition of data including storage Into
the STORE! national water quality data base.  Data management
questions will be resolved through the EPA Data Coordinator, Ray
Peterson.  His address and telephone number are as follows:

     Ray Peterson M/S 345
     EPA Region 10
     1200 Sixth Avenue
     Seattle, WA   98101

     Telephone (206) 442-1193

A.   Project area identification and characteristics:

     1.   Provide a map of the study area identifying all basins
          or similar drainage areas considered in the project.
          In addition, all project area characteristics gathered
          such as land use, soil maps, drainage conveyance
          systems, rainfall maps, etc., shall  be reported to  the
          Data Coordinator, on the sampling entities  reporting
          form.

8.   Monitoring site identification.

     1.   Provide the following information on all  monitoring
          sites:

          a)    Identification number,  if  any (12 character
               maximum).

          b)    Name (48  character maximum).

          c)    Latitude/longitude to  nearest second.

          d)    State.

          e)    County.

          f)    Purpose/description  of  monitoring site.

          g)    Copy (xerox okay)  of US6S  quad  map with  site
               located.

    2.   The EPA  Data Coordinator  in  turn  will  perform the
         following within three  weeks of receipt of  information
         from  sampling entity.

         a)   Oetemine which stations (sites) are to be entered
               1n  STORED.

         b)   Assign permanent STORET identification primary
              and secondary  numbers  as necessary and supply
              this information to  the sampling  entity  for
              future handling of data.

         c)   Code and store sites in EPA  comontpr

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                                -6-
               d)   Send printout  back  to  sampling  entity for
                    verification.

     C.   Collected physical/chemical data.

          1.   All data collected  will  be  submitted to  the EPA Data
               Coordinator on  sampling  entities reporting form within
               one month of availability.

          2.   For all data identified  by  the EPA Data  Coordinator as
               appropriate, the sampling entity has the
               responsibility  to get that  data coded on forms,
               punched on cards, or transferred to  tape in a format
               suitable for storage in  the EPA STORE! computer system
               within three months of availability.  Coding,
               punching, or tape formating details  shall  be approved
               by the Data Coordinator  prior to submission.  The Data
               Coordinator will store the  data on STORET  at no cost
               to the sampling entity.  Within one month  of receipt
               of the data, the Data Coordinator will provide a
               STORET printout for verification of  all   stored data.
               Verification of stored data is manditory and will  be
               the sampling entity's responsibility.

          3.   EPA will (as approved by the Data Coordinator)  provide
               standard STORET data retrievals to the sampling entity
               of raw data, summaries, statistical  analysis,  and/or
               graphics at no cost within two weeks of  request.

VI.  Report of findings.

     The responsibilities for degree and type of reporting should be
     spelled out in the objectives.  They should include the
     following:

     A.    Interpretation  of lab results  and other factors  useful  in
          interpreting data.

     B.    Have objectives been met?

     C.    Recommendations on  additional  work.

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                           Quality Assurance Sample Plan
                                      Outline
Project Name	-  Project Code	

Project Officer	3flte Initiated

QA Officer	_	  Date Approved^
Date Que	Peer Review  Yes	  No	

Date Completed	
    Purpose:   (This includes agency requesting justification  for conducting
               sampling; Technical objectives, intended use of cuiCd.  data
               quality required.)
1.
   Sampling Site:   (Description of problem area.)

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                                     2

3.   Parameters:   (What analyses requested of Lab; Limit of detection sought.)
4.  Laboratory notification:  (Lab number, instructions on  containers  AI-.H
                               documentation.)

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5.  Coordination;  (Names of contacts at requesting agency and at laboratory;
                    scheduling data.)
6.  Sample Documentation:   (Check list of  required records-. Chain-of-uri:ody
                            procedures.)

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                                     4



 7.   SampI a  Collection:  (Narrative description of proposed sampling.)
8.  Quality Assurance:  (Listing of blanks taken and controls cited  for

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     Sampiino handling:  (Any special methods or devices used; How sarnies
                          are to be transported.)
10.   Safety precautions:

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11.   Final Report/Data Usage.   (This may range from a Reportina Format for
                                samples only to a full  report including inter-
                                pretation of results, objective critique,
                                recommendations on additional  sampling, peer
                                review and administrative approval.)

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