UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                          WASHINGTON, D.C. 20460
                            MAR 281990
                                                        OFFICE OF
                                               SOLID WASTE AND EMERGENCY RESPONSE
                                       OSWER Directive 9242.6-06
MEMORANDUM
SUBJECT:  Quality Assurance Review for Extramural Projects;
          Environmental Measurem^its-Ej^vir^nmental^y Related
          Measurements
FROM:
TO:
Purpose:
Henry L. Longest II,v DiredgjSr
Office of Emergency and Remedial Resp

OERR Division Directors
Waste Management Division Directors
     To provide all OERR Project Officers and Managers with the
revised "Quality Assurance Review for Extramural Projects" form.

Background;

     EPA Order 5360.1  (April 3, 1984) established the policy and
program requirements for the conduct of quality assurance  (QA) for
all environmentally related measurements performed by or for this
Agency.

     The term "environmentally related measurements" is defined in
the Order  (attached),  and is quite comprehensive.  Unfortunately,
this definition was not contained in the QA review form, "Quality
Assurance Review for Extramural Projects"  which is required as
part of the pre-award  procurement package for all extramural
projects.  The result  has been that projects covering
environmentally related measurements (per the Order definition)
may not be considered  as such by the Project Officer.
Accordingly-,-, such projects are not covered by any formal QA
requirements, and, they may be in violation of Order 5360.1.

Objective;

     To assure that QA requirements are established as required by
5360.1, four changes have been made to the review form:

         1) Both Project Officer and Quality Assurance Officer
            must sign  even if no environmentally related
            measurements are required.

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                              - 2 -

         2) The term "Environmental Measurements" has been
            replaced with "Environmentally Related Measurements",

         3) The definition of Environmentally Related
            Measurements has been added to the form.

         4) The statement—"The signatures below verify that the
            QA requirements have been established."—has been
            replaced with, "The signatures below verify that the
            QA requirements have been reviewed and established
            where appropriate.

     In addition, the term "Pre-Award Document" has been added
to the header for clarification.

Implementation;

     Please ensure that all Project Officers are provided with
this memorandum as well as with a copy of the new review form
(attached).  Thank you for your assistance in the continued
improvement of our QA program.  If you have any questions
regarding the Order or the review form, please contact
Duane Geuder at 245-4027.

Attachments

    cc:  Stan Blacker, QAMS
         OERR Branch Chiefs

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          QUALITY ASSURANCE REVIEW FOR EXTRAMURAL PROJECTS
                                 PRE-AWARD DOCUMENT (contracts)

       I.  GENERAL INFORMATION

              Descriptive Title:

              Sponsoring Program Office:

              Approximate Dollar Amount:

              Duration:
       II.  THIS CONTRACT REQUIRES ENVIRONMENTALLY RELATED MEASUREMENTS*
              (If yes, complete form; if no, sign form - both PO & QA O and submit

            .  with procurement request).
yes
no
       ni. QUALITY ASSURANCE REQUIREMENTS
       (Projects involving environmentally related measurements)
             a.     Submission of a written quality assurance (QA) program plan
                   (commitment of the offerer's management to meet the QA
                   requirements of the scope of work) is to be included in the
                   contract proposal.

             b.     Submission of a written QA project plan Is to be Included in the
                   contract proposal.

             c.     A written QA project plan is required as a part of the contract.

             d.     Performance on available audit samples or devices shall
                   be required as a part of the evaluation criteria
                    (see list on reverse side).

             e.     An on-site evaluation of proposer's facilities will be made to
                   ensure that a QA system is operational and exhibits the
                   capability for successful completion of this project
                    (see schedule on reverse side).

             f .     QA reports will be required
                    (see schedule on reverse side).
ves
       ' See definition on reverse side
no
(OSWER Directive # 9242.6 -06)
        (February 1990)

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               QUALITY ASSURANCT RJCVXTH POR EXTRAMURAL PROJECTS

                                 (CONTRACTS)

z.   GZHIMI. ZMTOIMATION

     Daacriptiva Titlai

     Sponsoring Program Offica:

     Approximate Dollar Amount!

     Duration:
II.  THIS CONTRACT RSQOIRSS ENVIROWBNTAi. MEASUREMENTS
     (If yaa, complete form; if no,  sign foot and           Yea
     aubmit with procurement raqueat. )
HI. QUALITY ASSDRAMCX RZQUIRZMCHTS                         Y««       NO
     (Proj«et« involving anviroraMntal naasunaanta)        _    _
     a.  Sub«iaaioD of a writ tan quality aaauraae*
         (QA) program plan (coamitmant of tha
         offaror'« maaagaaant to aa«t tha OA.
         raquiraaanta of tha  acopa of work)  la  to
         ba ineludad in tha contract propoaal.

     b.  Suhmiaaion of a writtan QA projact  plan ia
         to ba includad in tha contract propoa*!.

     c.  A writtan QA projact plan ia raquirad  aa
         a part of tha contract.

     d.  Barforaanea on available audit aamplaa or
         davieaa a hall ba raquirad aa part of tha
         •valuation critaria  (aaa liat on ravaraa
         aida).

     a.  Aa oa-aita avmluation of propoaar'a facili-
         tia« will ba aada to anaura that a  QA  ayat«
         la omaratiooal and axhibita tha capability
         for •ueeaaaful coaplatlon of this projact
         (aa« aehadula on ravaraa slda).
     f.   QA raports  will ba  raquirad (aaa  aehadula
         on ravaraa  aida).
                                                              Sacond Edition

                                                              April 1984

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 IV.   DETERMINATION  (Projects involving environmental measurements)

      Percentage of  technical evaluation points assigned
      to QA                                                  	
      Project Officer estimate of percentage of cost
      allocated to environmental measurements
               QC Reference      Split Samples     Required      fTHQOZNCY
      ter   Saapling or D*vie«        for            for
                Availabl*	  Cross-Comparison   Praavard    During Contract
               (Yas or No)        (Yas or Ho)     (Yas or Me)
QA Systam Audits az» raqulrad:  Praaward	;  during contract!
QA Reports ara wquirad:  with Prograss Raports      ;  with Final lUport __


Tha signatures below verify that the QA requirements have been established.

QA Officer:                                  Project Officer:
       Signature              Date               Signature             Date

After signatures, a copy of this form must be included with the procurement
request and sent to the Contracts Office and a copy placed on file with the
QA Officer.


                                    3-74
                                                            Second Edition
                                                            Aoril 1984

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&EPA TRANSMITTAL
 CLASSIFICATION NO.:
 APPROVAL DATE:
5360.1
4/3/84
                              ADDRESSEE
      EPA ORDER 5360.1  — POLICY AND PROGRAM REQUIREMENTS  TO
                         IMPLEMENT THE MANDATORY QUALITY
                         ASSURANCE PROGRAM
  1.  PURPOSE.   This transmittal provides a new EPA Order  5360.1,
  Policy and Program Requirements to Implement the Mandatory
  Quality Assurance Program.

  2.  EXPLANATION.  This Order establishes policy and program
  requirements  for the conduct of quality assurance (QA) for all
  environmentally related measurements performed by or  for this
  Agency.

  3.  SUPERSESSION.  None

  3.  FILING INSTRUCTIONS.  File the attached in a three ring
  binder.Post  receipt of Transmittal on Checklist in  front of
  the  binder.
                         G<
                         M£
            igement
ector
ganization Division
ORIGINATOR:
             Office of Research  and  Development
EPA Form 1310-12 (R«v. 742) REPLACES EPA FORMS 131S-1A AND THE PREVIOUS EDITION Of 131B-12.

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  RPA ORDER                                                             5360.1

                                                                    APR  3 1984

                         POLICY AND PROGRAM REQUIREMENTS
               TO IMPLEMENT THE MANDATORY QUALITY ASSURANCE PROGRAM
  1.   PURPOSE.   This Order establishes policy and program requirements for the
  conduct of quality assurance  (QA) for all environmentally related measurements
  performed  by  or for this Agency.

  2.   BACKGROUND.  Agency policy requires participation in a centrally managed
  QA program by all EPA organizational units supporting environmentally related
  measurements.  Under Delegation of Authority 1-41, "Mandatory Quality Assurance
  Program" (dated 4/1/81), the Office of Research and Development (ORD) is the
  focal point in the Agency for quality assurance policy and is responsible for
 developing QA requirements and overseeing Agencywide implementation of the QA
  program.   ORD established the Quality Assurance Management and Special Studies
 Staff (QAMSS)  to serve as the central management authority for this program.
 The QAMSS  activities involve the development of policies and procedures; co-
 ordination for and direction of the implementation of the Agency QA program;  \
 and review, evaluation, and audit of program activities involving environmental
 monitoring and other types of data generation.

 The Agency QA program embraces many functions including: establishing QA policy
 and guidelines for development of program and project operational plans; establishing
 criteria and guidelines for assessing data quality; serving as a QA information focal
 point; auditing to ascertain effectiveness of QA implementation; and identifying and
 developing QA training programs.

 3.   GOALS AND POLICY.   The primary goal of the  OA program is to ensure that
 all  environmentally related measurements supported by the EPA produce data of
 known quality.  The quality of data is known when all components associated
 with its derivation are thoroughly documented,  such documentation being verifi-
 able and defensible.   It shall be the policy of all EPA organizational units to
 ensure that data representing  environmentally related measurements are of known
 quality. Decisions by management rest on the quality of environmental data;
 therefore,  program managers shall be responsible for: 1) specifying the quality
 of the data required from environmentally related measurements and 2)  providing
 sufficient  resources  to assure that  an adequate level of QA is performed.
 All  routine or planned  projects or tasks involving environmentally related
 measurements shall be undertaken  with an adequate QA project plan that specifies
 data  quality goals acceptable  to  the data user  and assigns responsibility for
 achieving these_goals.  ~

 In discharging its responsibility for implementing the Agency-mandated Quality
Assurance Program, the ORD/QAMSS  will  strive  for consensus by submitting for
 review proposed policies and procedures to affected program offices and regions.
 Responsibility for adjudication of unresolved issues, with respect to the above
 and QAMSS conducted audits,  will  be  at the lowest level  of authority consistent
with the scope of the issues.  The QAMSS will refer issues which remain un-
 resolved at lower levels of  authority to the  AA/ORD for  decision,  after con-
sultation with the appropriate AA or RA.

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  EPA ORDER                                                              5360.1

                                                                     APR   3  1984
  The following activities are basic to the implementation of the QA program:
      a.   Preparation and  annual update of a QA program plan based on guidelines
  established by QAMSS.

      b.   Development of a QA project plan for all projects and tasks involving
  environmentally related  measurements in accordance with guidelines established
  by QAMSS.

      c.   Assuring implementation of QA for all contracts and financial assistance
  involving environmentally related measurements, as specified in applicable EPA
  regulations,  including subcontracts and subagreements.

     d.   Conducting audits (system, performance evaluations, data quality,  bench,
 etc.) on a scheduled basis of organizational units and projects involving  environ-
 mentally related measurements.

     e.   Developing and adopting technical guidelines for estimating data quality
 in terms of precision (variability),  bias (accuracy), representativeness,
 completeness and ccmparability, as appropriate, and incorporating data quality
 requirements in all projects and tasks involving environmentally related      .
 measurements.

     f.  Establishing achievable data  quality limits for methods cited in
 regulations based on results of methods evaluations arising from the methods
 standardization process,  e.g.,  ASTM Standard D2777-77.

     g.  Implementation of corrective  actions,  based on audit results, and  for
 incorporating this process into the management accountability system.

     h.  Provision for appropriate training based on perceived needs,  for all
 levels of QA management,  to assure that  QA responsibilities and requirements are
 understood  at every stage of project  implementation.

 4.   RESPONSIBILITIES.

     a.  In  conformity with the  oversight responsibility for the mandatory  QA
program,  the fA/ORD shall:

         (1)  Establish Agency policies and procedures for implementing the
mandatory QA program.

         (2)  Provide guidance for  determining precision,  bias,  representativeness,
completeness,  and comparability of data.

         (3) Review QA Program Plans from Agency components  involved in
environmentally related measurements.

         (4) Conduct QA audits of  all organizational units supporting environ-
mentally  related measurements based on established audit criteria and procedures.


                                      -2-

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  EPA ORDER                                                               5360.1

                                                                       .: K    3 1.384

          (5)  Recommend corrective actions, based on audit results, for inclusion
  in the management accountability system.

          (6)  Establish achievable data quality limits for methods provided by ORD
  for citation in  regulations, based on results of methods evaluations arising from
  the methods  standardization process, e.g., AS1M Standard D2777-77, to help project
  officers define  data quality goals.

          (7)  Serve as the Agency QA information focal point.

          (8)  Develop generic training programs, based on perceived needs, for all
  levels of management to assure that QA responsibilities and requirements are
  understood at every stage of project implementation.

          (9)  Ensure that all QRD investigations involving data collection are
 covered by an acceptable QA plan with resources adequate to accomplish program
 objectives.

        (10) Ensure that deficiencies highlighted in review of ORD program plans
 or in audits of ORD components are appropriately addressed.

      b.  In accordance  with policies and procedures established by AA/ORD,
 National Program Managers shall:

         (1) Ensure that QA is an  identifiable activity with associated resources
 adequate to accomplish  program goals in the development and execution of all pro-
 jects and tasks,  both intramural  and extramural,  involving environmentally related
 measurements.

         (2) Ensure that  appropriate OA criteria are included in operating  guidance.

         (3) Establish data quality acceptance criteria for all projects and tasks
 conducted by the  program office.

         (4) Ensure that  an adequate degree of auditing is performed to determine
 compliance with QA requirements.

         (5) Ensure that  deficiencies highlighted  in audits are appropriately
 addressed.

         (6) Ensure that  all projects and tasks involving environmentally related
measurements  are  covered by an  acceptable OA project plan and that the plan is
 implemented.

         (7) Identify program-specific QA training needs and provide for the
required  QA training.

      c.   In accordance with policies and procedures established by AA/ORD, Regional
Administrators shall:


                                    -3-

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  EPA ORDER                                                                 5360.1
                                                                       -Hrt    3 i334
          (1) Ensure that QA is .-.n  identifiable activity with associated resources
  adequate to accomplish program and regional goals  in the development and execution
  of all projects and tasks involving environmentally related measurements, both
  intramural and extramural.

          (2) Ensure that QA guidelines are specified for estimating data quality
  in terms of precision,  bias,  representativeness, completeness, and comparability,
  for all environmentally related measurements which meet the operating guidance
  established by the program offices.

          (3)  Establish data quality acceptance criteria for all projects and tasks
 .initiated  by the Region.

          (4)  Ensure that all projects and tasks involving environmentally
  related measurements are covered by an acceptable QA project plan and that the
 plan is implemented.

          (5)  Ensure that an adequate degree of auditing is performed to determine
 compliance with QA requirements.

          (6) Ensure that deficiencies highlighted in audits are corrected
 expeditiously.

         (7) Identify program-specific QA training needs and provide for the
 required QA training.

      d.  The AA for Administration shall establish a mechanism for incorporating
 QA in the Agency's planning and budgeting cycle.

 5.   DEFINITIONS.  The  following terms  have special meanings in relation to this
 Order.

      (a) Documentation*   The  use of documentary evidence;  a written record
 furnishing  information that a procedure  has been  performed.   When applied to
 environmentally related measurements  it  includes  all calculations related to
 sampling design; all steps in the  chain  of custody, where  appropriate;  and
 all notes and raw data generated in the  sampling, analysis,  or data validation
 process.

      (b) Defensible.  The ability  to withstand any reasonable challenge related
 to  veracity or truthfulness.

      (c) Environmentally Related Measurement.  Any laboratory or  field  data
 gathering activity  or  investigation involving the determination of chemical,
 physical, or biological  factors related  to the environment.

     The following  are representative examples of environmentally related
measurements.   Data collection or  investigation of  chemical,  physical,  or bio-
 logical  factors for determination  of:


                                     -4-

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 EPA ORDER                                                                5360.1
                                                                      .. ,\    O IJC-i

          (1) pollutant concentrations from sources,  in the ambient  environment,
 or pollutant transport and fate;

          (2)  response of organisms to pollutants;

          (3)  the effects of pollutants on human health and on the  environment;

          (4)  risk/benefit analysis;

          (5)  environmental or economic impact.

          (6)  the environmental impact of  cultural and natural processes;

          (7)  pollutant levels, exposure levels,  etc.,  used in modeling.

      (d)  Organizational Unit.  Any  administrative entity (national  program
office, regional  office,  QRD or NEIC laboratory)  which engages in environmentally
related measurements.

      (e)  Project.  An organized undertaking or specified unit of investigation
involving environmentally related measurements.

      (f)  Quality Assurance.  The total  integrated program for assuring  the
reliability  of monitoring  and measurement data.

      (g)  Verifiable.  Ihe ability to prove or substantiate any claim or result
related to the documented  record.

6.  ADDITIONAL REFERENCE.  This Order will be amplified by a detailed implemen-
tation plan.
                               Howard M. Messner                                Q
                               Assistant Administrator
                               Office of Administration and Resources Management
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