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) 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.
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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:
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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:
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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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