NATE

WS. Ervin some _ “ton Agency

Chicag - ae HE



Page 11 of 15

V. Qua ty Assuranu> Requirements for Contracts.
“ Gr is, and Cooperative Agreements

In accordance with the Administrator's policy of june 14, 1979, QA Project Picas
are required for all contracts, grants, and cooperative agreements which include
environmental measurements. Because of some procedural and legal differences,
the QAMS will prepare two separate guidelines:

1. Guidelines for the Implementation of QA Requirements for Contracts

2.. Guidelines for the Implementation of QA Requirements for Grants
and Cooperative Agreements

These guidelines will be implemented by the beginning of FY 1981.

VI. Model QA Program Plan and Model QA Project Plans

Several model QA Program Plans will be jointly prepared by the QAMS and the
responsible QA Officer and organization.

1. Ambient Air (OAQPS)

2. Ambient Water (OWPS)

3. A Region (IV)

4, Laboratories (HERL-RTP and ERL-Narragansett)

Similarly, several model QA Project Plans will be jointly prepared by the responsible
QA Officer and Project Manager under the guidance of QAMS:

1. Ambient Air (Project or Pollutant Specific)

2. Ambient Water (Project or Pollutant Specific)

3. Region (Project or Pollutant Specific)

4, | Laboratory (Project or Pollutant Specific)

These model QA Program Plans and model QA Project Plans will then be used as


Werbiee TO mek

Page 2 of 15

studies involving laboratory simulation of environmental events; and studies
} :

r measurem .©s on pollutant transport, including diffusion models.
) :

This document presents the strategy for the development of an Agency QA program
in accordance with the Agency policy. This strategy describes, in general, the
total program effort with respect to what must be done. This strategy does not
attempt to describe how, in detail, the program is to be implemented within the
individual Program and Regional Offices, or the EPA Laboratories. Subsequent
guidance documents will enable the Program and Regional Offices and the EPA

Laboratories to develop detailed QA plans.

II.. Quality Assurance Goals and Objectives

The primary goal of the QA program is to insure that all environmentally-related
measurements supported or required by the EPA. result in data of known quality.

To meet this goal, the QA program must provide for the establishment and use of
reliable monitoring and measurement systems to obtain data of necessary quality

to meet planned Agency needs.

Initial objectives are the development and implementation of QA program plans by
each of the Program and Regional Offices and EPA Laboratories which will ensure

that the QA goal can be achieved nationally.

Long-term objectives include (1) providing quantitative estimates of the quality
of all data supported or required by the Agency, (2) improving data quality where

indicated, and (3) documenting progress in achieving data quality.

A continuing objective is to promote and develop optimally uniform approaches,


2

Finally, there were objections raised regarc ng the requirements that the
QA Officers for each unit be independent of the functional groups making envizon-
mental measurements. An independent QA review is essential to the success of the
program; however, we have revised the document to allow more flexibility to offi-
cials in designating QA Officers.

We believe that the revisions of the strategy document respond to the concerns
of the reviewing offices. It provides a clear explanation of the activities and
Fequirements of the QA program for the next two years. Therefore, I recommend thar
you sign the attached ACTION MEMORANDUM. Upon your concurrence, I will issue the
strategy for Agency use.

Attachments


. Completion
ajor Task or Output Responsibility Target Date

rocedures for Implementation

of Agency-wide QA Audit

an OMTS /Q4aMS : December 1, 2980
(Start)

Pro

itatistical Data Quality
Assessment Procedures ~

Precision and Accuracy gams /OPM
jemiannual Agency QA Report OMTS /QAMS
JA Workshops) . QAMS /EMSLs February, 1981

QA Reporting System Proposed
for agency Adoption and Use QAMS /OPM March 2

QA Cost Analysis System and

Guidence OMTS /QAMS March 30, 1982
JAMS Workshop (s) OMTS/EMSLs April, 1961

Guidelines for Establishing
Data Quality Acceptance

Criteria QAMS/POs, EMSLs May 4, 1981
Semiannual Agency Qa Report OMTS /OAMS June 8, 1981

EPA's Oa Program -A

OMTS /GAMS 1 Octeber i, 1352



rage / or 1)

reviewed and approved by the QAMS. QA programs for the States will be cooperatively
devel ‘sed with then through the appropriate Region. continual oversight of State
Qa programs will be a Regionai responsibility with guidance and assistance by the
QAMS.

3) Laboratories

Based upon guidelines established by the QAMS, each Laboratory will develop
and implement a QA Program Plan for its organization. These QA Program Plans will

be submitted to the QAMS for review and approval.

IV. Quality Assurance Plans

The implementation of a strong QA program will depend, in large measure, upon the
development of general management plans for each distinct program area along with
explicitly detailed plans for each individual project or study. It is essential

to understand the differences between the two types of plans.

QA Program Plans are written documents to be prepared by each Program Office,
Regional Office, and Laboratory which include the overall policies, organization,
objectives, and functional responsibilities designed to achieve data quality goals
for the activities for which the particular organization is responsible. These QA
Program Plans are to be developed in conformance with the "Guidelines and Specifi-

cations for Preparing QA Program Plans, QAMS—004/80."

QA Project Plans are written documents, one for each specific project or each
continuing operation (or group of very similar projects or group of very similar

continuing operations), to be prepared by the responsible Program Office, Regional



A.

are.to:

VALLI UITLz—OU

Page 4 of 15

Office of Monitoring and Technical Support (OMTS)

1) The Quality Assurance Management. Staff (QAMS)

The QAMS will manage the mandatory program. Major functions of the QAMS

- Develop model QA plans and guidelines for use by data
generating offices and laboratories in preparing QA plans.

- Review and approve QA plans of data generating offices and
laboratories.

- Conduct periodic reviews of Agency 0A Programs to determine
if deficiencies exist and recommend corrective actions.

- Provide assistance to Agency components developing and
vimplementing QA plans, including assistance in identifying
resources and outputs needed for the fulfillment of the
mandatory QA program.

- Provide annual report to the Administrator and others as
required.

- Chair and provide administrative support to the Agency
Quality Assurance Advisory Committee (AQAAC).

- Review selected Agency regulations containing QA requirements
for monitoring and measurements. 7

- Coordinate and assist in development of QA training programs.

- Maintain reference files of QA plans and procedures and serve
as a clearinghouse for QA information.

- Coordinate the development and approval of laboratory certification
ptocedures and criteria as part of the design of the azandatory OA
program.

- Coordinate liaison and support for QA plans and programs with other
agencies and professional societies, including cooperation with
national and international standards setting organizations.


Page 3 of 15

procedures, techniques, reporting methods, etc., across media and across
Regional Offices, Program Offices, and EPA Laboratories. It is important (and
most efficient and effective) for all organizations within EPA to employ the
game QA language, consistent policies, procedures, and techniques when inter-
acting with the States, industry, the public, contractors, grantees, QA~involved
professional societies, other Governmental agencies, and national and inter-

national organizations.

III. Quality Assurance Management, Organization, and Responsibilities

The QA program can succeed only if it is given attention by top management and
provided sufficient authority and resources to support a national program effort.
Therefore, the Assistant Administrators and Regional Administrators share the

major responsibility for implementing the Agency's QA policies and directives.

The Agency-wide QA program will be implemented through the ‘establishment of a
central management authority supported by a well-defined organizational structure
with clearly delineated areas of responsibility. The Administrator has delegated
to the Office of Research and Development (ORD) the authority and responsibility
for developing and coordinating ‘the national mandatory QA program and directing
its implementation. Within ORD, the responsibility has been delegated to the
Quality Assurance Management Staff and the twe Environmental Monitoring Systems
Laboratories and one Environmental Monitoring Support Laboratory of the Office

of Monitoring and Technical Support. The other agency organizations involved in
the management of the mandatory QA program are Program Offices, Regional Offices,

and Laboratories.


? 7 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
(SZ; . . WASHINGTON, D.C. 20460
See ams
i
4 OCT og 1980
OFFICE OF
. RESEARCH AND DEVELOPMENT

SUBJECT: Implementation Strategy for the Quality Assurance (QA) Program

FROM: Stephen J. cage SO LNG lave
Assistant Administrator ~/ ¥
‘ for Research and Development (RD-672)

TO: The Administrator

THRU: ‘AX-101

We haye completed the "red border" review process for the subject strategy
document. The reactions by the reviewing offices are shown on the clearance
record shown in Tab A.

We have since met with the staffs of the two nonconcurring offices and modi-
fied the strategy in response to their concerns and the concerns raised in the
comments from the other reviewing offices. A copy of the revised strategy is
shown in Tab B. Our specific actions in the nonconcurrences are summarized in
Tab C. The- specific responses from each office are contained in Tab D.

A major concern of all the responding offices was the potential resource
required to implement the mandatory QA program. Specifically, there was concer
that the strategy was not in accord with your policy to "make optimum use of
existitg Agency resources and expertise and provide for the least disruption of
ongoing activities." We have responded to thir by including a section on
resources that details the Office of Research and Development's support to the
mandatory program and reiterates your directive that the Assistant Administrators
and Regional Administrators must provide sufficient QA resources to assure that
we use data of known quality in our decisions.

Another point raised by several reviewers was the yagueness of the strategy
and implementation schedule with respect to specific activities. In response, we
revised the strategy to cover FY 1980-81 only and expanded the implementation
schedule accordingly. There were many comments raised concerning the need to
provide more specific guidance in the strategy. Since we are preparing separate

guidance documents for implementing the key parts of the QA program, we incorporated

them in the strategy by reference where appropriate.


Page 6 ot lo

Each office or laboratory generating data will designate a QA Of icer. This
person will be responsible for QA functions within his area of 1=sponsibility
and provide liaison with the QAMS and other QA groups. The functions of the

QA Officer will be consistent with those of the QAMS as described above but
limited to a specific area of responsibility. Specific responsibilities shall
include (1) liaison with the QAMS and other QA groups; (2) preparation of QA
program plans; (3) preparation or review and approval of QA requirements for
grants, cooperative agreements, and contracts; and (4) preparation of QA reports

including data quality assessment.

Each operating program (office, Region, or laboratory) will notizy the QAMS of
any new or planned monitoring or measurement activities. Each operating program
will also have a mechanism for accurately accounting and tracking resources for
QA. (For example, Region V has identified a QA-office for this purpose.)

1) Program Offices ;

Based upon guidelines established by the QAMS, the Program Offices, in
conjunction with their related laboratories, Regional programs, Regional QA
Offices, and other field units will develop and implement QA Program Plans.
These QA Program Plans will be submitted to the QAMS for review and approval.

2) Regional Offices

Based upon guidelines established by the QAMS and the guidance from the
National Program Managers, each of the Regional Offices will develop and implement
consistent QA Program Plans. These plans will address the responsibilities for

the Regions, State and local agencies, and the private sector. QA plans will be


600R80103 .

Strategy for the Implementation
of the
‘ Environmental Protection Agency's
Mandatory Quality Assurance Program

FY 1980 and FY 1981

QAMS-001/80

Quality Assurance Management Staff
Office of Monitoring and Technical Support
ffice of Research and Development

U.S. Environmental Protection Agency

.

Corea, RES La

March 11, 1980


Page ¥ or 15
’ 5. Gen ral procedures whereby QA Project Plans are prepared, reviewed,
anc approved.
6. A listing of the substantial current and planned project: and-
continuing activities for which QA Project Plans will be repared.
Target dates for the completion of each QA Project Plan will be
: indicated.
QA Program Plans will be prepared by each of the following Offices and Laboratories:
Enforcement (NEIC-Denver)
Water Enforcement
General Enforcement
Mobile Source and Noise Enforcement
Water Planning and Standards
Water Program Operations
Drinking Water Programs
Solid Waste Programs
Noise Abatement and Control
Air Quality Planning and Standards
Mobile Source Air Pollution Control
Radiation Programs
Monitoring and Technical Support |
Environmental Engineering and Technology
Health Research
Environmental Processes and Effects Research
Pesticides Programs
Chemical Control
Testing and Evaluation

Program Integration and Information
Regions I through X

ORD Laboratories (A Plan for Each of 15)

Note: See the "Guidelines and Specifications for Preparing QA Program Plans, _
QaMS-004/80" for more detail. .



ware. ve a we

Page 8 of 15

fice, Laboratory, Contractor. Grantee, or other organization which presents,
1

nm specific terms, the policies : organization (where applicable), objectives,
unctional activities, and specific QA and quality control (QC) activities designed
o achieve the data quality goals of the specific project(s) or continuing opera-
:ion(s). QA Project Plans are to be prepared in accordance with the "Guidelines
-nd Specifications for the Preparation of QA Project Plans, QAMS-005/80," to be

.ssued by June, 1980.

24 Program Plans only will be reviewed and approved by QAMS in accordance with
the "Procedures for QA Program Plan Review and Approval (Standard Operating

’rocedure 001/80). Project Plans are to be approved by the QA Officer of the
responsible organization. QAMS will examine selected QA Project Plans as part

»£ the ongoing review of the CA program implementation.

A. Quality Assurance Program Plan
The QA Program Plans must contain, as a minimum, the following information:

1. A statement of policy recognizing the organization's intent to
implement a QA program for their internal and extramural efforts
to result in measurement data of known quality.

‘ 2. An organizational chart showing the position of the QA Officer
who is accountable for the QA program. In establishing the
organizational position of the QA Officer, the designating
official (DAA, Laboratory Director, RA, etc.) should consider
the need for open lines of communication. The desirability of
avoiding a presumption of conflict of interest which might
result if ‘the QA Officer were not sufficiently removed organi-
zationally from the direct generation of the majority of the
data should also be considered.

3. A delineation of the responsibilities of the QA Officer and the
data quality responsibilities of the functional groups of the
organization.

4. General description of procedures or approach to be used to

routinely assess and document the precision, accuracy, and
completeness of measurement data.


2) Environmental Monitoring Systems Laboratories and
Environmental Monitoring Support Laboratory (EMSL)

The EMSLs! 2f the OMTS work closely with the QAMS and will have Agency-wide
7) )

technical responsibility for the mandatory QA program for their respective media

or area of expertise. These responsibilities include:
- Provision of technical assistance to the QAMS

"= Development of sampling and measurement methods and procedures

- Selection, testing, and validation of measurement methodology

- Development and implementation of procedures for assessing
equivalent and alternate measurement procedures .

-- Preparation of QA guidelines, handbooks, and other reference
information

- Development and implementation of criteria and procedures for
evaluations of routine performance of measurement systems and
operations

1). Provision of standards and reference materials including
all performance evaluation samples

2) Conducting performance evaluations
In some specialized areas, such as biomedical and pesticide residues, QA responsi~
pilities may be delegated to other ORD Laboratories.

B. Offices Generating Data (Program Offices, Regional Offices,
and =ZPA Laboratories)

Each office or laboratory generating data has the minimum responsibility
to implement procedures to assure that precision, accuracy, completeness, and
representativeness of its data are known and documented. In addition, an organi-

zation should specify the quality data must meet in order to be acceptable.


rage 2 uL id

Strategy for the Implementation
o* the
Environmental ‘rotection . .ency's
Mandatory Quality . ssurance (Qa) Program

I. Introduction

The EPA must have a comprehensive QA program to provide for the generation,
storage, and use of environmental data. Valid data of verifiable quality
must be available to provide a sound basis for effective decisions concerning
environmental quality, pollution abatement, and control measures. The QA
program can succeed only through rigorous adherence to established QA tech-

niques and practices.

In the past, there has been a high degree of fragmentation, lack of coordination,
poorly identified needs and resources, and duplication of efforts in the QA pro-
gram. For these reasons, it is now Agency policy, as enunciated by the Adminis—
trator in memoranda of May 30, 1979 and June 14, 1979, that. all Regional Offices,
Program Offices, EPA Laboratories, and those monitoring and measurement efforts
supported or mandated through contracts, regulations, or other formalized agree-
ments participate in a centrally managed QA program. Regional Offices should work

cooperatively with States to assist them in developing and implementing QA programs.

The mandatory QA program covers all environmentally-related measurements.
Environmentally~related measurements are defined as "essentially all field and
laboratory investigations that generate data involving the measurement of chemical,
physical, or biological parameters in the environment; determining the presence or
absence of pollutants in waste streams; health and ecological effect studies;

clinical and epidemiological investigations; engineering and process evaluations;



Page 12 of 15

models for the preparation of other QA Program Plans and QA Project .. 1s. Models

will be revised as needed to reflect new developments.

VIL. Quality Assurance Reports .

Each Program and Regional Office and each Laboratory will prepare a semiannual QA
Report which will be submitted to the QAMS. Such QA reports will include such
information as: :

1. Status of QA Program Plans

2. Status of QA Project Plans

3. Measures of data quality from their projects

4. Significant quality problems, quality accomplishments,
and recommendations

5. Results of Performance Audits
6. Results of Systems Audits

7. Summary of quality-related training

The QAMS will, in turn, prepare a consolidated summary report to the Administrator,

the Assistant Administrators, and others.

VIII. Special Quality Assurance Projects

The QAMS will place priority on several special projects of major interest:

1. Conduct QA Workshops. To assist in the preparation of QA Program
Plans and QA Project Plans and in the implemenration of the QA
requirements for contracts, grants, and other cooperative agree-
ments, the QAMS will conduct, in cooperation with the Program and
Regional Offices, EPA Laboratories, and Contract and Grant Adminis-
trations, a series of QA Workshops at Research Triangle Park,
Cincinnati, and Las Vegas. Attendees at the workshops will include:

Regional QA Officers Contract Administrators
Program QA Officers Grants Administrators
Laboratory QA Officers Project Officers

and Other Interested Persons


TABLE 1

IMPLEMENTATION REQUIREMENTS AND SCHEDULE

rage 14

OL as

Major Task or Output

Responsibility

Completion
Target Date

Agency QA Policy - General

agency QA Polic; ~ Contracts
and Grants

Draft Strategy for Developing
Mandatory QA Program

Draft Guidelines and Specifications
for Preparing QA Program Plans

Draft Guidelines for Implementing
QA Requirements for Contracts

Designation of QA Officers

Model QA Progra. Plans (Ambient
Air, Water, Region, (Laboratory)

Draft Guidelines for QA Project
Plans

Draft Model QA Project Plan
Quality Assurance Clearinghouse

Semiannual Agency Quality Assurance
Report

Draft QA Program Plans Submitted
Agency QA Progr: m Plans Approved
Qa Cost Study Report

Draft Guidelines for Implementing
QA Requirements for Grants

QA Workshops (QA Officers, Project
Officers, Grants Administrators)

QA Project Plans Prepared

Administrator

Administrator

ORD/Work Group

oMTS/QAMS

OMTS / CAMS

DAAs, Labs, RAs

ORD POs, ROs

OMTS /QAMS
OMTS /QAMS

OMTS/QAMS

OMTS /QAMS
POs, Labs, ROs
OMTS /QAMS

ORD Labs. RCs

OMTS /QAMS

OMTS /QAMS

Labs, POs, ROs

May 30, 1979

June 14, 1979

February 13, 1980

February 22, 1980

February 22, i580

March 1, 1980

May 19, 1980

May 5, 1980
May 5, 1980

May 1, 1980

June 2, 1980
June 6, 1980
September 15, 1980

September 15 “$30

September 15.

(To Be Planned)

October 1, 193¢
and continuing


Strategy for the Implementation
of the
Environmental Protection Agency's
Mandatory Quality Assurance Program

FY 1980 and FY 1981

“TABLE OF CONTENTS

Page
I. Introduction 1
II. Quality Assurance Goals and Objectives 2
III. Quality Assurance Management, Organization,
and Responsibilities 3
Iv. Quality Assurance Plans 7
Vv. Quality Assurance Requirements for Contracts,
Grants, and Cooperative Agreements 1
VI. Model Quality Assurance Program Plans and
Model Quality Assurance Project Plans i
VII. Quality Assurance Reports 12
VIII. Special Quality Assurance Projects 12
IX. Resource Requirements | 13
X. Implementation Requirements and Schedules - 13



tee Rgency

v8 Ene.


rage LU Or 419

B. Quality Assurance Project Plans

QA Project Plans for m iitoring and measurement projects should contain

the following, .3 applicable:
1. Title Page, with provision for approval signatures
2. Table of Contents
3. Project Description
4, Project Organization and Responsibilities

5. QA Objectives for measurement data in terms of precision,
accuracy, completeness, and representativeness

6. Sampling Procedures
7. Calibration Procedures and References
8. Analytical Procedures (manual and automated)

9, Data Analysis, Validation, and Reporting (manual
and automated)

10. Internal Quality Control Checks

ll. Performance and System Audits

12. Preventive Maintenance Procedures and Schedules

13. Sample Custody

14. Specific Procedures to be used to routinely assess and
document data precision, accuracy, and completeness of
specific measurement parameters involved

15. Corrective Action

16. Quality Assurance Reports to Management

The QA Project Plans will be prepared in document control format, with provision
for revision, as needed, and with a record of the official distribution.

Note: See the "Guidelines and Specifications for Preparing QA Project Plans,
QAMS-005/80" for more detail.


Page 13 of 15

2. Establish QA Clearinghouse(s). Each clearinghouse will maintain
listings of available reference materials, schedules of EPA inter-
laboratc <7 performance audits; files of past and current A Program
Plans, ct Project Plans, annual QA reports, etc.

3. Conduct Quality Systems Audits. Specific Offices or Projects will
be selected for on-site Quality System Audits. Audit teams will be
composed of qualified individuals from offices or laboratories other
than that being audited.

4, Perform a QA Cost Study. A systematic study will be made of the cost
of quality-related activities within EPA. Quality-related activities,
as differentiated from other monitoring and measurement activities,
will be carefully defined and costs for each quality-related activity
determined or estimated. This study will result in management guide—
lines. for determining costs and cost benefits for external and
internal QA programs and activities, ~

IX. Resources Requirements

In FY 1980 and FY 1981, ORD will provide minimum resources to support the QAMS
and additional requirements placed on the EMSLs. These resources are estimated
to be $500,000 and 7.0 FTE. Three positions (one each) will be assigned to the
EMSLs .

Program Offices, Regional Offices, and Laboratories should continue to provide

the resources to-assure that the environmental measurements carried out by or

for their purposes meet their QA requirements and result in data of documented and
kmown quality. ORD will provide assistance in defining the minimum requirements
and resources needed to achieve these requirements. ORD will also provide informa-
tion on the cost of improving data quality by April, 1981.

X. Implementation Requirements and Schedule
Table I shows the major tasks or outputs needed to implement the mandatory EPA QA

program through FY 1981. The organization(s) responsible for each maior task is
(are) indicated along with the known or expected completion dates.