5447 905R84125
FY 1982 and 1983
IMPLEMENTATION STRATEGY
FOR THE
MANDATORY QUALITY ASSURANCE PROGRAM
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Ctuttonmental Protection
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Introduction
In May 1979, the Agency initiated a mandatory quality assurance (QA) program.
This program was designed to assure that all environmental measurements
conducted by the regional offices, program offices, EPA laboratories,
contractors, grantees, or other extramural sources resulted in scientifically
valid data of documented precision, accuracy, representativeness,
comparability, and completeness. In May 1980, an implementation strategy
was developed covering the development of the mandatory program through
FT '81. That strategy concentrated on getting the essential elements of
the program in place through the issuance of guidance documents and the.
amendment of EPA orders and regulations, etc.
This document addresses the implementation of the mandatory QA program
for the balance of FT '82 and for FY '83. It describes, in general, the
total program effort and specifies the major QA responsibilities of EPA
program offices, regional offices, and laboratories in assuring that the
goal of well-documented, and valid scientific data is achieved.
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Quality Assurance Goals and Objectives
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The primary goal of the QA program ia to assure that all environmentally-
related measurements supported or required by the EPA result in data of
known and acceptable quality. To meet this goal, the QA program must
provide for establishment and use of reliable monitoring and measurement
systems to obtain requisite data quality.
For FT '82 and '83, emphasis will be on the achievement of the following
major objectives:
1. Implement QA program plans in all program and regional offices and
EPA laboratory's to ensure that QA goals will be achieved nationally.
2. Prepare QA project plans for each environmental measurement project
with priority for National Monitoring Programs. To the maximum extent
possible, these plans will be written prior to the initiation of the
environmental measurements.
3. Revise EPA grant regulations to require paricipation in the mandatory
QA program by all federally assisted activities involving environmentally
related measurements.
4. Promote and develop uniform approaches, standard operating procedures
and techniques, reporting methods, etc. across media and across regional
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offices, program offices, and EPA laboratories to the maximum extent possible.
It is important (and most efficient and effective) for all organizations
within EPA to employ consistent QA language, policies, procedures,
and techniques when interacting with the States, industry, the public,
contractors, grantees, QA-involved professional societies, other Governmental
agencies, and national and international organizations.
5. Conduct annual QA systems audits of all program offices, regional
offices, EPA laboratories, and selected contractors and grantees in
order to assess the status and implementation of the mandatory QA
program and the validity of the Agency's data bases.
6. Assist the program offices in the development and implementation of
procedures for incorporating precision and accuracy estimates into
each major environmental data base.
7. Establish data acceptance criteria and minimum performance standards
for environmental measurements made by or for EPA.
8. Establish and implement a mechanism to assure that corrective actions
are taken when QA problems are identified through PE studies, systems
evaluations, or QA program audits.
9. Develop procedures for measuring the actual cost for carrying out a
sufficient level of QA/QC to ensure adequate documentation of data
quality and conduct an Agency-wide study to determine these costs.
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10. Develop procedures and perform a study to determine the "failure
cost" to EPA associated with the rejection or revision of environmental
standards or regulations, or the loss of lawsuits due to the use of
inadequate data.
11. Perform technical reviews of major EPA monitoring and measurement
regulations during the development stage (prior to public notice) to
assure that QA requirements for environmental measurements are
adequately defined.
12. Develop training programs to educate different organizational levels
of EPA personnel (Project Officers, QA Officers, Regional Administrators,
Deputy Assistant Administrators, etc.) on the uses, misuses, and
benefits of QA. Conduct at*least four pilot training programs
involving ERG-Cincinnati, Ohio; ERC-Research Triangle Park, NC; HQ's
Washington, DC; and Region V, Chicago.
Philosophy
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The guiding principle of good QA is strong support and continued attention
by all levels of management. Agency management is responsible for the
quality of the data used to make decisions. Managers, therefore, have
direct responsibility for specifying the quality of the data desired and
for providing sufficient resources and authority to their Quality Assurance
Officers (QAOs) to assure that their data quality objectives are met. The
program also is based upon the premise of complete staff work. This means
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that the person responsible for an environmental measurement project has
stated-an objective, prepared a plan of work that describes his project,
documented what he did and why he did it, including any changes to the
original plan, and prepared a written report on the outcome.
Finally, it should be recognized by all members of EPA that the documentation
of environmentally related measurements activities is necessary to satisfy
the public sector that this Agency is doing its job properly. EPA
must establish and maintain the highest level of confidence and credibility
with the regulated community.
Organization and Management
The Agency-wide QA program will continue to be implemented by 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 Office of Monitoring Systems and Quality
Assurance (OMSQA). Operational responsibility for the QA program is
assigned to the Quality Assurance Management Staff (QAMS) and the two
Environmental Monitoring Systems Laboratories and one Environmental
Monitoring and Support Laboratory of OMSQA. The Agency organizations
involved in the management of the mandatory QA program are program offices,
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regional offices, and laboratories responsible for environmental monitoring
or data generation.
In an effort to assure that the mandatory QA program is consistent with
the Agency's mission and objectives, a QA Policy Review Group has
been formed. This group will be convened as necessary to address QA
Management and policy issues.
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ACTIVITIES
A. QA Program Plans
The QA program plans prepared by each program office, regional office,
and laboratory will be updated for each fiscal year and submitted to QAMS
for approval. These plans include the gverall policies, organization
objectives, functional responsibilities designed to achieve data quality
goals for the activities for which the particular organization is
responsible and milestones for implementing QA for each project.
These QA program plans conform to the "Guidelines and Specifications for
Preparing Quality Assurance Program Plans, QAMS-004/80."
B. QA Project Plans
QA project plans, one for each specific environmental measurement projects
or each continuing environmental measurement operation (or group of very
similar projects or continuing operations), shall be prepared by the
responsible Project Officer. These plans describe in specific terms the
requisite procedures, responsibilities, functional activities, and specific
QA and quality control (QC) activities necessary to achieve the data
quality goals of each specific project(s) or continuing operation(s). QA
project plans are to address the 16 elements identified in the "Guidelines
and Specifications for Preparing Quality Assurance Project Plans, QAMS-005/80,'
dated December, 1980.
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The QA ^reject plan can be prepared as either an integral part of the
plan of study (work plan, task plan, operations plan) or as a separate
document. The plan should be prepared by the principal investigator or
project officer and approved by the appropriate QAO for intramural envi-
ronmental projects; or prepared by the contractor/grantee and approved
by the project officer and QAO for extramural projects.
QA project plans should be written prior to the initiation of environmental
measurements whenever possible.^Trn particular, for those environmental
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measurement projects that are identified as a part of the FY '82 or '83
budget cycles, the plan study, including a QA project plan, should be
written and approved before the project begins. In few exceptional
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circumstances, it is recognized that the QA project plan cannot always be
prepared ahead of time. However, standard operating procedures (SOPs)
should be prepared on as many of the required technical, scientific, or
administrative operations as possible and should be available to personnel
conducting the environmental measurements.
For FY '82 and '83, the first priority is to prepare QA project plans for
all new environmental measurement projects and the second priority is to
prepare QA project plans for all continuing environmental measurement operations.
The national program offices have the responsibility for preparing the QA
project plans for the national or international environmental measurement
activities under their purview.
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expected that the revised regulations will be published during the third
quarter of FY '82. In preparation for these revisions, the program
offices, with responsibility for State and local assistance grants, should
prepare the appropriate guidance to the regions for implementing -the QA
requirements as soon as possible but no later than the FY '83 grants.
E. Audits
In FT '81, the QAMS initiated the annual QA program audits of all EPA
organizations involved with environmental measurements. These audits are
designed to evaluate the status of the QA program, the completeness of
documentation, and the valldty of environmental data. These audits will
be continued on an annual basis. They will be conducted in accordance
with the QAMS Audit Protocol, QAMS 007/81. It is also expected that the
QAOs of the various EPA units will conduct audits of their major
environmental mesurement activities such as States, contractors, internal
laboratories, etc., at least once each fiscal year.
F. Quality Assurance Reports
Each program and regional office and each laboratory will prepare an
annual QA report which will be submitted to the QAMS in September of each
year. QA reports will include such information as:
1. Status of QA program plan implementation
2. Status of QA project plan preparation and standard operating procedures
used
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3. Measures of data quality developed or incorporated into environmental
monitoring and research projects and reports
4. Significant quality problems, quality accomplishments, and recommendations
for program improvements
5. Results of performance audits conducted by the reporting unit
6. Results of systems audits
7. Correction actions resulting from unsatisfactory data
8. Summary of quality-related training
Detailed guidelines for preparing* the annual report have been issued to
all QAOs. These reports are primarily intended to inform the responsible
officials of the status of QA within their program, region, or laboratory.
Therefore, the QAO is to submit the report to QAMS through the chain-of-
command so that management is aware of the successes and shortcomings
within their realm of responsibility. The QAMS will, in turn, prepare an
annual status report to the Administrator based on these reports and
results of the audits and PE studies which will be circulated to all EPA
offices and laboratories.
G. Special Quality Assurance Projects
In addition to the activities described above, the QAMS will conduct the
following special projects during FT 1982 and 1983:
1. Complete a QA Costs and Benefits Study. A systematic study will be
made of quality-related activities within EPA and the benefits in terms
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of better data acceptability, better estimates of environmental quality, "
etc. 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 guidelines for determining costs and benefits for external
and internal QA programs and activities.
2. Complete the evaluation of the Agency's PE Studies* This study,
which was started in FT '81, will evaluate the differences between the
methods and procedures used^to carry out the PE studies in different media.
The report will identify the differences, discuss the reason for those
differences, and recommend standardization, where appropriate.
3. Develop national data acceptance criteria. A major effort for the
next two years will be to coordinate the development of national data
acceptance criteria. This activity is predicated on the premise that
since EPA develops and validates the methods used, then it should specify
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•I the quality of data that is acceptable for the Agency actions and decisions.
These criteria will be minimum acceptance levels with any program or
project allowed to set more stringent .criteria.
4. Develop training courses for QAOs, In FT '83, we will utilize a
support contract to develop and present training courses for QAOs and
Project Offices. These courses will address the principle elements of
QA, such as preparing project plans, conducting QA audits, analyzing data
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thro- ;h statist!* . methods, etc. The courses will be tailored to fit
the needs of the laboratory and regional QAOs and project officers who
are more technically oriented and the program office QAOs who are more
management and policy oriented.
5. Develop and Conduct Briefings on QA. In order to assist top management
in understanding their role in the QA program, QAMS will conduct several
briefings on the general theories, practices, and benefits of QA. These
briefings will be oriented toward Assistant Administrators, Regional
Administrators, Office Directors, and division directors since they bear
the primary responsibility of QA.
6. . Guidance on Biological QA. There is a recognized need to develop
Agency 'guidance on the proper collection, use, and validation of biological
data. In FT '83 a work group will be convened to summarize all the
present Agency guidance on biological QA. This work group will be asked
to issue a recommended practices manual for biological QA by the fourth
quarter of FT '83. The work of this group will be benefited by extramural
assistance.
7. Peer Review of QA Program Operations and Benefits. QAMS, through
the use of a contract with the National Academy of Sciences will review
the present QA program operations and prepare a report summarizing the
strengths and weaknesses of the current approach along with any recommen-
dations for Improvements.
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H. Quality Assurance Policy Issues. There are key policy issues"which
must bex addressed before an effective QA program can be fully implemented.
Some of the more critical issues include the following:
0 How can States be encouraged to adopt QA without providing additional
resources?
- Should QA be implemented at expense of the quantity of data
rather than quality?
- What mechanisms should be used for implementation of QA with
the States?'
grant conditions?
SEAs?
other?
0 What oversight roll and authority should be vested in ORD/QAMS over
Agency programs?
- What mechanisms should be used to ensure that Agency programs
will improve and document data quality?
0 How can QA training programs be revitalized and funded? (With
turnover of personnel, the Agency will be relying more and more on
poorly trained and inexperienced individuals in the employ of States
and others for collecting, analyzing samples and reporting data for
environmental protection. Also, large environmental programs and
extramural contracts are being managed by project officers with little
or no training or knowledge of QA).
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0 Should QA requirements be incorporated in EPA regulations? (Sue i
a measure would provide uniform guidance to the regions, States, and
"others for implementation of QA policies. As a precedence, the
air programs office has written requirements for QA in its
regulations for ambient air monitoring and for continuous .emission monitors
for stationary sources of air pollution.)
0 How can QA requirements be incorporated in the budget process for
program offices? (With only a few exceptions, e.g., NFDES, QA,
where it is practiced at all, is more or less run as a bootleg
operation because there are no identifiable resources for this
function. Identifying QA as a boha fide expenditure of program
operations would legitimate this activity and make it more acceptable
uniform QA work load models for all agency monitoring and measurement
programs appears as a viable, though partial", approach.)
Other policy issues, to be considered are the following:
Quality Assurance Resources
Program Offices responsible for major monitoring and measurement activities
should support a full time quality assurance position. Also, each office
manager should ensure that national program directives include sufficient
resources to cover QA oversight of all regulated, special purpose, and
projected emergency monitoring activities.
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Regional Offices should provide for an independent QA oversight function
consistent with the above.
N.
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Office of Research and Development, in addition to providing QA development
and operational support for QA/QC, should develop and standardize QA
protocols for inclusion in peer reviews; continue staffing plans for a
viable QAMS; and consider reprograming to provide increased resources for
FY 1983 as described below:
ADDITIONAL RESOURCES -FT 1983
5300K - (Priority 1) - Complete development and provide QA instructional
materials to EPA regions and States to satisfy laboratory certification
requirements for Drinking Water.
National Interim Primary Drinking Water Regulations require that any
laboratory analyzing public drinking water must be approved by EPA or the
State. ORD, prior to 82 budget cuts, provided instructions for EPA
personnel/States for evaluating labs and determining if they could be
certified as capable of monitoring the safety of public water supplies.
The States and EPA Regions desperately need mobile audio/visual and self
instructions to meet this minimum but critical qualification requirement.
$250K - Develop a manual of statistical data quality indicator models for
Regions, program offices, States and ORD laboratories*
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Develop statistical models for data quality assessment within predictable
confidence limits based on the intended use of the data. Wherein States,
N.
Regions, and most environmental programs demand certain creative rights
and reduction in the QA paper burden, the need is often and urgently
expressed for QA assistance in the critical area of documenting and
improving data quality.
$275K - Develop a manual(s) for program office QA officers to serve as a
model for State QA work plans. The States, while involved in environmental
measurements in support of regulatory requirements, are reluctant to
develop their own QA work plans (program, project, SOPs) because of the
paper burden involved and general lack of resources. Consequently, much
of the data generated by the States is of unknown quality, e.g. the data
stored in STORE!. This effort would produce a model plan for each major
program (TSCA, NPDES, Superfund, Drinking Water, etc) which the States
can adopt with very little expenditure of resources on their part. In
addition to assisting the States, these model plans will serve the Agency
by establishing uniform national quality criteria for all regulated
environmental monitoring. Further, it would automatically lead to data
entered into storage systems which satisfy minimum data quality criteria.
The absence of these criteria represents a major continuing unresolved
problem for EPA.
$50K - Establish cooperative relationships with leading voluntary
consensus standards-setting organizations. As a regulatory agency, EPA
must prevail on the private sector to accept regulatory guidelines for
U '~ r ronmental Protection AgMtcy
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environmental monitoring, including use of standard methods and quality
assurance practices on the quality of data generated. There are many
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professional organizations committed to the principle of developing voluntary
concensus standards whose work is supported by almost the entire private sector.
Many of these organizations (APHA, ACS, ASQC, ASTM, etc) are engaged in
technical areas which overlap EPA concerns. This Agency, by coordinating
work in these areas - QA and standards development - with this pool of
organizations, can gain broad public support for its activities. This
support will materially assist EPA in dealing with the States and private
sector.
The nature of cooperative efforts can take many forms from joint development
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and collaborative testing of methods to joint sponsorship of technical
seminars. Initially, it is proposed to approach several key organizations
to develop a mutual working relationship and help co-sponsor technical meetings.
$150K - Develop practical standard reference materials for hazardous
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wastes. A great need exists for these materials since the pollutants of
interest in hazardous wastes often exist in matrixes which interfere with
analyses thereby making recoveries difficult and results inconsistent.
At present we know very little about these materials and their chemical
properties and dynamics.
NBS is pre-eminently qualified to study these pollutant-matrix systems
and to develop, prepare, and manage environmental standards for the
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Agency's Hazardous Waste Program. We propose to establish a continu ng
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EPA NBS cooperative effort leading to standard methods and materials for
analyzing hazardous wastes.
$35K - This seeks to restore funds eliminated from the FT '83 budget for
the National Academy of Sciences (HAS) to continue its efforts to review
EPA data generation and data management activities and the general datj .
quality control operations.
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