5582
SERA
United States
Environmental Protection
Agency
Office of
Research and Development
Washington DC 20460
March 1980
905R80135
The Quality
Assurance Program:
An Overview
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Quality Assurance and
Monitoring Systems Division
The U.S. Environmental Protection Agency (EPA) is
charged to carry out the responsibilities outlined in a
number of Federal laws designed to protect and en-
hance the quality of the Nation's air, land, and water.
The EPA establishes and oversees the attainment of
standards of environmental quality to meet these
responsibilities. This effort requires extensive research
and monitoring of the various aspects of the environ-
ment.
Environmental monitoring is defined as the system-
atic collection and evaluation of physical, chemical,
biological, and other related data pertaining to the
parameters which characterize environmental quality.
An enormous amount of monitoring data is collected,
mostly by State and local agencies, for EPA use in:
• Identifying environmental problems
• Establishing standards and regulations
• Measuring compliance with standards
• Evaluating the effectiveness of EPA's programs
These data must be scientifically valid, legally defensi-
ble, representative, comparable, complete, and of
known precision and accuracy. Quality Assurance
(QA) plays the key role in the production of such data
through a variety of planned and systematic activities
and procedures. Thus, QA is the sum of activities that
document and maintain the quality of monitoring
data.
A QA program is a vital management tool that not
only supports efforts to protect public health and
welfare, but also saves money by greatly reducing the
production of useable data. It is the means of assur-
ing that only proven measurement methods are used,
that instruments are properly calibrated and main-
tained, that uniform operating procedures are estab-
lished and followed, and that field and laboratory per-
formances are audited. The techniques and pro-
cedures outlined in EPA's QA program must be strict-
ly followed to produce data that can be used by the
Agency to answer questions concerning environmen-
tal quality, pollution abatement, and control measures
to create policies that will protect and preserve the
environment.
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Organization Structure
Office of Research and
Development (ORD)
Program Offices
In May 1979, the EPA Administrator adopted a policy
making participation in the QA program mandatory
for all monitoring and measurement activities funded,
operated, or required by the Agency. To accomplish
this, QA must extend to all of the Agency's monitor-
ing program offices, laboratories, and through the
Regions, to all State and local agencies providing data
to EPA.
The ORD is responsible for developing the guidelines
and criteria of the Agency-wide program and directing
and coordinating its implementation. This includes the
review, evaluation, and approval of program QA plans
and activities; the provision of special guidance and
assistance in specific areas of QA as requested; and
the preparation of reports for the Administrator on the
overall program progress and efficiency. In connection
with these responsibilities, ORD is considered the
Central QA Authority and is the source of information
on new methods and equipment for use in QA in ac-
tivities as they become designated for EPA use, and
keeps current on all QA associated activities in
government agencies, technical societies, and the
private sector.
The Program Offices are responsible for developing
their own QA plans based on the specific guidelines
and criteria set forth by ORD and for ensuring that all
intramural and extramural programs are consistent
with Agency policies. Implementation responsibilities
extend to all internal monitoring and measurement ef-
forts as well as external — contracts, grants, and
Interagency Agreements. For the purpose of this
policy, ORD is considered a program office and the
responsibilities of implementation include the ORD
research laboratories and extend to their contractors
and grantees.
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Regional Offices
DAA Committee on
Monitoring and
Information
Management
QA Advisory
Committee
Regional offices follow the policies and criteria set
forth for the Agency-wide program. Implementation
and coordination of the program within each Region
has been, and continues to be, the responsibility of
the Regional Administrator. This responsibility also ex-
tends to external monitoring and measurement activi-
ties of State, local, and other agencies and labora-
tories involved in providing data to their appropriate
Regional office.
The Deputy Assistant Administrator (DAA) Commit-
tee is chaired by the Administrator's Principle Science
Advisor and is composed of key DAAs from the
Agency's Program Offices along with representation
from the Regional Offices. The Committee has the
authority to recommend monitoring and information
management policy for the Agency and is responsible
to the Administrator for ensuring that the policies of
the mandatory QA program are implemented.
The QA Advisory Committee's function is to ensure
proper coordination of the national effort by providing
advice on the development of Agency-wide QA
policies and technical recommendations. The Commit-
tee has representation from the Program Offices,
Staff Offices, Regional Offices, and the States, and is
chaired and administratively supported by the ORD.
Thus, ORD is charged with the overall guidance
and coordination of the mandatory QA program, but
it is the responsibility of each program manager,
laboratory director; and analyst to ensure that these
provisions are effectively used and that QA is prac-
ticed in all monitoring activities.
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Overview
The following six categories summarize ORD's
responsibilities for the direction and coordination of
EPA's QA program and provide an overview of its
major objectives and functions.
• Program Direction and Coordination — Planning,
directing, and coordinating the QA program.
• Criteria and Procedures — Planning, preparing, and
distributing criteria and procedure documents and
manuals to be used in (a) the development of the QA
plans from program offices. State and local monitor-
ing agencies, and (b) the establishment of minimum
QA requirements to be met by monitoring and mea-
surement projects under contracts, grants, and Inter-
agency Agreements.
• Testing and Standards — Testing, approving, and
promulgating official measurement methods and
developing and distributing reference samples,
reference materials, and quality control samples for
use in performance tests and routine procedures
checks.
• Quality Control and Data Analysis — Developing
and evaluating quality control procedures, statistical
methods for data validation, and QA requirements for
Agency data banks, and conducting surveys and
preparing reports on data quality and systems perfor-
mance.
• Evaluation and Certification — Reviewing, approv-
ing, and assisting in the development of QA plans and
requirements for Agency monitoring and measurment
activities, grants, contracts, Interagency Agreements,
and for evaluation of certification of laboratories.
• Reports — Preparing reports concerning the QA
program status for the EPA Administrator.
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Guidelines and Criteria
QA has been an integral part of EPA, State and local
monitoring programs for some time. Within EPA, the
responsibility of QA has been divided between the
operating monitoring programs and ORD. ORD's
QA and Monitoring Systems Division (QAMSD), En-
vironmental Monitoring Systems Laboratories in Las
Vegas, Nevada and Research Triangle Park, North
Carolina, and the Environmental Monitoring and Sup-
port Laboratory in Cincinnati, Ohio, have, in the past,
developed many basic tools, procedures, and mate-
rials to help guide and support QA activities in the
various monitoring programs. EPA's new QA program
is based upon this past experience and acquired
knowledge. The guidelines and criteria of the manda-
tory program are derived from the following major ob-
jectives and associated activities developed over the
years by ORD/QAMSD and its laboratories.
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Objective 1 Provide methods and materials necessary to produce
reliable data from operating monitoring programs.
Under this objective, ORD provides standardized
measurement methods and sampling procedures that
have been validated, through collaborative testing, for
precision and accuracy. Included are the development
and documentation of the statistical validation and
standardization of the total measurement system.
Some of the parameters of the total measurement
systems considered are:
• Site Selection — the location, placement, and
number of monitoring stations and instruments to be
used.
• Sampling Frequency — the rate at which samples
must be collected to provide the minimum number of
samples to adequately characterize environmental
conditions at a particular site.
• Sampling, Collection, Handling, and Preservation —
the specific procedures for collecting, transporting,
and storing samples
The second activity under this objective is to provide
quality control samples and materials. These include a
broad range of samples and instruments used by the
laboratories to check instruments, measurement
methods, and performances. For example, air pollu-
tion reference materials have been developed through
a cooperative effort with the National Bureau of Stan-
dards and are used to calibrate such instruments as
sulfur dioxide permeater devices and ozone
generators. In other cases, standard solutions such as
radionuclides in milk, or trace metals in water are
distributed. The third output is QA manuals and
guidelines. These documents set forth the procedures
to be followed for QA activities associated with
sampling, collecting, and other analytical procedures.
(To obtain a listing of these documents, see the back
page of this brochure.)
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Objective 2 Develop and implement a system for continually
evaluating the performance of monitoring laboratories
and personnel and the adequacy of methods and in-
struments used.
This objective includes activities that are intended to
provide both an internal evaluation of the program of-
fices, research laboratories, and an external check on
the quality of the data from the field laboratories. This
function is important not only to identify problem
areas but also to provide a comparison between dif-
ferent monitoring laboratories and programs. One
such activity is interlaboratory testing, in which
reference samples of known concentration are ana-
lyzed by various laboratories. The labs receive reports
of the results and possible corrective actions needed
to enhance the quality of the data being generated.
The on-site evluation, another QA activity, supplies
important information on facilities, instrumentation,
personnel, and the QA activities being implemented.
Together with interlaboratory testing, on-site evalua-
tions provide the basic information upon which deci-
sions can be made on the quality of the data.
Data auditing includes those activities that examine
data prior to acceptance into a data system. The pro-
cedure involves screening for data with obvious
outliers, improbable values, and improper station iden-
tifications.
The certification program, which currently applies
only to those laboratories anlayzing public drinking
water supplies, contains all of the essential elements
incorporated in the evaluation activities.
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Objective 3 Enhance the overall capability and performance of
monitoring activities.
A number of activities provide assistance and informa-
tion to maintain or improve the performance of a
monitoring system. For example, training courses,
workshops, conferences, and seminars give laboratory
directors, program managers, and analysts informa-
tion on the latest QA practices as well as a forum to
discuss problems of mutual concern.
Technical assistance is an important QA-supporting
activity that laboratories may receive upon request. It
includes such areas as the proper use of test pro-
cedures, reagent preparation, instrument calibration,
and data reporting.
To round out efforts to upgrade monitoring capa-
bilities, ORD publishes the QA Newsletter. The News-
letter maintains a central line of communication
among all of the laboratories involved in QA activities
and contains up-to-date information concerning new
methods and materials, training courses, and recent
QA advances or problems.
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Objectives and
Associated Activities
of EPA's Mandatory
Quality Assurance
Program
Provide Methods and Materials
Standardized Measurement Methods and
Sampling Procedures
• Site Selection
• Sampling Frequency
• Sampling Collection, Handling, and
Preservation
Quality Control Samples and Materials
• Calibration Standards
• Standardized Samples and Instruments
Guidelines and Procedure Manuals
Evaluate Performance of Monitoring
Activities
• Interlaboratory Tests
• On-Site Evaluations
• Data Audits
• Laboratory Certification
Enhance Capabilities and Performance
of Monitoring Activities
• Workshops and Seminars
• Technical Assistance
• QA Newsletter
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QA in Perspective
EPA's mandatory QA program is an essential element
in all monitoring programs. By ensuring that the data
collected are of known precision and accuracy, QA is
the first step towards correctly assessing the state of
the environment. From those assessments come deci-
sions, policies, and regulations that protect and
preserve the environment for future generations.
EPA's QA program provides the methods and mate-
rials needed to produce data of know quality. The
evaluation of monitoring performances ensures that
the methods and materials are in use and operating
properly. The third element of the QA program pro-
vides a means to identify possible problems and
discuss necessary corrections and improvements to
the overall program.
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For a complete listing of quality assurance manuals
and documents, request "The Quality Assurance
Bibliography," (EPA-600V4-80-Q09)
U.S. Environmental Protection Agency
Technical Information Operations Staff
Environmental Research Center
26 West Saint Clair St.
Cincinnati, OH 452-268
For more information on EPA's Quality Assurance
Program, write:
U.S. Environmental Protection Agency
QA and Monitoring Systems Division (RD-680)
401 M St., S.W.
Washington, D.C. 20460
FTS: 426-2026
COMMERCIAL: (202) 426-2026
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