EPA-600/1-77-036
June 1977
Environmental Health Effects Research Series
MANAGEMENT POLICY FOR THE ASSURANCE
OF RESEARCH QUALITY - HEALTH EFFECTS
RESEARCH LABORATORY/RTF, NC
Health Effects Research Laboratory
Office of Research and Development
U.S. Environmental Protection Agency
Research Triangle Park. North Carolina 27711
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EPA-600/1-77-036
June 1977
MANAGEMENT POLICY FOR THE ASSURANCE
OF RESEARCH QUALITV
HEALTH EFFECTS RESEARCH LABORATORY
RESEARCH TRIANGLE PARK, NORTH CAROLINA
Quality Assurance Document #1
This Manual Valid Through Fiscal Year 1978
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
HEALTH EFFECTS RESEARCH LABORATORY
RESEARCH TRIANGLE PARK, N.C. 27711
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DISCLAIMER
This report has been reviewed by the Health Effects Research
Laboratory, U.S. Environmental Protection Agency, and approved for
publication. Mention of trade names or commercial products does not
constitute endorsement or recommendation for use.
ii
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FOREWORD
The U.S. Environmental Protection Agency's Health Effects Research
Laboratory located at Research Triangle Park, North Carolina conducts an.
extensive research program to evaluate the hum^n health implications of
environmental factors related to industrialized society. The purpose of
this research is to provide information necessary to formulate environ-
mental regulatory policies to protect or improve public health and welfare
while at the same time enhancing the nation's productivity. To this end,
the Laboratory conducts a comprehensive program in toxicology, epidemiology,
and research on human subjects under controlled laboratory conditions. The
quality of the data resulting from this research is an overriding factor
in determining the usefulness of this information in EPA's regulatory
activities. In recognition of the importance of data quality assurance,
our Laboratory has initiated a comprehensive program to coordinate all
the current activities in this area. Accordingly, the policies enunciated
in this document become effective immediately upon publication and will
remain in effect until revisions are announced. In order to assist
scientists in our Laboratory in the preparation of research protocols that
include the best elements of data quality assurance, a guidelines manual
will be published shortly after the appearance of this policy document.
I am confident that full implementation of our data quality assurance
policy with the help of the guidelines manual and the increased awareness
of the importance.of good data acquisition and management procedures will
enhance the scientific merit of our research program.
Lson, M.D.
Director,
Health Effects Research Laboratory
iii
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ACKNOWLEDGEMENTS
Following considerations from many program managers within the
Health Effects Research Laboratory, this document was completed through
the work of the Quality Assurance Committee, HERL-RTP, whose members
reviewed and criticized the manuscript and made many helpful suggestions,
HERL Quality Assurance. Committee
1977-78
Ferris Benson - Criteria and Special Studies Office
Robert Burton - Population Studies Division
Dorothy Calafiore - Population Studies Division
Walter Crider - Clinical Studies Division
George Goldstein - Clinical Studies Division
Ralph Linder - Environmental Toxicology Division
Margarita Morrison - Program Operations Office
Gerald Nehls - Statistics and Data Management Office
Edward Oswald - Environmental Toxicology Division
Georgia Rehnberg - Experimental Biology Division
Ralph Smialowicz - Experimental Biology Division
David Svendsgaard - Statistics and Data Management Office
IV
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CONTENTS
Page
1.0 SUMMARY 1
2.0 INTRODUCTION 2
2.1 Document Organization 2
2.2 Definitions 2
2.2.1 Quality 2
2.2.2 Quality Assurance (QA) 3
2.2.3 Data Quality Control (DQC) 3
2.2.4 Data Quality Assurance (DQA). . . 4
2.2.5 Task 4
2.2.6 Protocol 4
2.3 Laboratory Mission 4
2.4 Data Quality at HERL-RTP . 5
3.0 QUALITY GOALS ........... 6
3.1 General Goal 6
3.2 Specific Goals 6
4.0 QUALITY POLICIES 8
4.1 Coverage of the Quality Assurance Program 8
4.2 Responsibility for Application of Quality. Procedures .... 9
4.2.1 Quality Control 9
4.2.2 Quality Assurance .9
4.3 Scope of Quality Assurance Program 9.
5.0 QUALITY ASSURANCE PROGRAM ORGANIZATIONS ............. 14
5,1 Organizational Structure 14
5.,2 Functional Responsibilities . 16"
5.2.1 Accomplishment Plan Manager ..16
5.2.2 Task Management 18
5.2.3 Functional Management 18
5.2.4 Quality Assurance Coordinator 19
5.2.5 Quality Assurance Representative. . . 21
5.2.6 Quality Assurance Committee 22
6.0 REFERENCES 23
7.0 BIBLIOGRAPHY 23
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FIGURES
Number Page
1 Example of major topics addressed in a task protocol .... 11
2 Example of required task protocol approvals 12
3 Summary of essential aspects of technical data quality ... 13
4 HERL-RTP's functional management structure 15
5 Quality assurance program structure within HERL-RTP 17
6 Quality assurance coordinator's communication links
with QA expertise outside of HERL-RTP 20
vi
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1. SUMMARY
This document presents policies, goals, and an organizational structure
for implementation of a management policy for quality assurance (QA) in the
Health Effects Research Laboratory, Research Triangle Park (HERL-RTP). Directed
toward functional managers, a system for QA monitoring of task quality
control functions is described. Following delineation of HERL-RTP
quality policy and goals, the organizational structure for the Quality
Assurance Program and its relationship to functional management responsibili-
ties are discussed.
The QA organization, consisting of a Quality Assurance Coordinator
and a Quality Assurance Committee, serves in advisory capacity to regular
functional management. Application of QA measures is the direct responsibility
of taskmasters or project officers. It is the responsibility of functional
management to insure that any project-oriented document or plan has
incorporated appropriate QA measures and has been reviewed and approved
through management channels.
This document, delineating management policies for quality assurance, is
the first in a series of HERL-RTP quality assurance guidelines which will be
incorporated into the HERL-RTP quality assurance policy manual. A companion
document directed toward taskmasters should be available by September 1977.
Areas requiring specific guidelines development are presently being identified.
The respective sections of this document are directed toward the various
management functions as follows:
APPLICABLE TO:
Accomplishmen
Taskmasters
Functional Managers
QA Cuordinator
QA Representatives
Section 1.
Subsections
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2. INTRODUCTION
2.1 DOCUMENT ORGANIZATION
The succeeding sections of this document present the HERL-RTP. quality
assurance (QA) management policy, and are organized as follows:
Section 3 lists general and specific goals of the HERL-RTP quality
assurance program.
Section 4 contains a discussion of the general features of the HERL-
RTP quality assurance program. Following a description of the coverage of
the program, the taskmasters' responsibilities for quality assurance are
outlined. The section ends with a brief discussion of the program and
a list of QA elements of importance to health-related research.
Section 5 delineates the organization for implementing the HERL-RTP
quality assurance program. Present management positions and their roles in
the QA program are first discussed, followed by a detailed description
of the integrated QA organization specifically relating to the functioning
of the program.
2.2 DEFINITIONS
It is useful to define six terms which will appear frequently in this
document: (data) quality, quality assurance (program or plan), data quality
control (DQC)., data quality assurance (DQA), task, and protocol. (1, 2).
2.2.1 Quality
Quality means the totality of features and characteristics of a
product or service that bear on its ability to satisfy a previously
specified need. For measurement systems, the product is measurement
data, and the characteristics of major importance are accuracy, precision,
and representativeness. For monitoring systems, completeness—or the
amount of valid measurements obtained relative to the amount expected to
have been obtained—is an additional important measure of quality.
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2.2.2 Quality Assurance
Quality assurance is the term used to describe a comprehensive system of
plans, specifications, and policies which are. designed to insure the collec-
tion, processing, and reporting of quality data in a cost-effective manner.
Thus, a QA plan for a particular task, or a QA policy for a laboratory (e.g.,
HERL-RTP) may properly be discussed. Quality assurance provides for
total system data quality, resulting from data quality control and data
quality assurance—from experimental design (e.g., sensor positioning)
through final report production (e.g., confidence limits and limits of
applicability of results). In addition, it addresses possible needs for
methods development and independent value judgments of the relevance of
a proposed technical task to prior specified HERL-RTP or EPA needs.
Responsible research laboratories are regularly involved with various
aspects of data quality verification as part of good laboratory practice.
A comprehensively defined QA plan, as will be described in this document,
serves several additional functions. First, it outlines the steps of the
program and therefore can be used to explain concisely what the program
involves. Second, it provides a means for independently assessing and
documenting data quality; and third, it provides a mechanism for evaluating
the relevance of a (proposed) task to laboratory and agency goals.
Maintaining the HERL-RTP quality assurance program is the function
of taskmasters and managers, with assistance from the HERL-RTP Quality
Assurance Coordinator.
2.2.3 Data Quality Control (DQC)
Data quality control is a system of activities designed to achieve and
maintain a previously specified level of quality in data collection, pro-
cessing, and reporting. DQC is performed by the organization actually
carrying out the task or project; i.e., it is executed by task personnel.
As discussed in section 4.3, DQC activities include control of or correction
for all variables suspected of affecting data quality. These variables
include instrument maintenance and calibration; quality of reagents and
supplies; technical personnel qualifications; animal care and handling
(where applicable); environmental parameters; and others.
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2.2.4 Data Quality Assurance (DQA)
Data quality assurance is a system of activities designed to provide
management with an independent assurance that total system data quality
control is being performed effectively. DQA activities are both
qualitative and quantitative. To perform qualitative reviews, DQA
personnel will visit sites to conduct systems reviews. A variety of
techniques are available for quantitative review. Blind samples, collaborative
testing, and round-robin analyses are some of the usual techniques used to
quantitatively verify DQC effectiveness. These and other, as yet undeveloped
DQA techniques will be applied to the health-related research performed
in the HERL-RTP.
2.2.5 Task
A task is an in-house or contracted project, or interagency agreement,
the purpose of which is to produce technical research data for the HERL-RTP
program.
2.. 2.6 Protocol
As used in this document, the term protocol should be understood to
include all task or project planning documents used at the HERL-RTP. Spe-
cifically included are task protocols, procedure statements, work plans, and
scopes-of-work, irrespective of the nature of the task or organization
actually performing the task.
2.3 LABORATORY MISSION
The Health Effects Research Laboratory, Research Triangle Park, conducts
animal and human studies under controlled conditions and performs additional
studies on human populations in order to assess the hazard to human
health of exposure to environmental pollutants. Laboratory scientists
determine the effects of environmental pollutants both alone and in
combination; pollutant types that are studied include air pollutants,
pesticides, toxic substances, and nonionizing radiation. Controlled
laboratory studies are devoted to determining effects of pollutants on
normal biological function as measured by clinical, chemical, biochemical,
physiologic, histopathologic, growth, reproduction, and other parameters.
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HERL-RTP also develops, evaluates, and improves analytical chemical
methods and biological screening techniques for direct and indirect
measurement of exposure to environmental toxicants. It also serves
as a resource for information on health effects of environmental pollutants
and coordinates health-related activities with international organizations.
2.4 DATA QUALITY AT HERL-RTP
HERL-RTP has long recognized the importance of quality control in
its research activities. For example, pesticide QA programs have been
supported for several years and have been of service to well over 100
laboratories. In addition to the pesticide analytical procedures, several
related QA manuals have been prepared under this program. Interlaboratory
pesticide QA programs have also been maintained for several years.
However, quality control has generally been practiced on a project-
by-project basis, with the preparation and implementation of a quality
control plan being the responsibility of individual taskmasters. Due
to increased awareness of the deleterious effects of pollutants on
living systems, HERL-RTP has recognized the need for a formal, comprehensive,
laboratorywide data quality program.
A formal HERL-RTP data quality program was initiated in May 1976
with the issuance of a "Quality Assurance Plan" by HERL-RTP (3).
Subsequent actions include the appointment of a Quality Assurance Coordi-
nator (QAC) and a Quality Assurance Committee for the purpose of designing
and implementing a QA program appropriate to the unique requirements of
the HERL-RTP. While specific quality assurance guidelines have been
developed for ambient air measurements, lack of adequate guidelines for
quality assurance in biological research has hampered the completion of
an integrated program at the HERL-RTP.
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3. QUALITY GOALS
3.1 GENERAL GOAL
The goal of the HERL-RTP Laboratory Quality Assurance Program is to
insure, assess, and document the medical and scientific reliability of
laboratory and field data used in EPA's activities and documents relating
to human health. Management, administrative, statistical, investigative,
preventive, and corrective techniques will be employed to maximize reliability
of the data.
3.2 SPECIFIC GOALS
The specific goals are to:
a. Provide a vehicle which will alert all personnel within HERL-RTP to
the basic concepts of quality control (QC) and quality assurance
CQA) , and to the level of quality expected within HERL-RTP.
In particular, the program should cultivate in each person a
consciousness of quality in daily work, and should enhance
their ability to recognize areas deficient in quality assurance
and to take corrective action.
b. Establish and maintain guidelines to assist HERL-RTP personnel in
the logical development of general and specific quality assurance
directives for current and future HERL-RTP analysis and testing
procedures, which include in-house and contracted tasks.
c. Present and maintain current an organization plan for HERL-RTP
management and administration which defines QA functions and respon-
sibilities of personnel and establishes lines of communication
necessary to achieve QA goals.
d. Provide a means for evaluating task RFP's, protocols, or procedures
statements for appropriateness to the current and anticipated data
requirements of HERL-RTP.
e. Use (and as necessary, develop) methods of analysis and data treatment
which are capable of meeting both (1) the needs of precision, accuracy,
sensitivity, and specificity demanded by HERL-RTP guidelines, and
(2) the use for which the data are intended.
f. Maintain awareness of new and/or improved methods of analysis and
data interpretation, and implement any needed changes in routine
and analytical measurements to achieve QA standards.
g. Monitor the routine operational performance of HERL-RTP through
appropriate intralaboratory and interlaboratory programs and
corrective action provisions.
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h. Participate in quality evaluation programs while data are being
collected, through coordination with: evaluation services
provided by other laboratories of ERC-RTP; other EPA laboratories;
other government agencies (NIOSH, OSHA, NBS); and private
contractors.
i. Insure that EPA contractors develop approved QA plans and proce-
dures (prior to contract work) and adhere to them in all stages
of the contracted work.
j. Implement, as part of the management plan, a procedure to review
QA aspects of research protocol and data currently being collected, or
data collected in the past, as deemed appropriate.
k. Identify problem areas, alert management to them, and correct the
problems; also, validate the soundness of the solution to each
problem.
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4. QUALITY POLICIES
HERL-RTP policies pertaining to the development, implementation, and
maintenance of a quality assurance (QA) program are described by category below.
4.1 COVERAGE OF THE QUALITY ASSURANCE PROGRAM
The HERL-RTP quality assurance program is complete in concept, encom-
passing all technical tasks, and it is strongly recommended that it also
include grants. All technical tasks, both in-house and contractual, must
have a research protocol quality control plan delineating the practices
and procedures to be followed at each level (e.g., technician, bench
chemist, project leader) and each phase in the life of the project. The
QA program also requires that each task contain a quality assurance plan .
for independently monitoring the effectiveness of that task's quality
control program. The administrative responsibility for evaluation and
approval of quality control and quality assurance aspects of the HERL-RTP
quality assurance program is assigned to the Quality Assurance Coordi-
nator. The QA program will be applied on a project-by-project basis
according to the project objectives and requirements. Responsibility
for design and implementation of the project QA plan rests with the
respective taskmaster and functional management.
Si~~Sa-±TruTcat~ea~above, the taskmaster is responsible for the design of a QA
plan suitable for a particular task, subject to functional management review
and approval. In this way, specific QA activities can be chosen that are
appropriate to the data quality requirements of the task and also to the
nature of the data collection and processing systems. For instance, re-
petitive measurement operations require QA activities significantly different
than those for measurement methods under development. Taskmasters should be
aware that truly unique measurement methods are used quite rarely; well-
characterized methods are the norm, even for tasks which are strongly
"research" oriented. Therefore, a QA plan may necessarily focus on specific
components of the data system for some tasks rather than on the system as a
whole.
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4.2 RESPONSIBILITY FOR APPLICATION OF QUALITY PROCEDURES
Data quality practices and procedures take two forms: data quality
control and data quality assurance. Responsibility for each is described
in this section.
4.2.1 Quality Control
The taskmaster must insure that data quality is sufficient to meet
project, requirements; it is therefore up to this.person to design and
insure adherence to procedures that will guarantee such data quality. For
example, on tasks conducted under contract (see section 4.3), the DQA *~~~
plan is prepared by the contractor and reviewed and approved by the EPA
project officer with optional assistance from the Quality.Assurance Coordi-
nator. In-house, tasks have DQA plans incorporated in the research protocol
by the responsible taskmaster, with optional assistance from the Quality
Assurance Coordinator.
4.2.2 Quality Assurance
The HERL-RTP Quality Assurance Coordinator, with assistance from the
Quality Assurance Committee, establishes and administers data quality
assurance procedures for independently monitoring and assessing the efficiency
and adequacy of individual quality control programs. The DQA procedures
shall be applied uniformly throughout the duration of the project. However,
at any time during the task life, either the subject taskmaster or the
Quality Assurance Coordinator, using accepted QA techniques, may assess
the HERL-RTP project's ongoing data quality control program as deemed
necessary.
4.3 SCOPE OF QUALITY ASSURANCE PROGRAM
The data quality assurance program for extramural (contracted) projects i
provides for data quality control procedures applied to the request for
proposal (RFP), the proposal, and extending through proposal evaluation,
workplan approval, project and quality control execution, and final report
preparation. It also provides for appropriate data quality audits.
In the case of intramural (in-house) projects, data quality control
procedures begin with the drafting of the protocol (see section 2.2.6).
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In particular, consideration of the hypothesis to be tested, data and data
processing requirements, data quality assurance plans and procedures, data
analysis techniques, and anticipated problem areas should be clearly
addressed. (See figures 1 and 2 for a description of typical points of
a task protocol and required approvals, respectively.) Protocol review
and approval will include evaluation of QA plans.
Planning for technical tasks should include provision for an appropriate
QA program. This program will be comprised of both DQC plans and DQA
plans. The following aspects of data quality should be addressed:
a. organizational structure as it relates to data quality;
b. sample collection and analysis procedures (including such items
as questionnaire design, animal integrity, tests and controls,
etc.);
c. calibration standards and procedures;
d. the validity and applicability of the experimental procedures
(to be) used, including sources of potential error. Assuring
appropriate experimental statistical design is involved here;
e. the validity and applicability of experimental variables affecting
data quality. These include procurement, acceptance, and storage
of consumables (reagents, animals, etc.) and nonconsumables (in-
strumentation, relevant laboratory design, etc.); data processing;
and statistical analysis;
f. plans for corrective action when data of unacceptably poor quality
are encountered;
g. statistical data analysis and report preparation, with estimates
of confidence limits on the data; a statement of the estimated
limits of applicability of the results;
h. personnel technical and professional qualifications as related to
their assigned responsibilities.
A summary of these essential aspects of technical data quality is
presented in figure 3.
10
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Providing a clear.statement of the hypotheses to be tested.
Considering generally how results are to be demonstrated, particularly
graphical presentations of data.
Proposing analyses of:
a. covariables (or covariates) considered
b. other possibly important covariables
c. controls to be used.
Considering what.data are needed to undertake this analysis and how
they are to be processed.
Considering what quality assurance plans and procedures will be
implemented. If comprehensively treated in other sections of the
protocol, they should be referenced. Also see section 4.3.
Determining whether new or old collection forms are needed.
Determining the number and kinds of study subjects needed, and the
statistical basis for the choice.
Deciding upon a schedule for testing, and other data collection (this
includes scheduling the obtaining of exposure data and collection in
particular areas when appropriate). Also, deciding upon the statistical.
basis for the sampling schedule and the number of sampling sites.
Determining how to initiate the study and when subject selection and data
collection are to begin.
Determining the time span necessary for data collection and when data .
will be available for analysis.
Determining the duration needed for data analysis: are analysis
programs on hand?
Deciding when draft reports and final report will be completed.
Estimating anticipated problem areas in carrying out the study.
(Details of the elements of QA will be developed in document #2.)
Figure 1. Example of major topics addressed in a task protocol.
11
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Submitted by:
Name
Approvals:
Section Chief
Branch Chief
Statistical Consultant
Division Director
AP Manager
Laboratory Director
Figure 2. Example of required task protocol approvals,
12
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a. ORGANIZATIONAL STRUCTURE FOR DATA QUALITY
b. SAMPLE COLLECTION
c. CALIBRATION
d. EXPERIMENTAL PROCEDURES
e. VARIABLES WHICH CAN AFFECT DATA QUALITY
f. PLANS FOR CORRECTIVE ACTION
g. DATA ANALYSIS
h. PERSONNEL QUALIFICATIONS
(See section 4.3 for details.)
Figure 3. Summary of essential aspects of technical data quality.
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5. QUALITY ASSURANCE PROGRAM ORGANIZATION
Within the existing management structure in the Health Effects Research
Laboratory9 Research Triangle Park, a simple but efficient quality assurance
(QA) substructure is intermeshed. The organization of the substructure, the
functional responsibilities of QA personnel and other EPA personnel involved
in the Quality Assurance Program implementation, and the lines of internal
and external communication for the achievement of a cost-effective
program are discussed in this section.
The Quality Assurance Coordinator (QAC) will be appointed by the
Laboratory Director. Representatives to the QA Committee will be appointed
by the respective Division or Office manager. Alternate representatives
will also be appointed by the respective Division or Office manager to
serve in the absence of that Division's representative. Considerations
in the choice of the alternate should include the possibility of representative-
alternate communication (if both are chosen from the same branch or
section) as well as the potential for broader based representation (if
the representative and alternate are from different disciplines).
5.1 ORGANIZATIONAL STRUCTURE
The HERL-RTP functional management structure is shown in figure 4.
As mentioned in the previous sections of this manual, the Quality Assurance
Program will encourage an awareness and usage of quality assurance principles
at every level of functional and task management. Primarily responsible
for the design and implementation of the program is the Quality Assurance
Coordinator, who reports on QA matters directly to the HERL-RTP Director.
An advisory committee chaired by the QAC is comprised of QA representatives
from each Division and Office. This committee, the Quality Assurance
Committee, is responsible for analyzing the efficiency of the program
across the Laboratory and for recommending viable improvements. The
quality assurance representatives, in addition to serving as members of
the QA Committee, act as liaisons between the QA Committee (and/or the
QAC) and their respective Divisions or Offices.
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PROGRAM OPERATIONS
OFFICE
CRITERIA AND SPECIAL
STUDIES OFFICE
ENVIRONMENTAL TOXICOLOGY
DIVISION
— Ionic Effects Branch
Acute & Chronic
Studies Section
Pathology & Microbio-
logical Studies Section
Inhalation Toxicology
Section
Iliochemistry Branch
Uiocheraical Screening
Section
t Metabolic Pathways
Section
Metabolic Effects
Section
Analytical Chemistry
Branch
Quality Assurance
Section
I Chemical Characterize-
1 tion Section
I Ifethodi Development
1 Section
HERL-RTP
Director
jL
SUPPORT SERVICES
OFFICE
Deputy Director
STATISTICS AND DATA
MANAGEMENT OFFICE
DATA MANAGEMENT
STAFF
POPULATION STUDIES
DIVISION
-
Spatial Pollutants Branch
Air Pollutants Branch
Exposure Assessment
Branch
Measure ment. Technology
Section
Systems Engineering
Section
Field Logistics Section
CLINICAL STUDIES
DIVISION
Biomedical Research Branch
Clinical Pathology Branch
Physiology Branch
ResEirch Services Branch
EXPERIMENTAL BIOLOGY
DIVISION
Nenroaiotogy Brand:
Bioengincerisj Branch
Animal Can Branch
Developments) Biology
Pesticides & Organic
Chcmkats Eraiwrttcu Sec.
Muttipb Stress Etaroa-
tion Section
Cellular & Molecular
Effects Evaluation Sec.
Social Studies & Resarch
Support Section
Figure 4. HERL-RTP's functional management structure.
15
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The actual incorporation of quality control procedures into individual
projects is the responsibility of each project's officer or taskmaster.
Beginning with the concept paper or request for proposal, all documents
which contain a description of the technical or analytical aspects of
the project must be accompanied by a description of the quality control
requirements and how they will be met. Hence, in the standard review
and approval process of any project-oriented document (e.g., RFP, proposal,
workplan, etc.), the DQC plan must be reviewed and approved along with
the other technical or analytical aspects of the work. DQA methodologies
must also be contained in the scope of the project and described in the
project documents. The Quality Assurance Coordinator or a designee may
work with the taskmaster/project officer to design or refine the DQA
procedures to meet the program requirements outlined in this quality
assurance manual.
Figure 5 shows the QA organization as described above. The
particular functions of each position (relative to QA) shown in the
diagram and the channels of communication will be delineated in section
5.2.
5.2 FUNCTIONAL RESPONSIBILITIES
The functional responsibility assignments for individuals: and organi-
zational components are given in this section.
5.2.1 Accomplishment Plan Manager
A comprehensive QA program includes consideration both of data
appropriateness to overall needs and of data quality, in a technical
sense. As previously noted, responsibility for planning and documenting
a data quality program rests with the taskmaster and within the normal
supervisory channels. Evaluation of the relevance of data to broad,
long-range HERL-RTP and EPA goals requires a perspective uniquely that
of the Accomplishment Plan Manager (APM). Relationships of the research
project data to other, spatially and temporally distinct tasks and
projects must also be evaluated. Complementarity of purpose between
this and other tasks must be weighed. An alert, informed APM can
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HERL-RTP
DIRECTOR
QA
COMMITTEE
QA
COORDINATOR
ACCOMPLISHMENT
PLAN
MANAGER
QA
CONTRACTOR
_ OPTIONAL_
"CONSULTATION
QA
REPRESENTATIVE
Advisory channel for
Quality Assurance
TASKMASTER
I
DIVISION
DIRECTOR
BRANCH
MANAGER
SECTION
MANAGER
Line of approval for
technical and Quality
Assurance procedures
Figure 5. Quality assurance program structure within HERL-RTP.
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increase the cost-effectiveness of a task by providing responsible insight
into possible; duplications between tasks, or.by recommending additional
technical work which would supplement the data from other tasks.
5.2.2 Task Management
The task management is defined here as the project officer or taskmaster
who holds the responsibility for fulfillment of the technical and administrative
requirements of a task or portion of a task. The task manager's responsibility
is to:
a. become acquainted with the technical and administrative requirements
of the HERL-RTP quality assurance policy and guideline documents;
b. include QA procedures and criteria with all project documentation
(i.e., protocols, RFP's, proposals, workplans, progress reports)
and optionally consult with the QA representative from the Division
or Office for QA recommendations as specified in the HERL-RTP
quality assurance manual (see section 4.3);
c. supply, upon request from the QAC or a designee, QA information
and/or data for evaluation by the QAC and/or the QA committee;
d. enlist the assistance of the Division or Office QA representative
in the formulation or implementation of QA procedures when
necessary; and
e. evaluate the effects of changes in quality assurance definition
on project scope, cost, and schedule.
5.2.3 Functional Management
Functional management supervises task management. The responsibilities
of the functional managers with respect to the Quality Assurance Program
implementation include:
a. reviewing all task documentation for quality control content;
b. soliciting the assistance of the QAC or a designee regarding the
QA content of task documents when deemed necessary;
c. insuring that all taskmasters are aware of HERL-RTP's emphasis
on maintaining QA performance throughout the task;
d. documenting and submitting a report to the QA representatives
on any problem areas in the implementation of the QA program;
e. submitting recommendations for possible improvements in the QA
program;
f. working with task management and the QAC or a designee in the appli-
cation of QA methodologies when necessary;
g. recommending appropriate action when deviations from the QA
program plan are identified, in order to maintain high-quality
technical performance by functional management; and
18
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h. recommending to the QAC special studies and special test
facilities when needed for QA purposes.
5.2.4 Quality Assurance Coordinator
The Quality Assurance Coordinator will administratively function in
four capacities, as:
1. coordinator of the HERL-RTP Quality Assurance Program;
2. chief advisor to the Director of HERL-RTP on quality assurance
matters;
3. chairman of the Quality Assurance Committee;
4. QA consultant available to all levels of functional and project
management.
These four functions are outlined below.
5.2.4.1 As coordinator of the HERL-RTP quality assurance program, the
QAC shall:
a. manage, the program budget for specific data quality assurance
tasks and programs;
b. provide for training of QA representatives in all facets of
quality assurance applicable to the projects at hand and those
anticipated;
c. identify, categorize, and document ihanges in QA management
philosophies, objectives, acceptable quality criteria, and
guidelines;
d. represent the HERL-RTP at Interlaboratory Quality Assurance
Coordinating Committee functions within the Environmental
Research Center, RTP, and at other QA functions
within the agency (see figure 6).
e. become involved with professional societies from which QA
expertise can be drawn;
f. recommend more cost-effective methods of quality assurance for
evaluation by the QA Committee.
5.2.4.2 The Quality Assurance Coordinator's responsibilities as chief
advisor to the HERL-RTP Director on quality assurance matters include:
a. submitting periodic progress reports both in the formulation and
implementation stages of the program;
b. enlisting the Director's support when necessary to further the
acceptance of the QA program throughout HERL-RTP; and,
c. recommending to the Director major changes in purpose, objectives,
or QA management philosophies.
19
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OFFICE OF RESEARCH
AND DEVELOPMENT
ro
o
EMSL-RTP
HERL-RTP
ERC-RTP
INTERLABORATORY
QUALITY ASSURANCE
COORDINATING
COMMITTEE
PROFESSIONAL SOCIETY
HERL-RTP
QUALITY ASSURANCE
COORDINATION
(HERL-RTP QA
COMMITTEE)
ENVIRONMENTAL
TECHNICAL
COMMITTEE
OF ASQC
Figure 6. Quality assurance coordinator's communication links with
QA expertise outside of HERL-RTP.
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5.2.4.3 Ac chairman of the Quality Assurance Committee, the QAC shall:
a, request sufficient information from the committee members to
permit adequate program evaluation;
b,. submit new QA methodologies to the committee for discussion and
study to determine extent of applicability across HERL-RTP;
c. initiate the committee's efforts in preparing and publishing QA
documentation;
d. work with the QA Committee in preparing a master plan for the use
of available funds and resources to meet the requirements of the
QA directive;
e. work with the QA Committee in planning, organizing, and executing
special quality assurance audits of section laboratories' equipment
and procedures; and
f. insure that all topics covered and decisions reached in Committee
meetings are properly recorded and communicated.
5.2.4.4 As the HERL-RTP Quality Assurance Consultant, the QAC shall:
a. be available for consultation with all levels of functional and pro-
ject management on QA matters;
b. maintain adequate status information on the quality of project per-
formance so that the taskmaster and functional management have
suitable data for evaluation and measurement;
c. provide "real time" feedback on assessments of individual project
performances or standard laboratory procedures, following independent
QA audits.
5.2.5 Quality Assurance Representative
Each Division or Office Director will designate a Quality Assurance
Representative and alternate who will serve as a member of the Quality
Assurance Committee as well as the liason between the QA Committee and
his or her Division or Office.
As a committee member, the representative shall:
a. study and report to the committee existing or anticipated quality assur-
ance activities within his or her Division or Office;
b. be aware of the scope and quantity of project work performed in-house
within the Division or Office;
c. be aware of the scope and quantity of project work contracted out from
the Division or Office;
d. identify and report possible problem areas in the implementation of
proposed QA activities; and
e. bring to the attention of the QA committee significant suggestions
made by functional or project managers within the Division or Office
related to quality assurance.
21
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Serving within the Division or Office as the prime source of information
on QA matters, the QA representative shall:
a. acquaint functional and task managers within the Division or Office
with QA program objectives, policies, and procedures; enlist their sup-
port of the program; and project the benefits of a QA program that is
incorporated into everyday Division or Office efforts;
b. provide appropriate and timely QA consultation, as necessary;
c. insure that each functional or project manager is supplied with QA
documentation applicable to the projects at hand or anticipated; and
d. work with functional and task managers in implementing the QA
program within the Division or Office.
5.2.6 Quality Assurance Committee
The Quality Assurance Committee will serve as an advisory committee to the
Laboratory Director, with the objective of furthering the continuity and applic-
ability of the Quality Assurance Program throughout HERL-RTP. Specifically,
the committee's responsibilities consist of but are not limited to:
a. developing both the short-term and the long-term objectives of the
QA Program;
b. periodically assessing program progress and organizational efficiency;
c. assisting in the refinement of the QA Program so that it will meet
the needs of all the Division or Offices, with minimum disruption
of existing workloads and procedures;
d. reviewing and discussing suggestions and recommendations presented
to the committee;
e. reviewing and making recommendations to the QAC as to the definition of
QA procedures, and later, assessing the general acceptance and applic-
ability of the QA manual; and
f. formulating, issuing, and maintaining applicable QA documentation.
22
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6. REFERENCES
1. Glossary and Tables for Statistical Quality Control, The American
Society for Quality Control, Milwaukee, Wisconsin, 1973.
2. Quality Assurance Handbook for Air Pollution Measurement Systems,
Volume I, Principles, EPA-600/9-76-005.
3. Quality Assurance Plan, Health Effects Research Laboratory, Research
Triangle Park, North Carolina, 1976 (unpublished).
7. BIBLIOGRAPHY
American Council of Independent Laboratories, Quality Control System for
Independent Laboratories, 1971.
Analysis of Pesticide Residues in Human and Environmental Samples, J.F. Thompson,
ed., U.S. Environmental Protection Agency, Health Effects Research Laboratory,
Research Triangle Park, North Carolina, December 1974.
Army Scientific Advisory Panel, Report of the Army Scientific Advisory Panel
. Ad Hoc Group on Environmental Quality Control, Washington, NTIS
AD-A009-191/8ST, 1975.
Clark, F.E., "Analytical Methodology, Standardization and Quality Control
in Environmental Information Systems," ASTM Standardization News,
Vol. 4, No. 4 (1976), p. 20-23.
Herbst, R.A., "Contamination Control Management," Quality Progress, Vol. 7,
No. 1 (1974), p. 10-12.
Rhodes, R.C., "Quality Assurance For ADP (and Scientific Interaction With
ADI?)," ORD, EPA Workshop, Proc. No. 2, Nov. 11, 1975.
Rhodes, R.C., and Seymour Hochheiser, "Quality Control Concepts for Environ-
mental Monitoring Systems," American Society for Quality Control Technical
Conference Transaction, The Quality Cost System for Air Pollution, Toronto,
1976, not published.
Sherma, Joseph, Manual of Analytical Quality Control for Pesticides and Related
Compounds in Human and Environmental Samples, EPA-600/1-76-017, U.S. Environ-
mental Protection Agency, Health Effects Research Laboratory, Research
Triangle Park, North Carolina, February 1976.
Shimmin., K.G., Quality Assurance Program, California State Water Resources
Control Board, Sacramento, 1974.
23,
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Smith, Franklin, and James Buchanan, IERL-RTP Data Quality Manual,
EPA-600/3-76-159, U..S. Environmental Protection Agency, Industrial
Environmental Research Laboratory, Research Triangle Park, North
Carolina, June 1976.
Smith, Franklin, and A. Carl Nelson, Jr., Guidelines for Development of
Quality Assurance Programs and Procedures Applicable to Measuring
Pollutants for Which National Ambient Air Quality Standards Have
Been Promulgated, EPA-Durham 68-02-0598, U.S. Environmental Protec-
tion Agency, National Environmental Research Center, Research
Triangle Park, North Carolina, August 1973.
Wening, Robert J., "Quality Assurance in the Laboratory," ASTM Standardisation
News. Vol. 4, No. 3 (March 1976), pp. 11-16.
24
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TECHNICAL REPORT DATA
(Please read Instructions on the reverse before completing)
1. REPORT MO.
EPA-600/1-77-036
3. RECIPIENT'S ACCESSION'NO.
4. TITLE AND SUBTITLE
Management Policy for the Assurance, of Research
Quality - Health Effects Research Laboratory/RTP,
NC
5. REPORT DATE
June 1977
6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
8. PERFORMING ORGANIZATION REPORT NO.
9. PERFORMING ORGANIZATION NAME AND ADDRESS
U.S. Environmental Protection Agency
Office of Research and Development
Criteria and Special Studies Office,
Research Triangle Park, NC 27711
10. PROGRAM ELEMENT NO.
1AA601
HERL
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS
Health Effects Research Laboratory
Office of Research and Development
U.S. Environmental Protection Agency
Research Trianqle Park, N.C. 27711
13. TYPE OF REPORT AND PERIOD COVERED
RTP.NC
14. SPONSORING AGENCY CODE
EPA 600/11
15. SUPPLEMENTARY NOTES
16. ABSTRACT
This document presents policies, goals, and an organizational
structure for the implementation of a management policy for the Quality
Assurance program in the Health Effects Research Laboratory, Research
Triangle Park, North Carolina. Directed toward functional managers, a
system for quality assurance monitoring or task quality control functions
is described.
General areas affecting data quality are discussed from the perspective
of the manager as a reviewer of documents or plans. The quality assurance.
organization, .consisting of a Quality Assurance Coordinator and a Quality
Assurance Committee, serves in an advisory capacity to taskmasters as
well as to regular functional management. Within this structure, the
application of quality assurance measures is the responsibility of
taskmasters or project officers. It is the responsibility of functional
management to ensure that all project-oriented documents or plans have
incorporated appropriate quality assurance procedures.
7.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b.lDENTIFIERS/OPEN ENDED TERMS C. COSATI Field/Group
Quality Assurance
Management
Research Projects
Health
Quality
Quality control
Health Effects Laboratory
Quality Assurance
05 A
14 B
8. DISTRIBUTION STATEMENT
19. SECURITY CLASS (ThisReport)'
Unclassified
21. NO. OF PAGES
30
20. SECURITY CLASS (Thispage)
Unclassified
22. PRICE
EPA Form 2220-1 (9-73)
25
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