600R80101
GUIDELINES AND SPECIFICATIONS
FOR
PREPARING QUALITY ASSURANCE PROGRAM PLANS
QAMS-004/80
t
Quality Assurance Management Staff
Office of Monitoring Systems and Quality Assurance
Office of Research and Development
United States Environmental Protection Agency
US. EnvlnonmtntaJ Protection
Region v, Library
230 South Dearborn Strett
Chrcag*. Illinois 60604
September 20, 1980
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Environmental
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TABLE OF CONTENTS
Subject Page
Introduction • 1
Scope • • 1
Quality Assurance Program Plan Preparation and Responsibility . . 2
Quality Assurance Program Plan Submission Procedures 2
Quality Assurance Program Plan Review and Approval 2
Quality Assurance Program Plan Content Requirements 3
1.0 Identification of Office, Region, or Laboratory
Submitting Quality Assurance Program Plan 3
2.0 Introduction 3
3.0 Quality Assurance Policy Statement 3
4.0 Quality Assurance Management ..... 4
5.0 Personnel Qualifications 6
6.0 Facilities, Equipment, and Services 6
7.0 Data Generation 7
8.0 Data Processing 9
9.0 Data Quality Assessment 10
10.0 Corrective Action 10
11.0 Implementation Requirements and Schedules ....... 11
Specific Guidance 13
Definition of Terms 16
Appendices
A. Administrator's Policy Statement of May 30, 1979
B. Administrator's Memorandum of June 14, 1979
i.
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GUIDELINES AND SPECIFICATIONS
FOR
PREPARING QUALITY ASSURANCE PROGRAM PLANS
INTRODUCTION
Environmental Protection Agency (EPA) policy requires participation
by all EPA Regional Offices, Program Offices, EPA Laboratories, and States
in a centrally-managed Quality Assurance (QA) program (see Appendix A—
Administrator's policy statement of May 30, 1979) and includes all
monitoring and measurement efforts mandated or supported by EPA through
regulations, grants, contracts, or other formalized means not currently
covered by regulation (see Appendix B—Administrator's memorandum of June
14, 1979). The responsibility for developing, coordinating, and directing
the implementation of this program has been delegated to the Office of
Research and Development (ORD) which established the Quality Assurance
Management Staff (QAMS) for this purpose.
In this document, we define "quality assurance" and "quality control"
as follows:
Quality Assurance - the total integrated program for assuring
reliability of monitoring and measurement data
Quality Control - the routine application of procedures for
obtaining prescribed standards of performance
in the monitoring and measurement process.
Accordingly, the QA program plan is a document to be prepared by each
Program Office, Regional Office, and Laboratory which includes the overall
policies, organization objectives, and functional responsibilities design-
ed to achieve data quality goals for the activities for which the parti-
cular organization is responsible.
SCOPE
The Agency QA program encompasses all environmentally-related mea-
surement activities supported or required by EPA. "Environmentally-
related measurement activities" include all field and laboratory investi-
gations that generate data involving the measurement of chemical, physi-
cal, or biological parameters in the environment; determining the pre-
sence or absence of pollutants in waste streams; health and ecological
effect studies; clinical and epidemiological investigations; engineering
and process evaluations; studies involving laboratory simulation of
environmental events; and studies or measurements on pollution transport,
including diffusion models.
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QUALITY ASSURANCE PROGRAM PLAN PREPARATION RESPONSIBILITY
Each Program Office, Regional Office, National Laboratory, State,
or other organization is responsible for the preparation and implementa-
tion of a QA program plan to cover all environmentally-related measure-
ment activities. For administrative purposes, these plans should be
issued at the Deputy Assistant Administrator (DAA), Regional Administra-
tor (RA), National Laboratory Director, or similar levels of responsibi-
lity within States and other organizations. For example, one overall QA
program plan would be prepared for the Office of Monitoring Systems and
Quality Assurance and a specific QA program plan for each of its two
Environmental Monitoring Systems Laboratories and its one Environmental
Monitoring and Support Laboratory (see, for example, page 8 of the
implementation plan) For States, each State agency carrying out environ-
mentally-related measurements will prepare a QA program plan.
QUALITY ASSURANCE PROGRAM PLAN SUBMISSION PROCEDURES
QA program plans should be submitted through normal channels of
authority for review or approval(s) as shown in Figure 1.
Completed EPA QA program plans must be submitted to the Director,
Quality Assurance Management Staff (RD-680), Office of Monitoring Systems
and Quality Assurance, Office of Research and Development, U.S. Environ-
mental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460.
States and other organizations will submit their QA program plans to the
appropriate Regional Quality Assurance Management Officer (RQAMO). Any
questions concerning the preparation of QA program plans or requests for
technical assistance should be directed to QAMS. The Director of
QAMS can be reached on (FTS/202) 426-2387. States and other organizations
shall direct questions to the appropriate RQAMO.
QUALITY ASSURANCE PRORGRAM PLAN REVIEW AND APPROVAL
QA program plans for EPA organizations will be evaluated by QAMS and
either approved or returned with explanation and target date for resub-
mission, in accordance with QAMS Standard Operation Procedure (SOP)
Number 1 of May 19, 1980 for the review and approval of QA program plans.
The QA program plans for State agencies will be reviewed and approved by
the appropriate EPA Region.
Approval of the QA program plans will be based on completeness and
appropriateness in covering the elements described in Sections 1 through
11. A basic requirement for each QA program plan is that either it is or
can be implemented and that its implementation can be measured relative
to program objectives. For the States, the approval and implementation
of the State QA program plan will be incorporated into the State-EPA
Agreement.
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QUALITY ASSURANCE PROGRAM PLAN CONTENT REQUIREMENTS
Sections 1 through 11 below describe the essential elements required
in any QA program plan and indicate format to be used. All eleven elements
listed must be considered and addressed. Where an item is not relevant,
a brief explanation of why it is not relevant must be included. Section
12 provides a list of reference documents that may be used in the
preparation of these plans.
1.0 Identification of Office, Region, or Laboratory
Submitting Quality Assurance Program Plans
Each QA program plan must have a cover sheet (shown on pp. 5 and 5a)
listing the following information:
o Document Title
o Document Control Number (assigned by the submitting office)
o Unit's Full Name and Address
o Name, Address (if different from above), and Telephone Number of
the Individual Responsible for the Unit
o QA Officer
o Plan Coverage shall identify all major organization units which
are required to participate in the QA program
o Concurrences must include the QA Officer for the respective
organization
o Approval will be by the RA or DAA or Laboratory Director, and the
Director of QAMS
2.0 Introduction
In this section, a brief background, purpose, and scope of the QA
program plan is set forth. This section must state the rationale for QA
application to monitoring and measurement activities and establish a
basis for integrating the mandatory QA initiative into the program plan.
3.0 Quality Assurance Policy Statement
This policy statement provides the framework within which a unit
develops and implements its QA program. The policy statement must de-
scribe the unit's goals and specify those requirements and activities
needed to realize these goals. Paralleling the Administrator's directive
of May 30, 1979, the unit's policy statement must emphasize those require-
ments and activities needed to ensure that all data obtained are of known
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quality. Policy is to be directed towards a formal commitment of time
and resources necessary to ensure that data are as precise and accurate
and as complete and representative as required.
The policy statement indicates management's commitment to QA through-
out the data generating and processing operations. All reported data
must be accompanied by a calculation of precision and accuracy. Where
appropriate, a statement on the completeness, representativeness, and
comparability is to be included.
4.0 Quality Assurance Management
4.1 Introduction
This section must present the QA management structure of the
organization and its relationship to the national program. This
section of the plan shows the interrelationships between the func-
tional units and the subunits which generate or manage data. Also,
the relationship between the national program managers and the
Regions is to be described.
4.2 Assignment of Responsibilities
The office with overall QA responsibility for the organization must
be identified. The success of the QA program depends on the QA
office being organizationally independent of data-generating groups.
In EPA, this office must report to at least a division director in
the Regions and Program Offices, and a comparable level in ORD
Laboratories and the National Enforcement Investigations Center-
Denver. Quality control (QC) responsibility within the various
organizational subunits should be stated.
The QA responsibilities of national program managers vs. those of
the EPA Regions must be described. For example, national program
managers will identify the monitoring and measurements which will
require QA coverage by Regions or ORD Laboratories, along with
minimum specifications and acceptance criteria for the data which
are generated. The Regions would be responsible for assuring that
QA program and project plans meet these requirements. Both Program
Offices and Regions will follow guidance provided by QAMS.
4.3 Communications
The "organizational type" chart should be used to indicate the
internal and external flow of QA information and reports. Examples
of information and reports are shown in Section 4.5.
The flow of reports and other QA information must be addressed and
should specify the following: (1) the responsibility of the QA
office; (2) what levels of the unit will receive various reports;
(3) how often the reports will be issued; (4) who will review these
reports; and (5) who will take follow-up action, if necessary.
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Revision Number 2
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QUALITY ASSURANCE PROGRAM PLAN IDENTIFICATION FORM
Document Title
Document Control Number (Internal Use Only)
Organization Title
Address
Responsible Official Telephone
Title
Quality Assurance Officer Telephone
Address
(If Different From Organization)
Plan Coverage
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Concurrences
(1) Name
Title (Quality Assurance Officer)
Signature Date
(2) Name
Title (Responsible Official)
Signature Date
Approval for Agency
(1) Name
Title (Director. QAMS)
Signature Date
Approval for Implementation
(1) Name
Title (RA, DAA, or National Laboratory Director)
Signature Date
Comments
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4.4 Document Control
QA reports and other vital information, plans, and directives are to
be maintained under a document control procedure as described in
Section 1.4.1 of the Quality Assurance Handbook for Air Pollution
Measurement Systems, Volume I (EPA-600/9-76-005). Distribution lists
of personnel who need to receive QA reports and information should
be maintained as part of the document control system.
4.5 QA Program Assessment
This section must describe how an organization will continually
review its QA program's benefits and effectiveness.
Each organization is required to conduct periodic assessments of its
total QA program. Based on these assessments, a semiannual written
status report of QA activities and progress will be forwarded to the
QAMS or RQAMO. These QA reports will include such information as:
1. Status of or Changes to QA Program Plans
2. Status of QA Project Plans
3. Measures of Data Quality
4. Significant QA Problems, Accomplishments, and Recommendations
5. Results of Performance Audits
6. Results of Systems Audits
7. Status of QA Requirements for Contracts and Grants
8. Summary of QA Training
5.0 Personnel Qualifications
Each organization must assure that all personnel performing tasks
and functions related to data quality have the needed education, training,
and experience. This includes laboratory technicians, analysts, mainte-
nance technicians, supervisors, principal investigators, statisticians,
project officers, and QA staff. Personnel qualifications and training
needs should be identified.
6.0 Facilities, Equipment, and Services
In this section, the unit's approach to the selection, evaluation,
and maintenance (both routine and corrective) of its equipment, facili-
ties, and services is to be described.
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The QA program plan should address general environmental aspects of
the facilities and equipment which might impact data quality (temperature,
humidity, lighting, dust levels, etc.)* It should also consider mainte-
nance requirements for general utilities and housekeeping services (vol-
tage control, reagent purity, supply of air and water, refrigerators,
incubators, laboratory hoods, glove boxes, etc.). In addition, this
plan should identify the monitoring and inspection procedures, service
manuals, maintenance procedures, and service agreements utilized to
maintain performance standards for equipment, Including essential ancil-
lary equipment.
7.0 Data Generation
This section of the QA program plan must describe procedures to
assure the generation of reliable data by all environmentally-related
measurement activities. To assure that all data generated are scientifi-
cally valid, defensible, comparable, and of known precision and accuracy,
these plans must provide for the use of QA project plans and SOPs.
7.1 Quality Assurance Project Plans
Each QA program plan must identify the types of monitoring and
measurement activities for which detailed QA project plans must be
developed and followed. QA project plans are to be written for each
specific project or each continuing operation by the responsible
Program Office, Regional Office, Laboratory, contractor, grantee, or
other organization. Project plans must contain the following, as
applicable:
o Title Page, with provision for approval signatures
o Table of Contents
o Project Description
o Project Organization and Responsibilities
o QA Objectives for Measurement Data, in terms of precision, accu-
racy, completeness, comparability, and representativeness
o Sampling Procedures
o Sample Custody
o Calibration Procedures and References
o Analytical Procedures
o Data Analysis, Validation, and Reporting
o Internal QC Checks
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7.1 Quality Assurance Project Plans (Continued)
o Transporation
o Safety
o Data Handling Procedures
o Service Contracts
o Measurement of Precision, Accuracy, Completeness, Representative-
ness, and Comparability
o Document Control
QA project plans must be prepared in document control format, with
provision for revision, as needed, and with a record of the official
distribution.
7.2 Standard Operating Procedures
SOPs should be developed and used to implement routine QC require-
ments for all monitoring programs, repetitive tests and measure-
ments, and for inspection and maintenance of facilities, equipment,
and services.
The organization's QA office will assist in the preparation, review,
and approval of all SOPs. These SOPs should be prepared in document
control format and a record kept of the official distribution. Once
prepared, these SOPs need only be included in the QA project plans
by reference.
8. Data Processing
QA program plans summarize how all aspects of data processing will
be managed and separately evaluated in order to characterize and maintain
the integrity and quality of the data. Data processing includes collec-
tion, validation, storage, transfer, and reduction. Those offices oper-
ating Automated Data Processing and computer systems for data processing
must describe their systems' operations and documentation. Specific
instructions should be addressed in QA project plans.
8.1 Collection
The QA project plan must address both manually collected data and
computerized data acquisition systems. The internal checks that
must be used to avoid errors in the data collection process should
be identified.
8.2 Validation
Data validation is defined as the process whereby data are accepted
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or rejected based on a set of criteria. This aspect of QA involves
establishing specified criteria for data validation. The QA project
plan must indicate the specified criteria that will be used for data
validation.
8.3 Storage
At every stage of data processing at which a permanent collection of
data is stored, procedures must be established to ensure data
integrity and security. QA project plans must indicate how specific
types of data will be stored with respect to media, conditions,
location, retention time, and access.
8.4 Transfer
QA project plans will describe procedures which must be used to
ensure that data transfer is error-free (or have an admlssable error
rate), that no information is lost in the transfer, and that the
input is completely recoverable from the output. Examples of data
transfer are: copying raw data from a notebook onto a data form for
keypunching, converting a written data set to punched cards, or
copying from computer tape to disk. A QA project plan must indicate
a minimum number of data transfer steps in the data processing.
8.5 Reduction
Data reduction Includes all processes which change either the form
of expression or quantity of data values or numbers of data items.
This category includes validation, verification, and statistical and
mathematical analysis. It is distinct from data transfer in that it
entails a reduction in the size or dimensionality of the data set.
Validation of the data reduction process itself must be addressed
(i.e., software validation) appropriate to that level of effort
involved. Common to each type of processing is the capability of a
reviewer to reliably check the validity of this conversion process
against some prescribed methodology.
9.0 Data Quality Assessment
QA program plans must describe how all data generated will be assessed
for accuracy, precision, completeness, representativeness, and comparabi-
lity. The QA program must require that data be accompanied by a calcula-
tion of precision and accuracy. Where appropriate, a statement on the
completeness, representativeness, and comparability also should be in-
cluded.
10.0 Corrective Action
Each QA program plan will include provisions for establishing and
maintaining QA reporting or feedback channels to the appropriate manage-
ment authority to ensure that early and effective corrective action can
be taken when data quality falls below required limits. The QA program
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plans also must include provisions to keep responsible management informed
of the performance of all data collection systems and will describe the
mechanlsm(s) to be used when corrective actions are necessary. Corrective
action relates to the overall QA management scheme: who is responsible
for taking corrective actions; when are corrective actions to be taken;
and who follows-up to see that corrective actions have been taken and
that they have produced the desired results.
Corrective actions will be minimized through the development and
implementation of internal controls prior to an adverse program impact.
Each measurement system must have limits to establish when corrective
action must be taken. A procedure must be established for each measurement
system to show what corrective action will be followed when established
limits for this procedure have been exceeded. The level within the
organization that is responsible for taking corrective action must be
specified.
Results from the following QA activities may initiate a corrective
action:
A. Performance Audits
B. Systems Audits
C. Interlaboratory/Interfield Comparison Studies
D. Failure to Adhere to a QA Program or Project Plan or to SOPs
11.0 Implementation Requirements and Schedule
The QA program plan must be accompanied by an implementation sche-
dule. An example of the QAMS implementation schedule is shown in the
Table on page 12.
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IMPLEMENTATION REQUIREMENTS AND SCHEDULE
Requirement
By Whom
Date
Agency QA Policy-General
Agency QA Policy-Contracts
and Grants
Strategy for Developing
Mandatory QA Program
Guidelines and Specifications
for Preparing QA Program Plans
Guidelines for Implementing
QA Requirements for Grants
Guidelines for Implementing
QA Requirements for Contracts
Designation of QA Officers*
Model QA Program Plans (Ambient
Air, Water, Region, (Laboratory)
Quality Assurance Clearinghouse
Guidelines for Preparing QA
Project Plans
Draft QA Program Plans Submitted
Agency QA Report
QA Programs/Plans Approved
QA Cost Study Report
QA Workshops (QAOs, Project
Officers, Grants Administra-
tors)
QA Project Plans
Administrator
Administrator
ORD/Work Group
OMSQA/QAMS
OMSQA/QAMS
\
OMSQA/QAMS
RAs, DAAs, Labs
ORD POs, ROs
OMSQA/QAMS
ORD POs, ROs
POs, ROs, Labs
OMSQA/QAMS
OMSQA/QAMS
ROs, ORD Labs
OMSQA/QAMS
POs, ROs, Labs
5-30-80
6-14-80
2-13-80
9-20-80
2-22-80
2-22-80
3-1-80
3-24-80
5-1-80
6-30-80
6-6-80
6-2-80
9-15-80
9-15-80
To Be Planned
10-1-80
and Continuing
*Regions and ORD have already designated QA Officers.
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SPECIFIC GUIDANCE
Technical details and other information of QA and QC can be obtained
from the documents listed below:
EPA-600/9-76-005
EPA-600/4-77-027a
EPA-600/4-77-027b
Federal Register
Volume 44, 27604
EPA-600/4-79-019
EPA-600/4-78-017
EPA-600/4-75-008
NTIS-PB-253258/AS
Quality Assurance Handbook for Air Pollution
Measurement Systems, Volume I—Principles
March 1976
Quality Assurance Handbook for Air Pollution
Measurement Systems, Volume II-Ambient Air
Specific Methods (especially Section 2.0.9)
May 1977
Quality Assurance Handbook for Air Pollution
Measurement Systems, Volume III—Stationary
Source Specific Methods
August 1977
Traceability Protocol for Establishing True
Concentrations of Gases Used for Calibration
and Audits of Air Pollution Analyzers
Protocol Number 2, June 1978
Transfer Standards for Calibration of Ambient
Air Monitoring Analyzers for Ozone
June 1978
List of Reference and Equivalent Methods
Criteria, Procedures, and Forms for the
Evaluation of Ambient Air Monitoring
Programs—Laboratory and Field
June 1979
Ambient Air Quality Monitoring, Data Reporting,
and Surveillance Provisions
May 10, 1979
Handbook for Analytical Quality Control in
Water and Wastewater Laboratories
March 1979
Procedures for the Evaluation of Environmental
Monitoring Laboratories
March 1978
Interim Radiochemistry Methodology for Drinking
Water
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EPA-600/8-78-008
EPA-600/8-78-017
EPA-600/4-79-202
EPA-670/4-73-001
EPA-600/7-77-088
EPA-600/4-77-144
EPA-600/4-78-033
NTIS-PB-286981/AS
EPA-600/4-78-032
NTIS-PB-284850/AS
EPA-600/1-79-008
Environmental Toxicology
Division, Health Effects
Research Laboratory,
U.S. EPA, Research
Triangle Park, NC
Manual for the Interim Certification of Laboratories
Involved in Analyzing Public Drinking Water Supplies,
Criteria, and Procedures
August 1978
Microbiological Methods for Monitoring the Environment
December 1978
Methods for Chemical Analysis of Water and Wastes
March 1979
Biological Field and Laboratory Methods for Measuring
the Quality of Surface Water and Effluents
July 1973
Handbook for Analytical Quality Control in Radio-
Analytical Laboratories
August 1977
Quality Control for Environmental Measurements Using
Gamma-Radiospectrometry
December 1977
Radioactivity Standards Distribution Program. 1978-1979
June 1978
Environmental Radioactivity Laboratory Intercomparison
Studies Program 1978-1979
June 1978)
Manual of Analytical Quality Control for Pesticides and
Related Compounds in Human and Environmental Samples
Analysis of Pesticide Residues in Human and Environ-
mental Samples—A Compilation of Methods Selected for
Use in Pesticide Monitoring Programs
Other guidance documents for the development and implementation of
the mandatory QA program are available from QAMS. These include:
QAMS-001/80
QAMS-002/80
Strategy for the Implementation of the Environmental
Protection Agency's Mandatory Quality Assurance Program
March 11, 1980
Guidelines and Specifications for Implementing Quality
Assurance Requirements for EPA Contracts and Interagencj
Agreements Involving Environmental Measurements
May 19, 1980
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QAMS-003/80
QAMS-004/80
QAMS-005/80
Guidelines and Specifications for Implementing Quality
Assurance Requirements for EPA Grants and Cooperative
Agreements Involving Environmental Measurements
September 30, 1980
Guidelines and Specifications for Preparing Quality
Assurance Program Plans
September 20, 1980
Guidelines and Specifications for Preparing Quality
Assurance Project Plans
October 17, 1980
A Model Quality Assurance Program Plan for Regional
Offices
May 1980
A Model Quality Assurance Program Plan for the Office
of Air Quality Planning and Standards
May 1980
A Model Quality Assurance Program Plan for the Office
of Water Planning and Standards
May 1980
A Model Quality Assurance Program Plan for the Health
Effects Research Laboratory-Research Triangle Park,
North Carolina
May 1980
A Model Quality Assurance Program Plan for the
Environmental Research Laboratory-Narragansett
May 1980
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DEFINITION OF TERMS
Definitions of key terms used in this guidance material are given
below:
AUDIT - a systematic check to determine the quality of operation of
some function or activity* Audits may be of two basic
types: (1) performance audits in which quantitative or
qualitative data are independently obtained for comparison
with routinely obtained data in a measurement systems, or
(2) systems audits of a qualitative nature that consist of
an on-site review of a laboratory's quality assurance system
and physical facilities for sampling, calibration, and mea-
surement.
CONTRACT - the legal instrument reflecting a relationship between
the Federal Government and a State or local government or
other recipient: (1) whenever the principal purpose of the
instrument is the acquisition, by purchase, lease, or barter
of property or services for the direct benefit or use of the
Federal Government; or (2) whenever an executive agency
determines, in a specific instance, that the use of a type
of procurement contract is appropriate.
COOPERATIVE AGREEMENT - the legal instrument reflecting the relation-
ship between the Federal Government and a State or local
government or other recipient whenever: (1) the principal
purpose of the relationship is the transfer of money, pro-
perty, services, or anything of value to the State or local
government or other recipient to accomplish a public purpose
of support or stimulation authorized by Federal statute,
rather than acquisition, by purchase, lease, or barter of
property or services for the direct benefit or use of the
Federal Government; and (2) substantial involvement is anti-
cipated between the executive agency acting for the Federal
Government and the State and local government or other
recipient during performance of the contemplated activity.
DATA QUALITY - the totality of features and characteristics of data
that bears on its ability to satisfy a given purpose. The
characteristics of major importance are accuracy, precision,
completeness, representativeness, and comparability. These
characteristics are defined as follows:
o accuracy - the degree of agreement of a measurement (or an
average of measurements of the same thing), X, with an
accepted reference or true value, T, usually expressed as
the difference between the two values, X-T, or the differ-
ence as a percentage of the reference or true value, 100
(X-T)/T, and sometimes expressed as a ratio, X/T. Accu-
racy is a measure of the bias in a system*
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o precision - a measure of mutual agreement among individual
measurements of the same property, usually under prescribed
similar conditions*
Precision is most desirably expressed in terms of the
standard deviation. Various measures of precision exist
depending upon the "prescribed similar conditions."
o completeness - a measure of the amount of valid data
obtained from a measurement system compared to the amount
that was expected to be obtained under correct normal
corrections.
o representativeness - the degree to which data accurately
and precisely represent a characteristic of a population,
parameter variations at a sampling point, or an environmen-
tal condition.
o comparability - a measure of the confidence with which one
data set can be compared to another.
DATA VALIDATION - a systematic effort to review data to identify any
outliers or errors and thereby cause deletion or flagging of
suspect values to assure the validity of the data to the
user. This "screening" process may be done by manual and/or
computer methods, and it may utilize any consistent tech-
niques such as sample limits to screen out impossible values
or complicated acceptable relationships of the data with
other data.
ENVIRONMENTALLY-RELATED MEASUREMENTS - a term used to describe
essentially all field and laboratory investigations that
generate data involving the measurement of chemical, physi-
cal, or biological parameters in the environment; determin-
ing the presence or absence of priority pollutants in waste
streams; health and ecological effect studies; clinical and
epidemiological investigations; engineering and process eval-
uations; studies involving laboratory simulation of environ-
mental events; and studies or measurements on pollutant
transport, including diffusion models.
GRANT - the legal instrument reflecting the relationship between the
Federal Government and a State or local government or other
recipient in which (1) the principal purpose of the relation-
ship is the transfer of money, property, services, or any-
thing of value to the State or local government or other
recipient in order to accomplish a public purpose of support
of stimuation authorized by Federal statute, rather than
acquisition, by purchase, lease, or barter, or property or
services for the direct benefit or use of the Federal Govern-
ment; and (2) no substantial involvement is anticipated
between the executive agency, acting for the Federal Govern-
ment, and State or local government or other recipient during
performance of the contemplated activity.
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Pre*ctton
South Dearborn
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Date: 9-20-80
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GRANTEE - any individual, agency, or entity jiich has been awarded a
grant pursuant to grant regulations
PERFORMANCE AUDIT - planned independent check of the operation of a
measurement system to obtain a quantitative measure of the
quality of the data generated. This involves the use of
standard reference samples or materials which are certified
as to their chemical composition or physical characteristics
QUALITY ASSURANCE - (1) the total integrated program for assuring
the reliability of monitoring and measurement data
(2) a system for integrating the quality plan-
ning, quality assessment, and quality Improvement efforts
of various groups in an organization to enable operations
to meet user requirements at an economical level* In pollu-
tion measurement systems, quality assurance is concerned
with all of the activities that have an important effect on
the quality of the pollution measurements, as well as the
establishment of methods and techniques to measure the
quality of the pollution measurements. The more authorita-
tive usages differentiate between "quality assurance" and
"quality control," where quality control is the system of
activities to provide a "quality product" and quality assu-
rance is the "system of activities to provide assurance
that the quality control system is performing adequately"
QUALITY ASSURANCE PROGRAM PLAN - an orderly assembly of management
policies, objectives, principles, and general procedures by
which an agency or laboratory outlines how it intends to
produce quality data
QUALITY ASSURANCE PROJECT PLAN - an orderly assembly of detailed and
specific procedures by which an agency or laboratory delin-
eates how it produces quality data for a specific project
or measurement method. A given agency or laboratory would
have only one quality assurance manual, but would have a
quality assurance plan for each of its projects or programs
(group of projects using the same measuremetn methods; for
example, a laboratory service group might develop a plan by
analytical instrument since the service is provided to a
number of projects)
STANDARD OPERATING PROCEDURE - an operation, analysis, or action
whose mechanics are thoroughly prescribed and documented and
which is commonly accepted as the usual or normal method for
performing certain routine or repetitive tasks
QUALITY CONTROL - the routine application of procedures for obtaining
prescribed standards of performance in the monitoring and
measurement process
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