PB83-219667
idelines and Specifications for
sparing Quality Assurance Program Plans
(U.S.) Environmental Protection Agency
Washington, DC
J'un 8 3
U.S. DEPARTMENT OF COMMERCE
National Technical Information Service
'-
-------
P883-219667
EPA-600/8-83-024
June 1983
GUIDELINES AND SPECIFICATIONS
FOR
PREPARING QUALITY ASSURANCE PROGRAM PLANS
QAMS-004/80
Quality Assurance Management Staff
Office of Monitoring Systems and Quality Assurance
Office of Research and Development
United States Environmental Protection Agency
-------
TECHNICAL REPORT DATA
(Please read Instructions on the reverse before completing/
1. REPORT NO.
EPA-600/8-83-024
3. RECIPIENTS ACCESSION NO.
4. TITLE ANO SUBTITLE
GUIDELINES AND SPECIFICATIONS FOR PREPARING
QUALITY ASSURANCE PROGRAM PLANS
5. REPORT DATE
June 1983
6. PERFORMING ORGANIZATION COOE
7. AUTHOR(S)
Thomas W. Stanley
S. Sidney Verner
8. PERFORMING ORGANIZATION REPORT NO.
QAMS-004/80
9. PERFORMING ORGANIZATION NAME ANO AOORESS
Quality Assurance Management Staff
RD-680
Washington, D.C. 20460
10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME ANO ADDRESS
Office of Monitoring Systems & Quality Assurance
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
13. TYPE OF REPORT AND PERIOD COVERED
14. SPONSORING AGENCY CODE
EPA/600/00
15. SUPPLEMENTARY NOTES
16. ABSTRACT
This document contains procedures-and guidelines for complying with EPA's
requirement that States and local jurisdictions submit a QA Program Plan when
applying for financial assistance. A QA Program Plan is an orderly assembly of
management policies, objectives, principles and procedures by which an agency or
laboratory specifies how it intends to produce quality data.
17.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b.lOENTIFIERS/OPEN ENDED TERMS C. COSATI Field/Group
Quality Assurance
Environmental Measurement
Program Plan
18. DISTRIBUTION STATEMENT
Release Unlimited
19. SECURITY CLASS (This Report)
21. NO. OF PAGES
20. SECURITY CLASS (This page)
22. PRICE
EPA Form 2220-1 (Rev. 4-77) PREVIOUS EDI TION is OBSOLETE .
-------
GUIDELINES AND SPECIFICATIONS
FOR
PREPARING QUALITY ASSURANCE PROGRAM PLANS
QAMS-004/80
This document is provided pursuant to 40CFR
Part 30 as revised July, 1983. Although
the document was prepared for internal
Environmental Protection Agency use, it is
being made available as a guide for pre-
paring Quality Assurance (QA) program
plans. In using this as a model, care
should be taken that EPA-specific language
is carefully edited to reflect the
recipient's own QA program requirements.
-------
TABLE OF CONTENTS
Subject Pag
Introduction 1
S cope 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 7
6.0 Facilities, Equipment, and Services 7
7.0 Data Generation 8
8.0 Data Processing 10
9. 0 Data Quality Assessment 11
10.0 Corrective Action 11
11.0 Implementation Requirements and Schedules 12
Specific Guidance 14
Definition of Terms 18
Appendices
A. Administrator's Policy Statement of May 30, 1979
B. Administrator's Memorandum of June 14, 1979
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 1 of 21
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 designed to achieve data quality
goals for the activities for which the particular organization is
responsible.
SCOPE
The Agency QA program encompasses all environmentally-
related measurement activities supported or required by EPA.
"Environmentally • related measurement activities" include all
field and laboratory investigations that generate data involving
the measurement of chemical, physical, or biological parameters
in the environment; determining the presence or absence of
pollutants in waste streams; health and ecological effect
studies; clinical and epidemiological investigations; engineering
and process evaluations? studies involving laboratory simulation
of environmental events; and studies or measurements of pollution
transport, including diffusion models.
1
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 2 of 21
QUALITY ASSURANCE PROGRAM PLAN PREPARATION RESPONSIBILITY
Each Program Office, Regional Office, National Laboratory,
State or other organization is responsible for the preparation
and implementation of a QA program plan to cover all environ-
mentally-related measurement activities. For administrative
purposes, the plan should be issued by the Deputy Assistant
Administrator (DAA), Regional Administrator (RA), or National
Laboratory Director, or at a similar level of responsibility
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 environmentally-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 and approval(s) as shown in Figure 1.
Completed EPA QA program plans must be submitted to the
Director, Quality Assurance Management Staff (RD-630), Office of
Monitoring Systems and Quality Assurance, Office of Research and
Development, U.S. Environmental 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) 382-5763. States and other
organizations shall direct questions to the appropriate RQAMO.
QUALITY ASSURANCE PROGRAM 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 resubmission, 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
Reg ion.
Approval of the QA program plans will be based on complete-
ness 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.
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 3 of 21
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 6) listing the following information:
° Document Title
° Document Control Number (assigned by the submitting
office)
0 Unit's Full Name and Address
0 Name, Address (if different from above), and Telephone
Number of the Individual Responsible for the Unit
0 QA Officer
0 Plan Coverage shall identify all major organization units
which are required to participate in the QA program
0 Concurrences must include the QA Officer for the
respective organization
° Approval will be by the RA or tfDA or Laboratory Director,
and the Director of QAMS
2.0 Introduction
In this section, a brief background, purpose, and scope of
the QA program 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 describe 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 requirements and
activities needed to ensure that all data obtained are of known
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.
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 4 of 21
The policy statement indicates management's commitment to QA
throughout 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 complete-
ness, 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 interrela-
tionships between the functional 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 organiza-
tion 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 organiza-
tional 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.
-------
ADMINISTRATOR
Policy
Report
QUALITY ASSURANCE MANAGEMENT STAFF
( QAMS )
& Approval
ASSISTANT ADMINISTRATORS (AA)
Concur A Submit:
REGIONAL ADMINISTRATORS (RA)
DEPUTY ASSISTANT ADMINISTRATORS (DAA)
OFFICES
Review & Concur
APPROVAL
REGIONAL QUALITY ASSURANCE
MANAGEMENT OFFICE (RQAMO)
Prepare & Recommend
Prepare
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 5 of 21
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
(IfDifferent From Organization)
Plan Coverage
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 6 of 21
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
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 7 of 21
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 T(EPA-500/9-76-005).Distributionlistsof
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, maintenance 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, facilities and services is to be described.
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
8
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 8 of 21
should also consider maintenance requirements for general
utilities and housekeeping services (voltage 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 ancillary 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 scientifically valid, defensible, comparable, and
of known precision and accuracy, these plans much 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:
0 Title Page, with provision for approval signatures
0 Table of Contents
0 Project Description
0 Project Organization and Responsibilities
0 QA Objectives for Measurement Data, in terms of
precision, accuracy, completeness, comparability and
representativeness
0 Sampling Procedures
0 Sample Custody
0 Calibration Procedures and References
0 Analytical Procedures
0 Data Analysis, Validation and Reporting
0 Internal QC Checks
0 Performance and Systems Audits
0 Preventive Maintenance Procedures and Schedules
0 Specific Procedures to be used to routinely assess data
precision, accuracy, comparability, and representa-
tiveness of specific measurement parameters involved
0 Corrective Action
0 QA Reports to Management
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 9 of 21
QA project plans should provide for the review of all
activities which could directly or indirectly influence
data quality and the determination of those operations
which must be cover.ed by SOPs. Activities to be reviewed
include:
0 General Network Design
0 Specific Sampling Site Selection
0 Sampling and Analytical Methodology
0 Probes, Collection Devices, Storage Containers and
Sample Additives or Preservatives
0 Special Precautions, such as heat, light, reactivity,
combustability and holding times
0 Federal Reference, Equivalent or Alternate Test
Procedures
0 Instrument Selection and Use
0 Calibration and Standardization
0 Preventive and Remedial Maintenance
0 Replicate Sampling
0 Blind and Spiked Samples
0 Colocated Samplers
0 QC Procedures, such as intralaboratory and intrafield
activities and interlaboratory and interfield activities
0 Documentation
0 Sample Custody
0 Transportation
0 Safety
0 Data Handling Procedures
0 Service Contracts
0 Measurement of Precision, Accuracy, Completeness,
Representativeness and Comparability
0 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
requirements for all monitoring programs, repetitive tests
and measurements and for inspection and maintenance of
facilities, equipment and services.
The organization's QA office will assist in the prepara-
tion, 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.
10
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 10 of 21
8.0 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 collection, validation, storage,
transfer and reduction. Those offices operating Automated Data
Processing and computer systems for data processing must describe
their systems' operations and documentation. Specific instruc-
tions 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 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 arr
admissable 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
11
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 11 of 21
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, completness, representa-
tiveness and comparability. The QA program must require that
data be accompanied by a calculation of precision and accuracy.
Where appropriate, a statement on the completeness, representa-
tiveness, and comparability also should be included.
10.0 Corrective Action
Each QA program plan will include provisions for establish-
ing and maintaining QA reporting or feedback channels to the
appropriate management authority to ensure that early and
effective corrective action can be taken when data quality falls
below required limits. The QA program plans also must include
provisions to keep responsible management informed of the
performance of all data collection systems and will describe the
mechanism(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
12
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 12 of 21
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
schedule. An example of the QAMS implementation schedule is
shown in the Table on page 13.
13
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 13 of 21
IMPLEMENTATION REQUIREMENTS AND SCHEDULE
Requirement
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
By Whom
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
Date
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
POs, ROs, Labs 10-1-80
and Continuing
*Regions and ORD have already designated QA Officers.
14
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 14 of 21
SPECIFIC GUIDANCE
Technical details and other information on 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
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 Ill—Stationary Source
Specific Methods
August 1977
Traceability Protocol for
Establishing True Concentrations of
Gases Used for Calibration and
Audits of Air Pollution Analyzers
Protocol Number2, 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
Federal Register
Volume 44, 27604
EPA-600/4-79-019
Ambient Air Quality Monitoring,
Reporting, and Surveillance
Provisions
May 10, 1979
Handbook for Analytical Quality
Control in Water and Wastewater
Laboratories
March 1979
Data
15
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 15 of 21
EPA-600/4-78-017
EPA-600/4-75-008
NTIS-PB-253258/AS
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
Procedures for the Evaluation of
Environmental Monitoring
Laboratories
March 1978
Interim Radiochemistry Methodology
for Drinking Water
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 ana Effluents
July 1973
Handbook for Analytical Quality
Control in Radio-Analytical
Laboratories
August 1977
Quality Control for Environmental
Measurements CJsing 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
16
-------
Environmental
Toxicology
Division, Health
Effects Research
Laboratory, U.S.
EPA, Research
Triangle Park, NC
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 16 of 21
Analysis of Pesticide Residues in
Human and Environmental Samples—A
Compilation of Methods Selected for
Use in Pesticide Montoring Programs
Other guidance documents for the development and implementa-
tion of the mandatory QA program are available from QAMS. These
include:
QAMS-001/80
Stragegy for the Implementation of
the Environmental Protection
Agency's Mandatory Quality Assurance
Program
March 11, 1980
QAMS-002/80
QAMS-003/80
Guidelines and Specifications for
Implementing Quality Assurance
Requirements for SPA Contracts and
Interagency Agreements Involving
Environmental Measurements
May 19, 1980
Guidelines and Specifications for
Implementing Quality Assurance
Requirements for EPA Grants and
Cooperative Agreements Involving
Environmental Measurements
September 30, 1980
QAMS-004/80
QAMS-005/80
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
17
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 17 of 21
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
18
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 18 of 21
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 indepen-
dently"1^for comparison with routinely
obtained data in a measurement system, or (2)
systems audits of a qualitative nature that consist
of an on-site review of a laboratory's quality
assurance systems and physical facilities for
sampling, calibration and measurement.
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
relationship 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, property,
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-
anticipated 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, representa-
tiveness, and comparability. These characteristics
are defined as follows:
19
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 19 of 21
0 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
difference as a percentage of the reference or
true value, 100 (X-T)/T, and sometimes expressed
as a ratio, X/T. Accuracy is a measure of the
bias in a system.
0 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*"
0 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 conditions.
0 representativeness - the degree to which data
accurately and precisely represent a
characteristic of a population, parameter
variations at a sampling point, or an
environmental condition.
0 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'
techniques 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, physical, or biological
parameters in the environment; determining the
presence or absence of priority pollutants in waste
streams; health and ecological effect studies;
clinical and epidemiological investigations;
engineering and process evaluations; studies
20
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 20 of 21
involving laboratory simulation of environmental
events; and studies or measurements of 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 relationship
is the transfer of money, property, services/ or
anything of value to the State or local government
or other recipient in order to accomplish a public
purpose of support or stimulation 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
Government; and (2) no substantial involvement is
anticipated between the executive agency, acting for
the Federal Government, and State or local
government or other recipient during performance of
the contemplated activity.
GRANTEE - any individual, agency, or entity which 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 planning, quality assessment, and quality
improvement efforts of various groups in an
organization to enable operations to meet user
requirements at an economical level. In pollution
measurement systems, quality assurance is concerned
with all of the activities that have an important
effect on the quality of the. pollution measure-
ments, as well as the establishment of methods and
techniques to measure the quality of the pollution
measurements. The more authoritative usages
differentiate between "quality assurance" and
"quality control," where quality control is the
system of activities to provide a "quality product"
and quality assurance is the "system of activities
to provide assurance that the quality control
system is performing adequately."
21
-------
Guidance for QA PROGRAM PLANS
Date: 9-20-80
Revision Number 2
Page 21 of 21
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 delineates 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
measurement methods; for example, a
service group might develop a plan by
instrument since the service is provided
of projects).
laboratory
analytical
to a number
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.
22
------- |