PbbJ- 17ot 1M
EPA-600/4-83-004
February 1983
INTERIM GUIDELINES AND SPECIFICATIONS FOR
PREPARING QUALITY ASSURANCE PROJECT PLANS
QAMS-005/80
Office of Monitoring Systems and Quality Assurance
Office of Research and Development
United States Environmental Protection Aqency
Washington, n.C. 20460
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TECHNICAL REPORT DATA
tf'lraic rroJ liiunii limn on Ihr m mr hrjn/r t'
si PORT NO
EPA-600/4-83-004
j TITLE AND SUBTITLE
Interim Guidelines and Specifications for
Preparing Quality Assurance Project Plans
7 AUTMOR(S)
Thomas W. Stanley & S. Sidney Verner
3 RECIP'E NT'S ACCESSION-NO.
PR* 3 1 7 0 3 1
5 REPORT DATE
February 1983
6. PERFORMING ORGANIZATION CODE
OER-QAMS
8. PERFORMING ORGANIZATION REPORT NO.
OER-QAMS-005/80
9. PERFORMING ORGANIZATION NAME AND ADDRESS
Office of Exploratory Research
RD - 675
Washington, D.C. 20460
10. PROGRAM ELEMENT NO.
11. CONTBACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS
Office of Exploratory Research
Office of Research and Development
U.S. Environmental Protection Aqency
Washington, DC 20460
13. TYPE OF REPORT AND PERIOD COVERED
14. SPONSORING AGENCY CODE
EPA/600/00
15. SUPPLEMENTARY NOTES
16. ABSTRACT
The Agency-wide quality assurance policy stipulates that every monitoring
and measurement project must have a written and approved Quality Assurance (QA)
Project Plan. This applies to extra-mural as well as internal projects. All
successful applicants for financial assistance must therefore prepare and
submit a Quality Assurance Project Plan.
This document describes the sixteen elements which must be considered
for inclusion in all Quality Assurance Project Plans and establishes
criteria for plan preparation, review, and approval. All project plans
must describe procedures which will be used to document and report precision,
accuracy, representativeness, comparability, and completeness of environmental
measurements.
17.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b.lOENTIF IERS/OPEN ENDED TERMS C. COSATI I icId/Gro'Jp
Quality Assurance Guidelines
Projects Plans
Financial Assistance
Measurement and
Monitoring Activity
Data
13. DISTRIBUTION STATEMENT
EPA Form 2220-1 (9-73)
19. SECURITY CLASS (This Kepori)
21. NO, OF PACKS
35
20. SECURITY CLASS (This page!
22. PRICE
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INTERIM GUIDELINES AND SPECIFICATIONS FOR
PREPARING QUALITY ASSURANCE PROJECT PUNS
QAMS-005/80
Office of Monitoring Systems and Quality Assurance
Office of Research and Development
United States Environmental Protection Agency
Washington, D.C. 20460
December 29, 1980
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ACKNOWLEDGEMENTS
This document has been prepared by the Quality Assurance Manage-
ment Staff of the Office of Research and Development in cooperation
with Systems, Science and Software of San Diego, California. We grate-
fully acknowledge the assistance of Mr. Darryl von Lehmden of the
Environmental Monitoring and Systems Laboratory of Research Triangle
Park, North Carolina. The assistance of the Agency's Quality Assurance
Officers in reviewing the document and providing comments during its
generation is also gratefully acknowledged.
DISCLAIMER
Mention of trade names or commercial products does not consti-
tute EPA endorsement or recommendation for use.
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ABSTRACT
The Agency-wide quality assurance policy stipulates that every
monitoring and measurement project must have a written and approved
Quality Assurance (QA) Project Plan. A QA Project Plan is a written
document, which presents, in specific terms, the policies, organization
(where applicable), objectives, functional activities, and specific QA
and quality control (QC) activities designed to achieve the data qual-
ity goals of a specific project(s) or continuing operation(s). The QA
Project Plan is required for each specific project or continuing oper-
ation (or group of similar projects or continuing operations). The QA
Project Plan will be prepared by the responsible Program Office,
Regional Office, Laboratory, contractor, grantee, or other organization.
This document describes the sixteen elements which must be con-
sidered for inclusion in all Quality Assurance Project Plans, and es-
tablishes criteria for plan preparation, review and approval. All QA
Project Plans must describe procedures which will be used to document
and report precision, accuracy and completeness of environmental mea-
surements.
n
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CONTENTS
Section
Pages
Revision
Date
ABSTRACT
1.0 INTRODUCTION
2.0 DEFINITION, PURPOSE, AND SCOPE
2.1 Definition
2.2 Purpose
2.3 Scope
3.0 PLAN PREPARATION AND
RESPONSIBILITIES
3.1 Document Control
3.2 Elements of a QA Project Plan
3.3 Responsibilities
4.0 PLAN REVIEW, APPROVAL AND
DISTRIBUTION
5.0 PLAN CONTENT REQUIREMENTS
5.1 Title Page
5.2 Table of Contents
5.3 Project Description
5.4 Project Organization and
Responsibility
5.5 QA Objectives for Measurement
Data in Terms of Precision,
Accuracy, Completeness,
Representativeness, and
Comparability
5.6 Sampling Procedures
5.7 Sample Custody
1
1
2
3
1
18
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CONTENTS (Continued)
Section
Pages
Revision Date
6.0
5.8 Calibration Procedures and
Frequency
5.9 Analytical Procedures
5.10 Data Reduction, Validation
and Reporting
5.11 Internal Quality Control
Checks
5.12 Performance and System Audits
5.13 Preventive Maintenance
5.14 Specific Routine Procedures
Used to Assess Data Precision,
Accuracy and Completeness
5.15 Corrective Action
5.16 Quality Assurance Reports to
Management
QUALITY ASSURANCE PROJECT PLANS
VERSUS PROJECT WORK PLANS
7.0 STANDARD OPERATING PROCEDURES
8.0 SUMMARY
REFERENCES
APPENDICES
A Glossary of Terms
1
2
1
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2
4
4
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IV
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Section No. ]_
Revision No. 4
Date: December 29, 1980
Page 1 of 1
1.0 INTRODUCTION
Environmental Protection Agency (EPA) policy requires participa-
tion by all EPA regional offices, program offices, EPA laboratories and
States in a centrally-managed quality assurance (QA) program as stated
in the Administrator's Memorandum of May 30, 1979. This requirement
applies to all environmental monitoring and measurement efforts man-
dated or supported by EPA through regulations, grants, contracts, or
other formalized means not currently covered by regulation. The re-
sponsibility for developing, coordinating and directing the implementa-
tion of this program has been delegated to the Office of Research and
Development (ORD), which has established the Quality Assurance Manage-
ment Staff (QAMS) for this purpose.
Each office or laboratory generating data has the responsibility
to implement minimum procedures which assure that precision, accuracy,
completeness, and representativeness of Its data are known and docu-
mented. In addition, an organization should specify the quality levels
which data must meet in order to be acceptable. To ensure that this
responsibility is met uniformly across the Atjency, each EPA Office or
Laboratory must have a written QA Project Plan covering each monitoring
or measurement activity within its purview.
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Section No. 2
Revision No. 4
Date: December 29, 1980
Page 1 of 2
2.0 DEFINITION, PURPOSE AND SCOPE
2.1 Definition
*»
QA Project Plans are written documents, one for each specific
project or continuing operation (or group of similar projects or con-
tinuing operations), to be prepared by the responsible Program Office,
Regional Office, Laboratory, Contractor, Grantee, or other organiza-
tion. The QA Project Plan presents, in specific terms, the policies,
organization, objectives, functional activities, and specific QA and
quality control (QC) activities designed to achieve the data quality
goals of the specific project(s) or continuing operation(s). Other
terms useful in understanding this document are defined in Appendix A.
2.2 Purpose
This document (1) presents guidelines and specifications that
describe the 16 essential elements of a QA Project Plan, (2) recom-
mends the format to be followed, and (3) specifies how plans will be
reviewed and approved.
2.3 Scope
The mandatory QA program covers all environmentally-related
measurements. Environmentally-related measurements are defined as all
field and laboratory investigations that generate data. These include
(1) the measurement of chemical, physical, or biological parameters in
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Section No. 2
Revision No. 4
Date: December 29, 1980
Page 2 of 2
the environment, (2) the determination of the presence or absence of
pollutants in waste streams, (3) assessment of health and ecological
effect studies, (4) conduct of clinical and epidemiclogical investiga-
tions, (5) performance of engineering and process evaluations, (6)
study of laboratory simulation of environmental events, and (7) study
or measurement on pollutant transport and fate, including diffusion
models. Each project within these activities must have a written and
approved QA Project Plan.
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Section No. 3
Revision No. 4
Date: December 29. 1980"
Page . i of 3
3.0 PLAN PREPARATION AND RESPONSIBILITIES
3.1 Document Control
All Quality Assurance Project Plans must be prepared - using a
document control format consisting of information placed in the upper
right-hand corner of each document page:
Section Number
e Revision Number
Date (of revision)
Page
3.2 Elements of QA Project Plan
Each of the sixteen - items listed below must be considered for
inclusion in each QA Project Plan:
(1) Title page with provision for approval signatures
(2) Table of contents
(3) Project description
(4) Project organization and responsibility
(5) QA objectives for measurement data in terms of precision,
accuracy, completeness, representativeness and comparability
(6) Sampling procedures
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Section No. 3
Revision No. 4
Date: December 29, 1980
Page 2 of 3
(7) Sample custody
(8) Calibration procedures and frequency
(9) Analytical procedures
(10) Data reduction, validation and reporting
(11) Internal quality control checks and frequency
(12) Performance and system audits and frequency
(13) Preventive maintenance procedures and schedules
(14) Specific routine procedures to be used to assess data pre-
cision, accuracy and completeness of specific measurement
parameters involved
(15) Corrective action
(16) Quality assurance reports to management
It is Agency policy that precision and accuracy of data shall be
assessed on all monitoring and measurement projects. Therefore, Item
14 must be described in all Quality Assurance Project Plans.
3.3 Responsibilities
Intramural Projects - Each Project Officer working in close co-
ordination with the QA Officer is responsible for the preparation of a
written QA Project Plan for each intramural project that involves
environmental measurements. This written plan must be separate from
any general plan normally prepared for the project (see caveat pre-
sented in Section 6). The Project Officer and the QA Officer must en-
sure that each intramural project plan contains procedures to document
and report precision, accuracy and completeness of all data generated.
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Section No. 3
Revision No. 4
Date: December 29, 1980
Page 3 of 3
Fitramural Projects - Each Project Officer working in close co-
ordination with the QA Officer has the responsibility to see that a
written QA Project Plan is prepared by the extramural organization for
each project involving environmental measurements. The elements of the
QA Project Plan must be separately identified from any general plan
normally prepared for the project (see caveat presented in Section 6).
The Project Officer and the QA Officer must enrure that each extramural
project plan contains procedures to document and report precision,
accuracy and completeness of all data generated.
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Section No. *
Revision No. 4
Date; December 29, 1980
Page 1 of 1
4.0 PLAN REVIEW, APPROVAL AND DISTRIBUTION
Intramural Projects - Each QA Project Plan roust be approved by the
Project officer's immediate supervisor and the QA Officer. Completion
of reviews and approvals is shown by signatures on the title" page of
the plan. Environmental measurements may not be initiated until the QA
Project Plan has received the necessary approvals, unless emergency
response is necessary. A copy of the approved QA Project Plan will be
distributed by the Project Officer to each person who has a major
responsibility for the quality of measurement data.
Extramural Projects - Each QA Project Plan must be approved by the
funding organization's Project Officer and the QA Officer. In addi-
tion, the extramural organization's Project Manager and responsible QA
official must review and approve the QA Project Plan. Completion of
reviews and approvals is shown by signatures on the title page of the
plan. Environmental measurements may not be initiated until the QA
Project Plan has received the necessary approvals. A copy of the
approved QA Project Plan will be distributed by the extramural organi-
zation's Project Director to each person who has a major responsiblity
for the quality of the measurement data.
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Section No. 5
Revision No. 4
Date: December 29, 1980
Page 1 of 18
5.0 PLAN CONTENT REQUIREMENTS
The sixteen (16) essential elements described in this section must
be considered and addressed in each QA Project Plan. If a particular
element is not relevant to the project under consideration, a brief
explanation of why the element is not relevant must be included. EPA-
approved reference, equivalent or alternative methods must be used and
their corresponding Agency-approved guidelines must be applied wherever
they are available and applicable.
It is Agency policy that precision and accuracy of data shall be
assessed routinely and reported on all environmental monitoring and
measurement data. Therefore, specific procedures to assess precision
and accuracy on a routine basis during the project must be described in
each QA Project Plan. Procedures to assess data quality are being
developed by QAMS and the Environmental Monitoring Systems Support
Laboratories. Additional guidance can be obtained from QA handbooks
for air, water biological, and radiation measurements (References 1, 2,
3, 12, 17, and 18).
. -**
The following subsections provide specific guidance pertinent to
each of the 16 components which must be considered for inclusion in
every QA Project Plan.
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Section No. 5
Revision No. 4
Date: December 29, 1980
Page 2 of 18
5.1 Title page
At the bottom of the title page, provisions must be made for
the signatures of approving personnel. As a minimum, the QA
Project Plan must be approved by the following:
A. For intramural projects
1. Project Officer's immediate supervisor
2. QA Officer
B. For extramural projects
1. Organization's Project Manager
2. Organization's responsible QA Official
3. Funding organization's Project Officer
4. Funding organization's QA Officer
5.2 Table of Contents
The QA Project Plan Table of Contents will address each of
the following items:
Introduction.
A serial listing of each of the 16 quality assurance
project plan components.
o A listing of any appendices which are required to aug-
ment the Quality Assurance Project Plan as presented
(i.e., standard operating procedures, etc.).
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Section No. 5_
Revision No. 4
Date: December 29. 1980
Page 3 of 18
At the end of the Table of Contents, list the QAO and all
other individuals receiving official copies of the QA Project
Plan and any subsequent revisions.
5.3 Project Description
Provide a general description of the project, including the
experimental design. This description may be brief but must
have sufficient detail to allow those individuals responsible
for review and approval of the QA Project Plan to perform
their task. Where appropriate, include the following:
o Flow diagrams, tables and charts.
Dates anticipated for start and completion.
Intended end use of acquired data.
^
5.4 Project Organization and Responsibility
,M>
Include a table or chart showing the project organization and
line authority. List the key individuals, including the QAO,
who are responsible for ensuring the collection of valid
measurement data and the routine assessment of measurement
systems for precision and accuracy.
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Section No. 5
Revision No. 4
Date: December 29, 1980
Page 4 of 18
5.5 QA Objectives for Measurement Data in Terms of PrecisionT
Accuracy, Completeness, Representativeness, and Comparability
For each major measurement parameter, including all pollutant
measurement .systems, list the QA objectives for precision,
accuracy and completeness. These QA objectives will be sum-
marized in a table. (See Table 1 for example of format.)
All measurements must be made so that results are representa-
tive of the media (air, water, biota, etc.) and conditions
being measured. Unless otherwise specified, all data must be
calculated and reported in units consistent with other organ-
izations reporting similar data to allow comparability of
data bases among organizations. Definitions for precision,
accuracy and completeness are provided in Appendix A.
Data quality objectives for accuracy and precision estab-
lished for each measurement parameter will be based on prior
knowledge of the measurement system employed and method vali-
dation studies using replicates, spikes, standards, calibra-
tions, recovery studies, etc, and "the requirements of the
specific project.
5.6 Sampling Procedures
For each major measurement parameter(s), including all pol-
lutant measurement systems, provide a description of the sam-
pling procedures to be used. Where applicable, include the
following:
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Table 1
EXAMPLE OF FORMAT TO SUMMARIZE PRECISION, ACCURACY AND COMPLETENESS OBJECTIVES
Measurement Parameter
(Method)
(Chemi luminescent)
S02 (24 hr)
(Pararosanlllne)
Reference
EPA 650/4-75-011
February 1975
EPA C50/4-74-027
December 1973
Experimental Conditions
Atmospheric samples
spiked with NO. as
needed
Synthetic atmosphere
* t
Precision,
Std. Dev.
<*10t
<120I
Accuracy
151
1151
Completeness
901
901
CW fu ($ ^5
»O rt- < O
n> n> -j« r+
o'
cr
ro
ro
vo
.
0*
en
CO
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Section No. 5
Revision No. 4
Date: December 29, 198(T
Page 6 of 18
Description of techniques or guidelines used to select
sampling sites.
Inclusion of specific sampling proceduresto be used (by
reference in the case of standard procedures and by
actual description of the entire procedure in the case
of nonstandard procedures).
o Charts, flow diagrams or tables delineating sampling
program operations.
A description of containers, procedures, reagents, etc.,
used for sample collection, preservation, transport, and
storage.
Special conditions for the preparation of sampling
equipment and containers to avoid sample contamination
(e.g., containers for organics should be solvent-rinsed;
containers for trace metals should be acid-rinsed).
Sample preservation methods and holding times.
Time considerations for shipping samples promptly to the
laboratory.
Sample custody or chain-of-custody procedures (to be
described later in this document).
Forms, notebooks and procedures to be used to record
sample history, sampling conditions and analyses to be
performed.
5.7 Sample Custody
Sample custody is a part of any good laboratory or field
operation. Where samples may be needed for legal purposes,
"chain-of-custody" procedures, as defined by the Office of
Enforcement, will be used. However, as a minimum, the fol-
lowing sample custody procedures will be addressed in the QA
Project Plans:
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Section No. 5
Revision No. 4 __
Date: December 29, 1980
Page 7 of 18
A. Field Sampling Operations:
e Documentation of procedures for preparation of
reagents or supplies which become' an integral
part of the sample (e.g., filters, and absorbing
reagents).
V
e Procedures and forms for recording the exact
location and specific considerations associated
with sample acquisition.
a Documentation of specific sample preservation
method.
Pre-prepared sample labels containing all infor-
mation necessary for effective sample tracking.
Figure 1 illustrates a typical sample label
applicable to this purpose.
Standardized field tracking reporting forms to
establish sample custody in the field prior to
shipment. Figure 2 presents a typical sample of
a field tracking report form.
B. Laboratory Operations:
e Identification of responsible party to act as
sample custodian at the laboratory facility
authorized to sign for incoming field samples,
obtain documents of shipment (e.g., bill of
lading number or mail receipt), and verify the
data entered onto the sample custody records.
Provision for a laboratory sample custody log
consisting of serially numbered standard lab-
tracking report sheets. A typical sample of a
standardized lab-tracking report form is shown
in Figure 3.
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Section No. b
Revision No. 4
Date: December 29, 1980
Page 8 of 18
(NAME OF SAMPLING ORGANIZATION)
SAMPLE DESCRIPTION
PLANT:
DATE:
TIME:
MEDIA:
SAMPLE TYPE:.
SAMPLED BY:.
SAMPLE ID NO.-
LAB NO.
LOCATION:.
STATION:
PRESERVATIVE:
ec.
tu
oc
Figure 1. Example of General Sample Label
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Section No. 5
Revision No. 4
Date: December 29, 1980
Page 9 of 18
H/O N'O.
FIELD '
FIELD SAMPLE CODS 1
(FSC) j
Page
BACKING REPORT:
(LOC-SN)
3?JSF DESCRIPTION
! 1
i i
1
1
1
!
.-.-
1
I
1
!
!
!
i
I
1
GATE
1
1
1
1
1
1
1
TIMS(s) SAMPLER
.
.
.
1
1
1"
1
1
1
Figure 2. Sample of Field Tracking Report Form
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Section No. 5
Revision No. 4
Date: December 29, 1980
Pa§e 10 of 18
W/O Mo.
EA8 TSAC3CIXG RESORT: - -
FRACTION
CODE
X
PRS?/ANAL
REQUIRED
i
1
.
'
(LOC-SN-FSC)
RESPONSIBLE
INDIVIDUAL
Page
^
DATS 1 DATE * .
DELIVERED j COMPLETED
1
1
i
i
-'
*
i
!
.
Figure 3. Sample of Lab-Tracking Report Form
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Section No. 5
Revision No. 4
Date: December 29, 1980"
Page IT of 18
Specification of laboratory sample custody pro-
cedures for sample handling, storage and dis-
persement for analysis.
Additional guidelines useful in establishing a sample custody
procedure are given in Section 2.0.6 of Reference JL, and
Section 3.0.3 of Reference 3, and References 13 and 14.
5.8 Calibration Procedures and Frequency
Include calibration procedures and information:
For each major measurement parameter, including all pol-
lutant measurement systems, reference the applicable
standard operating procedure (SOP) or provide a written
description of the calibration procedure(s) to be used.
List the frequency planned for recalibration.
List the calibration standards to be used and their
sources(s), including traceability procedures.
5.9 Analytical Procedures **
For each measurement parameter, including all pollutant mea-
surement systems, reference the applicable standard operating
procedure (SOP) or provide a written description of the ana-
lytical procedure(s) to be used. Officially approved EPA
procedures will be used when available. For convenience in
preparing the QA Project Plan, Elements 6, 8 and 9 may be
combined (e.g., Sections 5.6, 5.8 and 5.9).
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Section No. 5
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Date: December 29, 198CT
Page 12 of 18
5.10 Data Reduction, Validation and Reporting - For each major
measurement parameter, including all pollutant measurement
systems, briefly describe the following:
The data reduction scheme planned on collected data,
Including all equations used to calculate the concentra-
tion '-.or value of the measured parameter and reporting
units. ;
The principal criteria that will be used to validate
data integrity during collection and reporting of data.
The methods used to identify and treat outliers.
The data flow or reporting scheme from collection of raw
data through storage of validated concentrations. A
flowchart will usually be needed.
Key individuals who will handle the data in this report-
ing scheme (if this has already been described under
project organization and responsibilities, it need not
be repeated here).
5.11 Internal Quality Control Checks
Describe and/or reference all specific internal quality con-
trol ("internal" refers to both laboratory and field activi-
ties) methods to be followed. Examples of items to be con-
sidered include:
Replicates
e Spiked samples
Split samples
o Control charts
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Section No. 5
Revision No. 4
Date: December 29, 1980
Page 13 of 18
Blanks
» Internal standards
Zero and span gases
Quality control samples
Surrogate samples
Calibration standards and devices
Reagent.checks
Additional information and specific guidance can be found in
References 17 and 18.
Each project plan must describe the internal and external
performance and * systems audits which will be required to
monitor the capability and performance of the total measure-
ment system(s).
,**
The systems audit consists of evaluation of all components of
the measurement systems to determine their proper selection
and use. This audit includes a careful evaluation of both
field and laboratory quality control procedures. Systems
audits are normally performed prior to or shortly after
systems are operational; however, such audits should be
performed on a regularly scheduled basis during the lifetime
of the project or continuing operation. The on-site systems
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Section No. 5
Revision No. 4
Date: December 29, 1980
Page 14 of 18
audit may be a requirement for formal laboratory certifica-
tion programs such as laboratories analyzing public drinking
water systems. Specific references pertinent; to systems
audits for formal laboratory certification programs can be
found in References 19 and 20.
After systems are operational and generating data, perfor-
mance audits are conducted periodically to determine the
accuracy of the total measurement system(s) or component
parts thereof. The plan should include a schedule for con-
ducting performance audits for each measurement parameter,
including a performance audit for all measurement systems.
As part of the performance audit process, laboratories may be
required to participate in analysis of performance evaluation
samples related to specific projects. Project plans should
also indicate, where applicable, scheduled participation in
all other inter-laboratory performance evaluation studies.
In support of performance audits, the Environmental Monitor-
ing Systems/Support Laboratories ^provide necessary audit
materials and devices and technical assistance. Also, these
laboratories conduct regularly scheduled inter-laboratory
performance tests and provide guidance and assistance in the
conduct of systems audits. To make arrangements for assis-
tance in the above areas, these laboratories should be con-
tacted directly:
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Section No. 5_
Revision No. 4
Date; December Z9» 198IT
Page 15 of 18
Environmental Monitoring Systems Laboratory
Research Triangle Park, NC 27711
Attention: Dr. Thomas R. Hauser, Director
i
Environmental Monitoring and Support Laboratory
26 W. St. Clair Street
Cincinnati, OH 45268
Attention: .Mr. Robert L. Booth, Director
Environmental Monitoring Systems Laboratory
P.O. Box 15027
Las Vegas, NV 89114
Attention: Mr. Glen Schwitzer, Director
5.13 Preventive Maintenance
The following types of preventive maintenance items should be
considered and addressed in the QA Project Plan:
A schedule of important preventive maintenance tasks
that must be carried out to minimize downtime of the
measurement systems.
A list of any critical spare parts that should be on
hand to minimize downtime.
5.14 Specific Routine Procedures Used to Assess Data Precision.
Accuracy and Completeness
It is Agency policy that precision and accuracy of data must
be routinely assessed for all environmental monitoring and
measurement data. Therefore, specific procedures to assess
precision and accuracy on a routine basis on the project must
be described in each QA Project Plan.
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Section No. _
Revision No. 4
Date: December 29, 198(T
Page 16 of 18
For each major measurement parameter, including all pollutant
measurement systems, the QA Project Plan must describe the
routine procedures used to assess the precision, accuracy and
completeness of the measurement data. These procedures
should include the equations to calculate precision,.,accuracy
and completeness, .and the methods used to gather data for the.
precision and accuracy calculations.
Statistical procedures applicable to environmental projects
are found in References 1, 2, 3, 12, 17, and 18. Examples of
these procedures include:
e Central tendency and dispersion
- Arithmetic mean
- Range
- Standard deviation
- Relative standard deviation
- Pooled standard deviation
Geometric mean
Measures of variability
- Accuracy *"
- Bias
- Precision; within laboratory and
between laboratories
Significance test
u-test
- t-test
- F-test
- Chi-square test
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Section No. 5
Revision No. 4
Date: December zg» 1980
Pa9e 17 ofis
Confidence limits
Testing for outliers
t
Recommended guidelines and procedures to assess data
precision;-accuracy and completeness are being developed.
M
5.15 Corrective Action
Corrective action procedures must be described for each pro-
ject which include the following elements:
The predetermined limits for data acceptability beyond
which corrective action is required.
Procedures for corrective action.
For' each measurement system, identify the responsible
individual for initiating the corrective action and also
the individual responsible for approving the corrective
action, if necessary.
Corrective actions may also be initiated as a result of other
QA activities, including: *-
(1) Performance audits
(2) Systems audits
(3) Laboratory/interfield comparison studies
(4) QA Program audits conducted by QAMS
A formal corrective action program is more difficult to
define for these QA activities in advance and may be defined
as the need arises.
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Section No. 5
Revision No. 4
Date: December 29, 1980
Page 18 of 18
5.16 Quality Assurance Reports to Management
t
QA Project Plans should provide a mechanism for periodic
reporting to management on the performance of measurement
systems and data quality. As a minimum, these reports should
include:.
Periodic assessment of measurement data accuracy, pre-
cision and completeness.
Results of performance audits.
Results of system audits.
Significant QA problems and recommended solutions.
The individual(s) responsible for preparing the periodic
reports should be identified. The final report for each pro-
ject must include a separate QA section which summarizes data
quality information contained in the periodic reports.
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Section No. 6
Revision No. 4
Date: December 29, 1980"
Page 1 of 1
6.0 QUALITY ASSURANCE PROJECT PLANS VERSUS PROJECT WORK PLANS
This document provides guidance for the preparation' of QA Project
Plans and describes 16 components which must be included. Histori-
cally, most project- managers have routinely included the majority of
these .16 elements in their project work plans. In practice, it is fre-
quently difficult to separate important quality assurance and quality
control functions and to isolate these functions from technical perfor-
mance activities. For those projects where this is the case, it is not
deemed necessary to replicate the narrative in the Quality Assurance
Project Plan section.
In instances where specific QA/QC protocols are addressed as an
integral part of the technical work plan, it is only necessary to cite
the page number and location in the work plan in the specific subsec-
tion designated for this purpose.
It must be stressed, however, that whenever this approach is used
a "QA Project Plan locator page" must be inserted into the project work
plan immediately following the table of contents. This locator page
must list each of the items required for the QA Project Plan and state
the section and pages in the project plan where the item is described.
If a QA Project Plan item is not applicable to the work plan in ques-
tion, the words "not applicable" should be inserted next to the appro-
priate component on the locator page and the reason why this component
is not applicable should be briefly stated in the appropriate subsec-
tion in the QA Project Plan proper.
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Section No.
Revision No. 4
Date; December 29. 1980
Page 1 of 2
7.0 STANDARD OPERATING PROCEDURES
t
A large number of laboratory and field operations can be standard-
ized and written as Standard Operating Procedures (SOP). When such
procedures are applicable and available, they may be incorporated into
the QA Project Plan by reference.
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 covered by SOP's.
Examples are:
General network design
Specific sampling site selection
Sampling and analytical methodology
Probes, collection devices, storage containers, and sample
additives or preservatives
Special precautions, such as heat, light, reactivity, combust-
ability, and holding times
Federal reference, equivalent or alternative test procedures
Instrumentation selection and use
Calibration and standardization
Preventive and remedial maintenance
Replicate sampling
Blind and spiked samples
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Section No. 7
Revision No. 4
Date: December 29, 1980
Page 2 of 2
Colocated samplers
QC procedures such as intralaboratory and intrafield activi-
ties, and interlaboratory and interfield activities
\
Documentation
Sample custody
Transportation
Safety
Data-handling procedures
Service contracts
Measurement of precision, accuracy, completeness, representa-
tiveness, and-comparability
Document control
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Section No. 8_
Revision No. 4
Date: December Z9. 1980
Page 1 of i
8.0 SUMMARY
Each intramural and extramural project that involves environ-
mental measurements must have a written and approved QA Project Plan.
All 16 items described previously must be considered and addressed.
Where an item is not relevant, a brief explanation of why it is not
relevant must be included. It is Agency policy that precision and
accuracy of data must be routinely assessed and reported on all
environmental monitoring and measurement data. Therefore, specific
procedures to assess precision and accuracy on a routine basis during
the project must be described in each QA Project Plan.
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Section No. References
Revision No. 4
Date: December 29, 1980
Page 1 of ^2~~
REFERENCES
1. Quality Assurance Handbook for Air Pollution Measurement Systems.
Volume I - Principle's"! EPA-600/9-76-005, March 1976.
2. Quality Assurance Handbook for Air Pollution Measurement Systems.
Volume II - Ambient Air Specific Methods'! EPA-600/4-77-027a, May
1977.
3. Quality Assurance Handbook for Air Pollution Measurement Systems.
Volume III - Stationary Source Specific Methods. EPA-600/4-77-
027b, August 1977.
4. Systems Audit Criteria and Procedures for Ambient Air Monitoring
Programs. Currently under development and available from address
shown in Reference 1 after July 1, 1980.
5. Techniques to Evaluate Laboratory Capability to Conduct Stack
Testing.~~
6. Performance Audit Procedures for Ambient Air Monitoring Programs.
Currently under development.
7. Appendix A - Quality Assurance Requirements for State and Local
Air Monitoring Stations (SLAMS).Federal Register, Vol. 44, No.
92, pp. 27574-81, May 10, 1979.
8. Appendix B - Quality Assurance Requirements for Prevention of
Significant Deterioration I PSD) Air Monitoring, Federal Register.
Vol. 44, No. 92, pp. 27582-84, May 10, 1979.
9. Appendix E - Quality Assurance Requirements for Continuous
Emission Monitoring Systems (CEMS).To be submitted as a proposed
regulation to amend 40 CFR 60.
10. Test Methods for Evaluating Solid Waste - Physical/Chemical
Methods. EPA SW-846, 1980.
11. Quality Assurance Guidelines for IERL-CI Project Officers.
EPA-600/9-79-046. December 1979.
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Section No. References
Revision No. 4
Date: December 29, 1980
Page 2 of 2
12. Handbook for Analytical Quality Control in Water and Wastewater
Laboratories.EPA-600/4-79-019, March 1979.'
13. NEIC Policies and Procedures Manual. Office of ' Enforcement,
EPA-330-9-78-001, May 1978.
14. NPDES Compliance,- Sampling and Inspection Manual. Office of Water
Enforcement, .Compliance Branch, June 1977.
15. Juran, J. M. (ed), Quality Control Handbook. Second Edition,
McGraw Hill, New York, 1962.
16. Juran, J. M. and F. M. Gryna, Quality Planning and Analysis.
McGraw Hill, New York, 1970.
17. Handbook for Analytical Quality Control and Radioactivity
Analytical Laboratories.EPA-600/7-77-088, August 1977.
18. Manual of Analytical Quality Control for Pesticides and Related
Compou.ids in Human and Environmental Samples.EPA-600/1-79-008,
January 1979.
19. Procedure for the Evaluation of Environmental Monitoring
Laboratories. EPA 600/4-78-017, March 1978.
20. Manual for the Interim Certification of Laboratories Involved in
Analyzing Public Drinking Water Supplies - Criteria- -and
Procedures!EPA 600/8-78-008, August 1978.""""
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Section No. Appendix A
Revision No. 4
Date: December 29, 1980
1 of 5
APPENDIX A
GLOSSARY OF TERMS
AUDIT:
A systematic check to determine the quality of operation of some
functon or activity. Audits may be of two basic types: (1) per-
formance audits in which quantitative data are independently ob-
tained for comparison with routinely obtained data in a measure-
ment system, or (2) system 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
measurement.
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, represen-
**tiveness, and comparability. These characteristics are defined
follows:
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Section No. Appendix A
Revision No. 4
Date: December 29, 1980
Page 2 of 5
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 dif-
ference 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.
Precision - a measure of mutual agreement among individ-
ual measurements of the same property, usually under pre-
scribed similar conditions. Precision is best expressed
in terms of the standard deviation. Various measures of
precision exist depending upon the "prescribed similar
conditions."
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.
Representativeness - expresses the degree to which data
accurately and precisely represent a characteristic of a
population, parameter variations at a sampling point, a
process condition, or an environmental condition.
Comparability - expresses the confidence with which one
data set can be compared to another.
DATA VALIDATION
A systematic process for reviewing a body of data against a
set of criteria to provide assurance that the data are ade-
quate for their intended use. Data validation consists of
data editing, screening, checking, auditing, verification,
certification, and review.
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Section No. Appendix A
Revision No. 4
Date: December 29. 1980
Page 3 of 5
ENVIRONMENTALLY RELATED MEASUREMENTS:
A term used to describe essentially all field and laboratory
investigations that generate data involving (1) the measure-
ment of chemical, physical, or biological parameters in the
environment, (2) the determination of the presence or absence
of criteria or priority pollutants in waste streams, (3)
assessment of health and ecological effect studies, (4) con-
duct of clinical and epidemiological investigations, (5) per-
formance of engineering and process evaluations, (6) study of
laboratory simulation of environmental events, and (7) study
or measurement on pollutant transport and fate, including
diffusion models.
PERFORMANCE AUDITS:
Procedures used to determine quantitatively the accuracy of
the total measurement system or component parts thereof.
QUALITY ASSURANCE:
The total integrated program for assuring the reliability of
monitoring and measurement data. A system for integrating
the quality planning, quality assessment, and quality
improvement efforts to meet user requirements.
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Section No. Appendix A
Revision No. 4
Date: December 29, 1980
Page 4 of 5
QUALITY ASSURANCE PROGRAM PLAN:
An orderly assemblage of management policies, objectives,
principles, and general procedures by which an 'agency or
laboratory outlines how it intends to produce data of known
and accepted.quality.
QUALITY ASSURANCE PROJECT PLAN;
An orderly assembly of detailed and specific procedures which
delineates how data of known and accepted quality data is
produced for a specific project. (A given agency or labora-
tory would have only one quality assurance program plan, but
would have a quality assurance project plan for each of its
projects.)
QUALITY CONTROL:
The routine application of procedures for obtaining pre-
. scribed standards of performance in the monitoring and mea-
surement process.
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Section No. Appendix A
Revision No. 4
Date: December 29, 1980
Page 4 of 5 ~
QUALITY ASSURANCE PROGRAM PLAN:
An orderly assemblage of management policies, objectives,
principles, and general procedures by which an agency or
laboratory outlines how it intends to produce data of known
and accepted.quality.
QUALITY ASSURANCE PROJECT PLAN:
An orderly assembly of detailed and specific procedures which
delineates how data of known and accepted quality data is
produced for a specific project. (A given agency or labora-
tpry would have only one quality assurance program plan, but
would have a quality assurance project plan for each of its
projects.)
QUALITY CONTROL:
The routine application of procedure^ for obtaining pre-
. scribed standards of performance in the monitoring and mea-
surement process. :
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Soctiori II'.'- _A?2
Rev i s i on f.'o."
Date;: Jfi-^?^''^_
Pays s" o
STANDARD OPERATING PROCEDURE (SOP):
t
A written document which details an oper? -.nt analysis or
action whose rr.achanisms era thoroughly pre-.ribed and. which
is ccnsuonl.y accepted as the method for performing certain
routine or repetitive tasks.
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