NCD980602163_19801229_Warren County PCB Landfill_SERB C_Interim Guidelines and Specifications for Preparing QAPPs-OCR

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INTERIM GUIDELINES AND SPECIFICATIONS FOR
PREPARING QUALI'IY ASSURANCE PROJECT PLANS
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
ACKNOWLEDGEMENTS
This document has been prepared by the Quality Assurance Management Staff or
the Office or Research and Development in cooperation with Systems, Science and
Software or San Diego, California. We gratefully acknowledge the assistance or Mr.
Darryl von Lehmden of the Environmental Monitoring and Systems Laboratory or
Research Triangle Park, North Carolina. The assistance or 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 constitute EPA
endorsement or recommendation for use.
i
ABSTRACT
The Agency-wide quality assurance policy stipulates that every monitoring and
measurement project must have~ 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 quality goals or a
specific· project(s) or continuing operation(s). The QA Project Plan is required for each
specific project or continuing operation (or group or 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 considered for
inclusion in all Quality Assurance Project Plans, and establishes 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 or
environmental measurements.
ii
CONTENTS
Section ~ Revision
ABSTRACT 1 4 12-29-80
1.0 INTRODUCTION 1 4 12-29-80
2.0 DEFINITION, PURPOSE
AND SCOPE 2 4 12-29-80
2.1 Definition 4 12-29-80
2.2 Purpose 4 12-29-80
2.3 Scope 4 12-29-80
3.0 PLAN PREPARATION & 3 4 12-29-80 RESPONSIBILITIES
3 .1 Document Control 4 12-29-80
3.2 Elements of a QA
Project Plan 4 12-29-80
3.3 Responsibilities 4 12-29-80
4.0 PLAN REVIEW, APPROVAL & DISTRIBUTION 1 4 12-29-80
5.0 PLAN CONTENT
REQUIREMENTS 18 4 12-29-80
5.1 Title Page 4 12-29-80
5.2 Table of Contents 4 12-29-80
5.3 Project Description 4 12-29-80
5.4 Project Organization and
Responsibility 4 12-29-80
5.5 QA Objectives for Measurement
Data in Terms of Perecision, Accuracy, Completeness,
Representativeness, and
Comparability 4 12-29-80
i ii
CONTENTS (Continued}
Section .!3ill Revision Dill
5.6 Sampling Procedures 4 12-29-80
5.7 Sample Custody 4 12-29-80
5.8 Calibration Procedures
and Frequency 4 12-29-80
5.9 Analytical Procedures 4 12-29-80
5.10 Data Reduction,
Validation&·
Reporting 4 12-29-80
5.11 Internal Quality
Control Checks 4 12-29-90
5.12 Performance & System
Audits 5 10-18-91
5.13 Preventive Maintenance 4 12-29-80
5.14 Specific Routine
Procedures Used to
Assess Data Precision,
Accuracy & Completeness 4 12-29-80
5.15 Corrective Action 4 12-29-80
5.16 Quality Assurance
Reports to
Management 4 12-29-80
6.0 QUALITY ASSURANCE PROJECT PLANS VERSUS PROJECT
WORK PLANS 1 4 12-29-80
7.0 STANDARD OPERATING
PROCEDURES 2 4 12-29-80
8.0 SUMMARY 1 4 12-29-80
REFERENCES 2 4 12-29-80
APPENDICES
A Glossary of Terms 5 4 12-29-80
iv
Section No. 1
Revision No. 4
Date: December 29, 1980
Page 1 or __.IL...-_
1.0 INfRODUCTION
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 as stated in the Administrator's Memorandum of May 30, 1979. This
requirement applies to all environmental monitoring and measurement efforts mandated or
supported by EPA through regulations, grants, contracts, or other formalized means not
currently covered by regulation. The responsibility for developing, coordinating and directing
the implementation of this program has been delegated to the Office of Research and
Development (ORD), which has established the Quality Assurance Management Staff (QAMS)
for this purpose.
Each office or laboratory generating data has the responsibility to implement minimum
procedues which assure that ·precision, accuracy, completeness, and representativeness of its
data are known and documented. 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 Agency, each EPA Office or Laboratory must have a written QA Project
Plan covering each monitoring or measurement activity within its purview.
2.0 DEFINITION, PURPOSE, AND SCOPE
2.1 Definition
Section No. 2
Revision No. 4
Date: December 29, 1980
Page 1 or 2
QA Project Plans are written documents, one for each specific project or continuing
operation ( or group of similar projects or continuing operations), to be prepared by the
responsible Program Office, Regional Office, Laboratory, Contractor, Grantee, or other
organization. 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) reconupends the format to be followed, and (3) specifies
how plans will be reviewed and approved.
Section No. 2
Revision No. 4
Date: December 29, 1980
Page 2 or 2
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 the environment, (2) the determination of the presence or absence of pollutants
in waste streams, (3) assessment of health and ecologtcal effect studies, (4) conduct of clinical
and epidemiological investigations, (5) perform~ce 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. Eash project within these activities
must have a written and approved QA Project Plan.
Section No. 3
Revision No. 4
Date: December 29, 1980
Page 1 or 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 comer of each document page:
• Section Number
• Revision Number
• Date ( of revision)
• Page
3.2 Elements or 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
(S) QA objectives for measurement data in terms of precision
accuracy, completeness, representativeness and comparability
(6) Sampling procedures
(7) Sample custody
(8) Calibration procedures and frequency
(9) Analytical procedures
Section No. 3
Revision No. 4
Date: December 29. 1980
Page 2 or 3
( 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
precision, 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 .illl Quality Assurance
Project Plans.
3.3 Responsibilities
Intramural Projects -Each Project Officer ·working in close coordination 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 presented in Section 6 ). The
Project Officer and the QA Officer must ensure that each intramural project plan contains
procedures to document and report precision, accuracy and completeness of all data generated.
Section No. 3
Revision No. 4
Date: December 29, 1980
Page 3 of 3
Extramural Projects -Each Project Officer working in close coordination 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 ensure that each extramural project plan contains procedures to document and report
precision, accuracy and completeness of all data generated.
Section No. 4
Revision No. 4
Date: December 29, 1980
Page_l_ or 1
4.0 PLAN REVIEW, APPROVAL AND DISTRIBUTION
Intramural Projects -Each QA Project Plan must 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 addition, 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 organization's Project Director to each person who has a major respons ibility for the
quality of the measurement data.
5.0 PLAN CONTENT REQUIREMENTS
Section No. 5
Revision No. 4
Date: December 29. 1980
Page 1 or 18
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
consideratio~ 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 whenever 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.
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 signatures of approving
personnel. As a minimu~ 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.
• A listing of any append-ices which are required to augment the Quality AMurance
Project Plan as presented (i.e., standard operating procedures, etc.).
Section No. S
Revision No. 4
Date: December 29. 1980
Page 3 or 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:
• Flow diagrams, tables and charts.
• Dates anticipated for start and completion.
• Intended end use of acquired data.
5.4 Project Organization and Responsibility
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.
Section No. 5
Revision No. 4
Date: December 29, 1980
Page _L of 18
S.S QA Objectives for Measurement Data in Terms of Precision,
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
summarized in a table. (See Table 1 for example of format.)
All measurements must be made so that results are representative 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 organizations 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 established for each measurement
parameter will be based on prior knowledge of the measurement system employed and method
validation studies using replicates, spikes, standards, calibrations, recovery studies, etc., and the
requirements of the specific project.
TABLE I
Section No. S
Revision No. 4
Date: December 29. 1980
Page ___L of 18
EXAMPLE OF FORMAT TO SUMMARIZE PRECISION, ACCURACY AND COMPLETENESS OBJECTIVES
Measurement Reference Experimental Precision Accuracy Completeness
Parameter Conditions Std. Dev.
(Method)
EPA 650/4-75-011 Atmospheric samples <± 10% ± s~ 90%
NO2 February 1975 spiked with NO2 as
(Chemiluminescent) needed
EPA 650/4-74-027 Synthetic <± 20% ± 15~ ~
December 1973 atmosphere
SOi (24hr)
(Pararosanillne)
5.6 Sampling Procedures
Section No. S
Revision No. 4
Date: December 29, 1980
Page-6_ or 18
For each major measurement parameter(s), including all pollutant measurement systems,
provide a description of the sampling procedures to be used. Where applicable, include the
following:
• Description of techniques or guidelines used to select sampling sites
• Inclusion of specific sampling procedures to be used (by reference in the case of
I
standard procedures and by actual description of the entire procedure in the case of
nonstandard procedures).
• Charts, flow diagrams or tables delineating sampling program operations.
• A description of containers, procedures, reagents, etc., used for sample collection,
preservation, transpo~ 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.
• Tune considerations for shipping samples promptly to the laboratory.
• Sample custody or chain-of-custody procedures (to be described later in this
document).
Section No. __.S"---_
Revision No. __._4 __
Date: December 29, 1980
Page 7 of 18
• 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 following sample custody procedures
will be addressed in the QA Project Plans:
A. Field Sampling Operations:
• Documentation of procedures for preparation of peagents or supplies which become
an integral part of the sample ( e.g., filters, and absorbing reagents).
• Procedures and forms for recording the exact location and specific considerations
associated with sample acquisition.
• Documentation of specific sample preseivation method.
• Pre-prepared sample labels containing all information 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.
Section No. _5 ___ _
Revision No. 4 -----Date: December 29, 1980
Page 8 of 18
B. Laboratory Operations:
• 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 st~dardized lab-tracking
report is shown in Figure 3.
(NAME OF SAMPLING ORGANIZATION)
SAMPLE DESCRIPTION --------------
PLANT: LOCATION: -----------------DATE:
TIME: MEDIA-:----------~s=T=A~T=I~O~N~:---------------SAMPLE TYPE: PRESERVATIVE SAMPLED BY: ----------
SAMPLE ID NO. :
LAB NO.
REMARKS: -------------------
Figure 1. Example of General Sample Label
W/0. No.
FIELD SAMPLE CODE
(FSC)
Section No. __ 5 __
Revision No. ____,4 ____ _
Date: December 29. 1980
Page 9 or 18
Page No. --FIELD TRACKING REPORT:
(FSC-SN}
BRIEF DESCRIPTION DATE TIME(s) SAMPLER
Figure 2. Sample of Field Tracking Report Form
W/O. No.
FRACTION X
CODE
Section No. _..._S ___
Revision No. 4 _....__
Date: December 29, 1980
Page __lD._ or ...... 1 ...... 8_
Page No.
LAB TRACKING REPORT:
(LOC-SN-FSC)
PREP/ANAL RESPONSIBLE DATE DATE
REQUIRED IN IVIDUAL DELIVERED COMPLETED
Figure 3. Sample of Lab-Tracking Report Form
Section No. ___ 5 __
Revision No. ___ 4 __
Date: December 29, 1980
Page _ll_ of _....,18..___
• Specification of laboratory sample custody procedures for sample handling,
storage and dispersement for analysis.
Additional guidelines useful in establishing a sample custody procedure are given in Section
2.0.6 of Reference 2, 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 pollutant measurement
systems, reference the applicable standard operating procedures (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 source(s), including
traceability procedures.
5.9 Analytical Procedures
For each measurement parameter, including all pollutant measurement systems, reference
the applicable standard operating procedure (SOP) or provide a written description of the
analytical 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).
Section No. _..._S __
Revision No. ___ 4 __
Date: December 29, 1980
Page ~ of ____ 1....,8_
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 concentration 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 reporting 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 control ("internal" refers to
both laboratory and field activities) methods to be followed. Examples of items to be
considered include:
• Replicates
• Spiked samples
• Split samples
• Control charts
• 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.
5.12 Performance and System Audits
Section 5,12
Revision No. _.._5 __
Date: October 18. 1991
Page _n_ of ___...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
measurement 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 audit may be a requirement for formal laboratory certification 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, performance 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 conducting 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.
Section No. _....,S __
Revision No. _..._4 __
Date: December 29, 1980
Page_!Lor_a_
In support of performance audits, the Environmental Monitoring 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
assistance in the above areas, these laboratories should be contacted directly:
Atmospheric Research and Exposure Assessment Laboratory
Research Triangle Park, NC 27711
Attention: Mr. Gary J. Foley
Environmental Monitoring and Systems Laboratory
26 West St. Clair Street
Cincinnati, OH 45268
Attention: Mr. Thomas A Clark, Director
Environmental Monitoring Systems Laboratory
P. 0. Box 93478
Las Vegas, NV 89193-3378
Attention: Mr. Robert N. Sneeling
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.
Section No. _..._S __
Revision No. _...,4 __
Date: December 29, 1980
Page -1L of____,18,.___
S.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.
For each major measurement parruueter, 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:
• Central tendency and dispersion
Arithmetic mean
Range
Standard deviation
Relative standard deviation
Pooled standard deviation
Geometric mean
• Measures or variability
Accuracy
Bias
Precision; within laboratory and
between laboratories
• Significance test
u-test
t-test
F-test
Chi-square test
• Confidence limits
• Testing ror outliers
Section No. _..._5 __
Revision No. _...,4 __
Date: December 29, 1980
Page _li_ or 18
Recommended pidelines and procedures to assess data precision. accuracy and
completeness are bein1 developed, ,
5.15 Corrective Action
Section No. _ _.._S __
Revision No. 4
Date: December 29. 1980
Page _rz_ or 18
Corrective action procedures must be described for each Project 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.
5.16 Quality Assurance Reports to Management
Section No. _ ...... S __
Revision No. ___ 4 __
Date: December 29. 1980
Page 18 of --"'-'18 __
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, precision 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 project must include a .separate QA section
· which summarizes data quality information contained in the periodic reports.
Section No. ___ 6 __
Revision No. _...,4 __
Date: December 29. 1980
Page _l_ or __._1 _
6.0 QUALI'IY 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. Historically, most project managers have
routinely included the majority of these 16 elements in their project work plans. In practice, it
is frequently difficult to separate important quality assurance and quality control functions and
to isolate these functions from technical performance 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 subsection 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 question, the words "not applicable" should be inserted next to the appropriate component on
the locator page and the reason why this component is not applicable should be briefly stated in
the appropriate subsection in the QA Project Plan proper.
Section No. ___ 7 __
Revision No. _..._4 __
Date: December 29, 1980
Page 1 or __ 2_
7.0 STANDARD OPERATING PROCEDURES
. A large number of laboratory and field operations can be standardized 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, combustability, 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
• Colocated samplers
• QC procedures such as intralaboratory and intrafield activities, and
interlaboratmy and interfield activities.
Section No. 7
Revision No. 4
Date: December 29, 1980
Page _L of .....L
• Documentation
• Sample custody
• Transportation
• Safety
• Data handling procedures
• Service contracts
.
• Measurement of precision, accuracy, completeness, representativeness, and
comparability
• Document control
8.0 SUMMARY
Section No. _..._8 __
Revision No. __ 4 __
Date: December 29. 1980
Page _.l_ of _l _
Each intramural and extramural project that involves environmental 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 accur~cy on a routine basis during the
project must be described in each QA Project Plan.
Section No. References
Revision No. _ _.4 __ _
Date: December 29. 1980 Page _L_ of _2 __
REFERENCES
1. Quality Assurance Handbook for Air Pollution Measurement Systems, Volume I-
Principles, 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. Ouality Assurance Handbook for Air Pollution Measurement Systems. Volume 111-
Stationazy Source Specific Methods. EPA-600/4-77-027b, August 1977.
4. Systems Audit Criteria and Procedures for Ambient Air Monitorin& Pro~ams. Currently
under development and available from address shown in Reference 1 after July 1, 1980.
5. Techniques to Evaluate Laboratocy Capability to Conduct Stack Testin&,
6. Performance Audit Procedures for Ambient Air Monitorin& ProK[ams. Currently under
development.
7. Appendix A -Quality Assurance Requirement Quality Assurance Requirements for State
amd Local Air Monitorin& Stations (SIAMS), Federal Register, Vol. 44, No. 92, pp. 27574-
81, May 10, 1979.
8. Appendix B-Ouality Assurance Requirements for Prevention of Si&Qificant Deterioration
(PSD) Air Monitorin&, Federal Register, Vol. 44, No. 92, pp. 27582-84, May 10, 1979.
9. Appendix E-Ouality Assurance Requirements for Continuous Emission Monitorin& Systems
(CEMS). To be submitted as a proposed regulation to amend 40 CFR 60.
10. Test Methods for Evaluatin& Solid Waste-Physical/Chemical Methods, EPA SW-846,
1980.
Section No. References
Revision No. _ _._4 __
Date: December 29, 1980
Page 2 or 2
11. Oualib' Assurance Guidelines for IERL-CI Project Officers,
EPA-600 /9-79-046. December 1979.
12. Handbook for Analytical Oualitt 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, Samplin1 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. Geyna,. Quality Plannin1 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 or Analytical Quality Control for Pestlddes and Related Compounds in Human
and Environmental Samples, EPA-600/1-79-008, January 1979.
19. Procedure for the Evaluation or Environmental Mon1torin1 Laboratories, EPA 600/4-
78-017, March 1978.
20. Manual tor the Interim Certincation or Laboratories Involved In Analyzin1 Public
Drinkl11 Water Supplies-Criteria and Procedures. EPA 600/8-78-008, August 1978.
APPENDIX A
GLOSSARY OF TERMS
AUDIT;
Section No. Appendix A
Revision No. 4
Date; December 22, 12so
Page_Lof_L
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 QJlantitative data
arc· independently obtained for comparison with routinely obtained data in a measurement
system, or (2) system audits of a Qllalitative nature that consist of an on-site review of a
laboratory's quality assurance system and physical facilities for sampling, calibration, and
measurement
DATA QUALI'IY;
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, representativness, and comparability. These characteristics are defined as
follows:
•
•
•
•
•
Section No. &lPeodix A
Date: December 29. 1980
Revision No. __ 4...___
Page ----2._ of _6 __
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.
Precision -a measure of mutual agreement among individual measurements of the same
property, usually under prescribed 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 arc adequate for their intended use. Data validation consists of
data editing. screening. checking. auditing, verification, certification, and review.
ENVIRONMENTALLY RELATED MEASUREMENTS;
Section No. Appendix A
Revision No. __ 4 __
Date: December 29, 1980
Page _l_ of _6 ____ _
A term used to describe essentially all field and laboratory investigations that
generate data involving (1) the measurement 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) conduct
of clinical and epidemiological investigations, (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.
PERFORMANCE AUDITS;
Procedures used to determine quantitatively the accuracy of the total
measurement system or component parts thereof.
OUALJTY ASSURANCE;
1be 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.