United States
Environmental Protection
Agency
Office of Radiation Programs
(ANR-459)
EPA/520/1-89-030
October 1989
Quality Assurance Program
Plan of the Office of
Radiation Programs
\
Prinltd on Recycled Paper
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OCT 51989
AIR AND RADIATION
MEMORANDUM
SUBJECT: Office of Radiation Programs Quality Assurance
Program Plan
FROM: Lewis Battist, Quality -Agi^ance OfTlcei
Office of Radiation Programs (ANR-461)
TO: ORP Staff
Quality Assurance (QA) of environmentally related
measurements and data is important to the success of the
Environmental Protection Agency's role to protect the
environment. The primary goal of the Agency QA program is to
ensure that all environmentally related measurement programs
supported by the EPA produce data of known quality. It is EPA
policy that all EPA organizational units ensure that data
representing environmentally related measurements are of known
quality, verifiable, documented, and defensible.
Quality Assurance is the management process used to ensure
compliance with Agency policy and attainment of Agency goals.
Quality Assurance should not be confused with Quality Control.
The attached Quality Assurance Program Plan is the formal
statement of the Office of Radiation Programs' (ORP) QA policy.
It sets forth the responsibilities for implmentation of QA within
the ORP, the QA requirements which must be met and the procedures
to follow. The plan is applicable to ORP, is contractors and its
grantees. The plan establishes a process to ensure that all
aspects of monitoring or measurement projects are carefully
defined, goals specified, and all methods and procedures defined
and approved before a project is begun. The plan applies to ORP
computer models as well as environmental measurement projects.
It requires that all computer models be audited. Until specific
procedures for audits are defined, individual project plans to
audit each model are to be prepared.
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The QA process begins with the establishment of Data Quality
Objectives (DQOs) for each project. After DOQs are approved a
Quality Assurance Project Plan (QAPjP) containing procedures and
methods designed to produce data which meets the DQO requirements
is prepared. After the QAPjP is approved the project may begin.
The development of DQOs and QAPjPs is essential to the success of
environmental measurement projects. The EPA Quality Assurance
Management Staff conducts training on DQOs and QAPjPs. Staff
members who may serve as decision makers or project officers
should attend these training classes.
The ORP Quality Assurance Project Plan is furnished to ORP
staff members to aquaint them with ORP QA policy and to assist
them in discharging their Quality Assurance responsibilities as
necessary.
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QUALITY ASSURANCE PROGRAM PLAN
OF THE OFFICE OF RADIATION PROGRAMS
Prepared By:
Lewis Battist, Ph.D.
Quality Assurance Officer
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Foreword
Quality Assurance is an essential element of reliable
environmental data. All data used by the Environmental
Protection Agency must be of known quality. The Office of
Radiation Programs' (ORP) Quality Assurance Program Plan is based
on the EPA QA policies and defines the roles, policies, and
procedures used by ORP. This document, the ORP Quality Assurance
Program Plan, states current philosophy and meets present ORP
needs. The plan is not static and will be changed as needed to
insure that measurements performed by or for ORP meet Agency data
quality requirements. Inquiries or comments on the plan should
be directed to Dr. Lewis Battist.
111
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Program Plan
QORP-001/88/1
Section l
Revision 3
Date: 05/29/89
Concurrences
(1) Name Lewis Battist
Title Quality^Assurance Officer
Signature ^>^L<
Phone 475-9644
Date
Approval For Implementation
(1) Name Richay J.
Title Pi
Signature
ijceJL^f Radiatio/ Programs
2/^/^x^-^7 Date _Jj
£
Concurrence - AA Level
(1) Name William G. Rosenberg
Title Assistant Administrator
fcu^-Air and Radiation
Signature
(7
Approval for Agency
(1) Name Stanley Blacker
Signature
Date
Title Director. Quality Assurance
Management Staff
Date
IV
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Foreword
Signature Page
Table of Contents
Table of Contents
Page
iii
iv
v
Section 1
Section 1.1
Section 1.2
Section 2
Section 2.1
Section 2.2
Section 2.3
Section 3
Section 3.1
Section 3.2
Section 3.2.1
Section 3.2.2
Section 3.3
Section 3.3.1
Section 3.3.2
Introduction
Background
Purpose
Quality Assurance Policy
Goals and Priorities
Data Measurement Requirements
Responsibilities
1
1
3
4
4
4
5
ORP Environmental Data Collection
Activities 7
Environmental Data Collection
Activity Program Types 7
Assessment Monitoring 7
Environmental Radiation Ambient
Monitoring System Program 7
Special Studies 8
New Monitoring Programs 9
Future Programs 10
Environmental Models 10
Section 4
Section 4.1
Section 4.1.1
Section 4.2
Quality Assurance Management
Responsibilities and Functions
Office Director and
Quality Assurance Officer
Quality Assurance Officer
Responsibilities
11
11
11
11
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Section 4.3
Section 4.4
Section 4.5
Section 4.6
Section 4.7
Section 4.8
Section
Section
Section
Section
Section
Section
5
5.1
5.2
5.2.1
5.2.2
5.3
Division and Facility
Director Responsibilities
Quality Assurance Coordinators
Project Officers
Communication
Program Assessment and Audit
Tracking Quality Assurance
Objectives
Personnel Qualifications
General
Quality Assurance Staff
Quality Assurance Officer
Quality Assurance Coordinators
Project Officers
Page
13
13
14
15
16
19
20
20
20
20
21
21
Section 6
Section 6.1
Section 6.2
Facilities, Equipment, Consumables
and Services 22
General 22
Facilities and Equipment 22
Section
Section
Section
Section
Section
Section
7
7.1
7.2
7.2.1
7.3
7.3.1
Section 7.3.2
Section 7.4
Section 7.4.1
Section 7.4.2
Data Generation 23
General 23
Data Quality Objectives (DQO's) 23
Establishing DQO's 24
Quality Assurance Project Plans 25
Contents of Quality
Assurance Project Plans 26
Environmental Model Project Plans 27
Standard Operating Procedures (SOP's) 28
QA SOP Policy 28
Establishment and Approval
of SOP's 28
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Page
Section 8
Section 9
Section 10
Data Processing
Data Quality Assessment
Corrective Actions
30
32
34
Section 11
Section 11.1
Section 11.2
Implementation Requirements and
Schedules
Milestones
Annual Resources
35
35
36
Section 12
Distribution
37
viq.
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Program Plan Section I
QORP-001/88/1 Revision 3
Date: 05/29/89
1 INTRODUCTION
1.1 BACKGROUND
The Environmental Protection Agency (EPA) needs accurate,
reproducible, and defensible data to evaluate environmental
conditions, to assess potential health hazards, and to insure
compliance with its orders and regulations. To achieve these
needs, data must be of known and desired quality. Each Program
Office is responsible for developing and maintaining a program
that insures the quality of its environmental measurement
programs. The requirements of each office are documented in its
Quality Assurance Program Plan. The Quality Assurance Management
Staff of the Office of Research and Development is responsible
for overseeing the Agency's Quality Assurance activities.
The EPA's Office of Radiation Programs (ORP) develops and
implements programs that include measurements of both ionizing
and nonionizing radiation. The largest continuing environmental
measurements program is called the Environmental Radiation
Ambient Monitoring System, a national network of sampling
stations for air particulates, precipitation, surface water, and
milk. Measurements are also made to evaluate and define methods
to mitigate high radon concentrations, to assist States to
evaluate the proficiency of suppliers who perform radon
monitoring, and to provide calibration assistance to States
and industry-
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Program Plan Section 1
QORP-001/88/1 Revision 3
Date: 05/29/89
Special studies are performed to evaluate radiologically
contaminated sites and facility effluents, to locate potentially
hazardous areas, and to support State programs. These programs
are conducted by the Office of Radiation Programs staff, or by
contractors, grantees, or cooperating agencies with Office of
Radiation Programs oversight.
The Office has historically had an excellent quality assurance
and quality control program. Other organizations have often
requested ORP advice in establishing Quality Assurance projects
and programs. The Performance Audit (Intercomparison) program
currently operated by the Office of Research and Development at
the Environmental Monitoring Systems Laboratory in Las Vegas
originated in what is now the Office of Radiation Programs. ORP
facilities in Montgomery and Las Vegas both have quality
assurance programs predating the formation of the Agency.
Pursuant to the Administrator's directives of May 30 and
June 14, 1979, this Quality Assurance Plan documents this
Office's quality assurance program for all monitoring and
measurement efforts performed directly, those supported by
contracts, or those required by Agency regulations.
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Program Plan Section 1
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Date: 05/29/89
1.2 PURPOSE
The plan contains: (1) a description of the program, (2)
required Agency procedures, and (3) policies and procedures
required to produce data of known and acceptable quality, i.e.,
in conformance with data quality objectives. The plan documents
responsibilities and the management structure for quality
assurance in the Office of Radiation Programs.
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Program Plan Section 2
QORP-001/88/1 Revision 3
Date 05/29/89
2 QUALITY ASSURANCE POLICY
2.1 GOALS AND PRIORITIES
The success of any measurement program depends upon the
implementation of a good Quality Assurance Program. ORP's policy
requires that all radiation measurement under its jurisdiction
shall produce data of known and specified quality. Each ORP
project shall include sufficient quality assurance to produce and
document adequate, valid data without the expenditure of
unnecessary resources.
It is also ORP's policy that all QA standards be regularly
monitored for adequacy.
2.2 DATA MEASUREMENT REQUIREMENTS
The basic measurement requirement is to produce scientifically
valid, defensible data of known and specified precision and
accuracy. The quality of data shall be defined in Data Quality
Objectives (DQO's) by the Senior Manager having management
oversight and responsibility for the project.
The production of satisfactory measurement data requires:
a. Establishment of Data Quality Objectives for the
analytical results required for decisionmaking (See Section 7.2).
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Program Plan Section 2
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Date: 05/29/89
b. A monitoring protocol capable of producing results adequate
for decision making. The design of the environmental monitoring
protocol will include the selection of monitoring locations, the
frequency of monitoring or sampling, the selection of measurement
parameters, and the acceptable accuracy and level of uncertainty
in the data. All of these aspects of a monitoring program are to
be designed to meet the established DQO's.
c. Appropriate methods to make accurate and precise
measurements.
d. Insure that all analytical and sampling data are properly
and completely processed.
e. Documentation that items a, b, c, and d are properly
designed and performed.
f. Documentation for the requirements and responsibilities
defined in Sections 4 through 11.
2.3 RESPONSIBILITIES
The Director, Office of Radiation Programs, is responsible for
ensuring that environmental measurements meet established Data
Quality Objectives. The Office Director has delegated the
responsibility for overseeing Quality Assurance activities to the
Quality Assurance Officer (QAO). This delegation includes all
areas covered by the Office of Radiation Programs' Quality
Assurance Program Plan. The Quality Assurance Officer is located
in the Economics and Control Engineering Branch, Analysis and
Support Division (ASD), ORP. An Assistant Quality Assurance
Officer (AQAO) is also located in this Branch.
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Program Plan Section 2
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ORP Division and Facility Directors have primary responsibility
for their measurement programs. Division Directors exercise this
responsibility through Project Officers who work with the ORP
Quality Assurance Officer. Each Facility Director appoints a
Quality Assurance Coordinator (QAC) to direct the Facility's
Quality Assurance Program. QAC's report directly to the Facility
Director on all QA matters, work with Facility Project Officers,
and provide liaison to the QAO.
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Program Plan Section 3
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Date: 05/29/89
3 ORP ENVIRONMENTAL DATA COLLECTION ACTIVITIES
3.1 ENVIRONMENTAL DATA COLLECTION ACTIVITIES
Environmental data collection activities include:
(1) special studies (termed assessment monitoring);
(2) trend and baseline monitoring; and (3) accident and
incident monitoring. Special studies may either support
regulatory efforts or be performed as a service to other
governmental, State, and Federal agencies. Future activities
will include monitoring for compliance with EPA/ORP radiological
regulations and standards.
3.2 ASSESSMENT MONITORING
3.2.1 Environmental Radiation Ambient Monitoring System (ERAMS)
Program
The ERAMS was originally established to monitor radioactive
fallout. ERAMS* now consists of a nationwide network of stations
that sample airborne particulates, rainfall, milk, surface and
drinking water. Airborne particulates are sampled continuously
and analyzed twice weekly- Milk samples from representative
*The detailed ERAMS sampling schedules and locations are
contained in the Environmental Radiation Data Reports, published
quarterly by the Eastern Environmental Radiation Facility, Office
of Radiation Programs, USEPA, Montgomery, Alabama.
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Program Plan Section 3
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producing areas are collected and analyzed monthly. Surface and
drinking water samples are collected at many locations and
analyzed quarterly-
The ERAMS program, though routinely used for trend and baseline
monitoring, serves an important assessment function especially
for emergencies involving the spread of radioactive material
contamination. During a radiological emergency, such as Three
Mile Island or Chernobyl, the frequency of sampling and analysis
can be increased and additional ERAMS standby stations activated.
The ERAMS program has an approved Quality Assurance Project Plan
and approved DQO's.
3.2.2 Special Studies
Special Studies include:
a. Analyses of samples supplied by States or others.
b. Studies performed for other Federal agencies. For example,
studies are performed by ORP for the Navy of harbors where
nuclear ships are serviced to determine if there has been any
radiological contamination. For these studies, the decisionmaker
(the Navy) only wants to determine if ship operations are
contaminating the harbor.
Special studies also include the collection of data to support
the development of regulations. Effluents from several types of
facilities that emit radioactive materials may require monitoring
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Program Plan Section 3
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for both the quantity and nature of these materials. Airborne
concentrations and potential deposition characteristics are among
the factors needed to support the regulatory development process.
Each such sampling and analytical program requires a Quality
Assurance Project Plan (QAPjP) for which specific Data Quality
Objectives are established. (See Sections 7.3 and 7.2).
3.3 NEW MONITORING PROGRAMS
Before undertaking any monitoring program, except those of a
research or feasibility nature, DQO's and a QAPjP must be
established. This insures that necessary thought has been given
to the project, that the project is property planned, and proper
lines of communications have been defined. Some difficulties in
defining DQO's may arise when a new monitoring program begins
because previously established DQO's are no longer applicable or
need to be adapted to new requirements. Changes to the DQO's
require approval of the decisionmaker and QAO. Required changes
must be made as soon as possible.
Among^ ORP's new monitoring programs are those concerned with
radon in homes, schools, and other buildings. Radon monitoring
presents several difficulties that, with the present
state-of-the-art, result in large uncertainties in the monitoring
data. The DQO's being established for these programs will
reflect these inherent problems and will be changed as more
monitoring experience is gained.
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Program Plan Section 3
QORP-001/88/1 Revision 3
Date: 05/29/89
3.3.1 Future Programs
In the future, compliance monitoring programs will be established
for the standards and regulations promulgated by
EPA/ORP. Among the standards and regulations for which
monitoring efforts may be considered are those under the Clean
Air Act, Uranium Mill Tailings Act, and the Atomic Energy Act,
(40 CFR 190). Future standards and regulations may also require
compliance monitoring. Wherever necessary QAPjP's will be
prepared before each compliance monitoring effort is undertaken.
3.3.2 Environmental Models
Within the Office of Radiation Programs environmental transport
computer models are frequently developed to estimate exposure to
radioactive materials, doses, and health risjcs when measurements
of such data cannot be made. Information derived from these
models creates the base of information upon which environmental
standards and guidelines are developed. These models are also
used to evaluate compliance with EPA standards. Because of the
importance of the information obtained from models it is
necessary that the quality of models which contribute to the
standard-setting process be assured and that the input data be
correct.
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Program Plan Section 4
QORP-001/88/1 Revision 3
Date: 05/29/89
4 QUALITY ASSURANCE (QA) MANAGEMENT
4.1 RESPONSIBILITIES AND FUNCTIONS
This section defines responsibilities assigned to ORP staff
engaged in quality assurance activities. In addition to these
specific responsibilities ORP personnel are required to insure
that data for which they are responsible complies with the ORP QA
requirements contained in the Quality Assurance Program Plan.
4.1.1 Office Director and Quality Assurance Officer
The Office Director has the overall responsibility for quality
assurance. The Director exercises this responsibility
principally through periodic reviews of the program. The
implementation of the QA Program is delegated to the Quality
Assurance Officer.
4.2 QUALITY ASSURANCE OFFICER'S RESPONSIBILITIES
The Quality Assurance Officer (QAO) is responsible for
implementing the Quality Assurance Program Plan. His specific
functions are to:
a. Develop, evaluate, and document quality assurance policy,
guidelines, and procedures,
b. Act as a source of information and liaison between ORP and
the ORD Quality Assurance Management Staff (QAMS); to oversee
quality assurance work in the ORP Facilities and with contractors
and grantees; and to advise program offices of QA requirements,
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Program Plan Section 4
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c. Advise, guide, and support training of Quality Assurance
Coordinators, Project Officers, and technical staff,
d. Inventory quality assurance requirements and procedures for
existing measurement programs and recommend any needed changes,
e. Review and approve all Quality Assurance Project Plans for
projects administered by ORP,
f. Audit the Quality Assurance programs of Divisions,
Facilities, and contractors and spot-audit the implementation of
quality assurance programs of selected measurement projects and
recommend corrective actions,
g. Submit an annual quality assurance report to QAMS through
the Office Director,
h. Assist in the preparation of DQO's, and
i. Review and approve any Standard Operating Procedure (SOP)
prepared in ORP.
The Assistant Quality Assurance Officer (AQAO) will assist the
QAO in document preparation, audits, information collection, and
act for the QAO in his absence.
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Program Plan Section 4
QORP-001/88/1 Revision 3
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4.3 DIVISION AND FACILITY DIRECTOR RESPONSIBILITIES
ORP Division and Facility Directors have primary responsibility
for their measurement programs including quality assurance.
Directors will not authorize projects, contracts, or interagency
agreements which do not have an approved Quality Assurance
Project Plan. Facility Directors shall appoint QAC's to oversee
the operation of their QA programs.
Facility and Division Directors are responsible for:
a. Establishing DQO's;
b. Approving new SOP's and revisions to SOP's, and for
conducting periodic (annual or more frequent) reviews of SOP's;
c. Ensuring that audits have been scheduled and are performed
at required intervals;
d. Taking needed corrective actions for problems encountered or
uncovered by QAC or QAO audits; and
e. Reviewing the results of the corrective actions to insure
that problems have been resolved.
4.4 QUALITY ASSURANCE COORDINATORS (QAC's)
Quality Assurance Coordinators oversee the quality assurance
activities at ORP Facilities. They serve as the contact between
the Quality Assurance Officer and Project Officers and other
technical staff. They assist Project Officers in establishing
quality assurance requirements and review and approve Quality
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Assurance Project Plans. They review the quality of data
produced by measurement projects and recommend any needed
corrective action to the Project Officer. QAC's report to the
QAO on QA operations semi-annually or when there are unusual QA
problems or unexpected difficulties in any aspect of the QA
program. QAC's perform system audits with quality control samples
(spikes, etc.), review results of intercomparison studies and
institute corrective actions when necessary.
4.5 PROJECT OFFICERS
Project Officers are responsible for the preparation of Quality
Assurance Project Plans. Plans prepared in Washington by Project
Officers or contractors are reviewed and approved by the Quality
Assurance Officer. At Facilities, plans prepared by Project
Officers or contractors are approved by the Quality Assurance
Coordinator or QA staff. The approved project plans are
submitted to the Quality Assurance Officer for review and
approval.
Project Officers are responsible for ensuring that Quality
Assurance requirements for each contract are clearly stated in
the Scope of Work; that the technical evaluation criteria of each
proposal includes an evaluation of the contractor's proposed
QAPjP; and that suitable weight is given to the evaluation of the
QA evaluation plan submitted by the contractor. Project Officers
will audit projects for conformance with the QAPjP, to identify
and correct problems, and to document the measurement quality
achieved on each project. They will report the project QA
results to the QAO semi-annually. All contract task and work
orders require QAO signature prior to submission. Project
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Program Plan Section 4
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Officers or Work Assignment Managers are responsible for
obtaining the QAO's approval. Task or work orders may not be
issued without QAO approval.
4.6 COMMUNICATION
The ORD Quality Assurance Management Staff (QAMS) coordinates the
Agency's Quality Assurance program. QAMS provides Quality
Assurance information, guidance, and policy through the Quality
Assurance Officer.
The Quality Assurance Officer maintains a file of material
provided by the QAMS. The Quality Assurance Officer's principal
line of communication is directly to Project Officers in
Washington and through the Quality Assurance Coordinators at the
Montgomery and Las Vegas Facilities. The Quality Assurance
Officer maintains contact with the Office Director and Division
and Facility Directors on matters involving QA within ORP.
Periodic briefings, discussions and annual reports by the Quality
Assurance Officer on the status of the Quality Assurance program
are the QAO's principal communication link with the Office
Director. Special reports on the programmatic aspects of data
quality are made as the QAO or the Office Director deem
necessary.
QA reports, plans, and directives will be maintained under the
document control procedure described in EPA-600/9-76-005, Section
1.4.1. Document control procedures require that each page carry
a document number, revision number, date, and page number.
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Program Plan Section 4
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4.7 PROGRAM ASSESSMENT AND AUDIT
Effective management of the QA program requires periodic
assessment of data quality and functioning of the program. The
QAO and the Facility QAC's perform audits to ascertain that data
generated by the analytical and sampling programs meet the ORP
QA/QC requirements. Any problems found are to be addressed
immediately. Actions taken to correct problems and deficiencies
must be reviewed and documented. Several types of routine audits
are used to perform the periodic assessments.
The Project Officer will periodically audit the quality of the
data and the overall QA effort of each project to assure
conformance with the project plan (see Section 7.3). Audit
reports shall be made to the appropriate Division or Facility
Director and QAO. The Quality Assurance Officer or Quality
Assurance Coordinator will audit selected projects for compliance
with ORP Quality Assurance requirements.
The QAO will perform a Management Audit of each ORP Facility at
least annually.
The Management Audit is an essential part of Quality Assurance.
Management Audits will review Facility documentation, records,
and procedures, which demonstrate adherence to Agency and ORP QA
requirements. A review will be made of the procedures that lead
to the preparation of QAPjP's, contents of these plans, SOP's,
and the documentation and procedures used for approval. A part
of the Audit will evaluate the processes used to establish DQO's.
The Audit will insure that procedures for the internal management
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review process and reporting procedures are in place and
followed. The QAO may designate an alternate to conduct
Management Audits.
Contractors or grantees may be requested to demonstrate their
ability to conduct the required monitoring program. This
demonstration may include the analysis of quality control samples
as a performance and/or system audit, or a comparison of results
via interlaboratory control sample analyses. All programs and
contracts involving measurements shall be included in EPA
performance and system audits, interlaboratory comparisons, and
analysis and comparison with the ORD Environmental Monitoring
Systems Laboratory (EMSL) standards. Audits of contractors and
grantees will be made at least once during the period of the
contract or grant.
A Performance Audit evaluates the ability of a laboratory to
obtain data of known and required precision and accuracy.
Samples of known composition and concentration are provided to a
laboratory for analysis as blind samples. The analytical results
are reviewed. Specific accuracy and precision must be achieved
by the laboratory for the laboratory to be judged acceptable.
System Audits are similar to Performance Audits. Specific
samples of known concentration (spike samples), along with
samples of unknown concentration, are entered into the analytical
system to evaluate a particular analytic process for accuracy and
precision. Satisfactory completion of Performance Audits and/or
System Audits may be required before beginning work or award of a
contract or grant.
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Program Plan Section 4
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Project Officers, the Quality Assurance Officer, or the Quality
Assurance Coordinator, shall recommend corrective actions to
correct deficiencies found during Performance or System Audits.
They shall also evaluate the effectiveness of the corrective
actions. If corrective actions do not remove deficiencies, the
Quality Assurance Officer, or the Quality Assurance Coordinator,
may recommend to the Division or Facility Director that the
measurements be halted.
Computer models for assessment and evaluation of environmental
paramenters require a specialized and unique audit procedure.
These procedures will be defined in the Project Plan for the
model (See Section 7.3). An audit of each computer model will be
conducted by the Project Officer in accordance with the Project
Plan. The audit will be completed and approved by the ORP
Quality Assurance Officer before model outputs are used for
standard setting. Deficiencies noted in the audit and corrective
actions taken will be reported in the Audit Report. The Audit
Report will be furnished to the QAO for his review and approval.
Records of Quality Control checks taken to assure accuracy of
Computer model input data will be maintained in Project files.
The records will document any discrepancies found, causes for the
discrepancies, and corrective actions taken. The QAO or his
designated representative will periodically audit these records
to insure that proper corrective actions have been taken.
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Program Plan Section 4
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4.8 TRACKING QUALITY ASSURANCE ACTIVITIES
To date, there has not been a need to establish a management
tracking system for the development, implementation, review, and
revision for DQO's, QAPjP's, and SOP's. However, due to the
establishment of the Radon monitoring program and the increased
programmatic emphasis on QA, we plan to establish an automated
tracking system.
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Program Plan Section 5
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PERSONNEL QUALIFICATIONS
5.1 GENERAL
All personnel (ORP employees, contractors or others) working on
environmentally related measurements shall have appropriate
training and experience. Competency may be acquired through
formal education, on-the-job training, or experience. Division
and Facility Directors, working through their own organizations
and in consultation with the QAO, will evaluate the
qualifications of these personnel.
5.2 QUALITY ASSURANCE STAFF
5.2.1 Quality Assurance Officer (QAO)
The Quality Assurance Officer shall have a'broad technical
knowledge of the measurements made by or for ORP. He or she
should have experience with several types of these measurements
and education and training sufficient for an understanding of
other types of measurements. The QAO shall have been trained or
have experience in quality control and or quality assurance.
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Program Plan Section 5
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5.2.2 Quality Assurance Coordinators
Quality Assurance Coordinators shall have a general technical
understanding of the measurements used by or for their
organization. They should understand the statistical aspects of
Quality Control (QC) and Quality Assurance (QA). They should be
able to evaluate QAPjP's, SOP's, and the results of System and
Performance Audits.
5.3 PROJECT OFFICERS
Project Officers shall have a working knowledge of Agency Quality
Assurance requirements. They should be sufficiently familiar
with laboratory and related measurement techniques to develop
Quality Assurance Project Plans and make QA Performance Audits.
Project Officers should attend training programs to acquire and
maintain their QA skills.
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6 FACILITIES, EQUIPMENT, CONSUMABLES, AND SERVICES
6.1 GENERAL
The Project Officer is responsible for establishing and
evaluating the requirements for each project and the quality
assurance requirements for ORP-supported facilities, equipment,
consumables, and services. These requirements must appear in the
Quality Assurance Project Plan.
6.2 FACILITIES AND EQUIPMENT
Project Officers should evaluate the facilities used for
production of environmental measurement data. Attention will be
given to space, ventilation, and utility services. Electrical
supplies must be stable, and resistant to transients. Locations
where environmental samples are analyzed will be separate from
those where calibration standards are used. They shall also be
separate from areas where measurements are made on high activity
radioactive materials to reduce the chances of contamination.
Project Officers will evaluate the suitability of all measurement
equipment used for the project. The Quality Assurance program
will include requirements for equipment evaluation and preventive
maintenance. The QAC will retain equipment calibration and
maintenance records, records of QA inspections, and audit
records. The evaluation of facilities and equipment is
particularly important for work done by contractors. The Scope
of Work for all contracts will require prospective contractors to
submit records of equipment calibrations and tests.
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Program Plan
QORP-001/88/1
Section 7
Revision 3
Date: 05/29/89
7 DATA GENERATION
7.1 GENERAL
The most important management tool to insure the quality of data
generated in a measurement project are the QAPjP's. Each Project
Plan shall include steps to assure the production of
scientifically valid data. The data shall be defensible, of known
precision and accuracy, of acceptable completeness, and in a form
suitable for comparison with other measurement data and with
regulatory requirements. Wherever possible, calibrations shall
be traceable to the National Institute of Standards and
Technology (NIST) and validated through participation in
interlaboratory comparisons.
7.2 DATA QUALITY OBJECTIVES (DQO's)
Data Quality Objectives are "...statements of the level of
uncertainty that a Decisionmaker is willing to accept in results
derived from environmental data."* Included in DQO's are
specifications of the desired analytical accuracy and associated
errors. These specifications are necessary to establish the
DQO's. The DQO's are established prior to the preparation of the
QAPjP, which will define the analytical program required to meet
the DQO's.
The DQO's should include a clear statement of:
a. The decision required;
*The designation of the "Decisionmaker" is the responsibility
of the Director, ORP. It will depend upon who has the ultimate
responsibility for the project. There is no single designation
of the "Decisionmaker" within ORP.
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Program Plan Section 7
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Date: 05/29/89
b. The need for the data and the intended use of the data; and
c. A description of supporting data.
Guidelines which the Decisionmaker considers in establishing the
DQO's are presented in QAMS Quality Assurance and DQO courses.
The course manuals are available from the QAO.
Once established, DQO's need not be fixed or unyielding.
As a project progresses, the DQO's shall be reviewed and changed
to meet program or analytical requirements.
7.2.1 Establishing Data Quality Objectives (DQO's)
DQO's are established through iteration in a process involving
the technical and management staff and the Office Director or
their designee. The process involves consideration of several
factors which include the type of data sought, available
technology, cost tradeoffs, data timeliness, level of
uncertainty, data availability, and sampling design. These
factors do not constitute a complete list; however, they are
among the generic considerations used to establish DQO's. The
effort to establish DQO's is to be proportional to the
significance and magnitude of the project. The DQO process
should meet the needs and requirements of the project. The DQO
process is to be sufficiently flexible to permit matching of the
effort to the project.
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Program Plan Section 7
QORP-001/88/1 Revision 3
Date: 05/29/89
7.3 QUALITY ASSURANCE PROJECT PLANS (QAPjP's)
Each ORP measurement project, including those supported by
contract, interagency agreement, or grant shall have a Quality
Assurance Project Plan. The Project Plan is prepared to insure
that the analytical and sampling programs meet the required DQO's
that have been established for this project. The Project Plan
shall provide the following information*:
a. Experimental design,
b. Document sampling procedures and plans,
c. Specification of Data Quality Objectives,
d. Analytical and sample handling procedures,
e. Specific quality control procedures and frequency
employed,
f. Management and technical audits, and
g. Management reporting systems.
Precision shall be demonstrated by measurements on replicate
samples (including blinds and duplicates), reagent blanks, split
*Content, procedures, and instructions are contained in "Interim
Guidelines and Specifications for Preparing Quality Assurance
Project Plans", QAMS-005/80, QAMS, ORD, EPA, December 29, 1980.
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Program Plan Section 7
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Date: 05/29/89
samples, or co-located monitors or samplers. The Project Plan
shall require periodic checking of measurement devices for proper
operation and calibration. Precision is important in determining
the consistency and reliability of the method or instrument.
Each Quality Assurance Project Plan shall contain a means of
demonstrating the relationship of the reported data to the "true"
value or accuracy. To the extent possible, "true" values are
obtained by using radionuclides whose concentrations have been
certified by the National Institute of Science and Technology
(NIST) to calibrate instrumentation and measurement techniques.
The use of radioactive standards obtained from NIST or laboratory
who prepare secondary standards based on NIST standards are
termed "NIST-traceable".
7.3.1 Contents of Quality Assurance Prelect 'Plans (QAPjP's)
Each of the 16 items listed below must be included' in Quality
Assurance Project Plans:
a. Title page with provision for approval and
signatures;
b. Table of contents;
c. Project description;
d. Project organization and responsibility;
e. QA objectives for measurement data in terms of
precision, accuracy, completeness, representativeness, and
comparability;
f. Sampling procedures;
g. Sample custody;
h. Calibration procedures and frequency;
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Program Plan Section
QORP-001/88/1 Revision 3
Date: 05/29/89
i. Analytical procedures;
j. Data reduction, validation, and reporting;
k. Internal quality control checks and frequency;
1. Performance and System Audits and frequency;
m. Preventive maintenance procedures and schedules;
n. Specific routine procedures used to assess data
precision, accuracy and completeness of specific measurement
parameters involved;
o. Data Quality Assessment for precision and accuracy;
p. Corrective actions; and
q. Quality Assurance report to management.
If an item is not appropriate it may be omitted; however, the
reason for its omission shall be explained.
7.3.2 Environmental Model Project Plans
Quality Assurance Project Plans will be developed for all
computer models which contribute to the standard setting process,
These plans will include methods to:
a. Verify that the computer code correctly represents the
model's logic.
b. Verify that the computer code correctly implements the
model's mathematical operations.
c. Use Quality Control measures to insure the accuracy of
input data used by the model.
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Program Plan Section
QORP-001/88/1 Revision 3
Date: 05/29/89
7.4 STANDARD OPERATING PROCEDURES (SOP's)
7.4.1 OA SOP Policy
SOP's contain specific details and procedures which ensure that
data generated by their use will be satisfactory and adequate.
Examples of activities for which SOP's may be appropriate are
procedures for sampling, analysis, counting, calibration,
equipment inspection, and preventive maintenance. SOP's shall be
developed and used, wherever appropriate. They permit inclusion
of detailed procedures in Quality Assurance Project Plans by
reference.
Analytical and measurement procedures must provide results of
suitable quality for project needs. EPA approved analytical and
measurement procedures shall be used wherever feasible or
required. These procedures, if used, shall be designated as
SOP's and referenced by the appropriate SOP number. Any
procedure designated as an SOP shall have been tested and
verified as to accuracy, capability, and specified as to type of
sample, matrix, etc. for which it is applicable. SOP's will be
concurred in by ORP QAO.
7.4.2 Establishment and Approval of SOP's
The SOP's are procedures that have usually been developed and
employed over a period of time during which they have been
refined and proven valid. These procedures must be approved by
the Facility QAC's, and then by the Facility Director.
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Program Plan Section 8
QORP-001/88/1 Revision 3
Date: 05/29/89
Contractor laboratory SOP's are approved by contractor QA staff,
and forwarded to ORP project officer for concurrence. These
procedures then become part of the Facility, or contractor-
approved SOP's and can be incorporated in the QAPjP by reference.
EPA-approved procedures can be designated as SOP's.
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Program Plan Section 8
QORP-001/88/1 Revision 3
Date: 05/29/89
DATA PROCESSING
Data processing includes all the manipulations performed on raw
and processed data to change its form, its location, or its
quantity. Errors in the recording, reduction, calculation, and
transcription of data can result in the loss and the production
of flawed information. Each Quality Assurance Project Plan shall
include quality assurance for data processing. The Project Plan
shall include checks on:
a. Data collection, recording and entry.
b. Data Validation—Data shall be accepted or rejected based
upon criteria contained in the SOP's.
c. Data Transfers—Data transfers either manually or by
machine, including preparation of punched cards, conversion from
cards to tapes, and telemetering, shall include provisions for
error checking.
d. Data Storage—Data shall be securely stored to avoid
alteration or deletion. To prevent destruction or loss, backup
copies of important data should be kept separate from the
original data. Computer systems shall include provisions to
avoid the destruction or unwanted or unauthorized modification of
data.
e. Data Reduction—Data reduction includes calculation and
statistical analysis. Data reduction by computer shall be
documented and calculation procedures will be tested whenever
practical.
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Program Plan Section 8
QORP-001/88/1 Revision 3
Date: 05/29/89
f. Data Quality Assessments—Environmental measurements must
include data quality assessments (See Section 9.0).
Environmental databases must be capable of accepting, storing,
and retrieving these assessments with each measurement. The
assessments may be compressed into a directory that may be
automatically accessed during data retrieval. Guidelines for
assessments are contained in "Calculation of Data Quality
Indicators", Section 6.0, by James E. Longbottom and Paul W.
Britton of EMSL, Cincinnati, OH, August 15, 1983. A reference
copy is maintained by the QAO.
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Program Plan Section 9
QORP-001/88/1 Revision 3
Date: 05/29/89
DATA QUALITY ASSESSMENT
Generated and processed data should be assessed for completeness,
accuracy, precision, representativeness, and comparability to see
that it meets the needs expressed in the Quality Assurance
Project Plan, and the DQO's established for the project. DQO
requirements may be modified in the event analytical sensitivity
cannot be achieved. In that instance, data quality indicators
accepted by the scientific community for radiological
measurements, namely lower limits of detection (LLD) may be used;
however, the official who established the DQO's must approve the
use of these indicators.
a. The data from each monitoring project shall be frequently
compared with the Project Plan to ensure that the planned
measurements were obtained and the analytical results are in
accord with the objectives desired as stated by the DQO's. In
the event that the only analytical results obtained are stated as
LLD's the DQO's shall be immediately reviewed and new ones
established.
b. All measurements and data shall be "trackable" as to
analysis, receipt, handling, and analyst, including
identification of samples and, where necessary, identification of
instrumentation and equipment used.
c. The values obtained on known reference or spiked samples
shall be compared with the known values. EPA or other
intercomparison system or Performance Audit programs shall be
used to assess the facility's performance ability to obtain true
values; i.e., the accuracy of the method.
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Program Plan Section 9
QORP-001/88/1 Revision 3
Date: 05/29/89
d. The Project Plan shall require that the data be
representative of a locale or sampled media. Examples of
suitable evidence include reasons for selection of measurement
sites, descriptions of measurement sites, the basis for selection
of sampling or measurement frequencies, the method or methods of
homogenizing or mixing a sample or samples, and other sampling
conditions, as appropriate.
e. Each QAPjP shall contain procedures to ensure comparability
of data on the basis of consistency of reporting units,
standardized data format, and adequacy of procedures utilized.
The procedures may also include a demonstration that a particular
method used on two different media; e.g., water and soil, is
consistent from media to media in terms of results; i.e., percent
recovery in extractions, instrument response, etc.
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Program Plan Section 10
QORP-001/88/1 Revision 3
Date: 05/29/89
10 CORRECTIVE ACTION
Each Quality Assurance Project Plan includes provisions to
determine quickly the failure of data to meet the predetermined
quality levels. The routine internal quality control program
should detect degradation of component or system performance
before the data becomes unacceptable. The internal quality
control procedures are described in Section 9.
The Project Officer shall take necessary action to prevent the
generation of further inaccurate data, and to start procedures
for corrective action. He shall notify the Quality Assurance
Officer or Quality Assurance Coordinator, as well as the people
performing the measurements when problems arise. The Project
Officer, with the cooperation of the QAO or QAC, shall work with
the responsible measurement staff to correct the difficulty.
Persons recommending or taking corrective action should search
out the basic reason for the difficulty, and not merely take
actions that will correct the problem temporarily or
superficially. For example, difficulties with instruments may
originate in inadequate electrical supply or inadequate
grounding, rather than in the instrument. Corrective actions
shall be reported to the Project Officer and to the Quality
Assurance Officer or the Quality Assurance Coordinator. Facility
Directors or Division Directors are to be informed of any
problems that arise, corrective actions taken and the results of
these actions. Sampling and analytical programs are to cease if
corrective actions are not effective or the cause of problem
cannot be found.
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Program Plan
QORP-001/88/1
11 IMPLEMENTATION REQUIREMENTS AND SCHEDULES
Implementation of the ORP QA program will be
reported to QAMS in annual reports. Milestones
are given in Section 11.1.
Section 11
Revision 3
Date: 05/29/89
11.1 MILESTONES
MILESTONE
1. Revise Program Plans,
Project Plans, SOP's,
and other pertinent
program QA documents
2. Audit programs
a. ORP-LVF
b. EERF
c. Selected projects
3. QAC Report to QAO
4 . Prepare administrative guides
a. QA Project Plans
5. Review and revise technical guides
a. Internal Quality Control
b. Laboratory QC
6. Conduct training
a. ORP-LVF
b. EERF
7. Report to QAMS
DATE PLANNED
Continuous
Annual
Annual
Continuous
Semi-annual
As Needed
Continuous Laboratory
Responsibility.
To be Determined
Annually
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Program Plan Section 11
QORP-001/88/1 Revision 3
Date: 05/29/89
11.2- ANNUAL RESOURCES
Annual resources needed to accomplish the ORP QA program are
as follows:
1.0 person-years in ASD
l.2 person-years in EERF
0.3 person-years in LVF
0.3 person-years in RD
0.1 person-years in CSD
QA consultant, FTE 10 days
Travel, supplies, printing
Special laboratory cross-checks and intercomparisons
(Estimated at 1 percent of analytical workload)
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DISTRIBUTION
QAMS - Stanley Blacker, Director (RD-680)
ORP - Richard J. Guimond, Director (ANR-458)
CSD - J. William Gunter, Director (ANR-460)
ASD - David E. Janes, Director (ANR-461)
RD - Margo T. Oge, Director (ANR-464)
EERF - Charles R. Porter, Director
ORP/LVF - Wayne A. Bliss, Director
ORP/ASD/ECEB - Lewis Battist, QAO
ORP/ASD/ESSB - Philip Cuny, AQAO
Radiation Program Managers
Tom D'Avanzo
Paul A. Giardina
Jesse Baskerville
Charles Wakamo
Gary Gulezian
Gerald Fontenot
Carl Walter
Milton W. Lammering
Michael S. Bandrowski
Jerry Leitch
Quality Assurance Coordinators
Robert Lyon, ORP/LVF
James Moore, EERF
Project Officers - ORP
ORP Policies and Procedures
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