United States
Environmental Protection
Agency
Office of
Solid Waste and
Emergency Response
Publication 9240.1-01
EPA/540/R94/060
PB94-963416
December 1994
Superfund
EPA QUALITY MANAGEMENT PLAN
FOR THE
OFFICE OF EMERGENCY AND
REMEDIAL RESPONSE
REPRODUCED BY
U.S. DEPARTMENT OF COMMERCE
NATIONAL TECHN'CAL
INFORMATION SERVICE
SPRINGFIELD, VA 22161
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PB 94-963416
EPA/540/R94/060
9240.1-01
QUALITY MANAGEMENT PLAN
FOR THE
OFFICE OF EMERGENCY AND
REMEDIAL RESPONSE
DOCUMENT CONTROL NUMBER 9240.1-01
Prepared by
U.S. Environmental Protection Agency
Office of Emergency and Remedial Response
OS-200
401 M Street, SW
Washington, DC 20460
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PB 94-963416
EPA/540/R94/060
9240.1-01
NOTICE
Additional copies of this document may be obtained from the National Technical Information
Service (NTIS) at:
NTIS
5285 Port Royal Road
Springfield, VA 22161
Yj
V)
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OERR QA Plan
Table of Contents
Revision: 2
Date: 12/08/94
TABLE OF CONTENTS
Section Number and Title Page Number
1.0 IDENTIFICATIONS, CONCURRENCES, AND APPROVALS vii
2.0 INTRODUCTION 1
2.1 Scope and Purpose 1
2.2 Quality Assurance Approach 3
3.0 QUALITY ASSURANCE POLICY STATEMENT 5
4.0 MAJOR MISSION ELEMENTS REQUIRING QUALITY ASSURANCE 7
4.1 Office of Program Management 7
4.1.1 Environmental Data Collection Activities 10
4.1.2 Quality Assurance Practices 10
4.2 Hazardous Site Evaluation Division 10
4.2.1 Environmental Data Collection Activities 13
4.2.2 Quality Assurance Practices 14
4.3 Hazardous Site Control Division 14
4.3.1 Environmental Data Collection Activities 16
4.3.2 Quality Assurance Practices 16
4.4 Emergency Response Division 16
4.4.1 Environmental Data Collection Activities 17
4.4.2 Quality Assurance Practices 18
5.0 QUALITY ASSURANCE RESPONSIBILITIES AND MANAGEMENT 21
5.1 Office of Emergency and Remedial Response Director 21
5.2 Office of Emergency and Remedial Response Quality Assurance Manager 21
5.3 Office of Emergency and Remedial Response Division Directors 23
5.4 Office of Emergency and Remedial Response Quality Assurance Coordinators .... 23
5.5 Office of Emergency and Remedial Response Project Officers 24
5.6 Regional Project Officers 24
5.7 Regional Quality Assurance Managers 25
5.8 Other Superfund Quality Assurance Program Participants 25
6.0 DATA GENERATION AND MANAGEMENT .' 27
6.1 Regional Environmental Data Collection Activities 27
6.2 Extramural Environmental Data Collection Activities 27
6.3 General Quality Assurance Program Requirements 29
6.3.1 Data Quality Objectives 29
6.3.2 Quality Assurance Management Plan 30
6.3.3 Quality Assurance Project Plans 30
6.3.4 Computer Hardware and Software/Electronic Data Transfer 31
6.4 Standard Operating Procedures 31
6.5 Chain of Custody/Document Control Procedures 32
iii
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OERR QA Plan
Table of Contents
Revision: 2
Date: 12/08/94
TABLE OF CONTENTS (continued)
Section Number and Title Page Number
6.6 Data Quality Assessment 32
6.6.1 Data Review/Data Verification 32
6.6.2 Determination of Total Uncertainty 33
6.6.3 Data Useability Assessment/Data Validation 33
6.7 Agency Review of Contractor and State Performance 34
7.0 PROGRAM ASSESSMENT 35
7.1 Management Systems Reviews 35
7.1.1 Regional Management Systems Reviews 35
7.1.2 Contractor Evaluations 36
7.2 Audits of Data Quality 37
7.3 Technical Systems Audits 39
7.4 Performance Evaluations 39
7.5 Corrective Action System 39
8.0 ANNUAL PLANNING 41
9.0 TRAINING 43
APPENDIX A - Glossary of Terms and List of Acronyms
APPENDIX B - List of References
APPENDIX C - EPA Order 5360.1
IV
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OERR QA Plan
List of Exhibits
Revision: 2
Date: 12/08/94
LIST OF EXHIBITS
Exhibit Title Page Number
2-1 Superfund QA Organization 2
4-1 OERR Organization 8
4-2 OPM Organization 9
4-3 HSED Organization 12
4-4 HSCD Organization 15
4-5 ERD Organization 18
5-1 OERR QA Reporting Structure 21
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OERR QA Plan
List of Exhibits
Revision: 2
Date: 12/08/94
THIS PAGE LEFT INTENTIONALLY BLANK
VI
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1.0 IDENTIFICATIONS. CONCURRENCES. AND APPROVALS
Identifications and Concurrences:
OERR QA Plan
Section 1.0
Revision: 2
Date: 01/31/94
Page: 1 of 2
Duane A. Geuder
Quality Assurance Manager, Office of Emergency and Remedial Response
SIGNATURE
DATE
r
_ Henry L. Longest II
Director, pffjge_nf Emergencjtand Remedial Response
SIGNATURE
DATE
Deborah Dietrich
Director, Emergency Ri
SIGNATURE
Division
DATE
Larry Reed
Director,
DATE
SIGNATURE
DATE
VII
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OERR QA Plan
Section 1.0
Revision: 2
Date: 02/09/94
Page: 2 of 2
Tom Sheckells
Director, Office of Program Management
SIGNATURE DATE
Agency Approval:
Nancy Wentworth
Director, Quality Assurance Management Staff
SIGNATURE DATE
Mary Lou Melley
Quality Assurance Representative, Office of Solid Waste and Emergency Response
SIGNATURE DATE
Elliott P. Laws
Assistant Administrator, Office of Solid Waste and Emergency Response
SIGNATURE ' DATE
Gary J. Foley
Adtipg Assistant Administrator for Research and Development
SI
GNA1
via
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OERR QA Plan
Section 2.0
Revision: 2
Date: 12/08/94
2.0 INTRODUCTION
The EPA's Office of Solid Waste and Emergency Response (OSWER) has the authority under
Superfund to address threats to public health and the environment from improper disposal of hazardous
substances, and to ensure protection from these releases and potential future releases. Within OSWER, the
Office of Emergency and Remedial Response (OERR) is the National Program Office (NPO) responsible
for managing the Superfund program in accordance with the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and
Reauthorization Act (SARA) of 1986. In its capacity as Superfund NPO, OERR manages Superfund
response programs, develops policy, and manages budgetary resources. Several activities performed by
OERR in its role as the Superfund NPO include:
« Issuance of procedural, scientific, and technical regulations and guidance;
« Procurement, management, and oversight of in-house and extramural projects;
Oversight of Regional Superfund program implementation activities; and
Development and implementation of Superfund's quality assurance (QA) program for
environmental data collection activities (EDCAs).
EPA Order 5360.1, Policy and Program Requirements to Implement the Quality Assurance Program,
requires all NPOs to participate in a QA program and document their QA policies, responsibilities, and
procedures through a QA management plan (QAMP)1. This QAMP documents OERR's QA program for
Superfund EDCAs. It outlines the program's policies, requirements, organizational responsibilities, and
functional structure.
2.1 Scope and Purpose
The objectives of the OERR QA program are to: (1) ensure national consistency in the
implementation of the QA program for Superfund EDCAs; and (2) provide Superfund participants guidance
on QA activities required to promote the generation of data of known and documented quality with the end
result being data of the quality needed and claimed. The OERR QA program is applicable to all intramural
and extramural projects conducted by OERR in conjunction with the Regional Superfund offices, as well as,
other Superfund program participants that are involved in EDCAs. Exhibit 2-1 presents an overview of the
Superfund program participants and OERR's relationship in Agency QA activities. The dotted area
identifies OERR and its relationship to the Superfund QA program. Regional Superfund offices are
responsible for adhering to OERR QA requirements and developing Regional QAMPs that address Regional
programmatic needs. The Agency's Senior Council on Management Controls has concurred with the Office
of Research and Development (ORD) in identifying the lack of or incomplete QAMPs as an Agency-level
weakness in the Federal Managers' Financial Integrity Act (FMFIA) review process.
Both OERR and Regional offices are responsible for reviewing and evaluating Superfund QA
activities. OERR evaluates the implementation of the Superfund QA program on a national basis through
reports designed to assess Regional QA activities. These reports will contain summaries of numbers and
types of audits performed, audit findings, and corrective actions; and QA issues/problems. Once the reports
The Quality Assurance Management Staff has revised the terminology used for QA program and QA project plans. QA
program plans are now termed Quality Management Plans (QMPs) and QA project plans are abbreviated QAPP as opposed to
QAPJP.
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Exhibit 2-1
Superfund Quality Assurance Program
EM
ADMMNTRATOR
I
BMRONMENTAL
MUMTOflNO
$Y«TEM»
INVWION
J
AA/SOUO
WASTE AND
EMEROENCV
OSWER
OUAUTY
AMURANCE
REPRESENTATIVE
OFFICE OF
aouo
WASTE
OFFICE OF
WASTE
PROGRAMS
ENFORCEMENT I
OFFICE OF
MANAGEMENT
OA
OFFICER
HAZARDOUS
SITE
EVALUATION
DIVISION
OA
COORDINATOR
HAZARDOUS
SITE
CONTROL
DIVISION
QA
COORDINATOR
EMERGENCY
RESPONSE
DIVISION
QA
COORDINATOR
OFFICE OF
UNDERQROUNDl
STORAGE
TANKS
RCRA
ENFORCEMENT |
DIVISION
PROJECTOFFICERSAND
OUAUTY ASSURANCE
8/27/92
(28023-4
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OERR QA Plan
Section 2.0
Revision: 2
Date: 12/08/94
have been routinized the OERR QA Manager will evaluate all ten Regions' input, summarize into a National
picture for OERR Management, provide the summary to management, and initiate follow-up as required.
Regional offices evaluate the daily performance of site QA operations, including extramural activities
performed by contractors and states.
2.2 Quality Assurance Approach
EPA's QA program for environmental data collection is based on the fundamental principles of
Total Quality Management (TQM). OERR is responsible for tailoring principal elements of the Agency's
TQM policy to the Superfund QA program. Specific TQM components adopted for the OERR QA program
include:
Focus on the needs of internal and external clients. OERR internal clients include the divisional
and Regional offices. Congress and the general public are considered external clients. Currently,
OERR is in the process of developing mechanisms designed to improve long-term internal
communications. OERR has established a reporting structure, (see section 4.0), that will function
as a feedback mechanism for tracking the status of divisional and Regional QA activity, and
identifying areas in the program where additional guidance is required. A recent example of
service to all clients is the Superfund Accelerated Cleanup Model (SAC) initiative to reduce the
cost and time associated with Superfund activities, including environmental data collection.
Establish long-term commitments to the TQM process. OERR has accomplished this activity by
establishing a TQM steering committee, an internal communications task force, and a QA task
force. Quality action teams (QATs) have been formed to address critical quality issues in an
effort to improve the efficiency of products and processes. An example illustrating OERR's
application of the QAT process is in the development of a fact sheet (9200.2-16FS, Feb 93) on
Superfund QA requirements. This project was a collaborative effort between OERR divisions,
lead Regions and the OERR QA Manager.
Reliance on quality standards and measures of effectiveness. OERR is focusing its performance
measures on the identification of process improvements and not on the number of activities
conducted in support of the process. The Superfund Accelerated Cleanup Model (SACM) is
being used by OERR to evaluate the strengths and areas for improvement of the program, and to
evaluate and assess the effectiveness of past activities. OERR encourages Superfund program
participants to conduct management and systems reviews at the management and project levels as
an evaluation measure to assess the implementation and adequacy of the QA program.
Employee commitment and involvement. OERR has demonstrated its advocacy of the "bottom-
up" employee involvement philosophy through its staff participation in training courses and in
workgroups to formulate program policies and strategies. OERR is also encouraging more staff
members to participate in QAT leadership roles. Many of these groups have focused on EDCAs.
Within each division, OERR has identified QA coordinators, who will function as the focal point
for QA activities in their respective divisions, (refer to section 5.0). The QA coordinators should
function as liaisons between divisions and establish a QA network with the objective of improving
the QA program.
Training and employee career enhancement. A number of training activities are available to staff,
including: TQM training, career management workshops, and brown bag seminar series.
Headquarters and Regional contracts management training addresses implementation of QA
requirements for extramural projects. OERR also sponsors training through the CERCLA
Education Center which incorporates QA and EDCAs.
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OERR QA Plan
Section 2.0
Revision: 2
Date: 12/08/94
THIS PAGE LEFT INTENTIONALLY BLANK
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OERR QA Plan
Section 3.0
Revision: 2
Date: 12/08/94
3.0 QUALITY ASSURANCE POLICY STATEMENT
It is the policy of OERR that environmental data generated in support of Superfund activities be of
known and documented quality, and that they are adequate for the technical decisions to be made. This
objective is accomplished by satisfying requirements mandated by Agency policy and OERR QA protocol.
Elements of the OERR QA program include:
« Preparing and updating a QAMP based on guidelines established by QAMS;
Development of QA project plans (QAPPs) for projects involving environmental measurements;
Ensuring implementation of QA for contracts, cooperative agreements (CAs), and grants involving
EDCAs;
Conducting assessments of organizational units and projects;
Developing and adopting technical guidelines for determining data quality in terms of precision
(variability), bias (accuracy), representativeness, completeness, comparability, related meta-data,
uncertainty (both analytical and statistical), and useability as appropriate, and incorporating the
data quality objectives (DQOs) process in projects and tasks involving EDCAs;
Establishing achievable data quality limits for testing and analysis methods cited in regulations
based on results of methods evaluations arising from the methods standardization process;
Implementing response actions based on assessments performed as appropriate;
Reporting divisional and Regional QA activities at least annually to the OERR QA Manager.
These reports should include the status of divisional and Regional QA programs and address
corrective actions taken;
Facilitating appropriate QA training for all levels of management and staff involved in EDCAs;
and
Developing the QA annual report and work plan (QAARWP). The QAARWP is a combination
of an annual QA status report and QA work plan (see section 8 for a description of QAARWP
requirements).
Currently, the OERR QA Program strongly emphasizes the appropriate use and oversight of
Contractors per Agency Order 1900.2 (October 22, 1990). Specific contractor support is currently being
defined in Statements of Work and solicitations under the Long Term Contracting Strategy for Superfund
The OERR QA Manager continues to be involved with these activities providing technical review and
comment to the Project Officers. When the EPA Quality Management Tasks for Environmental Programs
(March 12, 1993) is promulgated as final, OERR will evaluate the document and apply its provisions as
appropriate.
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OERR QA Plan
Section 3.0
Revision: 2
Date: 12/08/94
THIS PAGE LEFT INTENTIONALLY BLANK
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OERR QA Plan
Section 4.0
Revision: 2
Date: 12/08/94
4.0 MAJOR MISSION ELEMENTS REQUIRING QUALITY ASSURANCE
OERR is responsible for providing oversight in the development and implementation of removal and
remedial response actions in support of Superfund. OERR is comprised of four divisions responsible for
providing support to Superfund in strategic program areas. Exhibit 4-1 presents the OERR organization.
The divisions include:
Office of Program Management (OPM) - Ensures Superfund resources are efficiently managed
and the program is effectively evaluated.
Hazardous Site Evaluation Division (HSED^ - Oversees Regional preliminary assessment (PA)
and site inspection (SI) activities; oversight to Contract Laboratory Program (CLP) and the non-
CLP tracking systems; hazard ranking listing; and toxics integration activities.
Hazardous Site Control Division (HSCD) - Manages the remedial response program. Remedial
actions are long-term responses that address persistent and complex problems. Remedial actions
are conducted at sites on the National Priorities List (NPL).
Emergency Response Division (ERD) - Manages the removal program and coordinates removal
actions associated with emergency responses. Removal actions are short-term in nature and can
be used whenever a hazardous substance response is required for immediate or emergency
situations.
These divisions collectively operate to fulfill OERR's Superfund responsibilities. Although OERR
generally does not conduct EDCAs itself, each division has a specific mission for addressing Superfund
activities that could involve EDCAs at the Regional level. The following sections discuss the mission and QA
activities of OPM, HSED, HSCD, and ERD.
4.1 Office of Program Management
OPM is responsible for the management of contract operations review and assessment, policy
analysis, management and systems development, program and systems development, and budgeting for
Superfund. Primary work areas include development of information systems, accounting procedures,
program planning, and evaluation measures. Activity areas associated with OPM include:
Providing QA management for OERR;
Establishing and communicating program management strategies;
Developing annual reports covering statutory activities and collection of program information;
Ensuring national consistency in the implementation of Superfund support programs and systems.
Exhibit 4-2 presents the organizational structure of OPM. OPM has developed comprehensive
systems for managing and tracking financial and technological data for selected Superfund activities.
Some of the activities currently undertaken by OPM include:
Developing systems to provide internal office information systems automation for Superfund data;
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Exhibit 4-1
Office of Emergency and Remedial Response
SPECIAL ASSISTANTS
Phyfft Andwion
(703)603-0783
I-
OFFICE OF THE MRECTOR
Henry L Longest. N. Director
Steve LutUg, Ad. Deputy Director
(703)603-8060
OUTREACH ft SPECIAL
PROJECTS STAFF
Cheryl Hawkins, Act. Dk.
(703)6034896
JL
OFFICE OF PROQRAM
MANAQEMENT
Thomas Sheckete, Dlredor
Suzanne Wste. Ad. Deputy Dlredor
(703)6034710
00
HAZARDOUS SITE
EVALUATION DIVISION
tarry Reed, Director
Sandra Lee. Deputy Director
(703)6034850
POLICY * CONTRACT
ASSESSMENT STAFF
Joan Barnes, Director
(703)6038720
MANAQEMENT
SYSTEMS STAFF
Mike Cutan. Dlredor
(703)6034730
PROGRAM
DEVELOPMENT4
BUDGET STAFF
David Evans, Dlredor
(703)6034750
PROGRAM MANAGEMENT
A SERVICE STAFF
Art Raks, Director
(703)6034740
SITE ASSESSMENT
BRANCH
Janet Qrubba.ChM
(703)6034860
ANALYTICAL
OPERATIONS BRANCH
Hint Crump-WlMTMr. CN«I
(703)6034880
TOXICS WTEORATION
BRANCH
Bruce Means. Acting Chief
(703)6034880
HAZARDOUS SITE
CONTROL DIVISION
Dave Dennett. Acting Dlredor
Paul Hadeau. Deputy Director
(703)6034800
SPECIAL PROJECTS
ft SUPPORT STAFF
Sue Sladek. Chief
(703)6034764
REMEDIAL OPERATIONS
ft GUIDANCE BRANCH
Bizabeh Shaw. Chief
(703)6034820
DESIGN ft CONSTRUCTION
BRANCH
John SmHh. Chief
(703)6034830
STATE ft LOCAL
COORDINATION BRANCH
EMERGENCY RESPONSE
DIVISION
Debbie Dietrich. Director
John RNey. Ad. Deputy Director
(703) 6034760
RESPONSE OPERATIONS
BRANCH
Mark Mjoness, Chief
(703) 6034770
RESPONSE STANDARDS
ft CRITERIA BRANCH
John Harris, Act Chief
(703) 6034780
OIL POLLUTION RESPONSE
ft ABATEMENT BRANCH
John Cunningham, ChUt
(703) 6034707
ENVIRONMENTAL
RESPONSE BRANCH
Murray Newton. Chief
(703)6034840
Joseph Lafomara, Chief
Royal Nadeau. Deputy
(908)3214740
3/4/94
128023-1
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Office of Program Management
(O
Office of Program Management
Thomas ShackaHt, Acting Director
Suzanne WaHa, Act Daputy Director
Kay Waters, Acting Special Assistant
(703) 6094710
1 1 1
Policy ft Contract
Aaaeeament Staff
Joan Barnes, Director
(703)603-8720
Policy Analyala
Section
Jim Fary, Chief
(703)6034899
Contracta Oversight
Section
Vacant
Management
Syetems Staff
Mika Cullan, Director
(703)603-8730
Headquarters Contract
~ Margrat Brown, Acting Chief
(703)6034876
a^nnrrilitfttlnn ^airtlmi
Maja Lee, Chief
(703)6034904
I
Program Development
& Budget Staff
David Evans, Director
(703) 603-8750
Section
Robin Nchardsor
(703)60349
Program Management
& Service Staff
Art Rate. Director
(703) 603-8740
I
gement
.Chief
12
Planning & Evaluation
Section
Jim McMttsteft Onto?
(703) 6034907
Customer Service
Section
Waft Johnson. Acting Chief
(703) 603-9089
a/27/82
128023-2
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OERR QA Plan
Section 4.0
Revision: 2
Date: 12/08/94
Developing life cycle management guidance;
« Advising OERR and Regional clients on database management procedures;
Advising OERR and Regional offices on the development and implementation of data
management plans; and
National program management data collection.
OPM is also responsible for data stewardship of Region-specific information. In this role, OPM
collects and archives environmental data from existing Superfund documents, such as records of decision
(RODs) into a national database and retrieves these data for statistical analysis purposes. OPM also
provides training on database management and consults on data management issues.
The OERR QA program is one of the systems OPM is responsible for evaluating and ensuring its
implementation is nationally consistent. Because of these specific responsibilities, the OERR QA Manager
has been located within OPM. The OERR QA Manager also functions as the Division QA Coordinator, and
must sign Quality Assurance Review Forms (QARFs) for all OERR funded extramural activities. These
include contracts, Grants, and interagency agreements. The solicitation/Grant cannot be completed without
a signed QARF. This process identifies all OERR extramural EDCAs which must have the appropriate QA
requirements in the solicitation or financial assistance agreement. The QA manager then works with the
project officers (and Region if appropriate) to develop said QA requirements.
4.1.1 Environmental Data Collection Activities
OPM does not participate in site-specific EDCAs and does not use Regional EDCAs for decision-
making purposes. As stated in the previous section OPM is responsible for data stewardship.
4.1.2 Quality Assurance Practices
OPM has established a QA system for managing its programmatic activities that embraces the
Agency's commitment to TQM. Currently OPM is improving the systems that ensure the efficient use of
Superfund program resources by OERR and Regional program offices. Specific activities include the
establishment of systems for communicating environmental improvements; development and revisions of
standard operating procedures (SOPs) for system administration; performing data entry, database
management, and data integrity, security, and retrievability in accordance with Office of Information and
Resources Management/General Services Administration (OIRM/GSA) guidelines; and performing
contractor performance evaluations. In addition, OPM provides regulatory and program management
guidance through Region, Headquarters, and contractor training programs and is an active participant in
third party independent testing for virus protection of Regional computers.
4.2 Hazardous Site Evaluation Division
HSED is responsible for assessing uncontrolled hazardous substance release sites and providing
technical information needed for Superfund cleanup activities. The Division is primarily responsible for
activities associated with the initial phases of Superfund's cleanup process, analysis and qualification of
environmental data, and site listing on the NPL. HSED conducts three basic programs: (1) site assessment,
which includes site inventory and discovery, PA and SI activities, federal facility evaluations, development of
10
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OERR QA Plan
Section 4.0
Revision: 2
Date: 12/08/94
NPL policies, hazard ranking, providing NPL updates, and performing pre-remedial contract management;
(2) analytical operations through the CLP, which includes monitoring analytical services and QA/quality
control (QC) activities, development and refinement of analytical protocols, and sample management and
coordination; (3) tracking non-CLP analytical services; and (4) coordination and guidance on health and risk
assessments and natural resource damage claims.
HSED is comprised of the Site Assessment Branch (SAB), the Analytical Operations Branch
(AOB), and the Toxics Integration Branch (TIB). Exhibit 4-3 presents the HSED organizational structure.
HSED provides and monitors resources required for sampling during Sis. This sampling may include
matrices such as groundwater, surface water, air, soil, sludge, and sediment. Results of these sampling
activities are used to support the inclusion of a site on the NPL or the identification of an emergency
situation. Data processed through the CLP also supports Superfund removal and remedial actions conducted
through Fund-, enforcement-, and state-lead activities.
The SAB is responsible for the oversight of investigations to evaluate the potential threat to human
health or the environment posed by uncontrolled hazardous substance release sites. The site assessment
process is initiated when a potential hazardous waste site is discovered and the National Response Center is
notified. The information pertaining to the site is then entered into the CERCLA Information System
(CERCLIS) where it can be used for purposes of tracking and evaluating Superfund program activities. SAB
provides support in the following areas:
Discovery and investigation of hazardous waste sites;
Site ranking by providing guidance for Hazard Ranking System (HRS) scoring and by ranking all
sites listed on the NPL; and
Development of the NPL, including proposing, listing, and delisting sites.
The AOB is responsible for providing and managing Superfund analytical services. The AOB
continually develops and improves analytical protocols and programs to meet Superfund requirements. The
AOB manages the CLP, which provides routine and specialized analytical services to support a variety of
Superfund sampling activities.
The AOB also designs method validation studies to verify the accuracy of new procedures. Other
specific responsibilities include:
Providing analysis of environmental samples through the CLP;
Developing data review guidance to promote consistent QA and data review for Superfund
analytical services;
Developing and validating analytical methods;
Conducting audits including laboratory and tape audits, data package audits, and evaluating
samples; and
Developing field analytical methods to streamline decision making at Superfund sites.
PE
11
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Exhibit 4-3
Hazardous Site Evaluation Division Organization
SITE ASSESSMENT
BRANCH
Janet Grubbs, Chief
(703) 603-8860
NPL CRITERIA SECTION
David Ouderklrk. Act. Chief
(703) 603-8721
SITE EVALUATION
SECTION
Steve Caldwell, Chief
(703) 603-8817
NPL OPERATIONS
SECTION
Robert Myers, Chief
(703) 603-8851
HAZARDOUS SITE
EVALUATION DIVISION
Larry Reed, Director
Sandra Lee, Deputy
(703) 603-8850
ANALYTICAL OPERATIONS
BRANCH
Hans Crump-Wlesner, Chief
(703) 603-8870
1
ANALYTICAL METHODS
IMPLEMENTATION
SECTION
Angeto Carasea, Chief
(703) 603-8870
REGIONAL OPERATIONS
SECTION
Howard Fribush, Chief
(703) 603-8831
ANALYTICAL SERVICE
GUIDANCE TEAM
Carlos Sands, Chief
(703) 603-8851
SPECIAL ASSISTANTS
Larry Zaragosa
Melissa Shapiro
1
TOXICS INTEGRATION
BRANCH
Bruce Means, Acting Chief
(703) 603-8880
HEALTH EFFECTS
SECTION
Jim Kooz, Act. Chief
(703) 603-8822
TOXICS INTEGRATION
PROGRAM
Vacant
3/4/94
(28023-6
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OERR QA Plan
Section 4.0
Revision: 2
Date: 12/08/94
The CLP involves numerous Agency programs, contractor laboratory facilities, and other groups
throughout the country. The CLP is used for routine high volume sample analysis requiring consistency of
methodology. Fast turnaround times and analysis of unusual matrices are obtained by using the Special
Analytical Services (SAS) option of the CLP.
The TIB is responsible for overseeing the Superfund risk assessment process. The TIB provides
guidance and technical assistance for health and environmental risk-related activities. In order to provide for
uniformity of risk assessments, TIB develops guidance (e.g., Risk Assessment Guidelines for Superfund and
Data Useability for Risk Assessment), fact sheets, and coordinates regular conference calls with Regional
Risk Assessors. While these steps are intended to provide direction for the preparation of risk assessments,
TIB has established a process for the review of the quality of risk assessments. In this process, a subset of
the risk assessments are reviewed for conformance with guidance. This information is used to assemble a
yearly report on the quality of risk assessments. TIB believes that this process is useful feedback that can be
used to make adjustments in guidance in order to provide for quality risk assessments. Several specific
responsibilities include:
Developing policies and procedures for OERR coordination with the Agency for Toxic Substances
and Disease Registry on programmatic and site-specific issues;
Developing policies and procedures for risk assessment guidance;
Developing protocols for the analysis of health and environmental risks at Superfund sites;
Developing and coordinating pilot programs for the cleanup of lead contaminated soil; and
Evaluating and revising health and ecological risk assessment policies and procedures.
4.2.1 Environmental Data Collection Activities
HSED is the primary supplier of analytical data through the CLP and is the secondary data user for
a number of Regional EDCAs. As a secondary data user, HSED does not second guess QA requirements
(per Regional DQOs) but generally uses available Regional data for QA oversight and management/budget
analyses. As a participant in the Superfund program, HSED is involved in a number of sampling and
analysis activities that use environmental data for decision-making purposes. Typical EDCAs associated with
the Division are provided as follows.
Sis use collected environmental data to define and further characterize site contamination. The
probability of the site being listed on the NPL is determined during this phase.
HRS scoring is performed to evaluate the relative threat to public health and the environment.
Environmental data are used to determine the rank of a site and the potential for placement on
the NPL.
. NPL listing and delisting involves utilization of the HRS score to determine the placement of a
site on or deletion from the NPL. The HSED QA team ensures that the evaluation is technically
accurate, legally defensible, and nationally consistent.
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Analytical services may be executed through either the CLP, which provides large volume
standardized analyses for Superfund, or through non-CLP services. HSED is also responsible for
providing oversight to the non-CLP tracking system.
Risk assessment activities use environmental data to assess conditions at Superfund sites to
determine the risk posed to public health and the environment.
4.2.2 Quality Assurance Practices
HSED promotes the Agency TQM policy and provides QA activities in its major mission programs
as identified earlier. In addition to the QA activities conducted at the branch and Regional levels, HSED
provides training to ensure that staff are cognizant of the policies and protocols required to meet OERR's
QA program requirements for data quality. Several of the major training programs offered within HSED
include: orientation training; site assessment and HRS training; CLP Analytical Results Data Base (CARD)
training; and risk assessment training.
4.3 Hazardous Site Control Division
The HSCD is responsible for managing and administering the Superfund remedial program in
conjunction with remedial investigation/feasibility studies (RI/FS), remedial design and construction, and
state and local government agency coordination. The Division is divided into three branches: Remedial
Operations and Guidance (ROGB), Design and Construction Management (DCMB), and State and Local
Coordination (SLCB). Exhibit 4-4 presents the HSCD organizational structure.
HSCD provides and monitors resources required to sample sites during remedial actions. Major
functional activities performed within HSCD include:
Regulation and policy development for the remedial selection process and QA/QC for the
remedial selection decision;
Technical evaluation and guidance development and establishment of environmental indicators and
public outreach programs;
Project support and Regional coordination for RI/FS, ROD, and post-ROD environmental
review;
Regional management, coordination, and training support for remedial design/remedial action
(RD/RA) projects preformed by EPA, states, and potentially responsible parties (PRPs); and
Development of short and long term strategies for state program development and participation.
Identifying applicable or relevant and appropriate requirements (ARARs) associated with
laboratory, site specific, and program compliance.
Remedial contracts and interagency agreements (US Army Corps of Engineers, Bureau of
Reclamation, etc.)
14
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Hazardous Site Control Division
8p«cW AMtotaM
QOOfQV AMOfBOfl
(703)603-6746
Remedial Operations
& Guidance Branch
Elizabeth Shaw, Chief
(703) 603-8820
Remedial Guidance
Section
David Cooper, Chief
(703) 603-8763
Remedial Operation
Section
Bruce Means, Chief
(703) 603-8848
Special Projects
& Support Staff
Sue Sladek, Acting Chief
(703) 603-8764
Hazardous Site Control
Division
Dav* Bennett. Acting Director
Paul Nadeau, Deputy Director
(703) 603-8800
Design & Construction
Management Branch
John Smith, Chief
(703) 603-8830
Remedial Action Contract
Section
Scott Fredericks, Chief
(703) 603-8771
Remedial Construction
Management Section
Tracy Hopkins, Chief
(703) 603-8788
State & Local
Coordination Branch
Murray Newton, Chief
(703) 603-8840
State Involvement
Section
Carolyn Offutt, Chief
(703) 603-8797
State Requirement
Section
William Ross, Chief
(703) 603-8779
3/4/94
(28023-5
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4.3.1 Environmental Data Collection Activities
EDCAs within HSCD are conducted at the Regional level. Samples are collected and analyzed in
conjunction with remedial activities. Environmental data may be used to support remedial action, litigation,
pre- or post-closure monitoring, and monitoring to determine the effectiveness of a remedy. Sampling and
analysis in support of these activities address all types of sample matrices encountered at a hazardous waste
site, including ground water, surface water, leachate runoff, air, soil, and sediment. For sampling specific to
RD/RA which involves EDCAs, appropriate QA/QC will be applied. Quality in the constructed project is
covered in 4.3.2.
4.3.2 Quality Assurance Practices
HSCD provides QA guidance to Regional Superfund program participants involved in EDCAs. QA
practices developed and implemented by the Division include:
Establishing communication between OERR, Regions, states, and contractors participating in
support of Divisional mission elements;
Training HSCD clients in the requisite QA activities to ensure the generation of data of known
quality;
Coordinating with the OERR QA Manager to establish QA priorities for implementing specific
Superfund QA program requirements;
Contracts and interagency agreement QA oversight;
Monitoring the internal HSCD QA program; and
Development of Data Quality objectives.
QA for RD/RA activities including oversight of actions performed by Potentially Responsible
Parties (EPA/540/G-90/001), Remedial Action Reports (pub. 9335.0-39Fs), and Quality in the
Constructed Project generally using Vol. 1 by the American Society of Civil Engineers as guidance.
4.4 Emergency Response Division
As manager of the Superfund removal program, ERD develops guidance procedures in response to
oil and hazardous substance releases and administers removal contracts. ERD provides contract support to
all phases of oil and hazardous substance removal activity and federally-financed underground storage tank
responses. The organizational structure for ERD is depicted in Exhibit 4-5. Through its Environmental
Response Team (ERT), ERD provides on-scene field support and technical expertise to the Regions. The
Team assists in planning and conducting field operations and investigations, with special emphasis on
application of new technology and equipment. Some major ERD functions include:
Maintaining an around-the-clock emergency response activation system;
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Assisting EPA Regional and program offices in responding to environmental emergencies and
uncontrolled oil and hazardous substance release sites;
Oil Pollution Act implementation;
Consulting on water and air quality criteria, health and safety protocols, ecological risk
assessment, interpretation and evaluation of analytical data, and engineering and scientific studies;
Development of Reportable Quantities for Hazardous Substances;
Providing technical expertise for SARA and Resource Conservation and Recovery Act (RCRA)
removal enforcement activities;
Developing technical manuals, policies, and SOPs for specialized equipment, computer systems,
and analytical processes; and
Managing the OSWER Integrated Safety and Health Program.
4.4.1 Environmental Data Collection Activities
EDCAs are performed at the Regional level with assistance from ERT. The ERT is a group of
scientists and engineers that provides 24-hour technical expertise. Depending on particular circumstances,
the ERT may include cleanup contractors. ERT supports the removal program by providing service to on-
scene coordinators (OSCs) and remedial project managers (RPMs). The data generated by ERT are used in
support of removal and remedial actions, immediate or emergency responses requiring rapid response action,
natural resource damage claims, enforcement support, and cost recovery actions. Data are generated by
ERT to determine the levels of threat sufficient to trigger a removal, the cleanup level, treatment and
disposal alternatives, and the level of safety equipment to be worn on site. In addition, sampling and analysis
of aqueous matrices, soil, sediment, sludge, and exposed or contained waste may be required at removal
sites.
4.4.2 Quality Assurance Practices
ERT provides Regional training courses for field operations that address SOPs and QA/QC
requirements. ERT monitors the effectiveness of the training programs by actively participating in field
activities. Regional offices responsible for performing EDCAs in support of the removal program receive
guidance from ERD (individual Regional QMPs may delegate responsibilites which have been defined in
Program Office guidance) in the following QA areas:
Developing site-specific QAPPs in conjunction with Regional OSCs. The responsibility for review
of the plans is delegated to the work assignment manager for technical review, and the OSCs are
responsible for Regional review of the plan prior to implementation. ERT participates in the
QAPP development process by providing input to the OSCs and conducting periodic audits of
selected QAPPs that have been approved by the OSC.
Auditing site-specific QAPPs for conformance with QAMS guidance. Review and approval of
final QAPPs is delegated to the Regional OSCs.
17
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Exhibit 4-5
Emergency Response Division
EMERGENCY RESPONSE DIVISION
Deborah Dietrich, Director
John Rltey. Acting Deputy Director
(703) 603-8760
Special Aeeletent
Janet Weiner
(703)603-8717
1 _L
Reeponee Operations
Branch
Mark MJonees, Chief
(703) 603-8770
Eastern Section
_. Patrida TWewel, Act Chief
(703) 603-8737
Western Section
- Patricia Hawkins, Act Chief
(703) 603-8716
Environmental Reeponee
Branch
Joseph Lafornara, Chief
Royal Nadeau, Deputy
(908)321-6740
«
Safety & Air
Surveillance Section
Rodney Turpin, Chief
(908)321-6741
Site Investigation
Section
George Prince, Chief
(908) 321-6649
Operations Section
Bruce Patoka, Chief
513)569-7537
Alternative recnnoiogy
Section
Andre Zbwr*. Chief
(908)321-6744
Contracts & Data
Management Section
1 , 1
Reeponee Standards &
Criteria Branch
John Harris. Act. Chief
(703) 603-8780
Reeponee Policy
Guidance & Support
Section
Elizabeth Zelter. Chief
(703) 603-8744
Response Regulations
Section
Geraln Perry, Chief
(703) 603-8732
Oil Pollution Response
& Abatement Branch
John Cummingham, Chief
(703) 603-8707
Oil Pollution
Prevention Team
~ Dana Stateup, Team Leader
(703) 603-8735
Oil Pollution Response
_ & Guidance Team
Karen Sahatjian, Team Ldr.
(703) 603-8724
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Providing Regional guidance on sampling and data validation. ERT has developed a guidance
document entitled, Quality Assurance/Quality Control Guidance for Removal Activities-Sampling
QA/QC Plan and Data Validation Procedures.
Training federal, state, and local government officials and private industry representatives in the
most recent hazardous substance response technology.
Establishing QA objectives for assessing and substantiating the collection of data to support its
intended use.
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5.0 QUALITY ASSURANCE RESPONSIBILITIES AND MANAGEMENT
OERR QA program goals are achieved through proper planning, organization, review,
communication of objectives, auditing, reporting, and corrective action. The QA program is administered for
the OERR Director by the QA Manager, in conjunction with the Divisions. The following subsections
present the organizational structure and associated QA responsibilities in the OERR QA program. The
reporting mechanism for this program is depicted in Exhibit 5-1.
5.1 Office of Emergency and Remedial Response Director
The OERR Director supervises OERR's compliance with Agency QA policies and procedures, and
is responsible for reviewing, approving, and implementing the OERR QA program. The OERR Director
has delegated the responsibility for ensuring the adequacy of the OERR QA program to the OERR QA
Manager and to each division director.
5.2 Office of Emergency and Remedial Response Quality Assurance Manager
The OERR QA Manager is the focal point for the development of QA policies and guidance and
the conduct of internal program audits for OERR. This authority extends to the review and approval of QA
requirements specified in procurements and CAs involving EDCAs, Regional QAMPs, and development of
DQOs. The QA Manager apprises Superfund management of Superfund QA activities through routine QA
reports, and meetings. The QA Manager generally accesses the Office Director through the normal chain-
of-command, but formal direct access outside the chain-of-command is available if needed.
The OERR QA Manager is generally not involved in any QC activities associated with site-specific
activities, e.g., the review and approval of site-specific QAPPs. The OERR QA Manager is consulted,
however, for advice on these activities and is kept informed of the results of all audits conducted. This
enables the OERR QA Manager to monitor the implementation of QA policies and procedures and the
progress of any corrective actions.
In addition, the OERR QA Manager provides assistance in the following activities:
Ensuring adequate identification of OERR actions which require QAPPs;
Ensuring the coordination of QA training for OERR staff;
Providing guidance in developing DQOs;
Planning upcoming fiscal year QA activities and ensuring that adequate resources are available;
Auditing a percentage of the QAPPs developed for Regional projects;
Evaluating and reviewing QA activity status reports from Regional QA managers and Regional
QA coordinators; and
Ensuring the development of procedures for collecting and tracking Superfund data.
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Exhibit 5-1
OERR QA RELATIONSHIPS
OERR
DRECTOR
PO'f
DIVISION
DRECTORS
DIVISION
QA
COORDINATOR
STATE
CONTRACTORS
T
OPM
QAM
REGIONAL
QAM
REGIONAL
PO's
STATE
CONTRACTORS
8/27/92
(28023-7
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Section 4.0
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5.3 Office of Emergency and Remedial Response Division Directors
OERR division directors are responsible for ensuring that all technical products associated with
EDCAs generated by their divisions are in compliance with the requirements specified in the OERR QAMP.
Several key QA responsibilities include:
Leading the development and review of DQOs, including the selection of technical staff for DQO
workgroups;
Overseeing the development and revision of sampling and analytical SOPs;
Participating in identifying and planning management systems reviews (MSRs) of internal EPA
and Superfund contractors, audits of data quality (ADQs), and technical systems audits (TSAs);
Identifying budgetary resources for QA activities;
Preparing elements of the QAARWP that are relevant to each division's measurement related
activities; and
Reporting division QA activities to the OERR QA Manager.
5.4 Office of Emergency and Remedial Response Quality Assurance Coordinators
Each OERR Division involved in EDCAs has at least one QA coordinator, who is the point of
contact for division management on QA matters. Table 5-1 lists the names of the QA coordinators
responsible for performing QA activities for each division, with the exception of OPM. The OERR QA
Manager has QA responsibility as OPM Division QA Coordinator. Specific responsibilities include:
Assisting division directors schedule audits, plan resources, and provide guidance on divisional QA
activities;
Reviewing and approving audit reports and corrective actions;
Functioning as liaison between other offices on QA issues and concerns;
Reporting the status of division QA activities to division directors with a sent copy (i.e., cc) to the
OERR QA Manager;
Identifying areas requiring additional guidance; and
Training staff on divisional QA policy and requirements.
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TABLE 5-1
DIVISIONAL QA COORDINATORS
DIVISION
ERD
HSCD
HSED
QA COORDINATOR
Bill Coakley
Carolyn Offutt
Jim Barron
:e
ensure
5.5 Office of Emergency and Remedial Response Project Officers
OERR project officers (POs) are responsible for ensuring that all contracts contain adequat
provisions for QA/QC. The OERR POs work closely with Regional project officers (RPOs) to ensv
national consistency in the implementation of QA policies and procedures and to ensure regular and
consistent performance evaluations. Their responsibilities include:
Evaluating and approving contractor QMPs (with OERR QA Manager or Coordinator's
assistance);
Assisting in developing and revising contractor operating procedures manuals and OERR SOPs;
Reporting QA/QC contract activities to the OERR QA Manager;
Participating in performance evaluations of internal EPA systems, Regional activities, and
Superfund contractors; and
Developing and/or reviewing audit reports for MSRs, TSAs, ADQs, and appropriate corrective
actions.
5.6 Regional Project Officers
The RPOs, OSCs, RPMs, and site assessment managers (SAMs) are responsible for overseeing
day-to-day site operations, including implementation of site-specific QA/QC activities, (individual Regional
QMPs may delegate responsibilites which have been defined in Program Office guidance)
Key responsibilities include:
Participating in DQO workgroups;
Ensuring incorporation of DQOs into QAPPs;
Reviewing and approving QAPPs, as appropriate, and ensuring implementation of the plans;
Participating in the review and evaluation of contractor operating procedures manuals;
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Ensuring implementation of appropriate document control and chain-of-custody procedures;
Participating in the technical caucuses that review analytical methods and protocols;.
Preparing contractor performance summary reports;
Ensuring that appropriate levels of review are applied to environmental data;
Reviewing Regional QA manager status reports and providing a summary of activities to the
OERR QA Manager; and
Participating in MSRs, TSAs, performance evaluations (PE), and verifications of HRS scores.
5.7 Regional Quality Assurance Managers
One of the major responsibilities of the Regional QA manager is to ensure implementation of
adequate QA/QC procedures in the Regional laboratory. The Regional QA manager also serves in an
advisory role to the Regional program offices for QA-related matters. For Superfund program activities, key
responsibilities may include:
Assisting in the development and review of site-specific project plans;
Assisting in the development and revision of standard sampling and analytical procedures;
Reviewing Regional audit reports;
Conducting field and laboratory audits; and
Providing oversight of the data validation process.
Reviewing and signing the QARFs.
5.8 Other Superfund Quality Assurance Program Participants
Other Agency offices and federal agencies involved in Superfund EDCAs should be cognizant of the
QA requirements identified in this QAMP. These participants are encouraged to establish communication
with the OERR QA Manager in an effort to comply with OERR QA program requirements. Each Region
is responsible for requesting routine QA reports from these Superfund program participants. Other Agency
offices or federal agencies that may have an role in conducting Superfund EDCAs include: '
Bureau of Reclamation (Department of Interior);
Department of Defense (all Services);
Department of Energy;
Federal Facilities Office (EPA Headquarters);
U.S. Army Corps of Engineers;
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Fish and Wildlife Service;
National Enforcement Investigations Center;
Office of Solid Waste; and
Office of Waste Programs Enforcement.
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6.0 DATA GENERATION AND MANAGEMENT
Superfund EDCAs must produce data of known and adequate quality, because the data may be used
to support Agency decisions. EDCAs generally are not performed within OERR, with the exception of ERT
activities; most EDCAs are performed by the Regions and by extramural groups. These activities are
discussed hi the following sections.
6.1 Regional Environmental Data Collection Activities
Regional EDCAs are performed in support of hazardous substance responses and the design and
implementation of response actions. Regional EDCAs include site assessment, remedial, and removal data
collection activities. The site assessment, also known as pre-remedial, process includes discovery, PA, and SI.
On the basis of these evaluations, sites may warrant further action or no further action. Sites that require
further action may be placed on the NPL for possible remedial action; others may require removal action.
The remedial process is long-term and is taken to prevent, minimize, or mitigate exposure and damage to
human health or the environment. It progresses through RI/FS and RD/RA. Removals are generally short-
term actions taken to clean up or remove a released hazardous substance into the environment and include
emergencies, tune-critical, and non-time-critical activities.
In addition to supporting the above activities, Regional EDCAs may support possible enforcement,
litigation, or cost recovery actions. Data for these activities must be well documented. Considerable effort,
therefore, is made to achieve and maintain data that eventually may be used for enforcement purposes.
6.2 Extramural Environmental Data Collection Activities
States and contractors participate in Superfund environmental monitoring and data collection
activities. States participate in removal, remedial, and enforcement activities through EPA Fund-lead and
state-lead responses. State involvement is promoted through an EPA/state Superfund Memorandum of
Agreement (SMOA). The SMOA generally defines the roles and responsibilities of both the state and EPA
during EPA-lead and state-lead responses. States participate in Superfund financed response in two ways:
(1) states may either assume the lead through a CA with the EPA for the response action; or (2) states may
be the supporting agency in EPA-lead remedial response. EPA uses the CA to transfer money, property,
services, or anything of value to states to undertake Fund-financed response activities.
Contractors are used to provide technical assistance to OERR hi site assessment, removal action,
remedial response, and support services contracts. Removal action contracts provide the Regional offices
with technical and management assistance for the removal, corrective action, and oil spill prevention
programs. Remedial action contracts provide Regional offices with technical assistance on site assessments,
remedial studies, designs, cleanup activities, support of enforcement actions, and community relations
activities. In addition, contractors provide personnel, equipment, and material to the removal and remedial
action programs. Contractors provide technical assistance and resources for cleanup and community
relations services in support of remedial response activities. Support services provided by contractors include
safety and technical training, demonstrations of advanced technology, laboratory analysis and sample control,
and QA support.
The following is a brief description of the major extramural contracts providing technical support to
OERR in support of Superfund. These activites are currently executed within the provisions of 1900.2, and
as stated at Section 3.0, the contracts are currently being reassessed pending respective solicitations, and will
be revised accordingly to reflect 1900.2.
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Alternative Remedial Contracting Strategy (ARCS) - provides support for all remedial response
activities with Regional office oversight. ARCS services encompass site assessments, RI/FSs, data
management, and oversight of remedial planning and implementation activities.
Technical Support for Environmental Monitoring Research and Development at the USEPA
Environmental Monitoring Systems Laboratory (EMSL/LV EMRD1 - provides research and
development of new methods and technologies to monitor the environment. Specific functions
include: field operations; field methods development and QA; analytical research and
development; analytical technical support; and analytical services.
Emergency Response Cleanup Services (ERCS) - provide rapid response (i.e., within hours or
days) to hazardous substance releases under the removal program. The ERGS contracts are
administered, by EPA Regions and provide cleanup personnel, materials, and equipment for
removal activities including: containment and countermeasures; cleanup, mitigation, and disposal
of contaminated material; analytical services (i.e., sample collection and analysis); and site
restoration.
Environmental Services Assistance Team (ESAT) - provides analytical and technical support to
each EPA Regional and Headquarters Superfund offices. ESAT performs sample analysis;
provides field analytical support; reviews and validates analytical chemistry data; provides QA/QC
reviews and assessments; and assists in methods development for analytical protocols.
Quality Assurance Technical Support (OATS') - provides QA/QC support to assist the Agency in:
(1) evaluating and improving laboratory and method performance; and (2) developing targeted
methodologies to focus analytical resources on meeting precise Superfund site needs. Specific
analytical tasks include preparing performance evaluation materials, reference materials, and
standards, and creating, evaluating, or improving analytical and QA/QC methods. QATS also
assists the Agency in conducting data and on-site laboratory audits, performs statistical analyses of
analytical performance, and provides technical review of QA/QC guidelines and documents.
Response Engineering and Analytical Contract (REAP - provides remediation support during the
release of hazardous substances at spills and abandoned waste sites. REAC provides technical
support to activities conducted by the ERT. Response activities using REAC include field
investigation and technical support for studies associated with removal and remedial actions. The
REAC contractor also performs evaluation and engineering design studies of innovative
commercially available technologies. In addition, the REAC contractor provides analytical
services, including on-site and mobile laboratory capability, rapid analyses of samples, and
development of analytical methodologies.
Sample Management Office (SMO) - provides management, operational, and administrative
support to the CLP. SMO is responsible for coordinating and scheduling sample analyses,
tracking sample shipment and analyses, receiving and checking data for completeness and
contractual compliance, and maintaining a repository of sampling records and program data.
Technical Assistance Team (TAT) - provides technical assistance to each EPA Regional and
Headquarters Superfund office for removal action, corrective action, and oil spill prevention and
countermeasure control programs. TAT activities include: monitoring response activities,
performing compliance inspections, performing removal site assessments, sampling, documenting
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project costs, providing QA/QC support, performing data management and reporting, and
providing enforcement, community relations, and contingency planning support.
OERR POs and RPOs are responsible for overseeing extramural projects and are responsible for
ensuring that all contracts or CAs contain adequate provisions for QA/QC. The OERR POs work closely
with the RPOs to ensure national consistency in program operations. The RPOs oversee day-to-day site
activities, including QA/QC activities.
6.3 General Quality Assurance Program Requirements
EPA Order 5360.1 requires EPA programs and contractors that support environmentally related
measurements to participate in a centrally managed QA program. QA program requirements include:
establishing criteria and.guidelines for assessing data quality; auditing to ascertain effectiveness of QA
implementation; identifying and developing QA training programs; and performing corrective action and
providing procedures that ensure the generation of data of known quality. In this context, known quality
means that the appropriate documentation has been compiled to support actions taken under the National
Oil and Hazardous Substances Pollution Contingency Plan (NCP) and the data are defensible for litigations.
The QA program is required to be formally documented through the development of an organizational
QAMP and project-specific QAPPs. SOPs are developed to establish consistency in the application of
routine activities associated with EDCAs.
6.3.1 Data Quality Objectives
DQOs are qualitative and quantitative statements which specify the quality of the data required to
support Agency decisions. DQOs are determined based on the uses of the data and are applicable to all
data collection and analysis systems. The level of detail and data quality needed will vary based on the
intended use of the data. Application of a generic set of DQOs to all activities is impossible due to
variabilities of site characteristics.
6.3.1.1 Development of Data Quality Objectives
DQOs must be integrated into the project planning phase and established prior to data collection.
Resultant DQOs are incorporated into the project sampling and analysis plan (SAP), which is comprised of
the field sampling plan (FSP) and the QAPP. The QAPP should include project-specific DQOs for
environmental sample collection and sample analysis activities. Further background information on the
purpose and development of DQOs can be obtained in "Guidance for Planning for Data Collection in Support
of Environmental Decision Making Using the DQO Process" (QAMS, 1994) and the "Data Quality Objectives
Process for Superfund" (OERR, 1993).
6.3.1.2 Data Quality Objective Development Responsibilities
Agency participation in the DQO development process was directed by the Deputy Administrator of
EPA in a memorandum dated April 17, 1984. The Assistant Administrator (AA) for OSWER is responsible
for ensuring that DQOs are developed for measurement activities and actively participates hi the
development of DQOs during the stages in which policy guidance is crucial. The QA representative for the
AA monitors the progress of DQO preparation and serves as the prime contact for QAMS in these efforts.
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OERR has lead responsibility for providing guidance on ensuring national consistency in the
development of DQOs for Superfund EDCAs. OERR provides Superfund participants guidance on: (!)
which EDCAs require formal DQOs; (2) senior managers responsible for decision making roles; and (3)
DQO development organizational structure.
All EDCAs that will be used in Superfund decision-making activities are required to have DQOs.
The Director of OERR has assigned each division director the responsibility for leading the development of
activity-specific DQOs. As "decision maker," the division directors are responsible for selecting the
appropriate technical staff to participate as a workgroup. The purpose of the workgroup is to reach a
detailed understanding of the problems being addressed, the data quality needed, and the limitations and
applicability of the data that will be collected within the time and resource constraints of the effort. The
OERR Regional QA managers should actively participate in the DQO workgroup.
6.3.2 Contractor Quality Management Plan
The QAMP should detail the contractor's organizational QA philosophy for attaining data of known
quality. It should be the template from which the QAPPs are developed. At a minimum, OERR requires
contractor QAMPs to address the following items in accordance with EPA Acquisition Regulations (48 CFR
Chapter 15, Part 1546) and EPA Requirements for Quality Management Plans (EPA QA/R-2).
A statement of policy concerning the organization's commitment to implement a QA/QC program
to ensure generation of measurement data of quality adequate to meet the project DQOs.
An organizational chart showing the position of the QA function within the organization. The
QA function must be independent of the operational group responsible for generating
measurement data.
A delineation of the authority and responsibilities of the QA function and the related data quality
responsibilities of other functional groups of the organization.
The type and degree of experience in developing and applying QA/QC procedures to the
proposed sampling and measurement methods needed for performance of project assignments.
The general approach for implementing, monitoring, and achieving the QA specifications. The
QAMP should describe the policy, organization, functional activities, and procedures for
developing project DQOs.
6.3.3 Quality Assurance Project Plans
The QAPP is a component of the SAP that is required by the NCP and EPA Order 5360.1 for
EDCAs. It describes the policy, organization, functional activities, and DQOs to produce data appropriate
for their intended use. Subpart E, section 300.4 of the NCP identifies four distinct hazardous substance
responses that require mandatory development of QAPPs for environmental sampling activities: (1) remedial
action; (2) remedial SI; (3) RI/FS; and (4) Removals. These plans should conform to EPA Requirements for
Quality Assurance Project Plans for Environmental Data Operations (EPA QA/R-5). In addition, the NCP
requires EPA to review the QAPPs for removal action and RI/FS projects.
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The RPM/OSC is responsible for coordinating, directing, and reviewing the work of EPA, states,
local governments, the Army Corps of Engineers, other agencies, and contractors to ensure compliance to
the NCP and development of QAPPs for Fund-financed responses. Upon receiving reports from these
parties, the RPM/OSC recommends action to the lead agency officials. The same level of authority is
mandated for other agencies, responsible parties, and contractors for federal-lead, non-Fund-financed
responses.
In some cases it may be necessary to relieve a removal action from the requirements for producing
formal documentation of QA procedures due to the emergency and quick turnaround nature of the response
prior to initiating the response action. Requirements for DQOs and QAPPs can only be waived by the OSC.
If a waiver is given, the OSC must notify the Regional QA manager of the waiver and provide justification
within seven days of the response date. Typically, the OSC will prepare a generic QA plan containing
specific information about the site, the samples taken, and the analyses requested. The format for this
generic plan is being developed by ERT. In addition, all emergency responses require a QAPP submitted no
later than 30 days after the response date, even though the requirement for the QAPP was initially relieved.
At the present time, no other CERCLA data collection activities are relieved from the requirements for
producing formal DQOs or QAPPs, due to the intended use of the data collected.
6.3.3.1 Sampling Quality Assurance Procedures
QAPPs provide the sampling and QA procedures to be followed at each site. QAPPs are developed
by either EPA, states, or contractors and are reviewed and approved by the OSC/RPM and Regional QA
manager. These plans generally reference SOPs that are described in existing contractor or state operational
manuals and are based on standard references which describe methods approved by EPA.
6.3.3.2 Analytical Quality Assurance Procedures
The QAPP references analytical procedures that may be further defined in the appropriate analytical
services contract. Analytical services may be procured through either CLP or non-CLP services. The site
manager is responsible for planning, monitoring, and assessing the quality of the data produced regardless of
the analytical service procured.
6.3.4 Computer Hardware and Software/Electronic Data Transfer
Within the CLP, the use of computer hardware and software as well as electronic data transfer
(EPA-specified format per the Office of Information Resources Management) are well defined in the various
Statement of Work (see the AOB Quality Assurance Program Plan). These same requirements are being
applied to non-CLP EDCAs.
6.4 Standard Operating Procedures
SOPs are established methods or procedures that are routinely followed for specific tasks. Within
Superfund, SOPs are used for all routine sampling, analytical, and management protocols. Use of SOPs is
an important QA tool, because it ensures that each task is performed in the same prescribed manner
regardless of who performs the task. Compliance with SOPs results in:
Performance of tasks using sound technical guidelines;
Reduced probability of error; and
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Documentation of procedures for possible future court actions.
6.5 Chain of Custody/Document Control Procedures
All work conducted by OERR, Regions, states, and contractors follow established chain-of-custody
and document control procedures detailed in National Enforcement Investigations Center (NEIC) Policies and
Procedures, U.S. EPA, NEIC, May 1978. Copies of this document are located in appropriate Agency,
contractor, and state offices, and serve as the official EPA guidance for ensuring that the procedures are
followed. The identification compilation, and maintenance of records (documents) requirements for OERR
are contained in OSWER Directive #9833.3A-1 (Guidance on Administrative Records for Selection of
CERCLA Response Actions).
The OSC/RPM and a representative from the Regional enforcement office are responsible for
ensuring that the contractor or state adheres to the chain-of-custody and document control procedures.
Adherence is evaluated by an evidence audit that may be conducted by Regional or Headquarters personnel,
or by a Contractor Evidence Audit Team (CEAT) from NEIC. These audits may examine procedures at the
site, in the contractor offices, laboratories, state or Regional offices, or any combination thereof.
6.6 Data Quality Assessment
Site managers and other data users assess data quality to determine if the data are consistent with
project DQOs and are appropriate for supporting a specific decision. Steps in assessing data quality may
include data review, uncertainty determination, and data useability assessment. Benefits data users can
obtain from proper assessment of data quality include: (1) establishment of data useability; (2) determination
of sufficient data quantity; and (3) improvement of future data collection efforts by identifying major sources
of error in the data.
6.6.1 Data Review/Verification
An initial step in assessing data quality is reviewing the data, a process nationally referred to as
either data review or data verification. Data review/verification is the technical examination of
environmental data and the associated QC data to determine their analytical limitations. During this process,
the reviewer applies analytical criteria to determine if analyses were performed under controlled conditions
and whether or not the data should be qualified. Because data review criteria are based on the analytical
methods used to generate the data, the results of a data review/verification are independent of the intended
use of the data. The data review/verification process establishes the analytical limitations of the data.
CLP data review is performed by technical personnel who have been trained by Regional staff. The
data package is reviewed using EPA's National Functional Guidelines for Data Review and Regional SOPs
that comprise standardized procedures and criteria based on the associated analytical methods. Non-CLP
data are reviewed based on available information and in accordance with the procedures and criteria
specified in the DQOs.
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6.6.2 Determination of Total Uncertainty2
Each step of the data acquisition process has an inherent uncertainty associated with it. The
uncertainty acceptance level depends on the purpose for which the data are being collected. Total error is
comprised of two types of error: sampling variability (also known as inference error) and measurement
error. Sampling variability is the variation between true sample values and is a function of the spatial
variation in the pollutant concentrations. Measurement error represents the difference between the true
sample value and the reported value.
Factors that can influence sampling and measurement errors include:
Instrument capabilities;
Variability (media, spatial, temporal);
Incorrect sample collection coordinates;
Improper decontamination procedures;
Improper sample preservation;
Inadequate storage procedures;
Inappropriate sample preparation analysis; and
Exceeded holding times.
Site managers and other data users establish procedures for estimating total uncertainty and data
acceptance criteria during the DQO development stage. EPA currently is developing procedures for
determining total error for soil analyses. EMSL/LV has developed a guidance, A Rationale for the
Assessment of Errors in the Sampling of Soils, 1990, to serve this purpose.
6.6.3 Data Useabilitv AssessmemAData Validation
After the data have been reviewed and the total uncertainty assessed (when possible), the data must
be examined in the context of the DQOs to determine whether they are valid for their intended use.
The site manager and other data user assess data useability by evaluating the sampling and analytical
performance against the quality indicators specified in the DQOs. Quality indicators consist of quantitative
statistics and qualitative descriptors and are used to interpret the degree of acceptability of data to the user.
Data quality indicators applicable to laboratory and field activities include the following:
Precision: The agreement or repeatability of a set of replicate results among themselves or the
agreement among repeat observations made under the same conditions.
Bias: The nearness of a result or the mean of a set of results to the true or accepted value.
Representativeness: Correspondence between the analytical result and the actual environmental
quality or the condition experienced by a contaminant receptor.
Uncertainty is a catch-all term used to describe the probability of any type of error associated with a specific decision.
Although there is no statistical definition of the term, (i.e., the definition is contingent upon the decision type), uncertainty is always a
function of the distribution of the statistics used in making the decision.
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Comparability: The degree to which two or more data sets are equivalent.
Completeness: The degree to which the data set is complete in terms of the percentage of
measurements that are deemed to be valid.
Site managers may be required to implement corrective action in the event the system fails to achieve the
established performance criteria.
A Data Useability Workgroup within OERR has been established to develop national guidance for
minimum data quality requirements to increase the useability of environmental data in support of Superfund.
Within this workgroup, the risk assessment subgroup has developed minimum requirements for risk
assessments (see Guidance for Data Useability in Risk Assessment: Interim Final). The site assessment
subgroup has developed similar guidance for site assessments.
6.7 Agency Review of Contractor and State Performance
The Regions ensure consistency in response activities (federal-lead and state-lead) that include the
coordination and implementation of the program through EPA Regional offices. The Regional offices
perform the oversight of EPA's, PRPs', contractors', and states' work at sites. Regional offices ensure that
program policies, procedures, goals, and objectives are met with respect to specific assignments. The OSCs
and RPMs in the Regions ensure (via on-site presence and audits) that the specifications of the sampling
plan are implemented at removal and remedial sites. OSCs and RPMs receive technical support to oversee
field activities from the ESD in each Region.
Contractors and states are also responsible for conducting internal on-site surveys to identify
problems encountered in executing response actions and for taking corrective action when performance is not
acceptable to the OSC or RPM. The specific requirements are contained in the applicable contracts,
Regional QMPs, and individual State financial assistance agreements. Guidance on Superfund/State
Agreements is contained in "Interim Final Guidance on Preparation of Superfund Memoranda of
Agreements" (SMOAs) (Directive #9375.0-01).
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7.0 PROGRAM ASSESSMENT
OERR conducts technical and management assessments at the program and project levels to ensure
that the QA program is being adequately implemented. OERR conducts several types of audits defined by
QAMS: MSRs, ADQs, TSRs, and PEs. These audits are required for OERR and Regional offices, states,
and contractors.
7.1 Management Systems Reviews
FMFIA requires ongoing evaluations and reports of internal accounting and administrative control of
each executive agency. One of EPA's mechanisms for strengthening Superfund's management control
program and evaluating whether FMFIA objectives are achieved is by conducting MSRs.
MSRs assess the effectiveness of the implementation of the approved QA program. They evaluate
elements of the QA program such as the procedures for developing DQOs, QAPPs, and SOPs, the schedules
and procedures for audits, and the degree of management support. MSRs developed to evaluate all program
areas (including Headquarters) within OERR should follow the QAMS Interim Guidance on Implementation
of Management Audits for National Program Offices. Currently, MSRs of CERCLA activities consist of
Regional reviews and contractor evaluations.
7.1.1 Regional Management Systems Reviews
OPM conducts reviews of Regional program offices periodically and may conduct special reviews as
needed. These reviews include, but are not limited to, an evaluation of:
Regional management and organization;
CERCLA program coordination and consistency;
Superfund analytical support;
CERCLA enforcement; and
Five year reviews/operation and maintenance reviews post closure.
The Regions should perform internal MSRs to assess Regional QA programs. In addition, the
Regions are required to report their QA activities to the OERR QA Manager at least annually. These
activities should be documented in a report that addresses the following areas:
Review of state and contractor QAMPs;
Development of QAPPs;
Audits of Regional program offices, laboratories, and contractors conducted by the Region;
Corrective actions taken;
Results of MSRs and TSRs; and
Existing QA tracking systems.
Headquarters' evaluation of periodic Regional reports assists in ensuring that the Regions are
consistently applying Agency QA/QC requirements and effectively managing their analytical resources.
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7.1.2 Contractor Evaluations
Another component of MSRs is the periodic evaluation of the removal, site assessment, remedial,
and technical support contractors. During these evaluations, the EPA assesses the contractor's compliance
with Agency QA requirements and procedures. The evaluations address the development and
implementation of QAPPs and the internal audit and corrective action functions of each contract. These
evaluations provide a mechanism to identify, document, and correct QA-related problems. A description of
each contractor evaluation is provided below.
7.1.2.1 Alternative Remedial Contracting Strategy
An EPA performance evaluation board (PEB) evaluates ARCS contractors every four months. The
PEB evaluates the contractors' ability to provide the necessary personnel, services, equipment, and materials
to support the remedial program in performance categories that correspond to the organization of contract
resources. Performance evaluation criteria are specific to each ARCS contract. During the evaluation, the
ARCS PO identifies contractor difficulties or trends on a Summary Evaluation Report and recommends
corrective action. The PO or RPM also may document less than or above satisfactory performance on
Performance Event Reports. As part of the evaluation, the fee determination official (FDO) determines the
award fee, and the PO develops a score used to determine annual work distribution. Both the award fee and
new tasks are assigned based on the contractors' performance on previous tasks. These tasks can include
certain QA support activities. For more information on the ARCS evaluation process, refer to the ARCS
Contracts Users' Manual, August 1989, EPA/540/G-89/008.
7.1.2.2 Emergency Response Cleanup Services
An EPA PEB annually performs a formal evaluation of ERCS contractors and determines the award
fee. The PEB also meets semi-annually to perform a preliminary review of the contractors' performance and
to recommend a provisional award fee payment. The PEB evaluates performance on every active delivery
order according to categories and subcategories identified in the contract's award fee plan, including QA/QC
adequacy. The PEB identifies problems, recommends corrective action, and documents the problems in the
PEB's report to the FDO and to the contractor.
7.1.2.3 Environmental Services Assistance Teams
The EPA evaluates ESAT contractors on the completion of each task and every six months when the
award fee is also determined. The corresponding EPA Regional or Headquarters office that each ESAT
Team supports evaluates the ESAT contractors on a task-specific basis. On ESAT's completion of each task,
the EPA Task Monitor for the assignment evaluates ESAT's performance based on (1) technical quality, (2)
compliance with schedule, and (3) management and budget quality. The Task Monitor provides input to the
ESAT Team on it's performance by issuing an Acknowledgement of Completion report that specifies scores
for each of the three criteria listed above. The scores reflect superior performance, as well as, deficiencies in
ESAT's performance.
In addition to evaluation of ESAT on a task-specific basis, an EPA PEB also subjectively evaluates
ESAT contractors performance every six months and determines an award fee in accordance with the award
fee plan. The PEB evaluates each ESAT Regional or Headquarters Team's performance in terms of
technical quality, management quality, timeliness, and cost effectiveness of performance.
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7.1.2.4 Response Engineering and Analytical Contract
Every four months, the REAC contractors' work assignment managers evaluate the contractors'
performance on each active work assignment during that cycle. The work assignment managers rate
contractor performance in technical and management categories for each work assignment, assigning
superior, satisfactory, and/or poor performance scores. The work assignment managers recommend
corrective actions for any contractor deficiencies. Also during the evaluation process, an EPA PEB submits
an award fee recommendation to the FDO based on the contractors' performance scores. In addition to the
periodic evaluations, work assignment managers monitor the REAC contractor's daily activities by evaluating
contractors' monthly status reports.
7.1.2.5 Sample Management Office
The SMO contractor's major evaluation is the award fee process and is mandated in the Award Fee
Plan of the contract. Services performed by the SMO contractor are evaluated every six months. The SMO
PO compiles evaluations from 20 Regional customers and 15 program office customers; summarizes the
results; prepares a report for an EPA PEB; supports the Chairman in convening the PEB deliberative
meeting; and prepares the recommendation report to the FDO who makes the award.
In addition to the semi-annual PEB meetings, the SMO PO conducts the following performance
measures on both a routine and ad hoc basis: (1) yearly review of the SOPs used in carrying out the tasks;
(2) yearly review of the internal QA plan and systems in place to identify and remediate problems; (3)
systematic upgrading and review of required reports, including financial and labor hour reports, technical
reports, and management reports; (4) in-house audits of specific systems and records such as SAS records
and mainframe cost charts; and (5) program reviews conducted in the quarter in which an award fee does
not occur, with the agenda set by the program office. On identification of contractor deficiencies, the SMO
PO recommends corrective action.
7.1.2.6 Technical Assistance Teams
EPA Regional offices monitor the day-to-day activities conducted by the TAT contractors. Regional
performance monitors and POs periodically review projects, tasks, and activities performed by the contractor.
The performance monitor may identify any problems or deficiencies in contractor performance on
Performance Observation Reports and, subsequently, recommend corrective actions. An EPA PEB
performs an evaluation of the contractors' performance and determines the award fee twice a year. This
process is described in the TAT Contracts Users' Manual, December 1991 (OSWER Directive 9360.6-08).
7.2 Data Quality Assessment (DQA)
DQA is an assessment of a data set to determine whether or not sufficient information exists to
establish whether the DQOs have been met. DQA evaluates a data set, or all the data sets of a particular
project, against the DQOs. Further, DQA determines whether or not the organization collecting or using
the data performed its own data quality assessment and were attentive to the results of that assessment in
terms of whether or not the data could be used to support the intended use. In case deficiencies are found,
DQA will look for the causes, both technical and management. The result of this audit will be a quantitative
measure of the limitations on the quality of that data.
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For all environmental data, the quality of the data must meet the objectives stated in the QAPP. It
is the responsibility of the Region, as the data user, to determine the applicability of each data package (CLP
and non-CLP) to its intended use (e.g., site investigation support, cleanup activities and/or enforcement
actions). See section 6 for a discussion on data quality assessment.
Within the CLP, the SMO performs Contract Compliance Screening (CCS) on contract
laboratory-generated data packages to verify compliance with contract requirements. OERR has
implemented CCS with the objective of controlling the timeliness, data quality, and completeness of CLP
data packages. CCS accomplishes this objective by Unking contractor payment with contractor performance
based on "liquidated damages" policy for late and/or noncompliant data. The CCS is further described as:
Contract Compliance Screening (CCS) is one aspect of the Government's contractual right of
inspection of analytical data. CCS examines the Contractor's adherence to the contract requirements
based on the sample data package delivered to the Agency.
CCS is performed by the Sample Management Office (SMO) under the direction of the EPA. To
assure a uniform review, a set of standardized procedures has been developed to evaluate the sample
data package submitted by a Contractor against the technical and completeness requirements of the
contract.
CCS results are mailed to the Contractor and all other data recipients. The Contractor has a
period of time to correct deficiencies. The Contractor must send all corrections to the Regional
Client, EMSL/LV, and SMO.
CCS results are used in conjunction with other information to measure overall Contractor
performance and to take appropriate actions to correct deficiencies in performance.
The Agency may generate a CCS trend report which summarizes CCS results over a given period
of tune. The Agency may send the CCS trend report or discuss the CCS trend report during an On-
Site laboratory evaluation. In a detailed letter to the Technical Project Officer and Administrative
Project Officer, the Contractor shall address the deficiencies and the subsequent corrective action
implemented by the Contractor to correct the deficiencies within 14 days of receipt of the report or
the On-Site laboratory evaluation. An alternate delivery schedule may be proposed by the
Contractor, but it is the sole decision of the Agency, represented by the Technical Project Officer or
Administrative Project Officer to approve or disapprove the alternate delivery schedule. If an
alternate delivery schedule is proposed, the Contractor shall describe in a letter to the Technical
Project Officer, Administrative Project Officer, and Contracting Officer why he/she is unable to
meet the delivery schedule listed in this section. The Technical Project Officer will not grant an
extension for greater than 14 days for the Contractor's response to the CCS trend report.
If the Contractor failes to adhere to the requirements listed in the contract, the Contractor may
expect but the Agency is not limited to the following actions: reduction of number of samples sent
under the contract, suspension of sample shipment to the Contractor, GC/MS tape audit, data
package audit, an On-Site laboratory evaluation, a remedial laboratory evaluation sample, and/or
contract sanctions, such as a Cure Notice.
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EMSL/LV performs a comprehensive QA audit on selected CLP sample data packages. A
description of the management, organization, and operations of the audit program used by EMSL/LV can be
found in Quality Assurance Project Plan: Superfund Data Audit Program, March 28, 1985.
7.3 Technical Systems Audits
TSAs focus on the actual QC and environmental measurement data collection systems. A TSA
entails an examination of calibration records, sampling and measurement procedures, general laboratory
cleanliness, support systems, equipment and facilities, maintenance and repair records, control charts, etc.
TSA auditors must be competent scientists who are familiar with the particular data collection technology
and QC procedures. These audits are performed on both in-house and extramural data collection activities
by QA managers or POs.
Three major types of TSAs should be conducted within OERR.
MRS audits;
The Site Assessment Branch (SAB) performs a detailed QA/QC review and analysis of every HRS
package submitted through the Regions. These reviews/audits determine consistency with HRS and EPA
guidance; national consistency; suitability of data; and complete documentation for technical defensibility.
Deficiencies hi the HRS package are brought to the attention of the responsible EPA Region, and a revised
package is developed for resubmission to SAB.
On-site CLP and non-CLP laboratory audits (see Regional and AOB QMPs); and
Field audits to ensure that sampling analysis activities are consistent with the corresponding
QAPP. (see Regional QMPs)
7.4 Performance Evaluations
A PE is a means of evaluating the performance of laboratory technicians and the instrumentation or
analytical systems on which they work. A PE audit is accomplished by providing PE samples containing
specific pollutants unknown to the technician in their concentration and/or identity.
All analytical laboratories, both CLP and Non-CLP should analyze PE samples to quantify method
performance. EMSL/LV prepares PE samples and evaluates PE sample data. In addition, EMSL/LV
performs PE audits on CLP laboratories before and after contract award. The AOB uses these audits to
formally evaluate contractor laboratory performance. Further information on the CLP PE audit program is
contained in the EMSL/LV document Quality Assurance Project Plan: Superfund Performance Evaluation
Program, September 28, 1984, and in OERR guidance (attached) for uniform use of PE samples.
7.5 Corrective Action System
Outside of the CLP, corrective actions are addressed in the Regional QA Management Plans, and
the site-specific QAPPs. Routine Regional reports to the OERR QA Manager identify corrective actions
and their implementation.
Corrective action for CLP TSA and PE audits are the same. If laboratory performance problems
have been identified, the administrative project officer (APO) and technical project officer (TPO) work
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closely with the laboratory to correct the problems. Depending on the nature of the problems, the
laboratory may be suspended temporarily from the program until the issue has been resolved.
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8.0 ANNUAL PLANNING
OSWER provides guidance to the office directors at the beginning of the budget planning cycle on
upcoming fiscal year priorities. This guidance is based on overall Agency goals and objectives, as well as,
program-specific issues and priorities. The office directors are responsible for communicating these priorities
to their divisions.
Each division director is responsible for identifying resources (Headquarters and Regional) for their
program areas, including QA resources. POs and division budget analysts assist the division directors in this
task. Generally, each division conducts a workload analysis which consists of:
Identifying key activities;
Estimating the level of activity (outputs) to be conducted; and
Calculating the resources (intramural and extramural) necessary to support the level of activity.
A key element of annual planning is the QAARWP. This report is prepared on a fiscal year basis,
and is to be submitted to QAMS by November 1.
Division directors have the responsibility of preparing elements of the QAARWP that are relevant to
each division's measurement-related activities. POs and technical staff provide input and assistance to the
division directors in preparing the elements of the QAARWP. The QA manager provides assistance to the
division directors in the preparation of these division-specific elements, and then assembles the elements into
a combined report. After the report is assembled, the office director reviews, concurs, and transmits the
report to the AA-QA Representative for concurrence. The document is then submitted to QAMS.
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9.0 TRAINING
In compliance with the Agency's TQM initiative, all personnel performing tasks and functions related
to data collection and data quality must have the needed education, training and/or experience to perform
their job. Initially this is ensured through the competitive hiring process which spells out educational and
experience requirements. Subsequently, annual Individual Development Plans and the Performance
Evaluation Process identify and allow for additional training, updating and cross-Program assignments. This
process is facilitated by the OERR Individual Training Assessment Tool and Core Curriculum, and the
CERCLA Education Center which provides numerous training courses for Superfund employees.
QA-related training courses should be available for OSWER Headquarters and Regional personnel. In
addition, contractors for ARCS, ERCS, ESAT, REAC, and TAT are required to have adequately trained
(per their contracts) personnel available prior to the initiation of work in the following areas:
QA/QC - defining the appropriate QA/QC activities required to promote the generation of data
of known quality that is capable of being used for its intended purpose;
Technical skills - a working knowledge of appropriate rules such as CERCLA, the NCP and
RCRA, appropriate sampling procedures, SOPs, equipment use, and computer use (as applicable);
Document control - procedures for identifying, managing, archiving, and retrieving project
documents including procedures stated in NEIC Policies and Procedures; and
Worker health and safety - identifying appropriate levels of personnel protection, proper
decontamination, first aid, and emergency response procedures.
At the Agency, QAMS maintains and updates a compendium of all of the QA/QC training courses
offered both internally and externally and which are available to most EPA employees. These courses range
in focus from technical or management classes that include some discussions on QA, to courses that deal
primarily with QA. Additional information on these courses may be obtained from QAMS.
Specific training and education requirements are contained in the Regional QA Management Plans.
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GLOSSARY OF TERMS
Cooperative Agreement (CA) - A legal instrument EPA uses to transfer money, property, services, or
anything of value to a recipient to accomplish a public purpose in which substantial EPA involvement is
anticipated during the performance of the project.
Data Quality Assessment (DQA) - An audit of collected data. An ADQ will determine whether or not
sufficient information exists with the data set to support an assessment of its data quality. It will evaluate a
data set or all the data sets of a particular project against its data quality objectives. Further, it will
determine whether or not the organization collecting or using the data performed its own data quality
assessment and followed through on the results of its assessment.
Data Quality Objectives (DQOs) -- Qualitative and quantitative statements of the quality of data needed to
support specific decisions or regulatory actions.
Environmental Data Collection Activities (EDCAs) Any activity contributing to the collection of
environmental (e.g., chemical, physical, biological) data. EDCAs include all stages of the environmental data
collection process, such as sampling and analysis, and include the collection of historical data.
Environmentally Related Measurement Any laboratory or field data gathering activity or investigation
involving the determination of chemical, physical, or biological factors related to the environment.
Hazard Ranking System (HRS) -- A scoring system used to evaluate potential relative risks to public health
and the environment from releases or threatened releases of hazardous substances. EPA and states use the
HRS to calculate a site score, from 0 to 100, based on the actual or potential threat of a release of
hazardous substances to air, surface water, or groundwater. This score is the primary factor used to decide if
a hazardous waste site should be placed on the National Priorities List and, if so, what ranking it should have
compared to other sites on the list.
Management Systems Review (MSR) A review process for determining the effectiveness of the
implementation of the approved QAMPs. An MSR evaluates a specific group's QA program associated with
EDCAs to either affirm the correctness and appropriateness of then- QA approach or to identify areas where
additional attention would bring significant benefits.
Potentially Responsible Party (PRP) - Any individual or company (such as an owner, operator, transporter,
or generator) potentially responsible for, or contributing to, the contamination problems at a Superfund site.
Whenever possible, EPA requires PRPs, through administrative and legal actions, to clean up sites
contaminated by hazardous substances.
Quality Assurance (QA) - The overall system of activities for assuring the reliability of data produced. This
system integrates the quality planning, assessment, and improvement efforts of various groups in the
organization to enable data generators to meet data user requirements.
Quality Assurance Management Plan (QAMP) - An orderly assembly of management policies, objectives,
principles, and general procedures by which an agency or laboratory outlines how it intends to produce
quality data.
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GLOSSARY OF TERMS (continued)
Quality Assurance Project Plan (QAPP) -- An orderly assembly of detailed and specific procedures by which
an agency or laboratory delineates how it produces quality data for a specific project or measurement
method. A given agency or laboratory would have only one QA manual, but would have a QA plan for each
of its projects or programs (group of projects using the same measurement methods; for example, a
laboratory service group might develop a plan by analytical instrument since the service is provided to a
number of projects).
Quality Control (QC) - The routine application of operations and procedures for obtaining prescribed
standards of performance in the monitoring and measurement processes.
Responsible Party (RP) - A party that admits to, or that EPA or the Department of Justice proves was
responsible for, contamination at a Superfund site.
Technical Systems Audit (TSA) - An audit of the actual quality control and environmental measurement
data collection systems. A TSA entails an examination of calibration records, sampling and measurement
procedures, general laboratory cleanliness, support systems, equipment and facilities, maintenance and repair
records, control charts, etc.
Total Quality Management (TQM) A management system where quality is defined in terms of customer
satisfaction, and the responsibility of implementing a quality program is delegated to the entire organization.
The goals of TQM are to deliver high quality, timely products/services using a system that is responsive to
the customer's need and to achieve continuous improvement in product/service quality.
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Date: 12/08/94
LIST OF ABBREVIATIONS AND ACRONYMS
AA Assistant Administrator
AOB Analytical Operations Branch
APO Administrative Project Officer
ARAR Applicable or Relevant and Appropriate Requirements
ARCS Alternative Remedial Contracting Strategy
CA Cooperative Agreement
CARD CLP Analytical Results Database
CCS Contract Compliance Screening-CLP
CEAT Contractor Evidence Audit Team
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act of 1980
CERCLIS CERCLA Information System
CLP Contract Laboratory Program
DCMB Design and Construction Management Branch
DQA Data Quality Assessment
DQO Data Quality Objective
EDCA Environmental Data Collection Activity
ERCS Emergency Response Cleanup Services
ERD Emergency Response Division
ERT Environmental Response Team
ESAT Environmental Services Assistance Team
ESD Environmental Services Division
EMSL/CN Environmental Monitoring and Support Laboratory/Cincinnati
EMSL/LV Environmental Monitoring Systems Laboratory/Las Vegas
FDO Fee Determination Official
FMFIA Federal Managers' Financial Integrity Act
FSP Field Sampling Plan
GSA General Services Administration
HRS Hazard Ranking System
HSCD Hazardous Site Control Division
HSED ' Hazardous Site Evaluation Division
HSWA Hazardous and Solid Waste Amendments of 1984
MSR Management Systems Review
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Appendix A
Revision: 2
Date: 12/08/94
LIST OF ABBREVIATIONS AND ACRONYMS (continued)
NCP National Oil and Hazardous Substances Pollution Contingency Plan
NEIC National Enforcement Investigations Center
NPL National Priorities List
NPO National Program Office
OERR Office of Emergency and Remedial Response
OIRM Office of Information Resources Management
OPM Office of Program Management
OSC On-Scene Coordinator
ORD Office of Research and Development
OSWER Office of Solid Waste and Emergency Response
OWPE Office of Waste Programs Enforcement
PA Preliminary Assessment
PE Performance Evaluation
PEB Performance Evaluation Board
PO Project Officer
QPRP Potentially Responsible Party
QA Quality Assurance
QAARWP Quality Assurance Annual Report and Workplan
QAMP Quality Assurance Management Plan
QAMS Quality Assurance Management Staff
QAPP Quality Assurance Project Plan
QAT Quality Action Team
QC Quality Control
RAS Routine Analytical Services-CLP
RCRA Resource Conservation and Recovery Act of 1984
REAC Response Engineering and Analytical Contract
RD/RA Remedial Design/Remedial Design
REM Remedial Engineering Management
RI/FS Remedial Investigation/Feasibility Study
ROD Record of Decision
ROGB Remedial Operations and Guidance Branch
RPM Remedial Project Manager
RPO Regional Project Officer
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Appendix A
Revision: 2
Date: 12/08/94
LIST OF ABBREVIATIONS AND ACRONYMS (continued)
SAB Site Assessment Branch
SACM Superfund Accelerated Cleanup Model
SAM Site Assessment Manager
SAP Sampling and Analysis Plan
SARA Superfund Amendments and Reauthorization Act of 1986
SAS Special Analytical Services-CLP
SI Site Inspection
SLCB State and Local Coordination Branch
SMO Sample Management Office-CLP
SMOA Superfund Memorandum of Agreements
SOP Standard Operating Procedure
TAT Technical Assistance Team
TIB Toxics Integration Branch
TPO Technical Project Officer
TQM Total Quality Management
TSA Technical Systems Audit
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Appendix B
Revision: 2
Date: 12/08/94
REFERENCES
EPA. December 1991. TAT Contracts Users' Manual. Office of Emergency and Remedial Response. OSWER
Directive 9360.6-08.
EPA. 1990a. Guidance for Data Useability in Risk Assessment: Interim Final. Office of Emergency and
Remedial Response. Part A: 9285.7-09A.
EPA. 1990b. A Rationale for the Assessment of Errors in the Sampling of Soils. Office of Research and
Development. EPA/600/4-90/013.
EPA. 1990c. Quality Assurance/Quality Control Guidance for Removal Activities, Sampling QA/QC Plan and
Data Validation Procedures, Interim Final. OSWER Directive 9360.4-01. EPA/540/G-90/004.
EPA. August 1989. ARCS Contracts Users' Manual. EPA/540/G-89/008.
EPA. 1988a. Laboratory Data Validation Functional Guidelines for Evaluating Inorganics Analysis. Office of
Emergency and Remedial Response.
EPA. 1988b. Laboratory Data Validation Functional Guidelines for Evaluating Organics Analysis. Office of
Emergency and Remedial Response.
EPA. 1988c. National Oil and Hazardous Substances Pollution Contingency Plan (NCP). 40 CFR 300.
EPA. March 1985. Quality Assurance Project Plan: Superfund Data Audit Program. EMSL/LV.
EPA. November 27, 1985. Interim Guidance on Implementation of Management Audits for the National
Program Offices. QAMS.
EPA. April 3, 1984. EPA Order 5360.1 - Policy and Program Requirements to Implement the
Mandatory Quality Assurance Program. Office of Research and Development.
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Appendix B
Revision: 2
Date: 12/08/94
REFERENCES (continued)
EPA. September 28, 1984. Quality Assurance Project Plan: Superfund Performance Evaluation Program.
EPA. 1994. Guidance for Planning for Data Collection in Support of Environmental Decision Making Using the
DQO Process. QAMS.
EPA. July 1993. EPA Requirements for Quality Management Plans. EPA QA/R2.
EPA. July 1993. EPA Requirements for Quality Assurance Project Plans for Environmental Data Operations.
EPA QA/R5.
EPA. May 1978. NEIC Policies and Procedures. NEIC.
EPA. December 3, 1990. Final Guidance on Administrative Records for Selection of CERCLA Response
Actions. OSWER Directive 9833.01A-1.
EPA. April 1990. Guidance on EPA Oversight of Remedial Designs and Remedial Actions Performed by
Potentially Responsible Parties. EPA/540/G-90/001.
EPA. June 1992. Remedial Action Report. Publication 9335.0-39FS.
American Society of Civil Engineers. 1990. Quality in the Constructed Project, Volume 1.
EPA. February 1993. Quality Assurance for Superfund Environmental Data Collection Activities. Publication
9200.2-16FS.
EPA. 1993. Data Quality Objectives Process for Superfund. OERR.
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Appendix C
Revision: 1
Date: 12/08/94
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