Publication Numbers:
EPA: EPA-505-F-03-001
DoD: DTIC ADA 395303
DOE: DOE/EH-0667
Intergovernmental Data Quality Task Force
Uniform Federal Policy for Implementing
Environmental Quality Systems
Evaluating, Assessing, and Documenting
Environmental Data Collection/Use and
Technology Programs
Final
Version 2
March 2005
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Intergovernmental Data Quality Task Force
Uniform Federal Policy for Implementing
Environmental Quality Systems
Evaluating, Assessing, and Documenting
Environmental Data Collection/Use and
Technology Programs
Final
Version 2
March 2005
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FOREWORD
The Intergovernmental Data Quality Task Force (IDQTF) was established to address real and
perceived inconsistencies and deficiencies in quality control for laboratory data within and across
governmental organizations which result in greater costs, time delays, and an increase in the potential
for risks. The task force is working to ensure that environmental data are of known and documented
quality and suitable for their intended uses.
This policy was developed by the IDQTF in accordance with the Memoranda of Understanding
signed by the participating agencies - Environmental Protection Agency, Department of Defense,
and Department of Energy. The policy is based on Part A of "Specifications and Guidelines for
Quality Systems for Environmental Data Collection and Environmental Technology Programs,
ANSI/ASQC E-4 1994." Part A addresses the management elements of a Quality System. Other
products of the IDQTF, currently under development, will address Part B of ANSI/ASQC E-4 -
project-specific requirements related to the collection and evaluation of environmental data.
The final policy, titled "Uniform Federal Policy for Implementing Environmental Quality Systems:
Evaluating, Assessing, and Documenting Environmental Data Collection/Use and Technology
Programs," provides recommendations and guidelines for documentation and implementation of
acceptable Quality Systems for Federal agencies. The document is guidance unless and until it is
formally adopted as policy by an agency. It is the intention of the IDQTF that the policy first be
implemented in the hazardous waste program and then be expanded to include other environmental
management programs such as air and water.
Marianne Lament Horinko
Assistant Administrator for Solid Waste and Emergency Response
U.S. Environmental Protection Agency
(LL PcuJ Jt+M
Paul Woodley * Date
Assistant Deputy Undersecretary of Defense
(Environment)
/ C*L
Beverly A. CookC/ Date
Assistant Secretary for Environment, Safety and Health
U.S. Department of Energy
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REVISION
The Uniform Federal Policy for Implementing Environmental Quality Systems: Evaluating,
Assessing, and Documenting Environmental Data Collection/Use and Technology Programs (UFP-
QS) was originally approved in January 2003. Version 2.0 of this policy includes an additional
appendix (Appendix G, Federal Quality Systems Roles and Responsibilities Guidance) which
establishes general principles for the roles and responsibilities relating to environmental data
collection and use at Federal facilities. Version 2.0 supercedes the Final Version 1 from January
2003.
//// /
Thomas Dunne Date
Acting Assistant Administrator for Solid Waste and Emergency Response
U.S. Environmental Protection Agency
Alex Beehler Date
Assistant Deputy Undersecretary of Defense
(Environment, Safety, and Occupational Health)
John Spitaleri Shaw Date
Acting Assistant Secretary for Environment, Safety and Health
U.S. Department of Energy
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TABLE OF CONTENTS
INTRODUCTION 1
1.0 MANAGEMENT AND ORGANIZATION 7
1.1 Mission and Organization 7
1.2 Quality System Roles, Responsibilities, and Authorities 10
1.3 Resources to Support the Quality System 12
1.4 Quality System Customers and Suppliers 13
1.5 Communication of the Quality System 15
1.6 Management Assessment of the Quality System 16
2.0 QUALITY SYSTEM AND DESCRIPTION 19
2.1 Documentation of the Quality System 19
2.2 Quality System Tools 21
3.0 PERSONNEL QUALIFICATION AND TRAINING 23
3.1 Establish Technical Proficiency and Quality Requirements at the Organization,
Program, and Project Levels 23
3.2 Evaluate Training Needs 23
3.3 Prioritize Training Resources 24
3.4 Provide Training 24
3.5 Provide Access to Information 24
3.6 Training Effectiveness and Retraining 24
3.7 Documentation of Training 25
4.0 PROCUREMENT OF PRODUCTS, SERVICES 27
4.1 Planning and Control 27
4.2 Assessment and Verification 27
4.3 Procurement Documents and Records 28
5.0 DOCUMENTS AND RECORDS 29
5.1 Identification of Technical and Quality-Related Documents and Records
Requiring Controls 29
5.2 Description of Systems for Controlling Technical and Quality-Related
Documents 30
5.3 Tracking and Retrieval of Technical and Quality-Related Documents and
Records 31
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TABLE OF CONTENTS (Continued)
6.0 COMPUTER HARDWARE AND SOFTWARE 33
6.1 Describe the Process, Roles, and Responsibilities for Configuration Testing
and Documentation 34
6.2 Describe the Process, Roles, and Responsibilities for Managing Changes to
Hardware and Software Configurations 35
6.3 Describe the Process, Roles, and Responsibilities for Developing and Evaluating
Software 35
6.4 Describe the Process, Roles, and Responsibilities for Verifying That the Data
Being Compiled and the Quality Control and Maintenance of These Data
Are Appropriate for Their Intended Use 35
6.5 Describe the Process, Roles, and Responsibilities for Developing Procedures
To Ensure That Historical Files Are Documented and Can Be Recovered 36
7.0 PLANNING 37
7.1 Management of Systematic Planning 37
7.2 Elements of Systematic Planning Processes 39
8.0 MANAGEMENT OF WORK PROCESS IMPLEMENTATION 41
8.2 Managing Quality Implementation Through the Use of SOPs 42
8.3 Work Processes Implemented Through Contracts and Other Assistance
Agreements 45
9.0 ASSESSMENT AND RESPONSE 47
9.1 Identification and Planning of Assessments 47
9.2 Design and Implementation of Assessments 48
9.3 Determination and Evaluation of Assessor Qualifications 51
9.4 Responsibilities and Authority of Assessors 51
9.5 Roles and Responsibilities of Contractors and Others in Performing
Assessments 51
9.6 Documentation, Reporting, and Review of Assessments 52
9.7 Response to and Follow-up After Assessments 53
10.0 QUALITY IMPROVEMENT 55
10.1 Quality System Improvement Process 55
10.2 Corrective Action for Quality-Related Problems 55
10.3 Creating an Environment for Facilitating and Promoting
Quality Improvement 56
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TABLE OF CONTENTS (Continued)
APPENDIX A ELEMENTS OF A SYSTEMATIC PLANNING PROCESS 57
APPENDIX B ELEMENTS OF COMPUTER HARDWARE AND SOFTWARE AND
INFORMATION TECHNOLOGY 65
APPENDIX C THE INTERGOVERNMENTAL DATA QUALITY FRAMEWORK 73
APPENDIX D QUESTIONS AND ANSWERS REGARDING THE IDQTF UNIFORM
FEDERAL POLICY 81
APPENDIX E GLOSSARY 93
APPENDIX F IDQTF MEMBERS 97
APPENDIX G FEDERAL QUALITY SYSTEMS ROLES AND RESPONSIBILITIES
GUIDANCE 103
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INTRODUCTION
Purpose
The Uniform Federal Policy for Implementing Environmental Quality Systems (UFP)
outlines essential elements of a Quality System1 for management of environmental data collection
and use and environmental technology programs. The UFP will serve as a high-level policy for
documenting and implementing acceptable Quality Systems for Federal agencies.2 The UFP
provides a framework to ensure that essential elements are addressed. The UFP must be used to
develop a new Quality System or to evaluate the adequacy of an existing Quality System. The
results of that evaluation must then be used to develop plans for correcting identified deficiencies.
The policy was developed as a joint initiative between the U.S. Environmental Protection
Agency (EPA), the Department of Defense (DoD), and the Department of Energy (DOE) to resolve
data quality inconsistencies and/or deficiencies to ensure that:
Environmental data are of known and documented quality and suitable for their intended
uses, and
Environmental data collection and technology programs meet stated requirements.
Ultimately, the benefits of a consistent policy for Quality Systems across Federal agencies
include:
Improved effectiveness of Federal environmental programs by focusing on results,
quality of data and services, and customer satisfaction;
Clarification of roles and responsibilities in managing and overseeing environmental data
and environmental technology programs;
Sufficient confidence in the systems such that duplication of oversight efforts are
minimized; and
Enhanced accountability and public confidence in environmental decisions.
'The term "Quality System," as used in this document, is adopted from ANSI/ASQC E4, Specifications and
Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs.
ANSI/ASQC E4 states that a Quality System is "A structured and documented management system describing the
policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of
an organization for ensuring quality in its work processes, products (items), and services. The Quality System provides
the framework for planning, implementing, and assessing the work performed by an organization and for carrying out
required quality assurance (QA) and quality control (QC) activities."
2Whenever the term "Federal agencies" is used in this document, it refers to agencies, departments, and
instrumentalities of the United States.
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This document provides requirements and guidelines to Federal agencies for documenting
and implementing Quality Systems for management of environmental data collection and use and
environmental technology programs. It becomes the policy for an agency when formally adopted
by that agency; each agency will determine how best to implement the policy.
This document represents a voluntary consensus policy. Implementation is, therefore,
not subject to oversight by another Federal agency or to a Notice of Violation if one agency
fails to implement all or part of the policy.
Background
In 1997, an audit report from the EPA Inspector General (Audit Report No. El SKB6-09-
004107100132) examined laboratory data quality at Federal facility National Priorities List
Superfund sites. An audit report from the DoD Office of the Inspector General (OIG Report 97-098,
Laboratory Support Service for Environmental Testing, February 21, 1997) addressed similar
issues. These reports found that real or perceived inconsistencies and deficiencies in data quality
within and across governmental organizations had resulted in greater costs, time delays, and the
potential for increased risk.
In response to these and other audit reports, as well as to environmental data quality issues
related to Federal facilities in general, EPA established the Intergovernmental Data Quality Task
Force (IDQTF), chaired by the Director of the Federal Facilities Restoration and Reuse Office
(FFRRO). The IDQTF operates as a partnership, reaching decisions through consensus. In addition
to the chair, other consensus members of the task force3 include:
The Department of Defense, represented by the DoD Environmental Data Quality
Workgroup (EDQW) chairperson;
The Department of Energy, represented by the Office of Safety, Health and Security
(EM-5);
The EPA Quality Staff, Office of Environmental Information;
The EPA Offices of Emergency and Remedial Response and Solid Waste in the Office
of Solid Waste and Emergency Response; and
3OtherEPA offices and DoD components participated in various IDQTF subgroups and meetings to provide
technical expertise. In addition to the above consensus members, participation of various other Federal agencies and
EPA offices was actively sought throughout the development of initial IDQTF products. These included the
Departments of Agriculture, Commerce (National Oceanographic and Atmospheric Administration), and Interior (U.S.
Geological Survey), who were invited to become consensus members.
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EPA Regional Offices, represented by quality assurance staff from EPA Regions 1, 2,
and 8 and Federal Facility Program staff in Region 5.4
DoD and DOE entered into separate MOUs with EPA. These MOUs have the following
goals:
The development of a written consensus agreement on what constitutes an adequate
Quality System for environmental data collection, and
The development of a consensus agreement that outlines the roles and responsibilities
of EPA and Federal agencies with regard to data management.
The parties agreed to meet these goals first by developing them in the context of hazardous
waste program management with the understanding that this will establish a framework for further
work under other environmental media programs.
Basis for the Intergovernmental Quality System
ANSI/ASQC E4 was selected as the basis for the intergovernmental Quality System because
it is a national standard that specifically addresses environmental data collection and use and
environmental technology programs. The E4 standard is written in three parts:
Part A addresses the management elements of a Quality System,
Part B addresses project-specific requirements related to the collection and evaluation
of environmental data, and
Part C addresses the Quality System issues related to "design, construction and operation
of environmental technology."
The UFP is designed to clarify and provide additional direction for the implementation
requirements of ANSI/ASQC E4 Part A. Other documents underdevelopment by the IDQTF will
address ANSI/ASQC E4 Part B requirements. These include:
Draft Federal Consensus Guidance for the Preparation of Quality Assurance
Project Plans
Presumptive Quality Assurance/Quality Control Measures for Superfund
4A full list of consensus members, alternates, and other regular participants in the IDQTF is found in appendix
E of this document.
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The IDQTF is not developing a project-specific work product to address ANSI/ASQC E4 Part C:
Design, Construction, and Operation of Environmental Technology.
To satisfy the second goal of the MOU, the IDQTF is developing an additional document,
Roles and Responsibilities Framework for Federal Facility Oversight.
Documentation of Intergovernmental Quality Systems
A Quality System is documented at an organizational level in a Quality Management Plan
(QMP) and at a program or project level in a Quality Assurance Project Plan (QAPP), or their
functional equivalents. The organizational QMP will detail how the Quality System is to be
implemented throughout the organization for which it is written. It will include information by
which the organization will manage, plan, implement, assess, conduct corrective action upon, and
continually improve the products, services, and activities involved in environmental data collection
or use or environmental technology management.
Organization
This document is organized according to the 10 elements that must be addressed in an
organization's QMP in order to conform with ANSI/ASQC E4 and this document:
1. Management and Organization
2. Quality System and Description
3. Personnel Qualification and Training
4. Procurement of Products, Services, and Activities
5. Documents and Records
6. Computer Hardware and Software
7. Planning
8. Management of Work Process Implementation
9. Assessment and Response
10. Quality Improvement
Each of these elements is covered in a separate section of the remainder of this document.
Requirements and Guidance
The requirements described in this policy are intended to facilitate implementation of
ANSI/ASQC E4 with regard to environmental data collection and use and environmental technology
development and implementation. ANSI/ASQC E4 covers both mandatory specifications and
nonmandatory guidelines for Quality Systems. In accordance with E4, this document addresses
both requirements and guidance. Requirements are presented in the text that makes up the
bulk of this document, while guidance is presented in text boxes. The text boxes attempt to
illuminate the requirements of this policy and enhance the reader's understanding. The text
boxes are not part of the formal policy. The requirements of this document also incorporate by
reference the definitions contained in the E4 standard.
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Relationship to Other Standards and Policies
Questions have been raised by reviewers of this document as to the relationship between this
document, international standards, and EPA policy documents. The text below is provided to
describe those relationships.
Relationship to International Standards
The relationship of this policy to international standards is as follows:
ANSI/ASQC E4 conforms with the ISO 9000 series of standards, "International
Standards for Quality Management," addressing Quality Systems. E4 and this policy
document, however, are specifically written for environmental data collection and
environmental technology programs.
The ISO 14000 series, Environmental Management addresses what an organization does
to minimize harmful effects on the environment caused by its products, services, and
activities. ISO 14000 does not address the issues covered by E4 or by the ISO 9000
series.
ISO/IEC Guide 25 (superceded in 1999 by ISO 17025, General Requirements for the
Competence of Testing and Calibration Laboratories) establishes specifications and
requirements for calibration and testing of laboratory systems. ISO 25 is the basis for
standards set by the National Environmental Laboratory Accreditation Conference,
Chapter 5. While E4 does not explicitly address quality systems for environmental
laboratories, it references ISO/IEC Guide 25, and other national standards as the
framework for other Quality Systems.
Relationship to EPA Policy
ANSI/ASQC E4 sets forth the general standards for a Quality System for environmental data
collection and technology. EPA recently published a number of documents designed to implement
E4 throughout EPA and for EPA funded activities. These documents include:
1. Policy and Program Requirements for the Mandatory Agencywide Quality System (EPA
Order 5360.1A2),
2. EPA Quality Manual for Environmental Programs (EPA Manual 5360 A1), and
3. EPA Requirements for Quality Management Plans (EPA QA/R2), which establishes
Quality System requirements for external organizations that implement programs for
EPA through funding mechanisms (e.g., contracts, grants, and other financial
agreements), or through other agreements (e.g., interagency agreements).
The EPA Order and the EPA Manual apply solely to EPA. This document differs from E4
and from QA/R2 in four important ways:
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It provides implementation policies for Federal agencies; therefore, it is more detailed
than either E4 or QA/R2.
It is intended to apply to Federal agencies, whereas QA/R2 applies only to organizations
that implement programs for EPA.
It represents a consensus policy reflecting the views of the IDQTF,
It benefits from the experience and lessons learned from a broader set of stakeholders
involved in managing quality across several Federal agencies.
This document is consistent with the EPA Order and EPA Manual. It is anticipated that
Quality Management Plans (QMPs) that meet the requirements of the EPA Order will require little
adjustment to conform to this policy.
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1.0 MANAGEMENT AND ORGANIZATION
This section of a QMP defines management responsibilities and authorities of management
for ensuring the quality of work products, monitoring work processes, and identifying and correcting
system nonconformance. Key elements of this section include:
Management commitment to and accountability for quality,
Independent oversight of quality,
Provision of resources commensurate with quality objectives, and
Commitment to performance assessment and continuous improvement of the Quality
System.
The "Management and Organization" section of the QMP establishes the framework that
fosters implementation of the Quality System. Managers within each organization who are
responsible for the mission and programs covered by the Quality System are held accountable for
quality.
1.1 Mission and Organization
a. Define the mission(s) of the organization(s) covered by the Quality System as the
mission relates to environmental data collection and use and/or environmental
technology programs. Identify the programs to which the Quality System is applied
(e.g., the remediation of hazardous waste as performed under the regulatory
authorities of the Resource Conservation and Recovery Act [RCRA] and the
Comprehensive Environmental Response, Compensation, and Liability Act
[CERCLA], or compliance assurance under the Clean Water Act's National Pollutant
Discharge Elimination System [NPDES]).
Programs Requiring Quality Management Controls:
In this section, you are asked to give careful attention to identification of the specific
programs that require quality management controls. This discussion must also address where
oversight is needed to ensure data quality, and where internal coordination of quality
assurance and quality control (QA/QC) activities among the group's organizational units
need to occur.
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Using Tables to Simplify the QMP:
See text box in Section 2.0 for an example of table headings that could be used to simplify
writing of the mission and organization section of the QMP.
Example Mission Statements:
"The Office of Analytical Services and Quality Assurance (OASQA)...is one of 30 Federal
laboratories operated by EPA to support its mission to protect the environment. OASQA's
primary function is to ensure the appropriate quality of scientific information for
environmental decisionmaking in Region III."
"The Department of Energy Nevada Radioactive Waste Acceptance Program (RWAP) will
facilitate management of radioactive waste in a safe and compliant manner to ensure the
integrity of the Nevada test site disposal operations, while maintaining the protection of the
public, workers, and the environment."
"The Army will develop and implement measures to protect and sustain the environment in
support of military operations, installation management, and material development."
b. Provide an organizational chart that shows all organizational units associated with
achieving the mission(s) covered by the Quality System. Identify the communication
reporting network and organizational relationships, the functions of each
organizational unit in achieving the mission, and the placement of the quality
management function in each organizational unit.
Definition of Organization:
An organization is defined by ANSI/ASQC E4 as "...a company, corporation, firm,
enterprise, or institution, or part thereof...that has its ownfunctions and administration."
When used in this document, the term "organization" refers to the entity within a Federal
agency that has "its own functions and administration" and that is responsible for writing a
QMP under this policy document. In some cases the term "organizational unit" is used to refer
to a unit of a larger organization that may have its own Quality System responsibilities, and
for which Quality System information and procedures will require documentation in the
QMP.
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Using References to Readily Available Documents:
The use of attachments, readily available references, or Internet links for organization charts
and tables with specific names, addresses, and telephone numbers allows for easy updating of
this part of the QMP without having to change text that is otherwise still current. Include
(such as with attachments to the QMP, references in the QMP to readily available documents,
or links to the Internet in the QMP) organizational unit titles and organization manager and
quality manager names. Include the street and electronic mail addresses and telephone
numbers for QA managers and organizational unit managers.
Describe the work performed by each organizational unit identified. Specify the
products, services, and activities that are supported by environmental data collection
and use and environmental technology programs.
Identify other entities that the organization will work with to achieve its mission.
Level of Specificity in Describing Other Entities:
You may describe these entities genetically (e.g., States or contractor) or specifically (e.g., by
State or contractor name), depending upon the specificity the program requires. For
example, a large contractor with a multi-year contract might be listed by name, while many
small contractors with short-term tasks might be listed genetically as categories of contracts.
State the Organization's Quality Policy.
Management must establish and implement a Quality Policy. The QMP must state
the organization's policy to demonstrate management commitment to:
Integration of the Quality System into management policies and systems;
A Quality System that promotes sound science, consistency, efficiency,
communication, responsiveness to customers, and innovation;
A Systematic Planning Process that results in the generation and use of
environmental data of the type, quantity, and quality needed for decision
making;
The use of QAPPs (e.g., project-specific quality plans, however named) in
documenting project-specific data collection;
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Design, construction, and operation of environmental technologies that meet
the established specifications; and
Provision of funding needed to accomplish the defined quality objectives.
1.2 Quality System Roles, Responsibilities, and Authorities
a. Identify the responsibilities, authority and independence, and resources associated
with the management of the Quality System.
1. Identify a Quality Assurance (QA) Manager(s), or person(s) assigned
equivalent duties, however named, who is responsible for overseeing the
effective implementation of the Quality System within each organizational
unit identified in the QMP.
The QA Manager, however named, must function independently of
direct environmental data generation and use, model development,
and technology development.
The QA Manager is responsible for reporting on quality issues to
executive level management.
2. Describe the roles, responsibilities, and areas of independence of QA
personnel in assessing, taking corrective actions on, and improving the
Quality System.
3. Describe the lines of communication between QA personnel and
management personnel and program/project staff in the organization.
4. Describe the corrective action process(es) including criteria used for
stopping work and resource expenditure when there is cause to believe that
a quality control failure or Quality System nonconformance has occurred.
For each organization or organizational unit covered by this QMP, identify
the responsible individual(s) authorized to stop work.
b Specify the QA/QC responsibilities for senior management, line managers,
program and project staff, and QA personnel in planning, implementing,
assessing, and improving the Quality System, and the technical activities associated
with that Quality System. Describe how attention to quality requirements is
incorporated into personnel performance standards.
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Accountability for the Quality System:
Successful development and implementation of the organization's Quality System depend
upon commitments to quality by individuals at every level of management and staff
throughout the organization. The success of these commitments is measured in performance
standards established at the beginning of a performance evaluation year and is assessed
during and at the conclusion of the year. Different types of standards are appropriate for
different responsibilities. Some examples are described below:
For the Executive Manager: Ensure that organizational levels are aware of Quality
System responsibilities. Ensure that all management and technical staff have
performance standards that hold them accountable for implementation of the Quality
System. Participate in an annual assessment of the performance of the Quality System.
Ensure that performance measures are established so that feedback on performance
occurs and that corrective measures are taken in a timely manner.
For the Technical Manager: Ensure that all organizational levels are aware of Quality
System responsibilities. Ensure that all management and technical staff have
performance standards that hold them accountable for implementation of the Quality
System. Ensure that customers and measurements of customer quality are identified for
all products, services, and activities within your areas of responsibility. Ensure that a
system is in place for communication with customers and suppliers. Establish a process
for ensuring that customer needs are agreed to and met. Establish a process for taking
corrective action when customer needs are not met.
Describe the roles and responsibilities of government contractors as well as
holders of Federal Government-funded assistance agreements (e.g., States,
universities, and nonprofit institutions operating through interagency agreements,
grants, or other agreements) in implementing and overseeing government Quality
Systems. Identify and describe the quality oversight functions for government
contracts that are inherently governmental and must be performed by government
personnel, as well as those that can be delegated to contractor personnel. Identify the
quality oversight functions that are inherent to the Federal Government in the
oversight of its assistance agreements, and those that can be delegated to other
governmental entities and assistance agreement holders.
Inherently Governmental Functions:
An "inherently governmental function" is defined in the Federal Acquisition Regulations (FAR Part 07,
Subpart 7.5, 7501), as well as in the Office of Management and Budget (OMB) circular A-76 and supplemental
guidance. The OMB A-76 definition notes that "an inherently governmental function is a function which is so
intimately related to the public interest as to mandate performance by Government employees. ... These
functions include those activities which require either the exercise of discretion in applying Government
authority or the use of value judgement in making decisions for the Government." The OMB circular and
supplementary guidance provides numerous examples of functions that are and are not inherently
governmental. According to the FAR, the definition of inherently governmental function is "a policy
determination, not a legal determination."
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1.3 Resources to Support the Quality System
a. Describe the process used by senior management to provide resources (e.g.,
staff, travel, training, contractor support, equipment, and supplies) to plan,
implement, assess, and improve the Quality System.
1. Resource Planning: For each organization and program covered by this
QMP, identify the responsibilities and procedures for annual estimation of
resources required for managing quality. Identify priority funding areas.
2. Evaluation of Expenditures: Describe an annual process for estimating
expenditures and evaluating the adequacy of these resources to address
potential weaknesses in the management of quality.
b. Resource planning and expenditure estimates must address: Government personnel,
support to Government personnel (e.g., training, travel), and costs associated with
contractor responsibilities where applicable.
Understanding What's Required for Estimating Resources:
In this section, you are asked to develop a process for planning adequate resources and
evaluating whether the budgeted resources sufficiently met targeted quality goals. Key
elements of this requirement include:
Deliberate use of the term "estimates" for both planning and evaluation so that
significant levels of detail are not added to the planning, budgeting, and program
evaluation process;
Recognition that you may not receive all the resources you request and that you will
have to target expenditures to the most critical areas; and
An annual evaluation of estimated expenditures tied to the assessment of quality required
in other sections of this document.
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1.4 Quality System Customers and Suppliers
A Word About Customers and Suppliers:
Each product, service, or activity of environmental data collection or environmental technology
programs involves both customers and suppliers. These relationships are often complex, and
customers can sometimes be suppliers and vice versa. Customers and suppliers may be both internal
and external to the organization.
Customers: For a Federal facility collecting environmental data for a CERCLA cleanup, for
example, the customer(s) may include members of the public, the regulators, or even the facility
Remedial Project Manager. When a Federal facility is collecting discharge information to support
its compliance with a State NPDES permit, the customer will be the State agency that will review
the compliance information.
Suppliers: Contractors, subcontractors, private and public laboratories, and many other providers
of equipment, supplies, and services are the typical suppliers of environmental data and
technology programs. It is important to recognize, however, that they may also be customers
seeking guidance and direction from contract management personnel and technical staff.
Quality System Customers: This section is designed to ensure that the Quality
System includes a thoughtful process for identifying the customer for environmental
data collection and use and environmental technology programs. Identify customers
and their specifications, and describe the process by which those specifications are
built into the systematic planning for and evaluation of environmental data collection
and use and environmental technology development and implementation.
A Word About Customer Needs, Expectations, and Specifications:
ANSI/ASQC E4 uses the terms "needs and expectations" when referring to the constellation of
specifications that are identified by customers. These specifications can be assigned different levels of
priority depending upon whether they are "legal requirements" or customer expectations or preferences
separate from legal requirements. For example, it will be an absolute requirement that a treatment
facility meet legally mandated effluent discharge limits. A number of choices exist for how the
treatment facility is built and designed to meet these requirements. While the customers (owner of the
constructed treatment facility) may expect or prefer certain design and operation features, the ability to
deliver these features may be dependent on a variety of resource (financial, schedule, and personnel)
and contractual constraints.
Identification of customer specifications will often require distinction between requirements,
expectations, and preferences, and will involve setting priorities in accordance with constraints to
achieving customer demands. These constraints may be financial, contractual, and technical.
Obviously more flexibility will exist in negotiating changes to customer expectations and preferences
than in negotiating requirements. Although this document uses the shorthand term "specifications"
when describing customer requirements, expectations, and preferences, that term is meant to reference
the full range of customer demands.
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1. Identification of Quality System Customers and Their Specifications:
Identify the customers for each product, service, and activity that are the
principal concern of the Quality System. Describe how customers'
requirements, expectations, and preferences (also called customer
specifications) are identified by senior management. Specify senior
management responsibilities in defining the work objectives to satisfy the
customer specifications.
2. Development of Quality Measures of Customer Specifications: Describe
the process for developing quality measurements associated with customer
specifications for the products, services, and activities identified for each
organizational unit covered by this QMP. Briefly describe the quality
controls established to evaluate the conformance of specific products,
services, and activities to customers' specifications.
3. Negotiation of Changes to Customer Specifications and/or Quality
Measurement: Describe the process for negotiating changes in customer
specifications based on resource limitations or other constraints (e.g.,
technical, political). Describe a process for negotiating acceptable quality
measures with customers when feedback from suppliers identifies resource
or other constraints that prevent achieving the customers' desired obj ectives.
Outline appropriate dispute resolution procedures for disagreements over
quality measures. Existing dispute resolution mechanisms can be cited (e.g.,
Federal facility agreements that govern CERCLA cleanups often have well-
defined dispute resolution procedures that meet this requirement).
4. Accessibility to Information and Complaint Management: Describe how
senior management provides customers with access to customer service
personnel or the equivalent to enable them to seek assistance, conduct
business, or voice complaints. Describe the organization's complaint
management process, including the chain of command for management of
complaint resolution. Describe a management process and roles and
responsibilities that ensure that complaints are resolved promptly and
effectively and that complaints are compiled and analyzed for improving
performance at all organizational levels.
5. Determining Customer Satisfaction: Briefly describe the process and
information used to determine customer satisfaction or dissatisfaction with
products and services. Describe the process that the organization uses to
follow up with customers to ensure prompt corrective action and feedback to
customers on performance issues.
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Establishing Quality Measurements:
The products, services, and activities of environmental programs are quite varied. The
challenge for each organizational unit is to identify the specific product, service, or activity
associated with environmental data collection and use and environmental technology
development and implementation, and to develop a measurable standard of quality.
For example, if an organization's environmental data collection product is compliance
monitoring to compare the effluent concentrations discharged against NPDES permit
requirements, the customer for this activity may be the State regulatory agency. In this case, a
customer quality measurement imposed on the supplier may be the percentage of samples
analyzed by a contractor laboratory over a 1-month period that meet data validation and
verification requirements.
b. Quality System Suppliers: Communication to and feedback from suppliers are
critical elements of the Quality System's ability to meet customer specifications.
This section is designed to ensure that suppliers are identified and that a process for
communication to and feedback from suppliers in meeting customer needs is put in
place. (Section 4.0 contains more-detailed requirements related to procurement.)
1. Identification of Suppliers: Identify the suppliers and backup suppliers of
the products, services, and activities for which the organization documenting
the Quality System is responsible.
Identification of Suppliers:
This refers to suppliers whose products, services, and activities directly affect the
quality of the organization's products, services, and activities. As many of these
specific suppliers are project-dependent and may not be known in advance, the
identification of generic types of suppliers may be appropriate.
2. Communication with Suppliers: Describe how customers' specifications are
communicated to suppliers to ensure that the product, service, or activity
meets these specifications. (See Section 1.5 below.)
3. Feedback from Suppliers: Describe how feedback is obtained from suppliers
on constraints (e.g., resources, technology) that affect their ability to meet
specifications established for the products, services, and activities for which
they are responsible.
1.5 Communication of the Quality System
a Describe how the Quality System is communicated to personnel at all
organizational levels by both management (senior and line) and QA personnel.
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b. Describe how key decisions, directions, and specifications are effectively
communicated to all customers and suppliers, both internal and external.
About Communication:
Importance: The most well-thought-out policies, procedures, and technical guidance to
manage quality are only effective if communicated to all those who supply the
organization's needs. Communication of these policies to customers prior to their
adoption is essential to ensure that the policies, procedures, and guidance are aligned
with customer needs. If policies and procedures are not communicated to customers
until after adoption, the organization and its customers may not have the same
expectations as to how the Quality System is maintained and how customer needs will
be met. Differing expectations are a frequent source of conflict in the implementation of
environmental programs.
Who? As described in this section, customers and suppliers incorporate the universe of
external and internal interests who are responsible for and are users of environmental
data collection and environmental technology programs. Sometimes these individuals
are also described as "stakeholders" and include: employees of the organizational units;
support contractors, subcontractors, and their field personnel; State and Federal
regulatory agencies; local government personnel; Indian Tribes; environmental
organizations; reuse committees; Restoration Advisory Boards; and many others.
How? Effective communication requires a thoughtful commitment to thinking through
the nature of the audiences and their needs for information. A communication strategy
can be used to outline communication of different information to different audiences.
1.6 Management Assessment of the Quality System
a. Describe the Regular Management Assessment Process: For each organizational
unit covered by the organization's QMP, describe how the implementation and
effectiveness of the Quality System are regularly assessed and documented. Such
assessment will take place at least annually.
Routine Management Assessments Are Important Quality Management Tools:
To evaluate whether the system produces environmental data and technologies of a
quality adequate to support the organization's mission;
To evaluate the adequacy of resources available to support the Quality System; and
To identify corrective actions that can improve, modify, and/or better implement the
Quality System.
b Identify Quality Measurements for the Quality System: Describe the process for
assessing successful implementation of the Quality System.
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Management Quality System Measurements:
Assessments of management Quality System performance and effectiveness are different but
directly related to measurements of customer satisfaction. While customer Quality System
measurements relate directly to customer specifications, management Quality System
assessments will measure:
The frequency with which customer satisfaction measurements are achieved,
Staff knowledge of the customers and their quality requirements, and
The existence of a feedback system that systematically conveys customer requirements to
suppliers.
c Describe the management responsibilities for the assessment of the Quality
System. Each organizational unit must be assessed.
d. Describe the processes used to report the results of assessments to senior
management, determine appropriate corrective actions, and evaluate the effectiveness
of the corrective actions.
Other elements of assessment procedures and requirements are contained in Section 9.0 of
this document.
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2.0 QUALITY SYSTEM AND DESCRIPTION
This section specifies that organizations must document a Quality System in a QMP or
equivalent document. Any QMP written in conformance with this UFP will also be in conformance
with ANSI/ASQC E4.
While this UFP establishes specific requirements for documenting a Quality System, it is not
necessary to write a lengthy narrative that sequentially addresses each requirement. Tables and
other simplifying charts are useful tools for communicating this information. For example, most of
the requirements found in Section 1.1 a-c can be consolidated and addressed in a table such as the
one below.
Mission
Covered
Program
Organizational
Unit
Products, Services, and/or
Activities
Example Table Headings for Section 1.1 of the QMP.
Whether documented in a Quality Management Plan organized in the manner of this
document or in some equivalent document, writing down the Quality System processes and
procedures is the foundation for a Quality System. Documented processes are the starting place for
communication of responsibilities and requirements throughout the organization. Common
expectations, when documented, yield accountability.
2.1 Documentation of the Quality System
a. The Quality System of an organization performing environmental data collection and
implementing environmental technology programs must be formally documented
in a QMP or an equivalent document.
Other Documents Included in Quality System Documentation:
The Quality System itself will include other documents, such as Quality Assurance Project
Plans and standard operating procedures. Furthermore, documents may be in electronic
format when the controls in Section 5.0 are applied to the electronic document system.
b. The QMP or equivalent document for each organization must also describe the
subdivisions of the organization required to provide either separate QMPs or
supplemental information to be referenced in the parent organization's QMP.
Responsibilities for receiving and incorporating supplemental information into the
organization's QMP must be identified.
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If documentation of the Quality System is not consistent with the headings of this
document, state how the organization's Quality System is documented and provide
cross-references to the UFP.
Describe the roles and responsibilities of senior management and QA personnel
for developing, reviewing, approving, and revising Quality System
documentation. Describe the frequency (at least annually) with which Quality
System documentation must be reviewed and updated.
Updating QMPs:
Many aspects of the Quality System will remain constant over a number of years:
An annual update of the entire QMP is not necessary (although an annual review must be
performed).
Frequent updates are needed only to change certain aspects (e.g., organizational changes,
designated quality management personnel).
Elements of the QMP that are subject to frequent change can best be handled as tables
and/or appendices that can be easily revised, or they can be referenced or linked to other
readily available documents.
The initial QMP or equivalent document should include the expected schedule for
updates, such as "annually if needed."
For each program in the organization, provide a list of all other quality-related
documents, including suborganization QMPs, program management plans, quality
manuals, organizational policy statements, requirements and guidance documents,
and standard operating procedures.
Identifying Other Quality-Related Documents:
This requirement can be accomplished either by attaching a list or by identifying (1) where
the list is maintained, (2) the process for maintaining the list, and (3) personnel responsible
for maintaining the list.
f. Provide a signature page for the QMP that demonstrates that (1) the QMP (or
equivalent document) is the official policy of the organization, and (2) the QMP has
been reviewed and approved for implementation by both senior management and QA
staff.
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Electronic Reviews and Approvals:
Reviews and approvals may be "electronic" when users and stakeholders have access to
electronic document control systems and the policy of the organization allows electronic
approvals.
2.2 Quality System Tools
The QMP must discuss the principal tools utilized in the Quality System and describe how
they are used to implement the Quality System. These tools include, but are not limited to, QMPs,
management assessments (self and independent), Systematic Planning Processes, QAPPs,
requirements and guidance documents, standard operating procedures, technical assessments (self
and independent), data quality assessments, and corrective action tools. The discussion must also
identify how and when these tools of the Quality System are to be applied to individual products,
services, and activities.
Table Format Ties Quality System Tools to Function:
A table may be a useful way of tying products, services, and activities to specific quality tools. A few examples
are provided below:
Product, Service, or
Activity
Planning for collection of
environmental data
Analysis of environmental
samples
Quality System Management Tool
Data Quality
Objectives
Systematic Planning
Process
Quality Assurance
Project Plan (QAPP)
Audit of laboratory quality system
Requirements
For each project requiring the
collection of environmental
data
Conducted annually or
verified that a recent audit to
an equivalent quality standard
has occurred within that time
period
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3.0 PERSONNEL QUALIFICATION AND TRAINING
Qualified and properly trained personnel are key elements of a Quality System. The
requirements of this section are designed to address how the organization will educate and train
personnel (management and technical) to support both the implementation of the Quality System
and the quality requirements of individual projects.
3.1 Establish Technical Proficiency and Quality Requirements at the Organization,
Program, and Project Levels
a. Training to Implement the Quality System: Describe how the organization's
management and technical training support the Quality System. Define roles and
responsibilities for implementing the training activities. Include basic training
requirements for:
Senior managers,
Line managers,
Program and project staff,
Quality assurance personnel, and
Other staff responsible for quality-related functions as appropriate.
Personnel must be provided the following training:
1. Training that provides a working understanding of the Quality System, along
with tools and techniques (e.g., technical, managerial, communication, and
interpersonal skills ) to enable them to participate in planning, implementing,
and assessing the Quality System.
2. Training based on project-specific requirements. Personnel must be trained
and qualified for the specific projects prior to the start of work.
b. Certification and Qualification Requirements for Special Activities: Describe
the process, roles, and responsibilities for establishing when formal certification or
qualification are required for personnel performing certain specialized activities.
Describe how personnel qualifications, experience, and education for specialized
activities are evaluated to determine these requirements.
3.2 Evaluate Training Needs
Describe how employee training needs are determined relative to the requirements in Section
3.1. The process of identifying training needs relates evaluation of personnel job proficiency to
corrective action through training. Include the management process, roles, and responsibilities for:
Tracking and evaluating personnel job proficiency for required tasks,
Identifying skills needed to perform required tasks,
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Seeking employee input on training needs, and
Periodically evaluating, updating, and improving the training program.
3.3 Prioritize Training Resources
Discuss roles and responsibilities for establishing training priorities and for obtaining and
allocating funds.
3.4 Provide Training
Describe how Quality System and project-specific training needs are met. Describe the roles
and responsibilities for providing training. Address the full range of formal and informal training
opportunities provided, including, for example:
Technical and management training,
Internal and external training courses and seminars,
On-the-job training, and
Training specifically targeted to enhance the understanding of and contribution of
personnel to the Quality System.
3.5 Provide Access to Information
Describe how individuals involved in implementing the Quality System and site-specific
projects are kept informed of updated quality policies and technical and quality requirements and
procedures. Continuing access to information on new requirements is an important aspect of
ongoing training.
The Information on Training Must Indicate:
How personnel are notified of relevant changes to the Quality System and technical requirements;
How personnel can obtain direct access to changed requirements and guidance; and
How personnel are kept informed of the status of current and obsolete requirements. (See also Section 5.0,
"Documents and Records.")
3.6 Training Effectiveness and Retraining
Describe the process, roles, and responsibilities for determining whether and when retraining
is needed (e.g., when job requirements change or when job performance is deficient).
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3.7 Documentation of Training
Describe the process, roles, and responsibilities for developing and maintaining formal
training records.
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4.0 PROCUREMENT OF PRODUCTS, SERVICES, AND ACTIVITIES
This section addresses procurement as an essential element of a complete Quality System.
Suppliers must be held accountable for supplying products, services, and activities that meet
specifications. The purchasing organization must be responsible for establishing specifications and
acceptance criteria and for verifying that the supplier is capable of meeting them. The organization
must have a formal process for assessing and documenting a supplier's Quality System. Remember,
the adequacy of an organization's Quality System depends on the adequacy of its supplier's system.
Refer to Section 8.3 for additional information on work processes implemented through contracts
and other assistance agreements.
4.1 Planning and Control
Describe the processes, roles, and responsibilities for:
Identifying purchased products, services, and activities (including items purchased
through contracts and subcontracts) that directly affect environmental data and data-
related decision quality and environmental technology programs;
Defining the specifications and acceptance criteria for products, services, and
activities (see Section 1.4); and
Identifying which suppliers must have a documented Quality System that complies
with these requirements. Every supplier of products, services, and activities that
affect environmental data quality and environmental technology programs must have
a documented Quality System.
Government Specifications for Contract Quality Requirements:
Recent revisions to the Federal Acquisition Regulations (FAR), 48 CFR, Part 46, Section
46.202-4, replaced references to government specifications for higher-level contract quality
requirements with references to commercial specifications. They also require that the
government contracting officer indicate in the solicitation which higher-level quality
standards will satisfy the Government's requirements. Examples of higher-level quality
standards are ISO 9001, ISO 9002, or ISO 9003; ANSI/ASQC Q9001, Q9002, or Q9003;
QS-9000; AS-9000; ANSI/ASQC E4; and ANSI/ASME NQA-1.
4.2 Assessment and Verification
Describe the process, roles, and responsibilities for evaluating the capability of a
supplier to meet the specifications and acceptance criteria for the products, services,
and activities to be provided. This process must be consistent with contracting
requirements and should include the following activities:
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1. Reviewing the supplier's documented Quality System to ensure that it is
consistent with these consensus requirements or with other appropriate
standards;
2. Performing an on-site audit of the supplier's Quality System;
3. Inspecting products, services, and activities and evaluating objective
evidence furnished by the supplier; and
4. Obtaining feedback from the supplier on constraints to meeting the
requirements.
b. Develop procedures for resolving disputes over quality with suppliers consistent with
existing dispute resolution procedures and appropriate regulations, such as Federal
Acquisition Regulations (FAR). If preexisting procedures are used, provide
appropriate reference to them.
c. Develop procedures that specify how changes are made, tracked, and communicated
to the organization.
4.3 Procurement Documents and Records
Describe the process, roles, and responsibilities for developing and maintaining procurement
documents and records consistent with FAR and contracting requirements.
Procurement Documents Should:
Contain information clearly describing the specifications and acceptance criteria for the products, services,
and activities to be procured;
Explain how the supplier's conformance to specifications will be verified;
Be reviewed for accuracy and completeness before being provided to the supplier [Note: Both the
procurement specialist and a person who is technically qualified to ensure that specifications and
acceptance criteria are properly developed should perform this review]; and
Be reviewed at the same level of review and approval when changes occur as was done for the original
documents.
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5.0 DOCUMENTS AND RECORDS
This section addresses the management of effective identification, preparation, control, and
storage of technical and quality-related documents and records. The requirements of this section
are designed to:
Identify required documents and ensure that their preparation meets the needs of
customers and suppliers;
Ensure that the latest version of policies, requirements, and guidances are known and
made available to users; and
Maintain a historical "record" that gives Quality System users access to the actual
body of information that was critical to decision making at the time the decision was
made.
Defining Documents and Records:
ANSI/ASQC E4 defines a document as any written or pictorial information describing, defining,
specifying, reporting, or certifying activities, requirements, procedures, or results pertaining to
environmental operations.
A record is a document that furnishes objective evidence of the quality of products, services, or
activities and that has been verified and authenticated as technically complete and correct.
For the purposes of this section, a document or record can be available in either print or
electronic media.
5.1 Identification of Technical and Quality-Related Documents and Records Requiring
Controls
Describe the process, roles, and responsibilities for identifying technical and quality-related
documents and records requiring control. Indicate which documents and records specify quality
goals and objectives and demonstrate attainment of those goals and objectives.
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Examples of Documents To Be Considered for
Control
Examples of Records Where Controls Are
Considered
Blueprints
Design Documents
Quality Assurance Project Plans (QAPPs)
Field Sampling and Analysis Plans
Quality Management Plans (QMPs)
Health and Safety Plans
Policy and Guidance Documents
Technical Manuals
Workplans
Other Types of Instructions, Procedures, and
Operating Guides
Standard Operating Procedures
Assessment Results and Findings
Calculations
Calibration Data
Data Usability Results
Field Logbooks
Inspection Results
Instrument Test Data
Materials Testing Results
Personnel Qualifications
Sampling and Analytical QC Data
Sampling and Analytical Data
Technical and Readiness Review Results
5.2 Description of Systems for Controlling Technical and Quality-Related Documents
Describe the systems for managing technical and quality-related documents and records from
preparation through disposal. Include document preparation tasks such as writing, categorizing,
reviewing, approving, issuing, using, and revising. Include management tasks such as collecting,
indexing, filing, storing, maintaining, protecting, archiving, retrieving, authenticating, distributing,
and disposing, and otherwise managing technical and quality-related documents and records.
System descriptions should specifically address such topics as:
1. The process for identifying, preparing, and adopting policies, guidances, regulations,
and other instructions;
2. The proper format for documents and records;
3. The process for updating and recording changes to requirements, guidance, and
procedural documents in response to changes to regulations, requirements, and
policies, as well as changes in the document management system;
4. The process for correcting or revising records;
5. Designation, qualification, and responsibilities of authorized personnel (e.g., writers,
reviewers, approvers) for each of the above; and
6. Allowable means of records transmission and document and record security,
traceability, retention, and accessibility to stakeholders.
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Retention and Storage of Documents and Records:
Document and record retention times are often determined by contractual and statutory
requirements. If these requirements are not applicable, senior management should
specify the retention time.
Stored documents and records must be protected from damage, loss, and deterioration.
Processes for the storage of documents and records must consider the uses to which the
documents and records may be put in the future and the resulting need for accessibility.
5.3 Tracking and Retrieval of Technical and Quality-Related Documents and Records
Describe the systems, roles, and responsibilities used to ensure documents and records are
easily retrievable even when the document/record is revised, if the organization changes, or when
information technologies and systems are replaced or become obsolete.
a. Describe the systems, roles, and responsibilities for storing and archiving technical
and quality-related documents and records, including a statement or reference
indicating where they are stored.
b. Describe the systems, roles, and responsibilities for controlling and maintaining
technical and quality-related documents and records that require restricted access
(e.g., national security, enforcement, or proprietary business information).
c. Describe the control systems, roles, and responsibilities for review, approval, and
revision of technical and quality-related documents and records, and for ensuring that
only current/superseding versions are available and used.
Document and Record Control Systems:
Control systems include techniques such as numbering consecutively and dating each
new document revision. Documents may be revised for a variety of reasons (e.g., to add
new information, to delete obsolete information, or to correct errors).
Although it is extremely important to ensure that people use the most current version of a
document or record, older outdated versions should be retained to maintain the ability to
reconstruct project/studies in the event they are later contested or challenged.
d. Describe specific change control procedures that ensure that the user can identify
those parts of previous documents that are superseded by new document versions.
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e. Describe the control systems, roles, and responsibilities for establishing,
implementing, and maintaining appropriate chain-of-custody and confidentiality for
evidentiary technical and quality-related documents and records.
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6.0 COMPUTER HARDWARE AND SOFTWARE
This section briefly addresses how the organization will ensure that computer systems are
managed such that they:
Meet customer needs;
Manage change;
Facilitate the development, transmission, use, and manipulation of quality data; and
Plan for obsolescence such that relevant information can be accessed in the future.
Computer hardware and software, including applications such as electronic communications
systems, are essential management tools for environmental data. Computer hardware and software
are used for a variety of purposes, including making calculations and projecting the impact of
information collected, storing data, and displaying visualizations. As such, the management of
computer hardware and software and the data they contain is critical in meeting the quality
requirements of electronic environmental data.
When computer hardware and software is purchased, it has been tested by the developer prior
to release. Once purchased, however, the systems are configured to meet the requirements of the
user. The use and manipulation of procured hardware and software leaves room for human error and
therefore unintended quality issues with data use. Finally, data is received and stored in large
computer systems from a variety of sources. Controlling the quality of the data coming into these
systems presents a tremendous challenge to agency managers.
Attention to computer-related issues is particularly important in this era when technology
is changing at a rate that makes it difficult for organizations to effectively manage such change.
Cross-References to Other Sections of This Document:
In addressing requirements of this computer section, you may cross-reference applicable Quality System
requirements documented in your QMP.
Requirements regarding the procurement of computer hardware and software and the development and
verification of acceptance criteria are addressed in Section 4.0, "Procurement of Products, Services, and
Activities."
The documentation requirements for computer hardware/software are provided in Section 5.0, "Documents
and Records."
Planning requirements for data collection and use are provided in Section 7.0, "Planning."
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Computer Software and Computer Hardware/Software Configurations and Programs:
Those processes covered by these requirements might include, but are not limited to:
Design and design analysis;
Modeling of environmental processes and conditions;
Operations or process control;
Data transmission;
Data validation, verification, and assessment;
Risk assessment;
Data storage; and
Databases or document control registers (when used as the controlled source of quality information).
Note: Laboratory computer systems are addressed in the National Environmental Laboratory Accreditation
Conference (NELAC) Standards.
The QMP must include a description of the management of computer hardware, software,
and electronically stored information. This description must include a discussion of the roles and
responsibilities assigned to management and staff. The QMP must document how the organization
manages its computer hardware and software operations that directly affect the quality of the results
of environmental programs. At a minimum, the QMP must perform the functions outlined below.
Additional description and detail for each of the following elements is provided in Appendix B.
Cross-Reference Agency Guidance on Information Management:
Many agencies have issued guidance on general information management and on specific issues such as
software development methodology. For example, the EPA has issued the EPA Information Resources
Management Policy Manual (EPA Directive 2100), andDoD has issued Directive 8000.1 on its Defense
Information Management (IM) Program. Cross-references in the QMP to other documented processes may be
appropriate to satisfy the requirements of the QMP to document the process, roles, and responsibilities for
computer hardware and software and information management.
6.1 Describe the Process, Roles, and Responsibilities for Configuration Testing and
Documentation
Describe the process, roles, and responsibilities for ensuring that systems (hardware
and software) are configured to perform their intended functions, meet user needs,
and preserve the integrity of the information used in the systems.
Describe the process, roles, and responsibilities for ensuring that computer hardware
and software are installed and operated in accordance with the manufacturer's
recommendations and that systems are adequately tested, inspected, and maintained
on a regular basis.
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About Configuration Testing and Documentation:
This section does not anticipate that it is the role of the quality staff of an organization to test the hardware and
software of the organization. This section does recognize that someone within the organization must have the
responsibility for ensuring that the hardware and software have been configured to the manufacturer's
specifications and that they operate as advertised. Responsibility for configuration management may be totally
outside the environmental programs that are the subject of this document. In that case, the QMP should briefly
cross-reference those procedures that are put in place by the organization to ensure appropriate configuration
management.
6.2 Describe the Process, Roles, and Responsibilities for Managing Changes to Hardware
and Software Configurations
Include a description of how changes to an existing hardware and software configuration will
be managed.
6.3 Describe the Process, Roles, and Responsibilities for Developing and Evaluating
Software
When purchased software is altered or programmed to perform a specific function, such
alteration and/or programming must be evaluated to ensure that results are accurate. Such evaluation
may range from checking the accuracy of software codes to formally peer reviewing the
programming and the logic behind the programming, depending on the nature and complexity of the
project.
Validating Software:
Commercial off-the-shelf (COTS) software that is purchased and used for its intended purpose and installed
according to the manufacturer's instructions need not be validated. However, all specialized software and
COTS software that is altered or programmed by the user for a particular purpose should be validated to ensure
that the programming will meet user specifications.
6.4 Describe the Process, Roles, and Responsibilities for Verifying That the Data Being
Compiled and the Quality Control and Maintenance of These Data Are Appropriate
for Their Intended Use
Evaluation of Data:
A number of issues affect the evaluating of data to ensure they are appropriate for their intended use. The
Systematic Planning Process described in Section 7.0 is designed to ensure that data collected is appropriate for
the use to which it will be put. When the data used are secondary data (i.e., not collected for the purpose for
which they are now being used), evaluation of the appropriateness of the data application will be particularly
important.
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6.5 Describe the Process, Roles, and Responsibilities for Developing Procedures To Ensure
That Historical Files Are Documented and Can Be Recovered
Include a description of a plan for storing and archiving relevant information so it can be
recovered even as hardware and software are changed.
Ensuring Information Retrieval:
You should develop a plan for storing, archiving, and retrieving information in a format you will be able to use.
This may involve:
(a) Identifying the timeframe for which old data will be retrievable.
(b) Storing old copies of software and hardware so that data can be retrieved in the future.
(c) Planning for the migration of data to new software so that you will be able to access information in the
future even as hardware and software systems become obsolete.
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7.0 PLANNING
This section describes how the organization or unit ensures quality in the planning of proj ects
that involve environmental data collection and technology programs. The foundation of the
planning process utilized is a Systematic Planning Process. This process:
Relies upon the scientific method,
Involves stakeholders, and either
Defines the quality of data appropriate for the intended uses or
Results in the implementation of a technology that meets customer specifications.
Orienting the planning process toward developing performance criteria appropriate to the
decision to be made ensures that the nature of the planning process (and the level of activity
required) is varied according to the needs to be met. This is called a "graded" approach.
Benefits of the Systematic Planning Process Include:
Encouraging comprehensive, careful planning by soliciting input from concerned customers and
stakeholders;
Addressing costs and schedule in the design phase, the critical time to address total project constraints;
Communicating and documenting proposed activities and decisions to be made so that everyone has a
common understanding of requirements when considering the data collection or work design, strategies,
and the end use of products;
Addressing the concerns of customers, suppliers, and relevant technical experts for products, services, and
activities, thus minimizing the possibility of repeating work because of inappropriate or inadequate project
implementation; and
Facilitating the application of promising innovative technology by reconciling technology capabilities with
site-specific considerations.
7.1 Management of Systematic Planning
The QMP must include a description of the management process that each organizational
unit will use to ensure the implementation of a Systematic Planning Process for environmental data
collection and use and environmental technology programs.
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Systematic Planning and the Data Quality Objectives Process:
In 1994, EPA developed a Systematic Planning Process called the Data Quality Objectives Process and
published a document called "Guidance for the Data Quality Objectives (DQO) Process" (EPA/600/R-96/055,
1996). While not mandatory, this process is the recommended planning approach for many EPA data
collection activities. The processes followed by other Federal agencies do not necessarily follow the seven
steps of the Systematic Planning Process. For example, using different terminology, but a similar Systematic
Planning Process, the U.S. Army Corps of Engineers adopted a four-step Technical Project Planning Process to
implement systematic planning for cleanup activities.
The term "systematic planning" is the generic term used to describe the "data quality objectives process"
(a specific type of systematic planning). Confusion is caused by the different names applied to the similar
Systematic Planning Processes used by different Federal agencies and departments. Although the DQO process
may not be applicable to all data collection, use, and technology implementation activities, systematic planning
is applicable. Therefore, the new EPA Order, "Policy and Program Requirements for the Mandatory Quality
System" (5360.1 A2 May 2000), requires that all EPA organizations use a Systematic Planning Process to
develop clearly articulated decision goals from which are derived acceptance or performance criteria for the
collection, evaluation, or use of environmental data and for implementation of environmental technology
programs.
The term "acceptance or performance criteria" replaces the term "data quality objectives" to describe the output
of the Systematic Planning Process. This document adopts the same language of the EPA Order and uses the
broader term, "Systematic Planning Process," rather than the frequently misunderstood terminology currently
associated with the DQO process.
At a minimum, this management process must:
a Describe the Applicability of the Systematic Planning Process: Describe the
products, services, and activities that require a Systematic Planning Process.
b Describe Roles and Responsibilities:
Describe the roles and responsibilities of managers in overseeing the
implementation of the Systematic Planning Process within the
organization(s) addressed by the QMP; and
Describe the roles and responsibilities of project personnel in planning and
carrying out a project. Project roles and responsibilities that must be
addressed include those of the Government project manager, contractor
project manager, quality assurance coordinator, technical experts, contract
managers/officers, and other customers and suppliers.
c Target the Level and Type of Planning to the Significance of the Activity or
Decision: Describe how a graded approach will be used to ensure that the level of
QA/QC is commensurate with the significance of the decisions and/orthe importance
of the work and the availability of resources.
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d. Identify Constraints: Describe the process used to consider operational constraints
(e.g., scheduling, logistics, budgetary, coordination, and communication) to adjust
the Systematic Planning Process and to cost-effectively meet the operational
purpose(s).
e. Describe Implementation and Control: For each organizational unit, activity, or
process subject to a Systematic Planning Process, describe how that planning process
is implemented and controlled. This discussion should include: resolving conflict,
developing project goals and acceptance criteria, and addressing the responsibility
for stopping the process when issues change the direction or warrant termination of
the process.
f. Provide Assessment and Feedback: Describe how the management of each
operational unit responsible for implementation of a Systematic Planning Process
will assess its effectiveness and provide corrective actions and additional direction.
g. Identify Planning Documentation:
Identify planning documents required by applicable standards, specifications,
statutes, and other requirements of society (e.g., management plans,
workplans, schedules, project plans, and operating procedures); and
Require that all project-specific environmental data collection and
environmental technology work be documented by a project-specific QAPP
containing a level of QA/QC appropriate to the decision.
h Describe Documentation Preparation, Review, and Approval:
Describe the process, roles, and responsibilities for preparation, review, and
approval of planning documents (e.g., workplan, schedule, project plan,
QAPPs, SOPs) prior to initiation of work;
Identify the responsible individual(s); and
Discuss this process as it applies to planning documents that are prepared (1)
directly by the organization and (2) by the organization's contractors,
subcontractors, and assistance or other type of agreement holders.
7.2 Elements of Systematic Planning Processes
The key elements of the Systematic Planning Process to be implemented for projects
involving environmental data collection and use and environmental technology development and
implementation must be described. The QMP should provide general guidance about the
implementation of a Systematic Planning Process, while site-specific QAPPs document the
individual elements.
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QAPPs are the primary outputs of the Systematic Planning Process and are used to document
the results of planning, to implement environmental operations, and to assess project results. The
National Consensus QAPP Guidance, currently under development by the IDQTF, will facilitate the
development of QAPPs based on the Systematic Planning Process. The minimum elements are
listed below, with additional description and detail for each element provided in Appendix A.
a. Establishment of a Team-Based Approach to Planning
b. Description of the Project Goal, Objectives, and Questions and Issues To Be
Addressed
c. Identification of Project Schedule, Resources (Including Budget) Milestones, and
Any Applicable Requirements (e.g., Regulatory Requirements, Contractual
Requirements)
d. Matching of the Data Collection and Analysis Process to Project Objectives
e. Identification of Collection and Analysis Requirements
f. Description of the Generation, Evaluation, and Assessment of Collected Data
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8.0 MANAGEMENT OF WORK PROCESS IMPLEMENTATION
This section describes the execution and administration of environmental data collection and
technology programs. This section should also describe how work products, services, and key
activities are monitored to ensure that work is performed according to the approved planning and
technical documents. Who is authorized to stop work? On what grounds?
The realization of appropriate quality will be achieved when the work process is correctly
and deliberately implemented. Work processes can vary substantially from one activity or project
to another in terms of simplicity, repetition, standardization, accuracy, and precision requirements,
and the level of required supervision. The planning process will help establish these parameters and
attributes at the earliest stages of the effort; the implementation structure of each project will vary
based upon these factors. This section describes key QMP elements to ensure that work processes
are implemented in a manner consistent with the specifications and acceptance criteria.
The management process outlined in the QMP specifies how the organization makes the
transition fromplanning an activity to doing it the actual performance of planned tasks. It should
also address the requirements for day-to-day supervision and monitoring (i.e., internal oversight)
of the staff creating or performing key products, services, and activities.
Relationship Between Day-to-Day Monitoring and Assessments:
This day-to-day monitoring, often performed through inspection/oversight by direct supervisors, is different
from the internal and external assessments performed by others in the organization (e.g., QA staff) or by
independent parties. These assessments, which are also critical to ensuring quality, are addressed in Section
9.0, "Assessment and Response."
8.1 Procedures for Implementation in Accordance with Plans
The implementation section of the QMP must describe:
a. The method for ensuring that work proceeds according to the approved planning and
technical documents.
b. The sequence of the work process and a level of organizational daily supervision
and/or oversight consistent with the importance of the project and the use of project
results.
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For Example:
If a key work process is the collection of environmental samples for effluent discharge
permitting or compliance evaluation, the QMP should describe the level of regular supervision
and oversight required for this data collection. The level should be based upon factors such as
past performance, experience of workers, and consequences of nonconformance. This
Uniform Federal Policy does not intend to add more supervision when it is not needed.
c. How performance is measured against the specifications developed during the
planning process (e.g., through the use of QA/QC samples or procedures). Describe
the process for routinely monitoring and reporting performance against
specifications, as well as the process for identifying routine corrective action.
Describe the timeframes for corrective action and the personnel responsible for
implementing them. (See Section 9.0 for details about the next layer of oversight, the
assessment.)
d. How the organization ensures that the personnel performing the work or activity
have the training and competency required to implement a specific project.
Similarly, describe how the organization ensures that the supervisor(s) of that daily
work is qualified to perform that regular monitoring. (See Section 3.0, "Personnel
Qualification and Training").
8.2 Managing Quality Implementation Through the Use of SOPs
Standard operating procedures (SOPs) are valuable tools for identifying operations and the
steps required to complete them. SOPs are used at the project level to facilitate consistency in the
quality and integrity of the product or activity. An individual project may demand the use and/or
modification of an existing SOP or the creation of a new one. The QMP must provide an overview
of how this is accomplished by the organization. The QMP must:
A Word About SOPs:
Numerous documents guide work processes. Procedures for management of documents are outlined in Section
5.0 of this Uniform Federal Policy. These more detailed procedures recognize that SOPs are special-case
documents that have an immediate impact on the way work is implemented and require special attention as to
how they are prepared, revised, and managed.
Identify Operations Requiring SOPs: The QMP must identify the operations
(products, services, and activities) to which SOPs apply and for which they must be
used. Completeness of this list may be ensured by cross-referencing the
organizational chart, list of operational centers, and current list of SOPs.
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For Example, the QMP May Specify That:
SOPs (written procedures) are not required
When work processes are directly supervised,
When an initial process is in development, or
When the process involves problem evaluation or repair of equipment.
SOPs (written procedures) are required
When there are multiple detailed steps,
When results must be within a specified accuracy and/or precision level,
When there is high turnover of workers,
When there is a need to document the steps followed for the record, such as for
repeatability,
Where the consequences of nonconformance are significant, or
When the results must be comparable between different workers.
Additional details about the development and use of written procedures are addressed in the
next subsection
b. Describe the Process for Managing SOPs: A list of the most current, approved
SOPs, with control documentation (including the revision number, date,
identification number) and approval date for each, must be maintained by the
organization as part of its Quality System documentation and must be referenced in
the QMP. Inventorying SOPs in a comprehensive list allows the organization to
easily identify the most recent SOP versions and those that may require updates.
This inventory also establishes a central database from which a document
distribution and control system can be managed. (See Section 5.0, "Documents and
Records").
Examples of SOPs That May Be Listed:
General sampling procedures such as cleaning of sampling equipment, well purging, field
measurement guidance, matrix-specific sampling techniques, and data validation procedures.
c.
Cross-checking to ensure completeness of the organization's SOPs with respect to
the operations it performs is a necessary management step. The QMP must identify
who is responsible for this activity and identify the process for ensuring that the
activity occurs.
Describe How the Appropriate SOP Is Identified and Selected: The QMP should
describe the process and criteria used to select an appropriate SOP and the procedure
for documenting the chosen SOP when an array of approved SOPs are specified for
a particular task. The QMP should also describe the method used to tailor an SOP
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to fit the needs of a particular project, and how this need is identified at the
beginning of the process.
Describe SOP Format and Content: The QMP should state the organization's
commitment to writing SOPs that are easily understood by the user and that contain
sufficient detail and clarity to ensure reproducibility in the implementation process.
SOPs Should Include the Following Elements:
(a) Title Page, Table of Contents, and Control Documentation (revision number, date,
identification number).
(b) A Procedures section addressing such items (where applicable) as scope and
applicability, definitions, warnings and cautions, personnel qualifications, materials and
equipment, calibration/benchmarking requirements, troubleshooting, data analysis, and
data management.
(c) A QA/QC section outlining the verification and/or oversight steps and materials
required to check the quality of the product or activity. As an alternative to a separate
QA/QC section, these steps may be integrated into the Procedures section and
appropriately identified.
(d) A References section listing other documents and procedures that interface with the
SOP, including any applicable checklists.
Describe the SOP Approval Process: Describe the roles and responsibilities for
SOP review and approval. Describe how the organization ensures that the SOP
reviewer is technically qualified to perform the review. The QMP must outline these
roles and responsibilities and specify how approval of SOP changes is
communicated. The QMP must also describe the timeframe(s) for these activities.
Describe the Process for Making Allowable Changes: Describe what triggers the
modification of an SOP. Describe how the organization manages the process when
changes to the procedure(s) are required. For example, the QMP may specify that
a field-based verbal approval to an SOP change is permissible, if immediately
followed by an approved written amendment to the QAPP. The QMP should create
a link between the scope of the change and the required level of approval, allowing
adequate time to implement the change and generate the supporting documentation.
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Building Flexibility into SOPs:
Incorporating appropriate decision tree strategies and contingency plans in conjunction with
preapproved, predefined SOPs during the planning process can establish a desirable level of
flexibility during the implementation phase of the project. For example, if a result lies
outside the instrument calibration range, an SOP describing an analytical procedure might
include an "If...then" analysis and contingency plan describing sample dilution processes.
The QMP should describe the conditions under which this type of analysis/plan is both
possible and desirable.
g. Describe the Process for Periodic Review, Revisions, Distribution, and
Archiving: Describe how the organization ensures that SOPs are periodically
reviewed and revised. Describe what triggers the review and/or modification of an
SOP. The QMP must describe the review process; the roles and responsibilities for
SOP revision, approval, and distribution; and the timeframe for reviews, revision,
and approval. The QMP should also address the removal and archiving of obsolete
documents from work areas, methods of ensuring that outdated SOPs aren't used, the
communication paths used to notify staff of procedural changes, and methods of
verifying that changes are made as prescribed.
Defining SOP Review Timeframes:
The frequency with which SOP reviews will be conducted should be SOP-specific. The
timeframe for reviewing SOPs should be appropriate to determine whether changes have
occurred and to ensure that SOPs remain living documents.
8.3 Work Processes Implemented Through Contracts and Other Assistance Agreements
Many organizations undertake the work processes to collect environmental data and manage
environmental technology programs on behalf of Federal agencies. These organizations include
contractors, grant recipients, and those entering other assistance agreements with the Government.
(For the purposes of this discussion, all of these organizations are referred to as "contractors.") The
QMP must:
a. Identify work processes (products, services, and activities) routinely carried out by
contractors.
b. Identify how the processes and procedures required by the Federal agency are
communicated to contractors.
c. Identify the roles and responsibilities of managers of contracts or other assistance
agreements, outside of the contractor's immediate project staff, in overseeing the
implementation of work processes.
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Identifying Roles and Responsibilities of Contractors:
Specific names do not have to be stated in the QMP, and a contractor's Quality System may
be used to identify contractor roles and responsibilities.
d. Describe the roles and responsibilities of Federal agency staff in overseeing the
implementation of work processes by contractors and holders of other assistance
agreements to ensure that work is conducted correctly and in accordance with
customer specifications.
e. Given the nature of contracting and other assistance agreement vehicles, describe any
constraints in overseeing the work of others and steps that may be taken to address
these constraints.
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9.0 ASSESSMENT AND RESPONSE
This section outlines the manner in which assessments will be identified and performed.
Assessments are performed so the organization can evaluate conformance with both technical and
procedural requirements. Various parts of this document identify the need for assessments. Section
1.6, for example, asks that annual assessments of the implementation of the Quality System take
place. Sections 7.0 and 8.0 ask that the planning process include measurements against which
achievement of quality objectives can be examined, and require routine assessment monitoring and
oversight of the implementation of work processes. Evaluating how work products routinely meet
customer needs and expectations is discussed in several sections (e.g., Sections 1.4 and 7.0).
Assessments are systematic, objective, and independent examinations of technical and
management processes. They are designed to identify problems, reveal areas of strength and
weakness, and allow management to evaluate the organization's processes and performance.
Types of Assessments Management and Technical:
Assessments differ from routine oversight in that they are objective, independent reviews conducted as part of
the Quality System. Two kinds of assessments are identified.
Management Assessments (also known as system audits) systematically measure the adequacy and
effectiveness of the organization's Quality System (as documented in the QMP) and its impact on work
products, services, and activities.
Technical Assessments are more narrowly focused to measure the performance of the work itself, with
respect to the established technical guidelines and SOPs and project requirements as identified by the
QAPP. Technical assessments will generally verify:
(a) Compliance with a project's QAPP or other planning documents;
(b) Effective implementation of procedures to ensure the quality of the products, services, and activities;
and
(c) Suitability of procedures to achieve project goals and measurement quality objectives (See Appendix
A.5.).
The results of routine technical assessments should feed into management assessments.
Note: The process for assessing environmental data to ensure that the quality of the data supports the use for
which they are intended is not addressed in this section. That assessment is an element of the Systematic
Planning Process that is implemented through a project-specific QAPP or equivalent document.
9.1 Identification and Planning of Assessments
The QMP must describe:
a. The types of assessments conducted (management self-assessment, management
independent assessment, technical self-assessment, and technical independent
assessment).
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b.
9.2
d.
How the organization determines the priority of the different types of assessments
and the criteria for selection of assessments to be conducted.
Criteria for Prioritization of Assessments:
In addition to an annual assessment of the Quality System as it is implemented throughout the
organization, management must identify priority technical assessments that will provide
objective information on the performance of the Quality System in producing quality
products, services, and activities. In selecting priority technical assessments, management
should consider:
The importance of the product, service, or activity to the mission of the organization;
The cost of quality failure (in either dollar or environmental terms);
The expectations and concerns of customers; and
Other factors that the organization deems appropriate.
How the organization determines the type, schedule, and tools for assessments.
(Tools include, but are not limited to, audits, data quality assessments, management
system reviews, peer reviews, performance evaluations, readiness reviews,
surveillance, and technical reviews.)
The process for determining the frequency of routine assessments (self and
independent) and any conditions and/or triggers under which additional assessments
may be required.
How the results of assessments will be evaluated to measure the effectiveness of the
implemented quality system.
Design and Implementation of Assessments
QMPs must describe a process for designing and implementing assessments that ensures that:
a. Specific objectives are identified for each assessment.
b. Assessments are based upon examination of objective evidence (observations of
current activities and examination of documentation of past performance) and, when
relevant, interviews of selected participants.
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An Example:
Examination of objective information is possible even in areas such as personnel knowledge
and awareness. For example, an organizational assessment of awareness of Quality System
requirements throughout the organization could be based on a combination of an objective
questionnaire, distributed to personnel, and follow-up interviews with selected individuals.
The objective questionnaire can seek basic information on knowledge of policies and
procedures and how that knowledge is communicated. Follow-up interviews can focus on
improvements to training and distribution of information on Quality System requirements.
Management assessments use objective criteria to determine:
If the Quality System is defined (i.e., documented) and if it adheres to
applicable requirements, and
If the Quality System has been implemented and if it is effective in meeting
the needs of the organization.
Assessments are developed to meet a specific scope of effort and to collect needed
information.
A Systematic Planning Process for Assessments:
Assessments, like the collection of environmental information, require a Systematic Planning
Process. This process starts with a decision on the scope of the assessment effort (the goal or
objective) and the identification of the information needed to achieve the goals. The
assessment team (which may be internal or external to the organization) will guide the effort.
The assessment team can systematically identify:
User or "customer" specifications;
The source of the information and the quantity, quality, and type of data to be collected;
Criteria against which the assessment will be performed; and
How the information collected will be evaluated to determine if it meets those criteria.
An assessment identifies whether it will address technical requirements, management
(or Quality System) compliance, or both.
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Technical Versus Management:
A decision as to the type of assessment (technical versus management) you are conducting
will affect the choice of personnel to conduct the assessment, the amount of information
collected, the information sources and, ultimately, the resources devoted to the assessment.
Assessing management or "systems" requirements may often seem easier to accomplish;
however, that type of assessment may or may not accomplish the objectives of the
assessment.
For example, if the organization wants to assess the role of QAPPs in planning for quality, it
must determine the focus of the assessment. If the organization wants to know whether
QAPPs are being developed and if they contain minimal specified information (e.g., data
quality objectives or analytical acceptance criteria), a strategy may be to:
(a) Select a percentage of projects for the assessment,
(b) Select a random number of projects for which QAPPs will be reviewed,
(c) Develop a checklist of what should be in the Table of Contents of the QAPP, and
(d) Assign personnel to determine if a QAPP was developed and if it had the right content.
If the purpose, however, is to assess the quality of QAPPs in documenting effective
Systematic Planning Processes, a higher level of personnel will be required to technically
assess the QAPPs. The development of objective qualitative measurements will be more
difficult. The cost of the assessment (for a similar number of QAPPs assessed) will be more
expensive.
f. Assessment design will result in reliable, consistent results that can measure
performance over time.
Assessment Instruments:
The production of consistent, reliable results often requires the production of assessment
instruments. These instruments may include questionnaires, audit and/or other review
checklists and procedures, or various quantitative performance measures based on results of
laboratory procedures. Procedures for ensuring reliable and consistent results may include:
Pretesting of survey instruments,
Pilot testing of audit procedures, and
Analysis of like information from similar sources to establish a reasonable range of
variability and uncertainty.
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9.3 Determination and Evaluation of Assessor Qualifications
The QMP must describe how the organization determines qualifications for assessor
personnel. These qualifications include management and technical skills, education, experience, and
training requirements, and may include requirements for formal qualification (or certification).
The QMP must also describe the system for ensuring that assessments are performed by
qualified personnel.
9.4 Responsibilities and Authority of Assessors
a. The QMP must describe the assessors' responsibilities and areas of authority. This
description must ensure that auditors or assessors have:
Sufficient authority,
Objectivity and independence from assessed organizations and
programs/proj ects,
Access to and support from management, and
Access to documents and records.
b. QMPs must also demonstrate that assessors have the organizational freedom to:
Identify and document problems affecting quality,
Identify opportunities for continuous improvement,
Propose corrective actions, when appropriate, for problems affecting quality
of work produced by assessed organizations, and
Independently confirm implementation and effectiveness of corrective
actions.
9.5 Roles and Responsibilities of Contractors and Others in Performing Assessments
The QMP must discuss the roles and responsibilities of Federal agency personnel versus
contractors or holders of assistance agreements in carrying out assessment functions. Those
assessment activities that are inherently governmental must be identified. In outlining the inherently
governmental functions, those activities that are discretionary (i.e., may be performed by either
governmental or nongovernmental personnel) must also be identified.
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In outlining the inherently governmental functions that are part of the assessment process,
the QMP must differentiate between internal and external assessments. Types of assessments that
must be addressed include:
a. External assessments performed by the Federal agency to oversee the work that the
contractor (or other assistance holder) performs,
b. Internal assessments conducted by the contractor or other assistance holder that
support the contractor's own Quality System, and
c. External assessments performed by the contractor or other assistance or agreement
holder to support the Federal agency in conducting external assessments of others.
For each of these, the QMP must identify:
a. The roles and responsibilities of contractor personnel in independently assessing the
implementation of their Quality System;
b. The roles and responsibilities of Federal agency personnel in assessing the
implementation of the contractor's (or other assistance holder's) Quality System; and
c. The roles and responsibilities of Federal agency personnel and contractors (or other
assistance holders) in assessing the Quality Systems of other entities (e.g., other
contractors, assistance holders, or Government organizational units).
9.6 Documentation, Reporting, and Review of Assessments
Documentation is a key element and output of the assessment process. The QMP must
describe:
a. The types of documents to be sent to those being assessed, as well as the types of
documents to be requested by assessors and the expected timeframe in which the
information must be transmitted.
b. The types of documents to be generated by the assessments, the recipients of the
documents, the timeframe for distribution, and any opportunity for the assessed
organization to provide in writing an initial response (e.g., comment on a draft to
allow for changes in report findings).
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Examples of Documents Sent to the Assessed:
Assessment notification and checklists or identification of what will be assessed.
Examples of Documents Requested by Assessors:
SOPs, QMPs, QAPPs, other planning documents, and prior assessment reports.
c. How conditions requiring corrective action will be communicated to those
responsible for the corrective action.
d. The requirements and procedures for reporting assessment findings to management.
e. Procedures for maintaining and controlling assessment findings and results.
9.7 Response to and Follow-up After Assessments
After an assessment is complete and the findings have been reported, the assessed
organization must respond to the findings, both to the assessor and within the assessed workgroup/
organization.
a. The QMP must describe the process, roles, responsibilities, and timeframe for the
response. Appropriate managers, QA staff, and technical staff must be involved.
b. The QMP must also discuss how follow-up is performed by the assessed
organization to ensure corrective action is taken in a timely manner.
c. The assessed organization must have a process in place for evaluating the
effectiveness of corrective actions and for approving and monitoring the corrective
actions triggered by the assessment.
d. The assessed organization must describe how it measures the success of the
assessment process in identifying problems (i.e., how assessments themselves are
assessed for effectiveness).
e. The assessed organization must document its response to and follow-up after
assessments.
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10.0 QUALITY IMPROVEMENT
This section describes requirements for continual quality improvement to lead to a better and
more responsive Quality System. Management must be the leader in the quality improvement
process to ensure adequate resources are provided, issues are resolved, and staff are motivated and
rewarded for helping the organization meet its quality improvement goals. "Quality improvement"
has three purposes:
Improving the quality system,
Detecting nonconformance and initiating corrective action, and
Creating an environment for facilitating and promoting quality improvement and
encouraging staff at all levels to participate in detecting areas for improvement and
identifying solutions.
Continuous Improvement:
Continuous improvement is a term used to describe the incremental improvements that take place over time as
the results of corrective actions are fed back into the Quality System. Continuous improvement does not
suggest that major revisions constantly place the Quality System in flux. Instead, continuous improvement
anticipates incremental changes that take place over time to minimize the recurrence of repetitive quality
problems.
10.1 Quality System Improvement Process
Describe how the Quality System is continually improved, including how regular reviews
of the Quality System (described in Section 1.6) and results of assessments (described in Section
9.0) are used to improve the Quality System. Define roles and responsibilities, including who
(organizationally) is responsible for quality improvement.
10.2 Corrective Action for Quality-Related Problems
a. Describe the processes, roles, and responsibilities used to:
Detect,
Determine the significance of,
Correct,
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Track, and
Report quality-related problems, including nonconforming work items.
Corrective Action:
When problems are found to be significant, the root cause must be determined before
permanent preventive measures can be implemented.
Corrective action must ensure that conditions adverse to quality are identified promptly
and corrected as soon as practical.
b. Describe the systems for planning and initiating appropriate response actions to
quality-related problems (i.e., the procedures for determining the root cause before
taking corrective action) and the procedures for tracking, documenting,
implementing, and evaluating the effectiveness of those response actions.
10.3 Creating an Environment for Facilitating and Promoting Quality Improvement
Describe how senior management ensures that the Quality System facilitates and promotes
continual quality improvement.
Examples of Management Involvement in Quality Improvement Efforts:
Setting and evaluating the attainment of quality improvement goals;
Encouraging a "no-fault" attitude;
Acknowledging successes, achievements, and contributions to quality at both the individual and group
level; and
Recognizing and rewarding excellent performance in attaining or exceeding quality goals.
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APPENDIX A
ELEMENTS OF A SYSTEMATIC PLANNING PROCESS
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ELEMENTS OF A SYSTEMATIC PLANNING PROCESS
The appendix that follows provides further clarification and definition of the elements of a
Systematic Planning Process that are listed in Section 7.2. These elements are typically documented
in project-specific project plans, such as a QAPP. Several guidance documents issued by EPA,
DoD, and DOE describe how to write a QAPP and provide more illumination on these project-
specific elements. This appendix is not meant to take the place of such documents, but rather to
provide further support for the text in this document.
A.I Establishment of a Team-Based Approach to Planning
Planning for environmental projects includes a wide variety of individuals and institutions,
including proj ect management and technical personnel, customers, suppliers, scientific experts, and
other stakeholders, who together will determine if the project is successful.
Example of a Team-Based Approach to Planning:
Team-based approaches to planning are often used in the Superfund process to streamline the process of
reaching cleanup decisions. By jointly determining the information (and the associated quality criteria), the
"team" ensures that needs and expectations are identified up front and that rework to meet these expectations
later is minimized.
Federal facility personnel (e.g., base personnel, contract managers, contractors) meet in a scoping meeting
with their counterparts in regulatory agencies to develop the plan for environmental data collection.
Technical experts in human health and ecological risk assessment, hydrogeology, chemistry, and quality
assurance, along with design engineers who understand remediation choices, may participate in the process,
either in team meetings or in consultations behind the scenes.
Community stakeholders participate in the process through routine briefings and public meetings on the
proposed team approach.
The team identifies the decision to be made, along with known and missing information.
The team determines what information must be collected to make, for example, a remedy selection decision
or a "no action required" decision.
Team Requirements for Small Projects:
A small project may not require a formal "team," but may involve one person interacting with people, as needed,
one-on-one or in small group meetings.
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A.2 Description of the Proj ect Goal, Obj ectives, and Questions and Issues To Be Addressed
In this part of the Systematic Planning Process, the project team identifies the decisions that
must be made, the information that is known, and the unknowns that must be answered to make the
decision. Explicit identification of uncertainties that exist, and of which of those uncertainties must
be addressed in meeting project goals, is essential.
A Word About Uncertainties:
Meeting project objectives usually requires dealing with uncertainties. Most data collection and technology
efforts cannot cost-effectively resolve all uncertainties, even if such resolution is technically practicable. The
project team will, therefore, want to consider whether uncertainties are to be reduced through process design,
such as the sampling strategy, mitigated through both process design and contingency planning, or ignored
because they are insignificant to the final decision. In any case, uncertainties should be fully disclosed.
A.3 Identification of Project Schedule, Resources (Including Budget), Milestones, and Any
Applicable Requirements (e.g., Regulatory Requirements, Contractual Requirements)
This part of the planning process identifies the practical boundaries of the effortresources
available, requirements that must be addressed, and the schedule and milestones that will be met.
An Example of Applicable Requirements:
A study project to determine the suitability of land for transfer may be subject to State standards for the cleanup
of groundwater or soil, requirements from the Federal Superfund program, Occupational Safety and Health
Administration (OSHA) regulations, and many other State and Federal standards.
The QMP must describe the process for identifying applicable regulations and standards. This process could
involve reference to, or the development of SOPs or guidance documents addressing regulations and standards
for common types of activities.
A.4 Match the Data Collection and Analysis Process to Project Objectives
This part of the planning process results in a series of clear and concise objective statements
that flow from the project goals and objectives, and it forms the framework for the design (e.g.,
sampling) and analysis efforts. The QMP must describe how the process of developing objectives
occurs.
The QMP Might Include an Example Objective Statement:
[Statement related to determining human health risk from direct contact with contaminated soil.]
Determine to a percent confidence level whether hazardous chemicals are present at levels that exceed
predetermined human health risk screening levels, in the top 1 foot of surface soil of the 1/4 square mile area
identified on Map .
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A.5 Identification of Collection and Analysis Requirements
This includes the process used to determine how, when, and where the data will be obtained
and any constraints on data collection. Identifying the rationale used to determine how samples
collected for a specific project will be analyzed (e.g., in the field or the laboratory), evaluated (e.g.,
QA review, validation, verification), assessed against their intended use and against the quality
performance criteria documented in the project-specific QAPP (or equivalent document) typically
requires several steps, which are listed below:
a Determine how, when, and where data (including existing data) will be obtained.
In this step, the planning team considers whether existing data can be used or if new
data collection efforts must be made. It also considers factors such as the location
of samples or measurements to be taken and the time period in which they must be
taken.
Activities Relate Back to the Purpose of the Data Collection Effort. Examples for a
Field Effort Include the Following:
Field sampling of soils while drilling will be different depending on the intended use of
the soils data. Soil samples for risk assessment purposes may be collected using brass
ring samplers (i.e., California split spoons), whereas soil samples for geotechnical
purposes may be collected using bulk sampling techniques.
Location of your sampling points will relate to the conceptual site model that has been
developed and the areas for which you are attempting to determine the likelihood of risk.
Timing of your sampling effort will relate to the specific weather and geographic
conditions that are important to understanding the outcome. For example, in areas with
high seasonal variability in the levels and flow rate of surface water, you may wish to
collect samples at two different times to understand the impact of seasonal variation on
your contaminant levels.
Determine the quantity of data needed and performance criteria for measuring
quality. The quantity and quality of data needed will directly relate to the objectives
identified and the desired confidence level in the data.
Specify QA/QC activities needed to assess the quality performance criteria.
Data Quality Indicators (e.g., blanks, field duplicates, or results of sensitivity or
uncertainty analysis) will be selected, and Measurement Quality Objectives
(specifying acceptance criteria) will be identified that reflect the quality of data
required for the decision. (See next box.)
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Matching Objective Statements to Requirements for Design of Work and Analysis of Results:
The components of data collection and analysis, including:
Project objectives,
Data and sample collection strategies,
Analysis of data, and
Acceptance and performance criteria for sample collection and data assessment,
converge in the graded approach of the Systematic Planning Process (as outlined in A.4 and A.5
above). The terminology used is sometimes confusing and therefore is clarified below.
The objective statements summarize the decision goals for the project and reflect the needs and
expectations of customers and stakeholders. Because these objective statements directly reflect the
purpose of the data collection, they guide the development of sampling and analysis, modeling and
technology design, and construction and operation activities. A sampling and analysis plan (SAP) is
then designed to produce the type, quality, and quantity of data that can be used to support site
decision-making. As the SAP is developed, specific data quality criteria, called Measurement Quality
Objectives (MQOs), are tailored to be specific to the data generation requirements.
A.6 Describe the Process for the Generation, Evaluation, and Assessment of Collected Data
Questions to be addressed include:
Will the samples be analyzed in the field or in a fixed laboratory?
What level of data review, validation, and verification will be required?
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Applicability of the Systematic Planning Process to Other Programs:
The examples used throughout this section generally describe typical field sampling and data
collection efforts, such as those that may occur in a cleanup or compliance project, documented in a
project-specific QAPP. It should be emphasized, however, that the Systematic Planning Process
applies to all environmental data collection and use and environmental technology development and
implementation efforts. Examples of activities to which the Systematic Planning Process will be
particularly important include:
(a) Development and application of models that use environmental data to estimate environmental
and health affects,
(b) Development and implementation of new technologies,
(c) Testing of existing technologies for new applications, and
(d) Demonstration of the ability of an existing technology to achieve design standards.
In each case, a Systematic Planning Process that identifies an appropriate project team; describes the
project goals and objectives; identifies schedules, resources, and requirements; matches project
objectives to data; and identifies appropriate QC measures and how they will be assessed is important.
Project-specific plans will be used to document the critical elements of the Systematic Planning
Process. These may look very different from the typical QAPP that frames the process for
environmental sampling and analysis efforts, but such plans will address the same issues as outlined in
this section.
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APPENDIX B
ELEMENTS OF COMPUTER HARDWARE AND SOFTWARE
AND INFORMATION TECHNOLOGY
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ELEMENTS OF COMPUTER HARDWARE AND SOFTWARE
AND INFORMATION TECHNOLOGY
The appendix that follows provides further details on the elements associated with
maintaining the quality of data as it is manipulated in the electronic environment. Sections 4.0
(Procurement of Products, Services, and Activities), 5.0 (Documents and Records), and 7.0
(Planning) provide further guidance on key elements of information management - hardware,
software, evaluation, and use. In addition, other agency policy documents may provide specific
guidance on issues related to hardware and software management. It is not intended that the user
of the Uniform Federal Policy create a duplicative Quality System for computer hardware and
software, but rather that the user build on what exists. The detail in this appendix is provided to
ensure that the document user can verify that all of the required Quality System elements have been
addressed.
B.I Configuration Testing and Documentation
Computer hardware and software configurations used in environmental operations have the
potential to affect environmental data and data-related decision quality. This section addresses the
process for ensuring that computer hardware systems used in environmental programs meet technical
requirements and quality expectations.
Describe the process, roles, and
responsibilities for ensuring that
computer hardware and
software systems accurately
perform their intended functions
and meet specific user needs.
Describe the process, roles, and
responsibilities for ensuring that
purchased hardware and
software systems are installed
and operated in accordance with
the manufacturer's recommendations.
Definition of Configuration Management:
Configuration management is an important aspect of
systems operation and maintenance. It encompasses
the management and implementation methodologies
associated with increasing or correcting system
capabilities, a partial system redesign, or determining
software obsolescence.
Source: EPA Directive 2181, Operation and
Maintenance Manual
A Word on Personnel Training for Computer Applications:
Ensuring that technical support personnel are regularly trained on newly developed or updated
systems and programs should be a top priority of a Quality System.
Describe the process, roles, and responsibilities for ensuring that computer hardware/
software configurations are tested and documented prior to initial use and after any
corrective actions are performed. Documentation should be readily available to
personnel responsible for use and maintenance.
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Describe the process, roles, and responsibilities for ensuring that computer systems
preserve the integrity, availability, and confidentiality of information used in the
system.
Describe the process, roles, and responsibilities for ensuring that a current
description of hardware/software systems is maintained to assist personnel in
tracking problems with the equipment and to assist in repair and replacement, and
to assist users in assessing current functionality and future needs.
Computer Systems Testing:
Ensuring that a computer system meets the needs of users and that it performs the functions
for which it is intended is a key component of a Quality System. Through testing, users can
determine if hardware and software meet these objectives, as well as whether the system
preserves the integrity of information generated and used on the system.
f. Describe the process, roles, and responsibilities for ensuring that computer hardware/
software components are adequately tested, inspected, and maintained on a regular
basis. Documentation of such operational maintenance should be kept up-to-date
and easily accessible.
Integrating and Updating Computer Systems:
Testing configuration capabilities is a necessary step in integrating new hardware and software
components into existing configurations and in updating program requirements.
B.2 Change Management
The QMP must address how changes to hardware are controlled to assess the impact of
change on program performance and technical and quality objectives.
a. Describe the process, roles, and responsibilities for assessing and documenting the
need for change to hardware/software configurations and for identifying how the
potential impact of the change on the performance and the technical and quality
objectives of the program are evaluated.
b. Describe the process, roles, and responsibilities by which the compatibility between
old and new versions of software and hardware will be assessed to ensure that
archived electronic data files can be accessed and read with the new format or system
configuration.
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Change Control Systems:
A centralized change control system is recommended in which a designated person or
organization is authorized to install or change program versions. The use of a designated
person(s) ensures that all change requests, problems, and corrections to software errors and
enhancement requests are handled in the same manner.
B.3 Development and Evaluation of Computer Software for Environmental Programs
a. Describe the process, roles, and responsibilities for developing, validating, and
verifying computer software to meet a specific user's needs.
b. Describe the process, roles, and responsibilities for ensuring that the software
development methodology selected contributes to the software's accuracy and
reliability in meeting user needs.
c. Describe the process, roles, and responsibilities for ensuring that documentation of
new software covers all phases of the software life cycle. These phases are initiation,
requirements analysis, design, programming, testing and quality assurance,
installation and operation, maintenance/enhancement, and retirement. Refer to
Section 5.0 for additional information about documentation.
d. Describe how acceptance criteria for software will be developed, documented, and
evaluated to ensure that user requirements are met and to comply with applicable
contractual requirements and standards.
B.4 Usage, Quality Control, and Maintenance of Computerized Data
The input of environmental data into computer systems, and the manipulation of that data
to facilitate decision making, introduces the possibilities of additional error into the management of
environmental data. This additional error can come from a number of sources:
a. The quality and variability of the data entered into the data management system,
b. Inappropriate use of the data,
c. Programming of software that leads to erroneous conclusions when data is
manipulated, or
d. Mistakes in the data entry process.
Environmental information systems encompass a wide range of sizes and complexity. These
include large systems used to track regulatory compliance, which require timeliness, accuracy, and
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consistency, as well as smaller systems, such as predictive models into which a single user or group
of users input data to facilitate decision making.
Automated Data Operations:
The importance of quality control in every step of the information management process is heightened by the
use of automated data transfer and the entry of vast quantities of data into computers for manipulation. In
environmental operations, computer systems are used to gather data, store data, enter data into databases, and
analyze data. Quality control at each step of the process helps to ensure that the environmental data analysis
and resulting products are accurate and reliable.
Uses of Environmental Data:
The uses of environmental data can vary greatly. For example, environmental data can be used to assist in
making risk assessment decisions or to make decisions on appropriate technology, or as input for modeling
efforts. Decisions must be made as to whether the data can be used for their intended purpose (e.g., to make
risk management decisions or to support modeling efforts). A key element of QA/QC for computerized data is
ensuring that the data is put to use in an appropriate manner. Project-specific QAPPs will frequently provide
the source of documentation of a particular data use.
Describe the process roles and
responsibilities for verifying the
appropriate quality, timeliness,
and consistency of data to be
gathered and stored.
Describe the process, roles, and
responsibilities for verifying
that data being compiled are
appropriate for their intended
use.
Describe the process, roles, and
responsibilities for ensuring and
documenting QA/QC of manual
and electronic data input.
Use of Secondary Data:
"Secondary data" is defined as data that were
collected for a different purpose than that for which
they are now being used. In addition to a different
purpose than the original data collection, the level of
QA/QC provided at the time of data collection may
be unknown. Issues for consideration in the use of
secondary data include, but are not limited to:
(a) Similarities between the purpose of the original
data collection and the purpose for which data
are currently used.
(b) Centrality of secondary data to the current
decision-making process.
(c) Acceptable level of uncertainty associated with
the current decision-making process to which
secondary data will be applied.
Describe the process, roles, and
responsibilities for ensuring transparency and documentation of decisions in every
step of the environmental data management process, including data compilation,
entry, use, analysis, and QA/QC.
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e. Describe the process, roles, and responsibilities for ensuring backup of all files and
applications.
Computer Modeling:
Computerized modeling is an area of data analysis in which apparently small errors in the
model structure, design, computer code, or data entry can result in inaccurate results.
Modeling QC activities typically include:
(a) Independent technical review of model structure and use,
(b) Independent checks of model code, and
(c) Independent checks of transcription and correction entry of model input parameters.
B.5 Historical Files
f. Describe the process, roles, and responsibilities for developing consistent procedures
for managing and documenting historical files of hardware and software, hardware
and software operating procedures (manuals), and hardware and software changes
and version numbers.
g. Describe the process, roles, and responsibilities for storing, archiving, and recovering
information from obsolete systems, including archiving and recovering software and
hardware necessary to retrieve stored information.
Maintaining Access to Information:
As hardware and software continue to evolve rapidly, it becomes increasingly important to
maintain the ability to access and use information that was created using configurations that
are no longer in use. Therefore, the ability to store, archive, retrieve, and use obsolete
software, hardware, and the information created on these systems should be maintained over
the long term.
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APPENDIX C
THE INTERGOVERNMENTAL DATA QUALITY
FRAMEWORK
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THE INTERGOVERNMENTAL DATA
QUALITY FRAMEWORK
Overview
The Intergovernmental Data Quality Task Force (IDQTF) was convened to promote the
exchange of environmental data quality information between Federal agencies. Since its inception
in 1997, the scope of the task force has expanded to comprehensively address a myriad of problems
and issues related to the management of environmental data quality at Federal facilities. The IDQTF
has developed and is in the process of developing several work products to promote its goals.
Mission and Goals
The consensus mission of the IDQTF is "70 document an intergovernmental quality system
beginning with the hazardous waste programs." Relying on definitions contained in the American
National Standards Institute/American Society for Quality Control Standard E4 (ANSI/ASQC E4),
the IDQTF agreed that although the intergovernmental Quality System should be comprehensive
and cover all environmental programs, it will focus its initial efforts on the hazardous waste
programs managed by EPA's Office of Solid Waste and Emergency Response.
The IDQTF identified three initial goals to accomplish its mission:
To develop a written agreement on what constitutes an adequate QA program;
To develop a guidance/framework that outlines the roles and responsibilities of the
EPA (Headquarters and Regions) and the Federal facilities with regard to QA/QC
oversight; and
To develop guidance for implementing Federal agencywide requirements and
procedures regarding data quality.
Membership
The IDQTF operates as a partnership and seeks consensus. The permanent chairman of the
task force is the Director of EPA's Federal Facilities Restoration and Reuse Office. Other current
consensus members of the IDQTF include:
EPA Regions 1, 2, 5, and 8
Office of Emergency and Remedial Response (EPA Superfund)
Office of Solid Waste (EPA Resource Conservation and Recovery Act RCRA)
Office of Environmental Information (Quality Staff)
Department of Defense (DoD)
Department of Energy (DOE)
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The IDQTF conducts much of its technical work in subgroups, which may pull in additional
personnel from parts of the organization that are not involved in the formal task force.
Key Work Products
Using the ANSI/ASQC E4 standard, Specifications and Guidelines for Quality Systems for
Environmental Data Collection and Environmental Technology Programs, as the foundation for
identifying the requirements of a Quality System, the IDQTF is in the process of developing a
number of major products. These products are described in detail below. Each is designed to
implement a specific part of the E4 standard.
Relationship of IDQTF Products to ANSI/ASQC E4
E4 Section
IDQTF Document
Part A, E4, Management Systems
Provides guidelines and specifications for an
overarching Quality System.
Uniform Federal Policy for Implementing
Environmental Quality Systems (UFP) Mirrors E4 in
organization and provides additional step-by-step
requirements for implementing a Quality System that
meets the E4 standard. (The draft final document is out for
agency review and consensus.)
Part B, E4, Collection and Evaluation of
Environmental Data Contains additional
Quality System specifications and guidelines
needed to plan, implement, and assess
environmental data operations. Part B includes
sections on planning and scoping, design of
data collection operations, implementation of
operations, assessment and response, and
verification of data usability.
Draft Federal Consensus Guidance for the
Preparation of Quality Assurance Project Plans
Implementation guide to Part B of E4. It provides specific
guidance on the process of planning for and conducting
environmental data collection operations. When adopted,
it will provide the framework for writing consistent
QAPPs at Federal facilities. (Draft document completed
and undergoing agency review and beta-testing.)
Presumptive Quality Assurance/Quality Control
Measures for Superfund Based on the Superfund
phase and associated data use, this product identifies those
quality assurance measures that should be addressed in
order to implement the QAPP guidance and Part B of E4.
(Under development by IDQTF subgroup.)
Roles and Responsibilities Framework for Federal
Facility Oversight Designed to address ongoing
sources of confusion and conflict between EPA and the
Federal agencies. (Initiation of work anticipated in the fall
of 2000.)
Note: The IDQTF is not developing a project-specific work product to address E4 Part C: Design, Construction,
and Operation of Environmental Technology. The Quality System reflected in the Uniform Federal Policy,
however, is designed to cover environmental technology programs as well as environmental data collection and use.
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Adoption and Review of Work Products
All work products of the IDQTF are developed by subgroups, with guidance from the
IDQTF. Each work product goes through several stages of development and review.
The need for the product is identified and verified by the IDQTF.
The product is developed by the subgroup and sent to the IDQTF to review.
Key policy issues are raised for discussion by the IDQTF during planned quarterly
meetings.
Once the IDQTF has indicated that the product is ready for a wider review, it is sent
to EPA Regional offices, DoD components, DOE personnel, other Federal agencies,
and other stakeholders for review.
Comments are received and documented in a database. Each comment is the subj ect
of an individual evaluation. Responses to comments (accepted, modified, or
rejected) are recorded, with explanations where appropriate.
The final document is reviewed by the IDQTF. The consensus members of the
IDQTF determine if the document requires further review or if it is ready to be sent
forward to their respective agencies for final consensus.
Commitment to the work of the IDQTF is the subject of two separate memoranda of
understanding (MOU). The first MOU was between the EPA and the Navy, acting as Lead Service
for Environmental Data Quality for DoD. The second MOU was between the EPA and DOE. A
subsequent MOU between these agencies will address implementation of adopted work products.
Relationship of IDQTF Work Products to Work Conducted in Nonhazardous Waste Programs
IDQTF members decided that a cooperative framework for an interagency quality assurance
program should begin with hazardous waste programs and should eventually become the basis for
other environmental compliance programs. The Uniform Federal Policy and the Draft Federal
Consensus Guidance for the Preparation of Quality Assurance Project Plans were both developed
to be suitable for adoption by all environmental programs (e.g., water, air) in their current form. The
Presumptive Quality Assurance/Quality Control Measures for Superfund is a targeted product that
could be used as a model for other programs.
DoD and DOE plan to adopt the consensus documents, when approved, to be used for all
environmental data collection, use, and technology programs. IDQTF members have actively
reached out to other environmental Programs within EPA to encourage their participation and input
into the development and implementation of the IDQTF products. Timothy Fields, Assistant
Administrator, Office of Solid Waste and Emergency Response, recently issued a memorandum to
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all EPA Assistant Administrators, requesting feedback on the Uniform Federal Policy and
encouraging support for a joint framework for quality assurance for all EPA Programs.
Relationship of IDQTF Work Products to Other Quality Documents
ISO 9000 Series
ISO 14000 Series
Executive Order 13148
EPA Order 5360.1 A2
The IDQTF products are in conformance with the ISO 9000 series of
standards addressing Quality Systems, but like ANSI/ASQC E4, the
IDQTF products are specifically written for environmental data
collection and use and environmental technology programs. Further, the
IDQTF products contain a significantly greater level of detail for
implementing Quality Systems for environmental data collection and use
and for environmental technology programs than does the ISO 9000
series.
The ISO 14000 standards for Environmental Management Systems
(EMS) address actions an organization takes to minimize harmful
environmental impacts caused by its products, services, and activities,
and do not address the quality issues covered by the IDQTF products.
The IDQTF products address the design of a Quality System for the
environmental data collection and environmental technology aspects of
EMS.
Executive Order (EO) 13148, "Greening the Government Through
Leadership in Environmental Management," mandates that Federal
agencies establish Environmental Management Systems that integrate
environmental accountability into basic operations and planning
processes. EO 13148 focuses on achieving Government leadership in
environmental management and improving the environmental compliance
of Federal agencies. The Uniform Federal Policy addresses the
environmental data collection and environmental technology elements of
environmental management.
While both this EPA Order and the UFP are based on ANSI/ASQC E4,
they differ in their applicability. EPA Order 5360.1 A2 establishes the
policy and program requirements for an EPA-wide Quality System, while
the more detailed UFP addresses the needs and practices of Federal
agencies in general and applies to those organizations that elect to
implement it. Because the UFP is a consensus policy that was developed
by an interagency task force, it was designed to ensure consistent
implementation across agencies. The UFP is in conformance with EPA
Order 5360.1A2.
EPA QA/R-2, QA/R-5
EPA QA/R-2, EPA Requirements for Quality Management Plans,
establishes Quality System requirements for contractors, grantees, and
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other assistance holders. It is equivalent to Chapter 3 of EPA Order
5360.1 A2. This document is not applicable to other Federal agencies
unless such an agency is a recipient of funds from EPA to conduct EPA's
work. EPA QA/R-5, EPA Requirements for Quality Assurance Project
Plans, similarly establishes requirements for Quality Assurance Project
Plans for those receiving funds from EPA. It is equivalent to Chapter 5
of EPA Order 5360.1 A2.
EPA QA/G-5 EPA QA/G-5, EPA Guidance on Quality Assurance Project Plans, was
developed to assist EPA Offices and Regions in preparing QAPPs. The
IDQTF Draft Federal Consensus Guidance for the Preparation of Quality
Assurance Project Plans was developed for use by all Federal agencies
that choose to implement it. The draft guidance is an implementation
guide that integrates G-5 and the Systematic Planning Process. It is
based on Part B of E4 and also on the Region I, EPA New England
Compendium of Quality Assurance Proj ect Plan Guidance. The IDQTF
document has been carefully tailored by representatives of several
agencies to be applicable and relevant to all Federal agencies, and it is
more detailed than E4.
Figure 1, following, describes IDQTF products and their relationship to other major
documents, to each other, and to the policy, program, and project level.
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Policy Level Documents
International and National Products
ISO 9000, International Standards for Quality
Management
ANSI/ASQC E4-1994, Specifications and Guidelines
for Quality Systems for Environmental Data
Collection and Environmental Technology
Programs
EPA Order 5360.1 A2, Policy and Program
Requirements for the Mandatory Agency-
wide Quality System
IDOTF Products
Memoranda of Understanding
(EPA/DoD/DOE)
Roles and Responsibilities Framework for
Federal Facility Oversight
Program Level Documents
National Products
EPA Requirements for Quality Management Plans
(EPA QA/R-2)
EPA Headquarters Program Office QMPs
EPA Regional Quality Management Plans (QMPs)
Federal Agency QMPs
IDOTF Product
Uniform Federal Policy for Implementing
Environmental Quality Systems (UFP)
Project-Specific Documents
National Products
EPA Requirements for Quality Assurance Project
Plans (EPA QA/R-5)
EPA Guidance on Quality Assurance Project Plans
(EPA QA/G-5)
IDOTF Product
Draft Federal Consensus Guidance for the
Preparation of Quality Assurance
Project Plans
Presumptive Quality Assurance/Quality
Control Measures for Superfund
Figure 1. Quality System Components and Tools: Relationship to IDQTF Products
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APPENDIX D
QUESTIONS AND ANSWERS REGARDING THE IDQTF
UNIFORM FEDERAL POLICY
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QUESTIONS AND ANSWERS REGARDING THE IDQTF
UNIFORM FEDERAL POLICY
I. Background
Q. 1 What is a Quality System?
A. 1 The definition of a Quality System used in the Uniform Federal Policy (UFP) is one adopted
from the national standard published by the American National Standards Institute and the
American Society for Quality Control and known as ANSI/ASQC E4, "Specifications and
Guidelines for Quality Systems for Environmental Data Collection and Environmental
Technology Programs." A Quality System is:
A structured and documented management system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation
plan of an organization for assuring quality in its work processes, products (items), and
services. The quality system provides the framework for planning, implementing, and
assessing the work performed by an organization and for carrying out required quality
assurance (QA) and quality control (QC) activities.
Q.2 What is the reason for the recent interest in Quality Systems? Is the quality of existing data
being questioned? By whom?
A.2 Issues related to inadequate data quality oversight at Federal facilities are documented in an
EPA Inspector General (IG) report (Audit Report No. E1SKB6-09-0041-7100132) andDoD
IG report (OIG Report 97-098, "Laboratory Support Service for Environmental Testing,
Audit Report," February 21, 1997). In addition, recent highly publicized incidents of
inappropriate laboratory practices related to work performed at some Federal facilities have
cost the Government millions of dollars in unacceptable analytical work, costly resampling
efforts, and delays in implementing environmental cleanup/restoration programs and site
closeouts. In 1997, three Federal agencies (EPA, DoD, and DOE) joined together to
"document a Quality System, starting with Hazardous Waste Programs."
The Uniform Federal Policy benefits all agency participants by:
1. Improving the effectiveness and accountability to the public of environmental data
and technology programs by focusing on results, quality of data and services, and
customer satisfaction.
2. Promoting improved and consistent Quality Systems across EPA Regions and
throughout DoD and DOE.
3. Permitting flexibility, or graded QA approaches, that are tailored to meet the desired
end uses of the data.
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4. Clarifying the roles and responsibilities for managing and overseeing the collection
and use of environmental data and for managing environmental technology efforts.
5. Improving confidence that the system can produce quality data and technology such
that duplication of oversight efforts can be minimized.
In addition to benefitting the Federal agencies involved, the implementation of the Uniform
Federal Policy will also improve public confidence in environmental data and technology
systems by ensuring that these activities take place in a context designed to ensure quality.
Q.3 What is the purpose of the UFP?
A.3 The UFP provides requirements and guidelines to Federal agencies for documenting and
implementing Quality Systems for the management of environmental data collection and use
and environmental technology programs. It follows the basic quality assurance principle
that documentation of procedures is essential to ensuring that these procedures remain in
place regardless of staffing and organizational changes. The UFP provides additional detail
to ensure consistent implementation of ANSI/ASQC E4.
Q.4 Why is this document needed? Doesn't the ANSI/ASQC E4 standard already define the
requirements for Quality Systems?
A.4 ANSI/ASQC E4 is a national voluntary consensus standard that includes standards
describing the basic elements of Quality Systems; however, it lacks sufficient detail to
promote the data quality needed to adequately address the DoD and EPA IG concerns. In
addition, Executive Order 13148 Greening the Government Through Leadership in
Environmental Managementrequires that each Federal agency implement environmental
management systems to "ensure that strategies are established to support environmental
leadership programs, policies, and procedures..." The UFP adds additional detail to E4 based
on experience and an explicit decision on the part of the Federal agencies involved that the
Quality Systems adopted by each of their agencies shall be consistent. In this regard, the
UFP clarifies ambiguous E4 language to facilitate uniform application of the E4 standard
across DoD, DOE, and EPA.
Q.5 How does the Uniform Federal Policy for Implementing Environmental Quality Systems
relate to E4?
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A.5 E4 addresses three components of a Quality System:
Part A: Management Systems, which contains specifications and guidelines for
routine quality management functions.
Part B: Collection and Evaluation of Environmental Data, which contains the quality
specifications and guidelines applicable to project-specific environmental activities.
Part C: Design, Construction and Operation of Environmental Technology," which
contains the minimum quality specifications and guidelines that apply to technology
programs.
This UFP addresses the elements of Part A of E4. Additional documents under development
by the IDQTF will address the implementation of Part B of E4.
II. Basis for the UFP
Q.6 Why was E4 selected as the source document? Aren't other existing Quality Systems
adequate (e.g., Total Quality Management, ISO 14000, ISO 9000)?
A.6 E4 was selected as the base document for several reasons:
1. The scope of E4 (environmental data collection and use and environmental
technology programs) is most appropriate for the IDQTF effort.
2. It is a national consensus quality standards document developed by an independent,
unbiased, nationally recognized group of quality assurance professionals.
3. It covers all necessary elements of a Quality System and provides a good framework,
but it is general enough to provide the flexibility needed by a range of agencies or
organizations.
ANSI/ASQC E4 is the only standard among those listed above that specifically addresses
Quality Systems for environmental data collection and use and environmental technology
programs. The ISO 9000 series addresses general Quality Systems but is not specific to
environmental data collection and technology programs. The ISO 14000 series of standards
for Environmental Management Systems (EMS) is not appropriate for application to
environmental data collection and use and environmental technology programs. It addresses
actions an organization takes to minimize harmful environmental impacts caused by its
products, services, and activities and does not address the quality elements covered by E4
for the ISO 9000 series.
Q.7 Does the UFP require the creation of a new Quality System?
A.7 The UFP is intended to serve as a high-level policy to document the essential elements of
an acceptable Quality System. The UFP does not require creation of yet another Quality
System, but rather provides a set of requirements to ensure that essential elements are
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addressed. It can be used either to develop a new agency-specific Quality System or to
evaluate the adequacy of an existing Quality System. Thus, existing Quality Systems based
on E4 or other standards may be adequate for continuing use as long as they fulfill the
essential elements of the UFP.
If a Federal agency has a Quality System in place, then the UFP can be used as a benchmark
against which to assess the existing systems, to ensure that all essential elements are
addressed, and to verify that there are no gaps in the existing Quality Systems.
Q.8 Why wasn't EPA Order 5360.1 A2 (Policy and Program Requirements for the Mandatory
Agency-wide Quality System) used as the source document for the IDQTF Quality System?
A. 8 Both the EPA Order and the UFP are based on ANSI/ASQC E4, the national standard.
However, the EPA Order is simply EPA's policy for implementing E4, while the UFP is
designed for implementation by Federal agencies. The EPA Order and Manual were
reviewed extensively during the process of constructing the UFP. The UFP is consistent
with these EPA documents.
Q.9 Why wasn't the EPA Order (5360.1 A2) and its associated manual or EPA QA/R-2 (EPA
Requirements for Quality Management Plans) simply adopted by the IDQTF?
A. 9 The EPA Order and its associated manual reflect EPA's organization and policies. As such,
many of these may not be appropriate for wholesale application to other Federal agencies.
QA/R-2 applies to work performed for and funded by EPA. It is not, therefore, applicable
to Federal agencies, except when they are doing work under an assistance agreement for
EPA.
Q.10 Doesn't use of the Contract Laboratory Program (CLP) provide sufficient quality for
environmental data by "ensuring data of known and documented quality"?
A. 10 No. The CLP provides a series of contract specifications, in the form of a statement of work
(SOW), that cover laboratory services purchased under specific contracts for Superfund sites.
While the CLP also provides guidelines for evaluating laboratory conformance to its contract
specifications, it does not address project-specific data usability requirements; therefore,
it does not provide assurance that collected data are appropriate for their intended uses.
There are many environmental programs that are not covered by CLP and many aspects of
environmental data collection and environmental technology programs that are outside its
scope (e.g., the Systematic Planning Process, sampling activities, QA oversight). The CLP
does not address overall Quality Systems.
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III. Implementation Issues
Q. 11 How will this document be used and implemented?
A. 11 When formally adopted by a Federal agency, this policy document will be used to develop
the Quality System for the management of environmental data collection and use and
environmental technology programs. Although the UFP describes a number of
requirements of a Quality System, these requirements are that the agency address certain
topics. The UFP leaves it to each agency to determine how best to meet these requirements.
Each individual agency will decide how many Quality Management Plans will be written,
and by whom. In addition, each agency (and the organizational units responsible for writing
QMPs) will decide how the mandatory requirements of the UFP are best addressed by that
organization. For example, the UFP asks that the QMP describe responsibilities for the
management of quality. It is up to the individual agency to describe the specific
responsibilities.
Q.12 How are existing programs with significant resource constraints supposed to meet the
additional demands of the UFP without additional resources (e.g., resources for planning,
implementation, and oversight)?
A. 12 The UFP is not a new program. It is a high-level policy that outlines essential elements that
must be contained in a Quality System. If a Quality System already exists, then the UFP
serves as a benchmark for evaluating the completeness and effectiveness of the system. If
an existing Quality System contains all the necessary elements and can be shown to be
effective, then it meets the requirements of the UFP. If the existing Quality System contains
only some of the essential elements, then only those areas not currently included in the
Quality System need to be addressed.
A Quality System based on the UFP includes provisions for regularly assessing the resources
that are needed to ensure effective Quality System implementation. The UFP recognizes that
senior-level EPA, DoD, and DOE decision-makers are responsible and accountable for
ensuring that adequate resources are provided. The initial assessment and updating of
Quality Systems are expected to require a commitment of resources, however, once the
UFP is implemented, the accommodation of graded approaches and improvements in quality
of work will result in streamlined proj ect execution with fewer mistakes and rework, thereby
saving both time and money over the long term.
It is important to recognize that failure to have in place a Quality System for the
management of environmental data collection and use and environmental technology
programs is itself costly. For example, lack of procedures to store and make retrievable
previously collected environmental data often creates a need for the collection of new data
because no one can trace the key quality elements of the older data. Likewise, failure to
implement a systematic planning process often leads to the collection of the wrong kind of
data, at a quality not appropriate for its intended use. This, in turn, often leads to additional
sample collection and analysis.
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Q.I3 In an environmental program with limited staff, how can the QA manager "function
independently of direct environmental data generation and use, model development, and
technology development," as required by the UFP?
A. 13 The independence of the quality assurance function (however named) is not a new concept;
most existing Quality Systems contain this requirement. In practice, providing independent
QA does not necessarily require either an independent organization or an independent QA
staff position. The QA role in any particular project needs to be independent of the work
performed on that project. This role can be performed by staff members who have data
collection and environmental technology responsibilities on other projects.
Q. 14 What is the relationship of the UFP to other environmental management system documents?
Where will it fit in the hierarchy of existing documents?
A. 14 The UFP is a high-level policy document that will be used as a guide for a Quality System.
It provides a benchmark for identifying the existing Quality System elements in each agency
that currently oversees environmental data collection and use and environmental technology
programs. When fully implemented, it will meet the requirements of the national standard
known as ANSI/ASQC E4. E4 is designed to implement ISO 9000 (International Standards
for Quality Management) for environmental data collection and use and environmental
technology programs. The Environmental Management System (EMS) required under EO
13148 may be modeled after the ISO 14000 series (Environmental Management). The EMS
is therefore focused on reducing the environmental impacts of delivering the products,
services, and activities of the Federal agencies. (See Question 4 for more detail about EO
13148.)
The Quality System outlined in this document is parallel to the EMS and will frame the
quality process that oversees the way environmental data is collected and used and the way
technology programs are managed in support of the products, services, and activities of the
Federal agencies.
Elements of the EMS and the Quality System developed to meet the requirements of this
document may be similar and will be complementary. To avoid unnecessary duplication,
agencies and organizations that adopt the UFP should review their existing management
systems and associated processes to determine what elements are already addressed in other
systems. The next step will be for each agency to identify gaps and use the UFP as a guide
for development of a comprehensive and integrated Quality System for environmental data
collection and technology programs.
Each agency must develop its own implementation strategy that is appropriate to that
agency. Often, the QMP for environmental data collection and use and environmental
technology programs can cross-reference elements or details in an existing document or
documents that contain the appropriate requirements.
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Q.I5 How will the UFP be implemented for suppliers and contracted work? What is the
timeframe for implementation?
A. 15 Federal Acquisition Regulations (FAR) already require, when appropriate, that contractors
maintain high-level quality standards with a Quality System based on existing standards,
such as E4. The applicability of standards will be specified in the solicitation for the
contract and will be appropriate to the significance and complexity of the associated data
collection efforts.
Development of the UFP was conducted under two intergovernmental MOUs (one between
EPA and DOE and a second between EPA and DoD). Implementation will be addressed in
a future MOU. Since a significant portion of products, services, and activities related to
environmental data collection and use and environmental technology programs are provided
by contracts, the UFP will be implemented in part through contracts. Each DOE office and
DoD component has unique contracting practices; therefore, each office and component will
need to determine a reasonable strategy and timeframe for implementation. DOE and DoD
expect that implementation will most likely occur in phases, as existing contracts expire and
new contracts are put into place.
Q. 16 If the Uniform Federal Policy represents requirements for Federal agencies, then what are
the consequences if an agency fails to meet the requirements? Will noncompliance result
in a Notice of Violation?
A. 16. The simple answer to this question is, no. Nonconformance with the UFP will not result in
issuance of aNotice of Violation, unless conformance is made part of a separate, enforceable
agreement. The UFP contains requirements that will be implemented voluntarily by parties
who decide to adopt the UFP. This voluntary commitment will be signaled by the signing
of an implementation Memorandum of Understanding between EPA and the other Federal
agency adopting the UFP. Since the UFP was not developed or promulgated through the
rule-making process, it is not a regulation and not subject to regulatory enforcement or
Notices of Violation. Each agency must determine its own procedures for assessing
nonconformance and initiating corrective action. The procedures will be described in the
organization's Quality Management Plan.
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APPENDIX E
GLOSSARY
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GLOSSARY5 6
Assessments Systematic, obj ective, and independent examinations of technical and management
processes designed to identify problems, reveal areas of strength and weakness, and allow
management to evaluate the organization's processes and performance.
Continuous improvement Incremental improvements that take place over time as the results of
corrective actions are fed back into the Quality System. Continuous improvement anticipates the
incremental changes that take place over time to minimize the recurrence of repetitive quality
problems.
Customer specifications The constellation of specifications, including requirements,
expectations, and preferences, that are identified by customers. These specifications can be assigned
different levels of priority depending upon whether they are "legal requirements" or customer
expectations or preferences separate from legal requirements. Although this document uses the
shorthand term "specifications" when describing customer requirements, expectations, and
preferences, that term is meant to reference the full range of customer demands.
Data Quality Indicators The quantitative statistics and qualitative descriptors that are used to
interpret the degree of acceptability or utility of data to the user. The principal data quality indicators
are bias, precision, accuracy (bias is preferred), comparability, completeness, representativeness.
(U.S. Environmental Protection Agency, EPA Guidance for Quality Assurance Project Plans.
EPA/600/R-98/018, February 1998. EPA QA/G-5)
Document Any written or pictorial information describing, defining, specifying, reporting, or
certifying activities, requirements, procedures, or results pertaining to environmental operations.
Inherently governmental functions "A function which is so intimately related to the public
interest as to mandate performance by Government employees. ...These functions include those
activities which require either the exercise of discretion in applying Government authority or the use
of value judgement in making decisions for the Government." (Office of Management and Budget
(OMB) circular A-76 and supplemental guidance). It is also, according to the Federal Acquisition
Regulations, "a policy determination, not a legal determination."(FAR Part 07, Subpart 7.5, 7501)
Measurement Quality Objectives Specified acceptance criteria used in a sampling and analysis
plan and designed to produce the type, quality, and quantity of data that can be used to support site
decision-making.
Organization "A company, corporation, firm, enterprise, or institution, or part thereof...that has
its own functions and administration." When used in this document, the term "organization" refers
to the entity within a Federal agency that has "its own functions and administration" and that is
responsible for writing a Quality Management Plan (QMP) under this policy document. In some
cases the term "organizational unit" is used to refer to a unit of a larger organization that may have
5Unless otherwise indicated, the definitions in this glossary are also found in the body of the report.
6NOTE: This glossary is included for informational purposes and is not the definitive final glossary.
Final, Version 2, March 2005 93
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its own Quality System responsibilities, and for which Quality System information and procedures
will require documentation in the QMP.
Quality Assurance Project Plan A formal document describing in comprehensive detail the
necessary quality assurance (QA), quality control (QC), and other technical activities that must be
implemented to ensure that the results of the work performed will satisfy the stated performance
criteria. The QAPP components are divided into four classes: 1) Project Management, 2)
Measurement/Data Acquisition, 3) Assessment/Oversight, and 4) Data Validation and Usability.
(U.S. Environmental Protection Agency, EPA Guidance for Quality Assurance Project Plans.
EPA/600/R-98/018, February 1998. EPA QA/G-5)
Quality Management Plan A formal document that describes the quality system in terms of the
organization's structure, the functional responsibilities of management and staff, the lines of
authority, and the required interfaces for those planning, implementing, and assessing all activities
conducted. (U.S. Environmental Protection Agency, EPA Guidance for Quality Assurance Project
Plans. EPA/600/R-98/018, February 1998. EPA QA/G-5)
Quality System A structured and documented management system describing the policies,
objectives, principles, organizational authority, responsibilities, accountability, and implementation
plan of an organization for ensuring quality in its work processes, products (items), and services.
The Quality System provides the framework for planning, implementing, and assessing the work
performed by an organization and for carrying out required quality assurance (QA) and quality
control (QC) activities. (ANSI, Specifications and Guidelines for Quality Systems for
Environmental Data Collection and Environmental Technology Programs. American National
Standard, ANSI/ASQC E4-1994.)
Record A record is a document that furnishes objective evidence of the quality of products,
services, or activities and that has been verified and authenticated as technically complete and
correct.
Secondary data Data not originally collected for the purpose for which they are now being used.
In addition, the level of QA/QC provided at the time of the original data collection may be unknown.
Systematic Planning Process Systematic planning is a planning process that is based on the
scientific method and includes concepts such as objectivity of approach and acceptability of results.
Systematic planning is based on a common sense, graded approach to ensure that the level of detail
in planning is commensurate with the importance and intended use of the work and the available
resources. This framework promotes communication between all organizations and individuals
involved in an environmental program. Through a systematic planning process, a team can develop
acceptance or performance criteria for the quality of the data collected and for the quality of the
decision. (U.S. Environmental Protection Agency, EPA Guidance for the Data Quality Objectives
Process. Peer Review Draft, December 1999. EPA QA/G-4)
A systematic planning process shall ensure that all organizations and/or parties who contribute to
the quality of the environmental program or use the results are identified and that they participate
in this process. The planning process shall also provide for direct communication between the
customer and the supplier to ensure that there is a clear understanding by all participants of the needs
Final, Version 2, March 2005 94
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and expectations of the customer and the product or results to be provided by the supplier.
(Memorandum from Norine E. Noonan.)
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APPENDIX F
IDQTF MEMBERS
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IDQTF Members, Alternates, and Participants
U.S. ENVIRONMENTAL PROTECTION
AGENCY
Office of Solid Waste and Emergency
Response (OSWER)
Consensus Member:
James Woolford (IDQTF Chair)
Director
Federal Facilities Restoration and Reuse
Office (FFRRO)
Crystal Gateway 1
1235 Jefferson Davis Highway
Arlington, VA 22202
(703) 603-0048
woolford.j ames@epa.gov
Alternate to James Woolford:
Mike Carter
QA Manager
Federal Facilities Restoration and Reuse
Office (FFRRO)
Crystal Gateway 1
1235 Jefferson Davis Highway
Arlington, VA 22202
(703) 603-0046
carter.mike@epa.gov
Consensus Member:
Charles Sellers
Quality Assurance Officer
Office of Solid Waste (OSW)
Mailcode 5307W
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(703) 308-0504
sellers.charles@epa.gov
Alternate to Charles Sellers:
Kim Kirkland
Office of Solid Waste (OSW)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(703) 308-0490
kirkland.kim@epa.gov
Office of Environmental Information (OED
Consensus Member:
Nancy Wentworth
Director
Quality Staff (QS)
Office of Environmental Information (OEI)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(202) 564-6830
wentworth.nancy@epa.gov
Alternate to Nancy Wentworth:
Esperanza Renard
Quality Staff (QS)
Office of Environmental Information (OEI)
2890 Woodbridge Ave. (MS 104)
Edison, NJ 08837
(732)321-4355
renard.esperanza@epa.gov
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IDQTF Members, Alternates, and Participants
EPA Regions
Former Consensus Member:
Deborah Szaro
Quality Systems Team Leader
EPA New England
Alternate to Deborah Szaro:
Moira Lataille
Quality Systems Team Leader
EPA New England
11 Technology Drive
N. Chelmsford, MA
(617)918-8635
lataille.moira@epa.gov
Consensus Member:
Robert Runyon
Chief
Hazardous Waste Support Branch, Division of
Environmental Science and Assessment
EPA Region 2
2890 Woodbridge Ave. (Bldg 10)
Edison, NJ 08837
(732)321-6645
runyon.robert@epa.gov
Alternate to Robert Runyon:
Pat Sheridan
Environmental Scientist
Hazardous Waste Support Branch, Division of
Environmental Science and Assessment
EPA Region 2
2890 Woodbridge Ave. (Bldg 10)
Edison, NJ 08837
(732)321-6780
sheridan.patricia@epa.gov
Former Consensus Member:
Ken Tindall
Chief
Federal Facilities Reuse Section
EPA Region 5
Consensus Member:
Steve Callio
Senior Chemist
Technical Management Services QA
EPA Region 8
999 18th Street, Suite 500
Denver, CO 80202
(303)312-7290
callio.steven@epa.gov
DEPARTMENT OF DEFENSE
Consensus Member:
Jackie Sample
Chief of Naval Operations (CNON457L)
Department of the Navy, Office of the Naval
Sea Systems Command (SEA04XQ (Labs))
1661 RedbankRoad, Suite 104
Charleston, SC 29445-6511
(843) 764-7337 ext. 11
samplejh@navsea.navy.mil
Alternate to Jackie Sample:
Douglas Scarborough
Senior Chemist
U.S. Army Environmental Center (USAEC)
Attn: SFIM-AEC-ERA (Mr. Scarborough)
Bldg. E4480, 4480 Hoadley Road
Aberdeen Proving Ground, MD 21010-5401
(410)671-1514
douglas. scarborough@aec. apgea. army. mil
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IDQTF Members, Alternates, and Participants
DEPARTMENT OF ENERGY
Consensus Member:
David Bottrell
Office of Environmental Management
Office of Safety, Health and Security
19901 Germantown Road
RM 1068/Cloverleaf Building
Germantown, MD 20874-1290
(301)903-7251
david.bottrell@em.doe.gov
Consensus Member:
Emile Boulos
Office of Environmental Safety and Health
1000 Independence Avenue, SW
Washington, DC 20585
(202)586-1306
emile.boulos@eh.doe.gov
OTHER REGULAR IDOTF
PARTICIPANTS (STAFF SUPPORT)
Ray Bath
DOE, Environmental Measurement Lab
201 Varick Street, 5th Floor
New York, NY 10014
(212) 620-3637
raymond.bath@eml.doe.gov
Deana Crumbling
Environmental Scientist
EPA, Technology Innovation Office,
OSWER
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(703) 603-0643
crumbling.deana@epa.gov
Skip Darley
Chemist
NAVSEA Program Field Office (SEA 07Q)
U.S. Navy
3601 Meeting Street Road
Charleston, SC 29405-5733
(803) 743-8673 ext. 20
darley_skip@hq.navsea.navy.mil
Khouane Ditthavong
Environmental Scientist
EPA, Office of Water
Mailcode 4303
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(202)260-6115
ditthavong.khouane@epa.gov
Ben Hull
EPA, Office of Air and Radiation, Office of
Radiation and Indoor Air
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(202) 564-9382
hull.benjamin@epa.gov
David Koran
DoD, USACE
20 Massachusetts Avenue
Washington, DC 20314-1000
(202) 761-4989
david.koran@HQ02.usace.army.mil
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IDQTF Members, Alternates, and Participants
Barbara Larcom
Lt. Col., USAF, BSC
Deputy for Public Health, Deputy Assistant
Secretary Air Force (ESOH)
DoD, U.S. Air Force
SAF/IEE
Air Force 1665
Pentagon
Washington, DC
(703)697-1019
barbara.larcom@pentagon.af.mil
Fred S. McLean
Chemist
DoD, USN, Naval Sea Systems Command
(NAVSEA)
NAVSEA 04XQ (Labs)
1661 Red Bank Road
Goose Creek, SC 29445
(843) 764-7337 ext. 22
mcleanfs@navsea.navy.mil
Eric Reynolds
Contract Lab Program, QA Coordinator
Office of Emergency and Remedial
Response (OERR)
EPA
Mailcode 52046
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(703) 603-9928
reynolds.eric@epa.gov
George Sundstrom
Environmental Scientist
U.S. Department of Agriculture
USDA Hazardous Materials Management
Group
201 14th Street, SW
YatesBldg., 3SE
Washington, DC 20250
(202) 260-6556
gsundstrom@usda.gov
Daniel Welch
Lt. Col., USAF, BSC
Chief of Restoration
HQ DLA/CAAE
Environmental and Safety Policy Office
(CAAE)
8725 John J. Kingman Road, Suit 2533
Ft. Belvoir, VA 22060-6221
(703) 767-6255
Daniel_Welch@hq.dla.mil
Contract Support
Project Manager:
Clem L. Rastatter
Director of Strategic Planning
Environmental Services Group
Versar, Inc.
6850 Versar Center
Springfield, VA 22151
(703) 642-6776
rastacle@versar.com
Task Manager:
Nicole Weymouth
Policy Analyst
Environmental Services Group
Versar, Inc.
6850 Versar Center
Springfield, VA 22151
(703) 642-6937
weymonic@versar.com
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APPENDIX G
FEDERAL QUALITY SYSTEMS ROLES AND
RESPONSIBILITIES GUIDANCE
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FEDERAL QUALITY SYSTEMS ROLES AND RESPONSIBILITIES GUIDANCE
1.0 Purpose
The purpose of this guidance is to establish general principles for the roles and
responsibilities relating to environmental data collection and use at Federal facilities. The guidance
was developed for use by those governmental organizations that have adopted the work products
(e.g., quality systems policy, quality assurance proj ect plan guidance) of the Intergovernmental Data
Quality Task Force (IDQTF). The goals of this appendix are to:
Define how to oversee implementation of the Uniform Federal Policy for
Implementing Environmental Quality Systems: Evaluating, Assessing, and
Documenting Environmental Data Collection/Use and Technology Programs (UFP-
QS) and Uniform Federal Policy for Quality Assurance Project Plans (UFP-QAPP)
throughout participating organizations;
Outline how problems between two or more agencies are to be resolved; and
Clarify the relationship between headquarters organizations (EPA/DoD/DOE) and
subordinate or other organizations, for quality systems oversight.
2.0 Scope
Policy and guidance issued by IDQTF (e.g., the UFP-QS and UFP-QAPP) are voluntary
consensus documents that become policies, procedures, and specifications when adopted by Federal
departments and/or agencies. This Roles and Responsibilities guidance applies to Federal, State,
and Tribal organizations and regulatory agencies that adopt IDQTF work products.
This guidance defines roles and responsibilities for implementing IDQTF work products and
managing environmental data quality. The initial focus of the IDQTF work products is hazardous
waste programs, although the scope may be expanded to address other environmental programs in
the future. The specifications in the IDQTF work products are consistent with current EPA quality
systems requirements and guidance (e.g., R-2, R-5, and G-5). Nothing in these work products shall
be construed to give up any rights of regulatory agencies to oversee environmental management
practices or to take necessary enforcement actions.
3.0 Roles and Responsibilities of Major Organizations
The roles and responsibilities described below were developed by the IDQTF based on its
evaluation of organizations that currently participate in IDQTF, including EPA, DoD and DOE.
Because the organization of other participating departments or agencies may vary, reasonable
judgment should be used to assign specified roles and responsibilities according to the intention of
this guidance.
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3.1 Intergovernmental Data Quality Task Force
The IDQTF has an ongoing role in the management and oversight of data quality, thereby
supporting implementation of IDQTF work products. The roles and responsibilities of the IDQTF
include:
Developing, updating, and revising IDQTF quality systems policy and guidance, as
appropriate;
Promoting and supporting intergovernmental quality systems training and outreach,
to encourage the use of IDQTF work products;
Developing a system for collection and evaluation of information to assess the use
and effectiveness of the IDQTF work products;
Promoting the sharing of quality systems documentation developed by other
organizations, provided they comply with the UFP-QS;
Conducting outreach to, and soliciting participation from, States, Territories, and
Tribes, to gain acceptance of the IDQTF work products; and
Providing assistance in identifying and resolving intergovernmental quality systems
implementation issues.
With regard to resolving intergovernmental quality systems issues , the IDQTF can provide
assistance in response to requests by participating organizations. Compliance with IDQTF
recommendations is voluntary. In general, IDQTF will agree to provide assistance if such
assistance adds value to the development or implementation of environmental data quality systems.
The following criteria must be met before IDQTF will provide such assistance:
IDQTF assistance can be provided in a timely manner; and
The problem represents a systemic problem that, if solved, will assist resolution of
similar issues among other organizations.
It is anticipated that issues will be elevated to IDQTF through one of its consensus members.
Appendix F to the UFP-QS provides a list of current IDQTF consensus members. Issues submitted
for IDQTF assistance must be described in writing. Attachment G-l provides a form for
summarizing issues and will serve as a response mechanism for indicating the IDQTF's intent to
provide assistance.
3.2 Environmental Protection Agency
The Environmental Protection Agency (EPA) is comprised of numerous programmatic
offices (e.g., Office of Water, Office of Solid Waste and Emergency Response [OSWER]), most of
whom have Regional counterparts. At this point in time, OSWER is the main EPA sponsor of
IDQTF work products, with the Quality Staff of the Office of Environmental Information (OEI), the
Office of Air, Office of Radiation and Indoor Air (ORIA), and the quality staff and/or hazardous
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waste management staff of several EPA Regions providing additional support.7 The EPA section
of this appendix is therefore divided into the separate headquarters program offices who have
assisted in development of IDQTF work products, as well as a general section on the roles and
responsibilities of Regional Offices.
3.2.1 EPA Office of Solid Waste and Emergency Response (OSWER)
OSWER is the program office within EPA that manages the national hazardous waste
programs, including Resource Conservation and Recovery Act (RCRA) and Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA). In this role, OSWER
develops regulations, issues policy and guidance, and plays oversight and technical assistance roles
in the implementation of hazardous waste programs in EPA Regions.
OSWER's roles and responsibilities include:
Continuing to provide the Chair and administrative and technical support for IDQTF,
through the Federal Facilities Restoration and Reuse Office (FFRRO) and other
OSWER offices;
Developing, implementing, and maintaining a quality system consistent with the
UFP-QS and EPA Order 5360.1, for hazardous waste programs;
Issuing directives to EPA Regions requiring them to develop quality systems
consistent with the UFP-QS;
Conducting and/or supporting assessments of Regional quality systems;
Promoting the use of the IDQTF work products by other EPA Program Offices
through the Quality and Information Council and other appropriate avenues;
Supporting the development and funding of intergovernmental quality systems
training for EPA, other Federal agencies, States, and Tribes via interagency
agreement (IAG) funding, as appropriate;
Conducting outreach to States, Territories, and Tribes to promote the use of IDQTF
work products; and
Promoting consistency across EPA Regions for the review and approval of quality
assurance project plans (QAPPs) consistent with the UFP-QAPP, for hazardous
waste programs.
Additional offices may sign on and their roles and responsibilities will be added to this appendix at that time.
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3.2.2 Office of Environmental Information (OEI)/Quality Staff
The OEI/Quality Staff plays a central leadership role throughout EPA in the development
of quality systems policies, procedures, guidance, and programs. The Quality Staff is responsible
for issuing quality systems policies, assessing EPA offices for implementation of such policies, and
developing quality systems training programs. The roles and responsibilities of the OEI/Quality Staff
include:
Continuing to participate as a Consensus Member in the IDQTF to ensure
consistency between IDQTF work products and the EPA Quality System;
Promoting the use of the UFP-QS and associated work products to other EPA
Program Offices through the Quality and Information Council and other appropriate
avenues;
Revising the Agency's quality policies and guidances to ensure consistency with
IDQTF work products that have Agency-wide applicability, as appropriate; and
Promoting IDQTF work products in communications with States, Territories, and
Tribes.
3.2.3 EPA Office of Radiation and Indoor Air (ORIA)
ORIA develops protection criteria, standards, and policies; works with other programs within
EPA and other agencies to control radiation and indoor air pollution exposures; provides technical
assistance to states through EPA's Regional Offices, and to other agencies having radiation and
indoor air protection programs; directs an environmental radiation monitoring program; responds
to radiological emergencies; and evaluates and assesses the overall risk and impact of radiation and
indoor air pollution. The roles and responsibilities of the ORIA Staff include:
Participating in the development and revision of IDQTF work products;
Developing, implementing, and maintaining a quality system consistent with the
UFP-QS;
Promoting consistency across EPA Regions for the review and approval of QAPPs
consistent with the UFP-QAPP;
Reviewing and approving QAPPs for environmental data collection operations that
are consistent with the UFP-QAPP;
Supporting the development and funding of intergovernmental quality systems
training for EPA, other Federal agencies, States, and Tribes via IAG funding, as
appropriate;
Promoting and supporting the application of the graded approach in developing
QAPPs; and
Conducting outreach to States, Territories, and Tribes to promote the use of IDQTF
work products.
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3.2.4 EPA Regional Offices
EPA Regional Offices implement environmental programs and oversee environmental
programs implemented by others. EPA Regional Offices have the following roles and
responsibilities:
Continuing to participate in the development and revision of IDQTF work products;
Developing, implementing, and maintaining Regional quality systems, consistent
with the UFP-QS and EPA Order 5360.1;
Conducting self-assessments of Regional quality systems against specifications in
the UFP-QS;
Utilizing the results of the self-assessments to develop plans to correct identified
deficiencies;
Promoting and supporting the development of intergovernmental quality systems
training;
Promoting the use of IDQTF work products to States, Territories, and Tribes;
Conducting audits of the quality systems of States, Territories, and Tribes;
Providing assistance to Federal facilities to enhance quality systems performance;
Reviewing and approving Federal facility QAPPs, including those prepared for sites
on the National Priorities List (NPL under CERCLA), consistent with the UFP-
QAPP;
Participating in the site-specific Systematic Planning Process (SPP) at Federal
facilities for data collection at non-NPL sites, at the request of other Federal agency
installations and field offices or State and Tribal agencies; and
Promoting and supporting the application of the graded approach in developing
QAPPs.
3.3 Other Federal Agencies
Other agencies currently include the Department of Defense (DoD) and the Department of
Energy (DOE).8
3.3.1 Headquarters of Other Participating Federal Departments and Agencies
Roles and responsibilities for participating Federal departments and agencies, at the
headquarters level, include:
Continuing to participate as Consensus Members in the IDQTF;
Issuing policy and guidance documents to develop, implement, and maintain quality
systems consistent with the UFP-QS, beginning with hazardous waste programs;
8 Additional agencies may sign on and their roles and responsibilities will be added to this appendix at that time.
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Providing review and oversight of UFP-QS implementation throughout the
Department/Agency;
Promoting consistency in UFP-QS implementation throughout subordinate
organizations;
Promoting and supporting the development of, and participation in,
intergovernmental quality systems training, as appropriate; and
Conducting and/or participating in outreach to States, Territories, and Tribes to
promote IDQTF work products.
3.3.2 Other Field, Regional, or Subordinate Organizations in Participating Federal
Departments and Agencies
Once a Department or Agency has adopted IDQTF work products, subordinate organizations
have the following roles and responsibilities:
Providing support to the IDQTF as requested by the authorized headquarters office;
Developing, implementing, and maintaining a quality system consistent with the
UFP-QS;
Overseeing the implementation and assessment of quality systems in subordinate
organizations;
Supporting the development of, and participating in, intergovernmental quality
systems training, as appropriate;
Implementing quality systems considerations into planning for all applicable
activities and operations related to environmental sampling and testing;
Promoting the development of and adherence to Q APPs that comply with the UFP-
QAPP;
Conducting the SPP and implementing graded approaches for the collection and use
of environmental data; and
Involving regulators, as appropriate, in the SPP.
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Attachment G-l
Form for Issue Submission to the
Intergovernmental Data Quality Task Force
The Intergovernmental Data Quality Task Force (IDQTF) may provide assistance in resolving intergovernmental
quality systems issues. The purpose of this form is to provide a brief synopsis of the issue that will allow the
members of the IDQTF to assess whether or not they wish to address the issue. The IDQTF retains discretion as
to which issues it will address. If the IDQTF decides to play a role in the issue resolution, and more information
is necessary, the IDQTF will contact the person who submitted the request for additional information.
Date of Submission I
Contact Information
Name, Organization
Phone Number
Email
Issue Number
(IDQTF Use Only)
Issue Statement
In the space provided, describe the
issue or issues for which advice is
requested. Frame the issue in crisp,
clear terms, using questions that pose
either/or choices, as appropriate.
Involved Parties
and Their Positions
In the space provided, identify the
parties who are involved and the
positions they have taken. If there
are no parties in disagreement,
describe who is asking for the advice
and why they are asking for it.
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Form for Issue Submission to the IDQTF (continued)
Concerns of Involved Parties
In the space provided, describe the
concerns that are driving the positions
of the parties involved (if the issue is
in fact a disagreement).
Background
In the space provided, describe the
history or background of the issue.
Include facts that will help the IDQTF
understand the issue. Include history
of attempts to resolve the issue. Cite
legal or policy requirements that you
believe should play a role in resolution
of the issue.
Submit completed form to:
EPA Personnel - FFRRO QA Manager
DoD Personnel - EDQW Chair
DOE Personnel -
IDQTF Disposition
The IDQTF will either agree to take on an issue or provide a rationale for why an issue will not be addressed.
An IDQTF representative will contact the person who submitted the request with the status of the issue
resolution.
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Issue Submission to the IDQTF
Tracking Sheet
(IDQTF Use Only)
Date Received
Responsible IDQTF Member(s)
Primary I
Organization |
Secondary(if necessary) [~
Organization I
Issue Number
Is additional information required? Yes
If yes, describe the type
of information requested.
No
Date of request
Identify the additional information received.
Document/E-mail/Phone Call
Date Received
The IDQTF can and should provide assistance in resolving this issue? Yes |
If no, provide rationale.
No I
Provide answer to the
person who submitted
the request.
Datel
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Issue Submission Tracking Sheet (continued)
(IDQTF Use Only)
Provide dates of meetings or conference calls with IDQTF members and/or parties
involved in the issue.
Date
Meeting/CC
Participants
Describe the final IDQTF
recommendation.
Provide IDQTF
recommendation to the
person who submitted the
request.
Date
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