Quality Policy: U.S. Environmental Protection Agency

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EPA Classification No.: CIO 2106.

0 CIO Approval Date: 10/20/08


CIO Transmittal No.: 09-001 Review Date: 10/11

Issued by the EPA Chief Information Officer,

Pursuant to Delegation 1-19, dated 07/07/2005

U.S. ENVIRONMENTAL PROTECTION AGENCY

QUALITY POLICY

1. PURPOSE

This Policy:
• recognizes existing policies and procedures as the foundation of an Agency-wide
Quality Program;
• establishes an approach for identifying and addressing Agency quality issues; and
• provides a structure and procedures to ensure and enhance the effectiveness of the
Quality Program and its application to Agency products and services.

This policy affirms:


• EPA’s commitment to applying quality principles and practices to products and
services resulting from Agency programs and activities;
• the Assistant Administrator for Environmental Information and Chief Information
Officer’s (AA/CIO) and the Quality and Information Council’s (QIC) leadership of the
Quality Program at EPA in assuring the quality of Agency products and services;
• the AA/CIO’s responsibility, as the designated federal official for quality at EPA, to
lead, coordinate and maintain an effective Quality Program; and
• the roles of other key Agency managers and organizations that are implementing
quality policies and practices across Agency programs.

2. S
COPE AND APPLICABILITY

The scope of this Quality Policy includes Agency products and services that are
developed for external distribution or dissemination. EPA organizations may consider
the application of this Policy to other products and services developed for internal use.
Agency products and services encompassed by this Policy include, but may not be
limited to: environmental data and technology; environmental information;
assessments; reports; peer review; scientific research; regulatory development; and
information technology supporting external applications such as services that collect
and provide access to data and information. In addition, national or Agency-wide

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11
systems that support administrative and financial activities may be included. Such
products and services support the Agency’s: compliance and enforcement decisions;
critical research; and regulations. The current range of products and services covered
by this Policy includes, but is not strictly limited to, those that are covered by the policy,
procedures and guidance documents cited in CIO Procedures (CIO 2106-P-01.0)
Procedure for Quality Policy, (henceforth “Procedure”), Appendix 1.

This Policy applies to all EPA organizations including Headquarters Offices, Program
Offices, Regions, and their sub-organizations. This Policy may apply to non-EPA
organizations (e.g., States, Tribes, localities, regulated parties, volunteer organizations,
contractors, cooperative agreement holders, grantees, other federal governmental
agencies, intergovernmental organizations, educational institutions) performing work in
support of EPA’s mission or national program priorities as defined by and in accordance
with federal laws, regulations or extramural agreements or performing work on a
voluntary basis.

3. AUDIENCE

The principal audience for this Policy is all Agency employees (managers and staff)
who are responsible for developing, distributing and disseminating products and
services in support of EPA’s mission as defined in Section 2. Managers and staff in
non-EPA organizations (see Section 2 for examples) performing work for EPA may find
this Policy helpful in understanding their roles and responsibilities in conjunction with
applicable federal laws, regulations or extramural agreements. Also included are
members of non-EPA organizations producing products and services on a voluntary
basis in support of EPA’s programs.

4. BACKGROUND

Since its inception, EPA has adopted the philosophy that the quality of environmental
data and information supporting the Agency’s decisions must be appropriate for their
intended use. To build this philosophy into policy, EPA adopted voluntary national and
international consensus standards for quality such as the American National Standard
Institute/American Society for Quality Control -- ANSI/ASQC E4-19941 while developing
and implementing organizational quality management systems. These systems have
promoted best quality management practices and continual improvement processes
specific to environmental data collection and use and to environmental technology
programs.

1
Later updated as ANSI/ASQ E4-2004, Quality Systems for Environmental Data and Technology
Programs - Requirements with Guidance for Use, Milwaukee, Wisconsin 2004.

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11
Independently, quality principles have also been applied to other lines of business
within EPA, including financial and administrative areas. Internationally recognized
quality management system principles and standards have been adopted by many
governmental, inter-governmental, and non-governmental organizations to ensure the
quality of their products and services. EPA, as a leader in the fields of environmental
science and management, has recognized the need to further incorporate such
standards and principles throughout its business operations.

While affirming EPA’s commitment to quality, this Policy recognizes new and emerging
factors influencing the need for ongoing assurance and continual improvement of the
quality of the Agency’s products and services. Moreover, this Policy recognizes that
the expanded and consistent application of such quality management principles and
practices in all areas of the Agency’s operations is a desirable business objective.

Critical factors and events leading to the development of this Quality Policy:

A. The Clinger-Cohen Act of 1996 assigned federal Chief Information Officers


(CIOs) the responsibility for developing information technology architecture and
processes linking the business, mission, strategic plans, and processes of an
organization to its information technology strategy. The Office of Management
and Budget’s (OMB) Circular A-130 Management of Federal Information
Resources established implementing policies for Federal agencies under the
Clinger-Cohen Act. Within EPA, the AA/CIO is responsible for coordinating and
implementing the Agency’s quality assurance program for environmental data and
information technology that support Agency programs.

B. In 1999, EPA strengthened senior management leadership and involvement in


information technology and the Agency’s quality system by establishing the Office
of Environmental Information and the QIC chaired by the AA/CIO.

C. Pursuant to the Information Quality Act (IQA) of 2001, EPA developed


Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and
Integrity of Information Disseminated by the Environmental Protection Agency
(IQG) providing EPA policy and procedural guidance to implement the IQA.

D. OMB published Bulletins and other guidance materials focusing on the stages
during the life-cycle of products and services.

E. The Agency recognizes that by coordinating cross-programmatic quality


assurance activities and quality management practices, it can more effectively
assure the quality of its distributed or disseminated products and services.

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11

5. A
UTHORITY

Authorities include:
• Clinger-Cohen Act of 1996 (PL 104-106)
• National Technology Transfer and Advancement Act of 1995 (PL 104-113,
March 1996)
• Information Quality Act, Section 515 of the Treasury and Government
Appropriations Act of 2001 (PL106-554, 31 USC 3516)
• Administrative Procedure Act (5 USC 511-599)
• OMB Circular A-119, Federal Participation in the Development and Use of
Voluntary Consensus Standards and in Conformity Assessment Activities,
Office of Management and Budget, February 1998
• OMB Circular A-130, Management of Federal Information Resources, Office of
Management and Budget, November 2000
• EPA Delegation of Authority 1-41, Mandatory Quality Assurance Program,
January 2000
• EPA Delegation of Authority 1-19, Directives, July 2005
• OEI CIO Policy Review Process July 2005
• EPA CIO Policy No. 2101, Senior Information Officials, July 2005
• EPA’s Quality and Information Council Charter, July 2005

6. POLICY

This Policy recognizes EPA’s Quality Program requiring products and services that are
distributed or disseminated externally, as described in Section 2, to be of appropriate
quality for their intended use(s) and to support EPA’s mission to protect human health
and the environment. The Agency’s Quality Program will conform to accepted national
and international consensus quality standards, federal and Agency requirements.

This Policy also re-affirms the Agency’s long-standing commitment to quality principles.
It recognizes and builds upon the existing quality-related policies and activities already
implemented across the Agency. It ensures a comprehensive, coordinated approach
for consistent implementation of, and continual improvement in, the quality of EPA’s
products and services. Organizations that oversee Agency-wide business lines will
ensure that quality-related practices are described within business-specific policy,
practices, and procedures. This Policy also defines the AA/CIO’s role in leading the
Agency’s Quality Program.

EPA organizations will also:

A. Describe and document their current Quality Program by identifying appropriate


quality-related policies, procedures and standards pertaining to the types of products
and services within their business lines that support the Agency’s mission.

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11
B. Implement appropriate EPA quality-related policies and procedures for the products
and services established under these business lines.

C. Assess and review the effectiveness of their Quality Program at a frequency


consistent with the standards or practices established by their mission-related lines of
business.

D. Ensure that quality-related issues or problems for products or services covered by


this Policy that may adversely impact other Agency operations or organizations are
reported through the appropriate Agency reporting mechanisms, for example, the
Federal Managers’ Financial Integrity Act (FMFIA), and if no mechanism exists, report
these issues or problems to the AA/CIO.

The AA/CIO, assisted by the QIC will conduct an annual Agency-wide Quality Progress
Review (QPR), maintain a current MAP, and establish a process to facilitate cross-
Agency notification of issues or problems with products or services that may adversely
impact Agency operations.

These activities are further described as:

A. The QPR will evaluate how well the Agency is meeting quality goals and objectives.
The QPR will reflect individual program results as reported by organizations as well
as the overall Agency status and progress. Information collected for the QPR will
rely on existing Agency reporting requirements and reporting relationships. No new
reports or additional tracking of information by EPA organizations will be necessary.
Any exceptions will require approval by the QIC.

Some examples of existing reporting include:


• EPA organizations annually report and will continue to report on the
implementation of their quality systems for environmental data operations via
Quality Assurance Annual Reports and Work Plans (QAARWPs) to the AA/CIO;
• Agency peer reviewed products and science activities will continue to be

reported by EPA organizations to EPA’s Science Advisor; and

• reporting required by the FMFIA will continue through assurance letters from
AAs and RAs to the Administrator via the Agency’s Chief Financial Officer
(CFO).

B. The MAP will be based on the annual Quality Progress Review (QPR) and will
identify issues and areas for improvement. The MAP will be reviewed annually and
changes will be reported to the QIC. It will also include proposed activities and
schedules for addressing identified issues as negotiated by the AA/CIO with the
appropriate organization(s). Progress will be tracked as each MAP is updated.

C. The AA/CIO will review standard Agency reporting mechanisms and notify all SIOs
in the Agency of any quality-related issues or problems with products or services
covered by this Policy that may adversely impact multiple Agency organizations.

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11

7. RELATED DOCUMENTS

CIO Procedure CIO 2106-P-01.0 Procedure for Quality Policy.

8. ROLES AND RESPONSIBILITIES

EPA Administrator: EPA ‘s Administrator promotes quality as an integral part of the


Agency’s mission by assuring that the products and services supporting EPA’s
programs and activities meet our customers’ needs and expectations of quality.
Assistant Administrators (AAs) and Regional Administrators (RAs) are responsible for
maintaining quality within their respective programs and activities as delegated by the
Administrator.

Assistant Administrator for the Office of Environmental Information /Chief


Information Officer: The Assistant Administrator for Environmental Information (AA)
and Chief Information Officer (CIO) acts as the Agency’s Senior Management Official
for quality management and leads Agency-wide implementation of this Policy and
EPA’s Quality Program. The AA/CIO is responsible for issuing the Agency’s QPR
maintaining and tracking the progress of implementing the Agency’s current
Management Action Plan and informing AAs and RAs of any issues or problems related
to the quality of Agency products or services encompassed by this Policy.

Senior Information Officials: EPA organizations’ Senior Information Officials (SIO)


constitute an Agency-wide network to assist the CIO in the effective oversight,
coordination and management of quality and related issues.

Senior Policy Council: An EPA internal leadership organization, chaired by the


Deputy Administrator with members comprising the Chief Information Officer (chair of
the Quality and Information Council), Science Advisor (chair of the Science Policy
Council) and Associate Administrator for Policy, Economics and Innovation (chair of the
Regulatory Policy Council).

Quality and Information Council: The Quality and Information Council (QIC),
composed of SIOs and other senior managers as stipulated in the QIC Charter, advises
and assists “the Assistant Administrator for Environmental Information/Chief Information
Officer in developing and implementing the Agency’s quality … goals and policies.”
The QIC also serves as a forum to discuss coordination of the development and
effective application of quality management principles and practices across EPA
business and organizational lines and will act to recommend actions to improve
consistency and uniformity in implementing the Agency Quality Program. The AA/CIO
and the QIC ensure that all other policies or procedures that support or implement
aspects of the Agency’s Quality Program are aligned and consistent with this Policy and
its related procedures and guidelines. The Science Policy Council, along with the QIC
and the Regulatory Policy Council, are primary members of the Senior Policy Council,
chaired by the Deputy Administrator.

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11

Assistant Administrators: Assistant Administrators (AAs) will ensure that quality-


related policies and procedures are developed and implemented for their programs
consistent with their specific missions, and will dedicate sufficient resources to support
the effective implementation of this Policy within their organizational units for products
and services across all business domains. Depending on the organization, such
implementation may be accomplished through the SIO or other designated
management representative(s).

Responsibilities, under this Policy, may be re-delegated by the AA to appropriate senior


managers (e.g., SIOs), where specified, who will oversee the implementation of quality
for business domains of environmental data and information, research, and
administration. Depending on the organization, various implementation responsibilities
may be accomplished through further re-delegations to an appropriate senior manager,
Quality Manager and/or other management representative(s).

Chief Financial Officer: Consistent with the Chief Financial Officer’s (CFO) Act of
1990 and the Clinger-Cohen Act of 1996, the CFO is responsible for ensuring that (1)
accounting, financial, and other relevant administrative information systems are
designed, developed, maintained, and used effectively to provide financial or program
performance data; and, (2) financial and related program performance data are
provided on a reliable, consistent, and timely basis to financial management systems.
In addition, the CFO is the responsible authority for activities under OMB Circulars A-
123 and A-127. This Policy does not supersede the quality assurance provisions of
these or other CFO authorities.

Regional Administrators: Regional Administrators (RAs) will ensure that quality-


related policies and procedures are developed and implemented for their regions
consistent with their specific programs and regional missions, and will dedicate
sufficient resources to support the effective implementation of this Policy within their
organizational units for products and services across all business domains. Depending
on the organization, such implementation may be accomplished through the SIO, or
other designated management representative(s).

Responsibilities under this Policy may be re-delegated by the RA to appropriate senior


managers (e.g., SIO, Regional Science & Technology [RS&T] Directors, et al.) who will
oversee the implementation of quality for business domains of environmental data and
information, research, and administration. Depending on the organization, various
implementation responsibilities may be accomplished through re-delegations to an
appropriate senior manager, a Quality Manager and/or other management
representative(s).

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11

Science Policy Council: The Science Policy Council serves as a mechanism for
addressing EPA's many significant science policy issues that go beyond regional and
program boundaries. With a goal of integrating policies that guide Agency decision-
makers in their use of scientific and technical information, the SPC works to implement
and ensure the success of selected initiatives recommended by Agency staff and
external advisory bodies such as the National Research Council and others such as the
Congress, industry and environmental groups.

The SPC is chaired by EPA’s Science Advisor with members representing all HQ
Offices and Regions. The SPC is supported by a Steering Committee of Agency
managers and scientific staff, ad hoc working groups formed to study specific topics,
EPA’s Risk Assessment Forum and staff from the Office of Science Advisor. The SPC,
along with the QIC and the Regulatory Policy Council comprise the Senior Policy
Council, chaired by the Deputy Administrator.

9. DEFINITIONS

Consensus Standards: Standards that are developed and adopted by achieving


agreement with all affected parties. These standards are developed in accordance with
procedures used by the International Organization for Standardization or organizations
accredited by the American National Standards Institute.

Data: A collection of facts and estimates from which conclusions may be drawn.

Data Standard: Documented consensus-based agreement on the format and


definition of common data.

Environmental Data: Any measurements or information that describe environmental


processes, location, or conditions; ecological or health effects and consequences; or
the performance of environmental technology. For EPA, environmental data include
information collected directly from measurements, produced from models, and compiled
from other sources such as databases or literature.

Environmental Data Operations: Work performed to obtain, use, or report information


pertaining to environmental processes and conditions.

Environmental Technology: An all-inclusive term used to describe pollution


monitoring, measurement and control devices and systems, waste treatment processes
and storage facilities, and site remediation technologies and their components that may
be utilized to remove pollutants or contaminants from or prevent them from entering the
environment.

Framework: For the purposes of this policy, an organizing structure comprising


Agency quality policies, procedures, guidance, and tools.

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11

Information: For purposes of this policy, information means any communication or


representation of knowledge such as facts or data, in any medium or form, including,
but not limited to, textual, numerical, graphic, cartographic, narrative, or audiovisual
forms. (OMB Information Quality Guidelines)

Information Product: Any book, paper, map, machine-readable material, audiovisual


production, or other documentary material, regardless of physical form or characteristic.
(OMB Circular A-130)

Information Quality Guidelines: An Agency document that provides criteria for


ensuring the quality, utility, and transparency of disseminated EPA data and information
products and services. Quality is defined as a performance measure that ensures that
products and services meet Agency requirements and customer needs.

Information System: An organized collection, storage, and presentation system of


data for decision making, progress reporting, and for planning and evaluation of
programs. It can be either manual or computerized, or a combination of both.

Life Cycle: The life span of a product or service from its original planning and
development, through to its use and maintenance, and then its final closure or disposal.

Management Action Plan: The ongoing Plan issued by the AA/CIO that identifies the
Agency’s quality issues, sets schedules and notes progress being made in addressing
areas for improvement. The Plan is based on the AA/CIO’s Quality Progress Review.

Management System: A system to establish policy and objectives and to achieve


those objectives (e.g., ISO 9000). A management system may describe the policies,
objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization covering its products and services.

Metadata: Information about data required to facilitate its use, understanding and
management. Metadata should answer questions about data such as why they were
collected, how they were collected, what was done to the data, what they were used for
and what were their limitations.

Process: A set of interrelated resources and activities which transforms inputs into
outputs. Examples of processes include analysis, design, data collection, operation,
fabrication, and calculation.

Product: The intended result or final output of an activity or process that is


disseminated or distributed among EPA organizations or outside of EPA.

Quality Assurance: A management or oversight function that deals with setting policy
and running an administrative system of management controls that cover planning,
implementation, review, and maintenance to ensure products and services are meeting
their intended use.

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11
Quality Control: The overall system of technical activities that measure the attributes
and performance of a process, item, or service against defined standards to verify that
they meet the stated requirements established by the customer; operational techniques
and activities that are used to fulfill requirements for quality.

Quality Management: The aspects of an organization’s overall management system


that drive the implementation of EPA’s Quality Policy. Quality management includes
strategic planning, allocation of resources, and other systematic activities (e.g.,
planning, implementation, and assessment) pertaining to an organization’s quality
program.

Quality Management Plans: A formal document or manual that describes a quality


system in terms of the organizational structure, functional responsibilities of
management and staff, lines of authority, and required interfaces for those planning,
implementing and assessing all activities conducted.

Quality Program: The totality of management controls, processes, and documentation


in EPA’s planning, implementation, and assessment of applying quality in the creation
of Agency products and services.

Quality Progress Review: This review evaluates how well the Agency is meeting its
quality goals and objectives. It reflects individual program results as reported by
organizations as well as overall Agency status and progress. Information collected for
the review will rely on existing Agency reporting requirements and reporting
relationships except for those which may be approved by the QIC.

Service: A discrete function that performs one or more operations and returns a set of
results to an external requester.

10. WAIVERS
No waivers from this Policy will be accepted. Because this Policy encompasses a
broad range of products and services based on various policies, procedures and
guidance documents as noted in Section 2, organizations that wish to appeal a
particular requirement should address their request to the Agency official responsible
for that requirement. For example, an organization that is seeking a waiver from peer
review requirements would address its appeal to EPA’s Administrator.

11. RELATED PROCEDURES AND GUIDELINES

CIO Procedure CIO 2106-P-01.0 Procedure for Quality Policy.

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EPA Classification No.: CIO 2106.0 CIO Approval Date: 10/20/08
CIO Transmittal No.: 09-001 Review Date: 10/11

12. MATERIAL SUPERSEDED

This Policy does not change the authorities or responsibilities of individual EPA
organizations to apply quality principles and practices in the development of their products
and services.

13. ADDITIONAL INFORMATION

For further information about this Policy or the Agency Quality Program, please contact the
Office of Environmental Information, Quality Staff.

Molly A. O’Neill, Assistant Administrator


and Chief Information Officer
Office of Environmental Information

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