Policies and Procedures for EPA OrganizationsThe EPA Quality System encompasses management and technical activities related to the planning, implementation, assessment, and improvement of environmental programs that involve:
- the collection, evaluation, and use of environmental data, and
- the design, construction, and operation of environmental technology.
A list of some example activities are contained in Example Activities. The following topics are discussed here:
- General Specifications
- Relationship to EPA's Information Quality Guidelines
- Organizational Implementation
- The Graded Approach
- Agency-wide Oversight
This information is also contained in the Overview of the EPA Quality System for Environmental Data and Technology (PDF 35pp, 160K About PDF). In addition, some common questions asked by EPA organizations are answered under FAQ #3 - EPA Organizations and Personnel.
For directions on accessing the references listed below, see Information About Downloadable Files.
There are 11 quality management specifications defined in EPA
Order CIO 2105.0 (PDF 12pp,
PDF) for all EPA organizations covered by the EPA Quality
System. It is EPA policy that EPA organizations conform to the minimum
specifications of ANSI/ASQC E4-1994 (an American National Standard) and:
- Identify a QA Manager and ensure that this individual can function
independently from environmental data collection and use and has access
to the top management with the organization. See Quality
System Contacts and Web Sites for a list of EPA QA Managers.
- Develop a Quality Management Plan and implement this plan following
Agency approval - see Quality Management Tools -
Quality Management Plans for examples, training, guidance, and other
- Provide sufficient resources to implement the quality system.
- Assess the effectiveness of the quality system at least annually
and implement corrective actions based on assessment results in a timely
manner - see Quality Management Tools - Quality
System Assessments for examples, training, guidance, and other resources.
- Submit an QA Annual Report and Work Plan that summarizes the previous
year's activities and outlines the work proposed for the current year
- see Quality Management Tools - QA Annual Report
and Work Plans for examples, guidance, and other resources.
- Implement Agency-wide Quality System specifications in all applicable
EPA-funded extramural agreements. See Chapter 2 of the EPA Contracts
Management Manual (EPA Directive 1900) which is available on the EPA
Intranet at intranet.epa.gov/oamintra/. Also, see Quality
Specifications for non-EPA Organizations for information on Federal
Regulations, documentation, and other resources.
- Provide appropriate training for all levels of management and staff
to assure that quality-related responsibilities and requirements are
understood - see Quality Management Tools -
Training Program for examples, training, guidance, and other resources.
- Use a systematic planning approach to develop acceptance or performance
criteria for all work covered by the EPA Quality System - see Quality
Management Tools - Systematic Planning for examples, training, guidance,
and other resources.
- Have approved QA Project Plans, or equivalent documents, for all
applicable projects and tasks involving environmental data - see Quality
Management Tools - QA Project Plans for examples, training, guidance,
and other resources.
- Assess existing data, when used to support Agency decisions or other secondary purposes, to verify that they are of sufficient quantity and adequate quality for their intended use - see Quality Management Tools - Data Quality Assessment for examples, training, guidance, and other resources.
EPA policy CIO 2105.0 also contains program-specific specifications and responsibilities for EPA managers and staff.
Relationship to EPA's Information Quality Guidelines
EPA's quality system policy includes procedures for developing and implementing program-specific quality-related activities. These activities then serve as a framework for information product developers to ensure that information products meet the specifications of the Information Quality Guidelines (IQGs). For more information, see EPA's Information Quality Guidelines.
Because of the diversity and dispersion of programs within EPA, the EPA Quality System is decentralized. EPA organizations have individual quality systems that specifically address their needs. As a result, the EPA Quality System is composed of individual quality systems developed and implemented by the various EPA Regions, National Program Offices, and the National Centers and Laboratories in the Office of Research and Development.
Overall, there are more than 40 EPA organizations that maintain quality systems. These organizations are usually at the Regional Office level, at the level immediately below each National Program Office, and at the National Research Center and Laboratory level. Specialized, complex, large, or highly-visible programs (for example, EPA's Great Lakes National Program) also may have their own quality systems. Typically, such programs cut across organizational lines and have their own organizational infrastructure.
The Assistant Administrator for Environmental Information is responsible for developing and coordinating the EPA Quality System in addition to directing its implementation within EPA. This role is performed by the Quality Staff. See Agency-wide Oversight for more information on the Quality Staff.
The Graded ApproachBecause of the diversity of work conducted through procurements and assistance agreements, EPA recognizes that a "one size fits all" approach to quality specifications will not work. Therefore, the implementation of the EPA Quality System is based on a graded approach. A graded approach means that quality systems for different organizations and programs will vary according to the specific objectives and needs of the organization. For example, the quality practices needed in a research program are different from those in a regulatory compliance program because the purpose or intended use of the data is different.
The graded approach applies to the development of a quality system and the resulting documentation. Example applications of a graded approach to documentation include:
- Documentation of the Organization's Quality System (Quality Management
Plan): The documentation should describe a Quality System that is designed
to support the objectives of the organization. The level of effort expended
to develop and document a Quality System should be based on the scope
of the program. For example, large grants to a State government may
require a comprehensive quality system and documentation, whereas smaller
grants for programs with relatively less significant impacts may require
less substantial documentation.
- Documentation of the application of quality assurance and quality control activities to an activity-specific effort (Quality Assurance Project Plan): The level of detail of the Quality Assurance Project Plan should be based on a graded approach so that the level of detail varies according to the nature of the work being performed and the intended use of the data. As a result, an acceptable plan for some environmental data operations may require a qualitative discussion of the experimental process and its objectives while others may require extensive documentation to adequately describe a complex environmental program.
Policies for EPA OrganizationsPolicies for EPA Organizations are defined in the internal Agency policies listed below.
- EPA Order
CIO 2105.0 - Policy and Program Requirements for the Mandatory Agency-wide
Quality System (PDF
12pp, 94K About
May 2000. Quality specifications for EPA organizations that produce
or use environmental data.
- EPA CIO
2105-P-01-0 - EPA Quality Manual
for Environmental Programs (PDF
62pp, 169K About
PDF) - May 2000. Instructions
for satisfying the mandatory Quality System specifications defined
in EPA Order CIO 2105.0.
- EPA Contracts Management Manual. Chapter 7 and Chapter 46 contain quality-related specifications for solicitations and contracts. This Manual is available on the EPA Intranet at epawww.epa.gov/oamintra/policy/.
- Introduction to EPA Quality System
Requirements. This one-day course is intended to introduce the concepts
of quality management. The course contains an overview of the Agency's
Quality System, an overview of basic quality assurance concepts and
practices, and a description of the application of these concepts and
practices to environmental programs involving environmental data collection
- Overview of the EPA Quality System. This is an abbreviated version of the Introduction to the EPA Quality System Requirements course that focuses on the specifications of the EPA Quality System. This course describes the EPA Quality System and the specific elements that managers and project personnel must address to comply with EPA policy.
Oversight of the implementation of the EPA Quality System is performed by:
- Agency Senior Management Official for Quality: The Assistant
Administrator for Environmental Information is the Agency's Senior Management
Official for Quality and is responsible for developing and coordinating
the EPA Quality System and directing its implementation within EPA.
- Quality and Information Council: The Quality and Information
Council is an advisory group of Agency senior managers that assists
the Assistant Administrator for Environmental Information in the role
of Senior Management Official for Quality. The Council serves as a forum
in which Agency-wide Quality System issues can be addressed.
- Office of Environmental Information's Quality Staff: The Quality Staff of the Office of Environmental Information supports the Assistant Administrator for Environmental Information in the role of Senior Management Official for Quality. The Staff is responsible for developing Agency-wide Quality System policy and procedures, coordinating with EPA's Program Offices, Laboratories, Regional Offices, and overseeing the implementation of the EPA Quality System. This role includes supporting Agency organizations in developing and implementing their individual quality systems and assessing these systems. See the Quality Staff's About Us page for more information.