Policies and Procedures about Quality Assurance for EPA Organizations
The 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
- the design, construction and operation of environmental technology
View some of the example activities.
The following topics are discussed below:
- 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. In addition, some common questions asked by EPA organizations are answered under FAQ #3 - EPA Organizations and Personnel.
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There are 11 quality management specifications defined in EPA Order CIO 2105.0 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 for projects for examples, training, guidance, and other resources.
- 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.
- 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.
- 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.
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 our Agency-wide Quality Systems Documents page for more information on the Quality Staff.
The Graded Approach
Because 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 Organizations
Policies 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 - May 2000. Quality specifications for EPA organizations that produce or use environmental data.
- EPA Order CIO 2016.0 - The EPA Quality Program Policy for Agency products and services.
- EPA Contracts Management Manual. Chapter 7 and Chapter 46 contain quality-related specifications for solicitations and contracts.
- 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 and use.
- 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.