EPA Quality Management Tools for Organizations
EPA has developed or adapted several quality management tools to assist in implementing its quality program. The tools and scope of activities supporting the EPA Quality Program differ at each level of the organization.
See the EPA's Terminology Search Web service for definitions of EPA's Quality Program terms.
On this page:
- Quality Management Plans
- Quality Program Assessments
- QA Annual Report and Work Plans
- Training
- Laboratory On-line Resources
Quality Management Plans
- Quality Management Plans
- References
Quality Management Plans
A Quality Management Plan documents how an organization will plan, implement, and assess the effectiveness of its quality assurance and quality control operations. Specifically, it describes how an organization structures its
- quality program,
- the quality policies and procedures,
- areas of application,
- and roles, responsibilities, and authorities.
The elements of a quality program are documented in a Quality Management Plan. Both EPA organizations and organizations performing data collection activities funded by EPA are required to document their quality programs.
The Quality Management Plan is an organization or program-specific document; it describes the general practices of an organization or program. Project-specific details of individual projects of the organization or program are documented in a Quality Assurance Project Plan (see QA Project Plans).
Thus, the Quality Management Plan may be viewed as the "umbrella" document under which individual projects are conducted.
References
- EPA Environmental Information Quality Procedure contains specifications for EPA organizations.
- Quality Management Plan Standard defines the minimum requirements for QMPs for all EPA and non-EPA organizations performing environmental information operations.
- Quality Management Plan Checklist (pdf) (278.27 KB, April 14, 2021) - April 14, 2021. Checklist for reviewing EPA Quality Management Plans submitted to EQMD for Agency approval. This checklist was developed solely for the EQMD to use in reviewing Agency QMPs. However, it may be used to review QMPs submitted to your organization. If so, you will need to remove any requirements specific to EPA and tailor the checklist to emphasize those elements important to your organization and the proposed work.
Quality Program Assessments
- Quality Program Assessments
- References
- Examples and Other On-Line Resources
Quality Program Assessments
Assessments add value to a quality program by promoting and supporting continuous improvement. EPA's quality program, in conformance with national consensus standards, requires that each organization assess the effectiveness of its quality programs' implementation.
Although organizations are expected to assess themselves, they may also need to assess or be assessed by others in EPA's quality program whose environmental information operations are linked by funding. EPA's EQMD also performs assessments of EPA organization's Quality Program on a 5-year cycle.
A Quality Program Assessment is used to verify, by examination and evaluations of objective evidence, that applicable elements of the quality program are appropriate and have been
- developed,
- documented,
- and effectively implemented
in accordance and in conjunction with specified specifications. The focus of these assessments is on the quality program process not on evaluating the quality of specific products -- not judging the quality of environmental information or the performance of personnel or programs.
Where quality programs are being developed or not fully implemented, a less rigorous Management Systems Review may be applied instead of a Quality Program Assessment.
References
- Guidance on Assessing Quality Systems (G-3)- March 2003, EPA/240/R-03/002. Guidance on assessing the adequacy and effectiveness of an environmental quality program.
- American Society for Quality Publications
Examples and Other On-Line Resources
- American Society for Quality, American National Standards Institute, International Standards Organization (ASQ/ANSI/ISO) Guidelines for Auditing Management systems
- U.S. Food and Drug Administration Guide to Inspections of Quality Systems
QA Annual Report and Work Plans
- Best Practice
- Other On-Line Resources
Best Practice
EPA requires annual reviews and planning of the quality program resources and activities for each EPA organization's quality program in a Quality Assurance Annual Report and Work Plan (QAARWP).
The QAARWP is used to report on changes to an organization's quality program (as documented in its approved Quality Management Plan) and provide information on the previous year's quality management activities and those planned for the coming year.
Topics addressed include quality program resources and their adequacy and activities undertaken for the management and implementation of the quality program.
Example activities include
- quality-related training given and received,
- system-level and project-level quality assessments,
- publications,
- and presentations.
QAARWPs are submitted annually to the Enterprise Quality Management Division (EQMD), Office of Records, Administrative Systems and eDiscovery (ORASE), Office of Mission Support.
All Federal Agencies participate in two other annual self assessment activities that are related to quality. They are the Government Performance and Results Act (GPRA) planning and reporting activities and the Federal Manager's Financial Integrity Act (FMFIA) declarations of material weaknesses.
Other On-Line Resources
- Office of Management and Budget's GPRA Web Site
- EPA’s planning, budget, and results activities, in accordance with the Chief Financial Officers Act and Office of Management and Budget Circular A-136, Financial Reporting Requirements
Training
- Training
- Other On-Line Resources
Training
- Quality assurance training plays a key role in implementing the EPA's Quality Program. It promotes program knowledge, provides guidance, and assists staff develop technical skills. EPA organizations are required to provide training, for all levels of management and staff according to the organization's Quality Management Plan.
- Agency-wide quality training courses are available on the Quality Assurance Training Courses page.
Note: As we update our Quality Directives, we will replace the training files on this page with revised training material.
Other On-Line Resources
Laboratory On-Line Resources
Laboratory On-Line Resources
- U.S. EPA Environmental Measurement's Collection of Methods: includes information on approved methods developed by EPA offices and laboratories, and outside organizations for measuring the concentration of a substance or pollutant.
- U.S. EPA's Office of the Science Advisor
- The American Chemical Society resources for the teaching of professional ethics.
- The American Council of Independent Laboratories Environmental Sciences Publications includes documents on a code of ethics, manual analytical data adjustment, corporate values and expectations, and ethics and data integrity. There are also standard operating procedures on data integrity and ethical practices, proper raw data handing, and manual integration.
- The NELAC Institute (TNI) is a 501(c)(3) non-profit organization whose mission is to foster the generation of environmental data of known and documented quality through an open, inclusive, and transparent process that is responsive to the needs of the community.
- The University of Georgia's Quality Assurance Unit has information and links to FDA documents, EPA documents, the Society of Quality Assurance, good clinical practices, good manufacturing practices and links to other quality-related pages. The page contains information on EPA's Good Laboratory Practice standards.
- The National Institutes of Health - Office of Clinical Research and Bioethics Policy site contains information and links related to responsible conduct of research.
- ISO/IEC 17025 Accreditation: General Requirements for the Competence of Testing and Calibration Laboratories ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. The standard is about competence, and the accreditation is a formal recognition of that competence based on overarching quality management systems.
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