EPA Quality Management Tools for Organizations and Programs
You may need a PDF reader to view some of the files on this page. See EPA’s About PDF page to learn more.EPA has developed or adapted several quality management tools to assist in implementing its quality system. The tools and scope of activities supporting the EPA Quality System differ at each level of the organization.
See the EPA's Terminology Search Web service for definitions of common terms used in the context of EPA's Quality System.
On this page:
- Laboratory Quality Systems - Best Practices
- QA Annual Report and Work Plans
- Quality Management Plans
- Quality Systems Assessments
- Training Programs
Laboratory Quality Systems - Best Practices
Best Practice
Many environmental decisions are supported by laboratory data. If data are not of the quality needed for the decision, then the decision may be incorrect, resulting in unacceptable risk to human health or the environment or the expenditure of funds for unnecessary activities.
Environmental laboratories that do not follow proper procedures can cause incorrect data to be used in decision making. Below are links to references, training, examples and other on-line resources for best practices for laboratory quality systems.
If you can recommend sources of best practices for laboratory quality systems for use in updating this page, please contact us by phone at (202) 565-2441 or E-mail at quality@epa.gov.
References
- Guidance on Environmental Data Verification and Validation (QA/G-8) - November 2002, EPA/240/R-02/004. Guidance to help organizations conduct data verification and data validation activities including information on Data Integrity.
- Best Practices for the Detection and Deterrence of Laboratory Fraud - This document was produced by the California Military Environmental Coordination Committee in association with the Chemical Data Quality/Cost Reduction Process Action Team to detect fraudulent laboratory practices. March 1997
Training
- Detecting Improper Laboratory Practices - This one and one half day course presents tools and techniques for identifying improper practices in environmental laboratories during routine laboratory assessments. The course identifies "red flags" in each step of the assessment process which can indicate improper practices in the laboratory.
The material can also be used by laboratory management or quality assurance staff to evaluate the laboratory's internal systems and processes to reduce the likelihood of the improper practices.
- Data Verification and Validation - This one day course presents tools and techniques for data verification and validation and includes training on data integrity. (This training is available at selected Quality System Training Events)
Examples and Other On-line Resources
- U.S. EPA Region 9 Quality Assurance Web page includes information on analytical methods, data validation, laboratory quality assurance, and links to quality assurance guidance from other EPA organizations.
- 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. Below are categories of methods:
- U.S. EPA's Office of the Science Advisor.
- U.S. Department of Defense - Defense Environmental Network and Information Exchange Exitserves as a central platform for the dissemination of environment, safety and occupational health news, policy, and guidance within Department of Defense activities worldwide and contains a link to the Department of Defense's Quality Systems Manual for Environmental Laboratories.
- The American Chemical Society Exit resources for the teaching of professional ethics.
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The American Council of Independent Laboratories Environmental Sciences Publications Exit 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.
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The NELAC Institute (TNI) Exit 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.
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The University of Georgia's Quality Assurance Unit Exit 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 Exit 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 Exit ISO/IEC 17025 is the standard for which most labs must hold accrditation in order to be deemed technically competent. The standard is about competence, and the accreditation is a formal recognition of that comptence based on overarching quality management sytems.
QA Annual Report and Work Plans
Best Practice
EPA requires annual reviews and planning of the quality system resources and activities for each EPA organization's quality system in a Quality Assurance Annual Report and Work Plan (QAARWP).
The QAARWP is used to report on changes to an organization's quality system (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 system resources and their adequacy and activities undertaken for the management and implementation of the quality system.
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 Quality Staff, Office of Environmental Information.
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
- 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
Quality Management Plans
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 system,
- the quality policies and procedures,
- areas of application,
- and roles, responsibilities, and authorities.
The elements of a quality system 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 systems.
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 Quality Manual for Environmental Programs EPA CIO 2105-P-01-0. Chapter 3 contains specifications for EPA organizations.
- EPA Requirements for Quality Management Plans (QA/R-2) - March 2001 (Reissued May 2006), EPA/240/B-01/002. Reissue Notice. Contains specifications for organizations that receive funding from EPA (equivalent to those in EPA Manual 2105-P-01-0).
- Guidance for Developing Quality Systems for Environmental Programs (G-1) - November 2002, EPA/240/B-02/008. Guidance on developing and documenting the elements of a functional quality system in organizations that carry out environmental data operations within, or on behalf of, EPA.
- Quality Management Plan Checklist - Version 4, March 2020. Checklist for reviewing EPA Quality Management Plans submitted to the Enterprise Quality Management Division (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.
Examples and Other On-line Resources
- EPA Office of Air Quality Planning and Standards
- EPA Region 4
- EPA Region 7
- Intergovernmental Data Quality Task Force - Uniform Federal Policy for Implementing Environmental Quality Systems
Quality Systems Assessments
Quality Systems Assessments
Assessments add value to a quality system by promoting and supporting continuous improvement. EPA's quality system, in conformance with national consensus standards, requires that each organization assess the effectiveness of its quality systems' implementation.
Although organizations are expected to assess themselves, they may also need to assess or be assessed by others in EPA's quality system whose environmental data operations are linked by funding. EPA's Quality Staff also performs assessments of EPA organization's Quality Systems on a 3-year cycle.
A Quality System Audit is used to verify, by examination and evaluations of objective evidence, that applicable elements of the quality system 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 system process not on evaluating the quality of specific products -- not judging the quality of environmental data or the performance of personnel or programs.
Where quality systems are being developed or not fully implemented, a less rigorous Management Systems Review may be applied instead of a Quality System Audit.
For directions on accessing the references and training listed below, see Information About Downloadable Files.
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 system.
- American Society for Quality Publications Exit
Training
- Assessing Quality Systems - This one-day course is designed to prepare those who will either assess or be assessed as part of an EPA or EPA-supporting quality system.
The focus of the course is to improve quality systems and conserve resources through careful planning. Knowledge of the principles and documentation of the quality system is a prerequisite for the course.
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 Exit
- U.S. Food and Drug Administration Guide to Inspections of Quality Systems Exit
Training Programs
Training Programs
Training consists of methods and techniques to ensure that all personnel have the necessary skills to effectively accomplish their work and that quality management responsibilities and requirements are understood at every stage of project implementation throughout the Agency.
Quality assurance training plays a key role in institutionalizing EPA's Quality System by promoting knowledge of the system, providing guidance on EPA quality assurance policies, and helping staff develop the technical skills necessary to implement the Quality System.
EPA organizations are required to provide training, for all levels of management and staff, to assure that quality assurance and quality control responsibilities and activities are understood at every stage of project implementation.
You may need a PDF reader to view some of the files on this page. See EPA’s About PDF page to learn more.
References
- Guidance for Developing a Training Program for Quality Systems (QA/G-10) - December 2000 (Reissued May 2006), EPA/240/B-00/004. Reissue Notice. Guidance on determining quality system training needs and developing a program-specific quality systems training program for all levels of management and staff.
Training
- Agency-wide training courses on quality assurance and quality management are available on the Quality Assurance Training Courses page.
Please note: The Quality Staff is currently in the process of using Skillsoft, the OEI/OARM Learning Management System, and is reviewing and updating our existing training. We thank you for your patience.