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Quality Management Tools - 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) (PDF 83pp, 556K About
PDF) - March 2003, EPA/240/R-03/002. Guidance on assessing the adequacy
and effectiveness of an environmental quality system.
- American Society for Quality Publications
www.asq.org/quality-press/index.html
- U.S. General Accounting Office - Evaluation Research and Methodology
www.gao.gov/special.pubs/erm.html
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
- EPA Federal Facilities Enforcement Office - Environmental Management
Reviews
www.epa.gov/Compliance/resources/publications/incentives/ems/
- International Standards Organization (ISO) Auditing Guidelines
www.isaca.org/Template.cfm?Section=Standards3&Template=/TaggedPage/TaggedPageDisplay.cfm&TPLID=29&ContentID=8477
- U.S. Food and Drug Administration
www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm