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A CHRONOLOGICAL HISTORY OF QUALITY ASSURANCE IN THE US EPA OFFICE OF RESEARCH AND DEVELOPMENT
Citation:
Rogers, R R. A CHRONOLOGICAL HISTORY OF QUALITY ASSURANCE IN THE US EPA OFFICE OF RESEARCH AND DEVELOPMENT. Presented at ORD QA Conference, Duluth, MN, Oct. 16-17, 2002.
Description:
The US EPA Office of Research and Development (ORD) has a fairly long, eventful, and largely successful QA history, in spite of the fact that the Agency' s QA focus has been elsewhere. For most of the past decade, we QA professionals in ORD have had little opportunity other than monthly conference calls to share ideas and expertise, or to work together to resolve concerns. This annual ORD QA Conference, re-established after being abandoned in 1990, provides that opportunity. However, because ORD's QA history and QA issues are somewhat unique, it may be wise, and ultimately efficient, to follow the old maxim about heeding the lessons of the past in order to avoid repeating past failures. QA perspectives and the key issues to be resolved will always differ across ORD, but in order to best take advantage of the opportunity that this annual conference provides us, a brief overview of the course that has been followed, charted in part by us and in part for us by the Agency Quality Staff, may be useful in ensuring that we all share a common understanding of how we reached this point. This summary history of important EPA and ORD QA milestones will reflect direct and indirect recollections by those of us with ORD QA tenure that precedes the contract conversions of 1995, plus key events that have followed that major transition, as perceived by both pre-1995 and post-1995 members of this ORD QA family.
ORD s QA history precedes by several years the 1979 Agency mandate for participation in an Agency-wide Quality System. Much of that early ORD effort was aimed at air programs, an inheritance from the Air Pollution Control Administration, which was the predecessor to many of ORD's early research programs. But other parts of ORD, in particular those elements of ORD that were not involved in the collection and analysis of soil, water, or air samples collected from environmental sites of interest, were slow to fully engage in the Agency Quality System. All of ORD chose to fulfill that mandate with money, that is, QA by contractor, rather than with hard-to-come-by FTEs. The success of that approach varied across ORD, but generally appeared great on paper while it was terrible in QA principle and practice. A number of ambitious efforts have been undertaken, with varied success, some on matters that continue to be of interest (e.g., QA guidelines and training, online QA documentation systems). Some of those earlier efforts may merit repeating or expanding (e.g., GED's Policies & Procedures database, HERL's 1984 Committee on GLP Compliance Requirements) and some clearly do not (e.g., OHR QA Manual).
The contract ethics issues resulting from ORD s decision to have QA-by-contract caught the attention of Agency acquisition and QA leaders in 1992, and the fix was implemented in 1995 with the conversion of contract dollars to EPA FTEs for QA staff. That resulted in a major shill in how things were done, and an almost universal, albeit still uneven, improvement in awareness and acceptance of QA issues and requirements. The question now is how to make the additional improvements that are still needed, to either old problems (e.g., records management) or fairly new ones (e.g., public access to ORD data).
This is an abstract for a poster presentation, and does not necessarily reflect the opinions nor views of the U.S. Environmental Protection Agency.