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QUALITY ASSURANCE IN RESEARCH LABORATORIES: RULES AND REASON
Citation:
Rogers, R R. QUALITY ASSURANCE IN RESEARCH LABORATORIES: RULES AND REASON. 23rd Annual National Conference on Managing Environmental Quality Systems, Tampa, FL, 04/13-16/04.
Impact/Purpose:
To discuss the topic of QA in research laboratories
Description:
The progression of QA policies and their interpretations, at all EPA levels, has at times been troublesome to some scientists and QA professionals in EPA's Office of Research and Development, suggesting a need for more open discussions among all stakeholders than routinely occurs. One QA size does not fit all.
Additional emphasis has been added to this topic by the recent Agency Policy Directive for Ensuring the Competency of EPA Laboratories, which was developed by the Forum on Environmental Measurements as directed by the Science Policy Council. That proposed policy is an exquisite example of an action taken without adequate input from several primary stakeholder groups, in this case the QA community, managers, and research scientists of the National Laboratories in the Office of Research and Development (ORD). A great deal of consternation has resulted from the after-the-fact manner in which those stakeholders learned of that policy. Unfortunately, that recent episode is but one of several such QA policy decisions and interpretations that have earned uneven acceptance across the Agency and particularly within ORD over the past two decades. At the core of each such situation are two constants:
(a) a perceived lack of understanding by the QA policy decision makers of the exploratory nature of much of the research that is carried out within ORD, and (b) a tendency toward all-or-none views by both the "enforcers" of those policies and by the scientists who are expected to comply with them.