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IMPLEMENTATION OF QUALITY ASSURANCE OF MULTILABORATORY STUDIES WITHIN THE US EPA
Citation:
Hughes, T. J. IMPLEMENTATION OF QUALITY ASSURANCE OF MULTILABORATORY STUDIES WITHIN THE US EPA. Presented at EPA Annual QA Meeting, St. Louis, MO, April 1-7, 2001.
Description:
Implementation of Quality Assurance on Multilaboratory Studies Within the U. S. EPA
Thomas J. Hughes1, Brenda Culpepper1, Nancy Adams2, and John Martinson3, 1National Health and Environmental Effects Research Laboratory (NHEERL), 2National Risk Management Research Laboratory (NRMRL), and 3National Exposure Research Laboratory (NERL), Office for Research and Development (ORD), U.S. EPA.
The purpose of this talk is to explain the approach the U.S. EPA has taken on quality assurance (QA) of research studies conducted within the Agency. The U. S. EPA, Office of Research and Development, was reorganized in 1995 into National Laboratories and Centers, and since that time the scientific collaboration among the National Laboratories and Centers has significantly increased. Consequently, the EPA-ORD quality assurance community has sought to reach a consensus on the mechanisms for QA activities on such research studies, which tend to be large multidisciplinary, multiyear studies. An operating procedure (OP) for multilaboratory studies was therefore written by QA personnel in the three National Laboratories identified in the header, in collaboration with the National Center for Environmental Assessment (NCEA) and the National Center for Environmental Research (NCER). This OP is entitled "Coordination of QA Efforts Across EPA Organizations for Multilaboratory/Center EPA Research Studies." At the present time, this OP is in final review by the participants, and will be signed and approved by all parties shortly. This OP provides general guidance to all parties concerned, and has been written so as not to interfere with specific mandates of any of the involved National Laboratories or Centers. The OP states that an umbrella QA Project Plan (QAPP) for such multilaboratory projects is the responsibility of the lead Principal Investigator (PI), who will be determined after consultation with all study personnel and QA Managers (QAMs) and Directors (DQAs). This umbrella QAPP will consist of individual sub-plans linked together under an overall format determined by the lead PI, who will also determine the QA categories for the study, after consultation with their QAM, DQA and management. At the end of the project, the lead PI will collect all QA reports from the study and write a QA Summary for the final report. The OP also discusses roles and responsibilities of study participants, encourages frequent communication among all study participants, and contains a flowchart of overall QA activities for the project. This talk will discuss the specific details in this OP, and describe how this OP for multilaboratory research studies has been employed in studies where NHEERL is the lead organization.