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ETD QA CORE TEAM: AN ELOQUENT SOLUTION TO A COMPLEX PROBLEM
Citation:
Hughes, T. J. ETD QA CORE TEAM: AN ELOQUENT SOLUTION TO A COMPLEX PROBLEM. Presented at US EPA Annual QA Meeting, Tampa, FL, April 13-15, 2004.
Description:
ETD QA CORE TEAM: AN ELOQUENT SOLUTION TO A COMPLEX PROBLEMThomas J. Hughes, QA and Records Manager, Experimental Toxicology Division (ETD), National Health and Environmental Effects Research Laboratory (NHEERL), ORD, U.S. EPA, RTP, NC 27709
ETD is the largest health division in NHEERL, and the 120 scientists in ETD conduct more than 50 research studies each year. Many of the studies in ETD are high profile studies through interagency agreements with EPA Regions (World Trade Center Dust Study), the U.S. Air Force (Dioxin/Diabetes Study) and the EPA Office of Water (Disinfection By-Products Study in Drinking Water). Therefore, a large number of technical system reviews (TSRs), surveillances and audits (more than 30) must be conducted in ETD each year. Consequently, Tom Hughes, the ETD QA Manager, obtained permission from the Branch Chiefs and Division Director in 2003 to form an eight-member ETD QA Core Team. Team Members assisted Tom in TSRs, audits and surveillances. They were trained in QA procedures, attended national EPA (New Orleans) and ORD (Ada) QA Meetings, and assisted Tom in writing QA reports. The ETD QA Core Team for 2003 included Mette Schladweiler, Lenny Walsh and Najwa Coates from the Pulmonary Toxicology Branch (PTB), Don Doerfler from the Immunotoxicology Branch (ITB), and Karen Herbin-Davis, Tracey Ross, Carol Mitchell and Brenda Edwards from the Pharmacokinetics Branch (PKB). Participation on the ETD QA Core Team enabled Team Members to have more accurate research records, and enabled them to more fully assist their PIs when their labs were audited. In addition, they became QA ambassadors in their respective research Branches. Team Members assisted Tom for a maximum of two weeks per year, but only when their assistance did not interfere with their laboratory research. A large QA Team allowed the QA Manager the flexibility to avoid conflict-of-interests during audits, and to use alternative Team Members on audits when selected Members were not available. Membership on the ETD QA Core Team will be reviewed each year, but it is anticipated that Team Members will serve a minimum of three years. Membership on the ETD QA Core Team is viewed by Division Management as a career-enhancing opportunity. Exceptional performances by Team Members were recognized by Management in 2003 with two Team Awards. The ETD QA Core Team was recognized as a best practice by Brenda Culpepper, the DQA for NHEERL, during a QMSA in 2003. The ETD QA Core Team is an eloquent solution which has solved many QA challenges in ETD. It has greatly improved research records in the entire Division, has provided a trained QA Team to conduct required Agency QA activities on ETD research studies, and has instilled an understanding of the usefulness of QA throughout the Division. This is an abstract for presentation which has been reviewed by the U.S. EPA; views expressed do not necessarily represent EPA policy.