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QUALITY CONTROL FOR RESEARCH STUDIES: A CRITICAL PART OF THE QUALITY SYSTEM AT THE U. S. EPA
Citation:
Schladweiler, M. AND T. J. Hughes. QUALITY CONTROL FOR RESEARCH STUDIES: A CRITICAL PART OF THE QUALITY SYSTEM AT THE U. S. EPA. Presented at US EPA Annual Meeting, Tampa, FL, April 13-15, 2004.
Description:
QUALITY CONTROL FOR RESEARCH STUDIES: A CRITICAL PART OF THE QUALITY SYSTEM AT THE U.S. EPA Mette C.J. Schladweiler, Scientist, and Thomas 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
The quality system in ETD in NHEERL at the U.S. EPA is composed of many parts (Scientists, QA Manager, Management, Statisticians, and others such as the ETD QA Core Team). However, the quality system starts with the scientist who generates the research protocols (Intramural Research Protocols [IRPs]), operating procedures (OPs), and safety and animal handling protocols for their research studies. A critical part of the IRP is the quality control (QC) section, which many scientists confuse with quality assurance (QA) activities. QC is what the scientist does in the laboratory to insure that the experiments are acceptable; therefore, QC is internal to the laboratory. On the other hand, QA activities are conducted by outside parties (QA Manager, Quality Staff at EPA Headquarters) to insure that the data are reproducible, are defensible, follow the IRP and OPs, and are of high quality; therefore, QA is external to the laboratory. Both QC and QA activities are critical to the quality of the research data. However, excellent QA can never overcome inadequate QC activities in the laboratory. Many scientists know instinctively when an experiment is valid, and when an experiment is not valid, but they fail to fully document these QC criteria in their IRPs. In an effort to assist the laboratory scientist in ETD with the QC portion of their IRPs, the ETD QA Manager and QA Core Team have developed an "ETD Quality Control Checklist for Research Studies" that provides general but targeted areas for the scientist to consider when developing their research protocols. Areas covered in the ETD QC Checklist include experimental design, samples, controls, chemicals, animals, cells, microorganisms, equipment, replication, statistics, data management and records. The positive impact of the ETD QC Checklist on research studies will be discussed. This is an abstract for presentation which has been reviewed by the U.S. EPA; views expressed do not necessarily represent EPA policy.