You are here:
DEVELOPMENT OF AN ETD SURVEILLANCE CHECKLIST FOR MONITORING EPA RESEARCH ACTIVITIES
Citation:
Hughes, T. J. DEVELOPMENT OF AN ETD SURVEILLANCE CHECKLIST FOR MONITORING EPA RESEARCH ACTIVITIES. Presented at EPA Annual QA Meeting, Phoenix, AZ, 04/08/02-04/11/02.
Description:
DEVELOPMENT OF AN ETD SURVEILLANCE CHECKLIST FOR MONITORING EPA RESEARCH ACTIVITIES, Thomas J. Hughes, National Health and Environmental Effects Research Laboratory (NHEERL), ORD, U.S. EPA, Experimental Toxicology Division (ETD), MD 66, RTP, NC 27711
Research studies conducted within the nine divisions of NHEERL are ranked in QA Categories from 1-4 based on their importance to the Agency's goals and impact on regulations. QA Category 1 studies have direct regulatory impact or very high visibility (e.g., World Trade Center research); QA Category 2 studies have potential regulatory impact or high visibility (e.g., research on black mold which has caused death in children); QA Category 3 research investigates research concepts and principles (e.g., will these assays produce a dose response after exposure to toxicants in water?); and QA Category 4 research is exploratory in nature (which bioassays will detect carcinogens in air?). The Principal Investigator, Branch Chief and QA Manager determine the category of the research when the intramural research protocol (IRP, which is equivalent to a QAPP) is written at the start of the study. The difference between a QA 1 or 2 study, or a QA 3 or 4 study can be subtle, and studies can be upgraded if the results of the research warrant. QA 1 and 2 studies are required to be audited by a QA review, called a technical systems review (TSR), during the life of the study (hopefully in the first third of the study to correct deficiencies). A TSR usually takes the division QA Manager (the lead reviewer), another scientist or QA Manager, and the laboratory staff several days to complete. A TSR for the QA Manager, from initiation of the agenda to the delivery of the final report, can take several weeks of time to complete. Priority for reviews of research is given to QA 1 and 2 studies, which can leave QA 3 and 4 studies with limited review by the QA Manager, especially in a large division such as ETD with 135 scientists and over 40 studies underway every year. It is virtually impossible to conduct a TSR on the majority of studies; reviews of ten percent of research studies in any one year is the goal. Consequently, if TSRs are the only QA review process, many research projects may not be reviewed during the life of the study. To overcome this obvious obstacle to timely QA review of research projects, an ETD surveillance checklist was developed and utilized to evaluate and review major components of all research studies within ETD. The ETD Surveillance Checklist is a condensation of the 20-page TSR checklist, is in a yes/no format, and covers notebooks, OPs, IRPs, computer files and data, data storage and filing, primary balance, primary pH meter, and two major pieces of equipment. The three page ETD Surveillance Checklist concludes with a section on exemplary findings and areas for improvement. The ETD Checklist allowed the QA Manager to quickly (one hour) and efficiently evaluate the QA status of studies for each PI in the Division. Although obviously not as thorough as a TSR, it does provide a documented basis to identify and correct deficiencies of all research studies within the Division regardless of QA Category. It is the intent of the ETD QA Manager to use this surveillance
checklist on a yearly basis. This is an abstract for presentation which has been reviewed by the U.S. EPA; views expressed do not necessarily represent EPA policy.