Science Inventory

A VIRTUAL TECHNICAL SYSTEMS AUDIT OF RESEARCH QUALITY ASSURANCE AND RECORD MANAGEMENT SYSTEMS IN ORD, U.S EPA

Citation:

HUGHES, T. J. AND B. CULPEPPER. A VIRTUAL TECHNICAL SYSTEMS AUDIT OF RESEARCH QUALITY ASSURANCE AND RECORD MANAGEMENT SYSTEMS IN ORD, U.S EPA. Presented at U.S. EPA Annual QA Meeting, Austin, TX, April 24 - 28, 2006.

Description:

NHEERL conducts technical systems audits (TSAs) on its research projects. The findings are reported by the QA Manager (QAM) to the Director of QA (DQA) as Exemplary Findings (things the QA Team liked); Corrective Actions (things that must be corrected immediately); and Areas for Improvement (things that should be corrected as recommended unless there is a reason why they should not be corrected or can be handled in another way). We thought it might be interesting to have a QA and Records Manager and the DQA in NHEERL conduct a virtual TSA on quality assurance (QA) and record management (RM) systems for research data in ORD. Here are the findings of such a virtual TSA.

A. Exemplary Findings

1. The meetings and QA training by EPA¿s Quality Staff are exceptional.

2. TSAs are a comprehensive and flexible means of auditing research studies, especially when combined with data audits and in-life surveillances.

3. The QA Community in ORD has an excellent communications system for collaboration and interacting on large inter/intralaboratory studies (e.g., National Coastal Assessment, World Trade Center, wadeable streams, disinfection

by-products in drinking water).

4. The ORD SOPs presently being developed are excellent standards for

inter/intralaboratory research studies.

5. ORD Division and Laboratory management are generally very supportive of QA and RM initiatives for research studies.

B. Corrective Actions

1. ORD needs a Quality Management Plan (QMP), especially with the recent development of ORD SOPs and large ORD interlaboratory studies.

2. The records management system in ORD consists largely of paper records (notebooks) and diverse electronic files. ORD needs a uniform E-records policy and monetary support for a comprehensive electronic system to maintain research records. Such an

E-records system for scientific records is especially important for highly visible and regulatory research studies (QA Category 1 and 2 studies).

C. Areas for Improvement

1. The QA, Records, and IT Staff need an effective way to talk and interact with each other. Presently, each of these entities meets separately several times a year.

2. ORD should consider a yearly meeting of QA, RM and IT Staff (i.e., the ORD QRIT meeting), possibly held in DC. This meeting could be held in conjunction with the EPA Science Forum held each year.

3. Electronic records training needs to be available to QA, Records, and IT Managers. This E-training could be given at the yearly ORD QRIT Meeting.

This is an abstract for presentation which has been reviewed by the U.S. EPA; views expressed do not necessarily represent EPA policy.

Record Details:

Record Type: DOCUMENT (PRESENTATION/ABSTRACT)
Product Published Date: 04/25/2006
Record Last Revised: 06/21/2006
Record ID: 148367

Organization:

U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF RESEARCH AND DEVELOPMENT

NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LABORATORY

EXPERIMENTAL TOXICOLOGY DIVISION

IMMEDIATE OFFICE