Performance-Based Evaluation of Laboratory Quality Systems:
An Objective Tool to Identify QA Program Elements that Actually Impact Data Quality
Sevada K. Aleckson, Western Region Quality Assurance Manager
Quanterra Inc., 1721 S. Grand Avenue, Santa Ana, California 92705
Tel. (714) 258-8610, Fax (714) 258-0921
Garabet H. Kassakhian, Ph.D., Quality Assurance Director
Tetra Tech, Inc., 670 N. Rosemead Blvd., Pasadena, California 91107-2190
Tel. (818) 351-4664
Paper published in the Proceedings of WTQA '97
(13th Annual Waste Testing & Quality Assurance Symposium), pp. 195-198.
On-site laboratory evaluations, a key element of the laboratory approval process, encourage the proper implementation of analytical methods and provide supporting documentation to demonstrate method performance. These evaluations, regardless of their complexity, usually do not focus on identifying the key, explicit QA program activities that may in fact adversely affect the production of acceptable level data quality. They emphasize secondary elements of a QA system or program, such as, the organization, facilities, equipment, good laboratory practices, record keeping habits, and performance in the external intercomparison studies.
This paper proposes a non-conventional, performance-based evaluation to effectively assess the technical ability of an analytical laboratory to perform acceptably over the lifetime of an extended project. It focuses on the assessment of (1) current, valid method proficiency data in terms of empirical method detection limits, (2) related quantitative measures of precision and accuracy, and (3) on-going demonstration of precision and accuracy through the analysis of laboratory control samples using statistical techniques. Effective, comprehensive laboratory QA programs comprise of, but are not limited to, internal audit and non-conformance/corrective action reports, training and analytical proficiency files, properly maintained instrument logbooks and laboratory bench sheets, etc. The evaluator's review of these documents can detect trends and systematic deficiencies, thus providing a more sweeping technical evaluation of the laboratory's potential to perform.
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