ALLTECH ASSOCIATES

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Record Keeping Adequate record keeping in an easily retrievable manner is an essential part of the quality assurance program. Records needed include the description of test samples, experimental procedures, and data on calibration and testing. Quality control charts should be diligently prepared and stored. A chain of custody of test materials should be operative and such materials should be retained and safeguarded until there is no doubt about their future use or need. Data Control The evaluation, review, and release of analytical data is an important part of the quality assurance process. No data should be released for external use until it has been carefully evaluated. Guidelines for data evaluation, applicable to almost every analytical situation, have been developed by the ACS Committee on Environmental Improvement (8). A prerequisite for release of any data should be the assignment of uncertainty limits, which requires the operation of some kind of a quality assurance program. Formal release should be made by a professional analytical chemist who certifies that the work was done with reasonable care and that assigned limits of uncertainty are applicable. Laboratory Accreditation Laboratory accreditation is one form of quality assurance for the data output of certified laboratories. Accreditation is based on criteria that are considered essential to generate valid data and is a formal recognition that the laboratory is competent to carry out a specific test or specific type of test (9,10). The certification is as meaningful as the care exercised in developing certification criteria and evaluating laboratory compliance. Generic criteria developed by national and international standardization organizations have been influential in this respect (11). These criteria are well conceived and provide general guidance for the sound operation of analytical laboratories, whether or not certification is involved.

Implementation Detailed quality assurance

plans are ineffective unless there is commitment to quality by all concerned. This commitment must be total, from management to technical staff. The former must provide the resources, training, facilities, equipment, and encouragement required to do quality work. The latter must have the technical ability and motivation to produce quality data. Some may argue that if there is such commitment, there is no need for a formal quality assurance program. CIRCLE

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ANALYTICAL CHEMISTRY, VOL. 53, NO. 14, DECEMBER 1981

However, the experience of many laboratories has demonstrated that a formal quality assurance program provides constant guidance for the attainment of the quality goals desired.

References (1) “Quality Assurance Handbook for Air Pollution Measurement Systems: Principles”; Vol. 1, E.P.A. Publication No. 600/9-76-005. (2) “Handbook for Analytical Quality Control in Water and Wastewater Laboratories”; EPA Publication No. 600/479-019. (3) Juran, J. M. “Quality Control Handbook,” 3rd ed.; McGraw-Hill: New York, •

1974.

(4) Kratochvil, B. G.; Taylor, J. K. Anal Chem. 1981,53,924 A. (5) Brewers, J. M., et al. “Data Are for Looking At, or Quality Control by Interpretation.” In “Water Quality Paramters”; American Society for Testing and

Materials: Philadelphia, 1975, ASTM STP573. (6) “Catalogue of NBS Standard Reference Materials”; National Bureau of Standards: Washington, NBS Special Publication 260. (7) Cali, J. P., et al. “The Role of Standard Reference Materials in Measurement Systems”; National Bureau of Standards: Washington, January 1975, NBS Monograph 148. (8) ACS Subcommittee on Environmental Analytical Chemistry. “Guidelines for Data Acquisition and Data Quality Evaluation in Analytical Chemistry”; Anal Chem. 1980,52,2242. (9) “Quality Control System-Requirements for a Testing and Inspections Laboratory”; American Council of Independent Laboratories: Washington. (10) “Testing Laboratory Performance: Evaluation and Accreditation”; Berman, G. A., Ed.; National Bureau of Standards: Washington, NBS Special Publication 591. (11) “Standard Recommended Practice for Generic Criteria for Use in Evaluation of Testing and/or Inspection Agencies”; American Society for Testing and Materials: Philadelphia, ASTM Publication No. E-548.

John K. Taylor, coordinator for quality assurance and voluntary standardization activities at the National Bureau of Standards Center for Analytical Chemistry, received his BS from George Washington University, and his MS and PhD degrees from the University of Maryland. His research interests include electrochemical analysisy refractometry, isotope separations, standard reference materials, and the application of physical methods to chemical analysis.