Quality Systems

Quality systems are systems that ensure that both the laboratory and its procedures, and the staff and overall management, together provide an overall quality of service. This necessitates regular reviews to check the maintenance of this quality. There are organizations that define standards to be met and issue certificates to qualifying laboratories. These are subject to repeated inspections, and the cost must be reflected in the charges for analyses. Such bodies are the Organisation for Economic Co-operation and Development (OECD) which has developed the Good Laboratory Practice (GLP) standard; the International Organization for Standardization has produced the ISO 9000 series of standards applicable to laboratories, with a web page at: http://www.iso.ch/iso/en/ISOOnline.frontpage The LGC promotes best practice in valid analytical measurement, and the principles are detailed at:

http://www.vam.org.uk/aboutvam/about_principles.asp with details on proficiency testing and links to other organizations accessible from the home page:

http://www.vam.org.uk/ Two UK proficiency testing schemes are the Food Analysis Performance Assessment Scheme (FAPAS), which replaced NAMAS in 2000, which is arranged by the Central Science Laboratory, with details at:

http://ptg.csl.gov.uk/fapas.cfm and the Food Examination Performance Assessment Scheme (FEPAS) for microbiological proficiency assessment. Proficiency testing (interlaboratory comparison programmes) with respect to chemical analysis involves the submission of a sample of the relevant material with validated known attributes, prepared in an accredited laboratory, to a comparative analysis in the subject laboratory. The results are then evaluated, either statistically or analytically and returned as a score to the subject laboratory. Any poor results are investigated to determine the cause of the inaccuracy, and the methodology is adjusted accordingly until the required degree of repeatability and reproducibility has been achieved (Charlett, 1996). Sometimes the customer's fitness-for-purpose criterion is different from that set by the proficiency testing scheme. One solution is for participants to calculate an auxiliary score called the 'zeta-score'. This is beyond the scope of this chapter, but details may be consulted in AMC (2000) and at:

http://www.rsc.org/lap/rsccom/amc/amc_index.htm Certain organizations will help laboratories to achieve accreditation, an example being the United Kingdom Accreditation Service (UKAS): http://www.ukas.com In the US, the NIST administers the National Voluntary Laboratory Accreditation Program (NVLAP), which complies with ISO 9002, and with details available at:

http://ts.nist.gov/ts/htdocs/210/214/summary.htm

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