How valid are our QA assumptions: an examination of underpinning Axioms

 There is no universally accepted approach to analytical quality assurance (QA) and different laboratories place emphasis on widely different aspects. The difficulties in agreeing what constitutes best practice originate, in part, from a lack of clarity concerning the underpinning principles or axioms. This paper aims to set out some of the axioms which underpin current thinking and to discuss their validity and interplay, in order to provide a more rational, or at least transparent basis, for the evaluation of different strategies. The selection of issues and the discussion are necessarily subjective and based on the authors experience. It is concluded that current practice is generally soundly based but there is a need for a better understanding of the efficacy and cost-benefit of the various QA techniques available. Scepticism concerning the value of systems and documentation is not well founded, provided they are not taken to excess. There are, however, issues concerning the military-based command-and-control style and the engineering origins of ISO 9000 and ISO Guide 25 requirements which make them not entirely suitable for a modern analytical laboratory. There are also dangers that the command-and-control style could discourage measurement scientists from thinking for themselves or lull them into a false sense of security. Received: 24 December 1998 · Accepted: 18 May 1999