Audit Protocols for the Assessor

Management should demonstrate more than arm s length support for quality improvement. They should provide involved leadership and constancy of purpose. There are three key aspects of this leadership. 

The chief executive should formally document the organization s quality policy. This policy should include the relative priority assigned to continuous quality improvement, the acceptable standard for quality, and the system to achieve that standard. 

The quality policy should be communicated throughout the organization and all personnel should be familiar with it. 

Management should assign clear responsibility for quality improvement. Those responsible should have the authority, or 

Management should also install a process for quality improvement. Continuous quality improvement will occur only through a defined, planned, documented and systematic approach that involves eveiy employee. 

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Regardless of which assessment method you choose, assessors and auditors should take detailed notes using a common format to help capture maximum information in a consistent manner. Forms for questionnaires, topical outlines, and audit protocols (as shown in the exhibits) can perform double duty by providing interviewers with a format for notes as well as reporting. 

ISO has two important functions in analytical chemistry. The first is to publish descriptions of accepted methods. These are effectively industry standard methods for particular protocols. The second is in laboratory accreditation. For a laboratory to be ISO accredited, compliance with international QA standards must be confirmed by an initial assessment and subsequently from repeated audits by an independent assessor. Since ISO has no legal or regulatory powers, the standards are voluntary. It is unlikely, however, that a forensic analysis which did not conform to an ISO standard would be upheld in court, for example. Most commercial laboratories need to be accredited to remain competitive and to deal with regulatory authorities. Most university labs are not accredited, mainly due to the time and costs involved, and also to the nonroutine nature of much university research. However, university accreditation may become a requirement in the near future, especially for publicly funded research in the UK. The details of laboratory accreditation are discussed by Christie et al. (1999) and Dobb (2004). 

It is essential that all proficiency scheme samples are treated as normal samples and are analysed along with the daily routine samples. One of the key purposes of a proficiency scheme is that laboratories thoroughly audit all failures and attempt to determine the cause of any failures. A laboratory should then implement suitable protocols to prevent further failures from the same cause(s). The laboratory should regularly monitor its cumulative proficiency scheme results to ensure that there are no consistent failures for any given determinands and make the results of its monitoring available to its risk assessor clients. 

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