This paper discusses the evolution of an internal laboratory quality audit which takes into account the needs and expectations of the laboratory customers, the laboratory management, and the laboratory employees. This audit has been in operation for over 15 years and its development and early years were reported at an ASTM Symposium in 1981. Since then a number of changes have been implemented to improve the effectiveness of the audit.
This paper describes the creation of the auditor position with organizational independence. Developments in the Quality Audit Manual, the Laboratory Report Format Procedure and other audit standards are also reported. The paper discusses the advantages and disadvantages of using a classification system to rank discrepancies identified by the audit process.
Because the underlying purpose of an internal quality audit is to improve laboratory report quality, the major beneficial role is as a learning tool. As originally structured the audit was conducted with complete anonymity of the laboratory employee. Unfortunately this anonymity constrained the reporting procedure and inhibited the universal implementation of corrective actions.
After several years with no improvement in the discrepancy rate, a process change was desired. Coinciding with this need, process improvement methodology based on Deming's Plan-Do-Check-Act cycle  was used to develop an improved process. An audit improvement team proposed and conducted a pilot audit procedure that audited reports monthly for the natural work groups with open discrepancy reporting at work group meetings. Based on the successful pilot, management approval was obtained to implement the revised procedure and improvements in laboratory report quality as assessed by the internal laboratory quality audit are observed.
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