Evaluating Laboratory Performance on Quality Indicators With the Six Sigma Scale

TLDR

Laboratory quality indicators are often reported as percentages of variance, which can be misleading, while industries use quality systems such as ISO 9000 to improve productivity and cost. The authors normalized laboratory quality indicator data and national College of American Pathologists Q‑Probes data to parts‑per‑million defects to benchmark performance. Laboratory data expressed in parts‑per‑million defects revealed opportunities for significant improvement, yet historical quality assurance programs have not markedly improved the total testing process, suggesting that systematic quality‑system solutions could drive performance gains.

Abstract

Abstract Context.—Laboratory quality indicator data, most often presented and reported as a percentage of variance, may be misleading, inasmuch as variances, and therefore percentages, appear to be low. Method.—Current data from laboratory quality indicators and national data derived from several years of College of American Pathologists Q-Probes studies were normalized to parts-per-million defects, as commonly practiced in the manufacturing and service industries for benchmarking performance. Results.—Laboratory data in parts-per-million defects demonstrated opportunities for significant improvements in laboratory performance across the total testing process. Conclusions.—Historical quality assurance programs do not appear to be significantly improving the total testing process. Manufacturing and service industries are using quality systems strategies, such as ISO 9000 and the Baldridge Award Criteria, to effect improvements in both productivity and cost. Quality system solutions for performance improvement may provide a systematic approach to improving laboratory performance.