基于西格玛度量优化临床检验风险分析质量控制计划

Prioritizing Risk Analysis Quality Control Plan Based on Sigma-Metrics

六西格玛（6σ）是一种允许对过程性能进行客观评估的技术,可用σ度量量化分析检测过程的性能和风险。EP23A为实验室提供了可选择的多种风险评估技术,以设计个性化的质量控制计划。方法决定图是区分σ性能的工具,使用方法性能数据产生可接受性的直观评估,而操作规范图是基于σ性能确定试验所要求质量控制的直观工具。故障模式和效应分析（FMEA）是风险评估中常用的一种技术,可用于观察医疗实施过程中的关键弱点。合理使用6σ质量控制设计工具能促进FMEA,风险评估过程和QC计划的设计。

Six sigma is a technique that allows objective assessment of process performance. The sigma metric quantifies the performance and the risk of an analytical testing process. EP23A empowers the laboratory to choose among many risk as sessment techniques to design an individualized quality control plan. The method decision chart is a visual tool that differentiates sigma performance,using data on method performance to generate a visual assessment of acceptability. And the operating specifications chart is a visual tool that identifies the quality control （QC） required by a test, based on sigma performance. Failure mode and effects analysis （FMEA） ,a technique commonly used in risk assessment, has been observed to exhibit key weaknesses in health care implementations. The rational use of the six sigma QC design tools can enhance FMEA, the risk assessment process,and design of QC plan.