Capunzo Mario, Cavallo Pierpaolo, Boccia Giovanni, Brunetti Luigi, Pizzuti Sante
Laboratory of Hygiene and Occupational Medicine, University of Salerno, Italy.
Clin Leadersh Manag Rev. 2004 Jan-Feb;18(1):37-41.
The authors have experimented the application of the Failure Mode and Effect Analysis (FMEA) technique in a clinical laboratory. FMEA technique allows: a) to evaluate and measure the hazards of a process malfunction, b) to decide where to execute improvement actions, and c) to measure the outcome of those actions. A small sample of analytes has been studied: there have been determined the causes of the possible malfunctions of the analytical process, calculating the risk probability index (RPI), with a value between 1 and 1,000. Only for the cases of RPI > 400, improvement actions have been implemented that allowed a reduction of RPI values between 25% to 70% with a costs increment of < 1%. FMEA technique can be applied to the processes of a clinical laboratory, even if of small dimensions, and offers a high potential of improvement. Nevertheless, such activity needs a thorough planning because it is complex, even if the laboratory already operates an ISO 9000 Quality Management System.
作者们在临床实验室中对失效模式与效应分析（FMEA）技术的应用进行了试验。FMEA技术能够：a）评估和衡量过程故障的危害，b）决定在何处执行改进措施，以及c）衡量这些措施的效果。对一小部分分析物进行了研究：确定了分析过程可能出现故障的原因，计算了风险概率指数（RPI），其值在1到1000之间。仅针对RPI>400的情况实施了改进措施，这些措施使RPI值降低了25%至70%，而成本增加<1%。FMEA技术可应用于临床实验室的流程，即使实验室规模较小，且具有很高的改进潜力。然而，此类活动需要进行全面规划，因为它很复杂，即便实验室已经运行ISO 9000质量管理体系。
