运用失效模式效应分析降低不合格检验标本的发生率

Reducing the happen rate of unqualified laboratory specimen by using Failure Mode Effect Analysis

目的完善检验标本采集和送检流程，降低不合格检验标本的发生率。方法应用失效模式效应分析（Failure Mode Effect Analysis，FMEA）对标本采集及送检各个流程中的相关因数进行分析，计算出事件发生的RPN值（Risk Priority Number），并根据RPN值的大小确定预防的重点，针对存在的问题及时进行整改。结果发生不合格检验标本的RPN值由2007年1月的1476，降低到2007年5月的1196，其中2007年3月达到936，为最低点，标本的不合格率相应降低。结论使用FMEA有效地降低了送检标本的不合格率，是一种行之有效的风险管理方法。

Objective To perfact the procedure of specimen acquaring and transfering so as to reduce the happen rate of unqualified laboratory specimen. Methods The relative factors in the procedure of specimen acquaring and transfering were analysed by using Failure Mode Effect Analysis （FMEA） so that the preventative emphases could be based on the caculated Risk Priority Number （RPN） and rectifying measurements could be adopted according to the existing problems. Results The RPNs of unqualified laboratory specimen were reduced from 1 476 in the January of 2007 to 1 196 in the May of 2007, among them the prominent reducing RPN was 936 in the March of 2007 and the happen rates of unqualified laboratory specimen were reduced accordingly. Conclusion FMEA is an effective rask management method by reducing the happen rate of unqualified labo- ratory specimen.