基于高风险FMEA管控机制的风险评估方法

Risk Assessment Method Based on FMEA High Risk Control Mechanism

失效模式与后果分析(FMEA)是一种质量分析工具,常常用于识别产品或过程的潜在失效模式,从而提前采取措施降低失效模式带来的危害。针对识别出来的失效模式,需要评估它们的风险等级,对于风险级别高的条目需要优先实施改进措施。传统的风险等级评估是由RPN(Risk Priority Number)数值判定,即失效严重度(S)、发生率(O)和不可探测度(D)的乘积。本篇提出了一种基于高风险FMEA管控机制的风险等级评估方法(Risk Priority Level,RPL),让FMEA团队快速、准确地识别高风险项,并对它们做出有效的管控措施。

Failure Mode and Effects Analysis(FMEA)is a quality analysis tool that is often used to identify potential failure modes of a product or process,thereby taking early action to reduce the risk of failure modes.For identified failure modes,their risk levels need to be assessed,and improvements need to be prioritized for items with high risk levels.The traditional risk level assessment is determined by the RPN(Risk Priority Number)value,which is the multiplication of failure Severity(S),incidence Occurrence(O)and un-Detectability(D).This paper proposes a Risk Priority Level(RPL)assessment method based on high-risk FMEA control mechanism,which enables the FMEA team to quickly and accurately identify high-risk items and make effective control measures for them.