2. 采用FMEA评估及分析风险项
在采用FMEA对风险进行评估和分析前,有必要先熟悉一些FMEA的知识点。
(1)FMEA (Failure Mode Effects Analysis) :潜在失效模式和结果分析。即找出产品/过程中潜在的故障模式根据相应的评价体系对找出的潜在故障模式进行风险量化评估;列出故障起因/机理,寻找预防或改进措施。
(2)FMEA关键项:
- Function (功能要求): What is design/process/service supposed to do at this stage?
- Failure Mode (潜在失效模式): A specific means by which a design (product), process, or service may fail.
- Effect (潜在失效后果): What happens when the failure occurs?
- Severity (严重度): How serious is the consequence of the failure? The value is 1~10.
- Cause (潜在的失效起因): What can occur to cause the failure?
- Occurrence (频度): How often will the cause/failure occur? The value is 1~10.
- Current Control (现行控制): Current method to detect/prevent transmission of failures to subsequent “customers”.
- Detection (探测度): Can the cause/failure be detected if it occurs? The value is 1~10.
- RPN (风险顺序数): Review Risk Priority Numbers,RPN = (Severity) x (Occurrence) x (Detection)
- Recommended Actions (建议措施): What can we do?
- Responsibility & Target Completion Date (责任及目标完成日期): When it can be fixed?
- Actions Taken Result (措施结果): The actually result after action have been taken.
(3)FMEA流程:
本文只给出了简单流程示意图,更详细的流程做法,请参看《FAILURE MODES AND EFFECTS ANALYSIS》Kenneth Crow 中的FMEA Procedure章节。
下面给出一个FMEA的简单模板,可以参照下图的表格填写上面人、料、法、环、时五大因素中所提及的各个风险子项填写在Function一列,并按公司的切实情况填写后续各列。