文档介绍：Annex
Failure Mode Effects Analysis
失效模式效应分析 (FMEA)
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: Failure Mode Effects Analysis 失效模式效应分析(FMEA)
(see IEC 60812 见 IEC60812)
Evaluation of potential failure modes for processes
The likely effect on es and/or product performance
Once failure modes are established, risk reduction can be used to eliminate, reduce or control the potential failures
FMEA relies on process understanding
Summarize the important modes of failure, factors causing these failures and the likely effects of these failures
How to perform? Break down plex processes into manageable steps
ICH Q9
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: Failure Mode Effects Analysis 失效模式效应分析(FMEA)
(see IEC 60812 见 IEC60812)
工艺的潜在失效模式的评估
对结果和产品性能的可能的影响
一旦失效模式建立,风险降低行动用于来消除、降低或控制潜在的失效
依赖于对工艺的理解
概述重要的失效模式,引起失效的因数和失效的可能的影响
如何实施? 将大的复杂的工艺分解成易处理的步骤
ICH Q9
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: Failure Mode Effects Analysis (FMEA)
Potential Areas of Use(s)
Prioritize risks
Monitor the effectiveness of risk control activities
Equipment and facilities
Analyze a manufacturing process to identify high-risk steps or critical parameters
RNP: Risk Priority Number C. Kingery, The Six Sigma Memory Jogger II
ICH Q9
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: 失效模式效应分析(FMEA)
可使用的潜在领域:
Prioritize risks优先考虑的风险
Monitor the effectiveness of risk control activities监控风险控制活动的效力
Equipment and facilities 设备和设施
Analyze a manufacturing process to identify high-risk steps or critical parameters为了识别高风险步骤和关键参数分析一个生产工艺
RNP: Risk Priority Number C. Kingery, The Six Sigma Memory Jogger II
ICH Q9
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: Failure Mode Effects Analysis (FMEA)
How to perform?
1. Establish a team
2. Identify the known and potential failure modes:
Develop lists of known problems and brainstorm other potentials… .
Product not meeting spec