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1、Annex I.2,Failure Mode Effects Analysis失效模式效应分析 (FMEA),I.2: 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 outcomes and/or product performanceOnce failure modes are established, risk reduction can be use
2、d to eliminate, reduce or control the potential failuresFMEA relies on process understandingSummarize the important modes of failure, factors causing these failures and the likely effects of these failuresHow to perform?Break down large complex processes into manageable steps,ICH Q9,I.2: Failure Mod
3、e 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,I.2: Failure Mode Effects Analysis (FMEA),Potential Areas of Use(s)Prioritize risksMonitor the effectiveness of risk
4、control activitiesEquipment and facilitiesAnalyze 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,I.2: 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 acti
5、vities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,I.2: Failure Mode Effects Analysis (FMEA),How to perform?1. Establish a
6、team2. Identify the known and potential failure modes:Develop lists of known problems and brainstorm other potentials e.g.Product not meeting specificationProcess not meeting yield requirementsMalfunctioning equipmentSoftware problemsNewly identified failure modes should be added at any time,I.2: 失效
7、模式效应分析 (FMEA),如何实施?1. 成立一个小组2. 识别已知和潜在的失效模式生成已知问题和集体讨论的其他潜在问题的列表例如.产品不符合标准工艺不满足收率需要设备故障软件问题新发现的失效问题应该随时加进来。,I.2: Failure Mode Effects Analysis (FMEA),How to perform?3. Characterise the severity, probability and detectability An equal number of levels is sometimes helpfulSome preference to 3, 4, 5, 6
8、 or 10 levelsBut: an even number of levels avoids the mid pointUse different scalesLinear:1, 2, 3, 4Exponential:1, 2, 4, 8Logarithmic:1, 10, 100, 1000Self made:1, 3, 7, 10Multiplying different scales will differentiate the outcome,The aim is to come up with a method of prioritising,I.2: 失效模式效应分析 (FM
9、EA),如何实施?3. 识别严重性、可能性和可检测性一个相当的数字等级常常是很有用的一般优先选择等级3，4，5，6或10但是: 一个偶数等级会避免中位数用不同的等级线性的:1, 2, 3, 4直数的:1, 2, 4, 8对数:1, 10, 100, 1000自定义:1, 3, 7, 10不同的等级的乘积将区分结果,目标是提出一个定义优先顺序的方法,I.2: Failure Mode Effects Analysis (FMEA),How to perform?4. Define actions5. Revisit the ranking6. Define residual risk7. Per
10、form a short summaryScopeData from the assessment & control (e.g. No. of identified failure modes)Level of accepted risk without actions i.e. residual risk(e.g. Risk priority Number 50)Recommended actions, responsibilities and due dates (including approval, if appropriate)Person in charge for follow
11、-up of FMEA,I.2: 失效模式效应分析 (FMEA),如何实施?4. 详细说明行为5. 重新评级6. 详细说明剩余的风险7. 完成一个简短的摘要范围从评估和控制中得到的数据 (例如已识别失效模式的编号)不需要采取措施的可接受的风险的等级 即 剩余风险(比如风险优先号 50)建议采取的措施, 相关职责 和完成日期 (如果需要也包括批准)负责下一步FMEA的责任人,Severity (Consequences of failure),10 ExtremePredicted to cause severe impact to quality (Product out of specifi
12、cations, no Expert Statement possible) 7 HighPredicted to cause significant impact on quality (Failure to meet specifications, no Stability data, Expert Statement possible) 3 ModeratePredicted to cause minor impact on quality (Failure to meet specifications, Stability data available) 1 LowPredicted
13、to have no/minor impact on quality of the product (Quality within specifications),严重性 (失效的结果),10 极高可能会对产品产品产生严重的影响 (产品OOS, 可能无专家声明) 7 高可能对产品质量产生重大的影响 (不能满足指标, 没有稳定性数据, 可能需要专家声明) 3 中可能对产品质量产生小的影响(不能满足指标要求, 可能没有稳定性数据) 1 低可能对产品质量无影响或很微小的影响 (质量在指标之内),Probability (Likelihood failure will happen),8 Regula
14、r failuresExpected to happen regularly4 Repeated failuresExpected to happen in a low frequency2 Occasional failures Expected to happen infrequently 1 Unlikely failuresUnlikely to happen,可能性 (失效发生的概率),8 经常失效期望有规律的发生4 重复的失效期望以较低频率发生2 偶尔失效 期望很少发生 1 几乎不会失效不太可能发生,Detectability (Ability to find the failur
15、e),4 Normally not detectedFailure very likely to be overlooked, hence not detected (no technical solution, no manual control)3 Likely not detectedFailure may be overseen (manual control, spot checks)2 Regularly detectedFailure will normally be detected (manual control, routine work with statistical
16、control)1 Always detectedFailure can and will be detected in all cases (monitoring, technical solution available),可检测性 (发现失效的能力),4 通常不能被发现失效非常容易被忽视, 因此不能发现 (没有技术解决方法, 没有手动控制)3 可能发现不了失效可能被检查到 (手动控制, 现场检查)2 定期检查可以发现失效通常都能发现 (手动控制, 统计控制的例行工作)1 随时可以发现失效随时会被发现 (检测器, 技术措施有效),FMEA: Quantitation of Risk : Severity,
