Q9 FMEA失效模式效應(yīng)分析課件

1、Annex I.2Failure Mode Effects Analysis失效模式效應(yīng)分析 (FMEA)I.2: Failure Mode Effects Analysis 失效模式效應(yīng)分析(FMEA) (see IEC 60812 見 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 used

2、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 stepsICH Q9I.2: Failure Mode Ef

3、fects Analysis 失效模式效應(yīng)分析(FMEA) (see IEC 60812 見 IEC60812)工藝的潛在失效模式的評估 對結(jié)果和產(chǎn)品性能的可能的影響一旦失效模式建立，風(fēng)險(xiǎn)降低行動(dòng)用于來消除、降低或控制潛在的失效依賴于對工藝的理解概述重要的失效模式，引起失效的因數(shù)和失效的可能的影響如何實(shí)施?將大的復(fù)雜的工藝分解成易處理的步驟ICH Q9I.2: Failure Mode Effects Analysis (FMEA) Potential Areas of Use(s)Prioritize risksMonitor the effectiveness of risk contro

4、l activitiesEquipment and facilitiesAnalyze a manufacturing process to identify high-risk steps or critical parametersRNP: Risk Priority Number C. Kingery, The Six Sigma Memory Jogger IIICH Q9I.2: 失效模式效應(yīng)分析 (FMEA) 可使用的潛在領(lǐng)域：Prioritize risks優(yōu)先考慮的風(fēng)險(xiǎn)Monitor the effectiveness of risk control activities監(jiān)控風(fēng)

5、險(xiǎn)控制活動(dòng)的效力Equipment and facilities 設(shè)備和設(shè)施Analyze a manufacturing process to identify high-risk steps or critical parameters為了識別高風(fēng)險(xiǎn)步驟和關(guān)鍵參數(shù)分析一個(gè)生產(chǎn)工藝RNP: Risk Priority Number C. Kingery, The Six Sigma Memory Jogger IIICH Q9I.2: 失效模式效應(yīng)分析 (FMEA)如何實(shí)施?1. 成立一個(gè)小組2. 識別已知和潛在的失效模式生成已知問題和集體討論的其他潛在問題的列表例如.產(chǎn)品不符合標(biāo)準(zhǔn)工藝不滿

6、足收率需要設(shè)備故障軟件問題新發(fā)現(xiàn)的失效問題應(yīng)該隨時(shí)加進(jìn)來。EXAMPLEI.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 or 10 levelsBut: an even number of levels avoids the mid pointUse differ

7、ent scalesLinear:1, 2, 3, 4Exponential:1, 2, 4, 8Logarithmic:1, 10, 100, 1000Self made:1, 3, 7, 10Multiplying different scales will differentiate the outcomeThe aim is to come up with a method of prioritisingEXAMPLEI.2: Failure Mode Effects Analysis (FMEA)How to perform?4. Define actions5. Revisit t

8、he ranking6. Define residual risk7. Perform 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

9、appropriate)Person in charge for follow-up of FMEAEXAMPLEI.2: 失效模式效應(yīng)分析 (FMEA)如何實(shí)施?4. 詳細(xì)說明行為5. 重新評級6. 詳細(xì)說明剩余的風(fēng)險(xiǎn)7. 完成一個(gè)簡短的摘要范圍從評估和控制中得到的數(shù)據(jù) (例如已識別失效模式的編號)不需要采取措施的可接受的風(fēng)險(xiǎn)的等級 即 剩余風(fēng)險(xiǎn)(比如風(fēng)險(xiǎn)優(yōu)先號 $1,000,0009Extremely highFailure could lead to injury to the customer. Failure would create non-compliance with regi

10、stered specifications. Failure likely to lead to recall. Financial: $1,000,0008Very HighFailure could lead to adverse reaction for customer. Failure would create noncompliance with GMP regulations or product registrations. Failure possible to lead to recall. Financial: $500,0007HighFailure leads to

11、customer percept ion of safety issue. Failure renders individual unit(s) unusable. Failure causes a high degree of customer dissatisfaction. Recall for business reasons possible but Authority required recall unlikely. Financial: $100,0006ModerateFailure causes a high degree of customer dissatisfacti

12、on and numerous complaints. Failure unlikely to lead to recall. Financial: $50,0005LowFailure likely to cause isolated customer complaints. Financial: $10,0004Very LowFailure relates to non-dosage form issues (like minor packaging problems) and can be easily overcome by the customer. Financial: $5,0

13、003MinorFailure could be noticed by the customer but is unlikely to be perceived as significant enough to warrant a complaint. 2Very MinorFailure not readily apparent to the customer. Financial: $1,000,0009極端高失效可能導(dǎo)致消費(fèi)者的傷害。失效將產(chǎn)生與已注冊的標(biāo)準(zhǔn)不符合，失效會(huì)導(dǎo)致產(chǎn)品召回財(cái)產(chǎn)損失：$1,000,0008很高失效會(huì)導(dǎo)致消費(fèi)者不良反應(yīng)?？赡墚a(chǎn)生不符合GMP法規(guī)或產(chǎn)品注冊?？赡軙?huì)導(dǎo)

14、致召回。財(cái)產(chǎn)損失： $500,0007高失效會(huì)引起客戶對安全問題的擔(dān)心，失效必須給單個(gè)單位給與補(bǔ)償，失效會(huì)導(dǎo)致客戶高度的不滿意，產(chǎn)品召回只是因?yàn)樯虡I(yè)原因而不會(huì)引起強(qiáng)制召回，財(cái)產(chǎn)損失: $100,0006中失效會(huì)引起客戶高度的不滿意和大量的投訴。失效未必會(huì)引起產(chǎn)品召回， 財(cái)產(chǎn)損失: $50,0005低失效會(huì)引起單個(gè)客戶投訴，財(cái)產(chǎn)損失: $10,0004非常低失效不涉及到劑型等問題（象包裝問題），可以很容易被客戶接受 ， 財(cái)產(chǎn)損失: $5,0003較小失效會(huì)被客戶注意但是未必會(huì)引起客戶投訴2非常小失效不容易被客戶接受. 財(cái)產(chǎn)損失: $1,0001無失效不會(huì)引起客戶注意。財(cái)產(chǎn)損失：無Dr. Gary

15、 Harbour, PfizerEXAMPLEFMEA: Quantitation of Risk : Probability10Very High: Failure is almost inevitableMore than one occurrence per day or a probability of more than three occurrences in 10 units (Cpk 0.33 or 2.00 OR 6 ).For batch failures use the time scale for unit failures use the unit scale.Dr.

16、 Gary Harbour, PfizerEXAMPLEFMEA: 風(fēng)險(xiǎn)數(shù)值 : 可能性10非常高: 失效幾乎不可避免每天發(fā)生超過一次或可能性大于3/10 (Cpk 0.33 or 2.00 OR 6 ).For batch failures use the time scale for unit failures use the unit scale.對于批失效用時(shí)間尺度，對于單元失效使用單位尺度Dr. Gary Harbour, PfizerEXAMPLEFMEA: Quantitation of Risk: Detection10Absolute UncertaintyThe produ

17、ct is not inspected or the defect caused by the failure is not detectable.9Very RemoteProduct is sampled, inspected, and released based on Acceptable Quality Level (AQL) sampling plans.8RemoteProduct is accepted based on no defects in a sample.7Very LowProduct is 100% manually inspected in the proce

18、ss.6LowProduct is 100% manually inspected using go/no-go or other mistake-proofing gauges.5ModerateSome Statistical Process Control (SPC) is used in the process and product is final inspected off-line.4Moderately HighSPC is used and there is immediate reaction to out-of-control conditions.3HighAn ef

19、fective SPC program is in place with process capabilities (Cpk) greater than 1.33.2Very HighAll product is 100% automatically inspected.1Almost CertainThe defect is obvious and there is 100% automatic inspection with regular calibration and preventive maintenance of the inspection equipment.Dr. Gary

20、 Harbour, PfizerEXAMPLESeverity / Probability / Detection (SPD)PhD R.C. Mendson, Menson & Associations, IncICH EWG London, March 2004EXAMPLEI.2: Failure Mode Effects Analysis (FMEA)Severity (S) Link to end product functional failureMedical Department involvementProbability (P) Use historical dataSim

21、ilar processes productsDetection Method validation studiesHistorical dataEXAMPLE Takayoshi Matsumura, Eisai Co.Drying ProcessRankingSeverity (S)Probability (P)Detection (D)10DeathMore than once a dayImpossible to detect9 3 4 times a dayRemote8Permanent injuryOnce a weekVery slight7 Once a monthSligh

22、t6Temporary injuryOnce in three monthLow5 Once in half one yearMedium4Reported/ dissatisfiedOnce a yearModerately high3 Once in 1 3 yearsHigh2Notice/ no reportOnce in 3 5 yearsVery High1 Less than once in 5 yearsVirtually certainI.2: Failure Mode Effects Analysis (FMEA) Takayoshi Matsumura, Esai CoE

23、XAMPLEDrying Process級別嚴(yán)重性 (S)可能性 (P)可檢測性 (D)10死亡超過一天一次不可能9 3 4 次/每天微弱的8永久傷害1次/周非常微小7 1次/月微小6暫時(shí)傷害1次/3月低5 1次/6月中4報(bào)告的/不高興1次/年適度高3 1次/13年高2通知/ 無報(bào)告1次/35年很高1 1次/5年近乎必然I.2: 失效模式效應(yīng)分析 (FMEA) Takayoshi Matsumura, Esai CoEXAMPLE干燥過程/工藝ProcessPotential Failure ModePotential CauseSPDRPN1. Set upcontaminationdish

24、eveled gown of operatorinsufficient cleaning of equipment2. Start dryingcontaminationdamage of inlet-air filterdegradation of productdamage of thermometer3.Maintain temperaturelong drying timeunstable supply-air volumehigh Loss On Drying (LOD)damage of timerlow LODhigh dew-pointnon-uniformity of LOD

25、uneven temperature distributionDrying ProcessI.2: Failure Mode Effects Analysis (FMEA) Takayoshi Matsumura, Esai CoEXAMPLERPN: Risk Priority Number = S*P*D工藝潛在失效模式潛在原因SPDRPN1. 進(jìn)料污染操作者不潔凈的服裝設(shè)備清洗不充分2. 開始干燥污染進(jìn)口過濾器損壞產(chǎn)品降解溫度計(jì)損壞3.保持溫度長的烘干時(shí)間不穩(wěn)定的供應(yīng)空氣體積高的干燥失重計(jì)時(shí)器損壞低的干燥失重高露點(diǎn)不均勻的干燥失重不均勻的溫度分布干燥過程/工藝I.2: 失效模式效應(yīng)分析

26、(FMEA) Takayoshi Matsumura, Esai CoEXAMPLERPN: 風(fēng)險(xiǎn)優(yōu)先因子 = S*P*DExisting controls: IPC of LOD and degradation product after drying processDrying ProcessProcessPotential Failure ModePotential CauseSPDRPN1. Set upcontaminationdisheveled gown of operator358120insufficient cleaning of equipment7281122. Sta

27、rt dryingcontaminationdamage of inlet-air filter736126degradation of productdamage of thermometer733633.Maintain temperaturelong drying timeunstable supply-air volume24540high LODmalfunction of timer2228low LODhigh due-point33327non-uniformity of LODuneven temperature distribution35345I.2: Failure M

28、ode Effects Analysis (FMEA) Takayoshi Matsumura, Eisai CoEXAMPLERPN: Risk Priority Number = S*P*D現(xiàn)有的控制: LOD 的 IPC 和 烘干過程后的降解產(chǎn)品干燥過程/工藝工藝潛在失效模式潛在原因SPDRPN1. 進(jìn)料污染操作者不潔凈的服裝358120設(shè)備清洗不充分7281122. 開始干燥污染進(jìn)口過濾器損壞736126產(chǎn)品降解溫度計(jì)損壞733633.保持溫度長的烘干時(shí)間不穩(wěn)定的供應(yīng)空氣體積24540高的干燥失重計(jì)時(shí)器損壞2228低的干燥失重高露點(diǎn)33327不均勻的干燥失重不均勻的溫度分布35345I

29、.2: 失效模式效應(yīng)分析 (FMEA) Takayoshi Matsumura, Eisai CoEXAMPLERPN: 風(fēng)險(xiǎn)優(yōu)先因子 = S*P*DTake action when RPN is over 100Take action when severity is over 5Remaining critical parameters after taking action; further controls requiredDrying ProcessProcessPotential CauseRPNRecommended ActionSPDRPN1. Set updisheveled

30、 gown of operator120use long gloves and goggles32848insufficient cleaning of equipment112change cleaning procedure724562. Start dryingdamage of inlet-air filter126change maintenance period72684damage of thermometer63change calibration period723423.Maintain temperatureunstable supply-air volume402454

31、0malfunction of timer82228high dew-point2733327uneven temperature distribution4535345I.2: Failure Mode Effects Analysis (FMEA) Based on Takayoshi Matsumura, Esai Co.EXAMPLERPN: Risk Priority Number = S*P*D當(dāng)RPN大于40采取措施當(dāng)嚴(yán)重性超過5時(shí)采取措施采取措施后保留關(guān)鍵參數(shù); 需要進(jìn)一步控制干燥過程/工藝工藝潛在原因RPN建議措施SPDRPN1. 進(jìn)料操作者不潔凈的服裝120使用長手套和眼睛

32、32848設(shè)備清洗不充分112變更清洗程序724562. 開始干燥進(jìn)口過濾器損壞126變更維護(hù)周期72684溫度計(jì)損壞63變更檢驗(yàn)周期723423.保持溫度不穩(wěn)定的供應(yīng)空氣體積4024540計(jì)時(shí)器損壞82228高露點(diǎn)2733327不均勻的溫度分布4535345I.2: 失效模式效應(yīng)分析 (FMEA) Based on Takayoshi Matsumura, Esai Co.EXAMPLERPN: 風(fēng)險(xiǎn)優(yōu)先因子 = S*P*DI.2: Failure Mode Effects Analysis (FMEA) Analyse a granulation process stepbecause o

33、nly a few parameters are adjustable and many problems can occur by manual operationsEXAMPLES. Rnninger, RocheI.2: 失效模式效應(yīng)分析 (FMEA) 分析制粒工藝步驟因?yàn)閮H僅很少的參數(shù)可以調(diào)整，手工操作許多問題都可能發(fā)生。EXAMPLES. Rnninger, RocheFailure Mode Effects Analysis (FMEA) EXAMPLES. Rnninger, RocheI.2 Failure Mode Effects Analysis (FMEA) EXAMPL

34、ES. Rnninger, RocheI.2: Failure Mode Effects Analysis (FMEA)Prepare a risk profileSeverity / Consequencesinegligible iimarginaliiicriticalivcatastrophicProbabilityAfrequentBmoderateCoccasionalDrare EunlikelyFvery unlikelyProbabilityConsequencesRisk protection levelEXAMPLES. Rnninger, RochePicture: Z

35、urich Insurance Ltd, SwitzerlandI.2: 失效模式效應(yīng)分析 (FMEA)準(zhǔn)備一個(gè)風(fēng)險(xiǎn)輪廓嚴(yán)重性/ 重要性i可以忽略 ii邊際iii嚴(yán)重的iv災(zāi)難性的可能性A頻繁的B中等的C偶爾的D很少 E不太可能F完全不可能可能性重要性風(fēng)險(xiǎn)保護(hù)水平EXAMPLES. Rnninger, RochePicture: Zurich Insurance Ltd, SwitzerlandI.2: Failure Mode Effects Analysis (FMEA)Prepare a risk profile: ProbabilityEXAMPLES. Rnninger, Roche

36、I.2: 失效模式效應(yīng)分析 (FMEA)準(zhǔn)備一個(gè)風(fēng)險(xiǎn)輪廓: 可能性EXAMPLES. Rnninger, RocheI.2: Failure Mode Effects Analysis (FMEA)Risk EvaluationPrepare a risk profile: ConsequencesEXAMPLES. Rnninger, RocheI.2: 失效模式效應(yīng)分析 (FMEA)風(fēng)險(xiǎn)評估準(zhǔn)備一個(gè)風(fēng)險(xiǎn)輪廓: 重要性（后果）EXAMPLES. Rnninger, RocheI.2: Failure Mode Effects Analysis (FMEA)Risk EvaluationPre

37、pare a risk profile: ConsequencesEXAMPLES. Rnninger, RocheI.2: 失效模式效應(yīng)分析 (FMEA)風(fēng)險(xiǎn)評估準(zhǔn)備一個(gè)風(fēng)險(xiǎn)輪廓: 重要性（后果）EXAMPLES. Rnninger, Roche風(fēng)險(xiǎn)評估: 風(fēng)險(xiǎn)輪廓For high risks, which are not acceptable, risk reduction measures have to be taken as a high priorityI.2:失效模式效應(yīng)分析 (FMEA)EXAMPLES. Rnninger, RocheHigh riskLow riskRisk

38、 Evaluation: Risk Profile對于不可接受的高風(fēng)險(xiǎn)，因?yàn)橐粋€(gè)高的風(fēng)險(xiǎn)因子風(fēng)險(xiǎn)消減措施必須實(shí)施I.2: Failure Mode Effects Analysis (FMEA)EXAMPLES. Rnninger, RocheHigh riskLow riskI.2: Failure Mode Effects Analysis (FMEA)How to perform?3. Summary (Risk Evaluation)The effects are rated in terms of their consequences and the causes are asses

39、sed in terms of their probabilitiesa) qualitative or b) quantitativeBased on these results a risk profile is completed. In this profile the risks are compared with the risk protection level, which determines the accepted probability for defined consequencesUse as an aid to prioritise actions!EXAMPLE

40、S. Rnninger, RocheI.2:失效模式效應(yīng)分析 (FMEA)如何實(shí)施?3. 總結(jié) (風(fēng)險(xiǎn)評估)效果在術(shù)語后果中評估，原因在術(shù)語可能性中評估a) 定性或 b) 定量在這些結(jié)果基礎(chǔ)上完成一個(gè)風(fēng)險(xiǎn)矩陣在這些矩陣中風(fēng)險(xiǎn)使用風(fēng)險(xiǎn)保護(hù)水平來比較。為描述的后果來確定可接受的可能性。將預(yù)先的措施當(dāng)作幫助EXAMPLES. Rnninger, RocheI.2: Failure Mode Effects Analysis (FMEA)QRM for facilities, equipment and utilities Assess an existing compressed air syste

41、mOld approach: 60 “risks” should have been solved in detailInitial RM-Approach: 4 sessions in total 16 people153 potential risks discussed 34 Cases beyond the action limit 30 Corrective actions have been performed (- 50%)Review of RM-Approach after inspectionDid you consider this hazard?- yes: show

42、and explain rationale- yes, butstart discussion for a yes/no decision- no:revisit initial risk assessmentEXAMPLEI.2:失效模式效應(yīng)分析 (FMEA)廠房設(shè)備設(shè)施的質(zhì)量風(fēng)險(xiǎn)管理 評估現(xiàn)有的壓縮空氣系統(tǒng)舊方法: 60 “風(fēng)險(xiǎn)” 應(yīng)該已經(jīng)在細(xì)節(jié)上被解決。最初的 風(fēng)險(xiǎn)管理方法: 4 次會(huì)議 總共16個(gè)人153個(gè)討論的潛在風(fēng)險(xiǎn) 34 個(gè)超過行動(dòng)限的案例 30 個(gè)糾正措施已經(jīng)被實(shí)施 (- 50%)檢查后風(fēng)險(xiǎn)分析方法的審核你考慮這個(gè)是危害嗎- 是: 說明并解釋基本原理- 是，但是開始討論做是或不是的決定- 不是:重新進(jìn)行風(fēng)險(xiǎn)評估EXAMPLEI.2: Failure Mode Effects Analysis (FMEA)Experiences Ease of applicabilityProspective toolGood tool for operators to useCan be used to identify critical steps for validationMore objective than Fault Tree AnalysisCovers minor risksEXAMPLEI.2:失效模式效應(yīng)分析 (FMEA)經(jīng)驗(yàn) 適用性預(yù)期工