FMEA失效模式及效应分析培训.pptx

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1、C.Y.I.E.Q.R.C.1 of 33陳陳 啟啟 政政中原大學品質研究中心中原大學品質研究中心中原大學工業工程系中原大學工業工程系The Quality Research CenterThe Quality Research CenterIndustrial Engineering DepartmentIndustrial Engineering DepartmentChung Yuan Christian UniversityChung Yuan Christian UniversityC.Y.I.E.Q.R.C.FMEA FMEA 意義說明意義說明 FMEA FMEA 是不良是不良預防

2、的工具預防的工具, ,是一種是一種 有條理程序可藉由一張包含所有有條理程序可藉由一張包含所有 的失效模式的表的失效模式的表, ,並以數據來表並以數據來表 示風險的大小和預先採取預防改示風險的大小和預先採取預防改 善措施。善措施。 2 of 33C.Y.I.E.Q.R.C.導入導入FMEAFMEA的優點的優點 Team work 方式提高部門或Function 間連繫溝通,共同預防改善問題 腦力激盪方式,讓每一成員在同一議題上發揮想像力, 經由有系統整合 提出有效之預防改善對策 徹底了解產品功能架構圖或產品製造組合流程圖 以魚骨圖分析方式列出失效模式每一種可能因子 以失效樹分析(FTA)方法了解

3、產品失效模式各種組合型式 把失效模式量化針對Top Failure Mode 優先採取對策預防 確保所有想像得到失效模式和影響,在正常操作情況之下均被考慮到 藉由過去的資料給未來參考, 協助分析失效的範圍和影響性 提供設計產品或製程管制預防採取對策時使用 3 of 33C.Y.I.E.Q.R.C. Core teamCore team :列出與FMEA team 相關人員名字,部門與職責 Failure modeFailure mode :失效模式種類 Effect Effect :失效後對產品產生影響 CauseCause :造成失效模式之原因 SeveritySeverity :失效模式發

4、生之嚴重程度等級(110) OccurrenceOccurrence :失效模式之發生頻度等級(110) DetectionDetection :失效模式發生可被偵測程度等級(110) RPNRPN : Risk Priority Number 指評估風險及優先處理指數 是Severity * Occurrence * Detection 之乘積 FTAFTA :Fault tree analysis 是失效樹分析是導果為因由頂端 事件利用邏輯(OR 或 AND) 持續分析第1.2層直 至真正Root cause 將這些原因謀求徹底改善FMEAFMEA相關名詞解說相關名詞解說4 of 33C.

5、Y.I.E.Q.R.C. QFD : Quality Function Deployment DOE : Design of Experiments VOC : Voice of Customer VOE : Voice of Engineering SOP : Standard Operation Procedure SIP : Standard Inspection Procedure FRACAS : Failure Report Analysis and Corrective Action System SPC : Statistic Process Control TQM : Tot

6、al Quality Management DVT : Design Valuation Test MTBF : Mean Time Between FailureFMEAFMEA書籍相關名詞解說書籍相關名詞解說5 of 33C.Y.I.E.Q.R.C.FMEA FMEA 型式型式 SYSTEM SYSTEM SFMEASFMEA Design Design DFMEADFMEA * Component * Unit * Module Process Process PFMEAPFMEA Machine Machine MFMEAMFMEA Equipment Equipment EFMEAE

7、FMEA Service Service SFMEASFMEA6 of 33C.Y.I.E.Q.R.C.組成FMEA團隊設計設計 FMEA 流程流程(DFMEA)蒐集資料完成FMEA執行方案系統特性系統功能硬品架構分析失效模式分析設計管制方法分析失效原因分析失效效應分析嚴重度計算關鍵指數分析發生率分析難檢度建議改正行動決定關鍵性失效模式 設計審查評估資料 設計改善參考資料 可靠度分析參考資料 標準檢驗程序資料 教育訓練參考資料失效報告。分析與改正作業系統(FRACAS)設計改善撰寫報告 維護度分析參考資料7 of 33C.Y.I.E.Q.R.C.組成FMEA團隊製程製程 FMEA 流程流程(P

8、FMEA)蒐集資料完成FMEA執行方案定義製造流程分析產品特性分析製程特性分析失效模式分析現行管制方法分析失效原因分析失效效應分析嚴重度計算關鍵指數分析發生率分析難檢度建議改正行動決定關鍵性失效模式 設計審查評估資料 設計改善參考資料 新製程設計參考資料 標準檢驗程序資料 教育訓練參考資料失效報告。分析與改正作業系統(FRACAS)製程改善檢驗程序改善撰寫報告8 of 33C.Y.I.E.Q.R.C.FMEA FMEA 實施步驟實施步驟1. 決定FMEA 對象2. 成立&組成FMEA team members3. 收集&準備相似產品之歷史資料4. 列出產品方塊圖或製程流程圖5. 列出Failu

9、re mode 各種可能情況6. 列出Failure mode 對產品/機器之 影響 (Effect)7. 魚骨圖分析造成此Failure mode 之可能原因 (Cause)8. 根據相關產品之歷史資料定義出 Severity /Occurrence Detection 之等級9. 根據 S/O/D 的定義定出每個 Failure mode 之 S/O/D 值10. 列出相似Model 目前採行之Action11. 計算出 RPN=S*O*D 值12. 取 RPN 值 100 (值大小需定義) or Top 20% 優先採取對策13. 針對 RPN 值超出上述定之項目提 出Action 再改

10、善14. 定出 Action item 之 owner 及完成 日期15. Action 切入後檢視其效果及切入時 間點 16. 重新計算Action 後之 RPN 值17. 若 RPN 值未達定義要求 RPN 100 or Top 20% 回覆到 item 13 重提 Action18. 若 RPN 達到要求完成 FMEA 表格9 of 33C.Y.I.E.Q.R.C.FMEA Team MembersFMEA Team Members DFMEA (Design)DFMEA (Design) Chairperson * Program Manager (PM)(PM) * Electron

11、ic Engineer (EE)(EE) * Mechanical Engineer (ME)(ME) * Quality Engineer (QE)(QE) * Quality Engineer (QA)(QA) * Manufacturing (MES)(MES) Support Team * Purchasing (Buyer) if Need PFMEA (Process)PFMEA (Process) Chairperson * Program Manager (PM)(PM) * Quality Engineer (QA)(QA) * Industry Engineer (IE)(

12、IE) * Mechanical Engineer (MFG ME)(MFG ME) * Test Engineer (TE)(TE) * Manufacture Supervisor (MFG)(MFG) * Electronic Engineer (EE)(EE) if Need * Mechanical Engineer (ME)(ME) if Need 10 of 33C.Y.I.E.Q.R.C.Failure Mode Fishbone AnalysisHi-Pot 不不良良FailureMode(Defect)錫面組立加工不良第一層分析第一層分析Workmanship第二層分析第三

13、層分析第四層分析正面裝插 零件插歪斜零件面有異物無線尾零件變形零件碰case零件相碰第一層分析第一層分析Material變壓器不良PCB不良Y電容不良Power Cable破EMI不良Case不良第二層分析第三層分析絕緣tape破引腳超出base焊點過大造成tape破儀器設備儀器設定Layout 安規距離不夠Arcing 規定過嚴零件間安規距離不足第一層分析第一層分析Design第一層分析第一層分析Test第二層分析第三層分析第二層分析第三層分析鎖螺絲過長套管短零件本体大Layout 面積小測試條件設錯O/I寫錯測試線接錯11 of 33C.Y.I.E.Q.R.C.Hi-Pot Failure

14、AnalysisFault Tree Analysis For Hi-Pot Failure5.板邊零件傾斜踫Case,造成安規距離不夠b.Socket上Y電容線腳靠近馬口鐵a.SocketFG線漏焊Process4.錫面3.正面裝插2.組立1.加工不良d.錫面短路錫珠,錫渣c.線腳過長b.漏焊Y電容 a.異物c.零件插歪斜零件變形碰Case碰T1碰H/S相互碰撞b.零件面有異物a.無線尾 h.鎖絲未鎖緊或漏鎖 g. 掉金屬物進產品 f.絕緣片放置不當或漏裝d.PCB沒有卡到位 c.組立時,B+B-線壓傷壓破b.絕緣片膠布破a.FG線有無Touch任何零件c.膠布沒貼到位Design 2. 元

15、 件 之 間 安 規 距離不夠3.Arcing規格過嚴c.鎖螺絲過長 b.套管短a.原件本体大Layout面積小4.板邊零件與Case安規距離不夠1.Layout安規距離不夠Material9.變壓器PFC電感8.膠雜質過多7.Y電容不良6.線材PowerCable破5.PCB4.EMISocket3.Case 2.接地小黃豆電容耐壓不夠c.有毛刺b.耳掛有凸起a.碎屑 b. 本 身 耐 壓不夠a.FG線氧化不吃錫b.Trace近似短路或開路a.PCB受潮e.絕緣 Tape破d.零件本体 歪斜 c. 焊 點 過 大, 造 成 錫 間 賜 破 絕緣層b.引線腳超出basea.絕緣膠布位置不恰當

16、1. 光 藕合器不良e.O/I寫錯誤Test2.儀器設定1.儀器c.測試條件設置錯誤b.O/I寫錯誤a.測試線接錯b.儀器本身電壓頻率誤差大a.接觸不良f.本身繞線造成Arcing過大其其他他2.接地銅箔被燒斷3.接地跳線斷4.未依O/I作業1.SocketY電容線腳斷5.油墨,黑色Mark筆,在初級側導電12 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Fu

17、nction responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to

18、detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNThis column is used to list the part nameand function. List all the functions for the functional blockFMEA 格式逐項解說格式逐項解說1.2.10.4.3.5.6.8.7.9.12.11.15.14.13.13 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Curre

19、nt or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accuratel

20、y dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPN2.In the failure mode column, list each of the failuremodes for the function.FMEA 格式逐項解說格式逐項解說1.10.4.3.5.6.8.7.9.12.11.15.14.13.14 of 33C

21、.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong I

22、ncorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceDetectionDetectionRPNRPNOccurrence3.List the effects of failure for each of thefailure modes.FMEA 格式逐項解說格式逐項解說1.10.4

23、.2.5.6.8.7.9.12.11.15.14.13.15 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuse

24、r of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNFor each one of the effects, list theseverity

25、 (scale from 1 to 10)4.FMEA 格式逐項解說格式逐項解說1.10.3.2.5.6.8.7.9.12.11.15.14.13.16 of 33C.Y.I.E.Q.R.C.嚴重度評點基準建議參考表 :效應評點評點準則無效應的None非常不重要的生產線不重要的中斷; 部份產品(小於 100%) 可能需要在線上重做, 不Very Minor需離站, 觀察力較強的顧客可能會注意到。不重要的生產線不重要的中斷; 部份產品( 小於 10 0 % ) 可能需要 在線上離站 重Minor做; 配 合、精度、雜音等項目不符合需求, 一般的顧客都可能會注意到。非常低的生產線不重要的中斷; 產

26、品可能需要挑選 , 而且部份產品( 小於 1 0 0 % )Very Low要重做; 配合、精度、雜音等項目不符合需求, 大部份的顧客者都可能會注意到。低度的生產線不重要的中斷; 1 0 0 % 產品可 能 需 要 重 做 ; 裝備仍可操作、但次Low要裝備功能要降低水準或性能下才能操作, 顧客會感到有些不滿。中度的生產線不重要的中斷; 部份產品( 小於 10 0 % ) 可能要報廢 ( 不經挑選 );Moderate裝備仍可操作, 但次要裝備功能無法操作, 顧客會感到不滿意。高度的生產線不重要的中斷; 產品可能要加以挑 選 , 而且部份產品High(小於 100%)可能要報廢; 裝備仍可使用

27、, 但會降低功能使用範圍,顧客會感到不滿意。非常高的生產線重要的中斷; 1 0 0 % 產品 可 能 需 要 重 工 或報廢; 對裝備損壞不Very High能使用,但仍安全(例 : 電 壓無輸出) , 主要功能 喪 失 ; 顧客感到非常不滿意。危險的 - 有預警9可能對機器或裝備的操作者造成傷害; 潛在危險性的效應, 會導致與Hazardous-安全有關的失效或不符合政府法規而有事先預警。with arning危險的 - 無預警10可能對機器或裝備的操作者造成傷害; 潛在危險性的效應, 會導致與Hazardous-安全有關的失效或不符合政府法規而無事先預警。without warning17

28、8系統操作無影響,客戶不會注意到此項不良。25634 符合需求 ,17 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batte

29、ryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNThe Class column is optional. It istypic

30、ally used if the severity is 9 or 10.5.FMEA 格式逐項解說格式逐項解說1.10.3.2.4.6.8.7.9.12.11.15.14.13.18 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitor

31、dissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetecti

32、onDetectionRPNRPNIn the Cause column, list the causesfor each failure mode6.FMEA 格式逐項解說格式逐項解說1.10.3.2.4. 5.8.7.9.12.11.15.14.13.19 of 33C.Y.I.E.Q.R.C.FMEA ModelLinking Failure Mode toCause and EffectCauseFailure Mode(Defect)Effect20 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or

33、Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately diss

34、atisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNEstimate the likelihood of the “causes” happening on a “1 to10” scale. The higher thenumber the more likely the“causes” will occur.7.FMEA 格式逐項解

35、說格式逐項解說1.10.3.2.4. 5.8.6.9.12.11.15.14.13.21 of 33C.Y.I.E.Q.R.C.發生率評點基準建議參考表 :發生率評點Cpk 值可能失效比例評點準則 1.67 in 1,500,000(0.67PPM) 1.501 in 150,000可能發生微小數量之失效, 以往歷史資料(6.67PPM)顯示同樣的程序只有獨立的失效發生 1.331 in 15,000可能發生非常少數量之失效, 以往歷史資料(67PPM)顯示類似程序只有獨立的失效發生4 1.171 in 2,000(500PPM)5 1.001 in 400 (0.25%)6 0.831 in

36、 80(1.25%)7 0.671 in 20(5%)以往資料顯示類似程序可能時常發生失效8 0.511 in 8(12.5%)9 0.331 in 3(33%)幾乎一定會發生失效10 0.33 1 in 2(50%)微小機會Remote1高High非常高Very High非常不可能失效, 以往歷史資料顯示同樣的程序無失效記錄非常低Very Low2中度Moderate以往資料顯示類似程序偶爾可能會發生失效, 但不佔重要比例低Low322 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) t

37、o Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction

38、 failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNList the prevention, design validation/ verification, or other activities which will assure the design adequacy for the failure mode and/or cause / mechan

39、ism under consideration. Tests Design reviews, Mathematical studies, Fail/safe (Example: redundant power supplies)8.FMEA 格式逐項解說格式逐項解說1.10.3.2.5.4.6.7.9.12.11.15.14.13.23 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Indivi

40、dual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wro

41、ng Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNEstimate the likelihood of the detection on a “1 to 10” scale. The lower the number the more likely the cause will be detected.9.FMEA 格式逐項解說格式逐項解說1.10.3.2.5.4.8.7.6.12.11.15.14.13.24 of 33C.Y.I.E.Q.R.C.難檢度評

42、點基準建議參考表難檢度評點基準建議參考表 :檢出能力評點檢出比率:評點準則非常高Very High中高ModeratelyHigh中度Moderate低Low非常低Very Low微小機會Remote非常微小機會Very Remote幾乎無法檢出10Almost Never現行管制方式檢出此一失敗模式之機會非常微小此一失敗模式尚無檢測方法89現行管制方式檢出此一失敗模式之機會微小20%10%0%幾乎一定Almost Certain1現行管制方式幾乎一定可以檢測出此一失敗模式; 針對類似程序已知有可靠的檢測管制方式2現行管制方式有非常高的可能性可以檢測出此一失敗模式90100%80%高High3

43、4756現行管制方式有高度可能性可以檢測出此一失敗模式現行管制方式有中度可能性可以檢測出此一失敗模式現行管制方式有低度可能性可以檢測出此一失敗模式現行管制方式檢出此一失敗模式之可能性非常低現行管制方式有中高度可能性可以檢測出此一失敗模式30%70%60%50%40%25 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEne

44、rgyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery Faults

45、SeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNRPN (Risk Priority Number) is theproduct of Severity, Occurrence,and Detection.The higher the number, the higher the risk.10.FMEA 格式逐項解說格式逐項解說1.2.4.3.5.6.8.7.9.12.11.15.14.13.26 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Curren

46、t or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately

47、 dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNWhat actions need to be taken to prevent the Failure Mode?If no action is taken, record “none” 11.FMEA 格式逐項解說格式逐項解說1.10.4.3.5.6.8.7.9.12.2

48、.15.14.13.27 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connec

49、tions spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNAssign appropriate individual, area,function or team.Set a real

50、istic target for completionTarget date could be establishedby development program12.FMEA 格式逐項解說格式逐項解說1.10.4.3.5.6.8.7.9.2.11.15.14.13.28 of 33C.Y.I.E.Q.R.C.Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEn