失效模式(FMEA详解).pptx

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1、Delta Confidential FMEAFailure Mode and Effects Analysis 失效模式與效應分析失效模式與效應分析1 of 33Delta ConfidentialFMEA FMEA 意義說明意義說明 FMEA FMEA 是不良是不良預防的工具預防的工具, ,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 33Delta Confidential導入導入FMEAFMEA的優點的優點 Team

2、 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 33Delta Confidential Core

3、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 * Occurre

4、nce * 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 33Delta Confidential QFD : Quality Function Deployment DOE : Design of Experiments VOC : Voice of Customer VOE : Voice of Engineering SOP : Standard Operation

5、Procedure SIP : Standard Inspection Procedure FRACAS : Failure Report Analysis and Corrective Action System SPC : Statistic Process Control TQM : Total 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 33Delta ConfidentialFMEA FMEA 型式型式 SYSTE

6、M SYSTEM SFMEASFMEA Design Design DFMEADFMEA * Component * Unit * Module Process Process PFMEAPFMEA Machine Machine MFMEAMFMEA Equipment Equipment EFMEAEFMEA Service Service SFMEASFMEA6 of 33Delta Confidential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

7、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 33Delta Confidential組成FMEA團隊製程製程 FMEA 流程流程(PFMEA)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

8、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 33Delta ConfidentialFMEA 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Failure 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 Detectio

9、n 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

10、 Action18. 若 RPN 達到要求完成 FMEA 表格9 of 33Delta ConfidentialFMEA Team MembersFMEA Team Members DFMEA (Design)DFMEA (Design) Chairperson * Program Manager (PM)(PM) * Electronic Engineer (EE)(EE) * Mechanical Engineer (ME)(ME) * Quality Engineer (QE)(QE) * Quality Engineer (QA)(QA) * Manufacturing (MES)(M

11、ES) Support Team * Purchasing (Buyer) if Need PFMEA (Process)PFMEA (Process) Chairperson * Program Manager (PM)(PM) * Quality Engineer (QA)(QA) * Industry Engineer (IE)(IE) * Mechanical Engineer (MFG ME)(MFG ME) * Test Engineer (TE)(TE) * Manufacture Supervisor (MFG)(MFG) * Electronic Engineer (EE)(

12、EE) if Need * Mechanical Engineer (ME)(ME) if Need 10 of 33Delta ConfidentialFailure 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

13、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 33Delta ConfidentialHi-Pot FailureAnalysisFault 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.

14、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 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

15、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 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.

16、SocketY電容線腳斷5.油墨,黑色Mark筆,在初級側導電12 of 33Delta ConfidentialPart 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 Bat

17、teryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNThis column is used to list the part n

18、ameand 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 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagemen

19、tCannotCustomer 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 FaultsSeveritySeve

20、rityOccurrenceOccurrenceDetectionDetectionRPNRPN2.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 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be

21、 taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdam

22、age 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1.10.4.2.5.6.8.7.9.12.11.15.14.13.15 of 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current or Action(s)

23、 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 dissatisfacti

24、on failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNFor each one of the effects, list theseverity (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 33Delta Confidential嚴重度評點基準

25、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

26、 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, 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

27、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 warning178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 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current

28、 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

29、dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNThe Class column is optional. It istypically 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 33D

30、elta ConfidentialPart 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. wro

31、ng Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNIn the Cause column, list the causesfor each failure mode6.FMEA 格式逐項解說格式逐項解說1.

32、10.3.2.4. 5.8.7.9.12.11.15.14.13.19 of 33Delta ConfidentialFMEA ModelLinking Failure Mode toCause and EffectCauseFailure Mode(Defect)Effect20 of 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function resp

33、onsibleEnergyManagementCannotCustomer 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 batt

34、ery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNEstimate the likelihood of the “causes” happening on a “1 to10” scale. The higher thenumber the more likely the“causes” will occur.7.FMEA 格式逐項解說格式逐項解說1.10.3.2.4. 5.8.6.9.12.11.15.14.13.21 of 33Delta Confidential發生率評點基準建議參考表 :發生率評點

35、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 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

36、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 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function respons

37、ibleEnergyManagementCannotCustomer 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

38、 FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNList the prevention, design validation/ verification, or other activities which will assure the design adequacy for the failure mode and/or cause / mechanism under consideration. Tests Design reviews, Mathematical studies, Fail/safe

39、(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 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonit

40、ordissatisfaction 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 FaultsSeveritySeverityOccurrenceOccurrenceDetec

41、tionDetectionRPNRPNEstimate 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 33Delta Confidential難檢度評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Mode

42、rate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High34756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

43、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 33Delta ConfidentialPart 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 FailureM

44、onitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNRPN (Ri

45、sk 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 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken I

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

47、. 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1.10.4.3.5.6.8.7.9.12.2.15.14.13.27 of 33Delta ConfidentialPart Failure Mode Effect(s)

48、 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 Incorrect battery usedCannot Customer Sof

49、tware accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNAssign appropriate individual, area,function or team.Set a realistic target for completionTarget date could be established

50、by 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 33Delta ConfidentialPart Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfac