1、FMEA Failure Mode and Effects Analysis 失效模式與效應分析,Prepared by : YS.Hsueh Issue date : April 12,2001,1 of 33,FMEA 意義說明,FMEA 是不良預防的工具,是一種 有條理程序可藉由一張包含所有 的失效模式的表,並以數據來表 示風險的大小和預先採取預防改 善措施。,2 of 33,導入FMEA的優(yōu)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(fā)揮想像力, 經由有系統(tǒng)整合 提出有效之預防改善對策 徹底了解產品功能架構圖

2、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(yōu)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 33,Core team :列出與FMEA team 相關人員名字,部門與職責 Failure mode :失效模式種類 Effect :失效後對產品產生影響 Cause :造成失效模式之原因 Severity :失效模式發(fā)生之嚴重程度等

3、級(110) Occurrence :失效模式之發(fā)生頻度等級(110) Detection :失效模式發(fā)生可被偵測程度等級(110) RPN : Risk Priority Number 指評估風險及優(yōu)先處理指數 是Severity * Occurrence * Detection 之乘積 FTA :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(xù)分析第1.2層直 至真正Root cause 將這些原因謀求徹底改善,FMEA相關名詞解說,4 of 33,QFD : Quality Function Deployment DOE : D

4、esign 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 : Total Quality Management DVT : Design Valuation Test MTBF

5、 : Mean Time Between Failure,FMEA書籍相關名詞解說,5 of 33,FMEA 型式,SYSTEM SFMEA Design DFMEA * Component * Unit * Module Process PFMEA Machine MFMEA Equipment EFMEA Service SFMEA,6 of 33,組成FMEA團隊,設計 FMEA 流程(DFMEA),蒐集資料,完成FMEA執(zhí)行方案,系統(tǒng)特性,系統(tǒng)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(fā)生率,分析難檢度,建議改正行動,決定

6、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(yè)系統(tǒng) (FRACAS),設計改善,撰寫報告,維護度分析 參考資料,7 of 33,組成FMEA團隊,製程 FMEA 流程(PFMEA),蒐集資料,完成FMEA執(zhí)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(fā)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

7、料,失效報告。分析 與改正作業(yè)系統(tǒng) (FRACAS),製程改善,檢驗程序改善,撰寫報告,8 of 33,FMEA 實施步驟,1. 決定FMEA 對象 2. 成立&組成FMEA team members 3. 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 Detection 之等級 9. 根據 S/O/

8、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Action,11. 計算出 RPN=S*O*D 值 12. 取 RPN 值 100 (值大小需定義) or Top 20% 優(yōu)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 Action

9、18. 若 RPN 達到要求完成 FMEA 表格,9 of 33,FMEA Team Members,DFMEA (Design) Chairperson * Program Manager (PM) * Electronic Engineer (EE) * Mechanical Engineer (ME) * Quality Engineer (QE) * Quality Engineer (QA) * Manufacturing (MES) Support Team * Purchasing (Buyer) if Need,PFMEA (Process) Chairperson * Pro

10、gram Manager (PM) * Quality Engineer (QA) * Industry Engineer (IE) * Mechanical Engineer (MFG ME) * Test Engineer (TE) * Manufacture Supervisor (MFG) * Electronic Engineer (EE) if Need * Mechanical Engineer (ME) if Need,10 of 33,Failure Mode Fishbone Analysis,Hi-Pot 不良 Failure Mode (Defect),錫面,組立,加工

11、不良,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 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(guī)距離不夠,Arcing 規(guī)定過嚴,零件間安規(guī)距離不足,第一層分析 Design,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,零件本體大Layout 面積小,測

12、試條件設錯,O/I寫錯,測試線接錯,11 of 33,Hi-Pot Failure Analysis,Fault Tree Analysis For Hi-Pot Failure,5. 板 邊 零 件 傾 斜 踫 Case, 造 成 安 規(guī) 距 離 不 夠,b. Socket 上 Y 電 容 線 腳 靠 近 馬 口 鐵,a. Socket FG 線 漏 焊,Process,4. 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

13、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(guī) 距 離 不夠,3. Arcing 規(guī) 格 過 嚴,c. 鎖 螺 絲 過 長,b. 套 管 短,a. 原 件 本 體 大 Layout 面 積 小,

14、4. 板 邊 零 件 與 Case 安 規(guī) 距 離 不 夠,1. Layout 安 規(guī) 距 離 不 夠,Material,9. 變 壓 器 PFC 電 感 ,8. 膠 雜 質 過 多,7. Y 電 容 不 良,6. 線 材 Power Cable 破,5. PCB,4. EMI Socket,3. 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 體

15、 歪 斜,c. 焊 點 過 大, 造 成 錫 間 賜 破 絕 緣 層,b. 引 線 腳 超 出 base,a. 絕 緣 膠 布 位 置 不 恰 當,1. 光 藕 合 器 不 良,e. O/I 寫 錯 誤,Test,2. 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 他,2. 接 地 銅 箔 被 燒 斷,3. 接 地 跳 線 斷,4. 未 依 O/I 作 業(yè),1. Socket Y 電 容 線 腳

16、 斷,5. 油 墨, 黑 色 Mark 筆, 在 初 級 側 導 電,12 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery use

17、r of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,This column is used to list the

18、part name and function. List all the functions for the functional block,FMEA 格式逐項解說,1.,2.,10.,4.,3.,5.,6.,8.,7.,9.,12.,11.,15.,14.,13.,13 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy Manag

19、ementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,

20、Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,2.,In the failure mode column, list each of the failure modes for the function.,FMEA 格式逐項解說,1.,10.,4.,3.,5.,6.,8.,7.,9.,12.,11.,15.,14.,13.,14 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name

21、 * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID statu

22、s Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Detection,Detection,RPN,RPN,Occurrence,3.,List the effects of failure for each of the failure modes.,FMEA 格式逐項解說,1.,10.,4.,2.,5.,6.,8.,7.,9.,12.,11.,15.,14.,13.,15 of 33,Part Failure Mode Effect(s)

23、Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Custom

24、er Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,For each one of the effects, list the severity (scale from 1 to 10),4.,FMEA 格式逐項解說,1.,10.,3.,2.,5.,6.,8.

25、,7.,9.,12.,11.,15.,14.,13.,16 of 33,符合需求 ,17 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Batt

26、ery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,The Class column is optio

27、nal. It is typically used if the severity is 9 or 10.,5.,FMEA 格式逐項解說,1.,10.,3.,2.,4.,6.,8.,7.,9.,12.,11.,15.,14.,13.,18 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustome

28、r Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,

29、Occurrence,Occurrence,Detection,Detection,RPN,RPN,In the Cause column, list the causes for each failure mode,6.,FMEA 格式逐項解說,1.,10.,3.,2.,4.,5.,8.,7.,9.,12.,11.,15.,14.,13.,19 of 33,FMEA Model,Linking Failure Mode to Cause and Effect,Cause,Failure Mode (Defect),Effect,20 of 33,Part Failure Mode Effec

30、t(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot C

31、ustomer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,Estimate the likelihood of the “causes” happening on a “1 to 10” scale. The higher the number the m

32、ore likely the “causes” will occur.,7.,FMEA 格式逐項解說,1.,10.,3.,2.,4.,5.,8.,6.,9.,12.,11.,15.,14.,13.,21 of 33,22 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Softwar

33、e Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrenc

34、e,Occurrence,Detection,Detection,RPN,RPN,List 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 (Example: redundant power

35、supplies),8.,FMEA 格式逐項解說,1.,10.,3.,2.,5.,4.,6.,7.,9.,12.,11.,15.,14.,13.,23 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure Mo

36、nitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RP

37、N,RPN,Estimate 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,1.,10.,3.,2.,5.,4.,8.,7.,6.,12.,11.,15.,14.,13.,24 of 33,25 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name *

38、 Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status

39、Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,RPN (Risk Priority Number) is the product of Severity, Occurrence, and Detection. The higher the number, the higher the risk.,10.,FMEA 格式逐項解說,1.,2.,4.,3.,5.,6.,8

40、.,7.,9.,12.,11.,15.,14.,13.,26 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of st

41、atus connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,What actions need to be taken to preven

42、t the Failure Mode? If no action is taken, record “none”,11.,FMEA 格式逐項解說,1.,10.,4.,3.,5.,6.,8.,7.,9.,12.,2.,15.,14.,13.,27 of 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCust

43、omer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severi

44、ty,Occurrence,Occurrence,Detection,Detection,RPN,RPN,Assign appropriate individual, area, function or team. Set a realistic target for completion Target date could be established by development program,12.,FMEA 格式逐項解說,1.,10.,4.,3.,5.,6.,8.,7.,9.,2.,11.,15.,14.,13.,28 of 33,Part Failure Mode Effect(s

45、) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual taken Function responsible Energy ManagementCannotCustomer Software Monitordissatisfaction Failure MonitorBattery Battery alert Battery user of status connections spec. wrong Incorrect battery used Cannot Customer Software accurately dissatisfaction failure ID status Battery Connections damage spec. wrong Unable to detect battery Faults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,List the results of the actions taken. Always enter a reference such as data or test reports.,13.,F