1、FMEA Failure Mode and Effects Analysis失效模式與效應分析,1 of 33,陳 啟 政 中原大學品質研究中心 中原大學工業工程系 The Quality Research Center Industrial Engineering Department Chung Yuan Christian University,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的優點,Team work 方式提高部門或Function 間連繫溝通
2、,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 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Eff
3、ect :失效後對產品產生影響Cause :造成失效模式之原因Severity :失效模式發生之嚴重程度等級(110)Occurrence :失效模式之發生頻度等級(110)Detection :失效模式發生可被偵測程度等級(110)RPN : Risk Priority Number 指評估風險及優先處理指數是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 o
4、f 33,QFD : Quality Function DeploymentDOE : Design of ExperimentsVOC : Voice of CustomerVOE : Voice of EngineeringSOP : Standard Operation ProcedureSIP : Standard Inspection ProcedureFRACAS : Failure Report Analysis and Corrective Action SystemSPC : Statistic Process ControlTQM : Total Quality Manag
5、ementDVT : Design Valuation TestMTBF : Mean Time Between Failure,FMEA書籍相關名詞解說,5 of 33,FMEA 型式,SYSTEM SFMEADesign DFMEA* Component* Unit* ModuleProcess PFMEAMachine MFMEAEquipment EFMEAService SFMEA,6 of 33,組成FMEA團隊,設計 FMEA 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,
6、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 33,組成FMEA團隊,製程 FMEA 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
7、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 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 /Occurrenc
8、eDetection 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
9、覆到 item13 重提 Action 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)Chairp
10、erson* Program 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
11、,加工不良,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 安規距離不夠,Arcing 規定過嚴,零件間安規距離不足,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,零件本体大Layout 面積
12、小,測試條件設錯,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 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
13、,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
14、邊 零 件 與 Case 安 規 距 離 不 夠,1. Layout 安 規 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 体 歪 斜,c.焊點
15、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,1. Socket Y 電 容 線 腳 斷,5. 油 墨, 黑 色 Mark 筆,
16、 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 takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectio
17、nsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,This column is used to list the part name and function. List al
18、l 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 takenFunction responsibleEnergy Management Cannot Customer SoftwareMon
19、itor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,Occurrence,Occurrence,
20、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 * Control(s) be taken Individual takenF
21、unction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable
22、 to detectbatteryFaults,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) Cause(s) Current or Action(s) to Area or Action(s
23、) Name * Control(s) be taken Individual takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID sta
24、tusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,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.,7.,9.,12.,11.,15.,14.,13.,16 of 33,符合需求 ,17 of 33,Part Fa
25、ilure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongIncorrectbattery
26、 usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,The Class column is optional. It is typically used if the severity is 9 or 10.,5.,FMEA 格式逐項解
27、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 takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery a
28、lert Battery user of status connectionsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,In the Cause column, list
29、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 Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be
30、 taken Individual takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connections
31、damage spec. wrongUnable to detectbatteryFaults,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 more likely the “causes” will occur.,7.,FMEA 格式逐項解說,1.,10.,3.,2.,4.,5.,8.,6.,9.,12.,11
32、.,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 takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status
33、 connectionsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,List the prevention, design validation/ verification,
34、 or other activities which will assure the design adequacy for the failure mode and/or cause / mechanism under consideration. TestsDesign reviews, Mathematical studies, Fail/safe (Example: redundant power 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
35、Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongIncorrectbattery usedC
36、annot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,Estimate the likelihood of the detection on a “1 to 10” scale. The lower the number the more likel
37、y 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 * Control(s) be taken Individual takenFunction responsibleEnergy Management Cannot Customer SoftwareMonit
38、or dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,Occurrence,Occurrence,De
39、tection,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.,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
40、) Name * Control(s) be taken Individual takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongIncorrectbattery usedCannot Customer Software accurately dissatisfaction failureID sta
41、tusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,Occurrence,Occurrence,Detection,Detection,RPN,RPN,What 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,1.,10.,4.,3.,5.,6.,8.,7.,9.,12.,2.,15.,14.,13.,27 o
42、f 33,Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s) Name * Control(s) be taken Individual takenFunction responsibleEnergy Management Cannot Customer SoftwareMonitor dissatisfaction Failure Monitor Battery Battery alert Battery user of status connectionsspec. wrongInco
43、rrectbattery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrongUnable to detectbatteryFaults,Severity,Severity,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,
