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1、 FMEAFailure Mode and Effects Analysis 失效方式與效應分析1 of 33FMEA 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一切 的失效方式的表,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,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方式每一種能够因子 以失效樹分析(FTA)方法了解產品失效方
2、式各種組合型式 把失效方式量化針對Top Failure Mode 優先採取對策預防 確保一切想像得到失效方式和影響,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控制預防採取對策時运用 3 of 33 Core team :列出與FMEA team 相關人員名字,部門與職責 Failure mode :失效方式種類 Effect :失效後對產品產生影響 Cause :呵斥失效方式之缘由 Severity :失效方式發生之嚴重程度等級(110) Occurrence :失效方式之發生頻度等級(110) Detection :失效方式發生
3、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来由頂端 事件利用邏輯(OR 或 AND) 持續分析第1.2層直 至真正Root cause 將這些缘由謀求徹底改善FMEA相關名詞解說4 of 33 QFD : Quality Function Deployment DOE : Design of Experiments VOC : Voice of Customer VOE : Voic
4、e 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 : Mean Time Between FailureFMEA書籍相關名詞解說5 of 33FMEA 型式
5、SYSTEM SFMEA Design DFMEA * Component * Unit * Module Process PFMEA Machine MFMEA Equipment EFMEA Service SFMEA6 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方式分析設計控制方法分析失效缘由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矫正行動決定關鍵性失效方式 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。分析與矫正作業系統(FRACAS)設
6、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方式分析現行控制方法分析失效缘由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矫正行動決定關鍵性失效方式 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。分析與矫正作業系統(FRACAS)製程改善檢驗程序改善撰寫報告8 of 33FMEA 實施步驟1. 決定FMEA 對象2. 成立&組成FMEA team members3. 搜集&準備类似產品之歷史資料4. 列出
7、產品方塊圖或製程流程圖5. 列出Failure mode 各種能够情況6. 列出Failure mode 對產品/機器之 影響 (Effect)7. 魚骨圖分析呵斥此Failure mode 之能够缘由 (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. 列出类似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
8、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. 假设 RPN 值未達定義要求 RPN 100 or Top 20% 回覆到 item 13 重提 Action18. 假设 RPN 達到要求完成 FMEA 表格9 of 33FMEA Team Members DFMEA (Design) Chairperson * Program Manager (PM) * Electronic Engineer (EE) * Mechani
9、cal Engineer (ME) * Quality Engineer (QE) * Quality Engineer (QA) * Manufacturing (MES) Support Team * Purchasing (Buyer) if Need PFMEA (Process) Chairperson * Program Manager (PM) * Quality Engineer (QA) * Industry Engineer (IE) * Mechanical Engineer (MFG ME) * Test Engineer (TE) * Manufacture Supe
10、rvisor (MFG) * Electronic Engineer (EE) if Need * Mechanical Engineer (ME) if Need 10 of 33Failure Mode Fishbone AnalysisHi-Pot 不良FailureMode(Defect)錫面組立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
11、過大呵斥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缺乏第一層分析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 面積小測試條件設錯O/I寫錯測試線接錯11 of 33Hi-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.加工不良d.錫面短路錫珠,錫渣c.線腳過長b.漏焊Y
12、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PowerCable破5.PCB4.EMISocke
13、t3.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
14、側導電12 of 33Part 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 Inc
15、orrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNThis column is used to list the part nameand function. List all the functions for th
16、e functional blockFMEA 格式逐項解說1.2.10.4.3.5.6.8.7.9.12.11.15.14.13.13 of 33Part 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 B
17、attery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPN2.In the failure mode
18、column, list each of the failuremodes 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 33Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordiss
19、atisfaction 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 FaultsSeveritySeverityOccurrenceDetectionDetectionRPN
20、RPNOccurrence3.List the effects of failure for each of thefailure modes.FMEA 格式逐項解說1.10.4.2.5.6.8.7.9.12.11.15.14.13.15 of 33Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer So
21、ftwareMonitordissatisfaction 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 FaultsSeveritySeverityOccurrenceOccu
22、rrenceDetectionDetectionRPNRPNFor each one of the effects, list theseverity (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 33Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function res
23、ponsibleEnergyManagementCannotCustomer 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 bat
24、tery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNThe Class column is optional. It istypically 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 33Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) b
25、e taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsda
26、mage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNIn the Cause column, list the causesfor each failure mode6.FMEA 格式逐項解說1.10.3.2.4.5.8.7.9.12.11.15.14.13.19 of 33FMEA ModelLinking Failure Mode toCause and EffectCauseFailure Mode(Defect)Effect
27、20 of 33Part 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 Incorr
28、ect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNEstimate the likelihood of the “causes happening on a “1 to10 scale. The higher thenumb
29、er the more likely the“causes will occur.7.FMEA 格式逐項解說1.10.3.2.4.5.8.6.9.12.11.15.14.13.21 of 3322 of 33Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatis
30、faction 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 FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetect
31、ionRPNRPNList 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 supplies)8.FMEA 格式逐項解說1.10.3.2.5
32、.4.6.7.9.12.11.15.14.13.23 of 33Part 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
33、tions spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNEstimate the likelihood of the detection on a “1 to 10 scale. T
34、he 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 3325 of 33Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer S
35、oftwareMonitordissatisfaction 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 FaultsSeveritySeverityOccurrenceOcc
36、urrenceDetectionDetectionRPNRPNRPN (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1.2.4.3.5.6.8.7.9.12.11.15.14.13.26 of 33Part Failure Mode Effect(s) Cause(s) Current or Action(s) to Area or Action(s)Name * Control
37、(s) be taken Individual taken Function responsibleEnergyManagementCannotCustomer SoftwareMonitordissatisfaction FailureMonitorBattery Battery alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connecti
38、onsdamage 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1.10.4.3.5.6.8.7.9.12.2.15.14.13.27 of 33Part Failure Mode Effect(s) Cause(s) C
39、urrent 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 accur
40、ately 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 establishedby developm
41、ent program12.FMEA 格式逐項解說1.10.4.3.5.6.8.7.9.2.11.15.14.13.28 of 33Part 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
42、alert Batteryuser of status connections spec. wrong Incorrect battery usedCannot Customer Software accurately dissatisfaction failureID statusBattery Connectionsdamage spec. wrong Unable to detect battery FaultsSeveritySeverityOccurrenceOccurrenceDetectionDetectionRPNRPNList the results of the actions taken.Always enter a reference such as data or test reports.13.FMEA 格式逐項解
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