FMEAFailureModeandEffectsAnalysis失效模式与效应分析

Delta Confidential,FMEA,Failure Mode and Effects Analysis,失效模式與效應分析,Prepared by : James.,Zhou,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,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 of 33,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,: Total Quality Management,DVT,: Design Valuation Test,MTBF,: 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 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 /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,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%,回覆到,item,13,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),Chairperson,* 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,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,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,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,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,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,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,This column is used to list the 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,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,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 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,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),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,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 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 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 optional. 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,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,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 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 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,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.,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 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 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.,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,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,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,* 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,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),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,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,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 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,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) 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.,FMEA,格式逐項解說,1.,10.,4.,3.,5.,6.,8.,7.,9.,12.,11.,15.,14.,2.,29,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 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,When reassessing SEVERITY, the,only factors that will influence a,change will be:,new experience,change in regulations,design change,change in customer priorities,14.,FMEA,格式逐項解說,1.,10.,4.,3.,5.,6.,8.,7.,9.,12.,11.,15.,2.,13.,30,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 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,If this RPN is not significantly less,than previous, then ACTION taken,has been ineffective.,15.,FMEA,格式逐項解說,1.,10.,4.,3.,5.,6.,8.,7.,9.,12.,11.,2.,14.,13.,31,of 33,32,of 33,33,of 33,