潛在失效模式及后果分析11

1、潛在失效模式及后果分析第四版Potential Failure Mode and Effects Analysis4th EditionAgendaIntroductions簡介Background背景The“New”Stuff“新增加”的內(nèi)容Developmentusingthe“new”stuff使用新增增加的內(nèi)內(nèi)容進(jìn)行行FMEA開發(fā)Introduction簡介FMEAPart of aFamily of OEMDocumentsPublished by AIAGFMEA-AIAG發(fā)布的OEM文件中的的一部分分Requirementsdocuments要求的文文件1）ISO/TS16949

2、Automotive SectorRequirements, ISO/TS16949汽車行業(yè)業(yè)要求-ISO9001：2000 is foundation, ISO9001是基礎(chǔ)-Standard &CustomerSpecificRequirements includethe implementation of an FMEAprocess標(biāo)準(zhǔn)和顧顧客特殊殊要求，包括FMEA過程的實(shí)實(shí)施2）PPAP:Product PartApprovalProcessPPAP:生產(chǎn)件批批準(zhǔn)：-PPAPincludesrequirements forFMEA implementation andissubje

3、ct to complianceaudit.-PPAP包括FMEA實(shí)施的要要求，以以及屬于于審核的的一個(gè)項(xiàng)項(xiàng)目。3）ReferenceDocuments參考文件件：-FMEA4thEDFMEA第四版-APQP2ndEDAPQP第二版-SPC2ndEDSPC第二版-MSA3rdEDMSA第三版4）Supportedby被支持-Manualschartered by theAIAG QualitySteeringCommittee.-符合AIAG質(zhì)量策劃劃委員會(huì)會(huì)的手冊冊TheFMEAReferenceDocumentsFMEA參考文件件A referencedocumentisguidance參

4、考文件件是指：-it is an OEMrecommendation,OEM的建議-it is notprescriptive,不是強(qiáng)制制的-it is NOTauditable, unless:不是審核核依據(jù)，除非Theorganization saysinits proceduresthatitwill followtheManual（versusbeconsistentwith it）or組織宣稱稱他們的的程序按按照此手手冊實(shí)施施（等同同采用）或A customer explicitlyrequiresthatyoumust(currently TS andtheCustomerSpec

5、ificRequirements do notdothisyouonlyhave to be consistentwiththemanual)顧客明確確要求你你必須使使用（目目前TS和顧客特特殊要求求不要求求你只能等等同采用用）TheFMEAReferenceDocumentsFMEA參考文件件UsageandApplicationofFMEAsisincludedinrequirements or compliancedocuments suchasISO/TS 16949 andPPAP使用和應(yīng)應(yīng)用FMEAs的要求被被包含在在16949標(biāo)準(zhǔn)或相相關(guān)文件件里面，如PPAP。ISO/TS169

6、49andPPAPdescribe“what”isrequiredorthe compliancecriteriafor FMEAs andaresubjecttoaudit.ISO/TS16949和PPAP描述“什什么”是是被要求求的，或或FMEA的接收準(zhǔn)準(zhǔn)則，并并且是作作為審核核的項(xiàng)目目。FMEA compliancerequirements mayalso be included in CSRFMEA的要求可可能被包包含在顧顧客特殊殊要求中中。TheFMEAReferenceDocumentsFMEA參考文件件TheFMEAreferencedocumentcontainsinforma

7、tionand guidance forcompleting andusingFMEAs-theFMEA document describesthe“how”; theimplementationtoolsforeffectivelydevelopingFMEAs-itisalso aresourcefor developingproceduresandtraininginFMEAFMEA參考文件件包括完完成和使使用FMEA的信息和和指南-FMEA文件描述述“怎么做”，有效開開發(fā)FMEA的實(shí)施工工具-同樣它也也是FMEA開發(fā)程序序和培訓(xùn)訓(xùn)的資源源Background背景What is FMEA

8、？FMEA是什么？FMEAstandsfor failuremodeandeffectsanalysis-FMEA is an analyticalmethodologyusedtoensurethatpotentialproblemshavebeen consideredand addressedthroughout theproduct andprocess development process-keyishavingthe right peoplehavinggooddiscussion about issuesandrisksinthe productand processdesig

9、n,andthe mitigationofhighrisk issues-thisbecomespart of theorganizationsknowledgemanagementFMEA表示失效效模式后后后果分分析-FMEA是一個(gè)分分析工具具，以確確保潛在在問題已已經(jīng)被考考慮，并并且貫穿穿于整個(gè)個(gè)產(chǎn)品和和過程開開發(fā)中-關(guān)鍵是在在產(chǎn)品和和過程開開發(fā)中，有資格格的人很很好的討討論了關(guān)關(guān)鍵點(diǎn)和和風(fēng)險(xiǎn)，并且降降低了高高風(fēng)險(xiǎn)的的發(fā)生-這成為組組織知識識管理的的一部分分FMEA is aprocessnotadocument-previous versionfocusedprimarilyonthe

10、completionofthe FMEAformandthe knowledgecontainedtherein.FMEA是一個(gè)過過程，而而不是一一個(gè)文件件-早期的版版本，主主要關(guān)注注到的是是FMEA的表格完完成和里里面的概概念。Reinforcethatmanagement is an integral partofthisprocess需要強(qiáng)調(diào)調(diào)的是，管理是是這個(gè)過過程所必必需的一一部分。WhyaFourthFMEA？為什么發(fā)發(fā)布FMEA第四版？MinimizeorEliminatecolumn shifting-placinginformationinthe wrong columnst

11、hushinderingthe analysis andproduct/processimprovementefforts減少或者者消除欄欄目-將信息填填入錯(cuò)誤誤的欄目目，會(huì)阻阻礙分析析和產(chǎn)品品/過程改進(jìn)進(jìn)的效果果WhyaFourthFMEA？為什么發(fā)發(fā)布FMEA第四版？WhyaFourthFMEA？為什么發(fā)發(fā)布FMEA第四版？MinimizeorEliminatesolerelianceontheRPN in theevaluation of riskprioritiesandimprovementactions-Practice of DeflatingoftheRPN to meetan

12、arbitrary threshold.減少或消消除單一一依靠RPN值，去評評價(jià)風(fēng)險(xiǎn)險(xiǎn)縫隙的的優(yōu)先程程度和改改進(jìn)措施施。-習(xí)慣于去去刻意降降低RPN值，以滿滿足某個(gè)個(gè)主觀的的指標(biāo)。Lack of understandingofthe roleofthe FMEAprocessthroughout theAPQP phases-includingcontinualimprovementduring production; i.e., lookingatthe FMEAasastaticdocumentnecessary onlyfor PPAPapproval.缺乏對FMEA在APQP各階段中中

13、的角色色的理解解。包括在生生產(chǎn)過程程中的持持續(xù)改進(jìn)進(jìn)。如，只將FMEA視為PPAP批準(zhǔn)所需需的靜態(tài)態(tài)文件。WhyaFourthFMEA？為什么發(fā)發(fā)布FMEA第四版？The“New”Stuff新內(nèi)容ImprovementsinFMEA4th第四版FMEA的改進(jìn)HighlyVisibleImprovements可見的改改進(jìn)Changes in format格式變化化-additional example增加例子子-bettergraphics更好的圖圖形Changes to S,O,and Drankingtables.更改了S，O，D值的表格格AlternativeForms可選的表表格Redu

14、ced Emphasis on RPN減少對RPN的強(qiáng)調(diào)-AlternativestoRPN RPN的可選AlternativeMethods to AnalyzeDesign Risk可選的方方法去分分析設(shè)計(jì)計(jì)風(fēng)險(xiǎn)Ease of Readingand Use更容易的的閱讀和和使用Changeinformat格式的變變化-Similar to thatofthe SPCandMSA manuals與SPC和MSA手冊相似似Anindexisalso included to aidinnavigating themanual.增加抬頭頭，以便便于索引引。Additional Examples增加

15、案例例Additional examples andverbiagehave beenprovidedtoimprovetheutilityofthemanual andtoprovide acloser tieintotheFMEAprocess as it develops.所提供增增加的案案例和內(nèi)內(nèi)容，以以改進(jìn)手手冊的效效果，以以及提供供一個(gè)更更接近的的關(guān)系去去開發(fā)FMEA過程。Changes to RiskRankingTables風(fēng)險(xiǎn)等級級表格的的更改Improvementstothe Severity,Occurrence,Detectionrankingtablessothatt

16、hey aremore meaningfultorealworldanalysisandusage.對S，O，D值表格的的改進(jìn)，可以讓讓他們更更有意義義的去分分析真實(shí)實(shí)世界和和使用。AlternativeForms替換表格格The3rdedition usedasingle“standard”form第三版FMEA使用單一一的“標(biāo)準(zhǔn)”表格-althoughitallowed forotherforms,noexampleswereprovided.盡管它允允許用其其他表格格，但沒沒有提供供例子。The4thedition identifiesalternativeexampleforms第四版

17、提提供了替替換表格格-the focus on the“standardform”hasbeenreplacedwith severaloptionsthat representthecurrentapplicationofFMEA in industry.關(guān)注“標(biāo)準(zhǔn)格式式”已經(jīng)被替替換成代代表當(dāng)前前工業(yè)領(lǐng)領(lǐng)域使用用的FMEA的多種選選擇-Manualidentifiestheminimuminformationthat shouldbecontainedonany form.手冊識別別了最低低內(nèi)容，這些內(nèi)內(nèi)容必須須被包括括在任何何使用的的表格中中。-allowsfor useofthe3rd

18、edition form允許使用用第三版版的表格格。DFMEAForm Examples例子：類似產(chǎn)產(chǎn)品的DFMEA及FMA項(xiàng)目/功能要求潛在失效模式潛在失效影響S級別潛在失效起因O現(xiàn)行設(shè)計(jì)控制預(yù)防現(xiàn)行設(shè)計(jì)控制探測DRPN項(xiàng)目/功能要求潛在失效模式潛在失效影響S級別潛在失效起因O現(xiàn)行設(shè)計(jì)控制預(yù)防現(xiàn)行設(shè)計(jì)控制探測D RPN項(xiàng)目/功能要求潛在失效模式潛在失效影響S級別潛在失效起因現(xiàn)行設(shè)計(jì)控制預(yù)防O現(xiàn)行設(shè)計(jì)控制探測DRPN項(xiàng)目/功能要求潛在失效模式潛在失效影響S級別潛在失效起因現(xiàn)行設(shè)計(jì)控制預(yù)防O現(xiàn)行設(shè)計(jì)控制探測D RPNDFMEAReduced Emphasis on RPN降低對RPN的強(qiáng)調(diào)Mor

19、e meaningfulmethodsforevaluatingpotentialdesign risk更有意義義的方法法去評價(jià)價(jià)潛在設(shè)設(shè)計(jì)風(fēng)險(xiǎn)險(xiǎn)Priorities shouldnotbebasedonRPN alone.并不能單單獨(dú)依據(jù)據(jù)RPN值的大小小來決定定采取措措施的優(yōu)優(yōu)先權(quán)。AlternativestoRPN可供選擇擇的RPNS andS *O(SeveritytimesOccurrence)嚴(yán)重度和和嚴(yán)重毒毒乘以頻頻度SOD(Severity-Occurrence-Detection)嚴(yán)重度乘乘以頻度度乘以探探測度AlternativeMethods to AnalyzeDesi

20、gn Risk多種方法法來分析析設(shè)計(jì)風(fēng)風(fēng)險(xiǎn)AlternativeMethods areintroduced thatare currentlybeingapplied in industry.介紹了多多種應(yīng)用用于當(dāng)前前工業(yè)的的方法FTA故障樹FMECA(Failure ModeEffectsandCriticalityAnalysis)失效模式式后果和和關(guān)鍵性性分析DRBFM(DesignReview BaseonFailureMode)基于失效效模式的的設(shè)計(jì)評評審FMECAFMECAissimilar to FMEA與FMEA相似TheCinFMECAindicatesthatthecrit

21、icality(or Severity)ofthevariousfailure effectsare consideredand ranked.FMECA中的C，指的是是：若干干個(gè)失效效影響的的關(guān)鍵度度（或嚴(yán)嚴(yán)重度）已經(jīng)被被考慮和和歸類。Today,FMEAisoftenused as asynonymforFMECA.今天，F(xiàn)MEA經(jīng)常等同同于FMECA來使用。ImprovementsinFMEA4th改進(jìn)Notsoeasily seen不能輕易易看到：1)Identification of theneed for,and types of,Management Support.識別了管管理

22、層支支持的所所需和類類型。2)IncreasedemphasisontheFMEAprocess強(qiáng)調(diào)了FMEA過程-AlignmentwithAPQP.和APQP的密切關(guān)關(guān)系-increasedemphasisof“Team”discussion anddevelopment強(qiáng)調(diào)了“小組”討論和開開發(fā)-Increasedemphasison“prerequisites”, Failuremodesbasedonrequirements.強(qiáng)調(diào)了“前提”，失效模模式基于于要求。-Linkage betweenDFMEAand PFMEA DFMEA和PFMEA的聯(lián)系Consistent FMEAa

23、pproachinChapter3 and4(DesignandProcess)第三章和和第四章章一樣的的FMEA方法Reduced Emphasis on RPN減少了對對RPN值得強(qiáng)調(diào)調(diào)。TheNeedandTypeofManagement Support管理層支支持的所所需和類類型Reinforcement of theneed formanagement support, interest,andreview of theFMEA processand results.增強(qiáng)對管管理者支支持的所所需，興興趣和FMEA過程的評評審和結(jié)結(jié)果?！癕anagement ownsthe FMEAp

24、rocess.Managementhasthe ultimate responsibility of selectingandapplyingresources andensuringaneffectiveriskmanagement processincluding timing”.管理層擁擁有FMEA過程。管管理層具具有最終終的職責(zé)責(zé)，以選選擇和提提供資源源，以及及一個(gè)包包括時(shí)機(jī)機(jī)的有效效的風(fēng)險(xiǎn)險(xiǎn)管理過過程。Emphasison“Prerequisites”andTeamDiscussions強(qiáng)調(diào)前提提和小組組討論Tominimizeoreliminatecolumn shifting,i

25、tisrecommended.為了減少少或消除除列項(xiàng)，建議：UseseparatecolumnsItem/Step,Function, andRequirements.使用獨(dú)立立的列項(xiàng)項(xiàng)：項(xiàng)目目/步驟，功功能，要要求。Base FailureModesonRequirements,notbrain-storming.制定基于于要求的的失效模模式，而而不是頭頭腦風(fēng)暴暴。Linkage BetweenDFMEAand PFMEADFMEA和PFMEA的聯(lián)系Defineand Strengthenthe understandingofthe linkagebetweenDFMEAandPFMEAas

26、wellasdefiningthelinkagestoothertools.確定和加加強(qiáng)對DFMEA和PFMEA聯(lián)系的理理解以及及和其他他工具的的聯(lián)系。-Main Linkageishow thedesigncan impactmanufacturing or assembly andconversely.主要的聯(lián)聯(lián)系是設(shè)設(shè)計(jì)如何何能夠影影響制造造或裝配配過程，反之亦亦然。-Product designrisk impacted by manufacturingofdesign thatmay be identifiedduring theDFMEAresearchandanalysispro

27、cess.產(chǎn)品設(shè)計(jì)計(jì)風(fēng)險(xiǎn)被被在DFMEA調(diào)查和分分析過程程中識別別的制造造過程設(shè)設(shè)計(jì)所影影響。-Theeffect of aProcessfailure modecan be aDesign failuremode(and allitseffects)一個(gè)過程程失效模模式的影影響，可可能是一一個(gè)設(shè)計(jì)計(jì)失效模模式（以以及所有有它的影影響）。-Also,connectionstoControl Plans,DVPR,etc同樣的，與控制制計(jì)劃，設(shè)計(jì)驗(yàn)驗(yàn)證的聯(lián)聯(lián)系Linkagesbetween DesignandProcess設(shè)計(jì)和過過程的聯(lián)聯(lián)系Designdevelopment設(shè)計(jì)開發(fā)發(fā)-A“st

28、andard”radiusspecified buthard to manufacture.一個(gè)標(biāo)準(zhǔn)準(zhǔn)的半徑徑，但是是難以加加工-Styling shapes,whichlookgood butarehardandexpensive to shape.一個(gè)外形形，看著著很漂亮亮，但是是難以，和需要要昂貴的的加工。-Sharpedgeswhichcouldinjurethe operator尖銳的棱棱角可能能會(huì)傷害害到操作作者-Characteristics thatare critical,excessivevariation willcausewarrantyissues.對于關(guān)鍵鍵特性，過

29、大的的變差會(huì)會(huì)導(dǎo)致保保修。噪音、粗粗糙、運(yùn)運(yùn)行不穩(wěn)穩(wěn)、無法法運(yùn)作、外觀不不良、不不適的異異味、不不穩(wěn)定、運(yùn)行減減損、間間歇運(yùn)行行、發(fā)熱熱、泄漏漏、定期期的不符符合SystemDevelopment系統(tǒng)開發(fā)發(fā)-A child failuremodecausesaparentfailuremodesandall itseffects.一個(gè)子失失效模式式，會(huì)導(dǎo)導(dǎo)致一個(gè)個(gè)母失效效模式和和它所有有的影響響。Process Development過程開發(fā)發(fā)-Process FailuremodecausesaDesignFailureModesandall itseffects.過程的失失效模式式，會(huì)導(dǎo)導(dǎo)

30、致設(shè)計(jì)計(jì)失效模模式以及及它所有有的影響響。Conduct aCaseStudy!聽了這么么久，做做個(gè)案例例吧？！回形針SCENARIO案例YouworkforDilbertWire Forming(DWF),afirm thathas longprospered by supplyingtheautomotiveindustrywith formedwire products,such as springsand wireclips.Tobecomeeconomically morerobust,DWFwishes to broadenits productlinesothat it coul

31、d moveintonewmarkets.A group is formedconsisting of marketresearch,production,sales, anddesignassociatestolook intowhatnewproductcouldbemade utilizingthecompanys experienceinwireformingYouare amember of thisgroup.你為DWF公司工作作。該公公司是一一個(gè)在汽汽車行業(yè)業(yè)用成型型鋼絲產(chǎn)產(chǎn)品（比比如彈彈簧和電電線夾）有著長長期成功功供貨經(jīng)經(jīng)驗(yàn)的公公司。為了公司司的發(fā)展展，公司司希望在在其他市市

32、場擴(kuò)大大其產(chǎn)品品線。一個(gè)由市市場調(diào)研研，生產(chǎn)產(chǎn)，銷售售和設(shè)計(jì)計(jì)人員在在內(nèi)的小小組已構(gòu)構(gòu)成，以以尋求能能基于公公司在鋼鋼絲產(chǎn)品品經(jīng)驗(yàn)的的基礎(chǔ)上上開發(fā)新新的產(chǎn)品品。你是小組組的成員員之一。Thegrouphas identifiedwirepaperclipsasa viablenewproduct.-inrecentyearsthe price of paper clips hadrisenalmostthreetimesasfastasthepricewire-demandfor theproduct wasup,and-thereappears to be littlecustomerloy

33、alty to anyparticular brand.Outlook-domesticmarketisestimated to be 500million paper clips peryear-ifthemanufacturingcostsare$0.0035perclip,DWF might expecttocapture 10 percentofthe market-ifthecostis$ 0.0025perclipdomesticsalescanexpect to be 80 millionpaperclipsand exportanother 20 millioneachyear

34、.小組已經(jīng)經(jīng)識別出出了回形形針是一一個(gè)可行行的新產(chǎn)產(chǎn)品：-在最近幾幾年中，回形針針的價(jià)格格漲了三三次，比比鋼絲的的價(jià)格上上漲次數(shù)數(shù)還多-產(chǎn)品的需需求在上上漲，并并且-顯示出，部分顧顧客對某某一特定定品牌的的忠誠度度很高。展望-本地市場場，每年年估計(jì)有有5億只需求求；-如果制造造成本是是每只0.0035美元，那那么公司司期望能能獲得10%的市場占占有率-如果成本本在0.0025美元，那那么每年年，本地地市場預(yù)預(yù)計(jì)可以以銷售8000萬只，出出口達(dá)到到2000萬只。Sincethestandard-size“Gem”accountsfor90percentofthemarket,itsoverall

35、dimensions usedasthe designstartingpoint.Tobecomecompetitive, yourgroupdecidedthat if thelegs could be cutoffshorter,upto10% lesstotalwirewouldbeneededfor eachpaperclipthus-reducingthecostofrawmaterials,whichrepresents overhalfthemanufacturingcost-reflect savingsinshippingcostssinceitwouldbelighter.

36、普通標(biāo)準(zhǔn)準(zhǔn)尺寸的的回形針針占了90%的市場占占有率，所以設(shè)設(shè)計(jì)的起起始點(diǎn)放放在產(chǎn)品品的外輪輪廓尺寸寸上。為了具有有競爭力力，小組組決定：如果回回形針的的腳能切切短一點(diǎn)點(diǎn)，達(dá)到到鋼絲原原有用量量的10%，那么，每一個(gè)個(gè)回形針針可以：-降低材料料成本，并能降降低一半半的制造造成本；-因?yàn)闇p輕輕了重量量，則同同時(shí)降低低了運(yùn)輸輸成本。Concern:Will thepaperclip still“Clip”?關(guān)注：回回形針還還能發(fā)揮揮作用嗎嗎？Howapaperclip works回形針如如何工作作的Paperclipsaresmallobjects,usuallyconstructedfrom me

37、tal wire, thatservetoholdseveral sheetsofpapertogetherasa singleunit.回形針是是個(gè)小物物體，通通常采用用金屬鋼鋼絲制造造，用于于夾緊一一層紙張張。Ineffect, apaperclipconsistsoftwometalsurfacesthatarepressedagainst oneanother by theelasticity of themetalwire fromwhichthe paper clipisbuilt.實(shí)際上，一個(gè)回回形針包包括兩個(gè)個(gè)互相貼貼合的金金屬表面面，通過過金屬絲絲的彈性性來夾緊緊紙張。Asy

38、oudistortthepaperclipaway fromits equilibrium shape,byspreadingthe twosurfacesapart,itexperiencesrestoring forces.當(dāng)你將回回形針的的兩個(gè)表表面分開開，使之之變形，會(huì)有一一個(gè)回彈彈力。Theseforcestendtoreturnthe paper cliptoits equilibrium shape andpush thetwosurfacestogether.這種力量量會(huì)導(dǎo)致致回形針針回復(fù)到到一個(gè)平平面，并并將兩個(gè)個(gè)表面合合在一起起。A testengineerdetermin

39、edthat thischange would resultinonly 2percentdecreaseinspringaction gripping.一個(gè)測試試工程師師確定，這種更更改只會(huì)會(huì)降低彈彈力的2%。BasicCustomerRequirementsfor apaperclip對于回形形針，顧顧客的基基本要求求。BasicFunction:Holdspapers securely基本功能能：安全全的夾緊緊紙張Maintainsintegrity of thestackofpaper保持一堆堆紙張整整齊Does notcatch,mutilate, or tearpapers不能卡住

40、住或撕破破紙張Holdsa thick setofpapers夾緊一摞摞厚紙Iseasilyinserted.能輕松插插入Safe to use使用安全全Does notgettangledwith other clips in thebox在盒子里里，不能能和其它它回形針針發(fā)生干干涉islightweightand requires lesspostage輕量，并并且需要要較少的的郵費(fèi)Ischeap便宜Isdurabledoes notrust耐用，不不能生銹銹BlockDiagram簡圖DFMEADevelop aDFMEAtodetermine whatare therisksinusi

41、ngthis designwith thenewchanges開發(fā)一個(gè)個(gè)DFMEA以確定這這個(gè)新的的更改所所產(chǎn)生的的設(shè)計(jì)風(fēng)風(fēng)險(xiǎn)。DFMEARequirement:Doesnotcatch, Mutilate,ortear papers要求：不不能卡住住或撕破破紙張Team Exercise小組測試試Develop thebranchinthe DFMEA forthis requirement of thebasicfunctionoftheitem:paperclip以以上要要求，開開發(fā)一個(gè)個(gè)DFMEA。DFMEARequirement：Does notcatch,Mutilate, or tea