质量管理系统QMS(ppt 420).ppt

,质量管理系统QMS,CourseObjectives也算是知識管理(KnowledgeManagement)當中的一種知識呈現/知識成文化(KnowledgeRepresentation):將內隱知識(ImplicitKnowledge)成文化、外化，成為外顯知識(ExplicitKnowledge),再和大家分享(KnowledgeSharing)!企業知識乃指能有效解決問題的方法及資訊，又可分為外顯知識及內隱知識。,說明:外顯知識是指可以有系統的語言來表示的知識(e.g.企業的內部ISO文件RequestcurrentCSPMbeforetheaudit,perhapsintheauditplan;ReviewtheCSPMasthefirstitemoftheaudit;IncludeanoticetotheclientoftheflexibilityoftheauditortochangetheaudittrackortimingbasedontheresultsoftheinitialreviewofCSPM;,RABsupportsalessrigidauditplantohandlethisvariability;AuditorshouldmaintainanawarenessoftheapplicableCSPMrequirementsbyeachOEM;PoorCSPMresultsshouldguidetheauditortowardsevaluationsofpotentialsourcedeficienciesintheQMS;Ifauditorisnotsatisfied,systemdeficienciescanbecomeadocumentedbasisforissuingnon-conformance;TheCSPMandrevisedaudittrailaredocumented;,Insufficientcoverageofrequiredsurveillanceitems-becauseofunplannedauditingresultingfromevaluatingCSPMandrelatedsystemnon-conformities-isnotacceptable;addedeffortshouldbeplanned.TS-2Rule:TheorganizationshallprovidethefollowingdocumentationtotheCBforreview,andforuseinplanningtheaudit:,Qualitymanual(foreachsitetobeaudited)InternalauditandmanagementreviewplanningandresultsfromprevioustwelvemonthsListofqualifiedinternalauditorsListofcustomerspecificrequirementsCustomercomplaintsstatusOperationalperformancetrendsfortheprevious12months,minimum.QS-90004.1.5AnalysisandUseofCompanyLevelDataThesuppliershalldocumenttrendsinquality,operationalperformance(productivity,efficiency,effectiveness,costofpoorquality)andcurrentqualitylevelsforkeyproductandservicefeatures.,Theseshouldbecomparedwiththoseofcompetitorsand/orappropriatebenchmarks.Trendsindataandinformationshouldbecomparedwithprogresstowardoverallbusinessobjectivesandleadtoactiontosupport:Developmentofprioritiesforpromptsolutionstocustomer-relatedproblems,Determinationofkeycustomer-relatedtrendsandcorrelationstosupportstatusreview,decision-makingandlonger-termplanning.,TS-28.4.1AnalysisanduseofdataTrendsinqualityandoperationalperformanceshallbecomparedwithprogresstowardobjectivesandleadtoactiontosupportthefollowing:Developmentofprioritiesforpromptsolutionstocustomer-relatedproblems;Determinationofkeycustomer-relatedtrendsandcorrelationforstatusreview,decision-makingandlongertermplanning;Aninformationsystemforthetimelyreportingofproductinformationarisingfromusage.NOTEDatashouldbecomparedwiththoseofcompetitorsand/orappropriatebenchmarks.,IATFGuidancetoTS-2:8.4.1AnalysisanduseofdataOperationalperformancemayincludeproductivity,costofpoorquality,processefficiencyandeffectiveness,productionoutput,qualityperformance,andequipmentutilization.TS-2Rule:2.10TheauditplanshallincludeevaluationofalloftheorganizationsQMSrequirementsforeffectiveimplementationofISO/TS16949:2002aswellasforeffectivenessinpractice.Assessmentshallevaluatetheeffectivenessofthesystem,itslinkages,itsperformanceanditsrequirements.,Note:Effectivenessofthesystemshouldconsiderhowwellthesystemisdeployed,asdemonstratedbythemeasuresdefinedbytheorganizationtomeetcustomersatisfactionandcompanyobjectives.Initialcertificationauditactivitiesshallbeconductedaccordingtothefollowingrules:RevieweffectivenessoftheimplementationoftheISO/TS16949:2002requirementsandforeffectivenessinpractice,relatedtoplannedandachievedqualityperformance.,TheAutomotiveIndustrys(IATF)CategorizationofQMSProcessesare:CustomerOrientedProcesses(COPs):常見之10COPsMarketAnalysis/CustomerRequirementsBid/TenderOrder/RequestProductandProcessDesignProductandProcessverification/validationProductProductionDelivery,PaymentWarranty/ServicePostSales/CustomerFeedback2)SupportProcesses:常見之SupportProcesses:Sales或以後製程人員稽核前製程(InternalCustomer之觀念),儘量採用精兵制或委外給專業人士來執行，而且要嚴格執行後續之“AuditorQualificationMaintenance”之規定(可參閱ISO10011-1,-2或授權以Internalauditplanner/scheduler責任，在每次排auditschedule/agenda時，必需review先前所開之CARs決定是否要增加稽核頻率。,ProcessorientedauditingIATFexpectsTS-2auditorstoauditCustomerOwnedProcesses(COP，也有人稱為CustomerOrientedProcesses或CoreProcesses).TheCOPisamodelthatwasintroducedbyISO9001:2000andreferstothefactthatanyorganizationneedscustomerinputtocomplytospecifiedandexpectedneedsofthecustomer(output).Thisisaccomplishedbyvalueaddingprocessesofproductrealizationandappropriatesupportprocesses,bothenabledbymanagementactivitiesandprovidedresources.TheauditapproachofTS-2mustnotbedrivenbyan“element”ora“section”drivenchecklist.Insteadthechecklistshallbeatooltoidentifythecompletenessoftheaudit,whichmeansthattheauditorshallauditallapplicablerequirementstoanidentifiedCOP.,AutomotiveValue-AddedAssessmentvs.CSPM-drivenAuditPlanningBestPractice#Auto1:EffectiveAutomotiveSectorAuditing-UsingCustomerSatisfactionPerformanceMetricstoGuideOn-siteAuditFocus.ItwasimportantthattheOEMsseeanimprovementinsupplierperformance-andthatthesupplierperformancemetricsshouldbeafirstitemonanyaudit.Ifthesewerebeneathexpectations,theyshouldbeusedasaguideforauditingpotentiallynon-conformingsystems.AuditorsshouldlookateachOEMsmetricsrelevanttoasite(notjustonechosenforcontractreview)ateveryauditevent.,“Outputmatters”-useCustomerSatisfactionPerformanceMetrics,CSPM,asanindicatorofQMSeffectivenessandimplementation;RequestcurrentCSPMbeforetheaudit,perhapsintheauditplan;ReviewtheCSPMasthefirstitemoftheaudit;IncludeanoticetotheclientoftheflexibilityoftheauditortochangetheaudittrackortimingbasedontheresultsoftheinitialreviewofCSPM;,RABsupportsalessrigidauditplantohandlethisvariability;AuditorshouldmaintainanawarenessoftheapplicableCSPMrequirementsbyeachOEM;PoorCSPMresultsshouldguidetheauditortowardsevaluationsofpotentialsourcedeficienciesintheQMS;,Ifauditorisnotsatisfied,systemdeficienciescanbecomeadocumentedbasisforissuingnon-conformance;TheCSPMandrevisedaudittrailaredocumented;Insufficientcoverageofrequiredsurveillanceitems-becauseofunplannedauditingresultingfromevaluatingCSPMandrelatedsystemnon-conformities-isnotacceptable;addedeffortshouldbeplanned.,MONITOR:“Observe,supervise,keepunderreview,measureortestatintervals,especiallyforthepurposeofregulationorcontrol”MEASURE:“Ascertainordeterminethespatialmagnitudeorquantityofsomething,bytheapplicationofsomeobjectofknownsizeorcapacityorbycomparisonwithsomefixedunit”,GlossaryCorrection(C):ActiontoeliminateadetectednonconformityNOTE1AcorrectioncanbemadeinconjunctionwithacorrectiveactionNOTE2Acorrectioncanbe,forexample,reworkorregradeCorrectiveAction(CA):ActiontoeliminatethecauseofadetectednonconformityorotherundesirablesituationNOTE1Therecanbemorethanonecauseforanonconformity.,NOTE2Correctiveactionistakentopreventrecurrencewhereaspreventiveactionistakentopreventoccurrence.NOTE3Thereisadistinctionbetweencorrectionandcorrectiveaction.PreventiveAction(PA):ActiontoeliminatethecauseofapotentialnonconformityorotherundesirablepotentialsituationNOTE1Therecanbemorethanonecauseforapotentialnonconformity.NOTE2Preventiveactionistakentopreventoccurrencewhereascorrectiveactionistakentopreventrecurrence.,ContinualImprovement(CI):Recurringactivitytoincreasetheabilitytofulfillrequirements(ISO9000)NOTETheprocessofestablishingobjectivesandfindingopportunitiesforimprovementisacontinualprocessthroughtheuseofauditfindingsandauditconclusions(8.2.2),analysisofdata(8.4),managementreviews(5.6)orothermeansandgenerallyleadstocorrectiveaction(8.5.2)orpreventiveaction(8.5.3).說明:建立目標和尋找改善之機會(CI)是一透過使用ISO9001之3工具(i.e.管審,稽核和資料分析)或其他方式之持續不斷之流程,並且通常會導致於CA和PA。因此,此概念也說明了新版ISO9001之條文編排順序:MRIAAODCICAPA想一想:ISO9001是一個大的toolkit,裡面有各種不同之tools(e.g.MR,IA,AOD等),含“small-step,on-goingimprovementactivities(i.e.continuous/incremental/localimprovementonexistingprocesses)”逐步漸進式的持續改善和“breakthroughprojects(i.e.discontinuousimprovementitwillusuallyrevealentirelynewbusinessprocessesatwhichanorganizationmustexcel)”突破式的流程/企業再造工程,e.g.6-sigmastrategies,Re-engineering(QS-9000:CIrequirementdoesnotreplacetheneedforinnovativeimprovement(流程/技術/知識)創新)ISO/TS16949:optimizationofcharacteristicsandparametersofaproductorprocessatatargetvalueNOTEContinualimprovementisonlyapplicablewhereconformancehasbeenestablished.,CustomerSatisfaction(CS):CustomersperceptionofthedegreetowhichthecustomersrequirementshavebeenfulfilledNOTE1Customercomplaintsareacommonindicatoroflowcustomersatisfactionbuttheirabsencedoesnotnecessarilyimplyhighcustomersatisfaction.NOTE2Evenwhencustomerrequirementshavebeenagreedwiththecustomerandfulfilled,thisdoesnotnecessarilyensurehighcustomersatisfaction.,CustomerDelight(CD):ISO9004:Organizationsdependontheircustomersandthereforeshouldunderstandcurrentandfuturecustomerneeds,shouldmeetcustomerrequirementsandstrivetoexceedcustomerexpectations(i.e.顧客喜悅customerdelight.)。,試由下列三條文來區分Correction和CA之差異:8.2.3Monitoringandmeasurementofprocesses:whenplannedresultsarenotachieved,correctionandcorrectiveactionshallbetaken,asappropriate,toensureconformityoftheproduct.8.2.2內部稽核8.3不良品管制ProblemResolutionCDProgression(演進):,條文說明Immediate/Interim/RemedialAction(s)e.g.rework/repair,regarde/downgrade,containment,scrap/reject,concession,G8D之D3(DeveloptheInterimContainmentAction),治標e.g.打退燒針,頭痛(只是syndrome):吃普拿疼,但root-cause可能是腦瘤,C,8.3(8.2.2objectivecriteriamustbedefinedtoensureconsistentinspections.”(主觀性用詞不好，必須訂定客觀性基準用以確保一致性之檢驗結果)。尤其是碰到一些外觀檢驗(visualinspections)，或QS-9000所謂的外觀件(AppearanceItems)之Controls/Inspections，需做到Theconformance/acceptancecriteriamustbeclearlydefinedandtheprocedurefordecidingifthesecriteriaaremetmustproduceconsistentresultsovertime)允收/符合基準必須定義清楚，而且用來決定是否符合這些基準之“程序”必須都能產出一致性之結果)。,舉例如下:AcceptanceSpec.Surfaceshouldbefreefromflaws.(表面不可以有瑕疵.)Surfaceshouldconformtomasterstandardincolor,texture,brightnessandimperfection.(表面必須符合顏色/光澤比對標準),CommentWhatisaflaw?-Doinspectorsagree?-Howmeasured?Conformtowhatdegree?Howmeasured?,QS-90004.9.6(AppearanceItems外觀件)要求工廠必須提供:Appropriatelightingforevaluationareas(執行外觀檢驗之區域要有適當的亮度)Mastersforcolor,grain,gloss,metallicbrillance,texture,distinctnessofimage(DOI)asappropriate(適當之外觀比對標準)MaintenanceandcontrolofappearancemastersandevaluationequipmentSeeISO9001:19944.11.2b(比對標準/設備之維護及管制)Verificationthatpersonnelmakingappearanceevaluationsarequalifiedtodoso(執行外觀比對人員之資格証明),-另外，出現在條文8.2.4這個字“theacceptancecriteria”也表示valueswithtolerancesorminimum/maximumvaluesmustbespecified(公差或最大/最小值必須訂清楚)(CommonAR:檢驗用之尺寸圖面沒有訂公差,Max.值或Min.值).-Assessor對於前述之檢驗報告沒有記上實測值，只show“checkedOK”之情況，最好investigatefurtherbywitnessingteststovalidaterecords(親自抽樣請工廠之inspector表演他是如何進行檢驗，用以驗證他填上“checkedOK”之有效性)。,-當然，記錄實測值之目的大部分是為了執行製程/產品能力分析當客戶退貨時，必須執行Root-CauseAnalysis和CAprocess!ISO/TS1694:Theorganizationshallinitiateareactionplanfromthecontrolplanforcharacteristicsthatareeitherunstableornon-capable.Thesereactionplansshallincludecontainmentofproductand100%inspectionasappropriate.Acorrectiveactionplanshallthenbecompletedbytheorganization,indicatingspecifictimingandassignedresponsibilitiestoassurethattheprocessbecomesstableandcapable.Theplansshallbereviewedwithandapprovedbythecustomerwhensorequired.,ISO/TS1694Rejectedproducttest/analysisTheorganizationshallanalysepartsrejectedbythecustomersmanufacturingplants,engineeringfacilitiesanddealerships.Theorganizationshallminimizethecycletimeofthisprocess.Recordsoftheseanalysesshallbekeptandmadeavailableuponrequest.Theorganizationshallperformanalysisand,initiatecorrectiveactiontopreventrecurrence.NOTECycletimerelatedtorejectedproductanalysisshouldbeconsistentwithdeterminationofrootcause,correctiveactionandmonitoringtheeffectivenessofimplementation.,e.g.2):有時客戶報怨是客戶找碴或錯不在工廠，雖然Rule#1:Customerisalwaysright.Rule#2:Ifcustomeriswrong,gotorule#1。但是碰到“澳洲來的客戶”客怎麼辦呢？注意:此處所指之nonconformities包含nonconformingincomingmaterials/parts(進料不良)，所以不能只用8.3Controlofnonconformingproduct來處理進料不良(例如只做退貨處理)。甚至也要考慮QS-9000/TS16949:2002所規定的“Productwithunidentifiedorsuspectstatusshallbeclassifiedasnonconformingproduct(檢驗狀態不明或處於懷疑狀態之產品均需視同不良品)”(e.g.逾期品，前一次校驗合格距離本次校驗NG之gage所量測過之產品)。,-b)determiningthecausesofnonconformities,-c)evaluatingthe“needforaction”toensurethatnonconformitiesdonotrecur,說明:觀念同前述對“CAsshallbeappropriatetotheeffectsofthenonconformitiesencountered”之說明。-d)determiningandimplementing“actionneeded”,-e)recordsoftheresultsofactiontaken,e.g.Root-CauseAnalysis:RootCauseAnalysisisalogical,systematicapproachtoidentifyingthebasicreasons(causes,mechanisms,etc.)foraproblem,failure,non-conformance,processerror,etc.Wheneverasignificantproblemoccurs(i.e.lowfrequencyofoccurrencewithhighcostintimeand/ormoney,orhighfrequencyofoccurrence),RootCauseAnalysisshouldbeimplemented.,TheresultofRootCauseAnalysisshouldalwaysbetheidentificationofthebasicmechanismbywhichtheproblemoccursandarecommendationforcorrectiveaction.“Nocorrectiveactionrequired”isanacceptablerecommendationforcorrectiveactionwhenproperlyjustified.RootCauseAnalysiscannotbeclosedoutuntilallrequiredcorrectiveactionhasbeendevelopedandimplemented.WhenRootCauseAnalysisisperformed,alloftheinvestigation,analysis,andresults(includingcorrectiveaction)mustbecompletelydocumented.,-(新)todefinerequirementsfor(f)reviewingCAtaken:含CA之效果確認之意。ISO/IEC170254.10.2(Root-)CauseanalysisTheprocedureforcorrectiveactionshallstartwithaninvestigationtodeterminetherootcause(s)oftheproblem.Note:(Root-)Causeanalysisisthekeyandsometimesthemostdifficultpartinthecorrectiveactionprocedure.Oftentherootcauseisnotobviousandthusacarefulanalysisofallpotentialcausesoftheproblemisrequired.Potentialcausescouldincludeclientrequirements,thesamples,samplespecifications,methodsandprocedures,staffskillsandtraining,consumables,orequipmentanditscalibration.,PaynterChart-ThePaynterChartisusedtodemonstratetheeffectivenessofcorrectiveactions.IthasthesamecategoriesastheParetoChartandidentifieswhenchangeshavebeenmade.Insomesituations,problemsmaybeconnected.Therefore,thecorrectiveactionappliedtoaproblemontheParetoChartmayhaveaninfluenceonothersub-problems.Thecorrectiveactionmayeitherimproveanotherproblemorhaveanegativeeffect.ThePaynterChartprovidesameansofevaluation,notonlytheproblemthatwastheprimaryfocusforProblem-Solving,butalsoothersthatmightbeaffected.,ThePaynterChartAbstractThePaynterchartissimilartoaParetoChartexceptthateachParetobarissplitupintosubgroups.Thisenablesyoutolookatwhatsubgroupsaregoingintothemakeupoftheparetobarandyoucanuseittospottrendsortroublespots.Keywords:Paynter,gpaynter,paretoProduct:Statit,4.35.2ThePaynterChartisatoolthatgoesbeyondaPareto.AParetoshowstheproblemswiththemostfrequency.APaynterChartshowstheParetoinformationbutbreakstheParetoBarsintosubgroups.TheSubgroupscouldbedays,hoursorsubgroupsfromapchart.TheexamplesbelowillustratethePaynterChart.,ThisPaynterwasrunbyrestrictingthenumberofgroupsto5andthenumberofsubgroupsto4.Inthiscaseittookthelast4subgroupstoplot.,ISO/IEC170254.10.3SelectionandimplementationofcorrectiveactionsWherecorrectiveactionisneeded,thelaboratoryshallidentifypotentialcorrectiveactions.Itshallselectandimplementtheaction(s)mostlikelytoeliminatetheproblemandtopreventrecurrence(i.e.最佳解決方案)。CommonAR:CA/PAcasewasprematurelyclosed，例如對策:加強檢驗或訓練。效果確認:yes/結案。-QS-9000:ProblemSolvingMethodsASuppliershallusedisciplinedproblemsolvingmethodswhenaninternalorexternalnonconformancetospecificationorrequirementoccurs.,Whenexternalnonconformanceoccur,thesuppliershallrespondinamannerprescribedbythecustomer.Refertothecustomerdocuments.e.g.DC-7D,Ford-G8D(Global8DAnalysis),GM-ProblemReportinginshort,SICCode3674(SemiconductorsForattributedata,C.I.指”縮緊規格”之後之C.I.,PPAP要求Cpk1.67,但是當Cp3時,QS-90004.9.2Whenprocess/productdataindicateahighdegreeofcapability(e.g.Cp3),thesuppliermayrevisetheControlPlan,asappropriatebyreducinginspection/sampling(cost)也是C.I.4.9.3ModifiedProcessControlRequirements:Insomecases,thecustomermayrequireeitherhigherorlowercapabilityorperformance(see4.9.2)requirements.Inthesecases,theControlPlanshallbeannotatedaccordingly(i.e.,intheProduct/Processspecification/TolerancecolumnofthesuggestedAPQPControlPlan)。此情況該如何C.I.呢?答:以當初和客戶PPAP核准之Capability/良率為準,從事提昇Capability/良率所做之effortsC.I.,WhyC.I.?其中一個原因是fieldfailure較少，或田口的LossFunctionMentality中的Losstocustomerand/orsociety較小(e.g.美國製和日本製汽車傳動軸之故事)另，QS-9000SPCManualSec.6:.forsomeprocesses,thecustomerwillbesensitiveeventovariationwithinengineeringspecifications.Intheseinstances,thevalueofC.I.willnotberealizeduntilvariationisreduced.此時可能要用到DOE及更高階之管制圖.。但這些觀念並不表示所有不同之processes都要如此之C.I.例如近幾年來日本工業界已開始認真思考:日本製之品質是否好過頭了？用都用不壞？！最明顯的例子是一部電視機壞了，裡面的許多日本製的電子零件還好的很！(換言之，應該要的是適當品質，而不是好過頭的品質吧！),QS-9000之C.I.之intent是“好,還要更好!”(good-better-best):對象:Q.C.D.;但也不能忽略innovativeimprovement優先對象:SpecialCharacteristics(管制特性)keyindicators含costelementsorprice(e.g.4.1.5之”失敗成本”,4.9.2當長時間Cpk3時,工廠mayrevisetheControlPlan)當前述之SpecialChar.為variabledata(計量值)時,C.I.means“optimizing(更佳化)thecharacteristicsandparametersatatargetvalueandreducingvariationaroundthatvalue”。當前述之SpecialChar.為attributedata(計數值)時,C.I.isnotpossibleuntilcharacteristicsareconforming.(Ifattributedataresultsdonotequalzerodefects屬於NCP/C.A.,非C.I.),8.2.1CustomerSatisfaction(顧客滿意)absenceofthemdoesnotimplyhighcustomersatisfaction(亦即Nonews不一定是goodnews,也許客戶正在物色別家supplier來把你幹掉!),光靠顧客報怨和退貨(customercomplaintscustomerrelationshipmanagement)工作。簡單的說就是企業為了滿足顧客的需要,運用,資料庫管理的技術,研究顧客的購買行為與習慣,採取一對一的行銷方式,在最適當的時間,透過最適當的管道,以最適當的價格,提供最適當的產品或服務;換言之,只要能夠把偶然交易的顧客變成長期忠誠的顧客所做的一切努力和活動均包括在內。CRM不僅讓企業能夠降低成本,推出更有價值的商品或服務,以及更有效的行銷活動。更重要的,CRM能夠讓企業快速的抓住市場的變化,滿足顧客的需求,獲得持續領先的競爭優勢,如果結合BSC之使用，因CRM而top-down下來的願景(Vision)策略(Strategy)目標(Objectives)量度(Measures)伸張指標(StretchTargets)行動方案(Initiatives)策略規劃/管理會更知行合一)。,(3).了解顧客:最了解商品與服務的專家並非企業內部的員工，而是顧客，唯有以他們的觀點去了解他們的世界，才能與顧客們建立長久的夥伴關係。(4).在管理上，先追求滿意的員工，再同時追求顧客的滿意，以達到股東滿意與社會滿意之全方位經營策略境界。亦即，ISO/TS16949:200之規定如下:,Employeemotivationandempowerment(員工激勵與授/賦權)Theorganizationshallhaveaprocesstomotivateemployeestoachievequalityobjectives,tomakecontinualimprovements,andtocreateanenvironmenttopromoteinnovation.Theprocessshallincludethepromotionofqualityandtechnologicalawarenessthroughoutthewholeorganization.(組織必須有一流程來激勵員工,以達成品質目標,進行持續改善,以及建立一個能鼓勵創新之環境。此流程需包括將品質及科技意識推廣至整個組織內。),Theorganizationshallhaveaprocesstomeasuretheextenttowhichitspersonnelareawareoftherelevanceandimportanceofth