QS introduction glenn.ppt

QualitySystemIntroduction,GlennLiu12/18/02,Topic,QualitySystemIntroductionISO9000IntroductionQualityAuditBriefContinualImprovement,WhatisQuality?,Qualityis:CustomersatisfactionReliabilityQualityisoneofthemostimportantelementtoacompany.,QualitySystemIntroduction,IncomingQA,ProcessQA,OutgoingQA,QualitySystemAssurance,DocumentControl,SupplierQA,QualitySystemIntroduction,RoleandresponsibilityofIQAIncomingmaterialinspection,samplingplanimplementation;Firstarticleinspection;MRBmanagementandresponsibility;Scoretosupplier.,QualitySystemIntroduction,RoleandresponsibilityofSQASuppliercommunicationandqualityaudit;RTVandSCARmanagement;Supplierpurgeandselection;Scoretosupplier,partofcontinualimprovement.,QualitySystemIntroduction,RoleandresponsibilityofPQAProcessqualityassurance;CFTinvolvement;Processaudit,firstarticleaudit;purgeandstopline;CARandCCARcoordinator;Processperformanceimprovement.,QualitySystemIntroduction,RoleandresponsibilityofOQAFinalinspectionandoutgoingqualityassurance;Communicationandperiodicallyqualityreviewwithcustomer,customerproductaudit;CFTinvolvement;PQPmaker;CCARresponsor;Productcontinualimprovement.,QualitySystemIntroduction,RoleandresponsibilityofQSAQualitysystemmaintenanceandsustain;Qualitysystemcertification;Qualitymanualinitialization;Proceduresmanagement;CustomerqualitysystemauditDCC.,QualitySystemIntroduction,RoleandresponsibilityofDCCDocumentcontrol;ECOcontrol;Qualityrecordkeep;customerdocumentcontrol.,QualityConceptBrief(I),QualityisforEVERYONE;Totalqualitymanagement;PreventbeforeDetect;ZeroDefect;Competitionandimprovement.,QualityConceptBrief(II),SomekeywordsofqualityReasonable;StandardizeSystematical;Records;CapabilityandStability;ContinualImprovement.,QualityConceptBrief(III),PDCACyclePlan,do,check,action.4M1EManpower,machine,material,methodandEnvironment.4W1HWho,when,where,what,andhow.,QAndA,ISO9000Introduction,GlennLiu12/27/02,WhatsISO9000,DoWhatYouSaySayWhatYouDoIdentifywhatyoudoandRecordit,WhatsISO9000,ISOstandforInternationalOrganizationforStandardization;ISO9000isastandardofqualitymanagementsystemISO9000:1994v.s.ISO9000:2000.,4CoreStandards,ISO9000:Qualitymanagementsystem-FundamentalsandvocabularyISO9001:Qualitymanagementsystems-RequirementsISO9004:Qualitymanagementsystems-GuidelinesforperformanceISO19011:Guidelinesforauditingmanagementsystem,ISO9001:2000OverallStructure,0Introduction1Scope2Normativereference3Termsanddefinitions4Qualitymanagementsystem5Managementresponsibility6Resourcemanagement7Productrealization8Measurement,analysisandimprovement,8QualityManagementPrinciples,CustomerfocusLeadershipInvolvementofpeopleProcessapproachSystemapproachtomanagementContinualimprovementFactualapproachtodecisionmakingMutuallybeneficialsupplierrelationships,0Introduction,ProcessApproachunderstandingandmeetingrequirements,theneedtoconsiderprocessesintermofaddedvalue,obtainingresultsofprocessperformanceandeffectiveness,continualimprovementofprocessesbasedonobjectivemeasurement.,ContinualimprovementofQMS,CustomerSatisfaction,CustomerRequirement,Managementresponsibility,Resourcemanagement,ProductRealization,Measurement,analysisandimprovement,Product,Modelofprocess-basedQMS,Value-addingactivities,Informationflow,Input,Output,4QualityManagementSystem,4.2.4Controlofrecords,Recordshallremainlegible,readilyidentificationandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords.,5ManagementResponsibility,ManagementcommitmentCustomerfocusQualitypolicyPlanningResponsibility,AuthorityandcommunicationManagementreview.,6ResourceManagement,ProvisionofresourcesHumanresourcesInfrastructureWorkenvironment,6.2.2Competence,awarenessandtraining,DeterminethenecessarycompetenceforpersonnelperformingworkaffectingproductqualityProvidetrainingortakeotheractionstosatisfytheseneedsEvaluatetheeffectivenessoftheactionstakenEnsurethatitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectivesMaintainappropriaterecordsofeducation,training,skillandexperience,7Productrealization,PlanningofproductrealizationCustomer-relatedprocessesDesignanddevelopmentPurchasingProductionandserviceprovisionControlofmonitoringandmeasuringdevices,7.1Planningofproductrealization,qualityobjectivesandrequirementsfortheproducttheneedtoestablishprocesses,documents,andprovideresourcesspecifictotheproductrequirementverification,validation,monitoringinspectionandtestactivitiesspecifictotheproductandcriteriaforproductacceptancerecordsneededtoprovideevidencethattherealizationprocessesandresultingproductmeetrequirements,7.2Customer-relatedprocesses,determinationofrequirementsrelatedtotheproductreviewofrequirementsrelatedtotheproductcustomercommunication,7.3Designanddevelopment,designanddevelopmentplanningdesignanddevelopmentinputsdesignanddevelopmentoutputsdesignanddevelopmentreviewdesignanddevelopmentverificationdesignanddevelopmentvalidationcontrolofdesignanddevelopmentchanges,7.3.1Designanddevelopmentplanning,Thedesignanddevelopmentstages,thereview,verificationandvalidationthatareappropriatetoeachdesignanddevelopmentstage,theresponsibilityandauthoritiesfordesignanddevelopment.Planningoutputshallbeupdated,asappropriate,asthedesignanddevelopmentprogresses,7.3.3Designanddevelopmentoutputs,Meettheinputrequirementsfordesignanddevelopment;provideappropriateinformationforpurchasing,productionandforserviceprovision;containorreferenceproductacceptancecriteria;specifythecharacteristicsoftheproductthatareessentialforitssafeandproperuse.,7.3.4Designanddevelopmentreview,Toevaluatetheabilityoftheresultsofdesignanddevelopmenttomeetrequirementstoidentifyanyproblemsandproposenecessaryactions,7.3.7Controlofdesignanddevelopmentchanges,Designanddevelopmentchangesshallbeidentifiedandrecordsmaintained.Thechangesshallbereviewed,verifiedandvalidated,asappropriate,andapprovedbeforeimplementation.Thereviewofdesignanddevelopmentchangesshallincludeevaluationoftheeffectofthechangesonconstituentpartsandproductalreadydelivered.,7.4Purchasing,Purchasingprocesspurchasinginformationverificationofpurchasedproduct,7.5Productionandserviceprovision,Controlofproductionandserviceprovisionvalidationofprocessesforproductionandserviceprovisionidentificationandtrace-abilitycustomerpropertypreservationofproduct,7.5.3Identificationandtraceability,Whereappropriate,theorganizationshallidentifytheproductbysuitablemeansthroughoutproductrealization.Theorganizationshallidentifytheproductstatuswithrespecttomonitoringandmeasurementrequirements.Wheretraceabilityisarequirement,theorganizationshallcontrolandrecordtheuniqueidentificationoftheproduct.,7.5.5Preservationofproduct,Theorganizationshallpreservetheconformityofproductduringinternalprocessinganddeliverytotheintendeddestination.Thispreservationshallincludeidentification,handling,packaging,storageandprotection.Preservationshallalsoapplytotheconstituentpartsofaproduct.,8Measurement,analysisandimprovement,GeneralmonitoringandmeasurementControlofnonconformingproductAnalysisofdataImprovement,8.2Monitoringandmeasurement,Customersatisfactioninternalauditmonitoringandmeasurementofprocessmonitoringandmeasurementofproduct,8.3Controlofnonconformingproduct,Theorganizationshalldealwithnonconformingproductbyoneormoreofthefollowingways:bytakingactiontoeliminatethedetectednonconformity;byauthorizingitsuse,releaseoracceptanceunderconcessionbyarelevantauthorityand,whereapplicable,bythecustomer;bytakingactiontoprecludeitsoriginalintendeduseorapplication,8.5Improvement,Continualimprovement;Correctiveaction;Preventiveaction,8.5.1Continualimprovement,Theorganizationshallcontinuallyimprovetheeffectivenessofthequalitymanagementsystemthroughtheuseofthequalitypolicy,qualityobjectives,auditresults,analysisofdata,correctiveandpreventiveactionsandmanagementreview.,8.5.2Correctiveaction,Adocumentedprocedureshallbeestablishedtodefinerequirementsforreviewingnonconformities(includingcustomercomplaints)determiningthecausesofnonconformitiesevaluatingtheneedforactiontoensurethatnonconfomitiesdonotrecurdeterminingandimplementingactionneededrecordsoftheresultsofactiontakenreviewcorrectiveactiontaken,8.5.3Preventiveaction,Adocumentedprocedureshallbeestablishedtodefinerequirementsfordeterminingpotentialofnonconformitiesandtheircausesevaluatingtheneedforactiontopreventoccurrenceofnonconfomitiesdeterminingandimplementingactionneededrecordsoftheresultsofactiontakenreviewpreventiveactiontaken,Thanks,QualityAuditbrief,GlennLiu2/29/2003,Whatstheauditorsinterested(I),QualitymanagementsystemQualityresolutionsDocumentation&recordsNon-conformingdetectiveandcorrectiveactionsappliedContinualimprovementapplicationCustomersatisfaction,Whatstheauditorsinterested(II),SystematicReasonableConsistenceClearResponsibleFullyactivity,Whatshallwedo?,ShowthemrealitiesShowthemresponsibilityShowthemthewholeprocesswefollowedDonottrytohidenon-conformitiesDonottalkstorytoauditorsDonotlie.,Facetofacewithauditor(I),BepoliteBeseriousBeeasygoingBeself-confidence,Facetofacewithauditor(II),JustsaywhatheaskedyouJustsaywhatyouareresp