国际型供应商管理.ppt

gehealthcaresupplierpartqualityplanssuppliertraining supplierpartqualityplanrequirementsrefdocdoc0519115 trainingobjectives understandtherequirementsofsupplierpartqualityplansunderstandtheindividualelementsofsupplierpartqualityplandefinetheresponsibilitiesofsupplierstogehealthcaredefinetheresponsibilitiesofgehealthcareunderstandthesuppliersubmissionrequirementsunderstandthesupplier sresponsibilitiesforthestorageandarchivaloftheplans assistsupplierstogehealthcare supplierpartqualityplans trainingsections supplierpartqualityplans introduction elementsplandocumentationresponsibilities supplierstogehealthcare gehealthcare whatisasupplierpartqualityplan thesupplierpartqualityplanis theprocessbywhichasuppliertogehealthcaredemonstratesthattheycanproduceparts sub assembliesorhigh levelassembliesthatmeetallgehealthcarerequirements demonstratingsupplierreadinesstomanufactureproductionorservicepartsusingproductionmachineryandtoolingatrequiredgehealthcarequalitylevels partofinitialpartqualificationactivity introduction whydoweneedsupplierpartqualityplans supplierpartqualityplansensure initialandongoingproductionpartqualitysupplierunderstandingofgehcrequirementsabilitytoachieveacceptablesupplierqualitylevelsappropriatetestcoverageanddatacorrelationtoproductspecificationsmanufacturingissuesdiscovered trackedandclosedpriortopartrelease evaluationandverificationoftestandmeasurementsystemspriortoproductionsystemsinplacetodetectorpreventpotentialfailures defects supplierpartqualityplans theindividualelementsofsupplierarebaseduponandreferenceindustrystandardssuchas productionpartapprovalprocess ppap industrystandard ppap referencedocuments aiag productionpartapprovalprocess ppap fourtheditionmarch2006orlater aiag potentialfailuremodeandeffectsanalysis fmea referencemanualrevision4orlater aiag measurementsystemsanalysis msa thirdeditionmarch2002orlater aiag advancedproductqualityandcontrolplan apqp secondeditionjuly2008orlater aiag statisticalprocesscontrol spc secondedition july2005orlater websitereference www aiag org orderofrequirementsprecedence 1 gehcdrawings documentation2 gehcstandards workinstructions3 industrystandards whichgehcpartsorassembliesrequireasupplierpartqualityplan partsandassemblieswillbeclassifiedduring newproductintroductionprograms suppliertransferssomeengineeringchangeactivity supplierpartqualityplanswillberequiredforallgehealthcareclassifiedparts supplierpartqualityplansdonotapplytogehcproductsoftware theminimumrequirementsofeachsupplierpartqualityplanwilldifferbasedonthegehcdefinedclassifications atthediscretionofgehcsupplierquality additionalelementsmayberequired baseduponpartcomplexity supplierqualityhistory newprocessrequirements etc whataretherequirementsofasupplierpartqualityplan gehcsupplierqualitywillforwardtheformallistoftherequiredelementstothesupplierforeachpartorassemblyusingthegehealthcarestandardform supplierpartqualityplanrequirementsform doc0527619 refertothepartqualityplan supplierrequirementsandresponsibilities doc0519115 foradetailedexplanation examples andinstructionsforallofthesupplierpartqualityplanelements thesupplierpartqualityplanelementsare designandrequirementsreviewprocessflowdiagramprocessfailuremodesandeffectsanalysis pfmea processcontrolplangagerepeatabilityandreproducibility gager r firstarticleinspectionprocesscapabilitystudypackagingplanpartsubmissionwarrant elements therequirementforany upongehealthcarerequest elements shallbedeterminedbysupplierquality supplierpartqualityplanelements tableno 1 supplierpartqualityplan gehealthcarewillprovidealistofwhichelementswillberequiredforeachclassifiedpartnumber example supplierpartqualityplanrequirementsform suppliersubmissionoverview thesuppliershallsubmiteachrequiredelementtogehcforreviewandapproval inmostcases standardgehctemplatesforeachelementwillbeused thesuppliermayusesomeoftheirowntemplateswithgehcapproval whenasupplierhascompletedasupplierpartqualityplan thesuppliermustsubmitasignedpartsubmissionwarrantform psw affirmingthatallgehcplanrequirementshavebeenmet whatarethesupplierrequirementsofasupplierpartqualityplan note referencethecurrentrevisionofthesupplierpartqualityplanrequirements doc0519115 forcompleteanddetailedexamplesofthesupplierpartqualityplan thisdocumentreferencesofallformsandtemplateswithexamplesofhoweachofthetemplatesaretobefilledout completed availableforsuppliersongehcsuppliermarketplace smp orbyrequestofyourassignedgehcsupplierqualityengineer supplierpartqualityplan elements individualelementoverview thefollowingsectionoffersabriefdescriptionofalloftheindividualelementsofasupplierpartqualityplan designandrequirementsreview thedesignandrequirementsreviewisacrossfunctional formalmeetingheldearlyinthedesignprocess whichisconductedbetweengehealthcareandthesuppliertopromoteclarityandunderstandingofthepartorassemblyrequirements itisalsotheforumforthesuppliertoofferrecommendationsofchangestoimproveprocess manufacturability orquality providesa two way mechanismtoensuresuppliershaveanadequateunderstandingofgehcrequirementsandallowssupplierstoprovidetheirsuggestionsandconcernspriortoproduction crossfunctionalreviewofthedesignintentandtechnicalrequirementsofthepartreviewofdrawings requirementsandapplicablespecificationspartmarkingandlabelingrequirementsdiscussionofspecialdesignrequirementssuppliersuggestionsonhowtoimprovequalityandefficiencyreviewofpackagingqualificationandrequirementsdiscussionofsuppliermanufacturingcapabilities designandrequirementsreview typicalcontent thesuppliershallcapturealloftheitemsdiscussedandimplementactionsandtimelinestoaddressandclosethoseitems gehcisresponsibletomakeagreedupondesignupdatestoimprovequalityormanufacturabilitywithinanagreedupontimeframe processflowdiagram aprocessflowdiagrammapsthesupplier sentireprocessrequiredtoproducethegehcpartorassembly typicalprocessflowdiagram thesuppliershalldetailalloftheessentialmanufacturing inspection andteststepsrequiredtomanufacturethegehcpartorassembly fromincomingreceivinginspectiononthroughpackagingandfinalshipping processfailuremodesandeffectsanalysis pfmea pfmeaisaprocesstoidentifyandevaluatethepotentialfailuresandeffectsofthesupplier smanufacturingprocess inaddition theanalysisidentifiesactionsthatwilleliminateorreducetheprobabilityofthatfailureoccurring thesupplierwillinitiatethisanalysisduringthepre productionphase priortotoolingforproduction theanalysisshouldaccountforallprimaryandsecondarymanufacturingoperations forthetop20 oftherisksidentified asdefinedbytheriskprioritynumber rpn numberofseverity thesuppliershallcreateanactionplantoaddresseachriskorwrittenrationaleastowhyactionswerenottaken processcontrolplan aprocesscontrolplanprovidesadocumenteddescriptionofthemethodsusedtominimizeprocessandproductvariation theprocesscontrolplanestablishescontrolsforgehealthcaredefinedcriticaltoquality ctq features thesefeatureswillbeidentifiedwithinthepartdocumentation drawings testspecs purchasespecificationsetc aspartoftheprocesscontrolplan thesuppliershallidentifytheoverallprocesscontrolstobeputinplacetocontrolthehigherriskprocessstepsasidentifiedintheprocessfailuremodesandeffectsanalysis gagerepeatabilityandreproducibility gager r thegager relementwherethesupplierdemonstratestherepeatabilityandreproducibilityoftherequiredpartmeasurementsystem s byestablishingprecisionandaccuracyoftheprocess why evaluatescapabilityofameasurementsystemtoaccuratelyassessifameasurementdevicemeetscertainrequirements specificationsestablishesconfidenceininitialproductionmeasurementsprovidesalevelofconfidenceintrustingreportedmeasurementvaluesreducingbothsupplierandgehealthcarepartorassemblyrisksensuresanalysisperformedongehealthcarectqs firstarticleinspection afirstarticleinspection fai isacompleteinspectionperformedbythesupplierofagivenpartorassemblytoevaluateconformancetothedocumentedspecifications inadditiontophysicalfeaturesinspected completionofspecifiedtests andresults labeling packagingqualificationrequirementssuchastemperature vibration anddroptesting arealsoinspectedandverified thequantityofpartstobeinspectedwillbedeterminedbygehealthcare typically5pieces featureidentifiedonthedrawingcorrelatestotheinspectionitemnumber forallfais thesuppliershallproduceamarked up bubble printoftheassemblydrawingorpurchasespecisrequired tyingallimportantfeaturestoaninspectionitemnumberinthefaitemplate processcapabilitystudy theprocesscapabilityelementisthestudyofthesupplier smanufacturingprocess withindefinedlimits wherethesupplierdemonstratestheirabilitytomeetgehealthcarerequirements providesaninitialdemonstrationofsupplier sabilitytoconsistentlymeetspecifiedrequirements capabilityisusedasabasisforanindicationofhowtheprocesswillperform usingstatisticaldatagatheredfromproductionpartsmanufacturedbytheproductionprocess expressedasaprocesscapabilityindex i e cpk firststeptowardprocesscontrolviastatisticalmethodology astatisticallysignificantsamplesizeisrequiredforprocesscapabilitystudy gehealthcareandthesupplierwilljointlydeterminethequantityrequired typicallya30pieceminimum processcapabilitystudy exampleofacapabilityanalysisgraph processcapabilityindex packagingplan thepackagingplanisadocumentedplanwherethesupplierdemonstratesthattheycansuccessfullypackandshipthegehcpartorassembly withoutanydamageorcontamination toitsrequired globallocation picturesordrawingsofproposedpackagingandlabelsa picklist ofdefinedpackagingitems forexample packingfoam staticbag desiccant etc proofofsuccessfulcompletionofrequiredpackagetestingproperlabelingrequirementsofthecontainerdefinedfru fieldreplaceableunit vsline usepackagingrequirementsmet typicalcontentofacompletepackagingplan note thepartorassemblypackagingmustmeettherequirementsofthegehealthcareglobalpackagingrequirementsspec 2100268pre partsubmissionwarrant apartsubmissionwarrant psw isthesupplier saffirmationthatthepartorassemblysamplessuppliedtogehealthcare weremadebyaprocessthatmeetsallsupplierpartqualityplanrequirements thesupplierwillsubmitasignedpartsubmissionwarrantformcertifyingallrequiredelementshavebeencompleted oncereviewedandapprovedbygehealthcaresupplierquality designengineering thesqewillsendthepswbacktothesupplierwithgehealthcareapprovalsignaturesadded onceasupplierpartqualityplanhasbeencompletedbythesupplier conditionalpartsubmissionwarrant aconditionalpartsubmissionwarrantmaybesubmittedtogehc whereadditionaldatamayberequiredforcompletion thisrequirespriorapprovalfromgesupplierquality mustbeclearlydefinedinthe declaration sectionofthepartsubmissionwarranttemplate astricttimelineforclosuremustbedefined forexample additionalproductionpartsmustbemanufacturedtoobtaintherequirednumberofpiecestocompletetheoverallprocesscapabilitystudy anupdatedpswisrequiredtoclosetheconditions howaresupplierpartqualityplansarchived supplierpartqualityplans introduction elementsplandocumentationresponsibilities supplierstogehealthcare gehealthcare howaresupplierpartqualityplansarchived thesupplierisrequiredtoretainallelementsofthesupplierpartqualityplan pergehcpmqr andmaketheelementsavailabletogehealthcareuponrequest documentationresponsibilities gehealthcareresponsibility pergehc gqp 11 01 003 purchasedmaterialqualityrequirements therecordsrequiredshallberetaineduntilgehealthcarenotifiesthesupplierthattheproductlifehasendedorforaminimumoffifteen 15 years whicheverislonger unlesstherequiredrecordsaresubmittedtogehealthcarebywrittenagreementorpurchasespecification gehealthcarewillarchiveacopyoftheapprovedandmutuallysignedpartsubmissionwarrantasarecordofthecompletionofthesupplierpartqualityplan supplierresponsibility partqualityplanupdates gehealthcaremayrequireongoingsupplierqualitypartplanupdates arequestforanupdatemaybebaseduponachangeinsupplier sperformance significantincreaseindemandquantities ageoftooling etc ifanupdateisrequired thesupplierqualityengineershallsubmitanupdatedsupplierpartqualityplanrequiredelementformtothesupplier allexecution submission andapprovalresponsibilitiesoftheplanshallremainthesameasaninitialpartqualityplansubmission inaddition supplierpartqualityplanupdatesmayberequiredaspartoftheecr eco engineeringchange process asabove gehealthcareshallprovideasupplierpartqualityplanelementrequirementsformtothesupplier summary supplierpartqualityplansarerequiredforallitemscategorizedasessentialtosafety essentialtofunction orminorbygehc elementrequirementswillvarybypartclassification whilecertainelementsaremandatory additionalelementsmayberequiredasdefinedbygehcsupplierquality itisthesupplier sresponsibilitytoperformandsubmitalloftherequiredelements thesupplierwillprovideasignedpartsubmissionwarranttogehctoaffirmtheyhavecompletedallthesupplierpartqualityplanrequirements itisgehealthcare sresponsibilitytoreviewandapprovethesubmission thesupplierisresponsibletoretainandarchiveallelementrecords thegehcsupplierqualityengineerisresponsibletoarchivethemutuallysignedpartsubmissionwarrant thankyou fromtheg