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1、VendorFactoryEvaluation(VFE)Copyright2011Target of14FactoryNameFactoryBPMIDBusinessArea0Instructions:TheVendorevaluatormustfillinallMandatorysections(notedingreenhighlight)andallalicableProductionSectorsections(notedinyellowhighlight)onthistab.oIfthefactorymeetstherequirement,orhasthedocumentationor
2、processrequestedanswerYESoIfthefactoryDOESNOTmeettherequirement,orhavethedocumentationorprocessrequestedanswerNOoIfaquestioninasectionofthefactoryevaluationisnotapplicableperinstructionintheResourceDocumentContentcolumnwithintheVFEtabanswerN/A.asedonyouranswertheformwillautomaticallycalculateyoursco
3、reatthetopandbottomofthedocument.WhenyoufirststarttheVendorFactoryEvaluation,thescoreissetto0andwilladjustonceyoustartansweringquestions.EachautofailquestioniswritteninRED.Eachsection/areaofautofailquestionswillbecalculatednexttothescoringsectiononthetopofthedocument.OnceyouhaveverifiedthatALLsectio
4、nsandquestionshavebeenfilledoutwithananswerofYES,NO,orN/Areviewyourscoreatthetopoftheform.MandatorySectionsPossibleAwardedProductionSectorSections1616DOCUMENTCONTROL152823SUPPLIERMANAGEMENT826516PRODUCTIONTESTPLAN231724CORRECTIVEACTION/REMEDIALACTIONPLANS14142522EQUIPMENT&EQUIPMENTMAINTENANCESOCIALC
5、OMPLIANCE1414WORKMANSHIPAUDIT(INITIALFACTORYONLY)262190#ofAutoFailsFURNITUREELECTRICALMATERIALSSPREADINGANDCUTTINGCOLOREVALUATIONPRESSINGFOOTWEARPossibleAwarded00000011544001313221061717882222008777SCORE76.50%GRADEYellow-ProceedwithCautionQREF#QuestionCategoryQuestionResourceGuide5001DocumentControl
6、Isthereaprocedureinplacethatdefineshowdocumentationiscontrolled?Thefactorymusthaveatleastonewrittenprocedurethatdescribestheprocessandactivitiestheyperformtoassuredocumentationiscontrolled.Thesecontrolsmayinclude,butnotlimitedtorevisioncontrol,authorizing&approving,controlofobsoletedocuments,retenti
7、onperiods,wheredocumentsarelocated,etc.5002DocumentControlIsthereaMasterListofcontrolleddocuments?Thedocumentcontrolsystemistoprovideameansofknowingwhatdocumentsthefactoryhasandtheirlatestrevisionlevel.Thefactorymusthaveamasterlistorsomeothermeansofcontrollingtheirdocumentation.5003DocumentControlAr
8、edocumentsinusethecurrentversionandaretheyauthorizedanddated?Duringthedocumentreview(Examples:QAprocedures,Productionworkinstructions,SOPs,etc.)andduringthefactoryfloorwalkthru,selectoridentifyasamplingofdocumentsandthencomparetheirrevisionlevelwiththemasterlistorwhatevermeansthefactoryisusingtotrac
9、ktheirdocuments.Themajorityofthedocumentssampledaretohavethesamerevisionasindicatedbythedocumentcontrolsystemandtheyaretohaveevideneeofauthorizationsuchasasignatureandadateofissuanee.5004DocumentControlIsthereaprocedureinplacetoensureobsoletedocumentationisremovedfromuse?Reviewandensurethedocumentco
10、ntrolprocedureorproceduresincludeadescriptionoftheprocessthefactoryusestoremoveobsoletedocumentationfromuse.Lookforevideneethatitisbeingused.5005DocumentControlIsthedocumentationreadilyaccessiblebyallrelevantstaffatalltimes?Interviewandobservetoconfirmfactoryworkershavereasonableaccesstothedocuments
11、neededtodotheirjobs.5006DocumentControlIsthereawrittenprocedurethatdefineshowqualityrecordsarestored,protected,anddisposedofaswellasadefinedretentionperiod?Reviewdocumentedprocedureonhowthefactorymaintainsqualityrecords.TheProceduremustindicatetheretentionperiodisatminimum5yearsafterproductionhasend
12、ed.Recordreviewmustvalidaterecordshavebeenmaintainedforaminimumof5yearsafterproductionhasended;ormaintainedsincethecreationoftheDocumentRetentionProcedure.5007QualityManagementDoestheQA(QualityAssuranee)orQC(QualityControl)departmentoperateseparatelyfromtheProductiondepartment?ReviewanOrganizational
13、CharttoseewheretheQAorQCDepartmentreports.IftheyreporttoGeneralManager,President,etc.scoreaYES.IftheyreporttoanybodyintheProductionDepartment,scoreisaNO.Iforganizationalchartisnotavailable,interviewfactoryQA/QCleadership.5008QualityManagementDoesthequalitydepartmenthavecoverageduringallshifts?Review
14、randomdocumentationofshiftschedules.Ifshiftscheduleisnotavailable,interviewfactoryQA/QCleadership.Foreveryproductionshift,theremustbeQCcoverage.5009QualityManagementAremeasureablequalitygoalsidentifiedandactualperformaneeresultscollected?Reviewrandomdocumentationofqualitygoalsperformaneeresults.Docu
15、mentationmustincludegoalsandpassrateperproductcategory.Mustbeavailableandcomplete.5010QualityManagementAredocumented,ongoingQualityControl(QC)meetingsheldatthefactoryinwhichProductionisrepresented?Thefactorymusthave,ataminimum,weeklyQCmeetingstodiscussproductionissues,defectissues,etc.Documentationm
16、ustincludeproductionissuesandcorrectiveactiontaken.AproductionmanagerorsupervisoristoattendtheQCMeetings.Mustseeevideneeoftheaboveinthedocumentedmeetingnotes.5011QualityManagementDotheongoingQCmeetingsdemonstratemeasureable,continuousimprovement?Validatebyreviewingrecords,datacollection,andinterview
17、ingleadership.Verifythereismeasureablecontinuousimprovement.5012QualityManagementAredailyorweeklyqualitygoalsandactualperformaneeresultspostedonthefactoryfloor?Whilewalkingtheproductionfloor,lookforpostedqualitygoalsandperformaneeresults.5013SupplierManagementIsthereaninventorycontrolsystemwithincom
18、ing/outgoingmaterialsmonitoredanddocumented(location,quantity,etc)?Reviewdocumentationtoverifythatallincoming/outgoingmaterialsaremonitoredbyaninventorycontrolsystem.Verifylocation,materialtypeandquantitymatchesinventoryrecords.5014SupplierManagementDoesthefactoryhaveadocumentedsupplierapprovalproce
19、dure,includingalistofapprovedsuppliersforproducts,materialsandservicesimpactingproductsafety,legality,orquality?Reviewdocumentationtoensurethesitehas:-Adocumentedsupplierapprovalprocedure-Alistofapprovedsuppliersforproducts,materialsandservicesimpactingproductsafety,legalityorqualityNotApplicablewil
20、lapplyiffactorydoesnotmanufactureafinishedproduct.5015SupplierManagementDoesthesupplierapprovalprocedureincludeclearcriteriaforongoingassessmentandthestandardsofperformaneerequired?Proceduresshallbeestablishedwhichincludeclearcriteriaforongoingassessmentandthestandardsofperformaneerequired.Ongoingas
21、sessmentmaytaketheformofmonitoringperformaneethroughoneormoreofthefollowing:inhousechecks;certificatesofanalysis;certificateofconformity;supplieraudits;traceabilitychecks,etc.NotApplicablewillapplyiffactorydoesnotmanufactureafinishedproduct.5016SupplierManagementAresupplierapprovalrecordskept?Suppli
22、erapprovalrecordsmustberetainedforaminimumof5yearsafterproductionhasended.NotApplicablewillapplyiffactorydoesnotmanufactureafinishedproduct.5017SupplierManagementDoesthefactoryreviewtheperformaneeofsuppliersagainstadefinedcriteria?Thefactoryistohavedefinedcriteriaforreviewingsuppliers.Therearetobere
23、cordsofthesuppliersbeingreviewedagainstthiscriteria.NotApplicablewillapplyiffactorydoesnotmanufactureafinishedproduct.5018SupplierManagementDoesthefactoryhaveadocumentedprocesstomakesurethatincomingrawmaterialsand/orsub-assembliesconformtospecificationsandqualitystandards?Askforthedocumentedprocessa
24、ndrecords.DocumentationmustincludeStandardsamplesandspecifications.FactoryNameFactoryBPMIDBusinessArea05019SupplierManagementDoesthefactoryhaveadocumentedprocesstomakesurethatincomingrawmaterials,components,and/orsub-assembliesconformtoUSSafetyandRegulatoryrequirements?Verifythatthereisaprocessdocum
25、entedtoensureallincomingrawmaterials,componentsand/orsub-assembliesmeetUSSafety&Regulatoryrequirements.Painttestedforleadcontent,etc.5020SupplierManagementDoesthefactoryhavedocumentedprocessesforreviewingproductandpackagingmaterialinthelightbox,underthecurrentTargetrequiredlightsourcetoensureconsist
26、encyofcolor?Verifythataprocesstoreviewcolorcriticalmaterialisdocumented.Documentationmustexplainhowtoevaluatematerial,quantitytocheckandhowtousethelightbox.NotApplicablewillapplyiffactorydoesnotmanufactureafinishedproductortherearenocolorcriticalmaterials.5021SupplierManagementArematerialsstoredinac
27、ontrolledareatoavoidtheft,loss,damage,deterioration?Allrawmaterialmustbeinanareawithinthefactoryperimeter,inasecureareathathasaroofandisnotsubjectedtobadweather,waterontheground,etc.Rawmaterialsmustbeplacedonpalletsorstoredonshelving.5022ProductionControlDodocumentedPRODUCTIONflowdiagramsexistanddot
28、heyidentifyqualitycontrolpoints?Verifyproductionproceduredocumentationsupportsthefactoryproduction.MustbewrittenintheIanguagethatisunderstoodbyworkers.Mustbedividedperdepartment-processandoperation.Verifyqualitycontrolpointsshownondiagram.5023ProductionControlAretheredocumentedPRODUCTIONinstructions
29、presentateachproductionoperation?Whileontheproductionfloorlookforproductionproceduresforeachoperation/machinery.MustbewrittenintheIanguagethatisunderstoodbyworkers.5024ProductionControlAretheredocumentedINLINEINSPECTIONinstructionsateachinspectionoperation?Verifyinspectionprocedureissuitableforthepr
30、oduct,processanddepartment.MustbewrittenintheIanguagethatisunderstoodbyworkers.Whileonproductionfloor,validateinspectionproceduredocumentationateachinspectionarea.Thesemustbespecifictothatphaseofproductionandindicaterequiredfrequency.5025ProductionControlDoesfactorykeepinternalINLINEinspectionrecord
31、s?Inlineinspectionreportmustbecurrentandincludethefollowinginformation:productionline,date,style,operation,frequency,defects,acceptandrejectquantityandinlineinspectorsname.5026ProductionControlDoesthefactoryperformDuringProduction(DUPRO)inspectionstoastandardAQLoracceptablestatisticalqualityleveltha
32、tisequaltoortighterthanTargetsAQL?VerifyFactoryAQL.MustbedocumentedandatleastasstrictasTargets.Inspectionsmustincludeworkmanshipandmeasurementwhenapplicable.NotApplicablewillapplyiffactorydoesnotmanufactureafinishedproduct.5027ProductionControlDoesfactorykeepinternalDUPROinspectionrecords?Verifyinte
33、rnalDUPROdocumentationiscurrent.NotApplicablewillapplyiffactorydoesnotmanufactureafinishedproduct.5028ProductionControlDoesthefactoryusedefectsamplesintheproductionareatoshowexamplesofcommondefects?Verifyifdefectsamplesorphotosareavailable.ThesemustbelocatedintheProductionarea.Samplesmustindicatetyp
34、eofdefect.mustbewrittenintheIanguagethatisunderstoodbyworkers.5029ProductionControlDoesthefactoryhavesometypeoflistingtoidentifyspecificdefectsandisitbeingusedintheirinspections?Factorydefectlistingmusthavecodesforalldefecttypes(similartoTargetsDCL).Validateutilizationthroughreviewofinspectionrecord
35、s.5030ProductionControlDoesthefactoryperformFinalRandomInspections(FRI)toastandardAQLoracceptablestatisticalqualitylevelthatisequaltoortighterthanTargetsAQL?VerifyFactoryAQL.MustbedocumentedandatleastasstrictasTargets.Inspectionsmustincludeworkmanshipandmeasurementwhenapplicable.5031ProductionContro
36、lDoesthefactorykeepinternalFRIinspectionrecords?VerifyinternalFRIresults.Mustbedocumentedanduptodate.ThisisaninternalfactoryinspectionseparatefromtheTargetconductedinspection.5032ProductionControlDoestheinternalFRIincludeinspectingpackagingandcartons?Informationregardinginspectionofpackagingandcarto
37、nsmustbedocumentedoninternalFRIform.NotApplicablewillapplyiffactorydoesnotmanufactureafinishedproduct.5033ProductionControlDoesthefactoryhaveaninternaldocumentedpre-productionprocess?Factorymustholdameetingbeforeproductionstarts.Documentedprocessmustindicatewhenthemeetingwilltakeplaceandattendees.Di
38、scussiontopicsmustincludesamples,productdetailreview,packaging&labeling,producttesting,andproductionplanning.5034ProductionControlDoesthefactoryholdapre-productionmeetingpriortostartofproduction?Verifypre-productiondocumentationshowsthemeetingtakesplacepriortothestartofproduction.5035ProductionContr
39、olDodocumentedPre-Productionmeetingrecordsexist?Verifyhistoricalrecordsconfirmtheexistenceofrecords.5036ProductionControlArebothproductionandfactoryQCrepresentedatthepre-productionmeeting?VerifydocumentedrepresentationincludesProductionandQCdepartments.5037ProductionControlAreproductspecificationsan
40、dapprovalsamplesreviewedpriortoproductionoratthepre-productionmeetingandisthisdocumentedinthemeetingnotes?Verifymeetingnotesdocumentdiscussionofproductspecificationsandapprovalsamples.5038ProductionControlAreproducttestrequirementsandresultsreviewedpriortoproductionoratthepre-productionmeetingandist
41、hisdocumentedinthemeetingnotes?Verifymeetingnotesdocumentdiscussionofproducttestrequirementsandresults.5039ProductionControlArekeyproductandqualityrequirementsreviewed,identifiedanddocumentedpriortoproductionoratthepre-productionmeeting?Verifykeyproductandqualityrequirementshavebeenidentifiedthrough
42、reviewofpre-productionmeetingnotes.5040ProductionControlArePre-productionmeetingnotes/issuescommunicatedtotheappropriatepersonnel?Validatefactoryhasaprocesstocommunicatetheoutputoractionplanofthepre-productionmeetingincludingactionitemsincludingaccountabilityandtiming.5041ProductionControlDoesadocum
43、entedprocessandrecordsexistforthefactorytocomparefirstproductionunitstoclientapprovalsampleandspecifications?VerifythatthereisaprocesswhereQC/Productioncomparesthefirstproductionunitsoffthelineagainsttheclientsapprovalsampleandspecifications.Requireddocumentationmustincludeverificationofmeasurements
44、,construction,workmanshipandifapplicablecorrectiveactionplan.5042ProductionControlArefinishedgoodsstoredinacontrolledareatoavoidtheft,loss,damage,deterioration?Verifyallfinishedmustbeinanareathatissecureandnotaccessiblebygeneralfactorypopulation.Thisareamusthaveasecureperimeterandaroof.Theremustbeas
45、signedpersonneltomonitorthisroom.Thegoodsmustbeonpalletsorshelving.5043ProductionControlIstheidentificationofrawmaterialsandcomponentsadequatetoensuretraceability?Verifyrawmaterialsandcomponentscanbeidentifiedtoensuretraceability.Thisincludes:packaging,processingaids,intermediate/semi-processedprodu
46、cts,part-usedmaterials,finishedproductsandmaterialspendinginvestigation.Thisincludesmaterialssourcedfrommorethanonesupplier.Anexamplewouldbetracingabuttontoitssupplier;orascrewtoitssupplier,etc.5044ProductionControlIstraceabilityavailablefromsourceofrawmaterialandcomponentsthrufinishedproduct?Select
47、asampleofdifferentfinishedgoodsandhavethefactoryexplain&demonstratethelot/batchidentificationoftherawmaterials&componentsusedtomanufacturethesefinishedgoods.5045ProductionControlDoesthefactorytestthetraceabilitysystemtoensureitworks?Verifythefactoryperiodicallyconfirmsthattheirtraceabilitysystemiswo
48、rking.Askthefactorytoproviderecordsintheformofreportsormeetingminutesthatwouldsupportthefactoryisensuringtheeffectivenessofthetraceabilitysystem.5046ProductionControlArefinalproductssuitablymarkedonpackagingand/orproducttoallowidentificationandtraceability?Selectasampleofdifferentfinishedgoodsandver
49、ify:Childrensproductshavetraceabilitylabelingonpackagingandproduct.Allotherproductshavetraceabilityonpackaging.NotApplicablewillapplyonlyiffactorydoesnotproducefinishedgoods.5047ProductionControlIsthereanSOPthatrequirescustomerapprovalwhenchangingmaterials,components,design,ormanufacturingprocessest
50、hatmayaffectmeetingsafety,regulatoryandqualityrequirementsoftheVerifythefactoryswrittenproceduresfornotifyingcustomersandobtainingapprovalwhenthefactoryischangingmaterials,components,designormanufacturingprocessesthatcouldaffectsafety,regulatoryandqualityrequirementsofthefinishedgoods.5048Production
51、TestPlanDoesthefactoryhaveadocumentedProductionTestPlan(s)(PTP)independentofTargetsrequirements?AskfordocumentationthatconfirmstheexistenceofaPTP.5049ProductionTestPlanDoesthePTPmeetTargetminimumrequirements?VerifythePTPdocumentationincludesthefollowingelementsoftesting,inspectionandmanufacturingcon
52、trols:TypeFrequencyCriteria5050ProductionTestPlanIsthePTPappropriatefortheproductandprocessesinvolved?IsthefactorysPTPappropriatewhentakingintoconsiderationtheproducttype,productrisklevel,siteconditions,manufacturingcapabilitiesandmanufacturingcontrolsandlevelofQualitySystemsimplementation.5051Produ
53、ctionTestPlanArethererecordstosupportthePTPisbeingexecutedasdocumented?Reviewtestreports,inspectionresultsandmanufacturingcontrolrecordstoverifythePTPisbeingexecutedaswrittenwithregardtofrequency,typeof,criteriaused,etc.5052ControlofNon-ConformingMaterialsDoesthefactoryhaveeffectivedocumentedprocedu
54、resforthecontrolofnon-conformingmaterialsandproductsincludingidentification,segregationanddispositioning?VerifythefactoryhasawrittenSOPwhichdescribeshownon-conformingmaterialisidentified,segregatedorkeptfromgettingplacedbackinwithnormalproduction.Also,thereistobeadispositionprocesswhereadocumentedde
55、cisionismadetoreworkorrepair,scrapordiscard,useAsIs,etc.alongwithdecisionstorecertifyornot,test,inspect,etc.Thedispositionistoidentifythepersonwhoauthorizedtheactions.VendorFactoryEvaluation(VFE)Copyright2011Target of14FactoryNameFactoryBPMIDBusinessArea05053ControlofNon-ConformingMaterialsAresuspec
56、tandidentifiednon-conformingmaterials,componentsandproductsclearlyidentifiedandsegregatedatallstagestopreventfurtheruse?Lookforareasinthefactorythatareusedonlyforsegregated,non-conforming-rejectedrawmaterialandproduct.Theseareasmustbeidentifiedbylabels,writing,etc.onthewalls.Productcanbefinishedorin
57、-process.Non-Conformingproductmustbeclearlyidentifiedbyspecialcoloredtagsorlabelsand/orplacedincontainersthatareclearlyidentifiedordifferentiatedfromnormalproduction.5054ControlofNon-ConformingMaterialsDorecordsofnon-conformingmaterials,componentsandproductsexist?Verifythatrecordsexistthatnon-confor
58、mingmaterial/productismonitoredpriortore-workordestruction.Non-conformingcanbeproductthathasfailedinspection,containsdefects,doesnotmeetspecs,etc.Therecordsmustincludethefollowing:QuantityTypeofnon-conformaneeordefectSourceorpointofwhereidentifiedasbeingnon-conformingCurrentstatusResultingdispositio
59、nPerson(s)makingthedispositionIfreworked,evideneeordocumentationofreinspectionTraceabilitytocorrectiveaction(remedialaction)records.Traceabilitytoengineeringchangerequestsandproductspecificationchanges.5055ControlofNon-ConformingMaterialsIsthereevideneetoprovethatnon-conformingmaterialsandtheirpacka
60、gingarehandledanddisposedofaccordingtocustomerrequirementsand/orlegalrequirements?Reviewdocumentationtoverifythatclientrequirementsarebeingfollowedbythefactoryindisposingofsecondquality,overrunsandcancellations,etc.IffactoryisworkingforTargetmustbeconsistentwithTargetspolicypostedonPOLBrandProtectio
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