驗(yàn)廠總匯1 bv品質(zhì)審核清單

FCCAQualitySystemAuditOutlineFCCA質(zhì)量體系審核綱要(Hardline雜貨(QualitySystempart質(zhì)量體系部分FactoryQualitySystemFactoryFacilitiesandEnvironmentThereissufficientlightingon:Production,revising,finishing,inspection,packingloadingThefacilitymaintainscleanandorganizedproduction,finishingandpackingFacilityhasseparateinspectionareawithinspectiontableandproperFacilityhas edpests/mildewandmoisturecontrolprogram,which frequentinspections.(In-houseor3rdparty)工廠是否有害蟲/霉菌和濕度的控制程序文件?是否有經(jīng)常巡查(公 Nobrokenwindowsorleakingroofsthatmayresulttoproductcontaminationwasobservedduringaudit.(Critical)Factoryimplementsstrictsharptoolscontrolproceduretopreventscissors,knives,blades,brokenglasses,andneedlestobemixedwithproduct.(嚴(yán)重工廠是否實(shí)行嚴(yán)格的利器控制程序，以防止剪刀、小刀、刀片、碎玻璃及針等混入產(chǎn)品MachineCalibrationandMaintenance機(jī)器校準(zhǔn)和Factory edsystemandprocedureforscheduledequipmentcleaningFactorymachinesandequipmentsappeartobecleanandingoodrunningMachines,equipmentsandtoolsareproperlylabeledwithdateoflastmaintenance/calibrationandschedule.Machines,equipmentsandtoolsthatneedtoberepairedareproperlylabeledtoavoidaccidentaluse.Factoryhasproper,cleanandorganizedstorageareaofcriticaltooling(i.e.injectionmoulds)withlabeledshelves.Factoryhasproper ationandupdatedinventoryofmachines,tools,spareparts,andequipments.Factoryhasmaintenanceteamwithsuitableskilllevelandequipmentstoperformnecessaryrepairandcalibrationonmachines.2.0QualityManagementSystem體FactoryhasestablishedQualityManagementSystemthatisappropriatetoproductsandWorkers&SupervisorsarefamiliartothesequalitypoliciesandFactory edcustomercomintsystemandedrecall (Critical)FactoryQCteamistfromProductiondivision.(嚴(yán)重)工廠QC團(tuán)隊(duì)是否獨(dú)立于生產(chǎn)部門。ProductionmanagementandQCteamdiscussandworktogetherinsolvingQualityissues/concerns.( 是否有記錄顯示生產(chǎn)管理和QC團(tuán)隊(duì)共同討論、解決質(zhì)量問題及其他相關(guān)的問題Factoryhassystemsandproceduresincetocontroltheriskofphysical,chemical,andbiologicalcontaminationthatmaydamagetheproductand nelaswell. Factoryconductsriskassessmentstoidentifyhazardsfromchemicals,rawmaterials,processequipments,andtools.Isfactoryaccreditedwithanyinternational,nationalorcustomerqualitystandardsassociation(e.g.ISO9001,etc.)?工廠是否取得了國際的,國家的或客戶的質(zhì)量標(biāo)準(zhǔn)組織認(rèn)證(例如:ISO9001,等ingMaterialsControlHasthefactorytakenadequatemeasurestoassurerawmaterialsconformancerequiredspecificationsbeforeProperfirstin-firstout(FIFO)systemonmaterialsareFactoryhasprocedures(instructions,guidelines,and edrecords)forqualityinspectionon ingrawmaterials,accessories,andcomponents.工廠是否有進(jìn)倉原物料、配件和部件的質(zhì)量檢驗(yàn)程序,作業(yè)指導(dǎo)書,Isneededtestingequipmentavailable,andmaintainedingoodArerawmaterialsproperlylabeled,stored,and所有的原物料是否有合適的標(biāo)識(shí),及可溯性Factoryhas edprocessandreferencesamplesthatensure ingrawmaterialsconformtospecifications.(Critical)Factoryhaspropersystemonmaterialsegregationtoavoidaccidentalcontaminationfromrejecteditems.(嚴(yán)重)工廠是否建立起適當(dāng)?shù)奈锪峡刂企w系,以不合格的原材料及避免意外污染Factoryproperlyseparategoodqualityitemsfromrejectsandidentifiesnon-conforming(rejects)materialsforrecement.Facility’sstorageareashavesufficientlighting,wellventilatedandcleanMaterials,components,andaccessoriesareproperlystackedandidentifiedwith/labelsandoffthe(Critical)Chemicalsandmaintenancesubstancesareproperlymarkedandstoredtopreventriskofcontamination. Doesfactoryhavea rselectionandapprovalDoesfactorytrack,evaluateandmaterial’srreliabilityDoesfactoryhaveanestablished,edqualityprocedureanddoesfactoryevaluate,monitorsub-contractorqualityperformanceandreliability?工廠是否建立起的對分包商的品質(zhì)控制流程文件?是否有評估及監(jiān)督分包商的品質(zhì)表現(xiàn)及ProcessandProductionControlDoesfactoryPDstudyandapplyproductsafetyfeatures,evaluatespatterns,moulds,andsamplesduringproductdesignanddevelopment?Factory edQualityprocedures(QP)ateachstageofDoesfactoryconductPre-productionmeetingpriortostartof(Critical)Arecriticalqualityandsafetychecksreviewed,identified,andactionsfor edduringPre-productionmeeting?Doesfactoryconduct“pilot-run”,reviewproductqualityspecificationsheetandresultswithcorrectiveactionspriortoproduction?Wasinhouselab-testingperformedoncurrentproduction?(Requestfortest DoesfactoryQCcomparefirstpiecesampleswithapprovalsampleandspecification工廠QCArethereadequateapprovedsamples,firstpiecesamples,referencesamples,andworkinstructionstoprovideworkerswithproperguidelines?(Critical)DoesQualityControlhasauthoritytostopproductionifqualityofproductsdidnotmeetspecification?(嚴(yán)重)QC是否被當(dāng)產(chǎn)品質(zhì)量不符合規(guī)格時(shí)是否有權(quán)停止生產(chǎn)In-lineinspections(IPQC)areperformedbyQCateveryoperation在每一個(gè)操作過程是否由QC執(zhí)行巡檢(IPQC)Isqualityofitemacceptableoncurrentproduction?(Check8finishedproductstakenfromfactoryfinalinspectedgoodsandcheckformajordefectsontheitem.)現(xiàn)行生產(chǎn)的產(chǎn)品質(zhì)量是否可以接受8個(gè)已檢驗(yàn)的完成品是否有主要缺陷FactoryQCinspectsperstandardAQLorasperindustry工廠QCAQL抽樣檢驗(yàn)標(biāo)準(zhǔn)或按照工業(yè)標(biāo)準(zhǔn)Factoryperforms100%functionalitycheckonfinalDoesfactoryusecorrectiveactionsandrootcause ysismethods?(Pleaseprovideexamples)DoesfactoryhaveguidelinesincetoensurepackagingiscorrectforDoespackingareahaveenoughspacetoperformpackingfunctionsproperly?Isitcleanandorganized?Packedcartonsarestoredinenclosedareanotexposedtosunshineandwet包裝紙箱是否在封閉區(qū)域內(nèi),沒有于陽光和潮濕天氣Doesfactorytrack on-timeship工廠是否有和記錄準(zhǔn)時(shí)的表現(xiàn)In-HouseLab- 測Doesfactoryperformin-houselabtestingandarefacilitiesappropria yequipped?(PleaserefertotheFCCAatta entforin-houselabtestingrequirements.) 測試和配備適當(dāng)設(shè)施(請參考 Allgaugesandtestequipmentshavevalid sofvariousindustrystandardsareavailableasIn-houseLabTechniciansareproperlytrainedtoperformtestingFinalinspectionDoesfactoryhaveprocedureandworkinginstructionforfinal工廠有沒有最終檢驗(yàn)程序,最終檢驗(yàn)QCFactoryQCconductsfinalinspectionperstandardAQLorasperindustry工廠QC有沒有根據(jù)AQLAnapprovedsampleorreferencesamplewithpackinglistandshipmarksareavailableasreferenceforfactoryQC.最終檢驗(yàn)QC有沒有客戶簽樣或參考樣品,包裝以及嘜頭作參考Arethereformalwrittenfinalinspectionreports?Aretheyproperlyfiledandtraceabletoreviewqualityofproducts?有沒有正式的最終檢驗(yàn)報(bào)告?這些報(bào)告是否歸檔及可追蹤產(chǎn)品質(zhì)量DoesfactoryfinalQCperforminternalmechanicalteststoensurethesafetyof工廠最終檢驗(yàn)QC有沒有做一些機(jī)械測試以確保產(chǎn)品的安全