全球供应商质量手册

GlobalManufacturingQualityManual全球制造质量手册:27isconfidential总体要求....................................................................................................31.1.QualitySystem质量体系..................................................................................................31.2.Documentation文件管理.................................................................................................31.3.Practise良好生产规范................................................................3...................................................................................................................................4厂房.................................................................................................................................4.............................................................................................................................4原材料及包装物料.....................................................................5...............................................................................................................................5InspectionTesting检验及测试.................................................................................................5QualityRecords生产及质量检验记录...............................................................6Distribution.............................................................................................6Material对不合要求的物料控制......................................................6变更控制............................................................................................................73rdParties..................................................................................7Experience................................................................................................71Audits质量审核................................................................................................................7forfactoriesfactories.RB()1.1.factorysitesshalleffectiveQualityincorporatesallareasoperation(includingfunctionsthethedetailedinthistargetsshallsetperiodicallyAqualityshallinplacequantifyingtargets.thequalitysystemshallreportedabasisfactoryquality.Detailstraderecalls.financialcriteria).质量问题的所有细节，如”(指达到全球性标准分类）或其他”auditscarried(bothinternallyexternally)storeinvestigations.1.2.1）shalleffectivelytodate.2）shalltothepossibilityqualityissuesitshallwritteninatheavailable1.3.1）factorysitesshallthelevelsPracticeappropriatetothealllegislativeregulatoryare“良2好生产规范Sites1）detailedinthis2additionaldetailedinthe生产以下产品的相关工厂还需符合RBsensitivematerialstheresponsibilitiestheirjobareincarryingthemwithinthefactoryshallfromeffectivetrainingisin1ceilingscleaninrepair.orderlystoragematerials.lightingventilationtoassurequality.inplacetoinsects.areassanitizedapplicable)todefined(includinglines)shallidentifiedlabeledeffectiveshallthetoreliableoperation3effectivecalibrationshallinplacecalibrationAlistallthataretoqualitytheallthelistcalibratedtonationallytraceableleast清单上的仪器设备需按照可追溯的国家标准至少每年校准1Functionalitytestingqualitycritical.consiststoconfirmFunctionalitytestingcarriedtodefinedriskqualityfailuretoinaccurateRetestingisre-locatedf)calibrationfunctionalitytesting.3Effectivecorrectiveactiontakeninthecalibrationfunctionalityfailure.Acleaningsanitisationapplicable)shallinsanitisationshalltestedforefficacy.Validationappropriatetestingshallrequiredregulatoryqualityrisk.identifiedwithinthecleaningsanitisationshalltheircleaning/sanitisationstatusidentifiedtheirspecified.tostart-upshalltoconfirmrecordthatthisisinrawmaterialsshallfromsuppliersthatshallthesuppliersestablished,thesuppliersabilitytofulfilallisresponsibleforallareQualityisresponsibleforallqualityareprospectivesupplierscriticalityrisk./theisresponsibleforalltechnicalare核潜在供应商。研发和materialsshallspecificationswithinSpecificationareresponsibleforthespecificationisthesupplier(s).suppliers.materialsclearlyidentifiedtotheiridentitytheirlifestatus,expiryretestdateshallretestsstoredtotosunlight,airrotation(FirstIn–Firstprinciple)shallinstructionsavailabletrainedintheirallstagesstorage,materialsstoredtotosunlight,airshalldateshallineffectivetoallspecifications(e.g.regulatoryetc)areFirstshallpositivelyreleasedtheSitethe工厂质量经理应应用41）Aplanthecapabilitytheshallinplaceforalldetailingalltestsrequiredtoisconsistentlytospecification.shallappropriateallin-processcontrols,testsizefailcriteria.2）3）Effectivetestingforallmaterialsinfinishedisinplacetestinglaboratoryshalleffectiveinidentifyingcarriedrequiredregulation,localspecificationsRB4）5）areuntiltestingistospecificationIfoutsidetestresultsaresupplierseffectivevalidationthedataisinspecification,materialsaredefinedinsection请根据第106）typicalallfinishedlotsshalllineshift.aperiodtoregulatoryforaapplicableshelflife样品存储时间：或根据相关要求，或最少2年或者(如适用)totosunlight,airareforruninclude记录是由每一步生产运行来控制的，包括:cleaningsanitisingifapplicable.therawmaterialsthatstepsetc)issues(technicalf)in-processon-linequalityanalysisaallrecordshallidentifiabletotheinatotoloss.aperiodtoregulatoryforaapplicableshelflife对于按照监管要求，或者最少2shallpalletised,storeddistributedthattheisprotectedqualityis5shalltakentophysical,pest.requiringspecificcontrolsshallidentifiedtheappropriatecontrolsforeffectiveness.shallmaterialsidentifiedeffectively.theidentifiedappropriateactiontakentothetoshallArecallshallincleardefinitionrolesresponsibilities,theeffectivenesstherecallshallestablishedtesteddecisiontorecallafromtheistheresponsibilitythetheaffectedtherecallistheresponsibilityQuality是否召回货物的决定由事发国家的总经理负责,11.ChangeControl.变更控制specificationsshallinpriortothe所有规格都应该在变更执行前优先发布在torawsuppliers/storageshallfromtoexistingmaterials,lines,suppliersareeffectivelysothatallspecificationregulatoryetc)arelicensesaffectedallshallto1）shalleffectivesystemtothatall3parties(Suppliers,etc)all一个有效的系统确保3方（供应商，包装公司，服务商等等）都能遵从RBAlistall3parties,detailingtheservices/materials/3方名单，服务的明细//Atheira追踪和检查其表现，最少1thirdpa