全球供應(yīng)商質(zhì)量手冊(cè)

GlobalManufacturingQualityManual全球制造質(zhì)量手冊(cè):27isconfidential總體要求....................................................................................................31.1.QualitySystem質(zhì)量體系..................................................................................................31.2.Documentation文件管理.................................................................................................31.3.Practise良好生產(chǎn)規(guī)范................................................................3...................................................................................................................................4廠房.................................................................................................................................4.............................................................................................................................4原材料及包裝物料.....................................................................5...............................................................................................................................5InspectionTesting檢驗(yàn)及測(cè)試.................................................................................................5QualityRecords生產(chǎn)及質(zhì)量檢驗(yàn)記錄...............................................................6Distribution.............................................................................................6Material對(duì)不合要求的物料控制......................................................6變更控制............................................................................................................73rdParties..................................................................................7Experience................................................................................................71Audits質(zhì)量審核................................................................................................................7forfactoriesfactories.RB()1.1.factorysitesshalleffectiveQualityincorporatesallareasoperation(includingfunctionsthethedetailedinthistargetsshallsetperiodicallyAqualityshallinplacequantifyingtargets.thequalitysystemshallreportedabasisfactoryquality.Detailstraderecalls.financialcriteria).質(zhì)量問題的所有細(xì)節(jié)，如”(指達(dá)到全球性標(biāo)準(zhǔn)分類）或其他”auditscarried(bothinternallyexternally)storeinvestigations.1.2.1）shalleffectivelytodate.2）shalltothepossibilityqualityissuesitshallwritteninatheavailable1.3.1）factorysitesshallthelevelsPracticeappropriatetothealllegislativeregulatoryare“良2好生產(chǎn)規(guī)范Sites1）detailedinthis2additionaldetailedinthe生產(chǎn)以下產(chǎn)品的相關(guān)工廠還需符合RBsensitivematerialstheresponsibilitiestheirjobareincarryingthemwithinthefactoryshallfromeffectivetrainingisin1ceilingscleaninrepair.orderlystoragematerials.lightingventilationtoassurequality.inplacetoinsects.areassanitizedapplicable)todefined(includinglines)shallidentifiedlabeledeffectiveshallthetoreliableoperation3effectivecalibrationshallinplacecalibrationAlistallthataretoqualitytheallthelistcalibratedtonationallytraceableleast清單上的儀器設(shè)備需按照可追溯的國(guó)家標(biāo)準(zhǔn)至少每年校準(zhǔn)1Functionalitytestingqualitycritical.consiststoconfirmFunctionalitytestingcarriedtodefinedriskqualityfailuretoinaccurateRetestingisre-locatedf)calibrationfunctionalitytesting.3Effectivecorrectiveactiontakeninthecalibrationfunctionalityfailure.Acleaningsanitisationapplicable)shallinsanitisationshalltestedforefficacy.Validationappropriatetestingshallrequiredregulatoryqualityrisk.identifiedwithinthecleaningsanitisationshalltheircleaning/sanitisationstatusidentifiedtheirspecified.tostart-upshalltoconfirmrecordthatthisisinrawmaterialsshallfromsuppliersthatshallthesuppliersestablished,thesuppliersabilitytofulfilallisresponsibleforallareQualityisresponsibleforallqualityareprospectivesupplierscriticalityrisk./theisresponsibleforalltechnicalare核潛在供應(yīng)商。研發(fā)和materialsshallspecificationswithinSpecificationareresponsibleforthespecificationisthesupplier(s).suppliers.materialsclearlyidentifiedtotheiridentitytheirlifestatus,expiryretestdateshallretestsstoredtotosunlight,airrotation(FirstIn–Firstprinciple)shallinstructionsavailabletrainedintheirallstagesstorage,materialsstoredtotosunlight,airshalldateshallineffectivetoallspecifications(e.g.regulatoryetc)areFirstshallpositivelyreleasedtheSitethe工廠質(zhì)量經(jīng)理應(yīng)應(yīng)用41）Aplanthecapabilitytheshallinplaceforalldetailingalltestsrequiredtoisconsistentlytospecification.shallappropriateallin-processcontrols,testsizefailcriteria.2）3）Effectivetestingforallmaterialsinfinishedisinplacetestinglaboratoryshalleffectiveinidentifyingcarriedrequiredregulation,localspecificationsRB4）5）areuntiltestingistospecificationIfoutsidetestresultsaresupplierseffectivevalidationthedataisinspecification,materialsaredefinedinsection請(qǐng)根據(jù)第106）typicalallfinishedlotsshalllineshift.aperiodtoregulatoryforaapplicableshelflife樣品存儲(chǔ)時(shí)間：或根據(jù)相關(guān)要求，或最少2年或者(如適用)totosunlight,airareforruninclude記錄是由每一步生產(chǎn)運(yùn)行來(lái)控制的，包括:cleaningsanitisingifapplicable.therawmaterialsthatstepsetc)issues(technicalf)in-processon-linequalityanalysisaallrecordshallidentifiabletotheinatotoloss.aperiodtoregulatoryforaapplicableshelflife對(duì)于按照監(jiān)管要求，或者最少2shallpalletised,storeddistributedthattheisprotectedqualityis5shalltakentophysical,pest.requiringspecificcontrolsshallidentifiedtheappropriatecontrolsforeffectiveness.shallmaterialsidentifiedeffectively.theidentifiedappropriateactiontakentothetoshallArecallshallincleardefinitionrolesresponsibilities,theeffectivenesstherecallshallestablishedtesteddecisiontorecallafromtheistheresponsibilitythetheaffectedtherecallistheresponsibilityQuality是否召回貨物的決定由事發(fā)國(guó)家的總經(jīng)理負(fù)責(zé),11.ChangeControl.變更控制specificationsshallinpriortothe所有規(guī)格都應(yīng)該在變更執(zhí)行前優(yōu)先發(fā)布在torawsuppliers/storageshallfromtoexistingmaterials,lines,suppliersareeffectivelysothatallspecificationregulatoryetc)arelicensesaffectedallshallto1）shalleffectivesystemtothatall3parties(Suppliers,etc)all一個(gè)有效的系統(tǒng)確保3方（供應(yīng)商，包裝公司，服務(wù)商等等）都能遵從RBAlistall3parties,detailingtheservices/materials/3方名單，服務(wù)的明細(xì)//Atheira追蹤和檢查其表現(xiàn)，最少1thirdpa