文件控制程序中英文对照

RevisionDCNInitialApprovedDCNonFileinDocumentAPPROVEDMotoakiAUTHORIZEDSKPROPERTYOFZHONGSHANSUNMINGOPTICALTECHNOLOGIESThisdocument,andtheinformationitcontains,arethepropertyofZhongshanSunmingOpticalTechnologiesLimitedandareprotectedbylaw.Bothmustbeheldinstrictconfidenceatalltimes.Nolicenseexpressedorimplied,underanypatent,copyrightorotherintellectualpropertyrightisgrantedorimpliedbytheprovisionorpossessionofthisdocument.Nopartofthisdocumentmaybereproduced,transmitted,transcribed,storedinaretrievalsystem,translatedintoanylanguageorcomputerlanguage,inanyformorbyanymeans,whatsoever,withoutthepriorwrittenconsentofZhongshanSunmingOpticalTechnologies©ZHONGSHANSUNMINGOPTICALTECHNOLOGIESALLRIGHTSPURPOSETodefineaprocedureforthegeneration,revision,handling,approval,retention,storageofinternaldocumentsaswellascontrolofexternaldocuments.SCOPEThisprocedureisapplicabletoqualitymanagementsystem(QMS)documentationsuchassystemmanual,procedures&workinstructions.ThisprocedurealsocoverstheDCN&ECNgenerationandapprovalsignatoryforQMSdocumentationandproductdocumentations.Thisprocedurealsocoverscontrolandhandlingofcustomerdocumentsandotherregulatoryrequirements.ThisprocedurealsocoverscontrolandhandlingofsupplierDEFINITIONS&ABBREVIATIONSQualityManagementSystem(QMS)Documentation-referstoadocumentcategorycomprisingofSystemManual,ProcedureandWorkInstruction.ProductDocumentation-referstoadocumentcategorycomprisingofBOM,ProductDrawings,ProductSpecificationsandProductManufacturingProcedure.产品文献-BOMSystemManual-adocumentdescribingthepolicies,proceduresandpracticesapplicabletoSUNMING.toattainthequalityofproductsandservices.AsystemmanualisclassifiedasLevel1document.1级文献。Procedure-asetoflogicalstepsinwhichweperformplannedtaskorexecuteaprocess.Itmaybeageneraldescriptionofactivitiessupportingthesystemmanual.AprocedureisclassifiedasLevel2document.程序–一套我们执行计划或执行任务的过程中合乎逻辑的环节。它能够是支持体系手册活动2级文献。WorkInstruction(WI)-acollectionofdetailedstatement,includingillustrationsonhowtoperformastepinaprocessoranactivity.AworkinstructionisclassifiedasLevel3作业指导书（WI）-具体陈说的聚集，涉及在某一过程或活动中如何执行某个环节的阐明。3级文献。DocumentChangeNotice(DCN)–isusedtoinitiate,reviseortoobsoleteanexistingQMSdocument(SystemManual,Procedure,WorkInstruction).文献变更告知（DCN）-是用来发起，修改或废止现有的质量管理体系文献（体系手册，程EngineeringChangeNotice(ECN)-isusedtoinitiate,reviseortoobsoleteanexistingProductDocumentation.工程变更告知（ECN）-ISOManagementRepresentative-QAManagerisappointedtobetheISOManagementISO管理代表QAISOPurpose-brieflystatesthedocument’sintended目的-Scope-brieflystatesthedocument’scoverageorextentof范畴-Definitions&Abbreviations-definestheterminologyusedinthetextsoastobeunderstoodattheleveloftheuser.定义与术语-AssociatedDocuments-listofotherdocumentsreferencedandothersupportingwork有关文献-GeneralRequirements-thebodyordetailedcontentoftheprocedure;astepbystep普通规定-程序本身或具体内容;ApprovalSignaturelistabbreviations: -ChiefExecutiveOfficer首席执行官 -VPofSales销售副总 -VPofGlobalMarketing全球市场副总 -DirectorofFailureAnalysis技术增援总监 -DirectorofQuality质量总监 -DirectorofProduction生产总监 -ManagerofAccounts财会经理 -ManagerofPurchasing采购经理 ManagerofQualityAssuranceQA -ManagerofAdmin/HumanResources行政与人力资源经理 -ManagerofAdvancedManufacturingEngineering高级制造经理 -ManagerofCleanRoom净化间经理ASSOCIATEDDOCUMENTS WorkInstructionforDocumentNumbering :WorkInstructionforDocumentChangeNotice(DCN) WorkInstructionforEngineeringChangeNotice(ECN)Generation.工程变更告知生成作业指导书 :WorkInstructionforReleasingDocumentsto :WorkInstructionforRetentionofQualityDocumentsand品质文献/GENERALREQUIREMENTSQualityManagementSystem(QMS)Documentation品质管理系统（QMS）Level1SystemManual2Procedure3WorkInstruction4Forms&LocallyControlledDocuments&DocumentControlCenter(DCC)shallberesponsibleintheassignmentandcontrolofdocumentnumbers.RefertoDC30001(WorkInstructionforDocumentNumbering)fordetailsofnomenclatureincludingtherevisionnumbering.文控中心（DCC）DC30001（文献编号作业指导书）有Aspecimenofworkingformsshallbeincorporatedineachdocumentasattachment.DCCshallprovidesoftcopiesoftheseformsuponrequest.InitialreleasedandcompletelyrewrittendocumentsshallundergoapprovaloftheManagementISODCCshallprinthardcopiesofapproveddocumentsandwillmakeitavailableforstaffreadingintheDCCroom.SUNMINGChangesissued(throughDCN&ECN)toinitiate,reviseandobsoleteadocumentshallbereviewedforadequacybeforeapprovalbythefollowingsignatory:QMSDocumentCategoryApprovalSignatureGeneralManagementCEO/VPS/DQA/NewBusinessCEO/VPS/ProductQualificationCEO/HR&AdminDocuments人力资源CEO/DocumentControlCEO/DQA/QualityAssuranceCEO/DQA/DesignandEngineeringCEO/ProductionDocumentsCEO/DOP/PurchasingDocumentsCEO/DQA/Documentcontrolstaffisresponsiblefor“routingforapproval”oftheEngineeringChangeNotice(ECN).AnormalChangeNoticeFormsshallbecompletelysignedwithin2workingdaysforECNand5workingdaysforDCNotherwisetheinitiatorshallbeinformedofthedelay.Urgent(sameday)changesshallberoutedbyinitiator.Thefollowingformatshallbeuseasageneralguidelineingeneratingnewsystemmanuals,proceduresandworkinstructions.Aspecimenofthestandarddocumentformatisshowninattachment1&2.12Purpose目的(ForLevel1&2ScopeDefinitions&Abbreviations术语与定义(ForLevel1&2AssociatedDocumentsSafetyRequirements安全规定(ForLevel3GeneralRequirementsProcedureshouldbeupdated,asrequired,asaresultofprocessreviewforcomplianceandSales&MarketingTeamshalldeterminetheneedforreviewofcustomerdocumentswithrelevantdepartments(refertoDC30004:WorkInstructionforReceivingandControlofCustomerandOtherDocument).销售/市场部和有关部门应拟定对客户文献评定的需求（DC30004SupplierQualityEngineershalldeterminetheneedforreviewofsupplierdocumentsDCCshallberesponsibleforarchivingqualitydocuments/records.Amasterlistwhichidentifiesthedocumentlocationshallbemaintainedfortraceability.Thisappliestobothhardcopyandsoftcopyformats(refertoDC30004:WorkInstructionforRetentionofQualityDocuments/Records).（DC30004：质量文献/统计保管作业指导书。Controlleddocumentsidentification.CONTROLLED–Documentthatshallbeusedasregulatoryproceduresandworkinstructionsinareasaffectedbysuchdocument,shallbemarkedasCONTROLLEDCOPYinredinkonallpages(seespecimeninattachment3).TheonlineversionofdocumentmaintainedintheQMSDocumentfolderofSUNMINGintranetisalsoconsideredcontrolledcopy.ThisdocumentshallbeautomaticallyrecalledandupdatedbyDCCwheneverchangesareofficiallymade.DCCshallmaintainarecordofcontrolleddocuments(hardcopy)distribution.CONTROLLEDCOPY（3样本）SUNMING内联网AnydocumentwhichdoesnotbearCONTROLLEDCOPYinredinkshallbydefaultbeconsideredasuncontrolleddocument.Uncontrolleddocumentsareissuedforreferenceonly.CONTROLLEDCOPY标记默认的状况下被视为未受控BothCONTROLLEDanduncontrolleddocumentsareproprietarydocumentsofthecompany;anyunauthorizeduse,photocopying,orpossessionofanydocumentotherthanforitssolepurposeandlegitimateuse,isstrictlyprohibited.SUNMINGdocumentmayexistinbothEnglishandChineselanguage.Incasewhereofadifferenceof