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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.產品文獻-BOMSystemManual-adocumentdescribingthepolicies,proceduresandpracticesapplicabletoSUNMING.toattainthequalityofproductsandservices.AsystemmanualisclassifiedasLevel1document.1級文獻。Procedure-asetoflogicalstepsinwhichweperformplannedtaskorexecuteaprocess.Itmaybeageneraldescriptionofactivitiessupportingthesystemmanual.AprocedureisclassifiedasLevel2document.程序–一套我們執行計劃或執行任務的過程中合乎邏輯的環節。它能夠是支持體系手冊活動2級文獻。WorkInstruction(WI)-acollectionofdetailedstatement,includingillustrationsonhowtoperformastepinaprocessoranactivity.AworkinstructionisclassifiedasLevel3作業指導書(WI)-具體陳說的聚集,涉及在某一過程或活動中如何執行某個環節的闡明。3級文獻。DocumentChangeNotice(DCN)–isusedtoinitiate,reviseortoobsoleteanexistingQMSdocument(SystemManual,Procedure,WorkInstruction).文獻變更告知(DCN)-是用來發起,修改或廢止現有的質量管理體系文獻(體系手冊,程EngineeringChangeNotice(ECN)-isusedtoinitiate,reviseortoobsoleteanexistingProductDocumentation.工程變更告知(ECN)-ISOManagementRepresentative-QAManagerisappointedtobetheISOManagementISO管理代表QAISOPurpose-brieflystatesthedocument’sintended目的-Scope-brieflystatesthedocument’scoverageorextentof范疇-Definitions&Abbreviations-definestheterminologyusedinthetextsoastobeunderstoodattheleveloftheuser.定義與術語-AssociatedDocuments-listofotherdocumentsreferencedandothersupportingwork有關文獻-GeneralRequirements-thebodyordetailedcontentoftheprocedure;astepbystep普通規定-程序本身或具體內容;ApprovalSignaturelistabbreviations: -ChiefExecutiveOfficer首席執行官 -VPofSales銷售副總 -VPofGlobalMarketing全球市場副總 -DirectorofFailureAnalysis技術增援總監 -DirectorofQuality質量總監 -DirectorofProduction生產總監 -ManagerofAccounts財會經理 -ManagerofPurchasing采購經理 ManagerofQualityAssuranceQA -ManagerofAdmin/HumanResources行政與人力資源經理 -ManagerofAdvancedManufacturingEngineering高級制造經理 -ManagerofCleanRoom凈化間經理ASSOCIATEDDOCUMENTS WorkInstructionforDocumentNumbering :WorkInstructionforDocumentChangeNotice(DCN) WorkInstructionforEngineeringChangeNotice(ECN)Generation.工程變更告知生成作業指導書 :WorkInstructionforReleasingDocumentsto :WorkInstructionforRetentionofQualityDocumentsand品質文獻/GENERALREQUIREMENTSQualityManagementSystem(QMS)Documentation品質管理系統(QMS)Level1SystemManual2Procedure3WorkInstruction4Forms&LocallyControlledDocuments&DocumentControlCenter(DCC)shallberesponsibleintheassignmentandcontrolofdocumentnumbers.RefertoDC30001(WorkInstructionforDocumentNumbering)fordetailsofnomenclatureincludingtherevisionnumbering.文控中心(DCC)DC30001(文獻編號作業指導書)有Aspecimenofworkingformsshallbeincorporatedineachdocumentasattachment.DCCshallprovidesoftcopiesoftheseformsuponrequest.InitialreleasedandcompletelyrewrittendocumentsshallundergoapprovaloftheManagementISODCCshallprinthardcopiesofapproveddocumentsandwillmakeitavailableforstaffreadingintheDCCroom.SUNMINGChangesissued(throughDCN&ECN)toinitiate,reviseandobsoleteadocumentshallbereviewedforadequacybeforeapprovalbythefollowingsignatory:QMSDocumentCategoryApprovalSignatureGeneralManagementCEO/VPS/DQA/NewBusinessCEO/VPS/ProductQualificationCEO/HR&AdminDocuments人力資源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術語與定義(ForLevel1&2AssociatedDocumentsSafetyRequirements安全規定(ForLevel3GeneralRequirementsProcedureshouldbeupdated,asrequired,asaresultofprocessreviewforcomplianceandSales&MarketingTeamshalldeterminetheneedforreviewofcustomerdocumentswithrelevantdepartments(refertoDC30004:WorkInstructionforReceivingandControlofCustomerandOtherDocument).銷售/市場部和有關部門應擬定對客戶文獻評定的需求(DC30004SupplierQualityEngineershalldeterminetheneedforreviewofsupplierdocumentsDCCshallberesponsibleforarchivingqualitydocuments/records.Amasterlistwhichidentifiesthedocumentlocationshallbemaintainedfortraceability.Thisappliestobothhardcopyandsoftcopyformats(refertoDC30004:WorkInstructionforRetentionofQualityDocuments/Records).(DC30004:質量文獻/統計保管作業指導書。Controlleddocumentsidentification.CONTROLLED–Documentthatshallbeusedasregulatoryproceduresandworkinstructionsinareasaffectedbysuchdocument,shallbemarkedasCONTROLLEDCOPYinredinkonallpages(seespecimeninattachment3).TheonlineversionofdocumentmaintainedintheQMSDocumentfolderofSUNMINGintranetisalsoconsideredcontrolledcopy.ThisdocumentshallbeautomaticallyrecalledandupdatedbyDCCwheneverchangesareofficiallymade.DCCshallmaintainarecordofcontrolleddocuments(hardcopy)distribution.CONTROLLEDCOPY(3樣本)SUNMING內聯網AnydocumentwhichdoesnotbearCONTROLLEDCOPYinredinkshallbydefaultbeconsideredasuncontrolleddocument.Uncontrolleddocumentsareissuedforreferenceonly.CONTROLLEDCOPY標記默認的狀況下被視為未受控BothCONTROLLEDanduncontrolleddocumentsareproprietarydocumentsofthecompany;anyunauthorizeduse,photocopying,orpossessionofanydocumentotherthanforitssolepurposeandlegitimateuse,isstrictlyprohibited.SUNMINGdocumentmayexistinbothEnglishandChineselanguage.Incasewhereofadifferenceof

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