文件控制程序中英文对照

RevisionHistoryREVDCN#INITIATEDBYEFFECTIVEDATE(MM/DD/YY)DESCRIPTIONA00D141601WilliamMagramo04/18/14InitialReleaseApprovedDCNonFileinDocumentControlAPPROVEDBYMotoakiWakuiAUTHORIZEDBYSKLamCONFIDENTIALPROPERTYOFZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDThisdocument,andtheinformationitcontains,arethepropertyofZhongshanSunmingOpticalTechnologiesLimitedandareprotectedbylaw.Bothmustbeheldinstrictconfidenceatalltimes.Nolicenseexpressedorimplied,underanypatent,copyrightorotherintellectualpropertyrightisgrantedorimpliedbytheprovisionorpossessionofthisdocument.Nopartofthisdocumentmaybereproduced,transmitted,transcribed,storedinaretrievalsystem,translatedintoanylanguageorcomputerlanguage,inanyformorbyanymeans,whatsoever,withoutthepriorwrittenconsentofZhongshanSunmingOpticalTechnologiesLimited.©ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDALLRIGHTSRESERVEDPURPOSE目的Todefineaprocedureforthegeneration,revision,handling,approval,retention,storageofinternaldocumentsaswellascontrolofexternaldocuments.为内部文献的生成，修改，解决，同意，保存，保存以及对外部文献的控制订义程序。SCOPE范畴Thisprocedureisapplicabletoqualitymanagementsystem(QMS)documentationsuchassystemmanual,procedures&workinstructions.本程序合用于质量管理体系（QMS）的系统文献，如体系手册，程序文献及作业指导书。ThisprocedurealsocoverstheDCN&ECNgenerationandapprovalsignatoryforQMSdocumentationandproductdocumentations.本程序还涉及质量管理体系文献和产品文献的文献变更告知（DCN）&工程变更告知（ECN）的生成和审批订立。Thisprocedurealsocoverscontrolandhandlingofcustomerdocumentsandotherregulatoryrequirements.本程序还涉及客户文献和其它法规规定的控制和解决。Thisprocedurealsocoverscontrolandhandlingofsupplierdocuments.本程序还涉及对供应商文献的控制和解决。DEFINITIONS&ABBREVIATIONS术语与定义QualityManagementSystem(QMS)Documentation-referstoadocumentcategorycomprisingofSystemManual,ProcedureandWorkInstruction.质量管理体系（QMS）文献-指的是由体系手册，程序文献和作业指导书构成的文献类。ProductDocumentation-referstoadocumentcategorycomprisingofBOM,ProductDrawings,ProductSpecificationsandProductManufacturingProcedure.产品文献-指的是由BOM，产品图纸，产品规格书，产品制造程序构成的文献类。SystemManual-adocumentdescribingthepolicies,proceduresandpracticesapplicabletoSUNMING.toattainthequalityofproductsandservices.AsystemmanualisclassifiedasLevel1document.体系手册-描述合用于SUNMING的政策，程序和实践，实现产品和服务质量的文献。体系手册归类为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的一种概括的描述。程序归类为2级文献。WorkInstruction(WI)-acollectionofdetailedstatement,includingillustrationsonhowtoperformastepinaprocessoranactivity.AworkinstructionisclassifiedasLevel3document.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。作业指导书归类为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，程序文献，作业指导书）。EngineeringChangeNotice(ECN)-isusedtoinitiate,reviseortoobsoleteanexistingProductDocumentation.工程变更告知（ECN）-是用来发起，修改或废止现有的产品文献。ISOManagementRepresentative-QAManagerisappointedtobetheISOManagementRepresentative.ISO管理代表-QA经理为指定的ISO管理代表Purpose-brieflystatesthedocument’sintendeduse/s.目的-简要陈说文献的使用意图。Scope-brieflystatesthedocument’scoverageorextentofuse.范畴-简要陈说文献的使用范畴或程度。Definitions&Abbreviations-definestheterminologyusedinthetextsoastobeunderstoodattheleveloftheuser.定义与术语-定义正文中使用的术语，方便使用者在此基础上更容易理解。AssociatedDocuments-listofotherdocumentsreferencedandothersupportingworkinstructions.有关文献-列出引用的其它文献和其它辅助作业指导书。GeneralRequirements-thebodyordetailedcontentoftheprocedure;astepbystepinstruction普通规定-程序本身或具体内容;逐步阐明。ApprovalSignaturelistabbreviations:同意签名名单缩写CEO -ChiefExecutiveOfficer首席执行官VPS -VPofSales销售副总VPM -VPofGlobalMarketing全球市场副总DFA-DirectorofFailureAnalysis技术增援总监DQA -DirectorofQuality质量总监DOP -DirectorofProduction生产总监MAC -ManagerofAccounts财会经理MPR -ManagerofPurchasing采购经理MQA -ManagerofQualityAssuranceQA经理MHR -ManagerofAdmin/HumanResources行政与人力资源经理MME-ManagerofAdvancedManufacturingEngineering高级制造经理MCR-ManagerofCleanRoom净化间经理ASSOCIATEDDOCUMENTS有关文献DC30001 :WorkInstructionforDocumentNumbering文献编号作业指导书DC30002 :WorkInstructionforDocumentChangeNotice(DCN)Generation文献变更告知生成作业指导书DC30003 :WorkInstructionforEngineeringChangeNotice(ECN)Generation.工程变更告知生成作业指导书DC30004 :WorkInstructionforReleasingDocumentstoSuppliers公布文档给供应商之工作指导DC30005 :WorkInstructionforRetentionofQualityDocumentsandRecords品质文献/统计保存作业指导书GENERALREQUIREMENTS普通规定QualityManagementSystem(QMS)Documentationhierarchy品质管理系统（QMS）文献等级Level等级Classification分类1SystemManual体系手册2Procedure程序文献3WorkInstruction作业指导书4Forms&LocallyControlledDocuments表格&本地控制文献DocumentControlCenter(DCC)shallberesponsibleintheassignmentandcontrolofdocumentnumbers.RefertoDC30001(WorkInstructionforDocumentNumbering)fordetailsofnomenclatureincludingtherevisionnumbering.文控中心（DCC）应负责文献编号的分派和控制。参考DC30001（文献编号作业指导书）有关命名涉及版本编号的细节。Aspecimenofworkingformsshallbeincorporatedineachdocumentasattachment.DCCshallprovidesoftcopiesoftheseformsuponrequest.工作表格的样本应在每个文献中纳入附件结合。文控中心应根据申请提供这些表格的电 子档。InitialreleasedandcompletelyrewrittendocumentsshallundergoapprovaloftheISOManagementRepresentative.早期发行和重写的文献必须通过ISO管理代表审批。DCCshallprinthardcopiesofapproveddocumentsandwillmakeitavailableforstaffreadingintheDCCroom.文控中心应打印已同意文献供SUNMING的职工在文献控制中心查看。Changesissued(throughDCN&ECN)toinitiate,reviseandobsoleteadocumentshallbereviewedforadequacybeforeapprovalbythefollowingsignatory:发起，修改和废止一份文献须审查其适宜充足后由下列人员签名同意才可发行变更（通过文献变更告知&工程变更告知）。QMSDocumentCategoryCategoryCodeApprovalSignatureListGeneralManagement日常管理GMCEO/VPS/DQA/MQANewBusinessDevelopment新业务开发NBCEO/VPS/VPMProductQualification产品资格PQCEO/DFAHR&AdminDocuments人力资源&行政文献HRCEO/MHRDocumentControl文献控制DCCEO/DQA/MQAQualityAssurance品质确保QACEO/DQA/MQADesignandEngineeringDocuments设计与工程文献DECEO/DFAProductionDocuments生产文献生产文献PDCEO/DOP/MQAPurchasingDocuments采购文献PRCEO/DQA/MQADocumentcontrolstaffisresponsiblefor“routingforapproval”oftheEngineeringChangeNotice(ECN).AnormalChangeNoticeFormsshallbecompletelysignedwithin2workingdaysforECNand5workingdaysforDCNotherwisetheinitiatorshallbeinformedofthedelay.Urgent(sameday)changesshallberoutedbyinitiator.文献控制工作人员负责跟进工程变更告知（ECN)的安排和同意。正常工程变更告知（ECN)应在2个工作日内完毕订立以及在5个工作日内完毕DCN的订立，若有延误应告知发起人。紧急的（当天）变更，应由发起人负责跟进。Thefollowingformatshallbeuseasageneralguidelineingeneratingnewsystemmanuals,proceduresandworkinstructions.Aspecimenofthestandarddocumentformatisshowninattachment1&2.下面的格式应作为生成新的体系手册，程序文献和作业指导书的一项通用指南来使用。原则文献格式的样本详见附件1和2Purpose目的(ForLevel1&2only)Scope范畴Definitions&Abbreviations术语与定义(ForLevel1&2only)AssociatedDocuments有关文献SafetyRequirements安全规定(ForLevel3only)GeneralRequirements普通规定Procedureshouldbeupdated,asrequired,asaresultofprocessreviewforcomplianceandeffectiveness.按照规定以及工序评审的一致性和时效性的需要来更新程序。Sales&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（参考DC30004：客户和其它文献的接受和管控作业指导书）。SupplierQualityEngineershalldeterminetheneedforreviewofsupplierdocumentsrespectively.供应商质量工程师应拟定对供应商的文献评审的需求。DCCshallberesponsibleforarchivingqualitydocuments/records.Amasterlistwhichidentifiesthedocumentlocationshallbemaintainedfortraceability.Thisappliestobothhardcopyandsoftcopyformats(refertoDC30004:WorkInstructionforRetentionofQualityDocuments/Records).文控中心应负责质量文献/统计的归档。应保持标示文献位置的主列表方便查找，此规定同时合用于印刷版和电子档。（参考DC30004：质量文献/统计保管作业指导书）。Controlleddocumentsidentification.受控文献鉴定CONTROLLED–Documentthatshallbeusedasregulatoryproceduresandworkinstructionsinareasaffectedbysuchdocument,shallbemarkedasCONTROLLEDCOPYinredinkonallpages(seespecimeninattachment3).TheonlineversionofdocumentmaintainedintheQMSDocumentfolderofSUNMINGintranetisalsoconsideredcontrolledcopy.ThisdocumentshallbeautomaticallyrecalledandupdatedbyDCCwheneverchangesareofficiallymade.DCCshallmaintainarecordofcontrolleddocuments(hardcopy)distribution.规范程序和受这类文献影响范畴内的作业指导书应受控使用，该类文献的每页应附有CONTROLLEDCOPY标记的红色水印，（见附件3样本）。保存在SUNMING内联网的质量管理体系文献的文献夹中的网络电子版本也视为受控文献。本文献在任何时候提出的正式变更都应由文控中心自动回收和更新。文控中心应保持一种分发受控文献（印刷版）的统计。AnydocumentwhichdoesnotbearCONTROLLEDCOPYinredinkshallbydefaultbeconsideredasuncontrolleddocument.Uncontrolleddocumentsareissuedforreferenceonly.任何文献在没有用红墨水印的CONTROLLEDCOPY标记默认的状况下被视为未受控的文献，不受控的文献印发只作参考。BothCONTROLLEDanduncontrolleddocumentsareproprietarydocumentsofthecompany;anyunauthorizeduse,photocopying,orpossessionofanydocumentotherthanforitssolepurposeandlegitimateuse,isstrictlyprohibited.受控和未受控文献均为公司的机密文献，任何文献除了其唯一目的和正当使用以外严禁任何未经授权的使用，复印，或拥有。SUNMINGdocumentmayexistinbothEnglishandChineselanguage.Incasewhereofadifferenceofinterpretationarise,theEnglishlanguageinterpretationshallprevail.SUNMING文献可能存在英语和汉语版本。在出现不同解释的状况下，以英文解释为准。Incasecorrectionorchangin