文件控制程序-中英文对照

1、TITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序DocumentNo.:DC20001Rev.No.:A00Page1of13RevisionHistoryREVDCN#INITIATEDBYEFFECTIVEDATE(MM/DD/YY)DESCRIPTIONA00D141601WilliamMagramo04/18/14InitialReleaseApprovedDCNonFileinDocumentControlAPPROVEDBYMotoakiWakuiAUTHORIZEDBYSKLamCONFIDENTIALPROPERTYOFZH

2、ONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDThisdocument,andtheinformationitcontains,arethepropertyofZhongshanSunmingOpticalTechnologiesLimitedandareprotectedbylaw.Bothmustbeheldinstrictconfidenceatalltimes.Nolicenseexpressedorimplied,underanypatent,copyrightorotherintellectualpropertyrightisgrantedorim

3、pliedbytheprovisionorpossessionofthisdocument.Nopartofthisdocumentmaybereproduced,transmitted,transcribed,storedinaretrievalsystem,translatedintoanylanguageorcomputerlanguage,inanyformorbyanymeans,whatsoever,withoutthepriorwrittenconsentofZhongshanSunmingOpticalTechnologiesLimited.?2014ZHONGSHANSUNM

4、INGOPTICALTECHNOLOGIESLIMITEDALLRIGHTSRESERVED(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)TITLE:CORPORATEPROCEDUREFORDOC.NO.DC20001DOCUMENTCONTROLREVISIONA00文件控制之管制程序PAGE2_OF_131.1 PURPOSE目的1.1 Todefineaprocedureforthegeneration,revision,handling,approval,reten

5、tion,storageofinternaldocumentsaswellascontrolofexternaldocuments.为内部文件的生成，修改，处理，批准，保留，保存以及对外部文件的控制定义程序。1.2 SCOPE范围.2.1 Thisprocedureisapplicabletoqualitymanagementsystem（QMS）documentationsuchassystemmanual,procedures&workinstructions.本程序适用于质量管理体系（QMS）的系统文件，如体系手册，程序文件及作业指导书。2.2 Thisprocedurealso

6、coverstheDCN&ECNgenerationandapprovalsignatoryforQMSdocumentationandproductdocumentations.本程序还包括质量管理体系文件和产品文件的文件变更通知（DCN）&工程变更通知（ECN）的生成和审批签署。2.3 Thisprocedurealsocoverscontrolandhandlingofcustomerdocumentsandotherregulatoryrequirements.本程序还包括客户文件和其他法规要求的控制和处理。2.4 Thisprocedurealsocoverscont

7、rolandhandlingofsupplierdocuments.本程序还包括对供应商文件的控制和处理。3.0DEFINITIONS&ABBREVIATIONS术语与定义3.1 QualityManagementSystem（QMS）Documentation-referstoadocumentcategorycomprisingofSystemManual,ProcedureandWorkInstruction.质量管理体系（QMS）文件-指的是由体系手册，程序文件和作业指导书组成的文件类。3.2 ProductDocumentation-referstoadocumentcate

8、gorycomprisingofBOM,ProductDrawings,ProductSpecificationsandProductManufacturingProcedure.产品文件-指的是由BOM,产品图纸，产品规格书，产品制造程序组成的文件类。3.3 SystemManual-adocumentdescribingthepolicies,proceduresandpracticesapplicabletoSUNMING.toattainthequalityofproductsandservices.AsystemmanualisclassifiedasLevel1document.体

9、系手册-描述适用于SUNMING的政策，程序和实践，实现产品和服务质量的文件。体系手册归类为1级文件。?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential（AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp）DOC.NO.DC20001REVISIONA00PAGE3OF13TITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序3.4 Procedure-asetoflo

10、gicalstepsinwhichweperformplannedtaskorexecuteaprocess.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步骤。它可以是支持体系手册活动的一个概括的描述。程序归类为2级文件。3.5 WorkInstruction(WI)-acollectionofdetailedstatement,including川ustrationsonhowtop

11、erformastepinaprocessoranactivity.AworkinstructionisclassifiedasLevel3document.作业指导书(WI)-详细陈述的汇集，包括在某一过程或活动中如何执行某个步骤的说明。作业指导书归类为3级文件。3.6 DocumentChangeNotice(DCN)-isusedtoinitiate,reviseortoobsoleteanexistingQMSdocument(SystemManual,Procedure,WorkInstruction).文件变更通知(DCN)-是用来发起，修改或废止现有的质量管理体系文件(体系手册，

12、程序文件，作业指导书)。3.7 EngineeringChangeNotice(ECN)-isusedtoinitiate,reviseortoobsoleteanexistingProductDocumentation.工程变更通知(ECN)-是用来发起，修改或废止现有的产品文件。3.8 ISOManagementRepresentative-QAManagerisappointedtobetheISOManagementRepresentative.ISO管理代表-QA经理为指定的ISO管理代表3.9 Purpose-brieflystatesthedocument'sintend

13、eduse/s.目的-简要陈述文件的使用意图。3.10 Scope-brieflystatesthedocument'scoverageorextentofuse.范围-简要陈述文件的使用范围或程度。3.11 Definitions&Abbreviations-definestheterminologyusedinthetextsoastobeunderstoodattheleveloftheuser.定义与术语-定义正文中使用的术语，以便使用者在此基础上更容易理解。3.12 AssociatedDocuments-listofotherdocumentsreferenceda

14、ndothersupportingworkinstructions.相关文件-列出引用的其他文件和其他辅助作业指导书。3.13 GeneralRequirements-thebodyordetailedcontentoftheprocedure;astepbystepinstruction一般要求-程序本身或详细内容；逐步说明。?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolle

15、dstamp)TITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序DOC.NO.REVISIONPAGEDC20001A004OF133.14 ApprovalSignaturelistabbreviations:批准签名名单缩写CEO-ChiefExecutiveOfficer首席执行官VPS-VPofSales销售副总VPM-VPofGlobalMarketing全球市场副总DFA-DirectorofFailureAnalysis技术支援总监DQA-DirectorofQuality质量总监DOP-DirectorofProduction

16、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4.0ASSOCIATEDDOCUMENTS相关文件4.1DC300014.2DC300024.3DC300034.4DC300044.5DC30005:WorkInstructio

17、nforDocumentNumbering文件编号作业指导书:WorkInstructionforDocumentChangeNotice(DCN)Generation文件变更通知生成作业指导书:WorkInstructionforEngineeringChangeNotice(ECN)Generation.工程变更通知生成作业指导书:WorkInstructionforReleasingDocumentstoSuppliers发布文档给供应商之工作指引:WorkInstructionforRetentionofQualityDocumentsandRecords品质文件/记录保存作业指导书5

18、.0GENERALREQUIREMENTS一般要求5.1 QualityManagementSystem(QMS)Documentationhierarchy品质管理系统(QMS)文件等级Level等级Classification分类1SystemManual体系手册2Procedure程序文件3WorkInstruction作业指导书4Forms&LocallyControlledDocuments表格&当地控制文件?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(Anyhardcopyprintoutof

19、thisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)TITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序DOC.NO.REVISIONPAGEDC20001A005OF135.2 DocumentControlCenter(DCC)shallberesponsibleintheassignmentandcontrolofdocumentnumbers.RefertoDC30001(WorkInstructionforDocumentNumbering)fordetailsof

20、nomenclatureincludingtherevisionnumbering.文控中心(DCC)应负责文件编号的分配和控制。参考DC30001(文件编号作业指导书)关于命名包括版本编号的细节。5.2.1 Aspecimenofworkingformsshallbeincorporatedineachdocumentasattachment.DCCshallprovidesoftcopiesoftheseformsuponrequest.工作表格的样本应在每个文件中纳入附件结合。文控中心应根据申请提供这些表格的电子档。5.3 Initialreleasedandcompletelyrewr

21、ittendocumentsshallundergoapprovaloftheISOManagementRepresentative.初期发行和重写的文件必须经过ISO管理代表审批。5.4 DCCshallprinthardcopiesofapproveddocumentsandwillmakeitavailableforstaffreadingintheDCCroom.文控中心应打印已批准文件供SUNMING的职员在文件控制中心查看。5.5 Changesissued(throughDCN&ECN)toinitiate,reviseandobsoleteadocumentshallb

22、ereviewedforadequacybeforeapprovalbythefollowingsignatory:发起，修改和废止一份文件须审查其适当充分后由下列人员签名批准才可发行变更(通过文件变更通知&工程变更通知)。QMSDocumentCategoryCategoryCodeApprovalSignatureListGeneralManagement日常管理GMCEO/VPS/DQA/MQANewBusinessDevelopment新业务开发NBCEO/VPS/VPMProductQualification产品资格PQCEO/DFAHR&AdminDocuments

23、人力资源&行政文件HRCEO/MHRDocumentControl文件控制DCCEO/DQA/MQAQualityAssurance品质保证QACEO/DQA/MQADesignandEngineeringDocuments设计匕工程文件DECEO/DFAProductionDocuments生产义件生产义件PDCEO/DOP/MQAPurchasingDocuments采购文件PRCEO/DQA/MQA?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(Anyhardcopyprintoutofthisdocumen

24、tisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.DC20001REVISIONA00PAGE1OF_13TITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序5.6 Documentcontrolstaffisresponsibleforroutingforapproval“oftheEngineeringChangeNotice(ECN).AnormalChangeNoticeFormsshallbecompletelysignedwithin2workingdaysforECN

25、and5workingdaysforDCNotherwisetheinitiatorshallbeinformedofthedelay.Urgent(sameday)changesshallberoutedbyinitiator.文件控制工作人员负责跟进工程变更通知(ECN)的安排和批准。正常工程变更通知(ECN)应在2个工作日内完成签署以及在5个工作日内完成DCN的签署，若有延误应通知发起人。紧急的(当天)变更，应由发起人负责跟进。5.7 Thefollowingformatshallbeuseasageneralguidelineingeneratingnewsystemmanuals,p

26、roceduresandworkinstructions.Aspecimenofthestandarddocumentformatisshowninattachment1&2.下面的格式应作为生成新的体系手册，程序文件和作业指导书的一项通用指南来使用。标准文件格式的样本详见附件1和25.7.1 Purpose目的(ForLevel1&2only)5.7.2 Scope范围5.7.3 Definitions&Abbreviations术语与定义(ForLevel1&2only)5.7.4 AssociatedDocuments相关文件5.7.5 SafetyReq

27、uirements安全要求(ForLevel3only)5.7.6 GeneralRequirements一般要求5.8 Procedureshouldbeupdated,asrequired,asaresultofprocessreviewforcomplianceandeffectiveness.按照要求以及工序评审的一致性和时效性的需要来更新程序。5.9 Sales&MarketingTeamshalldeterminetheneedforreviewofcustomerdocumentswithrelevantdepartments(refertoDC30004:WorkIns

28、tructionforReceivingandControlofCustomerandOtherDocument).销售/市场部和相关部门应确定对客户文件评估的需求(参考DC30004:客户和其他文件的接收和管控作业指导书)。5.10 SupplierQualityEngineershalldeterminetheneedforreviewofsupplierdocumentsrespectively.供应商质量工程师应确定对供应商的文件评审的需求。5.11 DCCshallberesponsibleforarchivingqualitydocuments/records.Amasterlis

29、twhichidentifiesthedocumentlocationshallbemaintainedfortraceability.Thisappliestobothhardcopyandsoftcopyformats(refertoDC30004:WorkInstructionforRetentionofQualityDocuments/Records).文控中心应负责质量文件/记录的归档。应保持标示文件位置的主列表以便查找，此要求同时适用于印刷版和电子档。(参考DC30004:质量文件/记录保管作业指导书)。?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIE

30、SLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.DC20001REVISIONA00PAGEOF_13TITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序5.12 Controlleddocumentsidentification.受控文件鉴定5.12.1 CONTROLLED-Documentthatshallbeusedasregulatoryproceduresandw

31、orkinstructionsinareasaffectedbysuchdocument,shallbemarkedasCONTROLLEDCOPYinredinkonallpages(seespecimeninattachment3).TheonlineversionofdocumentmaintainedintheQMSDocumentfolderofSUNMINGintranetisalsoconsideredcontrolledcopy.ThisdocumentshallbeautomaticallyrecalledandupdatedbyDCCwheneverchangesareof

32、ficiallymade.DCCshallmaintainarecordofcontrolleddocuments(hardcopy)distribution.规范程序和受此类文件影响范围内的作业指导书应受控使用，该类文件的每页应附有CONTROLLEDCOPY标识的红色水印，(见附件3样本)。保存在SUNMING内联网的质量管理体系文件的文件夹中的网络电子版本也视为受控文件。本文件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。文控中心应保持一个分发受控文件(印刷版)的记录。5.12.2 AnydocumentwhichdoesnotbearCONTROLLEDCOPYinredink

33、shallbydefaultbeconsideredasuncontrolleddocument.Uncontrolleddocumentsareissuedforreferenceonly.任何文件在没有用红墨水印的CONTROLLEDCOPY标识默认的情况下被视为未受控的文件，不受控的文件印发只作参考。5.13 BothCONTROLLEDanduncontrolleddocumentsareproprietarydocumentsofthecompany;anyunauthorizeduse,photocopying,orpossessionofanydocumentotherthanf

34、oritssolepurposeandlegitimateuse,isstrictlyprohibited.受控和未受控文件均为公司的机密文件，任何文件除了其唯一目的和合法使用以外严禁任何未经授权的使用，复印，或拥有。5.14 SUNMINGdocumentmayexistinbothEnglishandChineselanguage.Incasewhereofadifferenceofinterpretationarise,theEnglishlanguageinterpretationshallprevail.SUNMING文件可能存在英语和汉语版本。在出现不同解释的情况下，以英文解释为准

35、。5.15 Incasecorrectionorchangingofentryisunavoidable,thefollowingrequirementsshallapply.ThisrequirementextendstoSUNMINGQMSdocumentation,ProductDocumentation.如修正和更改不可避免的情况下，以下规定适用。该规定涵盖SUNMING(QMS)的质量管理体系文件，产品文件。?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(Anyhardcopyprintoutofthisdocu

36、mentisuncontrolledunlessitbearsDCCredcontrolledstamp)TITLE:CORPORATEPROCEDUREFORDOC.NO.DC20001DOCUMENTCONTROLREVISIONA00文件控制之管制程序PAGE8_OF_135.15.1 Donotusecorrectionfluid.不可使用涂改液。5.15.2 Donotusepencilinstead,usedarkinkpenforcorrection.不可使用铅笔，使用深色水笔修改。5.15.3 Crossoutusingonelinewiththecorrectedinform

37、ationstillreadable.修改划一道横线，使被更正的信息仍然可读。5.15.4 Writethecorrectionlegiblyclosetothecrossedoutinformation.紧靠所划除信息清晰填写修正信息。5.15.5 Signnexttothecorrectionandwritedownthedateofcorrection.在修正信息旁签名并写上修改日期。5.15.6 Initiatortakestheresponsibilitytonotifyrelevantpartyorsignatoryonthecorrectionorchangesmade.发起人负

38、责通知相关人员或签名人修正或更改事宜。?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.REVISIONPAGEDC20001A009OF13REVDCN4DATEDESCRlPTION3例?/品DCNnnFi?i-CH-rrmFC3nfJTITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序Attac

39、hment1附件1QMSDocumentFormatLevel1&2质量管理体系(QMS)1&2级文件格式ZhongshanSunmingOpticalTechnologiesLimitedSUNMKNS中山三鸣光学科技有限公司TITLE：CORPORATEPROCEDUREFOR3-直管程序Dogu巾修。tNdi*-Rev,Nq.：A<MJPas&1=f2Re.-isisnHi5dryAPPROVEnBYAUTHORIZEDBYPROPERTYOFZHONGSUftfH3UNMISGOP1rleALTECHNOLOGIESLMTED和s二二匚备-二i&&

40、quot;-7-«rrJ=一二二二一:="za-，£.'zt*z-£->=-二ariC_iT-士：二m%h>a2mx-j.lAdsr-daa二Kdg堂/SdtjjL*:»ri*arsr”jqgj-*i；3二h一口匐翔用eawcc.审宜ahntcHdmmcifigrr4jrarwvrdK时exi»»ordm衣jrrmoskd-th毋snrartKtidnrtsriiggrMr1vrt4is3Br-n-sz:z-:zanycraompuefr门anyorgy/TfS19.-V将-3-3E<JLgW目-z

41、nng3&:1.Ty”中h:rtk12nt4ZHONG3MAhSLNhHlhGOPDGALTECMhOlOGIE5LIMITEDALLRIGHTSRESERVED加，七£：，常巴SW!f”!£：+MJ-III：!"噂S"*-KlU81：rrn3C3JQQ1山®thACD?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolled

42、stamp)TITLE:CORPORATEPROCEDUREFORDOCUMENTCONTROL文件控制之管制程序DOC.NO.REVISIONPAGEDC20001Agg-10OF13Attachment1(Continuation)附件1(续表)QMSDocumentFormatLevel1&2质量管理体系(QMS)1&2级文件格式IITLE:CORPORATEPROCEDUREFORDOt科白_RE'/iSlOlADO.文怦控之管窜财2三空上1 .CPURPOSE目的1.1laiff*7reaprDCBdtrgfor-41DC3Q81:晒F*lY忖用Efn”匚HE

43、旨时NUTigri”号一噌EV.42DC3QXJ2:Vr'D(tInstrjctbrfQTDKjrBornC-flngsfDC)G<raralion工件董亶知礴酢储50GENFBALREIMIREMENTS充5.1QualityUanagement.Sstam口MS访施理累型;avs>52DwunientConlin-Cbntsr(DGC'5hall)二FiT',|:皿MWBWva»»-wwBW-n=bwb-n=»HSB1»-nvah»hsbw«hwsvwih*»>»-&#

44、187;2-3014ZHOhGSHkt,!SUSWIINQCPTIC41TECHI40LOQIESLIMITEDConfidentialArr?*lczr二1"二t工二"二ijtcctoq*dj-i:.££,二二cH二二±bha:五一:?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)TITLE:CORPORATE

45、PROCEDUREFORDOCUMENTCONTROL文件控制之管制程序DOC.NO.REVISIONPAGEDC20001A0011OF13Attachment2附件2QMSDocumentFormatLevel3质量管理体系(QMS)3级文件格式ZhongshanSunmingOpticalTechnologiesLimftedSUNMING中山三鸣光学科技有限公司HILEworkinstructorfor俳业指导节DcxxirreniherRgjMo.：AC。Page1of2RevisionHistoryREVDCh#INITIftTEDBYEFFECTIVEATE西卜DD.VT)DES

46、CRIPTION_aAXIrD门诊InitialJy且nrrgkDCN5nFieinDocuti&ttCyitplAPPROVEDBYAUTHORIZEDBYgNFIDEMi|ALPROPEFfTTOFZKDhGMHAM3UhHIMGOPFICALTECrOLDOIC3LIMFTEDr-i3塞F盟，：Sr-A士音力由野七弋旦-a;AWr-.：.士中我3一注二a缶Ldri得士至t勺meon-ui：»n«ianirz:or«irc*r*irtincic«itintnd7kleojtr:«itxocEgrrdorvwkiSW*TrK量才=？3

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48、sdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)TITLE:CORPORATEPROCEDUREFORD0c.NO.DOCUMENTCONTROLREVISION文件控制之管制程序PAGEDC20001A0012_OF13Attachment2（Continuation）附件2（续表）QMSDocumentFormatLevel3质量管理体系（QMS）3级文件格式TITLE：WORKINSTRUCTIONfb门手一小*善号节AZOREQUIR巨耐ENT安全次5t刍埠广纳，"：亡.1.1=rifirt-arkinfiiibzimis-a？picabelo率尼比扬里书埴三子1.2-tiE.vorkins-Tucticnm3cova-s-在吃、，界芝书也包精angeKafcCCtx'Gon&rs：'3ras-”辑静书ngi-iBBringC"iing»