文件控制程序中英文對照

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.為內(nèi)部文獻(xiàn)的生成，修改，解決，同意，保存，保存以及對外部文獻(xiàn)的控制訂義程序。SCOPE范疇Thisprocedureisapplicabletoqualitymanagementsystem(QMS)documentationsuchassystemmanual,procedures&workinstructions.本程序合用于質(zhì)量管理體系（QMS）的系統(tǒng)文獻(xiàn)，如體系手冊，程序文獻(xiàn)及作業(yè)指導(dǎo)書。ThisprocedurealsocoverstheDCN&ECNgenerationandapprovalsignatoryforQMSdocumentationandproductdocumentations.本程序還涉及質(zhì)量管理體系文獻(xiàn)和產(chǎn)品文獻(xiàn)的文獻(xiàn)變更告知（DCN）&工程變更告知（ECN）的生成和審批訂立。Thisprocedurealsocoverscontrolandhandlingofcustomerdocumentsandotherregulatoryrequirements.本程序還涉及客戶文獻(xiàn)和其它法規(guī)規(guī)定的控制和解決。Thisprocedurealsocoverscontrolandhandlingofsupplierdocuments.本程序還涉及對供應(yīng)商文獻(xiàn)的控制和解決。DEFINITIONS&ABBREVIATIONS術(shù)語與定義QualityManagementSystem(QMS)Documentation-referstoadocumentcategorycomprisingofSystemManual,ProcedureandWorkInstruction.質(zhì)量管理體系（QMS）文獻(xiàn)-指的是由體系手冊，程序文獻(xiàn)和作業(yè)指導(dǎo)書構(gòu)成的文獻(xiàn)類。ProductDocumentation-referstoadocumentcategorycomprisingofBOM,ProductDrawings,ProductSpecificationsandProductManufacturingProcedure.產(chǎn)品文獻(xiàn)-指的是由BOM，產(chǎn)品圖紙，產(chǎn)品規(guī)格書，產(chǎn)品制造程序構(gòu)成的文獻(xiàn)類。SystemManual-adocumentdescribingthepolicies,proceduresandpracticesapplicabletoSUNMING.toattainthequalityofproductsandservices.AsystemmanualisclassifiedasLevel1document.體系手冊-描述合用于SUNMING的政策，程序和實(shí)踐，實(shí)現(xiàn)產(chǎn)品和服務(wù)質(zhì)量的文獻(xiàn)。體系手冊歸類為1級文獻(xiàn)。Procedure-asetoflogicalstepsinwhichweperformplannedtaskorexecuteaprocess.Itmaybeageneraldescriptionofactivitiessupportingthesystemmanual.AprocedureisclassifiedasLevel2document.程序–一套我們執(zhí)行計(jì)劃或執(zhí)行任務(wù)的過程中合乎邏輯的環(huán)節(jié)。它能夠是支持體系手冊活動的一種概括的描述。程序歸類為2級文獻(xiàn)。WorkInstruction(WI)-acollectionofdetailedstatement,includingillustrationsonhowtoperformastepinaprocessoranactivity.AworkinstructionisclassifiedasLevel3document.作業(yè)指導(dǎo)書（WI）-具體陳說的聚集，涉及在某一過程或活動中如何執(zhí)行某個環(huán)節(jié)的闡明。作業(yè)指導(dǎo)書歸類為3級文獻(xiàn)。DocumentChangeNotice(DCN)–isusedtoinitiate,reviseortoobsoleteanexistingQMSdocument(SystemManual,Procedure,WorkInstruction).文獻(xiàn)變更告知（DCN）-是用來發(fā)起，修改或廢止現(xiàn)有的質(zhì)量管理體系文獻(xiàn)（體系手冊，程序文獻(xiàn)，作業(yè)指導(dǎo)書）。EngineeringChangeNotice(ECN)-isusedtoinitiate,reviseortoobsoleteanexistingProductDocumentation.工程變更告知（ECN）-是用來發(fā)起，修改或廢止現(xiàn)有的產(chǎn)品文獻(xiàn)。ISOManagementRepresentative-QAManagerisappointedtobetheISOManagementRepresentative.ISO管理代表-QA經(jīng)理為指定的ISO管理代表Purpose-brieflystatesthedocument’sintendeduse/s.目的-簡要陳說文獻(xiàn)的使用意圖。Scope-brieflystatesthedocument’scoverageorextentofuse.范疇-簡要陳說文獻(xiàn)的使用范疇或程度。Definitions&Abbreviations-definestheterminologyusedinthetextsoastobeunderstoodattheleveloftheuser.定義與術(shù)語-定義正文中使用的術(shù)語，方便使用者在此基礎(chǔ)上更容易理解。AssociatedDocuments-listofotherdocumentsreferencedandothersupportingworkinstructions.有關(guān)文獻(xiàn)-列出引用的其它文獻(xiàn)和其它輔助作業(yè)指導(dǎo)書。GeneralRequirements-thebodyordetailedcontentoftheprocedure;astepbystepinstruction普通規(guī)定-程序本身或具體內(nèi)容;逐步闡明。ApprovalSignaturelistabbreviations:同意簽名名單縮寫CEO -ChiefExecutiveOfficer首席執(zhí)行官VPS -VPofSales銷售副總VPM -VPofGlobalMarketing全球市場副總DFA-DirectorofFailureAnalysis技術(shù)增援總監(jiān)DQA -DirectorofQuality質(zhì)量總監(jiān)DOP -DirectorofProduction生產(chǎn)總監(jiān)MAC -ManagerofAccounts財(cái)會經(jīng)理MPR -ManagerofPurchasing采購經(jīng)理MQA -ManagerofQualityAssuranceQA經(jīng)理MHR -ManagerofAdmin/HumanResources行政與人力資源經(jīng)理MME-ManagerofAdvancedManufacturingEngineering高級制造經(jīng)理MCR-ManagerofCleanRoom凈化間經(jīng)理ASSOCIATEDDOCUMENTS有關(guān)文獻(xiàn)DC30001 :WorkInstructionforDocumentNumbering文獻(xiàn)編號作業(yè)指導(dǎo)書DC30002 :WorkInstructionforDocumentChangeNotice(DCN)Generation文獻(xiàn)變更告知生成作業(yè)指導(dǎo)書DC30003 :WorkInstructionforEngineeringChangeNotice(ECN)Generation.工程變更告知生成作業(yè)指導(dǎo)書DC30004 :WorkInstructionforReleasingDocumentstoSuppliers公布文檔給供應(yīng)商之工作指導(dǎo)DC30005 :WorkInstructionforRetentionofQualityDocumentsandRecords品質(zhì)文獻(xiàn)/統(tǒng)計(jì)保存作業(yè)指導(dǎo)書GENERALREQUIREMENTS普通規(guī)定QualityManagementSystem(QMS)Documentationhierarchy品質(zhì)管理系統(tǒng)（QMS）文獻(xiàn)等級Level等級Classification分類1SystemManual體系手冊2Procedure程序文獻(xiàn)3WorkInstruction作業(yè)指導(dǎo)書4Forms&LocallyControlledDocuments表格&本地控制文獻(xiàn)DocumentControlCenter(DCC)shallberesponsibleintheassignmentandcontrolofdocumentnumbers.RefertoDC30001(WorkInstructionforDocumentNumbering)fordetailsofnomenclatureincludingtherevisionnumbering.文控中心（DCC）應(yīng)負(fù)責(zé)文獻(xiàn)編號的分派和控制。參考DC30001（文獻(xiàn)編號作業(yè)指導(dǎo)書）有關(guān)命名涉及版本編號的細(xì)節(jié)。Aspecimenofworkingformsshallbeincorporatedineachdocumentasattachment.DCCshallprovidesoftcopiesoftheseformsuponrequest.工作表格的樣本應(yīng)在每個文獻(xiàn)中納入附件結(jié)合。文控中心應(yīng)根據(jù)申請?zhí)峁┻@些表格的電 子檔。InitialreleasedandcompletelyrewrittendocumentsshallundergoapprovaloftheISOManagementRepresentative.早期發(fā)行和重寫的文獻(xiàn)必須通過ISO管理代表審批。DCCshallprinthardcopiesofapproveddocumentsandwillmakeitavailableforstaffreadingintheDCCroom.文控中心應(yīng)打印已同意文獻(xiàn)供SUNMING的職工在文獻(xiàn)控制中心查看。Changesissued(throughDCN&ECN)toinitiate,reviseandobsoleteadocumentshallbereviewedforadequacybeforeapprovalbythefollowingsignatory:發(fā)起，修改和廢止一份文獻(xiàn)須審查其適宜充足后由下列人員簽名同意才可發(fā)行變更（通過文獻(xiàn)變更告知&工程變更告知）。QMSDocumentCategoryCategoryCodeApprovalSignatureListGeneralManagement日常管理GMCEO/VPS/DQA/MQANewBusinessDevelopment新業(yè)務(wù)開發(fā)NBCEO/VPS/VPMProductQualification產(chǎn)品資格PQCEO/DFAHR&AdminDocuments人力資源&行政文獻(xiàn)HRCEO/MHRDocumentControl文獻(xiàn)控制DCCEO/DQA/MQAQualityAssurance品質(zhì)確保QACEO/DQA/MQADesignandEngineeringDocuments設(shè)計(jì)與工程文獻(xiàn)DECEO/DFAProductionDocuments生產(chǎn)文獻(xiàn)生產(chǎn)文獻(xiàn)PDCEO/DOP/MQAPurchasingDocuments采購文獻(xiàn)PRCEO/DQA/MQADocumentcontrolstaffisresponsiblefor“routingforapproval”oftheEngineeringChangeNotice(ECN).AnormalChangeNoticeFormsshallbecompletelysignedwithin2workingdaysforECNand5workingdaysforDCNotherwisetheinitiatorshallbeinformedofthedelay.Urgent(sameday)changesshallberoutedbyinitiator.文獻(xiàn)控制工作人員負(fù)責(zé)跟進(jìn)工程變更告知（ECN)的安排和同意。正常工程變更告知（ECN)應(yīng)在2個工作日內(nèi)完畢訂立以及在5個工作日內(nèi)完畢DCN的訂立，若有延誤應(yīng)告知發(fā)起人。緊急的（當(dāng)天）變更，應(yīng)由發(fā)起人負(fù)責(zé)跟進(jìn)。Thefollowingformatshallbeuseasageneralguidelineingeneratingnewsystemmanuals,proceduresandworkinstructions.Aspecimenofthestandarddocumentformatisshowninattachment1&2.下面的格式應(yīng)作為生成新的體系手冊，程序文獻(xiàn)和作業(yè)指導(dǎo)書的一項(xiàng)通用指南來使用。原則文獻(xiàn)格式的樣本詳見附件1和2Purpose目的(ForLevel1&2only)Scope范疇Definitions&Abbreviations術(shù)語與定義(ForLevel1&2only)AssociatedDocuments有關(guān)文獻(xiàn)SafetyRequirements安全規(guī)定(ForLevel3only)GeneralRequirements普通規(guī)定Procedureshouldbeupdated,asrequired,asaresultofprocessreviewforcomplianceandeffectiveness.按照規(guī)定以及工序評審的一致性和時效性的需要來更新程序。Sales&MarketingTeamshalldeterminetheneedforreviewofcustomerdocumentswithrelevantdepartments(refertoDC30004:WorkInstructionforReceivingandControlofCustomerandOtherDocument).銷售/市場部和有關(guān)部門應(yīng)擬定對客戶文獻(xiàn)評定的需求（參考DC30004：客戶和其它文獻(xiàn)的接受和管控作業(yè)指導(dǎo)書）。SupplierQualityEngineershalldeterminetheneedforreviewofsupplierdocumentsrespectively.供應(yīng)商質(zhì)量工程師應(yīng)擬定對供應(yīng)商的文獻(xiàn)評審的需求。DCCshallberesponsibleforarchivingqualitydocuments/records.Amasterlistwhichidentifiesthedocumentlocationshallbemaintainedfortraceability.Thisappliestobothhardcopyandsoftcopyformats(refertoDC30004:WorkInstructionforRetentionofQualityDocuments/Records).文控中心應(yīng)負(fù)責(zé)質(zhì)量文獻(xiàn)/統(tǒng)計(jì)的歸檔。應(yīng)保持標(biāo)示文獻(xiàn)位置的主列表方便查找，此規(guī)定同時合用于印刷版和電子檔。（參考DC30004：質(zhì)量文獻(xiàn)/統(tǒng)計(jì)保管作業(yè)指導(dǎo)書）。Controlleddocumentsidentification.受控文獻(xiàn)鑒定CONTROLLED–Documentthatshallbeusedasregulatoryproceduresandworkinstructionsinareasaffectedbysuchdocument,shallbemarkedasCONTROLLEDCOPYinredinkonallpages(seespecimeninattachment3).TheonlineversionofdocumentmaintainedintheQMSDocumentfolderofSUNMINGintranetisalsoconsideredcontrolledcopy.ThisdocumentshallbeautomaticallyrecalledandupdatedbyDCCwheneverchangesareofficiallymade.DCCshallmaintainarecordofcontrolleddocuments(hardcopy)distribution.規(guī)范程序和受這類文獻(xiàn)影響范疇內(nèi)的作業(yè)指導(dǎo)書應(yīng)受控使用，該類文獻(xiàn)的每頁應(yīng)附有CONTROLLEDCOPY標(biāo)記的紅色水印，（見附件3樣本）。保存在SUNMING內(nèi)聯(lián)網(wǎng)的質(zhì)量管理體系文獻(xiàn)的文獻(xiàn)夾中的網(wǎng)絡(luò)電子版本也視為受控文獻(xiàn)。本文獻(xiàn)在任何時候提出的正式變更都應(yīng)由文控中心自動回收和更新。文控中心應(yīng)保持一種分發(fā)受控文獻(xiàn)（印刷版）的統(tǒng)計(jì)。AnydocumentwhichdoesnotbearCONTROLLEDCOPYinredinkshallbydefaultbeconsideredasuncontrolleddocument.Uncontrolleddocumentsareissuedforreferenceonly.任何文獻(xiàn)在沒有用紅墨水印的CONTROLLEDCOPY標(biāo)記默認(rèn)的狀況下被視為未受控的文獻(xiàn)，不受控的文獻(xiàn)印發(fā)只作參考。BothCONTROLLEDanduncontrolleddocumentsareproprietarydocumentsofthecompany;anyunauthorizeduse,photocopying,orpossessionofanydocumentotherthanforitssolepurposeandlegitimateuse,isstrictlyprohibited.受控和未受控文獻(xiàn)均為公司的機(jī)密文獻(xiàn)，任何文獻(xiàn)除了其唯一目的和正當(dāng)使用以外嚴(yán)禁任何未經(jīng)授權(quán)的使用，復(fù)印，或擁有。SUNMINGdocumentmayexistinbothEnglishandChineselanguage.Incasewhereofadifferenceofinterpretationarise,theEnglishlanguageinterpretationshallprevail.SUNMING文獻(xiàn)可能存在英語和漢語版本。在出現(xiàn)不同解釋的狀況下，以英文解釋為準(zhǔn)。Incasecorrectionorchangin