文件管理程序

Documentmanagementprocedure文獻管理程序Purpose目的：Thepurposeofthisdocumentistoensuremanagementsystemoperatesefficientlyandundercontrol,andeverydepartmenthaslatestversionofdocument.為確保我司管理體系有效運作和受控，各部門均能持有最新版的受控文獻. Scope范疇：Thisprocedureappliestoalllevelsofcontrolleddocumentsandexternaldocuments.合用于我司管理體系中各級文獻以及外來文獻。Definition定義：Managementsystemdocumentsareof4levels:Manual;Procedures,Criterion,andChecklist管理體系中文獻分四級:手冊；程序文獻；工作指導書、規(guī)范或原則；表單 3.1Manual手冊:Level1doc,acomprehensivedescriptionofthesystem,whichincludepolicyandtarget.第一級文獻，對體系進行綜合描述，涉及方針、目的。Procedure程序:Level2doc,explainshowtoworkandhowtocompletethepolicyandtargetinManual.第二級文獻，詳述如何進行工作及完畢手冊中所規(guī)定的政策及目的。WorkinstructionorCriterion:工作指導書、規(guī)范或原則:Level3doc,importantbasisorguidedocumentsformanagementprocedureexecution.第三級文獻，為支持各項管理程序于執(zhí)行階段時重要的根據(jù)或指導之文獻、原則。ChecklistandRecord表單及統(tǒng)計:Level4doc,testandverifymanagementsystem’sefficiencyfromconstantlyrecordingalltheprocedures.第四級文獻，為驗證管理體系有效運作，而對各個事項持續(xù)不停加以統(tǒng)計。Externaldocuments外來文獻:Includecustomerdrawing,international/nationalcriterion,relevantlawsandregulations,industrialstandards,customer/suppliertechnicaldocuments,andetc.指客戶圖面、國際、國標、有關法律法規(guī)、行業(yè)原則、客戶或供應商提供的技術文獻等。Controlleddocument:DCCreleaseddocument.受控文獻：由DCC發(fā)行的文獻屬受控文獻3.7Draftdocuments:onsitereworkinstructionshallbeissuedasdraftdocuments(e.g.reworkinstructionect.),markedwithexpiredate,anditsvalidityperiodshouldbenolongerthan1month.臨時文獻：現(xiàn)場需要臨時使用的受控文獻，如返工作業(yè)指導書等，臨時文獻上需注明失效日期，臨時文獻使用期不超出1個月。InthisdocumentDCCstandsfordocumentcontrolcenter文控中心,本文獻中均以DCC表達Responsibility權(quán)責：4.1DCCisresponsibleformanagingallthecompany’sdocumentsDCC負責公司全部管理體系文獻的管理工作。4.2Eachdepartmentisresponsibleformanagingtheirowndocuments.其它部門負責各自體系文獻的管理工作。Eachdepartmentisresponsibleformanagingtheirowndocuments.Procedure流程：輸入（Input）流程（Procedure）輸出（Output）權(quán)責（Owner）有關闡明（Explanation）Standarddemands原則化需求Law/regulationrelevantstandards/customerdrawing法律法規(guī)/有關原則/客戶圖紙Engineeringchange,standarddemands工程變更、原則化需求Creationofdocument/revisions文獻制訂Creationofdocument/revisions文獻制訂/修訂Approved審批Approved審批Train培訓OKTrain培訓OKDocumentrelease文獻發(fā)行Documentrelease文獻發(fā)行DocumentusingkeepingandmaintainingDocumentusingkeepingandmaintaining文獻使用保管維護ExternaldocumentExternaldocumentreceiving外來文獻接受Externaldocumentreview外來文獻評審Externaldocumentreview外來文獻評審NGExternaldocumentrelease外來文獻發(fā)放OKExternaldocumentrelease外來文獻發(fā)放DocumentusingkeepingandmaintainingDocumentusingkeepingandmaintaining文獻使用保管維護ECNorDocumentECNorDocument/FormRevisionandApproval&modifieddocument工程變更告知單/文獻表單修改和同意&修改好的文獻ReviewcountersignReviewcountersign審批會簽OK.OKTrain培訓Documentusingkeepingandmaintaining文獻使用保管維護Changeinvalidcontinuetouseoriginaldocument變更無效，沿用原文獻DocumentreleaseTrain培訓Documentusingkeepingandmaintaining文獻使用保管維護Changeinvalidcontinuetouseoriginaldocument變更無效，沿用原文獻Documentrelease文獻發(fā)行[document/formapplication]［文獻/表單申請表］Approveddocument審批后的文獻[Attendancerecord][培訓簽到表]Controlleddocument受控文獻[Documentmasterlist]［文獻總覽表］[DocumentIssue/RecallRecords]［文獻發(fā)放回收統(tǒng)計表］[ExternalFiles(Specification)ReviewReport][DrawingIdentificationReport][外來文獻評審表][判圖統(tǒng)計]［文獻總覽表］[DocumentIssue/RecallRecords]［文獻發(fā)放回收統(tǒng)計表］Controlleddocument受控文獻[Document/FormRevisionAndApproval]［文獻表單修改和同意表］[ECNApplication]［工程變更告知及申請］Approveddocument審批后的文獻[Attendancerecord][培訓簽到表]Controlleddocument受控文獻[Documentmaster]［文獻總覽表］[DocumentIssue/RecallRecords]［文獻發(fā)放回收統(tǒng)計表］Documentmanagement文獻管理Demanddocument需求部門Departmentmanager/managerrepresentative/GM/projectmanager部門經(jīng)理/管代/總經(jīng)理/項目負責人DCCDCCandDocumentControllerDCC及各部門文獻管理人DutyDepartmen各職能部門Team項目小組DCCDCCandDocumentControllerDCC及各部門文獻管理人Documentchangeinitiator文獻變更發(fā)起人Departmentmanager/managerrepresentative/GM/projectmanager部門經(jīng)理/管代/總經(jīng)理/項目負責人DCCDCCandDocumentControllerDCC及各部門文獻管理人Documentshallcomplywith<CriterionForDocumentNo.Version,FormatAndWriting>文獻編寫時需符合<文獻編號、版次、格式及書寫規(guī)范>,Documentissuedbasedon6.1文獻審批依此文獻6.1執(zhí)行Documentissuedbasedon6.3文獻發(fā)行依本文6.3執(zhí)行Documentusingkeepingandmaintainingissuedbasedon6.8文獻使用保管維護6.8執(zhí)行Externaldocumentsshouldbereviewedforitsfeasibility,butnomorethan2weeks,andreviewtheresultfeedbacktothecustomer,intwoweeks外來的客戶圖紙發(fā)行前需得到項目組的評審（評審時間不可超出兩周）并在2周內(nèi)將評審成果反饋給客戶Documentissuedbasedon6.3文獻發(fā)行依本文6.3執(zhí)行Documentusingkeepingandmaintainingissuedbasedon6.7文獻使用保管維護6.7執(zhí)行Demandingdepartmentsputforwardthechangingapplicationforreviseddocument.需求部門提出修改好的文獻及提出變更申請。Eachdepartmentreviewswhetherthemodificationcompliestorequirementsofsystem.各職能部門評審對應的修改與否符合系統(tǒng)及實際操作的規(guī)定。Documentissuedbasedon6.3文獻發(fā)行依本文6.3執(zhí)行Documentusingkeepingandmaintainingissuedbasedon6.7文獻使用保管維護依6.7執(zhí)行Content內(nèi)容：6.1Documentpreparationandapproval文獻的編寫與審批(Level2documentsofthemanagementrepresentativeshallbedraftedbyqualitymanager,checkedbymanagementrepresentativeandapprovedbygeneralmanager)(管理者代表的二階文獻由副總經(jīng)理審核，總經(jīng)理同意。)Iftheapproveraskforleaveorbeonabusinesstrip，thedocumentcan’tbeapprovedintime.itshouldbecompletedbytheagent當文獻審批人由于請假或出差等因素不能及時完畢文獻審批時，則由該負責人的代理人完畢文獻的審批工作。DocCategory文獻類別Preparedby制訂Reviewedby/sign審核/會簽Approvedby同意Quality/EHS/HSFPolicy質(zhì)量/EHS/HSF方針Quality/EHS/HSFobjective質(zhì)量/EHS/HSF目的Quality/EHSmanual質(zhì)量/EHS手冊Managementrepresentative管理代表EHSEngineeringEHS工程師/GeneralManager總經(jīng)理QP/EP程序文獻RelatedDepartment有關部門Headofdepartment有關部門主管/經(jīng)理Managementrepresentative管理代表WI三級文獻RelatedDepartment有關單位Headofdepartment有關單位主管PM/Manager項目經(jīng)理/部門經(jīng)理Externaldocument外來文獻Documentisreviewedbyprojectteam，itsdistributionisdeterminedbyreceivingdepartment,thenissuedbyDCC.由項目組評審，接受部門確認需要分發(fā)部門，DCC發(fā)行Form表單QPandWIshallbecheckedandapprovedtogether.隨附QP與WI文獻被審核，同意。Preparationofdocument:Documentshallbepreparedaccordingto<CriterionfordocumentNo.,version,format,andwriting>.Afterapproval,shallbesubmittedtoDCCtogether.文獻制訂:文獻制作需符合<文獻編號、版次、格式及書寫規(guī)范>，經(jīng)同意后交于DCC。Distribution/Return分發(fā)/回收作業(yè)6.3.1WhenDCCreceiveapproveddocument,DCCshallconfirmdocumentNo.andversion,andissuethenformandkeepdocumentinthePublicdrive\\1\ST-Quality\DCCorintheERPandupdatein[Documentmasterlist].DocumentcanonlyberevisedbyDCCandberead-onlybyotherdepartments.ITshouldbackupthePdrovedocumentonperiodically,incaseofthelost.DCC收到簽核完畢之文獻后，確認文獻編號、版本版次符合性，確認合格后將文獻發(fā)行，并存檔，地址存于公共盤：\\1\ST-Quality\DCC，或ERP中，同時更新到［文獻總覽表］中，該地址文獻只有DCC中心能夠修改，其它部門人員權(quán)限為只讀。公共盤DCC文獻定時由IT備份一份，以防資料丟失。6.3.2Thefollowingdocumentsshallbeissuedinpaper,othersine-document.下表文獻需要發(fā)行紙文檔，其它文獻一律發(fā)行電子檔。具體見下表：Category文獻類別Name文獻名稱ReceivingDepartment接受部門/單位Issuemethods發(fā)行方式OExternalDocument外來文獻OperationCenter/QualityDept./DevelopmentCenter運行中心/質(zhì)量部/開發(fā)中心Paper發(fā)行紙檔WI＜MoldingDataSheet＞＜注塑原則工藝＞OperationCenter運行中心Paper發(fā)行紙檔WI＜MoldingProductionOperatorWorkInstruction＞＜注塑生產(chǎn)作業(yè)員操作指導書＞OperationCenter運行中心Paper發(fā)行紙檔WI＜GP12WorkInstruction＞＜GP12作業(yè)指導書＞OperationCenter運行中心Paper發(fā)行紙檔WI＜InspectionInstruction＞＜檢查指導書＞OperationCenter/QualityDept.運行中心/質(zhì)量部Paper發(fā)行紙檔WI＜PackingSpecification＞＜包裝規(guī)范＞OperationCenter運行中心Paper發(fā)行紙檔WI<FixtureDrawingForInternalInspection>＜內(nèi)部檢治具圖紙＞QualityDept.質(zhì)量部Paper發(fā)行紙檔WICriterionandregulationdocumentsforworksite現(xiàn)場使用有關操作規(guī)范或規(guī)章制度類文獻OperationCenter/QualityDept./DevelopmentCenter運行中心/質(zhì)量部/開發(fā)中心Paper發(fā)行紙檔6.3.3DCCisresponsiblefordistributingdocumentstorelateddepartmentandisrequiredtokeeparecordofissuance/returnofahardcopyinto[Documentissuance/returnrecordform].Recipientrepresentingthereceivingdepartmenthastosignthe[Documentissuereturnrecordform]andrecyclingtheolddocument.Ifasoftcopyisdistributed,DCCshallinformrelateddepartmentbyE-mail.DCC負責分發(fā)受控文獻至有關部門，紙檔文獻發(fā)放/回收需統(tǒng)計在[文獻發(fā)行/回收記錄表]上。領取部門需在[文獻發(fā)行/回收記錄表]上簽收并同時回收舊版本文獻。電子檔文獻發(fā)行時，DCC以Email方式告知有關部門。[Document/FormApplication]needtobefilledandapprovedbytherequestingdepartmentheadandthemanagementrepresentativewhendocumentisinsufficient,missingordamaged,beforeanewcopyofdocumentshallbereissuedtorelateddepartmentforworkpurposes.由于工作的需要而又沒有文獻或原文獻丟失、破損時，申請方填寫[文獻/表單申請表]經(jīng)所在部門負責人審核、管理者代表后，可補發(fā)。6.5Documentorcopiesofdocumentswithoutstampof“受控文獻”areineffective.文獻未蓋有"受控文獻"章之文獻或復印的“文獻受控”，視同無效文獻。6.6Changeofdocument文獻的變更6.6.1.Modifiedcontentshouldbeshowninitalicfondmarkedwithunderlineandkeeparecordinthedocumentissue/revisionrecord,atthesametimetrainingtorelevantpersonnel.文獻修改時，在修改部分用斜體加下劃線體現(xiàn)并統(tǒng)計在文獻制/修訂履歷表上，同時需對有關人員進行培訓。6.6.2Intheoperation,whenoneoffollowingcaseshappensandneedtochangedocument,theengineeringchangeapplicationshouldberaised.我司生產(chǎn)運行中遇下列狀況并涉及文獻變更時，需提出工程變更申請。Changesputforwardbycustomer客戶端發(fā)起的變更Changesofproductperformancecharacteristics,andspecifications產(chǎn)品性能，規(guī)格的變更Materialoritssourcechange材質(zhì)或者其來源變更Significantimprovementofproductionprocess制造過程或生產(chǎn)方式重大改善Theuseofnewproductionequipment運用新的生產(chǎn)設備生產(chǎn) 6.6.3Whenthedocumenttoupdatebecauseofcustomercomplaintorinternal8D,onlyremarkthe8dnumber,don’tneedtodoECNprocess6.6.3當客戶投訴/內(nèi)部8D等引發(fā)文獻更新時，則在變更備注中備注8D單號即可，無需ECN流程。6.6.4Whenotherdocuments/formneedchanging,thechangingrequestsin[Document/FormRevisionandApproval]shallbefilledbytherelateddepartmentandsubmittedtotheheadofthedepartmentandotherrelateddepartmentswhowillneedtogiveestimateandreviewonthechangesandtheirpossibleimpacts,thentodecideifthechangeisnecessary.Ifyes,theywillneedtosignonthe[Document/FormRevisionandApproval].Anychangeonadocumentneedtobeapprovedbytheoriginalapproverofthedocument.Whenoriginalapprovalpersonnelisoutofduty,itcanbeapprovedbythepersonnelwhoactsforhis/herposition.6.6.4其它文獻/表單修改時由有關部門提出申請，并需填寫[文獻/表單修改和同意表]，報部門經(jīng)理以及各部門，對修改的內(nèi)容和修改可能造成影響進行評定和預測，擬定修改與否必要，并在[文獻/表單修改和同意表]訂立意見，如確需修改，經(jīng)文獻原同意人同意后可進行修改。若原同意人發(fā)生變動，則由原職務的接任人負責審批。6.6.5level3documentofmedical醫(yī)療產(chǎn)品三級文獻[level3documentlistofmedical]whichrelatetomedicalproductshouldberecordedthelist，thislistneedtodefinethedocumentapproverandtrainingparticipants,andissuetorelevantdepartmentaccordingto[Level3documentlistofmedical]andexecute.醫(yī)療產(chǎn)品有關的三級文獻識別出后要統(tǒng)計在[醫(yī)療產(chǎn)品三級文獻清單]中，該清單需定義各文獻的審批及培訓對象，同時將該表單發(fā)行到有關單位依[醫(yī)療產(chǎn)品三級文獻清單]規(guī)定進行文獻的審批及培訓；When

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edition.[醫(yī)療產(chǎn)品三級文獻清單]中的文獻更改時，審批必須得到原始部門或指定部門確實認，培訓對象依清單中定義的人員進行培訓。DCC在發(fā)行的同時需更新[醫(yī)療產(chǎn)品三級文獻清單]中的對應文獻版本；Whenthelisttrainingparticipantsischanged,supervisorneedtoinformDCCupdatethelist.Thenthedirectsupervisorordocumentwritertodotraining[醫(yī)療產(chǎn)品三級文獻清單]中的培訓對象有變更時，所在單位主管第一時間告知到DCC更新[醫(yī)療產(chǎn)品三級文獻清單]，并由直接主管或文獻撰寫人進行培訓。ThepersonwhoisresponsibleforapprovingMedicaldocumentshallhavethecorrespondingprofessionalbackground.醫(yī)療產(chǎn)品文獻的審核和同意人應含有對應的專業(yè)背景6.7Maintain/Obsolete保存/作廢作業(yè)6.7.1Thecorrespondingfilesshouldbereviewedandrevised/abolishedbyofeachdepartmentbasedonitssituation,inwhichprocessthesoftcopy,hardcopyand[document/formapplication]shallbehandovertotheDCCforissuanceorobsoleting.各部門視需要對對應文獻進行評審修訂/廢止，然后將電子文檔、打印文獻、[文獻/表單申請表]交于DCC發(fā)放或作廢.6.7.2Oldversionorobsoletedocumentsshouldbestampedwith“作廢”itssoftcopyshouldbemaintainedin“作廢舊文獻”fileofEdiveinDCCcomputerorERPsystem.舊版及作廢文獻紙檔蓋"作廢"章作廢,電子檔存于DCC電腦E盤“作廢舊文獻”夾或ERP系統(tǒng)中6.7.3Maintainatleastoneobsoletedocumentformedicalproducts.Itsoldversionminimumsavingperiodisreferringtotherelevantlawsandregulationsfortheproductifecycleortheprescribedtimelimit.Theobsoletemedicaldocumentsshouldberecordinto[Document/FormObsoleteMaster]針對醫(yī)療器械產(chǎn)品應最少保存一份作廢文獻，舊版文獻保存時，保存期限最少為產(chǎn)品的有關法律法規(guī)壽命周期或規(guī)定的期限，醫(yī)療類作廢文獻需登錄與[文獻/表單作廢一覽表]中.6.7.4Thecontrolfileholdingdepartmentisresponsibleforreceivingandupdatingfile,andverifywithDCCtoensurehasthelatestversion.文獻持有之部門，負責文獻接受及更新統(tǒng)計，并定時到DCC處核對文獻版本，以確保文獻為最新版本。6.8Controlofexternaldocuments外來文獻的控制6.8.1Externaldocumentsshouldbeverifiedforitsfeasibilityuponreceiving,andgivenanauditingifnecessary,whichshallbecompletedwithnomorethan2weeksbeforesubmittedtoDCCandupdatein[Documentmasterlist].外來文獻接受后，應由接受單位確認其適宜性，必要時進行評審，評審時間不超出兩周，然后轉(zhuǎn)交DCC并登陸[文獻總覽表]。6.8.2Theexternaldocumentsissuedbasedon6.3外來文獻發(fā)行時，依6.3執(zhí)行.