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RevisionHistory更改統(tǒng)計(jì)Issue版本Page#頁(yè)碼Rev版次CHANGE更改內(nèi)容WRITTENBY編寫DATE日期ReviewandApproval審查和同意Review[x][x][x][x][x][x][x][x][x][x][x]Signature/DateQSOfficer:________________________QCSup:_____________________________QESup:____________________________QAMgr&MR:__________________________ProgramDirector:__________________________PM:________________________________StoreMgr:_________________________PurchasingMgr:______________________PMCSup:_____________________________ShippingSup:________________________FacilityMgr:______________________Review[x][x][x][x][x][x][x][x][x]Signature/DateFacilityEngineeringMgr:___________________________________MEMgr:_____________________________1stprocessMgr:______________________2ndProcessMgr:______________________PPCMgr:____________________________ToolingRepair&MaintenanceMgr:_____________________________________HRMgr:_____________________________ADMMgr:_____________________________MISMgr:_____________________________APP[x]Signature/DatePlant.Manager:____________________CheckedbyDCC/Date:文控審核/日期:EffectivedateExpirydate文獻(xiàn)生效日期:_________________________文獻(xiàn)失效日期:_________________________Confidential&ProprietaryInformationofZJKC.目的Purpose:對(duì)品質(zhì)保証系統(tǒng)和環(huán)境管理系統(tǒng)(涉及GreenPartner)文獻(xiàn)及與之有關(guān)的資料規(guī)定控制辦法,旨在確保使用有效版本,避免使用失效或作廢文獻(xiàn),確保其系統(tǒng)有效運(yùn)作。Provideaguidefortheeffectiveoperationofqualitysystemandenvironmentsystem(includingGreenPartner)andensureusingvalidversionandavoidinvalidoruselessdocumentbeingused.範(fàn)圍Scope:全部品質(zhì)系統(tǒng)、環(huán)境系統(tǒng)(涉及GreenPartner)文獻(xiàn)及與之相關(guān)的資料的控制。Controlofallthequalitysystemandenvironmentsystem(includingGreenPartner)anditsrelevantdocuments定義Definitions:DCC:是文獻(xiàn)控制中心的英文縮寫。DCCistheshortformofDocument書面文獻(xiàn)Hardcopy:從計(jì)算機(jī)輸出資料打印在紙張上的文獻(xiàn)。DocumentsprintedorcopiedonpaperfromthePC.受控文獻(xiàn)ControlledDocument:受更改和分發(fā)控制,并蓋有DCC紅色“紅印有效控制文獻(xiàn)”印章的書面文獻(xiàn),文控中心會(huì)自動(dòng)以舊換新。Thedocumentisstampedwithred“DOCCONTROLREDCHOPVALID”seal.DCCwillreplacetheobsoletedocumentwiththeupdaterevisionautomatically.參考文獻(xiàn)ReferenceDocument:DCC蓋有蘭色“參考文獻(xiàn)”印章的文獻(xiàn),文獻(xiàn)中心不會(huì)回收及進(jìn)行更新。Thedocumentisstampedwithblue“FORREFERENCEONLY”seal.DCCwon’trecalltheobsoletereferencedocumentanddistributetheupdaterevision.作廢文獻(xiàn)ObsoleteDocuments:不適合使用的文獻(xiàn),可能被新文獻(xiàn)所替代,或者是已失效。Documentsthatisnotvalidtouseastheyareeitherreplacedwithanewrevisionorexpired.GP:Sony綠色伙伴的簡(jiǎn)稱GPistheshortformofGreenPartner.內(nèi)部文獻(xiàn):外部文獻(xiàn):職責(zé)Responsibility:編寫者應(yīng)使用對(duì)的的文獻(xiàn)格式并按照本文獻(xiàn)的規(guī)定排版,并將文獻(xiàn)檔和電子檔一起交由文獻(xiàn)控制中心。OriginatorofprocedureistoproperlyfillupprocedureusingcorrectformsandtypedneatlyaccordingtothisFOPandsubmitthehardcopytogetherwithsoftcopytoDocument文獻(xiàn)控制中心文獻(xiàn)管理員DocumentControlCenterclerk:負(fù)責(zé)文獻(xiàn)的接受、復(fù)制、分發(fā)、維護(hù)和及時(shí)更新文獻(xiàn)目錄總清單。Isresponsibletoreceive,duplicate,distribute,maintainandupdatemasterlistintime.根據(jù)規(guī)定分發(fā)文獻(xiàn)編號(hào),并登記文獻(xiàn)標(biāo)題。IssuerelatedDOCNo.uponrequestandregistertitle.檢查文獻(xiàn)的同意與否齊全及格式與否符合規(guī)定。Checkcompletionofsignatureloopandwhetherthedocumentformatmeetdocumentcontrolprocedure.全部部門經(jīng)理Alldepartmentmanager/head在3個(gè)工作日內(nèi)審視文獻(xiàn)并批復(fù)。Reviewrelateddocumentsbeforesignoffwithin3workingdays;在本人缺席的狀況下,應(yīng)指定代理人執(zhí)行此項(xiàng)工作,協(xié)助審視并批復(fù)。Duringabsenceofanydepartmenthead,he/shemustappointhis/heragenttoreviewandsignprocedureonhis/herbehalf;當(dāng)文獻(xiàn)不再合用時(shí),應(yīng)主動(dòng)召集更改有關(guān)文獻(xiàn)。Initiatechangesonprocedurethatareoutdated.新程序生效后或程序更新后,若需培訓(xùn),則培訓(xùn)本部門人員,并將培訓(xùn)統(tǒng)計(jì)送培訓(xùn)部歸檔。Afteranewprocedureentersintoeffectoranoldprocedureismodified/amended/revised/updated,iftrainingisnecessary,thentrainsallpersonnelbelongingtohis/herowndepartmentandcompletethetrainingrecordandsendthetrainingrecordtoTrainingDepartmentforfiling.生產(chǎn)主管ProductionSupervisor負(fù)責(zé)將全部作業(yè)指導(dǎo)書擺放在所使用位置并確保文獻(xiàn)的執(zhí)行。Isresponsibletodisplaytheworkinginstructionatthelocationofuseandensurethemanufacturingprocessiscarriedout;確保全部用于生產(chǎn)線的作業(yè)指導(dǎo)書為最新版本文獻(xiàn),并確保其沒有任何修正液或隨意改正的狀況。Isresponsibletoensureallworkinginstructiondisplayedorusedinproductionlinearethelatestrevisionandtheworkinginstructiondoesnothaveanywhite-washand/orcorrection.各部門文獻(xiàn)接受員:Documentcontrolclerkofeverydepartment/section:核對(duì)所接受文獻(xiàn)的完整性。Checkthecompletenessofreceiveddocument.將DCC分發(fā)的受控文獻(xiàn)轉(zhuǎn)交給各主管/組長(zhǎng)張貼于工作需要的地方或交給本部門內(nèi)各有關(guān)人員傳閱后收回歸檔。Forwardthecontrolleddocumentstosupervisor/leadertopostworkstation,orsentittoallrelativepersontoreadandcollectitforfiling.負(fù)責(zé)將全部舊版文獻(xiàn)及時(shí)還回文獻(xiàn)控制中心文獻(xiàn)管理員。IsresponsibletoreturnallobsoletecontrolleddocumentstoDCCClerk.程序Procedure:文獻(xiàn)分類、制訂和審批Documentclassification,establishment,reviewandapproval從文獻(xiàn)資料內(nèi)容上分,分為四層文獻(xiàn),編寫及審批權(quán)限具體以下﹕Fourlevelsofdocumentsareclassified,prepared,reviewedandapprovedasbelow:類別Category級(jí)別Level內(nèi)容Content編寫Preparedby審核人Reviewedby同意人Approvedby一級(jí)1stlevel公司質(zhì)量手冊(cè)QualityManualQSOffice質(zhì)量管理代表ManagementRepresentative總經(jīng)理GeneralManager二級(jí)2ndlevel控制程序ControlProcedureQSOffice、各職能部門Respectivefunctiondept與文獻(xiàn)內(nèi)容有關(guān)的全部部門經(jīng)理/主管AllDept.Manager/supervisorrelatedtothedocument.總經(jīng)理GeneralManager品質(zhì)系統(tǒng)QualitySystem三級(jí)3rdlevel操作指導(dǎo)OperationInstructionQC檢查指導(dǎo)票QCinspectioninstruction產(chǎn)品作業(yè)指導(dǎo)書WorkInstructionforOperation包裝作業(yè)指導(dǎo)書PackingInstruction管理類文獻(xiàn)Administrationdocuemt各職能部門RespectivefunctiondeptN/A部門經(jīng)理/主管DeptManager/supervisor外來文獻(xiàn)(涉及來自客戶的文獻(xiàn))Externaldocument(includingcustomerprovideddocument)N/AN/A見FQP-DOC03SeeFQP-DOC03有關(guān)工作控制規(guī)范通用文獻(xiàn)relevantoperationcontrol各職能部門Respectivefunctiondept與文獻(xiàn)內(nèi)容有關(guān)的全部部門經(jīng)理/主管AllDept.Manager/supervisorrelatedtothedocument.質(zhì)量管理代表ManagementRepresentative四級(jí)4thlevel質(zhì)量統(tǒng)計(jì)QualityRecord表格Form各職能部門RespectivefunctiondeptN/A使用部門經(jīng)理/主管UsingDeptManager/supervisor文獻(xiàn)格式:Thestandardformatofdocument:程序文獻(xiàn)和控制規(guī)范封面格式見QF-QA-026,程序文獻(xiàn)和控制規(guī)范內(nèi)容格式見QF-QA-027。ThestandardformatofprocedureandcontrolworkisasQF-QA-026andQF-QA-027;QC檢查指票格式見QF-QC-049。ThestandardformatofQCinspectioninstructionisasQF-QC-049.第一工序產(chǎn)品作業(yè)指導(dǎo)書(含包裝作業(yè)指導(dǎo)書)格式見QF-QA-034TheformatofoperationinstructionforthefirstprocessisasQF-QA-034第二工序產(chǎn)品作業(yè)指導(dǎo)書格式見QF-QA-029TheformatofoperationinstructionforthesecondprocessisasQF-QA-029.機(jī)械設(shè)備、儀器操作,維修和保養(yǎng)作業(yè)指導(dǎo)書及工藝操作指導(dǎo)書格式無特定規(guī)定。普通狀況下用可采用表格QF-QA-028。若不合用時(shí),各部門可根據(jù)實(shí)際運(yùn)作需要自行編寫格式。Thereisnospecialrequirementfortheformatofworkinstructionsofmachine/equipmentoperation,repair,andmaintenanceandprocessoperation.GenerallySpeaking,theformofQF-QA-028canbeused.IfN/A,Everydept.canworkouttheappropriateformattomeettheactualneed.儀器校驗(yàn)作業(yè)指導(dǎo)書格式見QF-QA-036SeeQF-QA-036fortheformatofworkinginstrumentofinstructioncalibration.產(chǎn)品質(zhì)量控制計(jì)劃格式見QF-QC-019A.QualitycontrolisasQF-QC-019A。FMEA格式見QF-ME-005。FMEAisasQF-ME-005.程序文獻(xiàn)和控制規(guī)范的內(nèi)容原則格式以下,但不局限于:Thestandardformatofallprocedureandcontrolworkisasbelow,butnotlimitto:目的(編寫此文獻(xiàn)的目的)。Purpose(purposeofqualityproceduretobewritten).范疇(此文獻(xiàn)所合用的范疇)。Scope(scopethatthequalitydocumentisappliedfor).定義Definition。如果沒有,請(qǐng)寫無。Ifnone,stateN/A.職責(zé)Responsibility。程序Procedure.相關(guān)文獻(xiàn)和資料Relevantdocumentanddata。如果沒有,請(qǐng)寫無。Ifnone,stateN/A品質(zhì)統(tǒng)計(jì)QualityRecord.如果沒有,請(qǐng)寫無。Ifnone,stateN/A.流程圖Flowchart.如果沒有,請(qǐng)寫無。Ifnone,stateN/A.附錄(涉及印章樣本,表格等)Attachmentincludingstampsample,formetc.)針對(duì)作業(yè)指導(dǎo)書內(nèi)容格式,除規(guī)定有文獻(xiàn)編號(hào),生效日期,版次,頁(yè)碼,修訂歷史統(tǒng)計(jì),制作人和核準(zhǔn)人外,無特定規(guī)定。由制作人根據(jù)實(shí)際需要而設(shè)定。Forthecontentformatofworkinstructions,thereisnospecialrequirementexceptforthefollowingitem:documentno,effectivedate,revision,page,change/revisionhistory,originatorandapprover.全部變更的內(nèi)容應(yīng)顯示在文獻(xiàn)的“歷史統(tǒng)計(jì)”欄中。Allupdatedportioninthedocumentmustbeidentifiedinthe“Revisionhistory”.對(duì)于一級(jí),二級(jí)文獻(xiàn)和控制規(guī)范類文獻(xiàn)必須有版本和版次。全部文獻(xiàn)版本用阿拉伯?dāng)?shù)字表達(dá),從1開始,依次2,3,4……;全部文獻(xiàn)版次用大寫26個(gè)英文字母表達(dá),從A開始,依次B,CD…..。For1stleveldocumentsand2ndleveldocuments,musthavedocumentissueandrevision.Issueshouldbeinalphaletters,startfrom1,inturn2,3,4,…..;RevisionshouldbeinCapEnglishletters,startfromA,endtoZ.對(duì)于三級(jí)文獻(xiàn)(除控制規(guī)范外)只需用版次識(shí)別文獻(xiàn)更改次數(shù)。用阿拉伯?dāng)?shù)字表達(dá),從0開始,依次1,2,3,.For3rdleveldocuments(excludingcontrolworkdocument),wejustuserevisiontoidentifythechangelevel.Revisionshouldbeinalphaletters,startfrom1,inturn2,3,4,…..表格版次用“nn”表達(dá),從00開始,依次01,02,03…99止。Therevisionforformshouldbe“nn”,startfrom00,inturn01,02,03….,endto99.受控文獻(xiàn)的編號(hào)Numberingdocument:全部受控文獻(xiàn)由文控中心文獻(xiàn)管理員根據(jù)《文獻(xiàn)編碼與識(shí)別辦法》FQWDOC01或《表格管理規(guī)定》FQW-DOC02統(tǒng)一進(jìn)行編號(hào)。Allcontrolleddocumentno.shouldbeallocatedbyDCCclerkaccordingto《DocumentNumberingandIdentifyingMethods》FQW-DOC01or《FormManagementandRegulations》FQW-DOC-02.文獻(xiàn)起草者在編寫文獻(xiàn)時(shí)須向文控中心文獻(xiàn)管理員申請(qǐng)文獻(xiàn)編號(hào)。Anyonewhoneedtowriteanewdocumentmustapplydocument’snumberingforDCCclerk.文控中心文獻(xiàn)管理員接到申請(qǐng)后,根據(jù)電腦中的各類文獻(xiàn)索引資料進(jìn)行查詢及擬定文獻(xiàn)編號(hào),并將文獻(xiàn)編號(hào)、文獻(xiàn)標(biāo)題、或產(chǎn)品名稱、或產(chǎn)品編號(hào)、申請(qǐng)者姓名和申請(qǐng)日期等識(shí)別性標(biāo)示輸入電腦。Afterreceivedtheapplication,DCCclerkwillcheck&numberaccordingly,andinputDocNo.,DocTitleorproductnameorproductpartno,theapplicant’sname,dateetc.tocomputer.文獻(xiàn)的接受:全部與品質(zhì)及環(huán)境相關(guān)之質(zhì)量控制文獻(xiàn),都交由文控中心文獻(xiàn)管理員接受。文控中心文獻(xiàn)管理員收到受控文獻(xiàn)原稿時(shí),須進(jìn)行下列確認(rèn):AllcontrolleddocumentsregardingqualityandenvironmentshallbesenttoDCC.Afterreceivedtheoriginaldocument,DCCclerkwillcheckthefollowingitems:標(biāo)題、文獻(xiàn)編號(hào)、版本號(hào)/版次號(hào)、頁(yè)數(shù)與否完整。若有不完整的狀況,退回編寫人進(jìn)行修正。Whetherlosinganyofthefollowing:title,numbering,version/issue,pagesandtheformatis;Ifyes,returntohewriterforcorrection.文獻(xiàn)格式與否符合,若不符合規(guī)定的格式,退回編寫人重做。Whethertheformatmeetdocumentcontrolprocedure.Ifno,returntotheoriginatortoremake.檢查文獻(xiàn)的同意與否齊全及有效;Whetherallsignaturesinlooparecompletedandvalid;文獻(xiàn)與否有用涂改液涂改或直接涂改,若有退回文獻(xiàn)起草人重做。Whetherthedocumentisamendedbycorrectionfluidorhandwriting.Ifany,returnittotheoriginator.如果檢查OK的是程序文獻(xiàn)及控制規(guī)范,則DCC文員在文獻(xiàn)封面頁(yè)“文控審核/日期”欄簽名及簽日期,以示進(jìn)行了全部檢查及檢查成果是OK的。Forproceduresandworkcontrol,ifcheckresultisOK,thenDCCclerkneedtosignhis/hernamewithdatein“CheckedbyDCC/Date”onthecoverpage.將審核OK的文獻(xiàn)或資料輸入各類文獻(xiàn)總清單表中。(闡明:文獻(xiàn)總清單共享于全部人員,途徑為:\\Gmgnt002\DOC_INDEX.)DCCclerkenterneworupdateddocument/dataintoeverykindofmasterlistincomputeraftercheckresultisOK.(Note:allkindsofmasterlistaresharedbyeveryone.Thepathis:\\Gmgnt002\DOC_INDEX.)文獻(xiàn)的發(fā)放:文控中心文獻(xiàn)管理員根據(jù)《文獻(xiàn)發(fā)放范疇一覽表》FQW-DOC08填寫“發(fā)文登記”QF-QA-001A,及復(fù)印對(duì)應(yīng)份數(shù)文獻(xiàn)副本,在副本上每一頁(yè)加蓋紅色“紅印有效,控制文獻(xiàn)”印章。DCCclerkfillout<DistributionList>(QF-QA-001)andcopyaccordingto《DocumentDistributionScopeList》(FQW-DOC08).Allcopiesofcontrolleddocumentanddatashallbestampedwithredchopmarked“RedChopValidineachpage.ControlledDocument”..《文獻(xiàn)發(fā)放范疇一覽表》FQW-DOC08由文控中心編制,并按文獻(xiàn)的類別進(jìn)行管理,由QS系統(tǒng)工程師核準(zhǔn)?!禗ocumentDistributionScopeList》ispreparedbyDCCclerkandapprovedbyQSsystemengineer.文獻(xiàn)接受者當(dāng)場(chǎng)核對(duì)頁(yè)數(shù)、頁(yè)碼、印章、編號(hào)、版次后,需于《發(fā)文登記》QF-QA-001A上簽收,并注明日期。Therecipientshouldsignhis/hernameon《DistributionList》aftercheckingpage,sheet,chop,documentnoandrevisionNo.etc.onthespot.對(duì)於換版本或某頁(yè)修訂(換版次)的文獻(xiàn)發(fā)行時(shí),需重新進(jìn)行發(fā)文登記,收文者簽收。Re-registrationshallbedonebyrecipientwhendistributionnewversionorpartlyrevised(changerevision).對(duì)于特急文獻(xiàn),文控員必須當(dāng)場(chǎng)立刻分發(fā)給全部使用部門。對(duì)于普通緊急的文獻(xiàn),文控員必須在1個(gè)工作日內(nèi)完畢分發(fā)。對(duì)于正常文獻(xiàn),應(yīng)在2個(gè)工作日內(nèi)完畢分發(fā)。各部門接受人在收到更新版本文獻(xiàn)后須于一周內(nèi)將舊版受控文獻(xiàn)交文控文員。ForEmergencycontrolleddocument,itshouldbereleasedimmediatelybyDCCclerk;Forurgentcontrolleddocument,shouldbereleasewithin1workingday;Forroutinecontrolleddocument,shouldreleasedwithin2workingdays.Whenreceivingtheupdateddocument,therecipientmustreturnedtheinvalidcopywithinoneweek.當(dāng)需使用文獻(xiàn)的人員未領(lǐng)到文獻(xiàn)時(shí),不得隨意借用其別人的文獻(xiàn)復(fù)印,應(yīng)填寫《文獻(xiàn)領(lǐng)用申請(qǐng)表》QFQA014交部門經(jīng)理/主管核準(zhǔn)后到文控中心辦理領(lǐng)用手續(xù)。公司內(nèi)不得使用未加蓋“紅印有效,控制文獻(xiàn)”印章的受控文獻(xiàn)復(fù)印件以指導(dǎo)員工操作,一經(jīng)發(fā)現(xiàn),由文控中心收回,并追究其責(zé)任。Ifanybodyneedtouseanycontrolleddocumentbuthe/shedidn’treceivethecopyofthisdocument,he/shecan’tborrowfromotherstocopy.He/shemustfillin《ApplicationforusageofDoc.》QF-QA-014andgettheapprovalofthemanager/supervisorinhis/herdepartment.Noduplicationofallcontrolledcopywith“RedCopyValidControlledDocument”stampisallowedtouseforinstructingoperator/technician’soperation.Ifso,DCCwillgettheduplicationbackandblamerelatedperson.文獻(xiàn)保存和使用管理。受控文獻(xiàn)的原稿不須蓋印任何印章,寄存于文控中心指定文獻(xiàn)夾,。TheoriginalcopyofcontrolleddocumentsmustbepreservedintheappointedfileinDCC.任何人不能夠在受控文獻(xiàn)上加以標(biāo)記或書寫任何文字符號(hào)。Noindividualisallowedtomarkortosignanywordorsymbolinthecontrolledcopy.全部紅印受控版本文獻(xiàn)不得私自復(fù)印,但在以下2種狀況時(shí)能夠復(fù)?。篘oduplicationcopyisallowedforanycontrolledcopywithredcontrolstampapartfromthefollowingstatus:當(dāng)客戶規(guī)定我司提供蓋有紅色受控版本最新版本文獻(xiàn)的副本時(shí),提供者能夠復(fù)印蓋有紅色受控版本的最新版本文獻(xiàn)給客戶;Whencustomerrequesttoprovidetheduplicationoftheupdateddocumentswiththered“controlcopy”,theprovidercanduplicateit.當(dāng)文獻(xiàn)需要修改時(shí),修改人能夠復(fù)印蓋有紅色受控版本的最新版本文獻(xiàn),并在復(fù)印件上直接修改。Whenthedocumentneedstobemodified,theoriginatorcanduplicateitanddirectlywritedownontheduplication.各部門經(jīng)理需指派專門的人員接受本部門文獻(xiàn),妥善解決和保管全部紅色受控版本文獻(xiàn)。對(duì)于需要張貼于各工作現(xiàn)場(chǎng)的文獻(xiàn)如若作業(yè)指導(dǎo)書類,各部門文獻(xiàn)管理員將DCC分發(fā)的受控文獻(xiàn)轉(zhuǎn)交給各自主管/組長(zhǎng)張貼于工作需要的地方(注意:生產(chǎn)現(xiàn)場(chǎng)/各生產(chǎn)車間使用之文獻(xiàn)須置于作業(yè)場(chǎng)合,保証任何員工在需要的時(shí)候隨時(shí)能夠方便地獲得相關(guān)文獻(xiàn)以指導(dǎo)工作),對(duì)于不須張貼但需歸檔保管的文獻(xiàn)如程序則交給本部門內(nèi)各有關(guān)人員傳閱后收回歸檔,并做好文獻(xiàn)檔案索引和標(biāo)記,便于別人查閱。。Eachdepartment/sectionmustassignonespecialpersonreceiveandtakecareofallcontrolledcopy.Foroperationinstructionsneedtobepostedinthelocationofusetoinstructoperators/techniciansoperationatalltime,thedepart/sectiondocumentmanagementclerkneedtoforwardthecontrolleddocumentstohis/hersupervisortoposttheappropriateworksite.Deptmanager/supervisorshallensurerelevantdocumentisavailablewhereveritisrequiredtosatisfythecustomerrequirementsandactualneeds.Forthosecontrolledcopyneedtobekeptinfilesuchasprocedures,Thedepartment/sectiondocumentmanagementclerkneedtopassthelatestversiontoreaderandkeptitwellafterreaderreturnittoher/him.文獻(xiàn)如有缺頁(yè)、破損、筆跡含糊等需重新發(fā)放時(shí),須到文獻(xiàn)中心以舊換新。任何部門不能夠以影印方式自行解決。Ifthedocumentismissingapage,rippedorhasblurryletterings,thentheusingdeptmusttakeittoDCCforreplacingnewone.Itshouldnotbeselfcopiedandreplaced.文獻(xiàn)修訂及更改、換版Revision&modify,versionchangeofdocument文獻(xiàn)如有更改、換版,需由原評(píng)審和/或同意人同意。全部巳生效的文獻(xiàn)不能夠手寫更改和涂改,必須改正后用電腦打印出來交有關(guān)人員評(píng)審或核準(zhǔn)。Anymodificationoreliminationofreleaseddocumentshallbeapprovedbyoriginalauditoror/andapprovalperson.Allreleaseddocumentsmustnotbemodifiedbyhandwritingandmustbeincomputerandprintoutandsubmitittorelevantpersonnelforreviewor/andapproval.如原審批人不在職時(shí),由接替其崗位的人依“修訂歷史”和原件進(jìn)行,全部更改在“修訂歷史”上標(biāo)明其更改性質(zhì)。Iftheoriginallyreviewedorapprovedpersonisnolongerinthatposition,thenthenewpersonreviewsthemodificationaccordingto“Revisionhistory”andoriginalversion,anyupdateshallbemarkedinthe“Revisionhistory”.文獻(xiàn)分發(fā)后,QS部門和各使用部門須根據(jù)公司的實(shí)際運(yùn)作狀況對(duì)文獻(xiàn)進(jìn)行評(píng)審,對(duì)不合用之處須提出修改的建議或進(jìn)行修改。對(duì)于一.二級(jí)文獻(xiàn)及與文獻(xiàn)編號(hào)以FQW-開頭的控制規(guī)范文獻(xiàn),須告知QSoffice,由QSOffice組織修改。對(duì)于三級(jí)文獻(xiàn)修改參見“作業(yè)指導(dǎo)書產(chǎn)生及修訂”FQW-DOC04;對(duì)于表格的修改詳見“表格管理規(guī)定”FQW-DOC02。QSOfficeandallusingdepartmentneedtoreviewthesuitabilityandeffectivenessandadequacyofreleaseddocumentationanddatabasedontheactualoperation,Iffoundanydiscrepancies,needtoinformQSOfficetocorrectitorcorrectitbytheusingdepartment/section.For1st、2nddocsandworkcontrolwhichdocumentnostartswith“FQW-”,ifsomeusingdepthaveanysuggestionforchangeorupdateormodification,shallinformQSofficeoforganizingchangeorupdateormodification.Foroperationinstructionschange/modification,pleaseseethe<OperationInstructionsGeneratingandupdating>FQW-DOC04.Forformchange/modification,pleaseseethe<FormmanagementandRegulations>FQW-DOC02.文獻(xiàn)某頁(yè)最多經(jīng)過五次小修改后或一次大幅修改(修改章節(jié)條款占50%以上)時(shí),應(yīng)進(jìn)行換版,原版本文獻(xiàn)作廢,換發(fā)版本需增高一位?!鞍姹尽睂?duì)應(yīng)英文為“Issue”,使用“1,2,….”表達(dá),“版次”對(duì)應(yīng)英文為“Revision”,使用“A,B,….”表達(dá)。Ifany5minorchangestoanypageofthedocumentoronemajorchange(morethan50%)tothedocument,thenthedocumentshallberevisedandupdatetonextrevisionorissue.Oldversionshallberemovedandeliminated.andEnglishrepress‘Issue’for‘版本’,showingnumber“1,2….”;the‘Revision’for‘版次’showingnumber“A,B…..”。文獻(xiàn)的取消:全部需取消的原受控文獻(xiàn)由原審核或同意者或更高級(jí)管理者在正本文獻(xiàn)封面上同意作廢。Ifthecontrolledoriginaldocumentneedbecancelled,itshallbeapprovedbytheoriginalreviewerorapprovalpersonorhigherrankingperson.作廢或失效文獻(xiàn)撤除管理以及文獻(xiàn)遺失處理Withdrawalanddispositionofuselessorinvaliddocumentandthecontrolofdocsmissing,handingover.規(guī)定事項(xiàng)和現(xiàn)行運(yùn)轉(zhuǎn)狀況完全不符時(shí);或同一事項(xiàng)已有新規(guī)定時(shí);或文獻(xiàn)更改時(shí),原來文獻(xiàn)自動(dòng)過時(shí)或無效。Theoriginaldocumentwillautomaticallyoutofdateorinvalidincasethatnewregulationhasbeendecidedandexecutedinpublicknownordocumentbeingmodifiedbecauseit’snon-conformancebetweenregulatedrulesandpracticaloperation.過時(shí)或無效的文獻(xiàn)由文控員按《發(fā)文登記》QFQA001A及時(shí)從全部保管﹑使用的部門一一繳舊換新而追進(jìn)撤銷和回收,各部應(yīng)主動(dòng)將過期文獻(xiàn)上交到文控中心。OutofdateorinvaliddocumentshallbereplacedbynewversionandshallbefollowedupbyQSofficedocumentadministratortowithdrawandretractimmediatelyfromtheholdingandapplicationdept.Eachdeptshouldhandininvaliddocumenttodocumentcontrolcenter.文獻(xiàn)如有遺失,遺失部門需填寫《文獻(xiàn)遺失報(bào)告》QF-QA-002,并由其部門經(jīng)理/主管審批后至文控中心方可補(bǔ)放,文控中心定時(shí)將各部門文獻(xiàn)的遺失情況進(jìn)行反饋。若文控中心所管制的文獻(xiàn)資料如:客戶色牌,不能復(fù)制分發(fā),如相關(guān)部門需使用,必須填寫《文獻(xiàn)和資料借用單》QF-QA-023。Whoevermissingthecontroldocumentmustwritethe《DocumentMissingReport》QF-QA-002toDCC,DCCwillre-issuedonconditionthatdeptmanagerorsupervisorsigned,;DCCwilltaketimefeedbackthemissingratio.IftheDoc.iscontaminatedorotherconditionsandmustbere-issued,theusingdeptmusttakeittoDCCforreplacingnewone.Deptneedtousethedocumentordatathatcannotbephotocopied(e.g.:customersuppliedcolorstandardsample)shallfillin《Doc&DataBorrowedNote》QF-QA-023andreturninspecifiedperiod.全部換版﹑作廢文獻(xiàn)回收后文控中心文獻(xiàn)管理員需及時(shí)登記于《發(fā)文登記》QFQA001A上,并注明收回日期。收回因素、Uponreceiptofoldversionoruselessdocuments,DCCclerkshallimmediatelyrecordon《DistributionList》QF-QA-001Aandwritedownretracteddateandreason.全部原版作廢文獻(xiàn)應(yīng)由文獻(xiàn)控制中心在每一頁(yè)蓋以作廢章,同時(shí)將其放入指定的作廢文獻(xiàn)資料夾。作廢文獻(xiàn)的保持期限見“ISO系統(tǒng)管理(QA)質(zhì)量統(tǒng)計(jì)總清單”(QF01)?;厥盏呐f版受控文獻(xiàn)可視具體狀況進(jìn)行銷毀或用碎紙機(jī)碎掉或在每一頁(yè)蓋上作廢章后作廢紙的再次運(yùn)用。AlloriginalobsoletedocumentsinDocumentControlCenterisstampedwith“OBSOLETE”ineverypage,andputintotheappointedfileforreference.Theretentionperiodofobsoletedocumentsshallbeinaccordancewithqualityrecordlist(QF01).Iftheretrievedobsoletehardcopydocumentscanbedestroyed/shreddedTemporaryDocumentControl:臨時(shí)文獻(xiàn)控制此條合用于首批產(chǎn)品生產(chǎn)、或少量試跑時(shí)用的文獻(xiàn)。由于此時(shí)的文獻(xiàn)可能是不完整的生產(chǎn)或檢查用指導(dǎo)文獻(xiàn)。Thisitemisapplicableforfirstarticle,prototypeand/orpilotrun.ItmaynotbeacompletesetofproductionlineinstructionorQCinspectioninstruction.全部這類文獻(xiàn)的版本均以“00”表達(dá)。Allthesedocumentsstartwithrevisionof“00”.由臨時(shí)文獻(xiàn)的發(fā)放部門在臨時(shí)文獻(xiàn)的每一頁(yè)蓋印蘭色“試用”章。The“TEMPORARY”shouldbestampedoneachpagebyreleasedepartment.臨時(shí)文獻(xiàn)的使用期不得超出一種月。Temporarydocumentsshallhaveanaffectivityofnotmorethanonemonth.如有任何變更在首批產(chǎn)品生產(chǎn)、或少量試跑中,作者可在需更改的內(nèi)容上劃上刪除線,在空處標(biāo)明更改后內(nèi)容。更改必須易讀取,易分別。更改應(yīng)注明時(shí)間及更改人。若有書面的更改的證據(jù),最佳附在所修改的文獻(xiàn)背面以證明更改的對(duì)的性。Iftherearesomechangesduringfirstarticle,prototypeand/orpilotrun,theoriginatorcanuseapentostrikethrough(singlelinecrossout)theoldcontentandmakechangesontheavailablespaceontheoriginalcopy.Ifsupportingdataforchangeisavailable,thenattachitonthebackofthechangeddocuments.Thechangesshallbereadableanddistinguish.文獻(xiàn)的更改嚴(yán)禁涂改或使用修正液。更新內(nèi)容及刪除內(nèi)容應(yīng)可對(duì)比以協(xié)助更加好的理解。Obliteratetheoldcontentorblankbyusingcorrectionfluidisprohibited.The“original”or“old”contentshallbevisibleinordertolettheusertoseeandunderstandwhathappened.臨時(shí)文獻(xiàn)應(yīng)在首批產(chǎn)品生產(chǎn)或少量試跑結(jié)束后轉(zhuǎn)成正式受控文獻(xiàn)。Preliminaryissueisupdatedtocontrolledcopyforproductionrunafterthepreliminaryfirstarticle,prototypeand/orpilotrun.非受控文獻(xiàn)的發(fā)放Distributionofuncontrolleddocument如果客戶規(guī)定提供手冊(cè)及程序文獻(xiàn)時(shí),必須經(jīng)管理者代表同意,且加蓋“參考文獻(xiàn)”印章,為非受控文本。Qualitymanualandproceduredocumentprovidedtocustomerbyrequestshallbeapprovedbymanagementrepresentativeandchoppedwithbluestamp“ForReferenceOnly”isuncontrolledcopy.某些僅供參考或臨時(shí)使用之文獻(xiàn)或資料,如培訓(xùn)用。如需發(fā)放時(shí),則由文控員依使用單位的需求進(jìn)行發(fā)放,蓋參考文獻(xiàn)印章。Somedocumentsareusedtemporarilyorasreferencee.g.trainingmaterial.Documentcontrolclerkaccordingtorequirementofapplicationdeptdistributesthosedocumentsstamped“ForReferenceOnly”chop.暫行參考文獻(xiàn)之發(fā)行,以“暫行”或“參考文獻(xiàn)”樣印標(biāo)識(shí),方便和“控制文獻(xiàn)紅印有效”章區(qū)別。Distributionoftemporarilyreferencedocumentshallbeidentifiedwithstamp“TemporarilyUse”or“ReferenceDocument”soastodistinguishwithchop“controlleddocument,redchopvalid”.暫行參考文獻(xiàn)之發(fā)行,需另立《發(fā)文登記(非受控)》QFQA001B登記,以備忘和避免多次領(lǐng)用。Distributionoftemporarilyreferencedocumentshallbeseparatelyregisteredin《DistributionList(uncontrollable)》QF-QA-001Bformemorandumandavoidingre-collectusage.暫行參考之文獻(xiàn)不具正式效力,只作為作業(yè)之參考,不列入回收管理。Temporarilyreferencedocumentareusedasreferenceonly.Noneedtogetbackandmaintenanceaccordingtothedocumentcontrolsystem.發(fā)給供應(yīng)商資料的管理Thedocupdatingcontrolfromoutsideanddocsmanagementofdistributetosupplier:對(duì)于技術(shù)資料的更改、換版和作廢時(shí),由采購(gòu)員負(fù)責(zé)及時(shí)向供方傳真相關(guān)新版文獻(xiàn),同時(shí)聲明相關(guān)舊版文獻(xiàn)作廢(注意:我司不回收舊版文獻(xiàn)與資料)。對(duì)于發(fā)送給供方的有關(guān)技術(shù)資料由采購(gòu)部負(fù)責(zé)登記造冊(cè)。Technicalorstandarddocsneededforprocurementshallbesenttorespectivesupplierbypurchasingdept.,andshallpromptlyadvisesupplierwithdrawalofoldversionandusenewrevisiondocumentincasethatmodification,Purchasingdeptperformregistrationrecordfordocswhichhavebeensenttosupplier.文獻(xiàn)年度評(píng)審:QS系統(tǒng)工程師每年需對(duì)第一、二層文獻(xiàn)和控制規(guī)范進(jìn)行一次定時(shí)的評(píng)審。評(píng)審成果統(tǒng)計(jì)在“年度文獻(xiàn)評(píng)審需求分析”(QF-QA-037)中。The1st&2ndlevelshouldbereviewedbyQSsystemengineerforadequacyandeffectivenessandsuitabilityonayearlybasis.TheresultsofthisreviewshallbedocumentedinYearlyProcedureReviseNeedAnalysis(QF-QA-037).第一、二層文獻(xiàn)必須為中、英文對(duì)照版,第三層文獻(xiàn)必須有中文,其它語言視狀況而定。當(dāng)中文與英文有出入時(shí),以中文為準(zhǔn)。The1stlevel&2ndlevelmustuseEnglish&ChineseLanguage,forthe3rdlevel,ChineseLanguageismust,andotherLanguageisoptional.WhenChineseversionisdifferentfromEnglishversion,thenChineseversionprevails.新程序生效后或程序更新后,若需要培訓(xùn),則由各部門經(jīng)理/主管培訓(xùn)本部門有關(guān)人員,并做好對(duì)應(yīng)的培訓(xùn)統(tǒng)計(jì),及將填寫好《培訓(xùn)簽到記錄》QF-TN-001送培訓(xùn)部歸檔。Afteranewprocedureentersintoeffectoranoldprocedureismodified/amended/revised/updated,ifthetrainingrelatedtothisreleaseddocumentisnecessary,thendepartmentheadneedtotrainsallpersonsrelatedtothisprocedureinhis/herowndepartmentandcompletetrainingrecordandsendthe<RecordofTrainingSignature>QF-TN-001completedtoTrainingDepartmentforfiling.印章的管理Maintenanceofstamp/chop與文獻(xiàn)和資料的管理有關(guān)的印章,由文控員保管。Stamp/chopwhichrelatetoadministrationofdocumentanddataispreservedandmaintainedbydocumentcontrolclerk.印章如有遺失,重新刻制時(shí),應(yīng)具備與原印章相區(qū)別特性,由DCC在涉及范圍內(nèi)通報(bào)。Ifanystamp/chopdisappears,makeamewonewithidentificationwhichdiffersfromtheoriginalone.DCCshallinformtherelevantdeptandpersonnel.印章識(shí)別及說明見附錄2Stampidentificationandremarksreferappendix2.電子檔文獻(xiàn)管制:Controlofelectronicscopies.當(dāng)書面文獻(xiàn)被核準(zhǔn)后,編寫人須將電子檔文獻(xiàn)送交文控中心文獻(xiàn)管理員,若文控中心文獻(xiàn)管理員收到核準(zhǔn)的書面文獻(xiàn)但未收到電子檔時(shí),須規(guī)定編寫人提供電子檔。Whencontrolhardcopyisapprovedbyallauthorizedperson,theoriginatorneedto

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