Corrective and Preventive Action Control Procedure糾正及預(yù)防措施控制程序 A1

ContacSolutionsAB文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage1of12DocumentNumberandRevision文件編號(hào)及版本：CSS-QP-09Rev?A2DocumentTitle文件題目：Non-Conformance,Corrective&PreventiveActionManagementProcedure不符合糾正預(yù)防措施控制程序Approvals（批準(zhǔn)）Responsible（負(fù)責(zé)）NameSignatureDate（日期）Originator（制作）DepartmentLeader（部門負(fù)責(zé)人）MR（管理者代表）GM（總經(jīng)理）ContacSolutionsAB文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage2of12生效日期Effectivedate:Feb.1,2015RevisionHistory（更改歷史）:RevisionFromTo更改Date日期RevisionDescription/更改內(nèi)容Changedby/更改人Checkedby/復(fù)核A12014/6/5首版發(fā)行FirstIssueAllenPuDennisHuangA22015/2/1AddtheEMSnon-conformancecorrective&preventiveactionintheprocedureLiviaHeDennisHuang:contao:contao■ ■POWERFULSOLUTIONSContacSolutionsAB文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage3of121.目的Purpose此份文件制定了控制修正性及預(yù)防性行動(dòng)的方法，這些行動(dòng)用于修正及杜絕現(xiàn)有及潛在的不合規(guī)格事項(xiàng)。Thisdocumentdefinesthecontrolofcorrectiveactionandpreventiveactiontakentocorrectandeliminateexistingandpotentialnon-conformance.范圍Scope該程序適用于CONTAC與品質(zhì)和EMS相關(guān)的修正及預(yù)防行動(dòng)。ThisprocedureappliestocorrectiveandpreventiveactiontakenforthequalityandEMSinCONTAC.定義Definition糾正及預(yù)防措施（C/PAR）：-份要求相關(guān)部門進(jìn)行糾正行動(dòng)的要求。為容易控制糾正行動(dòng)要求及實(shí)行狀況均需記錄于C/PAR狀態(tài)報(bào)告內(nèi)。CorrectiveActionRequest(C/PAR):Arequestforcorrectiveactiontobetakenbyandactionparty.Foreaseofcontrol,a“CorrectiveandpreventivereportC/PARStatusReport”isusedtorecordtherequestandstatusofimplementation.責(zé)任Responsibility品質(zhì)部負(fù)責(zé):Quality&EnvironmentDepartmentisresponsiblefora）接收CONTAC以外的投訴及儲(chǔ)存有關(guān)資料;ContacSolutionsAB.POWERFULSOLUTIONSCSS-QP-09Rev?A2文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage4of12ReceivingthosecomplaintsfromoutsideofCONTACandkeepingrelevantinformation.b） 發(fā)NCP&C/PAR給公司相關(guān)部門或外部相關(guān)方要求修正行動(dòng)；IssuingNCP&C/PARtorelateddepartmentswithincompanyorexternalinterestedpartyforcorrectiveactions.c） 若品質(zhì)問(wèn)題與供應(yīng)商有關(guān)，則發(fā)出NCP&C/PAR給該供應(yīng)商；若與客戶投訴有關(guān)，則按客戶要求回復(fù)客戶；IssuingaNCP&C/PARtothesupplierforthecaseofsupplierqualityproblem;ifitiscustomercomplaint,replycustomeraccordingtocustomer’srequirement.d） 編配NCP&C/PAR的編號(hào)；AssigningaNCP&C/PARnumbertoeachNCP&C/PARinCONTAC.e） 保持NCP&C/PAR的狀況登記；ThemaintenanceofNCP&C/PARstatus.f） 將所有發(fā)出的NCP&C/PAR存檔；KeepingafileofallNCP&C/PARsissued.g） 監(jiān)察NCP&C/PAR上記載的修正行動(dòng)實(shí)施情況；Monitoringtheimplementationofcorrectiveactions.h） 審核實(shí)施的修正行動(dòng)及預(yù)防性行動(dòng)后，確定是否有必要修改程序文件；Reviewingthenecessityofprocedurechangesasaresultofimplementingcorrectiveandpreventiveactions.總結(jié)所有發(fā)出的NCP&C/PAR或其它糾正措施報(bào)告并在管理評(píng)審會(huì)議上報(bào)告..ContacSolutionsAB. .POWERFULSOLUTIONSCSS-QP-09Rev?A2文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage5of12SummarizingallNCP&C/PARs,andothercorrective&preventiveactionreport,thenreportingthesummarytotheManagementReviewMeeting.內(nèi)部審核員負(fù)責(zé)向內(nèi)部審核發(fā)現(xiàn)的不符合項(xiàng)發(fā)出相應(yīng)的NCP&C/PARoInternalAuditorisresponsibleforperforminginternalqualityauditorenvironmentauditandissuingaNCP&C/PARaccordingtotheNonConformity.如果關(guān)鍵的測(cè)量指標(biāo)的最低要求還沒(méi)有達(dá)到時(shí)，則需向相關(guān)部門發(fā)出糾正行動(dòng)的要求。Iftheminimumrequirementofkeymeasurementisnotachieved,aNCP&C/PARshallbeissuedtorelateddepartment.資格及培訓(xùn)QualificationAndTraining內(nèi)部審核員一定要在接受正式之審核技巧培訓(xùn)后才可以進(jìn)行內(nèi)部審核。InternalAuditormustreceiveformaltraininginauditingtechniquesbeforebeingassignedtoconductinternalaudit.程序Procedure發(fā)出糾正行動(dòng)要求(NCP&C/PAR)InitiationofCorrectiveActionRequest(NCP&C/PAR)下列情況均可發(fā)出NCP&C/PAR:NCP&C/PARmayberequiredunderfollowingsituations:管理評(píng)審會(huì)議；ManagementReviewMeeting.ContacSolutionsAB.POWERFULSOLUTIONSCSS-QP-09Rev?A2文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage6of122） 生產(chǎn)線上發(fā)現(xiàn)的品質(zhì)問(wèn)題;Qualityproblemidentifiedinproduction.3） 內(nèi)部質(zhì)量環(huán)境管理體系審核所發(fā)現(xiàn)的不合格；Nonconformityidentifiedininternalaudit.4） 外部審核所發(fā)現(xiàn)的不合格；Nonconformityidentifiedinexternalaudit.5） 供應(yīng)商的品質(zhì)問(wèn)題報(bào)告；Supplierqualityproblemreport.6） 關(guān)鍵衡量指標(biāo)的最低要求沒(méi)有達(dá)到；Theminimumrequirementofkeymeasurableisnotachieved.7） 法律法規(guī)和其他要求變更引起的不符合。Nonconformitycausedbythechangeoflegalandotherrequirements.8） 數(shù)據(jù)分析的結(jié)果Theresultsofdataanalysis9） 員工的合理化建議Theresultsofdataanalysis10） 環(huán)境的監(jiān)測(cè)數(shù)據(jù).ContacSolutionsAB. .POWERFULSOLUTIONSCSS-QP-09Rev?A2文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage7of12Environmentalmonitoringdata客戶投訴CustomerComplaint5.2.1當(dāng)品質(zhì)部收到客戶投訴后，與相關(guān)部門確認(rèn)該投訴，品質(zhì)部在需要的情況下可向客戶要求進(jìn)一步的資料；Uponreceivingcustomercomplaint,QualityDepartmentshallconfirmthiscomplaintwithrelateddepartments.QualityDepartmentcanaskmoredetailsfromcustomerifnecessary.5.2.2若客戶投訴被確認(rèn)，品質(zhì)部可就該投訴發(fā)出8D報(bào)告或按客戶要求制定相應(yīng)的糾正及預(yù)防措施；Oncecustomercomplaintisconfirmed,QualityDepartmentshallissuean"8DReport”orothercorrective&preventiveactionwhichberequiredbycustomer.5.2.3品質(zhì)部回復(fù)客戶糾正行動(dòng)的結(jié)果.QualityDepartmentshallkeepthecustomerinformedtheresultsofcorrectiveactions.供應(yīng)商的來(lái)料品質(zhì)問(wèn)題MaterialQualityProblemfromsupplier:5.3.1供應(yīng)商來(lái)料檢驗(yàn)問(wèn)題一般由QC識(shí)別；MaterialinspectionproblemfrommaterialsupplierisusuallyidentifiedbyQualityControl(QC).5.3.2根據(jù)《來(lái)料檢驗(yàn)報(bào)告》或其它類似資料，品質(zhì)部可向有品質(zhì)問(wèn)題的供應(yīng)商發(fā)出NCP&C/PAR和8DBasedon“IncomingInspectionreport”orotherinformation,QualityDepartmentmayissueaNCP&C/PARand8Dtosupplierwhichexistedqualityproblems.ContacSolutionsAB.POWERFULSOLUTIONSCSS-QP-09Rev?A2文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage8of12內(nèi)部審核發(fā)現(xiàn)的不合規(guī)格事項(xiàng)Non-conformityidentifiedinInternalAudit.:5.4.1內(nèi)審時(shí)，內(nèi)審員會(huì)識(shí)別哪些是品質(zhì)系統(tǒng)不容許的項(xiàng)目，該內(nèi)審員就相關(guān)問(wèn)題發(fā)出NCP&C/PAR,細(xì)節(jié)參照《內(nèi)部審核控制程序》。Duringinternalaudit,theinternalauditormayidentifythenon-conformityofqualitysystem.TheinternalauditorcanissueNCP&C/PARsaccordingtoauditresults,fordetails,pleasereferto“InternalAuditControlProcedure”.其它發(fā)出NCP&C/PAR來(lái)源OthersSourcesforNCP&C/PARInitiation:5.5.1NCP&C/PAR可由任何人發(fā)出，并經(jīng)徹她的部門主管復(fù)核之后發(fā)出，發(fā)出前須在QA工程師處登記并編號(hào)管理。如有爭(zhēng)議，需由品質(zhì)部最終確認(rèn)裁決。NCP&C/PAR的發(fā)出者需對(duì)NCP&C/PAR進(jìn)行跟進(jìn)直至結(jié)案。NCP&C/PARcanbeinitiatedbyanyemployee,he/sheneedssendthepreparedNCP&C/PARtohis/herdepartmentheadforreview,theNCP&C/PARneedberegisteredwithanumberatQAengineertomanager.Foranycontroversy,itshouldbejudgedanddecidedbyQualityDepartment.NCP&C/PARinitiatorshallfollowuptheNCP&C/PARuntilcaseclosure.準(zhǔn)備NCP&C/PARPreparationofNCP&C/PAR:5.6.1每一份NCP&C/PAR都有品質(zhì)部給出的登記編號(hào)，其組成如下：ANCP&C/PARnumberisassignedtoeachNCP&C/PARbyQualityDepartmentandidentifiedasfollows:NCP-YYMMxxYY:年份MM:月份（如2010年3月記作201003）;xx:NCP&C/PAR的序列號(hào)從01開始..ContacSolutionsAB. .POWERFULSOLUTIONSCSS-QP-09Rev?A2文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage9of12YY:Year.MM:month(e.g.Year2010/Marchisrecordedas201003;xx:NCP&C/PARnumber,beginwith01.B.客戶投訴8D報(bào)告編號(hào)：8Dnumberisassignedtoeach8DbyQualityDepartmentandidentifiedasfollows:CONTACxxCSAB-8D-YYMM-xxCSS-8D-YYMM-xxYY:年份MM:月份(如2010年3月記作201003);xx:8D的序列號(hào)從01開始.YY:Year.MM:month(e.g.Year2010/Marchisrecordedas201003;xx:8Dnumber,beginwithxx從01開始xxbeginwith01.NCP&C/PAR的發(fā)出者需填寫NCP&C/PAR表格，接受者需為負(fù)責(zé)執(zhí)行糾正行動(dòng)的部門主管.NCP&C/PARoriginatorshallfilltheNCP&C/PARForm.TheNCP&C/PARrecipientshalleitherbethedepartment/sectionheadresponsibletocarryoutcorrectiveaction.5.8發(fā)出者需在NCP&C/PAR表格內(nèi)填寫下列資料：NCP&C/PARoriginatorshallfillthefollowinginformationintheNCP&C/PARForm:問(wèn)題描述NonconformityDescription認(rèn)可的簽名Signatureforendorsement.ContacSolutionsAB. .POWERFULSOLUTIONSCSS-QP-09Rev?A2文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage10of12一 行動(dòng)的最后期限；DueResponseDate:duedatefortherecipienttoreplytheshorttermcorrectiveaction.E.監(jiān)督NCP&C/PAR的實(shí)行MonitoringofNCP&C/PARImplementation5.9在預(yù)定回復(fù)日期前，負(fù)責(zé)行動(dòng)的部門需提交品質(zhì)部已填寫源因分析”、“糾正行動(dòng)”的NCP&C/PAR給品質(zhì)部，上述各項(xiàng)行動(dòng)均需寫上開始日期、預(yù)期日期。OnorbeforetheNCP&C/PARresponseduedate,theactionpartyshallsubmittoQualityDepartmenttheNCP&C/PARwithcompleted“RootCausesAnalysis”、“CorrectiveActions”，togetherwiththestartdatesandexpectedcompletiondatesoftheseactions.5.10當(dāng)收到回復(fù)的NCP&C/PAR后,QA工程師將會(huì)：OnreceivingtheNCP&C/PARfromactionparty,theQAEngineershall:更新NCP&C/PAR狀態(tài)報(bào)告；UpdateNCP&C/PARStatusReport加入一合適的跟進(jìn)日期于NCP&C/PAR狀態(tài)報(bào)告內(nèi)。Enteranappropriatefollow-updateintheNCP&C/PARStatusReport.5.11在跟進(jìn)日那天，報(bào)告人和QA工程師要審查所承諾的行動(dòng)是否已實(shí)施？是否有效？并于NCP&C/PAR的跟進(jìn)欄里填寫資料以完結(jié)這份NCP&C/PARoOnthefollow-update,reporterandQAEngineershallauditifcommittedactionsareimplementedandeffectiveandthenfillinandsignontheNCP&C/PARtosignifyitsclosure..ContacSolutionsAB. .POWERFULSOLUTIONSCSS-QP-09Rev?A2文件名稱：不符合糾正預(yù)防措施控制程序Name:Non-Conformance,Corrective&PreventiveActionManagementProcedurePage11of12NCP&C/PAR的正本最終送給品質(zhì)部，品質(zhì)部按其編號(hào)存檔。TheoriginalNCP&C/PARisfinallypassedtoQualityDepartment,whoshallfiletheNCP&C/PARaccordingtotheNCP&C/PARnumber.發(fā)出新的NCP&C/PARIssueofSubsequentNCP&C/PAR:如果在跟進(jìn)復(fù)核時(shí)，發(fā)現(xiàn)不合格項(xiàng)仍未解決，QA工程師將顯示這些資料于相應(yīng)的NCP&C/PAR內(nèi)及更新NCP&C/PAR狀態(tài)報(bào)告；QA工程師需發(fā)出一份新NCP&C/PAR,該新NCP&C/PAR的編號(hào)為原來(lái)的號(hào)碼加上一個(gè)英文字母，由A開始，如一份NCP&C/PAR被退兩次，該不合格項(xiàng)需在管理層會(huì)議上討論。Ifthefollow-upauditindicatesthatthenon-conformityhasnotbeensolved,QAEngineershallindicatethisincorrespondingNCP&C/PARand叩date“NCP&C/PARStatusReport”.TheQAEngineerthenissuesan