《QA-0078DProblemSolvingRegulation8D方法实施规范-中英对照.docx》由会员分享，可在线阅读，更多相关《QA-0078DProblemSolvingRegulation8D方法实施规范-中英对照.docx（5页珍藏版）》请在三一办公上搜索。
1、LOGOManagementregulation管理规范NUmber文件编号：WD-QA-007DePartment部门:QA质量部SUbjeCt文件名称：8D方法实施规范8DProblemSolvingRegulalHonReViSion版本：1.0EffectiveDate生效日期：2012-01-01Page1of6批准：审核：作成：ChangeHistory变更记录Revision版本EffectiveDate生效日期Originator编写人ReasonsforChange修改原因1.1 Purpose目的提高解决问题的效率，积累解决问题的经验。提供找出现存的与质量相关问题的框架，杜
2、绝或尽量减少重复问题出现。8D格式的原则是针对出现的问题，找出问题产生的根本原因，提出短期、中期、和长期对策，并采取相应行动措施。Improvetheefficiencyandaccumulateexperienceinsolvingproblem.Providetheframetofindpresentedproblemsrelatedtoqualityandeliminateorreducetherecurrenceofproblems.Theprincipleof8Disbasedonexistingproblemstofindrootcause,putforwardshort-term
3、,mid-termandlong-termstrategiesandtakecorrespondingmeasures.1.2 Scope范围该方法适用于在公司内部重复出现的问题、外部发生的不合格和顾客抱怨等较为重大或者系统性的问题。以便识别和消除不符合发生的根本原因。Thismethodisappliedtoseriousorsystematicproblemssuchasrecurringproblemsinsidethecompany,disqualificationoutsidethecompanyandcustomercomplaint,withaviewtoidentifyande
4、liminatetherootcauseofnonconformity.3.0Definitions定义3.1 小组小组成员应该是来自能够解决问题的所有的部门。3.2 TeamTeammembersshallcomefromalldepartmentscapableofsolvingproblems.3.3 问题描述简单描述问题的发生，提供尽可能多的定量的信息包括问题发生的日期、频率、或缺陷的百分率、实际尺寸等等。3.4 ProblemdescriptionBrieflydescribetheproblemsandprovideasmuchquantitativeinformationaspo
5、ssible,includingthedateandfrequencyofproblems,defectpercentageandactualsize,etc.3.5 围堵措施决定一个避免客户收到缺陷材料，立即采取围堵措施（分类,重工,延迟交货,报废）以确保正常生产得以继续进行,直到采取纠正措施将问题解决。给出每一个围堵措施的日期并且预测每一个的有效性。3.6 ContainmentmeasuresItcanavoidcustomerstoreceivedefectivematerials.Containmentmeasures(classification,rework,latedelive
6、ry,scrap)shallbeimmediatelyimplementedtoensurethecontinuationofnormalproductionuntilcorrectivemeasuresaretakentosolveproblems.Giveinformationonitsdateandeffectivenessofeachcontainmentmeasure.3.7 寻找确认根本原因一不断地问为什么直到真正的根本原因被确定。保证确定的根本原因不仅仅是一个现象。可以通过试验验证根本原因。3.8 Findandidentifytherootcausecontinuouslyfi
7、ndtherootcauseuntilitisactuallyidentified.Ensurethattheidentifiedrootcauseisbasedonactualsituationandcanbeverifiedbytest.3.9 选择永久措施进行合适的更改阻止问题的发生。如果预防是不可能的，进行的更改要提高问题的可发现性。调查长期措施，设计更改，材料更改，新的供应商和不同的工艺等等。3.10 SelectpermanentmeasuresPreventtheoccurrenceofproblemswithappropriatemodification.Ifpreventio
8、nisnotpossible,modificationshallimprovediscoverabilityofproblems.Investigatelong-termmeasures,designmodification,materialchange,newsupplier,differenttechnology,etc.3.11 久措施效果验证使用数据验证所有的更改并证明所有措施的有效性。3.12 VerifytheeffectivenessofpermanentmeasuresUsedatatoverifyallchangesandverifytheeffectivenessofall
9、measures.3.13 统预防措施一改变使问题发生的管理系统。更新DFMEA、PFMEA,需要新的可行的程序或工艺。3.14 SystematicpreventivemeasuresChangemanagementsysteminwhichproblemsoccur.UpdateDFMEA,PFMEAandnewandfeasibleprocedureortechnologyareneeded.3.15 题解决、祝贺小组一当所有的步骤都完成以后，感谢和祝贺问题解决小组的辛勤劳动。3.16 CongratulatetheTeamAfterallstepsarefinished,givetha
10、nkstotheteamthatsolvesproblemsandcongratulatetheirhardwork.3.17 8D8Disciplines,解决问题的8个步骤。它基于使用描述工具、格式化、分析、量化等工具，从而提供彻底解决问题的指引。3.18 8D8Disciplines,8stepstosolveproblems.Itprovidesguidestocompletelysolveproblemsbysuchtoolsasdescriptiontools,conventionalmeasures,analysisandquantification.4.0Responsibil
11、ityK三4.1 质量部：4.2 QualityDepartment1)对接收到的内外部发生的不符合项进行判定，识别是否需要发出8D报告；1) Determinethenonconformityoccurredinsideandoutsidethecompanytoidentifywhethertheissuanceof8Dreportisnecessary.2)组织成立相应不符合项的8D解决问题小组，跟踪进展情况，验证各项措施的有效性：2) Organizetosetup8Dteamforsolvingnonconformity,tracksolvingprocessandverifythe
12、effectivenessofallmeasures.3) 8D报告原件的最终整理归档部门。3)Departmentforthefinalarchivingoftheoriginal8Dreport.4.2 8D小组成员：4.3 8Dteammembers:1)参与根本原因问题分析，提议形成围堵及永久措施；1) Analyzetherootcauseofproblemsandproposecontainment&permanentmeasures;2)执行形成决议的围堵及永久措施；2) Carryouttheagreedcontainment&permanentmeasures;3)协助质量部
13、验证措施的有效性。3) AssistQualityDepartmenttoverifytheeffectivenessofmeasures.5.0Proceduregf?问题Problem责任/参与Responsibility/participation措施Measures1确定要解决的问题1Identifytheproblemtobesolved任何员工Anymember1.向部门主管或质量部主管提供所发现的不符合项问题点的描述，由部门主管与质量部主管协商是否启动8D小组。1. Describetheproblemsofdiscoverednonconformitytodepartments
14、upervisororQualityDepartmentsupervisor,whowillholdadiscussionanddecidewhether8Dteamshallbesetupornot.2. 任何部门均可针对公司内部运作中发现的不符合事项，如果认为需要发起8D小组解决该问题点，向质量部主管建议启动8D小组。3. Fornonconformitieswhicharediscoveredinsidethecompany,anydepartmentmaysuggestQualityDepartmentsupervisortosetup8Dteamiftheythinkitisnece
15、ssarytosolvethisproblem.3.任何部门在接收到来自外部的客户抱怨、退货等影响到客户满意的不符合项时，均可向向质量部主管申请启动8D小组。4. Afterreceivingnonconformitythatmayaffectcustomersatisfaction,suchasexternalcustomercomplaintandreturnofgoods,anydepartmentmaysuggestQualityDepartmentsupervisortosetup8Dteam.2.启动8D2.Setup8D质量部主管QualityDepartmentsupervis
16、or1.同内外部与问题相关的各方沟通，初步确定解决该问题的8D小组成员，问题责任部门。1. Communicatewitheachpartyinsideandoutsidethecompanywhoisrelatedtotheproblem,andprimarilydetermine8Dteammemberssolvingtheseproblems,aswellasdepartmentthatshallberesponsiblefortheproblem.2. 每一个8D问题都将有一个编号，可以知道它产生的日期和顺序，由XX论血组成。包括了“年月流水号”，此编号由质量部主管统一给出。3. Ea
17、ch8Dproblemwillbeaccompaniedwithaserialnumberindicatingitsdateandsequence.ThenumberiscomposedofXXXXXXX,year,monthandflowNo.,whichisuniformlygivenbyQualityDepartmentSupervisor.3.指定组长3.Appointteamleader总经理/质量部主管或合适的部门主管Generalmanager/QualityDepartmentsupervisororappropriatedepartmentsupervisor组长由各部门主管
18、推举，总经理认可，应该是管理层中合适的成员(中层或更高)。Teamleader,whoshallbetheappropriatepersonnelinmanagementlevel(inthemiddlemanagementlevelorabove),iselectedbyeachdepartmentsupervisorandapprovedbygeneralmanager.4.启动小组会议4.Holdteammeeting质量部主管/小组成员，各相关部门主管QualityDepartmentsupervisor/teammembers,allrelateddepartmentsupervis
19、ors1 .小组成立会议，明确小组成员及职责，详细沟通问题点，分析问题；1. Theteamholdsameetingtodefineteammembersandtheirresponsibilities,todiscussproblemsindetail,andtoanalyzeproblems.2.如果会议同意作为一个8D问题，8D问题报告将成为一个记录保存。2. Ifan8Dproblemisestablishedonthemeeting,8Dproblemreportwillberetainedasonerecord.5.分析原因并解决问题5.Analyzecausesandsolve
20、problems组长/小组成员Teamleader/teammembers小组开展活动，按8D问题分析报告的项目按术语要求按步骤逐个完成C8D报告的表格是8D小组的措施的记录，由小组选择的成员或组长填写。Theteamcarriesoutactivities,theprojectsincludedin8Dproblemanalysisreportshallbefinishedonebyoneaccordingtorequirements.Formin8Dreportrecordsthemeasurestakenby8Dteam,andshallbefilledinbyappointedteam
21、memberorteamleader.6.报告整理6.Sortoutreports组长/小组成员Teamleader/teammembers当小组完成了所有的8D的步骤，组长审核报告的完成情况。Whentheteamfinishesall8Dsteps,teamleaderreviewthecompletionofreport.7.问题点关闭7.Completionofproblemsolving质量部主管/质量会议参加者QualityDepartmentsupervisor/participantsinqualitymeeting1.结束的8D报告在下次的质量问题会议上提交，与会者审阅通过8
22、D问题的关闭。如果一个或几个因素没有解决或不令人满意，8D报告就没有结束，退回组长继续工作，直至问题完全解决。1. Thefinished8Dreportshallbesubmittedonthenextqualityproblemmeeting.Meetingparticipantsreviewthereportandapprovetheclosingof8Dproblems.8Dreportisnotfinishedifoneorseveralproblemsarenotclosedornotsatisfactorilyclosed.8Dreportwillbereturnedtoteam
23、leaderandshallbeworkeduntilproblemsarecompletelysolved.2. 8D报告的原版交质量部保存。3. Theoriginal8DreportwillbesubmittedtoQualityDepartmentforretention.8.8D项目跟踪8.Track8Dproject质量部主管QualityDepartmentsupervisor1.提供一个所有的完成的以及未完成的8D问题报告的月度状态报告，所有的已完成的8D报告将保存在质量部永久存档。1.Provideamonthlyreportconcerningallfinishedandunfinished8Dproblemreport.Allfinished8DreportwillbepermanentlyretainedinQualityDepartment.6.0ReferenceDocuments参考文件6.1PD-S7-01CorrectiveandPreventiveProcedure纠正和预防措施程序7.0ReferenceForms参考表单7.1FN-QA-0388Danalysisreportofproblems8D问题分析报告
