QA-0078DProblemSolvingRegulation8D方法实施规范-中英对照.docx
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,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,withaviewtoidentifyandeliminatetherootcauseofnonconformity.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 ProblemdescriptionBrieflydescribetheproblemsandprovideasmuchquantitativeinformationaspossible,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,latedelivery,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 Findandidentifytherootcausecontinuouslyfindtherootcauseuntilitisactuallyidentified.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.Ifpreventionisnotpossible,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 VerifytheeffectivenessofpermanentmeasuresUsedatatoverifyallchangesandverifytheeffectivenessofallmeasures.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,givethankstotheteamthatsolvesproblemsandcongratulatetheirhardwork.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.4.0ResponsibilityK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,tracksolvingprocessandverifytheeffectivenessofallmeasures.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. DescribetheproblemsofdiscoverednonconformitytodepartmentsupervisororQualityDepartmentsupervisor,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,anydepartmentmaysuggestQualityDepartmentsupervisortosetup8Dteamiftheythinkitisnecessarytosolvethisproblem.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QualityDepartmentsupervisor1.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,aswellasdepartmentthatshallb
