《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)》请在优知文库上搜索。
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