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The8Discipline(8D)

ProblemSolvingProcess

解决问题的流程-8条戒律第一页,共六十九页。课程目标使参与者通过下列方式解决问题Toenableparticipantstosolveproblemsby使用8D流程followingadisciplineproblemsolvingmethodologyusingthe8Discipline(8D)Process使用合适的质量工具applyingtheproperqualitytools课程目标2第二页,共六十九页。课程内容组建团队teamsetup描述/定义问题Describe&defineproblem采取临时的遏制措施Takesinterimcontainmentaction定义/验证根本原因define&verifytherootcause(s)

识别/验证建议的永久性纠正措施Identify/verifyproposedpermanentcorrectiveaction(s)实施永久性纠正措施Implementpermanentcorrectiveaction(s)预防再发生Action(s)topreventRe-occurrence交流/庆祝成功communicate/celebratesuccess.练习excise:3第三页,共六十九页。解决问题高低急迫性高重要性8D既重要又急迫重要但不急迫既不重要又不急迫“不理他”不重要但急迫低

什么时候使用8DWhendoyouuseaReactiveProblemSolvingprocess?

当高优先权问题出现时Forhighpriorityproblems

当产品的标准和规范不能得到满足时Whenstandardsandspecificationsarenotbeingmet当过程失控时Whenaprocessisoutofcontrol

当要求正式提供解决问题的证据时Whenformalevidenceofproblemresolutionisrequired4第四页,共六十九页。统计工具ProblemSolving-StatisticalTools如果手中只有锤子,那么我们看任何东西都像钉子IftheonlytoolyouhaveisaHammer,everythinglookslikeanail对解决问题的正规方法要求你使用数据对问题和解决方法的有效性进行评估,而不是仅凭思考和主观臆断Theformalapproachtoproblemsolvingrequiresthatyoubaseyourassessmentoftheproblemandtheeffectivenessofthesolutionondata,notspeculationoropinions在解决问题的过程中,使用基本的统计工具确保结果的可测性Fundamentalstatisticaltoolsareusedthroughouttheproblemsolvingprocesstoensuremeasurableresults

5第五页,共六十九页。统计工具ProblemSolving-StatisticalToolsStep1-形成团队FormaTeamStep2–描述问题DescribetheProblemStep3–遏制问题ContainProblemStep4–识别和验证原因Define&VerifyCausesStep5–找出纠正措施Identify/verifypermanentCorrectiveActionStep6–执行及验证措施Implement&VerifyActionStep7–防止在出现PreventRecurrenceStep8–庆祝成功CelebrateSuccess流程图FlowchartsXXXXX脑筋风暴法BrainstormingXXXXXXForceFieldAnalysisXX因果图CauseandEffectXX面谈InterviewingXX调查SurveyingXXX检查表ChecksheetsXXXX直方图HistogramsXXXX排列图ParetoAnalysisXXXX运行图RunChartsXXX饼图PieChartsXXXX关键线路表格CriteriaRatingFormsXX网络图ListReductionX权重图WeightedVolumeX甘特图GanttChartXXX矩阵图PERTChartXXX6第六页,共六十九页。8DProblemSolving8D体系流程包含下述内容:The8Dsystemisaproblemsolvingprocessthat识别问题Identifiesproblems采取临时的遏制措施Takesinterimcontainmentaction将问题量化Describesproblemsinmeasurableterms使用统计工具分析问题Analyzesthemusingdataandbasicstatisticaltools找出根本原因Findstherootcause通过消除根本原因来解决问题Correctstheproblembyeliminatingtherootcause7第七页,共六十九页。8DProblemSolving行动ACT执行DOPlan计划检查CHECK4定义和验证根本原因define&VerifyRootCauses3遏制问题ContainmentProblem2描述/定义问题Describe/defineProblem1

组建团队TeamSet-up7

防止再发生PreventRecurrence8

庆祝成功/交流CelebrateandCommunicateSuccess5

识别/验证纠正措施Identify&verifyproposedCorrectiveActionPlan6

实施和验证纠正措施Implement&VerifyCorrectiveAction8DProcess8D遵循PDCA循环followsthelogicofthePDCACycle(a.k.a.ShewhartorDemingCycle)8第八页,共六十九页。8D特点8DProblemSolvingCharacteristics对指定的,可管理的,有明确定义的问题有效。Worksonproblemsthatarespecific,manageableandwelldefined分析问题的所有方面Analyzesallaspectsofaproblem对建议的方法进行合理化分析Developsrationaleforproposedsolutions

收集对问题和建议方法有意义的数据Gatherscriticaldataabouttheproblemandproposedsolutions基于团队的过程Teamorientedprocess制定如何成功的实施和评估纠正措施的计划Planshowtoimplementandevaluatetheactionsuccessfully9第九页,共六十九页。步骤1:8DProcessStep1ACTDOPLANCHECK

1-组建团队TeamSet-up

8D10第十页,共六十九页。决定对此问题是否需要成立一个团队,如果需要:Determinewhetherateamisneededtoaddresstheissue:ifso,选择成员Selectandenlisttheteammembers明确角色和职责Establishrolesandresponsibilities评审团队的活动范围和目标Reviewthescopeandobjectiveoftheteam’sactivity组建团队:Step1:TeamSet-up-Objectives11第十一页,共六十九页。成员Membership利益关系人Stakeholders技能专家Knowledgeablepeople/technicalexperts问题涉及的人Peopleaccountable&responsibleforproblemarea团队规模TeamSize理想状态是4~6人Ideally,4to6membersto

加强内部互动Enhanceinteraction促进交流Promotecommunication承担责任Drivecommitmenttothetask范围,目标,角色和职责Scope,Objective,RolesandResponsibilities明确团队的期望Identifywhattheteamisexpectedtoaddress评估成员的参与性Reviewtheteamsavailability明确决策权限Clarifythelevelofdecision-makingauthorityStep1:-TheProblemSolvingTeam12第十二页,共六十九页。Step1:-TeamActivity目标Goals1.明确陈述的问题Clarifytheissuetobeaddressed评价支持性的数据Reviewsupportingdata评价规模Assessthemagnitude2.明确团队的角色,职责,范围和目标Establishtheteamroles,responsibilities,scopeandobjectives3.针对此问题采用脑筋风暴法Brainstormpotentialproblemssurroundingtheissueandideasrelatedtothem4.收集支持性数据Collectsupportingdataabouttheproblemarea(s)5.讨论针对此问题的一般性计划Discussthegeneralplanforapproachingtheproblem(s)13第十三页,共六十九页。问题是否被确认Havethereportedissuesbeenidentified?问题的主题是否被明确Hastheproblemtopicbeenidentified?团队是否被建立Hasateambeenestablished?会议和决策流程是否被统一Havemeetinganddecision-makingprocessesbeenagreedupon?一般性项目计划是否被制定Hasageneralprojectplanbeendeveloped?Step1:TeamSet-up-ChecklistAreweontarget?14第十四页,共六十九页。8DProcessStep2ACTDOPLANCHECK2描述和定义问题Describe/defineProblem

TeamSet-up8D15第十五页,共六十九页。目标Step2:Describe/defineProblem-Objectives分析和解释数据来缩小问题范围Analyzeandinterpretdatatonarrowdowntheproblemtobeaddressed2.给出问题的正式描述Developaformalproblemstatement16第十六页,共六十九页。一般性流程Step2:Describe/defineProblem-GeneralProcess明确问题的主题Identifytheproblemtopicsthatmaysurroundtheissue,andselecttheproblemtargetarea.针对问题采用脑筋风暴法并记录想法Brainstormandrecordtheteam’sideasabouttheproblemarea收集数据来确定评判问题的标准Collectdatatovalidatethataproblemexists

确定可应用于此问题的标准和规范Establishwhatstandardorspecificationappliestothesituation考虑所有和问题相关的,可得到的信息。Considerallavailablesourcesofinformationthatmayrelatetotheproblem(includingexternalsources)提出并实施解决问题的初步方法Developandimplementageneralplanforapproachingtheproblem17第十七页,共六十九页。1.总结和解释数据SummarizeandInterpretData解释已有的数据,如果需要,收集额外的数据来澄清问题Interpretthedatacollected,obtainingadditional(morespecific)dataifnecessarytoclarifytheproblem使用统计工具Usethebasicstatisticaltoolstoclarifythedataanddisplaythefindingsinanappropriateformat基于是否满足标准或规范,应评估收集到的数据ThecollecteddatashouldbeevaluatedagainstthestandardorspecificationrequiredtobemetB.把数据和商业目标,测量性能,应用标准,规范进行比较Comparethedatawithbusinessobjectives,performancemeasures,andapplicablestandardsorspecifications一般性流程Step2:Describe/defineProblem-GeneralProcess18第十八页,共六十九页。2.给出问题的文字说明DevelopandWriteaProblemStatement用“目前状态”条目描述当前的形势Writethe“Currentstate”statementdescribingthepresentsituation.B.用“期望状态”描述要求Writethe“Desiredstate”statementdescribingtherequirementorspecification.C.明确两种状态的差距Identifythegap.D.基于上述三条完整的描述问题CombinethethreetogeneratetheProblemStatement

一般性流程Step2:Describe/defineProblem-GeneralProcess19第十九页,共六十九页。1.基于可测量的方式,清晰的描述问题Aclearstatementoftheprobleminmeasurableterms基于数据,非猜测Basedondata,notspeculation根本原因尚未发现Nocauses-Rootcausehasnotyetbeendeveloped不包含解决方案Nosolutions-Solutionsmusttargettherootcause不要太笼统Nottoogeneral

2.描述问题必需包含:TheProblemStatementmustinclude:当前状态The“Currentstate”or“asis”condition期望状态The“Desiredstate”orrequiredposition差距The“Gap’ordifferencebetweenthecurrentanddesiredstates问题描述Step2:Describe/defineProblem–ProblemStatement20第二十页,共六十九页。提交的问题ReportedIssues客户测试失败率太高Customertestfailureratesaretoohigh2.和此有关的商业关系被伤害Businesswiththishighproisinjeopardy问题主题·ProblemTopic客户的测试直通率不可接受Customertestyieldsareunacceptable分析给出下列描述Analysisreflectsleadsustothefollowingproblemstatement客户的测试直通率是75%(当前状态),要求的直通率是95%(期望状态),客户测试的直通率比可接受水平低20%(差距)Thecustomer’stestyieldonourproductis75%(currentstate),therequiredyieldis95%minimum(desiredstate),thecustomer’stestyieldis20%lessthantheacceptablelevel(gap).评估描述内容Reviewofthestatement1.是否基于数据Isitbasedondata?

Yes2.是否包含原因Aretherecausesinthestatement?

No3.是否包含方案Aretheresolutionsinthestatement?

No4.是否太笼统Isthestatementtoogeneral?

No结论:问题描述满足上述标准Conclusion:TheProblemStatementmeetsthegeneralcriteria问题描述--例子Step2:Describe/defineProblem-TheProblemStatement:Example21第二十一页,共六十九页。团队活动Step2:Describe/defineProblem-TeamActivity目标Goals分析和问题有关的数据来确认问题Analyzetheproblemdatatotrytoconfirmtheproblems2.把数据和商业目标,测试性能,使用标准,规格进行比较Comparethedatatobusinessobjectives,performancemeasures,andapplicablestandardsorspecifications3.使用收集到的数据来建立当前状态,期望状态和两者之间的差距Usethecollecteddatatoestablishthecurrentanddesiredstates,andgap4.写出问题陈述WritetheProblemStatement22第二十二页,共六十九页。可使用的标准是否被识别Havetheapplicablestandardsbeenidentified?和问题相关的数据是否被收集和评估Hasdataabouttheproblembeentakenandreviewed?问题是否基于什么事情,什么时候,为什么,如何,多少被识别HastheproblembeenidentifiedbyWhat,When,Why,HowandHowMuch?问题是否基于可测量的手段定义Hastheproblembeendefinedinmeasurableterms?客户的反馈是否被输入到问题Hasthecustomerprovidedinputtotheproblem?我们是否找到合适的人员处理下一步工作Dowehavetherightteammemberstoproceedtothenextstep?检查表Step2:Describe/defineProblem-ChecklistAreweontarget?23第二十三页,共六十九页。8DProcessStep3ACTDOPLANCHECK3遏制措施ContainmentProblemDescribe/DefineProblem

TeamSet-up

8D24第二十四页,共六十九页。目的:Step3:ContainProblem-Objectives识别和选择临时遏制措施Identifyandselectcontainmentaction(s)

2.实施临时遏制措施

Developandimplementacontainmentplan3.评估临时遏制措施的效果Analyzetheeffectivenessofthecontainmentactions25第二十五页,共六十九页。遏制问题Step3:ContainmentProblem遏制Containment

也称作短期纠正措施Alsoknownasshorttermcorrectiveaction当根本原因在调查中或纠正措施在实施中,采取的防止进一步影响客户的临时措施Objectiveistotakeimmediateinterimactiontopreventtheproblemfromimpactingthecustomerwhiletherootcauseisbeinginvestigatedandcorrectiveactionisestablishedandimplemented典型的遏制措施包含分类,筛选,返工等。Typically,containmentinvolvessorting,screeningortestingwithreworkasrequired,andsequesteringaffectedproductormaterialswhileawaitingdisposition26第二十六页,共六十九页。Verification&validation;Occurrence&Escape验证Verification–确定纠正措施是否实施theswitchon,switchoffmeasurementoftheactiontakeni.e.confirmationthattheactionhastakenplace.确认Validation–基于一段时间对措施的测量themeasurementoftheactionoveraperiodoftimee.g.Shift,days,week,monthetc.发生的事情Occurrence实际发生的事情,如纠正措施是否实施逃逸Escape事情发生的渠道27第二十七页,共六十九页。利用脑筋风暴法来收集遏制措施,从中选择遏制措施Brainstormandselectinterimcontainmentaction(s)实施计划Planforimplementation实施遏制措施Implementcontainmentactions

验证遏制措施已经被实施并评估有效性Verifyinterimactionsareinplaceandeffective一般性流程Step3:ContainProblem-GeneralProcess28第二十八页,共六十九页。利用团队的创造性能力来产生观点Usesthecreativecapacityofagroupofpeopletogenerateideas使用Uses

识别问题范围Identifyingproblemareas找出问题潜在的原因Findingpotentialcausesofproblems得出可选的方案Generatingalternativesolutions指导Guidelines没有评价和批评Noevaluationorcriticism鼓励异想天开的想法Encouragewildideas提出尽可能多的想法Striveforquantity类型Types

结构Structured成员顺序发言Membersparticipateinsequenceverbally(RoundRobin)成员写下各自的想法Memberswritetheirideasdowninthesession(Slipmethod)非结构的Unstructured随机发言Randomverbalinput(Freewheeling)头脑风暴法Step3:ContainProblem-Brainstorming29第二十九页,共六十九页。头脑风暴法Step3:ContainProblem-Brainstorming一般方法GeneralApproach:1.识别任务组织者Identifyafacilitatortoguidethesession保持任务一直被关注Keepsessionmoving追求观点的数量Promoteavolumeofideas提问Promptandaskquestions2.识别想法的记录Identifytherecorderofideas(scribe)尽可能的记录未经修改的想法Ideasshouldberecordedascloselytowhatissaidaspossible让被记录的观点可以被看见Useaflip-charttokeepideasvisible3.定义主题Definethetopic4.定义任务时间Definethetimeperiodforthesession30第三十页,共六十九页。计划Planning确保正式的措施在体系层面上展开Objectiveistoensurethatformalactionsaretakeninasystematicfashion精心组织和可追溯的计划是必须的。推荐使用甘特图Astructuredandtrackableplan,usingaformaltoolsuchasaGanttchartisrecommended一般过程GeneralProcess把任务分解成可执行的若干步Breaktasksintoachievablesteps.分配任务Assigntaskresponsibilities.设置里程碑Setuptimeframeandmilestones.建立跟踪过程的文件Createadocumentfortrackingtheprogressoftheimplementation对至关重要的额外信息要评估Additionalconsiderationforinclusionintheplanarestrategiesforcommunicatingandgainingcommitment,contingencyplans,andmeasurestoevaluatetheeffects实施计划Step3:ContainProblem-TheImplementationPlan31第三十一页,共六十九页。甘特图GanttChart实施计划Step3:ContainProblem-TheImplementationPlan32第三十二页,共六十九页。团队活动Step3:ContainProblem-TeamActivity目标Goals选择遏制措施Selectthecontainmentaction(s)tobetaken提出必要的计划Developanynecessaryplans实施遏制措施Implementtheaction(s)验证遏制措施已经被实施并评估有效性Verifythecontainmentactionsareinplaceandeffective33第三十三页,共六十九页。检查表Step3:ContainProblem-Checklist潜在的遏制措施是否被识别Havepotentialcontainmentactionsbeenidentified?遏制措施是否被执行Havecontainmentactionsbeenimplemented?遏制措施是否能保护客户免于此中问题Arethecontainmentactionseffectiveatprotectingthecustomerfromdefects?遏制措施是否被评估Havecontainmentactionsbeenverified?我们是否找到合适的人员处理下一步工作Dowehavetherightteammemberstoproceedtothenextstep?Areweontarget?34第三十四页,共六十九页。8DProcessStep4ACTDOPLANCHECK4定义/验证根本原因define&VerifyRootCausesContainmentProblemDescribe/DefineProblem

TeamSet-up8D35第三十五页,共六十九页。目的Step4:defineandVerifyRootCauses-Objectives识别引起问题的可能原因Identifytheprobablecausesoftheproblem选择根本原因Selecttherootcause识别和澄清潜在的纠正措施Identifyandclarifypotentialcorrectiveactions36第三十六页,共六十九页。1.识别可能的原因IdentifyProbableCauses评估客户的要求Reviewcustomerrequirements使用脑筋风暴法来发现可能的原因Brainstormandorganizepossiblecauses

使用因果图(e.g.,causeandeffectdiagram)试图把原因分级Explorelevelsofcause识别可能的原因Identifyprobablecauses依原因的重要性对原因进行排序;如:重要,较重要Rankcausesbycorrelationtoeffect:Strong,ModerateorWeak2.分析可能原因AnalyzeProbableCauses为可能原因准备收集数据Selectprobablecausesfordatacollection决定收集方法Determinecollectionmethod(e.g.,Checksheet)收集,分析数据来识别根本原因Collect/analyze/displaydatatoidentifyrootcausespreventingthe"desiredstate”frombeingreached一般性流程Step4:defineandVerifyRootCauses-GeneralProcess37第三十七页,共六十九页。3.选择根本原因SelectRootCausesforAction把根本原因按优先级排序Prioritizerootcauses选择根本原因展开工作Selectrootcause(s)toworkon决定采取的措施是否在团队的工作范围之内,或需要新的外部资源Determineiftakingactioniswithinthescopeortheteamorifadditionalresourcesneedtobeenlisted设计和执行实验来验证根本原因Developandimplementexperimentstotestandvalidaterootcauses修正根本原因Reviseproblemstatement(ifrequired)一般性流程Step4:defineandVerifyRootCauses-GeneralProcess38第三十八页,共六十九页。因果图CauseandEffectDiagram

脑筋风暴法AstructuredformofBrainstorming识别,探索和列出问题和可能的原因Identify,explore,anddisplayaproblem(effect)andallpossiblecauses使用Uses

分析问题Analysisofaproblem

指导讨论Guidefordiscussion图解技术状况Illustrateleveloftechnology评估流程Evaluateknowledgeofaprocess收集数据Collectionofdata学习工具Educationtool最普通的原因类别Mostcommoncausecategories人,机,料,法,环People,machine,materials,methods,environment因果图Step4defineandVerifyRootCauses-CauseandEffectAnalysis39第三十九页,共六十九页。Name: Date: Time-frame:

Causes

Material

Method EnvironmentUnavailableDidn’t

Order

Effect Notonbill

(Current

State)

Missing Parts

Training

SetUp

人员People

机器Machine因果图Step4:IdefineandVerifyRootCauses-CauseandEffectAnalysis40第四十页,共六十九页。Name: Date: Time-frame:

Causes

Material

Method

Environment UnavailableADidn’t

Order Effect Notonbill

(CurrentState)

Missing Parts

B C

Training SetUp

People

MachineRelationshiptoEffectA=StrongB=ModerateC=Weak因果图Step4:defineandVerifyRootCauses-CauseandEffectAnalysis41第四十一页,共六十九页。团队活动Step4:DefineandVerifyRootCauses-TeamActivity目标Goals使用脑筋风暴法,因果图找出可能的原因Brainstormthepossiblecausesoftheproblem,usingacauseandeffectdiagram对可能的原因排序并收集支持数据Rankthepossiblecausesandcollectsupportingdata选择根本原因Selecttherootcausetarget(s)如果需要,执行测试来确认根本原因Runteststoconfirmtherootcause(s),ifnecessary如果需要,改变问题陈述Revisetheproblemstatement,ifnecessary42第四十二页,共六十九页。问题陈述是否被评估Hastheproblemstatementbeenreviewed?可能的原因是否被识别Haveprobablecausesbeenidentified?针对可能的原因是否收集相关的数据Hasdatabeencollectedontheprobablecauses?可能的根本原因是否排定优先权Haverootcausesbeenprioritizedandselected?潜在的根本原因是否被识别和澄清Havepotentialcorrectiveactions/solutionsbeenidentifiedandclarified?我们是否找到合适的人员处理下一步工作Dowehavetherightteammemberstoproceedtothenextstep?检查表Step4:IdentifyandVerifyRootCauses-ChecklistAreweontarget?43第四十三页,共六十九页。8DProcessStep5ACTDOPLANCHECKDefine&VerifyRootCausesContainmentProblemDescribe/DefineProblem

TeamSet-up5

识别验证纠正措施Identify/verifypermanentCorrectiveActionPlan8D44第四十四页,共六十九页。目的Step5:Identify/verifypermanentCorrectiveActionPlan-Objectives评估潜在的纠正措施Evaluatethepotentialcorrectiveaction(s)选择欲实施的措施Selectthecorrectiveaction(s)tobetaken提出并对纠正措施的实施计划达成一致Developandagreeuponacorrectiveactionimplementationplan45第四十五页,共六十九页。选择一般性的纠正措施标准,基于Selectthegeneralcorrectiveactioncriteriaconsidering:时间Time资源Resource可控制性Control成本Cost基于上述标准选择最优化的纠正措施Usethecriteriatoselectthebestcorrectiveaction从所有成员处得到输入Getinputfromallteammembers脑筋风暴法Brainstormalistofideas评估优缺点Assessbenefitsanddrawbacks组合各种观点Combineideas选出最好的潜在纠正措施,必须是可行的和团队的控制范围内Voteonbestpotentialcorrectiveaction(s)-Ideasmustbeactionableandwithinthescopeoftheteam一般性流程Step5:Identify/verifypermanentCorrectiveActionPlan-GeneralProcess46第四十六页,共六十九页。3.提出实施计划Developanimplementationplan包含实施步骤和时间计划Includeactionitemsandaschedule安排资源(如果需要,包括供应商和客户)Arrangeforresources(includingsupplierandcustomer,ifneeded)分配和评估任务Assignandreviewresponsibilities考虑实用的测量方案,计划,先期测试Considerapplicablemeasures,contingencyplans,andpilottests(ifappropriate)一般性流程Step5:Identify/verifypermanentCorrectiveActionPlan-GeneralProcess47第四十七页,共六十九页。团队活动Step5:Identify/verifypermanentCorrectiveActionPlan-TeamActivity目标Goals

1.通过脑筋风暴法收集纠正措施的想法Brainstormalistofcorrectiveactionideas2.决定最优化的潜在纠正措施Decidethebestpotentialcorrectiveaction(s)3.提出纠正措施计划Developacorrectiveactionplan48第四十八页,共六十九页。潜在的纠正措施是否被甄选和组合Havepotentialcorrectiveactions/solutionsbeenfilteredandcombined?选择的标准是否被识别Havecriteriaforselectionbeenidentified?纠正措施计划是否被提出Hasacorrectiveactionplanbeendeveloped?纠正措施对其他的流程和客户的影响是否被评估Hastheimpactofthecorrectiveactiononotherprocessesorcustomersbeenevaluated?基于评估结果,纠正措施是否能完全消除和根本原因有关的缺陷Basedonevaluation,willthecorrectiveaction/solutiontotallyeliminatethedefectassociatedwiththerootcause?处理下一步的合适人员是否能得到Dowehavetherightteammemberstoproceedtothenextstep?检查表Step5:Identify/verifypermanentCorrectiveActionPlan-ChecklistAreweontarget?49第四十九页,共六十九页。8DProcessStep6ACTDOPLANCHECKDefine&VerifyRootCausesContainProblemDescribe/defineProblemTeamSet-up

Identify/verifypermanentCorrectiveActionPlan实施/验证纠正措施Implement&VerifyCorrectiveAction8D50第五十页,共六十九页。目的Step6:Implement&VerifyCorrectiveAction-Objectives测试可能的纠正措施,如果可能,更改相应的计划Testtheintendedcorrectiveaction(s)andadjusttheplanifrequired实施纠正措施并验证引起问题的根本原因已被消除Implementthecorrectiveaction(s)andverifythattherootcausehasbeeneliminated移走临时遏制措施并验证问题不再发生Removethecontainmentactionandverifythattheproblemdoesnotrecur51第五十一页,共六十九页。1.准备实施Prepareforimplementation

评估问题的描述Reviewtheproblemstatement再次澄清根本原因Restatetherootcause评估纠正措施计划Reviewthecorrectiveactionplan让所有相关的人员理解纠正措施Train/reviewplanwithalleffectedpersonnel2.实施纠正措施Implementthecorrectiveaction实施纠正措施计划Implementthecorrectiveactionplan移走临时的遏制措施Removetheinterim(shortterm)containmentaction跟踪实施过程Trackimplementationprogress和相关人员保持交流Continuouslycommunicatewithalleffectedpersonnel一般性流程Step6:Implement&VerifyCorrectiveAction-GeneralProcess52第五十二页,共六十九页。3.评估纠正措施的效果Evaluatetheeffectivenessoftheaction

收集相关数据(包括客户的反馈)Collectresultsdataforevaluationoftheeffectivenessofthecorrectiveaction(s)Note:Includecustomerfeedback分析数据,和以下几个方面比较Analyzedataincomparisonwith:以前的分析Previousanalysis商业目标Businessobjectives期望状态“Desiredstate”确定是否仍然存在差距Determineifthereisstillagap4.完成评估Completeevaluation陈述差距Addressthegap(ifany)如果需要,陈述有解决方案引起的新的问题IIdentifyandaddressnewproblemareascreatedbythesolution(s),ifapplicable一般性流程Step6:Implement&VerifyCorrectiveAction-GeneralProcess53第五十三页,共六十九页。5.形成标准Standardizechanges

列出那些因为改变而要标准化的文件Listthestandardprocessdocumentationthatneedstobemodifiedtomakethechangesystemic考虑引起最初问题的作业流程Considerpractices,procedures,andsystemsthatallowedtheinitialproblemtooccur更新应用文件,提供培训,确保ISO的要求。如Updateapplicabledocumentationtoformalizecontrol,provideavehiclefortraining,andensureISOcompliancesuchas:

检验计划Inspectionplans/Procedures流程规范ProcessSpecifications使用中的仪器MachineOperatingInstructions工作指导书WorkInstructions标准化操作流程StandardOperatingProcedures

产品和元器件的规范Product/ComponentPrintsandSpecifications一般性流程Step6:Implement&VerifyCorrectiveAction-GeneralProcess54第五十四页,共六十九页。团队活动Step6:Implement&VerifyCorrectiveAction-TeamActivity目标Goals评估问题描述的准确性,根本原因被陈述Reviewtheproblemstatement,androotcausebeingaddressed评估纠正措施计划Reviewthecorrectiveactionplan实施纠正措施计划Implementthecorrectiveactionplan移走临时遏制措施Removethecontainmentaction评估纠正措施的效果Evaluatetheeffectivenessofthecorrectiveaction对系统的改变使之标准化Formalizeanysystemchanges55第五十五页,共六十九页。先期措施是否起效Havepilot(s)beenconducted?数据是否收集Hasdatabeencollected?基于客户反馈和缩小差距,是否成功Hassuccessbeenachievedbasedonclosingtheproblemgapandaddressingcustomerfeedback?新的问题(如果有)是否被识别Havenewproblems(ifany)beenidentified?临时遏制措施是否被移走Havethecontainmentaction(s)beenremoved?为了处理下一步问题,合适的人员是否能得到Dowehavetherightteammemberstoproceedtothenextstep?检查表Step6:Implement&VerifyCorrectiveAction-ChecklistAreweontarget?56第五十六页,共六十九页。8DProcessStep7ACTDOPLANCHECKDefine&VerifyRootCausesContainProblemDescribe/DefineProblemTeamSet-up7防止再发生

PreventRecurrence

Identify/verifypermanentCorrectiveActionPlanImplement&VerifyCorrectiveAction8D57第五十七页,共六十九页。目的Step7:PreventRecurrence-Objectives确认实施纠正措施的计划已经被执行Verifythatthecorrectiveactionimplementationplanisbeingfollowed2.实施系统控制Developandimplementthesystemiccontrols3.寻找其他实施这种纠正措施的场合Lookforotheropportunitiestousetheactiontaken58第五十八页,共六十九页。一般性流程Step7:PreventRecurrence-GeneralProcess确认实施纠正措施的计划已经被执行Verifythattheimplementationplaniscomplete如果在计划中有未完成项,或由于实施纠正措施而产生新的情况,要确保有合适的正式计划来解决它们Ifthereareincompleteitemsontheplanorotherissuesthatneedtobeaddressedasaresultoftheaction,ensurethattheyareresolvedorthereisaformalplaninplacefortheirresolution采用足够的检查来确信纠正措施结果的一致性Ensurethatthereareenoughchecksperformedovertimetoestablishthattheresultsoftheactionareconsistent评估控制计划Reviewthecontrolplan确保监控关键参数的控制计划在执行Ensurethatthecontrolstomonitorcriticalparametersassociatedwiththeeffectedprocessareinplace评估控制计划来确保在不合格品出现之前有预警信号Evaluatetheplantoensurethatunfavorabletrendstriggeractionpriortononconformancesoccurring59第五十九页,共六十九页。一般性流程Step7:PreventRecurrence-GeneralProcess3.寻找其他实施这种纠正措施的场合Lookforadditionalapplicationsoftheaction

其他的产品,流程,运营,客户等,他们也许能够得益通过实施相同的纠正措施Otherproducts,processes,operations,customers,etc.relatedtothebusinessmaybenefitfromthesamecorrectivemeasures60第六十页,共六十九页。团队活动Step

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