[质量管理]ISOTC 176SC 2N 544R3过程(doc 15页)中英对照

HYPERLINK"http://www.3722.cn"www.3722.cn中国最庞大的下载资料库(整理.版权归原作者所有如果您不是在3722.cn网站下载此资料的,不要随意相信.请访问3722,加入)3722.cn必要时可将此文件解密成可编辑的DOC或pptDocument:ISO/TC176/SC2/N544R31.Introduction简介Thisguidancedocumentprovidesanunderstandingoftheconcepts,intentandtheapplicationofthe“processapproach”totheISO9000familyofQualityManagementSystemstandards.Theguidancemayalsobeusedtoapplytheprocessapproachtoanymanagementsystemregardlessthetypeorthesizeoforganization.Thisincludesbutisnotlimitedtomanagementsystemsfor:本指导文件提供了质量管理体系标准ISO9000族“过程方法”的概念、意图及应用。本指导文件也可用于将过程方法应用于任何管理体系，无论组织的类型和规模。包括但不限于以下管理体系：Environment(ISO14000family),OccupationalHealthandSafety,BusinessRisk,SocialResponsibility.Thisguidealsoaimstopromoteaconsistentapproachtothedescriptionofprocessesanduseofprocessrelatedterminology.本指导文件目的：在描述过程和使用过程相关术语方面提供统一的方法。Thepurposeoftheprocessapproachistoenhanceanorganization’seffectivenessandefficiencyinachievingitsdefinedobjectives.InrelationtoISO9001:2008thismeansenhancingcustomersatisfactionbymeetingcustomerrequirements.过程方法的目的是增强组织达成既定目标的有效性和效率。结合ISO9001：2008，就是通过某种顾客要求增强顾客满意。Benefitsoftheprocessapproachare:过程方法的益处：Integrationandalignmentofprocessestoenableachievementofdesiredoutcomes整合过程实现既定目标Abilitytofocuseffortonprocesseffectivenessandefficiency.能够关注于过程的有效性和效率Provisionofconfidencetocustomers,andotherinterestedparties,abouttheconsistentperformanceoftheorganization.得到顾客和其他相关方对组织的持续业绩方面的信心Transparencyofoperationswithintheorganization.组织内操作透明化Lowercostsandcreationofshortercycletimes,throughtheeffectiveuseofresources.通过有效利用资源缩短循环产生的时间，降低成本Improved,consistentandpredictableresults.改善，持续的和可预测的结果Provisionofopportunitiesforfocusedandprioritizedimprovementinitiatives【Reengineering,QualityControlCircles,5S,6sigma,BalancedScorecard,ISOCertification,JustInTime,CostofQuality,Benchmarking,TotalQualityManagement,CustomerServiceProgrammes,TaguchiMethods,QualityFunctionDeployment——Jelly】.为关注于改善行动并将其排序提供机会Encouragementoftheinvolvementofpeopleandtheclarificationoftheirresponsibilities.鼓励员工参与，分清他们的责任2.Whatisaprocess?什么是过程A“Process”canbedefinedasa“setofinterrelatedorinteractingactivities,whichtransformsinputsintooutputs”.Theseactivitiesrequireallocationofresourcessuchaspeopleandmaterials.Figure1showsagenericprocess.“一组相互联系或相互作用的将输入转换为输出的活动”。这些活动需要资源如人和原材料的配置。Amajoradvantageoftheprocessapproach,whencomparedtootherapproaches,isinthemanagementandcontroloftheinteractionsbetweentheseprocessesandtheinterfacesbetweenthefunctionalhierarchiesoftheorganization(asfurtherexplainedinsection4).比较其他方法，过程方法的主要优点体现在这些过程之间的相互作用和职能部门接口的管理和控制（见第4节解释）Figure1.Agenericprocess通用过程Inputsandintendedoutputsmaybetangible(suchasequipment,materialsorcomponents)orintangible(suchasenergyorinformation).Outputscanalsobeunintended,suchaswasteorpollution.输入和预期输出可以是有形的（如设备、原材料和样件）或无形的（如能源或信息）。输出也可以是非预期的，如废物或污染。Eachprocesshascustomersandotherinterestedparties(whomaybeeitherinternalorexternaltotheorganization),withneedsandexpectationsabouttheprocess,whodefinetherequiredoutputsoftheprocess.每个过程都有顾客和其他相关方（组织内部或外部），他们对过程有需要和期望，他们确定了所需的过程输出。Asystemshouldbeusedtogatherdatatoprovideinformationaboutprocessperformance,whichshouldthenbeanalyzedtodetermineifthereisanyneedforcorrectiveactionorimprovement.应该利用系统收集提供过程业绩信息的数据，然后这些数据确定是否需要采取纠正措施或改进。Allprocessesshouldbealignedwiththeobjectives,scopeandcomplexityoftheorganization,andshouldbedesignedtoaddvaluetotheorganization.所有过程应与组织的目标、范围和复杂程度相结合，并以能为组织增值为目的设计这些过程。Processeffectivenessandefficiencycanbeassessedthroughinternalorexternalreviewprocesses.可以通过内外审来评价过程的有效性和效率3.Typesofprocesses过程类型3.1ReferencestoprocessesinISO9001:2008:引用ISO9001:2008相关过程ISO9001:2008states:ISO9001:2008规定：Insubclause0.1General:“Thedesignandimplementationofanorganization‘squalitymanagementsystemisinfluencedby:itsbusinessenvironment,changesinthatenvironment,orrisksassociatedwiththatenvironment;itsvaryingneeds;itsparticularobjectives;theproductsitprovides;theprocessesitemploys;itssizeandorganizationalstructure.ItisnottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation”.0.1总则条款：“一个组织质量管理体系的设计和实施受下列因素的影响：组织的业务环境、该环境的变化或与该环境有关的风险，组织的不同需求，组织的特定目标，所提供的产品，所采用的过程，组织的规模和组织结构。统一质量管理体系的结构或文件不是本标准的目的”。Insubclause0.2ProcessApproach:“Theapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagementtoproducethedesiredoutcome,canbereferredtoasthe“processapproach“.0.2过程方法条款：“为了产生期望的结果，组织内诸过程组成的系统的应用，连同这些过程的识别和相互作用，以及对这些过程的管理，可称之为“过程方法””。Insubclause4.1Generalrequirements:“Theorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.Theorganizationshall:a)determinetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,d)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e)monitor,measure(whereapplicable),andanalysetheseprocesses,andf)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.4.1总要求：组织应按本标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。组织应：a)确定质量管理体系所需的过程及其在整个组织中的应用（见1.2）；b)确定这些过程的顺序和相互作用；c)确定为确保这些过程的有效运作和控制所需的准则和方法；d)确保可以获得必要的资源和信息，以支持这些过程的运作和监视；e)监视、测量(适用时)和分析这些过程；f)实施必要的措施，以实现对这些过程所策划的结果和对这些过程的持续改进。TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard”.组织依照本国际标准管理这些过程。Basedontheabove,eachorganizationshoulddefinethenumberandtypeofprocessesneededtofulfilitsbusinessobjectives.ItispermissibleforaprocessthatisrequiredbyISO9001:2008tobepartofaprocess(orprocesses)thatisalreadyestablishedbytheorganization,ortobedefinedbytheorganizationintermsthataredifferenttothoseinISO9001.基于上述规定，每个组织都应该确定达成业务目标所需的过程数量和类型。ISO9001：2008规定的过程可以是组织已经建立的某一（组）过程的一部分，或者以与ISO9001规定不同的方式确定该过程。3.2Typicaltypesofprocessesthatcanbeidentified:过程的典型类型Inaccordancewith3.1above,organizationshavetodefinethenumberandtypesofprocessesneededtofulfiltheirbusinessobjectives.Whilethesewillbeuniquetoeachorganization,itishoweverpossibletoidentifytypicalprocesses,suchas:按照上面3.1之规定，组织须确定达成业务目标所需的过程数量和类型。由于这些过程对每个组织而言是独特的，但可以识别典型过程，如：Processesforthemanagementofanorganization.Theseincludeprocessesrelatingtostrategicplanning,establishingpolicies,settingobjectives,ensuringcommunication,ensuringavailabilityofresourcesfortheotherorganization’squalityobjectivesanddesiredoutcomesandformanagementreviews.组织管理过程：包括与为组织质量目标和预期输出和管理评审而进行的战略策划、建立方针、设定目标、沟通保证机制、资源提供保障相关的过程。Processesformanagingresources.Theseincludealltheprocessesthatarenecessarytoprovidetheresourcesneededfortheorganization’squalityobjectivesanddesiredoutcomes.资源管理过程：包括为组织质量目标和预期输出提供所需资源所必需的过程。Realizationprocesses.Theseincludeallprocessesthatprovidethedesiredoutcomesoftheorganization.实现过程：包括提供组织预期输出的所有过程。Measurement,analysisandimprovementprocesses.Theseincludetheprocessesneededtomeasureandgatherdataforperformanceanalysisandimprovementofeffectivenessandefficiency.Theyincludemeasuring,monitoring,auditing,performanceanalysisandimprovementprocesses(e.g.forcorrectiveandpreventiveactions).Measurementprocessesareoftendocumentedasanintegralpartofthemanagement,resourceandrealizationprocesses;whereasanalysisandimprovementprocessesaretreatedfrequentlyasautonomousprocessesthatinteractwithotherprocesses,receiveinputsfrommeasurementresults,andsendoutputsfortheimprovementofthoseprocesses.测量、分析和改进过程：包括测量和收集用于业绩分析和改进有效性和效率所需的过程。包括测量、监控、评审、业绩分析和改进过程（即，纠正和预防措施）。作为管理、资源管理和实现过程有机整体的一部分，通常测量过程需要记录在案；而分析和改进过程经常被当作是自发的过程，它与其它过程相互影响，把测量结果作为输入，并把输出传递给这些过程的改进。.4.Understandingtheprocessapproach理解过程方法Aprocessapproachisapowerfulwayoforganizingandmanagingactivitiestocreatevalueforthecustomerandotherinterestedparties.过程方法是组织和管理为顾客和相关方创造价值的强有力的方法。Organizationsareoftenstructuredintoahierarchyoffunctionalunits.Organizationsareusuallymanagedvertically,withresponsibilityfortheintendedoutputsbeingdividedamongfunctionalunits.通常组织的结构是职能部门的层级体系。通常实行垂直管理，实现预期输出的责任被分散到职能部门。Theendcustomerorotherinterestedpartyisnotalwaysvisibletoallinvolved.Consequently,problemsthatoccurattheinterfaceboundariesareoftengivenlessprioritythantheshort-termgoalsoftheunits.Thisleadstolittleornoimprovementtotheinterestedparty,asactionsareusuallyfocusedonthefunctions,ratherthanontheintendedoutput.所有相关部门看不见最终顾客或相关方。其结果是，通常相关部门内的短期目标优先于发生在部门与部门之间的问题。从而导致相关部门改善甚微或没有改善，因为其措施侧重于职能而非预期输出。Theprocessapproachintroduceshorizontalmanagement,crossingthebarriersbetweendifferentfunctionalunitsandunifyingtheirfocustothemaingoalsoftheorganization.过程方法引入水平式管理，消除部门之间的障碍统一到组织的主要目标上来。Italsoimprovesthemanagementofprocessinterfaces(seeFigure2).过程方法也改善了过程接口（见图2）Figure2.ExampleofProcesslinkagesacrossdepartmentsinanorganization.图2横跨组织内各部门的过程链接举例Theperformanceofanorganizationcanbeimprovedthroughtheuseoftheprocessapproach.Theprocessesaremanagedasasystemdefinedbythenetworkoftheprocessesandtheirinteractions,thuscreatingabetterunderstandingofaddedvalue.通过使用过程方法可以改善组织业绩。提供把过程的网络及其相互作用，就这些过程当作系统来管理，这样对增值有更深入的理解。Note:Theconsistentoperationofthisnetworkisoftenreferredtoasthe"systemapproach"tomanagement.注：这个网络的持续运作通常被称之为管理的“系统方法“Oftentheoutputsfromoneprocesscanbetheinputsintootherprocessesandareinterlinkedintotheoverallnetworkorsystem(forgenericexamples,seeFigure3andFigure4).通常一个过程的输出可以是另一过程的输入，并以此连环形成整个网络或系统（通用例子见图3和图4）Figure3.Exampleofagenericprocesssequence图3：通用过程次序举例Figure4.Exampleofaprocesssequenceanditsinteractions.图4：过程次序和相互作用举例5.Implementingtheprocessapproach实施过程方法Thefollowingimplementationmethodologycanbeappliedtoanytypeofprocess.Thestepsequenceisonlyonemethodandisnotintendedtobeprescriptive.Somestepsmaybecarriedoutsimultaneously.以下实施方法可用于各种类型的过程。步骤次序只是一种方法，并无意成为规定。某些步骤可以同时执行。5.1Identificationoftheprocessesoftheorganization组织过程的识别（见附页）5.3Implementationandmeasurementoftheprocess过程的实施和测量Implementtheprocessesandtheiractivitiesasplanned.按策划实施过程及其活动。Theorganizationmaydevelopaprojectforimplementationthatincludes,butisnotlimitedto组织可以为实施建立项目，包括，但不限于：Communication,沟通Awareness,了解Training,培训Changemanagement,不断变化的环境Managementinvolvement,管理层的参与Applicablereviewactivities.实用的评审活动Applythecontrols,andperformthemonitoringandmeasurementsasplanned.按策划应用控制并进行监控和测量。5.4Analysisoftheprocess过程分析Analyzeandevaluateprocessinformationobtainedfrommonitoringandmeasuringdata,inordertoquantifyprocessperformance.Whereappropriate,usestatisticalmethods.分析和评价通过监控和测量数据得来的过程信息，以便量化过程业绩。适用时，使用统计方法。Comparetheresultsofprocessperformanceinformationwiththedefinedrequirementsoftheprocess,toconfirmprocesseffectivenessandefficiencyandtoidentifyanyneedforcorrectiveaction.将过程业绩结果信息与规定的过程要求进行对比，确认过程的有效性和效率，识别纠正措施需求。Identifyprocessimprovementopportunitiesbasedontheresultsoftheanalysisofprocessinformation.根据过程信息分析结果，识别过程改进机会Reporttotopmanagement,andotherrelevantpeopleintheorganization,ontheperformanceoftheprocess,asappropriate.适当时，将过程业绩上报最高管理层和组织内其他相关人员。5.5.Correctiveactionandimprovementoftheprocess纠正措施和过程改进Whenevercorrectiveactionsareneeded,themethodforimplementingthemshouldbedefined.Thisshouldincludetheidentificationandeliminationoftherootcausesoftheproblems(e.g.errors,defects,lackofadequateprocesscontrols).Theeffectivenessoftheactionstakenshouldbereviewed.Implementthecorrectiveactionsandverifytheireffectivenessaccordingtoplan.无论何时需要纠正措施，应该对实施纠正措施的方法进行规定。应该包括问题（即错误，过失，缺乏足够的过程控制）根本原因的识别和消除。应该评审采取行动的有效性。实施纠正措施并按验证其有效性。Whenplannedprocessoutcomesarebeingachievedandrequirementsfulfilled,theorganizationshouldfocusitseffortsonactionstoimproveprocessperformancetohigherlevels,onacontinualbasis.但策划的过程输出得以实现不要要求得以满足时，组织应该关注于持续改进过程业绩至更高的水平。Themethodforimprovementshouldbedefinedandimplemented(examplesofimprovementsinclude:processsimplification,enhancementofefficiency,improvementofeffectiveness,reductionofprocesscycletime).Verifytheeffectivenessoftheimprovement.应该规定和实施改进方法（改进的例子包括：简化过程，提高效率和改进有效性，减少过程循环时间）。验证改进的有效性。Riskanalysistoolsmaybeemployedtoidentifypotentialproblems.Therootcause(s)ofthesepotentialproblemsshouldalsobeidentifiedandeliminated,preventingoccurrenceinallprocesseswithsimilarlyidentifiedrisks.可以采用风险分析方法识别潜在问题。还应该识别和消除潜在问题的根本原因，防止已同样识别出来的风险在所有过程发生。ThePlan-Do-Check-Act(PDCA)methodologycanbeausefultooltodefine,implementandcontrolcorrectiveactionsandimprovements.ExtensiveliteratureexistsaboutthePDCAcycleinnumerouslanguages.PDCA（计划-实施-检查-纠正）方法在规定、实施和控制纠正措施和改进方面是个很有帮助的方法。有各种各样语言的关于PDCA环的文献。ThePDCAisadynamicmethodologythatcanbedeployedwithineachoftheorganization’sprocessesandacrosstheirinteractions.Itisintimatelyassociatedwithplanning,implementation,verificationandimprovement.PDCA是种动态方法，可应用于组织每个过程及其相互作用。它将策划，实施，验证和改进有机地结合在一起。MaintainingandimprovingprocessperformancecanbeachievedbyapplyingthePDCAconceptatalllevelswithinanorganization.Thisappliesequallytoallprocesses,fromhigh-levelstrategicprocessestosimpleoperationalactivities.通过在组织内所有阶层应用PDCA理念就可以实现过程业绩的保持和改进。这同样适用于所有过程，从高层战略过程到简单的操作活动。5.1Identificationoftheprocessesoftheorganization组织过程的识别Stepsintheprocessapproach过程方法的步骤Whattodo?干什么？Guidance指导5.1.1Definethepurposeoftheorganization确定组织目的Theorganizationshouldidentifyitscustomersandotherinterestedpartiesaswellastheirrequirements,needsandexpectations,todefinetheorganization’sintendedoutputs.组织应该识别顾客及其他相关方，还有他们的要求、需求和期望，以确定组织的预期输出。Gather,analyzeanddeterminecustomerandotherinterestedparties’requirements,andotherneedsandexpectations.Communicatefrequentlywithcustomersandotherinterestedpartiestoensurecontinualunderstandingoftheirrequirements,needsandexpectations.收集、分析和确定顾客及其他相关方要求、其他需求和期望。频繁与顾客和其他相关方进行沟通确保持续了解他们的要求、需求和期望。Determinetherequirementsforqualitymanagement,environmentalmanagement,occupationalhealthandsafety,management,businessrisk,socialresponsibilitiesandothermanagementsystemdisciplinesthatwillbeappliedwithintheorganization.确定组织采用的质量管理，环境管理，职业健康和安全，管理，业务风险，社会责任和其它管理体系原则的要求。↓↓↓5.1.2Definethepoliciesandobjectivesoftheorganization确定组织方针和目标Basedontheanalysesoftherequirements,needsandexpectations,establishtheorganization’spoliciesandobjectives.基于对要求、需求和期望的分析，建立组织的方针和目标Topmanagementshoulddecidewhichmarketstheorganizationshouldaddressanddeveloprelevantpolicies.Basedonthesepolicies,managementshouldthenestablishobjectivesforthedesiredoutcome(e.g.products,environmentalperformance,occupationalhealthandsafetyperformance).最高管理层应该决定组织应该想做的市场，制定相关的方针。基于这些方针，最高管理层应该为预期输出建立目标（即产品、环境绩效、职业健康和安全绩效）↓↓↓5.1.3Determinetheprocessesintheorganization确定组织过程Determinealltheprocessesneededtoproducetheintendedoutputs.确定所有产生预期输出所需的全部过程Determinetheprocessesneededforachievingtheintendedoutputs.TheseprocessesincludeManagement,Resources,RealizationandMeasurement,AnalysisandImprovement.确定实现预期输出所需的过程。这些过程包括管理、资源、实现和测量、分析和改进。Identifyallprocessinputsandoutputs,alongwiththesuppliers,customersandotherinterestedparties(whomaybeinternalorexternal).同（内部或外部的）供应商、顾客和其他相关方一道识别所有过程的输入输出↓↓↓5.1.4Determinethesequenceoftheprocesses确定过程的次序Determinehowtheprocessesflowinsequenceandinteraction.确定过程依次流动及其相互作用关系Defineanddevelopadescriptionofthenetworkofprocessesandtheirinteraction.Considerthefollowing:Thecustomerofeachprocess,Theinputsandoutputsofeachprocess,Whichprocessesareinteracting,Interfacesandtheircharacteristics,Timingandsequenceoftheinteractingprocesses,Effectivenessandefficiencyofthesequence.确定和指导过程及其相互作用关系网络的描述。考虑如下内容：每个过程的顾客每个过程的输入输出哪些过程相互影响接口及其特性相互作用过程的时序这些次序的有效性和效率Note:Asanexample,realizationprocesses(suchasproductdeliveredtoacustomer)willinteractwithotherprocesses(suchasthemanagement,measurementandmonitoring,andresourceprovisionprocesses).注：举例，实现过程（如运往顾客的产品）将与其他过程（如管理，测量和监控，资源提供过程）相互影响。Methodsandtoolssuchasblockdiagrams,matrixandflowchartscanbeusedtosupportthedevelopmentofprocesssequencesandtheirinteractions.可使用诸如方框图，矩阵和流程图方法协助制定过程次序及其相互影响。↓↓↓5.1.5Defineprocessownership确定过程归属Assignresponsibilityandauthorityforeachprocess.为每个过程指派责任和权限Managementshoulddefineindividualrolesandresponsibilitiesforensuringtheimplementation,maintenanceandimprovementofeachprocessanditsinteractions.Suchanindividualisusuallyreferredtoasthe"processowner".最高管理层应该确定个人任务和职责以保证每个过程及其相互作用的实施，保持和改进。该人通常被称之为“过程所有人”Tomanageprocessinteractions,itmaybeusefultoestablisha"processmanagementteam",thathasanoverviewacrossalltheprocesses,andwhichincludesrepresentativesfromeachoftheinteractingprocesses.为了管理过程相互影响，建立过程管理小组是很用的，小组对所有过程进行审视，小组包括每个相互作用过程的代表。↓↓↓5.1.6Defineprocessdocumentation确定过程文件Determinethoseprocessesthataretobedocumentedandhowtheyaretobedocumented.确定哪些过程需要建立文件以及如何建立文件Processesexistwithintheorganizationandtheinitialapproachshouldbelimitedtodeterminingandmanagingtheminthemostappropriateway.Thereisno“catalogue”,orlistofprocesses,thathavetobedocumented.应该以最恰当的方法把组织现有的过程和初期（管理）手段限定在确定和管理过程。没有需要文件化的目录或过程列表。Themainpurposeofdocumentationistoenabletheconsistentandstableoperationoftheprocesses.文件化的主要目的是持续和稳定地执行这些过程。Theorganizationshoulddeterminewhichprocessesaretobedocumented,onthebasisof:Thesizeoftheorganizationanditstypeofactivities,Thecomplexityofitsprocessesandtheirinteractions,Thecriticalityoftheprocesses,andTheavailabilityofcompetentpersonnel.组织应基于以下内容确定哪些过程需要文件化：组织类型及其活动过程和相互作用的复杂程度过程的危险程度是否有称职的人员Whenitisnecessarytodocumentprocesses,anumberofdifferentmethodscanbeusedsuchasgraphicalrepresentations,writteninstructions,checklists,flowcharts,visualmedia,orelectronicmethods.必须进行对过程进行文件化时，可以使用许多种不同的方法如图示法，书面，检查表，视觉媒体或电子方法。Note:FormoreguidanceseetheISO9000IntroductionandSupportPackagemoduleGuidanceontheDocumentationRequirementsofISO9001:2008注：更多的指导见ISO9000介绍和支持包“ISO9001:2008文件要求指导”模块【ISOTC176SC2N525R2】5.2Planningtheprocess策划过程5.2.1Definetheactivitieswithintheprocess规定过程内的活动Determinetheactivitiesneededtoachievetheintendedoutputsoftheprocess.确定实现过程预期输出所需的活动Definetherequiredinputsandoutputsoftheprocess.确定过程所需的输入输出。Determinetheactivitiesrequiredtotransformtheinputsintothedesiredoutcomes.确定将输入转换为预期输出所需的活动Determineanddefinethesequenceandinteractionoftheactivitieswithintheprocess.确定和规定过程内涵的的次序和相互作用Determinehoweachactivitywillbeperformed.准确确定每个活动是如何执行的Note:Insomecases,thecustomermayspecifyrequirementsnotonlyfortheoutputsbutalsofortherealizationoftheprocess.注：在某些情况下，顾客不仅对输出而且对过程的实现提出特别的要求。↓↓↓5.2.2Definethemonitoringandmeasurementrequirements确定监控和测量要求Determinewhereandhowmonitoringandmeasuringshouldbeapplied.Thisshouldbebothforcontrolandimprovementoftheprocessesandtheintendedprocessoutputs.Monitoringisalwaysapplicablebutmeasurementmaynotbepracticableorevenpossible.Neverthelessmeasurementgivesmoreobjectivedataontheperformanceoftheprocessanditisapowerfulmanagementandimprovementtool.确定在应该应用测量的地点和方法。用于过程控制和改进，以及过程预期输出。经常是可应用监控手段，而测量也许行不通甚至不可能应用。不过测量在过程业绩方面提供更客观的数据，它是强有力的管理和改进方法。Determinetheneedforrecordingresults.确定记录结果的需求Identifythemonitoringandmeasuringcriteriaforprocesscontrolandprocessperformance,todeterminetheeffectivenessandefficiencyoftheprocess,takingintoaccountsuchfactorsas:为过程和过程业绩，识别监控和测量准则，以确定过程的有效性和效率，考虑如下因素：Conformitywithrequirements,与要求的符合性Customersatisfaction,顾客满意Supplierperformance,供应商业绩Ontimedelivery,及时供货Leadtimes,供货时间Failurerates,失效率Waste,损耗Processcosts,过程成本Incidentfrequency.事故率↓↓↓5.2.3Definetheresourcesneeded确定所需资源Determinetheresourcesneededfortheeffectiveoperationofeachprocess.确定每个过程有效操作所需的资源Examplesofresourcesinclude:资源的例子包括：Humanresources,人力资源Infrastructure,基础设施Workenvironment,工作环境Information,信息Naturalresources,自然资源Materials,原材料Financialresources资金来源↓↓↓5.2.4Verifytheprocessagainstitsplannedobjectives用策划的目标验证过程Confirmthatthecharacteristicsoftheprocessesareconsistentwiththepurposeoftheorganization(see5.1.1)确认过程特性符合组织目的（见5.1.1）Verifythatalltherequirementsidentifiedin5.1.1aresatisfied.Ifnot,considerwhatadditionalprocessactivitiesarerequiredandreturnto5.2.1toimprovetheprocess.验证所有5.1.1识别出来的要求得以满足。如果未得到满足，考虑需要哪些额外的过程，并返回到5.2.1改进过程。Jelly翻译于长春2009年2月25