XXXX01风险分析及方法简述

风险分析及方法简述（中英文）1BasicRiskManagementFacilitationMethods基本的风险管理的便利方法Someofthesimpletechniquesthatarecommonlyusedtostructureriskmanagementbyorganizingdataandfacilitatingdecision-makingare:下面是一些简单的通常使用的方法，进行风险管理和制定决策：charts/流程图检查清单过程图因果图（或者叫鱼骨图）2FailureModeEffectsAnalysis(FMEA)失效模式与效果分析2.1Describe/描述FMEA(seeIEC60812)providesforanevaluationofpotentialfailuremodesforprocessesandtheirlikelyeffectonoutcomesand/orproductperformance.Oncefailuremodesareestablished,riskreductioncanbeusedtoeliminate,contain,reduceorcontrolthepotentialfailures.FMEAreliesonproductandprocessunderstanding.FMEAmethodicallybreaksdowntheanalysisofcomplexprocessesintomanageablesteps.Itisapowerfultoolforsummarizingtheimportantmodesoffailure,factorscausingthesefailuresandthelikelyeffectsofthesefailures.FMEA提供了工艺潜在失效模式的评估和对产品性能或结果的潜在影响。一旦将建立了失效模式，风险的降低可被用来消除、囊括、降低或控制潜在的失效活动。FMEA依赖于对产品和工艺的理解。FMEA将复杂的工艺系统地分解为简单的步骤。FMEA对重要的失效模式、引起失效的因素以及失效可能带来的后果进行汇总的有力工具。2.2PotentialAreasofUse(s)使用的潜在区域FMEAcanbeusedtoprioritizerisksandmonitortheeffectivenessofriskcontrolactivities.FMEA可用来安排风险的优先顺序，监控风险控制活动的有效性。FMEAcanbeappliedtoequipmentandfacilitiesandmightbeusedtoanalyzeamanufacturingoperationanditseffectonproductorprocess.Itidentifieselements/operationswithinthesystemthatrenderitvulnerable.Theoutput/resultsofFMEAcanbeusedasabasisfordesignorfurtheranalysisortoguideresourcedeployment.FMEA可用于设备和设施，也可用于分析某一生产操作及其对产品或工艺的影响。它可识别系统内的元素/操作的弱点。FMEA的结果可被作为设计或深入分析或指导资源配置的依据。3FailureMode,EffectsandCriticalityAnalysis(FMECA)失效模式、效果与关键程度的分析3.1Describe/描述FMEAmightbeextendedtoincorporateaninvestigationofthedegreeofseverityoftheconsequences,theirrespectiveprobabilitiesofoccurrence,andtheirdetectability,therebybecomingaFailureModeEffectandCriticalityAnalysis(FMECA;seeIEC60812).Inorderforsuchananalysistobeperformed,theproductorprocessspecificationsshouldbeestablished.FMECAcanidentifyplaceswhereadditionalpreventiveactionsmightbeappropriatetominimizerisks.FMEA可以延伸到结果严重程度的调查、发生的概率和可检测性，发展为FMECA。为执行这样的分析，应建立产品或工艺的质量标准。FMECA可以鉴定何时采用预防措施可以将风险家最小化。3.2PotentialAreasofUse(s)使用的潜在区域FMECAapplicationinthepharmaceuticalindustryshouldmostlybeutilizedforfailuresandrisksassociatedwithmanufacturingprocesses;however,itisnotlimitedtothisapplication.TheoutputofanFMECAisarelativerisk“score”foreachfailuremode,whichisusedtorankthemodesonarelativeriskbasis.制药企业的FMECA应最大的利用与生产工艺相联系的失效和风险，但是不局限于这一应用。FMECA的结果是每一风险模式的相对的风险“中心”，用来分级相对风险根据。4FaultTreeAnalysis(FTA)失误树分析4.1Describe/描述TheFTAtool(seeIEC61025)isanapproachthatassumesfailureofthefunctionalityofaproductorprocess.Thistoolevaluatessystem(orsub-system)failuresoneatatimebutcancombinemultiplecausesoffailurebyidentifyingcausalchains.Theresultsarerepresentedpictoriallyintheformofatreeoffaultmodes.Ateachlevelinthetree,combinationsoffaultmodesaredescribedwithlogicaloperators(AND,OR,etc.).FTAreliesontheexperts’processunderstandingtoidentifycausalfactors.失误树分析是假定产品或工艺性能的失效的方法。这些工具评估系统失效，但是可以结合失效的多种原因。在树的每一个水平内，应描述失效模式的结合。FTA依赖于专家的工艺理解去鉴别起因。4.2PotentialAreasofUse(s)潜在区域的使用FTAcanbeusedtoestablishthepathwaytotherootcauseofthefailure.FTAcanbeusedtoinvestigatecomplaintsordeviationsinordertofullyunderstandtheirrootcauseandtoensurethatintendedimprovementswillfullyresolvetheissueandnotleadtootherissues(i.e.solveoneproblemyetcauseadifferentproblem).FaultTreeAnalysisisaneffectivetoolforevaluatinghowmultiplefactorsaffectagivenissue.TheoutputofanFTAincludesavisualrepresentationoffailuremodes.Itisusefulbothforriskassessmentandindevelopingmonitoringprograms.FTA可用于建立失效起因的途径。FTA可用于调查投诉或偏差，以便全面理解它们的起因，确保预定的改进能全面解决争议，并且不会导致其他的争议（例如：解决完一个问题但是引起了其他的问题）。失误树分析是评估多种因素怎样影响争议的有效的工具。失误树分析的结果包括失效模式的可见的代表。这对风险评估和发展监控系统是有用的。5HazardAnalysisandCriticalControlPoints(HACCP)危害分析和关键控制点5.1Describe/描述HACCPisasystematic,proactive,andpreventivetoolforassuringproductquality,reliability,andsafety(seeWHOTechnicalReportSeriesNo908,2003Annex7).Itisastructuredapproachthatappliestechnicalandscientificprinciplestoanalyze,evaluate,prevent,andcontroltheriskoradverseconsequence(s)ofhazard(s)duetothedesign,development,production,anduseofproducts.HACCP是确保产品质量、可靠性和安全（见WHO技术报告系列）系统的、积极的、预防性的工具。它是一综合性的方法，运用技术和科学的原则去分析、评估、预防和控制由药品的设计、研发、生产、风险和使用引起的风险或危害的后果。HACCPconsistsofthefollowingsevensteps:HACCP包括以下七个步骤：(1)conductahazardanalysisandidentifypreventivemeasuresforeachstepoftheprocess;执行危害分析，确定过程每一步骤的预防性措施(2)determinethecriticalcontrolpoints;决定关键控制点(3)establishcriticallimits;设立关键限度(4)establishasystemtomonitorthecriticalcontrolpoints;设定监测关键控制点的系统。(5)establishthecorrectiveactiontobetakenwhenmonitoringindicatesthatthecriticalcontrolpointsarenotinastateofcontrol;设立关键控制不受控时的采取的整改措施(6)establishsystemtoverifythattheHACCPsystemisworkingeffectively;设立证实HACCP有效工作的系统(7)establisharecord-keepingsystem.设定记录保持的系统5.2PotentialAreasofUse(s)使用的潜在的区域HACCPmightbeusedtoidentifyandmanagerisksassociatedwithphysical,chemicalandbiologicalhazards(includingmicrobiologicalcontamination).HACCPismostusefulwhenproductandprocessunderstandingissufficientlycomprehensivetosupportidentificationofcriticalcontrolpoints.TheoutputofaHACCPanalysisisriskmanagemen