如何完成风险评估(1)

1HowtocompleteaRiskAssessment如何完成“风险评估”？ISAChina培训课程Properitary&Confidential2风险（Risk）vs.危害（Hazard）?风险（Risk）：风险通常为某危害（hazard）和危害发生的发生的可能（likelihood）的综合结果。『即：ProbabilityxHazard=Risk』发生的可能（likelihood）在这里可表达为概率（rate）或可能性（probability）。例如：空肠弯曲杆菌（Campylobacter）的风险可以表述为每5年发生1次（likelihood）。危害（Hazard）：食品中含有或在某状态下有潜在可能导致对健康的负面影响的某种生物、化学或物理物质。Properitary&Confidential3风险评估（RiskAssessment）风险分析（riskanalysis）：识别和降低风险的结构性目标。风险评估（riskassessment）：根据危害的暴露（程度），评价已知影响或负面影响。注：以上定义摘自BRCNon-GM标准。Properitary&Confidential4风险评估的目的：识别潜在的危害；应用适当的方法，估计危害发生的可能（likelihood）和不确定性（uncertainty）；提供降低风险的其他解决方案；估计上述解决方案的有效性；为风险管理的决定提供信息；估计与分析相关的不确定性。Properitary&Confidential5风险评估的程序和步骤：1.危害（hazard）识别；2.评估风险的暴露和负面影响之间的关系；3.暴露的评估（exposureassessment）-评估导致风险暴露的状况；4.风险特性描述（riskcharacterization）-描述负面影响（这里指危害）的类型、可能性及隐藏在这些描述后面证据的效力（通常使用可能性和数据来完成）。Properitary&Confidential6怎样估计风险（Risk）？使用历史数据；模型方式；如果手头没有数据，可将系统分解成子系统的方式，使用事件树（eventtrees）或错误树（faulttrees）等方式；模拟相似的状况；或与类似行为比较。Properitary&Confidential7风险评估案例分析：某工厂生产烘培产品，在多年生产的基础上，该工厂已经完成危害分析和研究…Properitary&Confidential8风险评估案例分析：5432112345SeverityLikelihoodProperitary&Confidential9风险评估案例分析（改进方案）：5432112345SeverityLikelihoodProperitary&Confidential10风险评估案例分析：Riskdetermination:Withthediagramforriskdetermination,itisdeterminedifandhowthehazardhastobecontrolledforfoodsafety.Foreveryhazardthechance(Likelihood)thatthehazardoccurs,isdeterminedwiththe‘chancedeterminationtable’onthenextpage.Theeffect(severity)isdetermined(rightline)withthe‘effectdetermination’table.Bymultiplyingthechanceandtheeffect,theriskisquantifiedandthekindofcontrolisdetermined.Inthisway,anunderstandingforleveldifferencesisdeveloped,butquantifyingrisksisextremelydifficult.Iftheriskis9orless,controllingwithgeneralcontrolmeasuresorpreventionsareenough(PRPs).Iftheriskis10ormore,theriskhastobecontrolledbyaneffectivecontrolmeasure.TheCodexdecisiontreeisusedtodeterminetheCCPs.Ifthe3questionsareansweredwithNo,Yes,Yes,theriskiscontrolledbyaspecificmeasureinaspecificstepintheprocessanditiscalledaCCP(=CriticalControlPoint).Properitary&Confidential11LikelihoodTermOntimebaseOnincidentbase5ProbablyPerday(s)20incidents/year4ReasonablePerweek(s)11–20incidents/year3PossiblePermonth(s)4–11incidents/year2UnlikelyPeryear(s)1–3incidents/year1VeryunlikelyPer10year(s)1incident/yearProperitary&Confidential12SeriousnessTermRemarks5DisastrousSeverehealthinjuryordeathLargeamountofpeopleseriouslyill/injured4Veryserious•SeriousillnessorhospitalisedLargeamountofpersonsill3Serious•TeethdamageorvisittodoctorSeveralillnessespeopleLargeamountofunsatisfiedcustomers2Lessserious•ApersonisillorlightlyallergicSeveralunsatisfiedcustomers1Smallinconvenience•Noticeable,butnoharmfulonthehealthofpersonOnesinglecustomerProperitary&Confidential13如何确定“危害”HazarddeterminationDiagramIsthepresenceofapotentialhazardinrawmaterialprobable?Isthepresenceofapotentialhazardinthelineortheenvironmentprobable?Isreduction,ifany,atafurtherstepadequate?(Significant)HAZARDIsanunacceptablelevel,survival,persistenceorincreaseatthisstepprobable?Isanunacceptablecontaminationatthisstepprobable?NoHazard*YESYESYESYESNoHazard**NONONONONOYES***Notahazardtobecontrolledatthisstep.**ReductionstepthusbecomesaCCP.Properitary&Confidential14如何确定某可管理的CCP点－原料HowtodetermineamanageableCCP?Q1.Isitlikelythattherawmaterialcontainsthehazardunderstudyatunacceptablelevels?Q2.Willprocessing,includingexpectedconsumeruse,eliminatethehazardorreduceittoanacceptablelevel?NotaCCPYESNONotaCCPYESRawmaterialmustberegardedasaCRITICALCONTROLPOINTforthishazard.NOProperitary&Confidential15如何确定某可管理的CCP点－加工过程HowtodetermineamanageableCCP?Q3.Istheformulation/compositionorstructureoftheintermediateproduct/finalproductessentialforpreventingthehazardunderstudyfromincreasingtounacceptablelevels?Q4.Isitlikelythat,atthisstep,ahazardwillbeintroducedoranexistinghazardwillincreasetounacceptablelevels?NotaCCPNOFormulation/compositionorstructureisaCRITICALCONTROLPOINTforthishazard.YESNOQ5.Willsubsequentprocessingsteps,includingexpectedconsumeruse,guaranteeremovalofthehazardorreductiontoanacceptablelevel?Q6.Istheprocessstepintendedtoeliminateorreducethehazardtoanacceptablelevel?ThisprocessstagemustberegardedasaCRITICALCONTROLPOINTforthishazard.YESYESNONotaCCPYESNOProperitary&Confidential16NrProcessstepHazardKindControlmeasureLSRQ1Q2Q3CCPY/N……22DosageintoblueboxesBoxesarenotclean(FB)PInspectandcleanbeforeusing23623OrganizingofreworkNotcompetentoperatorsNoPR16Trainingonthejob22424MoisturecontentToohighToolowPoorsampletakingTimebetweenbakingandanalyzingtolargeGrindingnotstandardizedOperatornottrainedinmoistureanalyseEquipmentnotcalibratedMNoMMMMMCheckmoisturecontentPR16TrainingonthejobPR16TrainingonthejobBuyastandardizedgrinder(Retchmill)PR16TrainingonthejobPR143223224333331266966NYYCCP125TransportintosiloContaminatedwithFBPoorhygienePPMOpenprocess;generalcontrolmeasuresPR03,GMPaudits3243126NYN26SilostorageContaminatedwithFBHumidityofairtoohighWrongsiloPoorsiloidentificationRemainsofotherbiscuitsInfestationPMPPMPPOpenprocess;generalcontr