如何完成风险评估(1)

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1、How to complete a Risk Assessmentow to complete a Risk Assessment如何完成如何完成“风险评估风险评估”？ISA China 培训课程1风险风险（Risk）vs.危害危害（Hazard）?l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：Probability x Hazard=Risk 发生的可能（发生的可能（likelihood）在这里可表达为概率概率（rate）或可能性（可能性（probability）。例如：空肠弯曲杆菌（Campylobacter）的风险可以表

2、述为每5年发生1次（likelihood）。l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。2Properitary&Confidential风险评估（风险评估（Risk Assessment）l风险分析（risk analysis）：识别和降低风险的结构性目标。l风险评估（risk assessment）：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BRC Non-GM标准。3Properitary&Confidential风险评估的目的：风险评估的目的：l识别潜在的危害；l应用适当的方法，估计危害发生的可能（lik

3、elihood）和不确定性（uncertainty）；l提供降低风险的其他解决方案；l估计上述解决方案的有效性；l为风险管理的决定提供信息；l估计与分析相关的不确定性。4Properitary&Confidential风险评估的程序和步骤：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（exposure assessment）-评估导致风险暴露的状况；4.风险特性描述（risk characterization）-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）。5Properita

4、ry&Confidential怎样估计风险（怎样估计风险（Risk）？）？l使用历史数据；l模型方式；l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（event trees）或错误树（fault trees）等方式；l模拟相似的状况；或l与类似行为比较。6Properitary&Confidential风险评估案例分析：风险评估案例分析：l某工厂生产烘培产品，在多年生产的基础上，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该工厂已经完成危害分析和研究7Properitary&Confidential风险评估案例分析：风险评估案例分析：5432112345Se

5、verityLikelihood8Properitary&Confidential风险评估案例分析（改进方案）：风险评估案例分析（改进方案）：5432112345SeverityLikelihood9Properitary&Confidential风险评估案例分析：风险评估案例分析：Risk determination:lWith the diagram for risk determination,it is determined if and how the hazard has to be controlled for food safety.lFor every hazard the

6、chance(Likelihood)that the hazard occurs,is determined with the chance determination table on the next page.lThe effect(severity)is determined(right line)with the effect determination table.lBy multiplying the chance and the effect,the risk is quantified and the kind of control is determined.In this

7、 way,an understanding for level differences is developed,but quantifying risks is extremely difficult.lIf the risk is 9 or less,controlling with general control measures or preventions are enough(PRPs).lIf the risk is 10 or more,the risk has to be controlled by an effective control measure.lThe Code

8、x decision tree is used to determine the CCPs.If the 3 questions are answered with No,Yes,Yes,the risk is controlled by a specific measure in a specific step in the process and it is called a CCP(=Critical Control Point).10Properitary&ConfidentialLikelihoodTermOn time baseOn incident base5 ProbablyP

9、er day(s)20 incidents/year4 ReasonablePer week(s)11 20 incidents/year3 PossiblePer month(s)4 11 incidents/year2 UnlikelyPer year(s)1 3 incidents/year1 Very unlikelyPer 10 year(s)1 incident/year11Properitary&ConfidentialSeriousnessTermRemarks5 DisastrousSevere health injury or deathLarge amount of pe

10、ople seriously ill/injured4 Very seriousSerious illness or hospitalisedLarge amount of persons ill3 SeriousTeeth damage or visit to doctorSeveral illnesses peopleLarge amount of unsatisfied customers2 Less seriousA person is ill or lightly allergicSeveral unsatisfied customers1 Small inconvenienceNo

11、ticeable,but no harmful on the health of personOne single customer12Properitary&Confidential如何确定如何确定“危害危害”Hazard determination DiagramHazard determination DiagramIs the presence of apotential hazard in raw materialprobable?Is the presence of a potentialhazard in the line or theenvironment probable?I

12、s reduction,if any,at a furtherstep adequate?(Significant)HAZARDIs an unacceptable level,survival,persistence or increaseat this step probable?Is an unacceptablecontamination at this stepprobable?No Hazard*YESYESYESYESNo Hazard*NONONONONOYES*Not a hazard to be controlled at this step.*Reduction step

13、 thus becomes a CCP.13Properitary&Confidential如何确定某可管理的如何确定某可管理的CCP点点原料原料How to determine a manageable CCP?How to determine a manageable CCP?Q1.Is it likely that the raw material contains the hazard under study at unacceptable levels?Q2.Will processing,including expected consumer use,eliminate the h

14、azard or reduce it to an acceptable level?Not a CCPYESNONot a CCPYESRaw material must be regarded as a CRITICAL CONTROL POINT for this hazard.NO14Properitary&Confidential如何确定某可管理的如何确定某可管理的CCP点点加工过程加工过程How to determine a manageable CCP?How to determine a manageable CCP?Q3.Is the formulation/compositi

15、on or structure of the intermediate product/final product essential for preventing the hazard under study from increasing to unacceptable levels?Q4.Is it likely that,at this step,a hazard will be introduced or an existing hazard will increase to unacceptable levels?Not a CCPNOFormulation/composition

16、 or structure is a CRITICAL CONTROL POINT for this hazard.YESNOQ5.Will subsequent processing steps,including expected consumer use,guarantee removal of the hazard or reduction to an acceptable level?Q6.Is the process step intended to eliminate or reduce thehazard to an acceptable level?This process

17、stage must be regarded as a CRITICAL CONTROL POINT for this hazard.YESYESNONot a CCPYESNO15Properitary&ConfidentialNr Process step Hazard Kind Control measure LSRQ1Q2Q3CCPY/N 22Dosage into blue boxesBoxes are not clean(FB)PInspect and clean before using23623Organizing of reworkNot competent operator

18、sNoPR16 Training on the job22424Moisture contentToo highToo lowPoor sample takingTime between baking and analyzing to largeGrinding not standardizedOperator not trained in moisture analyseEquipment not calibratedMNoMMMMMCheck moisture contentPR16 Training on the jobPR16 Training on the jobBuy a stan

19、dardized grinder(Retch mill)PR16 Training on the jobPR143223224333331266966NYYCCP125Transport into siloContaminated with FBPoor hygienePPMOpen process;general control measuresPR03,GMP audits3243126NYN26Silo storageContaminated with FBHumidity of air too highWrong siloPoor silo identificationRemains of other biscuitsInfestationPMPPMPPOpen process;general control measuresMonitor humidity and ventilate extra if necessaryPR09,identificationPR09,identificationPR03,visual inspectionPR05 pest control,GMP audits3222324422131284436NYN 16Properitary&Confidential17Properitary&Confidential