如何完成风险评估(1)ppt课件

1、How to complete a Risk Assessment如何完成“风险评价？ISA China 培训课程.风险Riskvs. 危害Hazard? 风险Risk：风险通常为某危害hazard和危害发生的发生的能够likelihood 的综合结果。即： Probability x Hazard = Risk 发生的能够likelihood在这里可表达为概率rate或能够性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：食品中含有或在某形状下有潜在能够导致对安康的负面影响的某种生物、化学或物理物质

2、。.风险评价Risk Assessment风险分析risk analysis：识别和降低风险的构造性目的。风险评价risk assessment：根据危害的暴露程度，评价知影响或负面影响。注：以上定义摘自BRC Non-GM规范。.风险评价的目的：识别潜在的危害；运用适当的方法，估计危害发生的能够likelihood和不确定性uncertainty ；提供降低风险的其他处理方案；估计上述处理方案的有效性；为风险管理的决议提供信息；估计与分析相关的不确定性。.风险评价的程序和步骤：危害hazard识别；评价风险的暴露和负面影响之间的关系；暴露的评价exposure assessment - 评价

3、导致风险暴露的情况；风险特性描画risk characterization - 描画负面影响这里指危害的类型、能够性及隐藏在这些描画后面证据的效能通常运用能够性和数据来完成。.怎样估计风险Risk？运用历史数据；模型方式；假设手头没有数据，可将系统分解成子系统的方式，运用事件树event trees或错误树fault trees等方式；模拟类似的情况；或与类似行为比较。.风险评价案例分析：某工厂消费烘培产品，在多年消费的根底上，该工厂曾经完成危害分析和研讨.风险评价案例分析：5432112345SeverityLikelihood.风险评价案例分析改良方案：5432112345Severity

4、Likelihood.风险评价案例分析：Risk determination:With the diagram for risk determination, it is determined if and how the hazard has to be controlled for food safety.For every hazard the chance (Likelihood) that the hazard occurs, is determined with the chance determination table on the next page.The effect (

5、severity) is determined (right line) with the effect determination table.By multiplying the chance and the effect, the risk is quantified and the kind of control is determined. In this way, an understanding for level differences is developed, but quantifying risks is extremely difficult.If the risk

6、is 9 or less, controlling with general control measures or preventions are enough (PRPs). If the risk is 10 or more, the risk has to be controlled by an effective control measure. The Codex decision tree is used to determine the CCPs. If the 3 questions are answered with No, Yes, Yes, the risk is co

7、ntrolled by a specific measure in a specific step in the process and it is called a CCP (= Critical Control Point).LikelihoodTermOn time baseOn incident base5 ProbablyPer day(s) 20 incidents / year4 ReasonablePer week(s)11 20 incidents / year3 PossiblePer month(s)4 11 incidents / year2 UnlikelyPer y

8、ear(s)1 3 incidents / year1 Very unlikelyPer 10 year(s) 1 incident / year.SeriousnessTermRemarks5 DisastrousSevere health injury or deathLarge amount of people seriously ill / injured4 Very seriousSerious illness or hospitalisedLarge amount of persons ill3 SeriousTeeth damage or visit to doctorSever

9、al illnesses peopleLarge amount of unsatisfied customers2 Less seriousA person is ill or lightly allergicSeveral unsatisfied customers1 Small inconvenienceNoticeable, but no harmful on the health of personOne single customer.如何确定“危害Hazard determination DiagramIs the presence of apotential hazard in

10、raw materialprobable?Is the presence of a potentialhazard in the line or theenvironment probable?Is 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

11、 Hazard*YESYESYESYESNo Hazard*NONONONONOYES* Not a hazard to be controlled at this step.* Reduction step thus becomes a CCP.如何确定某可管理的CCP点原料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 ex

12、pected consumer use, eliminate the hazard or reduce it to an acceptable level?Not a CCPYESNONot a CCPYESRaw material must be regarded as a CRITICAL CONTROL POINT for this hazard.NO.如何确定某可管理的CCP点加工过程How to determine a manageable CCP?Q3. Is the formulation/composition or structure of the intermediate

13、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 or structure is a CRITICAL CONTR

14、OL 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 stage must be regarded as a C

15、RITICAL CONTROL POINT for this hazard.YESYESNONot a CCPYESNO.Nr Process step Hazard Kind Control measure LSRQ1Q2Q3CCPY/N 22Dosage into blue boxesBoxes are not clean (FB)PInspect and clean before using23623Organizing of reworkNot competent operatorsNoPR16 Training on the job22424Moisture contentToo h

16、ighToo 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 standardized 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 pr