如何完成风险评估(1)69369

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Properitary & Confidential,*,H,ow to complete a Risk Assessment,如何完成“风险评估”？,ISA China,培训课程,1,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：,P,robability,x,H,azard =,R,isk,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。,2,Properitary & Confidential,风险评估（Risk Assessment）,风险分析（risk analysis）：识别和降低风险的结构性目标。,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。,3,Properitary & Confidential,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。,4,Properitary & Confidential,风险评估的程序和步骤：,危害,（,hazard,）,识别；,评估风险的暴露和负面影响之间的关系；,暴露的评估,（,exposure,assessment,）,-,评估导致风险暴露的状况；,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）。,5,Properitary & Confidential,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（event trees）或错误树（fault trees）等方式；,模拟相似的状况；或,与类似行为比较。,6,Properitary & Confidential,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,7,Properitary & Confidential,风险评估案例分析：,5,4,3,2,1,1,2,3,4,5,Severity,Likelihood,8,Properitary & Confidential,风险评估案例分析（改进方案）：,5,4,3,2,1,1,2,3,4,5,Severity,Likelihood,9,Properitary & Confidential,风险评估案例分析：,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,(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 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 controlled by a specific measure in a specific step in the process and it is called a,CCP,(= Critical Control Point).,10,Properitary & Confidential,Likelihood,Term,On time base,On incident base,5 Probably,Per day(s), 20 incidents / year,4 Reasonable,Per week(s),11 20 incidents / year,3 Possible,Per month(s),4 11 incidents / year,2 Unlikely,Per year(s),1 3 incidents / year,1 Very unlikely,Per 10 year(s), 1 incident / year,11,Properitary & Confidential,Seriousness,Term,Remarks,5 Disastrous,Severe health injury or death,Large amount of people seriously ill / injured,4 Very serious,Serious illness or hospitalised,Large amount of persons ill,3 Serious,Teeth damage or visit to doctor,Several illnesses people,Large amount of unsatisfied customers,2 Less serious,A person is ill or lightly allergic,Several unsatisfied customers,1 Small inconvenience,Noticeable, but no harmful on the health of person,One single customer,12,Properitary & Confidential,如何确定“危害”,Hazard determination Diagram,Is the presence of a,potential hazard in raw material,probable?,Is the presence of a potential,hazard in the line or the,environment probable?,Is reduction, if any, at a further,step adequate?,(Significant) HAZARD,Is an unacceptable level,survival, persistence or increase,at this step probable?,Is an unacceptable,contamination at this step,probable?,No Hazard*,YES,YES,YES,YES,No Hazard*,NO,NO,NO,NO,NO,YES*,* Not a hazard to be controlled at this step.,* Reduction step thus becomes a CCP.,13,Properitary & Confidential,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 expected consumer use, eliminate the hazard or reduce it,to an acceptable level?,Not a CCP,YES,NO,Not a CCP,YES,Raw material must be regarded as a CRITICAL CONTROL POINT for this hazard.,NO,14,Properitary & Confidential,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 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 CCP,NO,Formulation/composition or structure is a CRITICAL CONTROL POINT for this hazard.,YES,NO,Q5. 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 the,hazard to an acceptable level?,This process stage must be regarded as a CRITICAL CONTROL POINT for this hazard.,YES,YES,NO,Not a CCP,YES,NO,15,Properitary & Confidential,Nr,Process step,Hazard,Kind,Control measure,L,S,R,Q1,Q2,Q3,CCP,Y/N, ,22,Dosage into blue boxes,Boxes are not clean (FB),P,Inspect and clean before using,2,3,6,23,Organizing of rework,Not competent operators,No,PR16 Training on the job,2,2,4,24,Moisture content,Too high,Too low,Poor sample taking,Time between baking and analyzing to large,Grinding not standardized,Operator not trained in moisture analyse,Equipment not calibrated,M,No,M,M,M,M,M,Check moisture content,PR16 Training on the job,PR16 Training on the job,Buy a standardized grinder (Retch mill),PR16 Training on the job,PR14,3,2,2,3,2,2,4,3,3,3,3,3,12,6,6,9,6,6,N,Y,Y,CCP1,25,Transport into silo,Contaminated with FB,Poor hygiene,P,PM,Open process; general control measures,PR03, GMP audits,3,2,4,3,12,6,N,Y,N,26,Silo storage,Contaminated with FB,Humidity of air too high,Wrong silo,Poor silo identification,Remains of other biscuits,Infestation,P,M,P,PM,P,P,Open process; general control measures,Monitor humidity and ventilate extra if necessary,PR09, identification,PR09, identification,PR03, visual inspection,PR05 pest control, GMP audits,3,2,2,2,3,2,4,4,2,2,1,3,12,8,4,4,3,6,N,Y,N, ,16,Properitary & Confidential,17,Properitary & Confidential,