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1、1,How to complete a Risk Assessment 如何完成“风险评估”？,ISA China 培训课程,Properitary & Confidential,2,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： Probability x Hazard = 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 （likel
2、ihood）。 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 & Confidential,3,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。,Properitary & Confidential,4,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（unc
3、ertainty ）； 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 & Confidential,5,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）。,Properitary & Confidential,6,怎样
4、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。,Properitary & Confidential,7,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 & Confidential,8,风险评估案例分析：,Severity,Likelihood,Properitary & Confidential,9,风险评估案例分析（改进方案）：,Severity,Likel
5、ihood,Properitary & Confidential,10,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 o
6、n 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 ex
7、tremely 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 wi
8、th 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).,Properitary & Confidential,11,Likelihood,Properitary & Confidential,12,Seriousness,Properitary & Confidential,13,如何确定“危害” Hazard determination Diagram,Is
9、 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
10、 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.,Properitary & Confidential,14,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 r
11、aw 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,Properitary
12、 & Confidential,15,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
13、 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 a
14、cceptable 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,Properitary & Confidential,16,Properitary & Confidential,17,多谢！ 北京雅德士工程技术服务有限公司 北京市朝阳区东三环北路30号紫荆豪庭2座11A 电话：010 8596 7093 传真：010 8596 7911 网址：,
