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Thermally Processed, Commercially sterile 8417.2 Hazard Analysis and HAcCP Plan. (a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls (2)A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified Generic establishment X, which we are using for our example, is capturing these regulatory requirements on a 6-column Hazard Analysis Form See Figure 3). a good way to use a form like this is to create the first column by using the Process Flow Diagram and the second by answering the question. Once the HACCP team has considered all the steps in the flow diagram and determined if a food safety hazard could be introduced it needs to consider whether the hazard is"reasonably likely to occur", using the meaning of this phrase included in 4172(a). On the 6-column form used by generic establishment X, the third and fourth columns address this issue. If the establishment's HACCP team has decided that the hazard is not reasonably likely to occur, they enter"No" in column three, explain the basis for their determination in column four and do not need to further consider activity at this point in the process If, however, the team has determined there is a"food safety hazard reasonably likely to occur" introduced at a certain point in the process, column five is used to describe a measure which could be applied to"prevent, eliminate, or reduce to acceptable levels" the food safety hazard identified in column three. Column six is used when a critical control point(CCP)is identified based upon the decision made in the hazard analysis. Each CCP has a number -the order corresponds to steps in the process. For example, 1 is the first CCP in the process flow, 2 the next,etc. The letter indicates whether the hazard is biological-B; chemical-C; or physical Look at the entries for"Receiving- Non-meat Food Ingredients"on the first page of the six column form; the HACCP team has determined that even though bacterial spore loads may be present at high levels oming product, they put a"No"in the third column. Column fo explains the basis for the teams determination. The bacterial spore load which is introduced into the product either at the producer or supplier operations, can be controlled at the canning 8Thermally Processed, Commercially Sterile § 417.2 Hazard Analysis and HACCP Plan. (a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls. (2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified. Generic establishment X, which we are using for our example, is capturing these regulatory requirements on a 6-column Hazard Analysis Form (See Figure 3). A good way to use a form like this is to create the first column by using the Process Flow Diagram and the second by answering the question. Once the HACCP team has considered all the steps in the flow diagram and determined if a food safety hazard could be introduced, it needs to consider whether the hazard is "reasonably likely to occur", using the meaning of this phrase included in 417.2(a). On the 6-column form used by generic establishment X, the third and fourth columns address this issue. If the establishment's HACCP team has decided that the hazard is not reasonably likely to occur, they enter "No" in column three, explain the basis for their determination in column four, and do not need to further consider activity at this point in the process. If, however, the team has determined there is a "food safety hazard reasonably likely to occur" introduced at a certain point in the process, column five is used to describe a measure which could be applied to "prevent, eliminate, or reduce to acceptable levels" the food safety hazard identified in column three. Column six is used when a critical control point (CCP) is identified based upon the decision made in the hazard analysis. Each CCP has a number – the order corresponds to steps in the process. For example, 1 is the first CCP in the process flow, 2 the next, etc. The letter indicates whether the hazard is biological – B; chemical – C; or physical – P. Look at the entries for “Receiving-Non-meat Food Ingredients” on the first page of the six column form; the HACCP team has determined that even though bacterial spore loads may be present at high levels in incoming product, they put a “No” in the third column. Column four explains the basis for the team’s determination. The bacterial spore load which is introduced into the product either at the producer or supplier operations, can be controlled at the canning 8
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