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§120.8 HACCP计划(Hazard Analysis and Critical Control Point (HACCP) plan)

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核心提示:当如120.7危害分析表明:加工过程中有可能发生一种或多种食品危害时,所有加工者都应建立并实施相应的书面HACCP计划。根据120.13的规定,HACCP计划应由经过培训的人员制定,且应满足120.12有关记录保持的要求。HACCP计划的具体内容应包括:(1)加工者的每个果汁加工地点(2)加工者加工的每一种果汁。

  §120.8   Hazard Analysis and Critical Control Point (HACCP) plan.

  (a) HACCP plan. Each processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as described in §120.7. The HACCP plan shall be developed by an individual or individuals who have been trained in accordance with §120.13 and shall be subject to the recordkeeping requirements of §120.12. A HACCP plan shall be specific to:

  (1) Each location where juice is processed by that processor; and

  (2) Each type of juice processed by the processor. The plan may group types of juice products together, or group types of production methods together, if the food hazards, critical control points, critical limits, and procedures required to be identified and performed by paragraph (b) of this section are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and are observed in practice.

  (b) The contents of the HACCP plan. The HACCP plan shall, at a minimum:

  (1) List all food hazards that are reasonably likely to occur as identified in accordance with §120.7, and that thus must be controlled for each type of product;

  (2) List the critical control points for each of the identified food hazards that is reasonably likely to occur, including as appropriate:

  (i) Critical control points designed to control food hazards that are reasonably likely to occur and could be introduced inside the processing plant environment; and

  (ii) Critical control points designed to control food hazards introduced outside the processing plant environment, including food hazards that occur before, during, and after harvest;

  (3) List the critical limits that shall be met at each of the critical control points;

  (4) List the procedures, and the frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

  (5) Include any corrective action plans that have been developed in accordance with §120.10(a), and that are to be followed in response to deviations from critical limits at critical control points;

  (6) List the validation and verification procedures, and the frequency with which they are to be performed, that the processor will use in accordance with §120.11; and

  (7) Provide for a recordkeeping system that documents the monitoring of the critical control points in accordance with §120.12. The records shall contain the actual values and observations obtained during monitoring.

  (c) Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with §120.6, they are not required to be included in the HACCP plan.

 
【发布单位】:FDA

【备注】:当如120.7危害分析表明:加工过程中有可能发生一种或多种食品危害时,所有加工者都应建立并实施相应的书面HACCP计划。根据120.13的规定,HACCP计划应由经过培训的人员制定,且应满足120.12有关记录保持的要求。HACCP计划的具体内容应包括:(1)加工者的每个果汁加工地点(2)加工者加工的每一种果汁。HACCP计划的内容至少应包括:(1)根据120.7列出有可能发生的食品危害,且每种产品针对这些危害都应建立控制;对识别的每一种可能发生的食品危害列出关键控制点;(3)列出每个关键控制点应满足的关键限值;(4)列出用于监控每个关键控制点的方法和频率,以确保其符合关键限值;(5)包括按120.10(a)制定纠偏行动计划,在关键控制点偏离关键限值时执行;(6)列出按120.11的要求,加工者采用的确认和验证程序及频率;(7)按120.12条的规定,提供记录有关关键控制点监控情况的记录保持系统,该记录应包含监控过程中的实测值和观察结果。HACCP计划中可以包括卫生控制。然而,在某种程度上卫生控制是按120.6的要求进行实施的,不一定必须包含在HACCP计划中。