§417.4 HACCP计划的核查、审核和评价(Validation, Verification, Reassessment)

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　    § 417.4   Validation, Verification, Reassessment.

　　（a） Every establishment shall validate the HACCP plan's adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented.

　　（1） Initial validation. Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy of the CCP's, critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities.

　　（2） Ongoing verification activities. Ongoing verification activities include, but are not limited to:

　　（i） The calibration of process-monitoring instruments;

　　（ii） Direct observations of monitoring activities and corrective actions; and

　　（iii） The review of records generated and maintained in accordance with §417.5（a）（3） of this part.

　　（3） Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; personnel; packaging; finished product distribution systems; or, the intended use or consumers of the finished product. The reassessment shall be performed by an individual trained in accordance with §417.7 of this part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan no longer meets the requirements of §417.2（c） of this part.

　　（b） Reassessment of the hazard analysis. Any establishment that does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food safety hazard exists. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; packaging; finished product distribution systems; or, the intended use or consumers of the finished product.

　　§417.4 核查 审核 评价

　　（a）每个企业都必须核查HACCP计划在控制危害分析时所确定的食品安全危害的适宜性，还必须审核计划在有效地实施。

　　（1） 初期核查

　　企业必须按照完成的危害分析和制定的HACCP计划进行预定的工作，以决定HACCP计划按预期的目的在有效地进行。在此HACCP计划核查期间，企业必须反复地测试该HACCP计划中提出的关键点，关键限值，监测，记录保存程序和纠正措施的适宜性。核查还包括记录本身、HACCP系统日常得到的记录、其它核查活动的检查。

　　（2）进行的审核工作

　　进行的审核工作包括、但不限于：

　　（i）加工过程中监测仪器的标准；

　　（ii）直接观测监测活动和纠正措施；

　　（iii）按照本部分 §417.5 （a）（3）检查得到和保存的记录。

　　（3）评价HACCP计划

　　每个企业至少每年及发生任何可能影响危害分析的变化，或修改HACCP计划时必须对HACCP计划进行充分的评价。这种变化可能包括、但不限于：因原料或原料来源，产品配方，屠宰或加工方法或系统，产量，人员，包装，成品流通系统，或成品预期使用或消费的改变。这种评价必须由按照本部分417.7受过培训的人员完成。当评价表明该计划不符合本段417.2要求时，必须立即对HACCP计划进行修改。

　　（b）危害分析的评价

　　因危害分析已表明没有可能发生的食品安全危害而没有HACCP计划的任何企业，当发生变化，不管一种食品安全危害的是否存在都可能受到影响时，都必须对该危害分析进行充分的评价。这种变化可能包括、但不限于：因为原料或原料来源，产品配方，屠宰或加工方法或系统，产量，包装，成品流通系统，或成品的预期使用或消费的变化。