§123.8 HACCP计划的验证(Verification)

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    　　§ 123.8   Verification.

　　（a） Overall verification. Every processor shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include, at a minimum:

　　（1） Reassessment of the HACCP plan. A reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way or at least annually. Such changes may include changes in the following: Raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product. The reassessment shall be performed by an individual or individuals who have been trained in accordance with §123.10. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of §123.6（c）.

　　（2） Ongoing verification activities. Ongoing verification activities including:

　　（i） A review of any consumer complaints that have been received by the processor to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;

　　（ii） The calibration of process-monitoring instruments; and,

　　（iii） At the option of the processor, the performing of periodic end-product or in-process testing.

　　（3） Records review. A review, including signing and dating, by an individual who has been trained in accordance with §123.10, of the records that document:

　　（i） The monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within 1 week of the day that the records are made;

　　（ii） The taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with §123.7. This review shall occur within 1 week of the day that the records are made; and

　　（iii） The calibrating of any process control instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the processor's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the processor's written procedures. These reviews shall occur within a reasonable time after the records are made.

　　（b） Corrective actions. Processors shall immediately follow the procedures in §123.7 whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.

　　（c） Reassessment of the hazard analysis. Whenever a processor does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur, the processor shall reassess the adequacy of that hazard analysis whenever there are any changes that could reasonably affect whether a food safety hazard now exists. Such changes may include, but are not limited to changes in: Raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product. The reassessment shall be performed by an individual or individuals who have been trained in accordance with §123.10.

　　（d） Recordkeeping. The calibration of process-monitoring instruments, and the performing of any periodic end-product and in-process testing, in accordance with paragraphs （a）（2）（ii） through （iii） of this section shall be documented in records that are subject to the recordkeeping requirements of §123.9.

　　§123.8验证

　　（a）总体验证。每个加工者都必须验证其HACCP计划能有效控制有理由而且有可能发生的食品安全危害，且计划得到有效执行。验证至少包括以下内容：

　　（1）对HACCP计划的复审。当发生任何可能影响危害分析的变化，或在任何方面改变HACCP计划，或者至少每个年度，都要对HACCP计划的适用性进行复审。这些变化可以是：原料或原料来源，产品配方，加工方法或体系，成品销售体系或预期用途和用户。复审必须由经过按照§123.10培训的人员进行。当复审表明计划已不再完全符合§123.6（c）的要求时，必须立即修改HACCP计划。

　　（2）实施验证措施。包括：

　　（i）复查加工者收到的各种消费者投诉，以确定它们是否与关键控制点的执行有关，或发现存在有尚未识别的关键控制点；

　　（ii）工序监测仪器的校正；

　　（ⅲ）根据加工者的选择，定期进行成品和半成品的检验。

　　（3）复查记录。复查包括签字和日期，由经过按§123.10培训的人员进行，内容包括：

　　（i）关键控制点的监测。复查至少是为了确保记录的完整，并且证实记录所记的数据是在关键限值内，复查必须在作记录后一周内进行。

　　（ⅱ）采取纠正措施。复查至少是为了确保记录完善，并且证实按照§123.7采取了纠正措施。复查必须在作记录后一周内进行。

　　（ⅲ）校正关键控制点上所用的工序监控装置，并进行各种定期的成品和半成品检验，这是加工记录。这些复查要在作记录后合理的时间内进行。

　　（b）纠偏行动。当验证程序（包括对消费者投诉的复查）显示需要采取纠正措施时，加工必须立即执行§123.7的程序。

　　（c）危害分析的重新评估。由于危害分析表明无发生食品安全的可能和理由。而制定HACC计划的加工者，当出现任何可能会对食品安全危害的存在产生影响的变化时，重新审查危害分析的适应性。这些变化包括，但不限于：原料及其来源、产品配方、加工方法或体系，成品销售体系或预期用途、成品的消费者等变化。重新审查必须由经过按照§123.10进行培训的人员实施。

　　（d）记录保存。按照本部分（a）段（（2）（ii）至（iii），对工序监按装置的校正；成品和斗成品的定期检验都要做好记录，并符合123.9的记录保存要求。

　　更多有关美国FDA水产品HACCP法规内容，请点击美国FDA水产品HACCP法规汇总。