§123.7 HACCP纠正措施(Corrective actions)

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    　　§ 123.7   Corrective actions.

　　（a） Whenever a deviation from a critical limit occurs, a processor shall take corrective action either by:

　　（1） Following a corrective action plan that is appropriate for the particular deviation, or

　　（2） Following the procedures in paragraph （c） of this section.

　　（b） Processors may develop written corrective action plans, which become part of their HACCP plans in accordance with §123.6（c）（5）, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:

　　（1） No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

　　（2） The cause of the deviation is corrected.

　　（c） When a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation, the processor shall:

　　（1） Segregate and hold the affected product, at least until the requirements of paragraphs （c）（2） and （c）（3） of this section are met;

　　（2） Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review. Adequate training may or may not include training in accordance with §123.10;

　　（3） Take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

　　（4） Take corrective action, when necessary, to correct the cause of the deviation;

　　（5） Perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with §123.10, to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

　　（d） All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with §123.8（a）（3）（ii） and the recordkeeping requirements of §123.9.

　　§123.7纠正措施

　　（a）当发生偏离关键限值的情况时，加工者必须采取以下纠正措施：

　　（1）    执行一个与具体偏离相对应的纠正措施计划。

　　（2）    依据本部分（c）段采取的程序

　　（b）加工者可以制定书面的纠正措施计划，按照§123.6（c）（5），它可以作为HACCP计划的一个部分，这样加工者就可以预先确定一旦关键限值出现偏离时，他们将采取的措施。一个针对某种偏离的纠正措施计划需交待所要采取的步骤，并明确执行这些步骤的责任，以保证：

　　（1）进入市场的产品不会国为偏离关键限值而对健康造成危害，或成为伪劣食品；并且

　　（2）偏离的原因得到了纠正。

　　（c）当发生关键限值的偏离而加工者无纠正措施计划时，针对相应的偏离，加工者要：

　　（1）隔离并存放受影响的产品，至少直到满足（c）段（2）和（c）段（3）的要求。

　　（2）进行或接受一次复查，以确定受影响产品销售的可行性。进行复查的人员必须经过专门培训或有这方面的经验。专门培训可包括，也可不包括§12.310所要求的培训。

　　（3）必要时对受影响的产品采取纠正措施，以确保进入市场的产品不会因为偏离而对健康构成危害，或成为伪劣食品；

　　（4）必要时对受影响的产品采取纠正措施，以确保进入市场的产品不会国为偏离而对健康构成危害，或成为伪劣食品；

　　（5）及时进行和接受由经过按照§123.10进行培训的人员所做的复审，以确定HACCP计划是否需要修改，以避免再次发生偏离。并对HACCP计划作必要的修改。

　　（d）对按照本条款所采取的各种纠正措施要做好详细的记录，这些记录的验证要符合§123.8（a）（3）（ii）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。