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§ 417.3 Corrective actions.
(a) The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure:
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.
(b) If a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment shall:
(1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met;
(2) Perform a review to determine the acceptability of the affected product for distribution;
(3) Take action, when necessary, with respect to the affected product to ensure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce;
(4) Perform or obtain reassessment by an inpidual trained in accordance with §417.7 of this part, to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan.
(c) All corrective actions taken in accordance with this section shall be documented in records that are subject to verification in accordance with §417.4(a)(2)(iii) and the recordkeeping requirements of §417.5 of this part.
§417.3 纠正措施
(a)书面的HACCP计划必须确定偏离关键限值时相应的纠正措施。HACCP计划必须记述采取的纠正措施,及指明采取纠正措施的职责,以保证:
(1) 发生的偏离得到识别和消除;
(2) 采取纠正措施后,CCP处于控制中;
(3) 建立了防止再发生的办法,及
(4) 没有因偏离有害于健康的或掺杂的产品进入贸易。
(b)如果发生一种没包括在已规定的纠正措施中的偏离,或发生了其它的预料外的危害,企业必须:
(1) 隔离并保留受影响的产品,至少符合本节(b)(2)和(b)(3)段的要求。
(2) 进行检查以决定受影响的产品可否销售。
(3) 需要时对受影响的产品要采取措施以保证没有因偏离有害于健康的或掺杂产品进入贸易。
(4) 按照本部分417.7的要求由受过培训的人员评估,以决定新确定的偏离或其它预料外的危害是否应包括在HACCP计划中。
(c)按照本节采取的纠正措施必须按照本部分417.4 (a)(2)(iii)和417.5 记录保存的要求进行记录以便审核。
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