原文后附帶中文翻譯,由食品伙伴網食品論壇網友gaoketian提供,食品伙伴網在此表示感謝!
§ 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糾正措施
(a)當發生偏離關鍵限值的情況時,加工者必須采取以下糾正措施:
(1) 執行一個與具體偏離相對應的糾正措施計劃。
(2) 依據本部分(c)段采取的程序
(b)加工者可以制定書面的糾正措施計劃,按照§123.6(c)(5),它可以作為HACCP計劃的一個部分,這樣加工者就可以預先確定一旦關鍵限值出現偏離時,他們將采取的措施。一個針對某種偏離的糾正措施計劃需交待所要采取的步驟,并明確執行這些步驟的責任,以保證:
(1)進入市場的產品不會國為偏離關鍵限值而對健康造成危害,或成為偽劣食品;并且
(2)偏離的原因得到了糾正。
(c)當發生關鍵限值的偏離而加工者無糾正措施計劃時,針對相應的偏離,加工者要:
(1)隔離并存放受影響的產品,至少直到滿足(c)段(2)和(c)段(3)的要求。
(2)進行或接受一次復查,以確定受影響產品銷售的可行性。進行復查的人員必須經過專門培訓或有這方面的經驗。專門培訓可包括,也可不包括§12.310所要求的培訓。
(3)必要時對受影響的產品采取糾正措施,以確保進入市場的產品不會因為偏離而對健康構成危害,或成為偽劣食品;
(4)必要時對受影響的產品采取糾正措施,以確保進入市場的產品不會國為偏離而對健康構成危害,或成為偽劣食品;
(5)及時進行和接受由經過按照§123.10進行培訓的人員所做的復審,以確定HACCP計劃是否需要修改,以避免再次發生偏離。并對HACCP計劃作必要的修改。
(d)對按照本條款所采取的各種糾正措施要做好詳細的記錄,這些記錄的驗證要符合§123.8(a)(3)(ii)并符合§123.9的記錄保存要求。
更多有關美國FDA水產品HACCP法規內容,請點擊美國FDA水產品HACCP法規匯總。