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!
§ 123.8 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驗證
(a)總體驗證。每個加工者都必須驗證其HACCP計劃能有效控制有理由而且有可能發生的食品安全危害,且計劃得到有效執行。驗證至少包括以下內容:
(1)對HACCP計劃的復審。當發生任何可能影響危害分析的變化,或在任何方面改變HACCP計劃,或者至少每個年度,都要對HACCP計劃的適用性進行復審。這些變化可以是:原料或原料來源,產品配方,加工方法或體系,成品銷售體系或預期用途和用戶。復審必須由經過按照§123.10培訓的人員進行。當復審表明計劃已不再完全符合§123.6(c)的要求時,必須立即修改HACCP計劃。
(2)實施驗證措施。包括:
(i)復查加工者收到的各種消費者投訴,以確定它們是否與關鍵控制點的執行有關,或發現存在有尚未識別的關鍵控制點;
(ii)工序監測儀器的校正;
(ⅲ)根據加工者的選擇,定期進行成品和半成品的檢驗。
(3)復查記錄。復查包括簽字和日期,由經過按§123.10培訓的人員進行,內容包括:
(i)關鍵控制點的監測。復查至少是為了確保記錄的完整,并且證實記錄所記的數據是在關鍵限值內,復查必須在作記錄后一周內進行。
(ⅱ)采取糾正措施。復查至少是為了確保記錄完善,并且證實按照§123.7采取了糾正措施。復查必須在作記錄后一周內進行。
(ⅲ)校正關鍵控制點上所用的工序監控裝置,并進行各種定期的成品和半成品檢驗,這是加工記錄。這些復查要在作記錄后合理的時間內進行。
(b)糾偏行動。當驗證程序(包括對消費者投訴的復查)顯示需要采取糾正措施時,加工必須立即執行§123.7的程序。
(c)危害分析的重新評估。由于危害分析表明無發生食品安全的可能和理由。而制定HACC計劃的加工者,當出現任何可能會對食品安全危害的存在產生影響的變化時,重新審查危害分析的適應性。這些變化包括,但不限于:原料及其來源、產品配方、加工方法或體系,成品銷售體系或預期用途、成品的消費者等變化。重新審查必須由經過按照§123.10進行培訓的人員實施。
(d)記錄保存。按照本部分(a)段((2)(ii)至(iii),對工序監按裝置的校正;成品和斗成品的定期檢驗都要做好記錄,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。