21 CFR 123.8 - Verification.

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There is 1 rule appearing in the Federal Register for 21 CFR 123. View below or at eCFR (GPOAccess)
§ 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.

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

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  • 2013-11-22; vol. 78 # 226 - Friday, November 22, 2013
    1. 78 FR 69992 - Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability
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      21 CFR Part 123

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 123 after this date.

  • 2013-11-22; vol. 78 # 226 - Friday, November 22, 2013
    1. 78 FR 69992 - Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of availability.
      Submit either electronic or written comments on FDA guidances at any time.
      21 CFR Part 123