[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.8]

[Page 278-279]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 123_FISH AND FISHERY PRODUCTS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  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

[[Page 279]]

use or consumers of the finished product. The reassessment shall be 
performed by an individual or individuals who have been trained in 
accordance with Sec.  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 Sec.  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 Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  123.9.