[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
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 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
[[Page 279]]
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.
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