[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: 21CFR120.11]
[Page 270-271]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of
Subpart A General Provisions
Sec. 120.11 Verification and validation.
(a) Verification. Each processor shall verify that the Hazard
Analysis and Critical Control Point (HACCP) system is being implemented
according to design.
(1) Verification activities shall include:
(i) A review of any consumer complaints that have been received by
the processor to determine whether such complaints relate to the
performance of the HACCP plan or reveal previously unidentified critical
control points;
(ii) The calibration of process monitoring instruments;
(iii) At the option of the processor, the performance of periodic
end-product or in-process testing; except that processors of citrus
juice that rely in whole or in part on surface treatment of fruit shall
perform end-product testing in accordance with Sec. 120.25.
(iv) A review, including signing and dating, by an individual who
has been trained in accordance with Sec. 120.13, of the records that
document:
(A) 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 the records document values that are within the
critical limits. This review shall occur within 1 week (7 days) of the
day that the records are made;
(B) 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. 120.10. This review shall occur within 1 week (7 days) of the day
that the records are made; and
(C) The calibrating of any process monitoring instruments used at
critical control points and the performance 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; and
(v) The following of procedures in Sec. 120.10 whenever any
verification procedure, including the review of consumer complaints,
establishes the need to take a corrective action; and
(vi) Additional process verification if required by Sec. 120.25.
(2) Records that document the calibration of process monitoring
instruments, in accordance with paragraph (a)(1)(iv)(B) of this section,
and the performance of any periodic end-product and in-process testing,
in accordance with paragraph (a)(1)(iv)(C) of this section, are subject
to the recordkeeping requirements of Sec. 120.12.
(b) Validation of the HACCP plan. Each processor shall validate that
the HACCP plan is adequate to control food hazards that are reasonably
likely to occur; this validation shall occur at least once within 12
months after implementation and at least annually thereafter or whenever
any changes in the process occur that could affect the hazard analysis
or alter the HACCP plan in any way. Such changes may include changes in
the following: Raw materials or source of raw materials;
[[Page 271]]
product formulation; processing methods or systems, including computers
and their software; packaging; finished product distribution systems; or
the intended use or consumers of the finished product. The validation
shall be performed by an individual or individuals who have been trained
in accordance with Sec. 120.13 and shall be subject to the
recordkeeping requirements of Sec. 120.12. The HACCP plan shall be
modified immediately whenever a validation reveals that the plan is no
longer adequate to fully meet the requirements of this part.
(c) Validation of the hazard analysis. Whenever a juice processor
has no HACCP plan because a hazard analysis has revealed no food hazards
that are reasonably likely to occur, the processor shall reassess the
adequacy of that hazard analysis whenever there are any changes in the
process that could reasonably affect whether a food hazard exists. Such
changes may include changes in the following: Raw materials or source of
raw materials; product formulation; processing methods or systems,
including computers and their software; packaging; finished product
distribution systems; or the intended use or intended consumers of the
finished product. The validation of the hazard analysis shall be
performed by an individual or individuals who have been trained in
accordance with Sec. 120.13, and, records documenting the validation
shall be subject to the recordkeeping requirements of Sec. 120.12.
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