[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: 21CFR120.12]
[Page 271-272]
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. 120.12 Records.
(a) Required records. Each processor shall maintain the following
records documenting the processor's Hazard Analysis and Critical Control
Point (HACCP) system:
(1) Records documenting the implementation of the sanitation
standard operating procedures (SSOP's) (see Sec. 120.6);
(2) The written hazard analysis required by Sec. 120.7;
(3) The written HACCP plan required by Sec. 120.8;
(4) Records documenting the ongoing application of the HACCP plan
that include:
(i) Monitoring of critical control points and their critical limits,
including the recording of actual times, temperatures, or other
measurements, as prescribed in the HACCP plan; and
(ii) Corrective actions, including all actions taken in response to
a deviation; and
(5) Records documenting verification of the HACCP system and
validation of the HACCP plan or hazard analysis, as appropriate.
(b) General requirements. All records required by this part shall
include:
(1) The name of the processor or importer and the location of the
processor or importer, if the processor or importer has more than one
location;
(2) The date and time of the activity that the record reflects,
except that records required by paragraphs (a)(2), (a)(3), and (a)(5) of
this section need not include the time;
(3) The signature or initials of the person performing the operation
or creating the record; and
(4) Where appropriate, the identity of the product and the
production code, if any. Processing and other information shall be
entered on records at the time that it is observed. The records shall
contain the actual values and observations obtained during monitoring.
(c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3)
of this section shall be signed and dated by the most responsible
individual onsite at the processing facility or by a higher level
official of the processor. These signatures shall signify that these
records have been accepted by the firm.
(2) The records in paragraphs (a)(2) and (a)(3) of this section
shall be signed and dated:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) Upon verification and validation in accordance with Sec.
120.11.
(d) Record retention. (1) All records required by this part shall be
retained at the processing facility or at the importer's place of
business in the United States for, in the case of perishable or
refrigerated juices, at least 1 year after the date that such products
were prepared, and for, in the case of frozen, preserved, or shelf
stable products, 2 years or the shelf life of the product, whichever is
greater, after the date that the products were prepared.
[[Page 272]]
(2) Offsite storage of processing records required by paragraphs
(a)(1) and (a)(4) of this section is permitted after 6 months following
the date that the monitoring occurred, if such records can be retrieved
and provided onsite within 24 hours of request for official review.
Electronic records are considered to be onsite if they are accessible
from an onsite location and comply with paragraph (g) of this section.
(3) If the processing facility is closed for a prolonged period
between seasonal packs, the records may be transferred to some other
reasonably accessible location at the end of the seasonal pack but shall
be immediately returned to the processing facility for official review
upon request.
(e) Official review. All records required by this part shall be
available for review and copying at reasonable times.
(f) Public disclosure. (1) All records required by this part are not
available for public disclosure unless they have been previously
disclosed to the public, as defined in Sec. 20.81 of this chapter, or
unless they relate to a product or ingredient that has been abandoned
and no longer represent a trade secret or confidential commercial or
financial information as defined in Sec. 20.61 of this chapter.
(2) Records required to be maintained by this part are subject to
disclosure to the extent that they are otherwise publicly available, or
that disclosure could not reasonably be expected to cause a competitive
hardship, such as generic type HACCP plans that reflect standard
industry practices.
(g) Records maintained on computers. The maintenance of computerized
records, in accordance with part 11 of this chapter, is acceptable.
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