Q1: If HACCP records will be maintained
on a computer, is a specific software program required?
A1: No. HACCP records can be maintained on computers, if
suitable measures are in place to ensure that the integrity of the
records is maintained, and that the computer records cannot be altered
(9 CFR 417.5(d)).
Q2: Can meat or poultry food products
be moved to an off-site location before pre-shipment review has
A2: When the producing establishment maintains control
(e.g. product moved to a company owned and operated cold storage)
of the meat/poultry food products, the products may be at a location
other than the official producing establishment, as long as the
review of appropriate documents and compliance with 9 CFR 417.5(c)
occurs before the product leaves the control of the producing establishment.
Q3: If a monitoring procedure
consists of taking multiple measurements, are separate entries required
for each measurement (i.e. must each measurement includes a time,
date and initials)?
A3: If the establishment’s HACCP plan
lists the monitoring procedure (9 CFR 417.2(c)(4)) and that monitoring
procedure consist of multiple measurements to ensure compliance
with the critical limit, the entry made on the HACCP record should
include each of the measurements made during the monitoring procedure.
Only one time and one initial or signature would be required per
9 CFR 417.5(b) for the monitoring event. The establishment is responsible
for ensuring the accuracy of all measurements, regardless of the
Q4: Are records generated as part of an
establishment’s prerequisite program required to be reviewed when
the establishment performs pre-shipment review?
A4: No, an establishment is not required to review
prerequisite program records during pre-shipment review 9 CFR 417.5(c).
However, the records generated under the pre-requisite program would
need to be maintained as part of the establishment’s decision making
documents (see 9 CFR 417.5(a)(1)).
Q5: When an unforeseen hazard occurs,
how long does the establishment have to reassess the HACCP plan
and develop a new CCP or CL if needed?
A5: No time is specified in the applicable regulation,
9 CFR 417.3(b)(4). Depending upon the unforeseen hazard, a prudent
establishment will perform the required reassessment and make any
identified changes to its food safety system as quickly as possible
to ensure that no product is produced or shipped that may be adulterated
or create a food safety hazard.