Food Safety Magazine, October/November 2010

• Ability to verify that work has been
done
• Print capability: summaries, schedules
• Ability to “talk” to other systems
Be forewarned, however, electronic
maintenance management systems take a
great deal of time and effort to get up
and running. There is a huge amount of
information to input into the system. In
addition, it is absolutely imperative that
several persons be trained to manage and
use the system. This is one situation
where “putting all your eggs in one bas-
ket” can be huge mistake. I have seen
such systems abandoned when the only
trained person leaves the company.

As noted above, calibration records are mandatory for all instruments used to monitor Critical Control Points (CCPs) in a HACCP program. In addition, the importance of developing documented calibration procedures that include corrective actions cannot be overemphasized. One of the gaps observed in many calibration programs is that the corrective actions do not include what to do with product that may

R-Biopharm Vitamin Analysis

be affected. The protocol may contain statements like the following:

“If the instrument is not in calibration,
make the necessary adjustments to bring it
back into calibration and retest,” or
“If the instrument is out-of-calibration,
take it out of service and send it to the vendor
for repairs. If it cannot be repaired, replace it
immediately.”

It is imperative that the procedures
address any product that might be af-
fected. Here is an example: many years
ago, a processor of acidified peppers, a
seasonal item, received a visit from the
U.S. Food and Drug Administration
(FDA) at the end of the season. The
company’s records indicated that all of
the products packed throughout the sea-
son had a pH of 4. 6 or below. When the
FDA began checking the pH values of
products, they found pH values of 4. 8
and above. These findings indicated that
the product was potentially unsafe as it
could support the growth of Clostridium
botulinum. Unfortunately, the company
had no records documenting that their
pH meters had been calibrated. The
company said that they did it each and
every day, but they had failed to docu-
ment that the work had been done. The
FDA told them to embargo the entire
season’s pack and develop a sampling
plan to show compliance. The company
elected to destroy the entire season’s
pack, estimating that the testing would
cost too much. So in this case, a failure
to maintain proper calibration records
cost a company a full season’s pack.