By Richard F. Stier
Building an Effective
• Observe the employees doing the calibration procedure to ensure they are
following the procedures; or, audit
third parties contracted to do similar
It is also important to assign someone to manage the calibration program
to ensure that it is properly designed,
implemented and maintained.
Calibration: The comparison of a measurement instrument or system of unverified accuracy to a measurement
instrument or system of known
accuracy to detect any variation from
the required performance specification.
–American Society for Quality
It is absolutely essential that calibration be an integral part of a food or ingredient processor’s quality and safety program. Almost all regulations and management
standards that address food quality and safety include language that stresses the importance of calibration. The low-acid canned food regulations found in the U.S.
Code of Federal Regulations 21 CFR Part 113 reference the need for calibration:
“Each thermometer should have a tag, seal or other means of identity that includes the date
on which it was last tested for accuracy.”
As does the Hazard Analysis and Critical Control Points (HACCP) regulations
that are mandated for meat and poultry, seafood and juice:
“Records that document the calibration of process monitoring instruments.”
And, finally, ISO 22000, the food safety management system’s requirements for
any organization in the food chain, states in Section 8.3:
“The organization shall provide evidence that the specified monitoring and measuring
methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.”
The bottom line is that all instruments used for ensuring quality, safety, sanitation and legal compliance must be calibrated. In addition, if there are monitoring
devices that are necessary to ensure worker safety and/or safe operation of equipment, they must be included in the calibration program. An example of such a device would be a pop-off valve on a pressure vessel.
To achieve this goal, processors need to perform the following:
• Develop effective procedures for calibration;
• Document those procedures;
• Maintain records of calibration activities, including corrective actions;
• Review records to ensure that procedures are being followed;
Who Manages the Program?
So, who should manage the calibration program? This depends on each
and every company. What happens frequently is that processors do not assign
an individual to manage the calibration
program, but allow it to be done by different operating groups. The production
people might be responsible for unit operations such as metal detectors or magnets, whereas engineering takes
responsibility for temperature-indicating
devices (TIDs) and pressure gages. The
quality manager or laboratory supervisor
will ensure that the instruments in the
laboratory are properly calibrated. There
may be other groups that get involved.
For example, the warehouse people
might be responsible for looking after
refrigerators, freezers and relative humidity controls.
What can happen in a situation like
this is that there are many different calibration programs that use different
forms and procedures. In addition, there
may be critical instruments that “fall
through the cracks” and are either not
being calibrated or not being calibrated
frequently enough to adequately ensure
safety or quality. It is okay to have different persons responsible for their
areas, but one person needs to manage
the entire program. His or her role is to
ensure that there is a consistent program
that addresses all calibration activities
that need to be done to ensure product
quality and safety. The calibration manager needs to work with his group to establish a standard format for procedures.
The manager must also evaluate all
monitoring instruments in the plant and
determine not only whether calibration
is necessary, but how often this should