be done. By conducting a risk assessment, they can determine not only
which devices are essential for the production of safe, wholesome and high-quality products, but also whether the
procedures are being employed properly.
The job description of the manager
responsible for calibration should clearly
state that this individual is responsible
for managing the program. He or she
must accept their job description, acknowledging responsibility. Among their
duties will be to ensure that the program
remains on schedule, that it is audited
per established schedules and that calibration records are being reviewed per
established schedules. In addition, the
calibration manager must ensure that all
persons responsible for calibrating instruments or ensuring that they are calibrated have been trained on the
procedures and/or work instructions required to do the work and that records
of these sessions are maintained.
“It is absolutely essential that calibration be an
integral part of a food or ingredient processor’s
quality and safety program.”
Developing and Documenting
Procedures
It is absolutely imperative that all
procedures involved in the calibration
program be documented. There should
be a general protocol that describes how
the calibration program will be developed and implemented, plus work instructions that describe how each
instrument or class of instruments
should be calibrated.
The general protocol should include
the following elements:
• Objective of the program
Each work instruction should include
step-by-step procedures on how the cali-
bration should be done, the standards
that will be employed, the tolerances
and how the results shall be reported. If
the instrument is out of calibration, the
procedures must not only describe what
will be done with the instrument, but
more importantly, it must address what
to do with any product that might be af-
fected. Most operations “tag” their in-
struments after calibration. The
calibration tag may include who did the
work, the date the work was done and
the date of the next scheduled calibra-
tion. These tags should be made of ma-
terials that are water- and oil-resistant so
they will survive the rigors of produc-
tion, including cleaning. Additionally, if
tagging is part of the program, removal
of outdated tags and replacement with
new ones should be included in the pro-
cedures.
Procedures for sending instruments
out must also be documented. If a state
agency comes into your facility once a
year to calibrate scales, load cells and
other devices, procedures describing
how this is done, who is responsible and
what needs to be done if the instrument
is found to be out-of-calibration are
necessary
One of the most valuable tools for
documenting and organizing a calibra-
tion program is a master calibration
schedule (Table 1). Rolling all instru-
ments that require calibration into this
master list allows a processor to easily
monitor the program and makes life
much easier for auditors. The whole pro-
gram is summarized in one document.
Of course, hard copy records of calibra-
tion records must be available for review
and to verify that the work was not only
done, but done properly.
Records and Corrective Actions
Records of all calibration activities
must be maintained either as hard copies
or electronically. Many processors roll
their process instrument calibration into
a maintenance management software
program. These systems are available
commercially or can be developed internally using programs such as Excel™ or
Access™. If your company decides to
purchase or build an electronic system to
maintain and monitor a calibration program, consider incorporating the following features:
• Maintenance scheduling
• Flags when items are due
• Flags for past-due items
• Procedures for doing work
• Automatic entry by workers
• Ability to have records scanned and
accessed by the system
Instrument Serial# Location
Frequency
of calibration
Test
method
Standards/
tolerances
Person Date last
responsible calibration
Date next Comments
calibration
Table 1: Master Calibration Schedule
