portance of record review. Management must develop a program to review all calibration records deemed critical to quality
and safety by the risk assessment. Procedures on how to review
the records should be developed and implemented. In addition, employees who conduct the reviews must be trained on
said procedures. For CCPs, review of the records for calibrating the instruments would be incorporated into the HACCP
plan.
Processors should also establish programs to verify that the
calibration program is being properly followed. Persons doing
these internal audits should be independent of this area. For ex-
ample, if calibration is managed by the production group, the
auditor could be drawn from quality, warehouse operations or
elsewhere. The verification activities should include the follow-
ing elements:
• Procedures – The auditors should make sure that the persons
responsible for doing work are following established proce-
dures. Auditors should use procedures and work instruc-
tions as a guide when doing this phase of the audit.
Auditors should also look to see that calibrations were car-
ried out according to schedule.
• Competencies/Training – This starts with the auditor reviewing
the training records. However, training should lead to com-petencies. To verify the latter, the auditor needs to observe
the individual doing the calibration to determine if the person is actually following the procedure. When work is done
by an outside agency, confirm that the group doing the
work is competent and that there is some protocol for selecting and evaluating potential contractors.
• Records – The auditors should also review records, which
would include looking for deviations and corrective actions.
The review should also look for evidence of management
review.
The individuals conducting these audits must be trained on
audit procedures. In addition, records of training must be
maintained. This is something that may be done internally or
through an outside agency. Many processors send their people
to programs that certify them as ISO auditors. Again, this is a
choice that each company should make.
Evaluating the Program
Calibration and, in fact, all programs should be evaluated
on a regular basis. The program should be reviewed by the
plant manager and the management team at least once a year.
The review should draw heavily on the verification activities
and on the company’s performance related to quality and
safety goals. The objective of this exercise is to look at the program as it exists and look for ways to enhance it. One of the results of the management review should be an improvement
plan that includes programs, assigned responsibilities, timelines
to complete the project and the resources needed to complete
the work. If such a program has been operating, the review
should also address past improvement plans, their status and
success or failure. This is an essential element for continuous
improvement and an integral element of ISO 22000.
Making the Calibration Program “Audit
Friendly”
As mentioned, calibration is an integral part of a processor’s
quality and safety program. Getting the program organized,
particularly ensuring that it is managed by one person rather
than many, will help make the program “audit friendly.” The
master calibration schedule provides users and auditors with an
organized summary of the program. In fact, to make it even
easier to manage, processors should add one more field: the location of the records for that instrument. Of course, the best
means for getting everything in one place is an electronic system. As noted, maintenance management software programs
are a tool that can capture the whole program; so rather than
looking at piles of records, one can audit the complete program
by sitting in one place in front of a computer. If electronic systems are used, the computer should have security systems that
meet 21 CRF 11, the electronic recordkeeping requirements.
So, take a long look at how calibration programs are being
managed and ask yourself, “Is this the best we can do?” My
guess is that you can do better. n
Richard F. Stier is a consulting food scientist with international
experience in food safety (HACCP), plant sanitation, quality systems, process optimization, GMP compliance and microbiology.
Among his many affiliations, he is a member of the Institute of
Food Technologists and an editorial advisor to Food Safety Magazine. He can be reached at rickstier4@aol.com.
