Latest from the Commissioning and Qualification Community of Practice Discussions:

“Setting a Calibration Grace Period for Instruments”

Question: I have been mapping the calibration process in my SAP system. I have set the initial calibration frequency for all my

instruments to 01 yr. Next I need to set a grace period for the above frequency. If it exceeds this period the system would initiate an SAP

notification (notice to all concerned) as a deviation. What is the usual practice in the industry? Would it be appropriate to be have 01

month as a grace period as this is inevitable in cases where I depend on external vendors for services? (Mohammad, Eng Manager)

Response: It is up to you and your company to decide, document, and defend. I have previously used a 1 month grace period for 

yearly calibrations; a 15 day grace period for 6 month calibrations, and a 5 or 7 day grace period for monthly calibrations. Keep in

mind, there is nothing wrong (other than paying for it) with calibrating early if you cannot establish an acceptable grace period.

(Merrick, Validation Engineer)

Response: We set ours at 1 year +/- 15 days; otherwise we are in deviation. (Stig, Global Manager)

Question: Referring to the above matter, I would like to know how it is that we can calibrate the instrument after the due date if the grace

 period is mentioned in the protocol/SOP of calibration. My understanding was that we need to calibrate the instrument on or before the

due date and you cannot cross the due date; although early calibration prior to the due date is ok. (Ravi, Assistant Manager Validation)

Response: As long as you proceduralize your process to include grace periods, you should be fine. As long as the periods are

rational, i.e. for annual calibrations give 15 days or 1 month. I would say you probably could not get away with giving an annual

calibration 1 years grace though. (Padraig, Systems Engineer)

Response: Please be aware that grace periods are OK, but you are not allowed to misuse them by calibrating every 13 months.

Instead, you should still aim at calibrating every 12 months. The purpose of the grace period is to be pragmatic, not to allow the

 postponement of your calibrations. (Jakob, Engineer)

Response: We use the end of the month as our due dates. We send out a notice of items coming due 1-3 months ahead of time.

There have been some instances where a piece of equipment simply could not be shut down for a scheduled PM or CAL. In that

 particular instance, we allow a two week extension, and document this per our SOP via a memo to file. Just make sure that you do

what you say you are going to do in your SOP. (James, Senior Analytical Metrologist)

Response: I am in on the train of thought as James. We look at the criticality of the equipment and the impact of the equipment on

GMP operations prior to establishing its maintenance and calibration interval. Would you feel it is safe to calibrate a sterilizer 

yearly? What happens if it is found to OOT after a year, would you not have to perform a review of ALL products made for the

year? We have a classification method for equipment and use that as the basis. We have a System Impact Assessment (form) to

define the criticality of the system to manufacturing. These are the basis of calibration/maintenance. We do have a 30 day grace

 period for calibrations as well. (Hector, Senior QA Manager - Automation)

Question: I would like to know if the same principal of grace periods can also be applied to periodic requalification of laminar air flow

units. The reason is that we are having 95 laminar airflow units at our site and we need to perform a non-viable particle count by sampling

each location for one cubic meter. This is really time consuming. (Ravi, Assistant Manager Validation)

Response: In requalification of LAF you are checking the integrity of the machine as a whole. You do not establish the test

frequency based on previous performance. Whereas in calibration, you compare results of “Unit Under Cal” (UUC) to a known and 

traceable standard of measurement. The results not only influence your calibration frequency, but they also influence the daily

measurements which you had taken based on your data/result at the shop floor using this particular instrument under scrutiny.

(Mohammad, Eng Manager)

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