Justification for Month End Calibration Date

To all- Running a QMS for a 13485 company and have made all calibration due dates month end. Wrote the Quality Manual to stae:

The calibration due date method used to determine when a unit is due for scheduled calibration is determined by the BCS. The determined method is based on requirements, cost, and the ability of Calibration Service Supplier to perform calibration. Any of the following methods are acceptable and may be applied as necessary by the BCS according to process requirements:
1. Month/Year Calibration – Due date is established based on the month the unit is calibrated and the interval assigned to the unit. Calibration will be due no later than midnight on the last day of the month on the certificate and/or label. This method allows the unit to go beyond the stated interval but will not carry over into the next month.
2. Month/Day/Year – Due date is established based on the day of the month the unit was calibrated and the interval assigned to the unit. Calibration will be due no later than midnight on the date on the certificate and/or label.
3. These methods are not exclusive and a supervisor/manager can request in writing or via the BCI electronic mail system for modification of the method to be approved by BCS.

Pretty self explanatory. 15 sites in the US are using this new system of month end but I now have one internal QA auditor stating that this is not compliant for FDA and 13485. I know that only the customer can establish cal due dates and the QM needs to reflect. What I am looking for is hard written facts some where to "prove" that we are comliant for month endcal dates. Big stink has brewed and a wildfire is rampant. Any information

I have used the mm/yyyy format for calibration due dates. Never have had any issues with the FDA or otherwise. This method helps prevent silly NCR's in the case the IMTE was due on a Saturday and the calibration was performed the following Monday.

This system worked well as we generally scheduled our calibration house for the 4th Monday of every month.

Hope this helps!

One last thought, make sure your procedure agrees with your practice.

mentalcrew said:

To all- Running a QMS for a 13485 company and have made all calibration due dates month end. Wrote the Quality Manual to stae:

The calibration due date method used to determine when a unit is due for scheduled calibration is determined by the BCS. The determined method is based on requirements, cost, and the ability of Calibration Service Supplier to perform calibration. Any of the following methods are acceptable and may be applied as necessary by the BCS according to process requirements:
1. Month/Year Calibration ? Due date is established based on the month the unit is calibrated and the interval assigned to the unit. Calibration will be due no later than midnight on the last day of the month on the certificate and/or label. This method allows the unit to go beyond the stated interval but will not carry over into the next month.
2. Month/Day/Year ? Due date is established based on the day of the month the unit was calibrated and the interval assigned to the unit. Calibration will be due no later than midnight on the date on the certificate and/or label.
3. These methods are not exclusive and a supervisor/manager can request in writing or via the BCI electronic mail system for modification of the method to be approved by BCS.

Pretty self explanatory. 15 sites in the US are using this new system of month end but I now have one internal QA auditor stating that this is not compliant for FDA and 13485. I know that only the customer can establish cal due dates and the QM needs to reflect. What I am looking for is hard written facts some where to "prove" that we are comliant for month endcal dates. Big stink has brewed and a wildfire is rampant. Any information

Click to expand...

Just my but I would personally turn the question on him to show you where in ISO 13485 and/or the CFRs it states that month end due dates are NOT acceptable. Both just require that you have a calibration cycle defined and that items past calibration or found out of tolerance are quarantined and product impact assessed. Good luck.

Jon

I have to agree with the others. I have never seen an issue with end of month due dates; nor have I really ever heard the practice questioned.

I think its better to have a consistent (and compliant) calibration process. If you start setting to the day, you will have more headaches/ issues/ past due/ etc.

This job is hard enough, without making it more difficult.

If all of the months had 30 days and there was not a leap year, the dd/mm/yyyy would work fine!

I have rounded back several times and can not get an answer of what is actually in non compliant. The issue came about with a worse case scenario. Unit calibrated on the 1st of the months and then had a six month interval with month end date. Technically giving the unit a possible 7 month calibration date. The term "VALIDATED calibration frequency" was thrown around. Nor can I get the validation on the frequency is said report.

I have never heard of a validated calibration frequency requirement. If you calibration process always captures 'as found' data prior to calibration then there should be no issue with a theoretical worst case 7 month interval. It merely becomes a manufacturer's risk if the unit is found OOT at the end of seven months and now your product quality is in question.

The requirement is that calibration occur at "specified intervals". As long your interval is adequately specified in your procedure and your equipment is not routinely OOT, you should be well within the requirements.

Heck I have never heard of a validated calibration frequency. Think this was an auditor talking about something he is not familiar with. Unforntunatley, I can not find something in writing. So now its a he said she said who knows better.

Tell your auditor to chill out, the standards only require you to define your process and follow it. I've used a MM/DD/YY format for all my cal's and stated only the month was important and have had no problems.

I did get challanged on a registration audit with a similar worst case as you stated, but the focus was not on calibration frequency as much as if the people they were interviewing were aware of why the procedure was written the way it was. They were seaching for the rational behind the development of our calibration process to ensure we did not pick numbers out of the air. I don't think your internal auditor is searching for that.