Integrity of Filter Integrity Test

As an auditor, how would you ensure the integrity of the HEPA Filter Integrity Test? Or to put it the other way, how do you prove the integrity of your HEPA filter integrity test to the auditor?

Just for the very sake of example, consider the following scenario. Say you have the responsibility to audit a facility where you are presented with the HEPA filter integrity test reports. How would you make sure that their photometer was used to actually take reports from under the HEPA, not from any clean air source?

Or as an auditee, how do you prove to the auditor, that the HEPA filters were actually scanned and the reports are legit?

From my point of view I think you can not check or prove that vissually unless you open the ventilation unit for physical damage … the only way to know that by report and compare the results with standards

Usually, during an inspection from a health authority (e.g. FDA, EMA, etc.), there is no need to prove that the information and data you are presenting is legit. If the inspector has these doubts, it is most likely that he has seen data integrity issues during the inspection; and when an inspector sees data integrity issues during the inspection, the audit is practically over (failed), since he will have objective evidence of data integrity loss, and will question all other data that had been presented for review.

In short, I suggest that instead of looking for ways to prove you are being honest on doing your due dilligence, it is best for you to ensure that yout integrity test records are robust by demonstrating data integrity in those records, so that its integrity is not even questioned.

There are plenty of guidelines issued worldwide related to data integrity, if you want to get some ideas to consider to make your records compliant with Good Documentation Practices (GDP)

I hope this suggestion is helpful!

This topic was automatically closed 3 days after the last reply. New replies are no longer allowed.