Does the CFR require minimum frequency for QMS audits?

[Javier Guan]

Hello EC team,
I couldn't find anything in the CFR regarding the frequency of QMS audits. I recently reviewed an SOP for internal audits stating that the QMS will be fully audited every two years. Any advice will be appreciated.

Thank you, J

 

[Ed Panek]

The requirement is to audit the QMS periodically. The catch could be in Management Review "... sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives."

If you are not performing audits and reviewing the outputs of those audits annually, how do you respond to an FDA auditor who states "FDA Adopted this revised standard" or " FDA released this new guidance... 18 months ago." Without internal audits between then and now how can you be assured your QMS was in compliance for that period?"

Answer?

 

[ronaldino81]

As Ed mentioned above - specifically there is no frequency stated in the regulation and you can follow whatever approach you define in your QMS.
But as audits are a major input for mgmt. review this is a critical think, from my experience at least 2 Mgmt. reviews/year are considered to be acceptable. So based on that I would also conduct at least one round of audit for each period (Meaning at least 2/year).

 

[Javier Guan]

Thank you @Ed Panek. I read somewhere that FDA will not accept a partial QMS audit and the whole QMS should be covered a least once a year, but as you mentioned here, the is nothing in the CFR stating that. Thank you!