7 replies to this topic

[yoel.astorga]

Hi, I need help. One of the minor in my past SQF audit was no GMP records for 6 months because the Quality Manager left and no one carried out this activity. What would be the corrective action if it is something that couldn't  be completed? What will be done to make the prevention happen, even if the Quality Manager is gone?

Thank you

Edited by yoel.astorga, 30 August 2023 - 02:13 PM.

[MDaleDDF]

You've got to have a designated backup at all times.

[yoel.astorga]

I have two month in this position and they never designated a substitute 

[PQAManager]

You need to pick a person, give them at least HACCP, have them read the SQF code and your company SQF code and manual.  Then train them to do GMP audits.  I would give them auditing training too.  Submit all these documents of training and certificates to correct the non-conformance.  Sometimes you can only prove you put yourself on the right track.  Have the person you trained do the 1st GMP audit for the month and submit it too in your objective evidence.  You can state that you cannot do corrective action because it is too late, preventative action is what you need to show.

[SQFconsultant]

I don't understand why this could not have been completed and I am curious to know what the thought process was going into an audit where for 6 months previous this lack was building?

 

Regardless rather lucky this was only a minor.

 

I assume the other minor was not having a backup?

 

So the solution is that you immediately hire a QA and designate a backup and begin the process again with proof of solution.

[Brothbro]

I have two month in this position and they never designated a substitute 

 

It may just never have occurred to the rest of your team that it's important. If you work for a smaller company, it can be common that only one person (you, the QA Manager) will have any insight into the regulatory/SQF standard. It's not supposed to be that way, but that's how things can end up. It's going to be your responsibility to present this issue to the team and make everyone is aware of the importance of training a backup. They should know SQF is important to your company's clients, so drive home the fact that your certification hinges on this. Because it really is quite surprising you only got a minor for not having a QA manager for 6 months!

[SoupsNStuff]

In my case, I came in to just two months missing records due to lack of QAM (not CCP, thank god but GMP inspections, EMP swabbing, monthly meetings, tons of missing verifications etc.) and yes, it was a lot of corrective action reports all with the same conclusion: backup was not established due to poor communication. Solution: established and trained back up. 

And for some things like the missing EMP, I did a big swab-a-thon for a month to ensure we were ok for missing so much. So in terms of mitigating risk and really correcting that action, it depends what was missing.

 

Auditor seemed disappointed (not at me, as I wasn't here) but no NCs on it due to trying to recover the best I could, having documented CAPA, and then having every record from my start date be perfect haha. 

[jfrey123]

Beyond hiring or designating a backup individual to act in the absence of a QA Manager, your SOP's need to reflect who performs certain duties when a key employee is absent or a position becomes vacant.  Some folks handle this in their organization charts/SOP where it will state "x person performs the duties of the QA Manager," but IMO the auditors prefer to see backup information directly into SOPs. In case of internal audits, your SOP for performing them should note the QA Manager is responsible for performing them, but a designated person (QA supervisor, etc) is trained to perform them as well.

 

The SOP should also call for an independent department to verify compliance (such as the production manager reviewing internal audits to verify QA has performed them at the prescribed frequency).  Reviewing your SOPs to determine if you have such verifications in place will help prevent this situation from repeating and can be part of your documented CAPA.