How to Cover for Months of Missing Work

Hello,

I just started at a new company and the last QA manager seemed to stop doing sanitation verifications or monthly management reviews back in June 2022 after their audit. Also they didnt assign someone to do the weekly environmental monitoring when they left so that is missing for three months....
And that's just what I found on day 2...

What the heck do I even do about this? For SQF, FDA, etc etc

Hello,

I just started at a new company and the last QA manager seemed to stop doing sanitation verifications or monthly management reviews back in June 2022 after their audit. Also they didnt assign someone to do the weekly environmental monitoring when they left so that is missing for three months....
And that's just what I found on day 2...

What the heck do I even do about this? For SQF, FDA, etc etc

I was in the same kind of position when I got my QA lead job. Write up a bunch of non conformities with the root causes and corrective actions.

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Agree totally with Sheena---that's all you can do

 

Note the day you found the non conformance and the plan moving forward

And if SQF looks into it, they won't give points off or FDA won't shut us down? 😓

And if SQF looks into it, they won't give points off or FDA won't shut us down?

No because you found the problem and the root cause, and came up with a corrective action. If your environmental results are coming back clean, and there are no other risks, you should be okay.

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By discovering the problems yourself prior to your SQF audit, you should be insulated from taking it as a finding in the formal audit.  A small scale comparison would be rodent activity discovered during the audit is an automatic finding, yet rodent activity noted in your logs with corrective actions taken will be documented as compliant with the relevant code.

 

Same thing should apply to an FDA check, though if the finding is serious enough it can cause a citation or other action.

 

But the whole point of a good quality management system, run by properly trained personnel, is to catch these types of problems before they spiral out of control.  You've discovered opportunities to improve the procedures around these processes, the methods of which you're going to be able to document in your root cause analysis.  Find out how these things ended up being swept to the side, and implement real change to make sure it won't happen again.  

Hi SoupsNStuff,

 

You have 3 months get back on track before your audit so document the non-conformances, root cause analysis and corrective actions then get your records all spot on for the next 3 months.

 

You may get a non-conformance during your audit but you will have done the maximum you can to get back on track, so in that situation I would be happy. An auditor will take a more positive view when they see that you have identified the deficiencies and corrected them than to just find the gaps themselves.

 

Kind regards,

 

Tony

Hello,

I just started at a new company and the last QA manager seemed to stop doing sanitation verifications or monthly management reviews back in June 2022 after their audit. Also they didnt assign someone to do the weekly environmental monitoring when they left so that is missing for three months....
And that's just what I found on day 2...

What the heck do I even do about this? For SQF, FDA, etc etc

Write a CAPA for the issue and be specific with what was missed and the dates. Create a plan going forward for backups and verifications. Do not miss anymore requirements.

If it were me, I would curious as to why they stopped doing these verifications.

 

I would also wonder if there is not enough management commitment given that this was not noticed until you stepped in.

 

A similar situation happened to me and I found that more communication with upper management was required - the food safety culture was lacking.

Agreed that documenting the non conformity yourself makes it more pro active.
You can't go back in time but you can maybe take send some extra product samples away to show that the cleaning was sufficient even though the monitoring got dropped.
What a situation to be in
If you also document Root cause and show your plan moving forward - also will help you to assess the risk to final product of these checks not being in place.

Good luck