4 replies to this topic

[nickrhoward]

Hello all,

 

I've recently began a new QA manager position, and have come into a neglected quality system due to brief periods of there not being a QA manager between the previous long-term QA manager, one that didn't work out, and now myself.  Fortunately the operations manager has kept up on pre-ops, label verifications, line inspections, and product releases, but many things including various records, record reviews, monthly meetings, and internal audits have not been done.  The operations manager did an amazing job doing what she could without strong quality management experience.  It's a small operation with 10ish employees, so I'm also a one-person quality department. 

 

My question is - I there a way to document such failures and corrective actions in a manner that will satisfy the code and not be deemed an outright system failure.  The audit I have coming up is an unannounced BRC audit.  I'm finding discrepancies between company policies and the code requirements as statement, was going to proceed to pick things apart, but at this point I think the focus has to be on saving the ship in general.  I'm very organized and want things to be on-time and as written, which I can at least accomplish for the most part from this point forward, but I'm very concerned about the few months of neglect that have occurred and how to satisfy an audit through identifying said failures and implementing corrective actions.  I could wait for an auditor to find the issues, rather than straight up identifying them for them, but I feel like 3 weeks of missing incoming material inspections is a pretty serious thing, for example, for an auditor to find and it appear the company hadn't identified the problem at any point other than to resume doing said inspection.

 

I know this type of thing happens at plants all over, and some likely resort to falsification to resolve such issues, but what is the safe compliant and right way to correct inexcusable system failures due to such neglect and personnel vacancies?  Any guidance is MUCH appreciated.

 

Thank You

Edited by nickrhoward, 20 February 2025 - 01:46 PM.

[BlueWinter]

Firstly, this company is lucky to have you!  If I were in your situation, I would create an internal memo that documents an internal audit was conducted [(include the date(s)], and summarize your findings and root cause (personnel shortage, no QA Manager etc..).  Also, document what you did to address this concern and how it can prevented (mitigated) moving forward if such an absence in FSQ management were to recur.  

 

If it is accurate and there are no known food safety concerns as of the time the documented was created (or audit findings), deviations as a result of the lack of supporting documentation, I would include this as well.  You can subsequently update this document (add additional addendum update - include new date additional information became available) if additional information becomes available that confirms a different result.  This way, there is an official record that documents the gaps that occurred.  

[GMO]

I would record all of the gaps honestly as internal non conformances but also consider if the food you are now selling is safe and if any needs to be held.

 

Once you've done this and controlled the immediate issue, I think this would be a great time to do your senior management review.  This is where you can genuinely document your concerns and the gaps you've found.  This is then a great opportunity to thank the Ops Manager for keeping on top of so much but to point out that there will need to be a significant effort required for compliance to your next BRCGS audit.  For that, I would suggest bringing in some hands for want of a better word.  You can outsource a lot of the internal audits for example, while you and the rest of the senior team concentrate on getting the problems which have been found, fixed.

 

You're right not to fake it.  You already knew you were but I just wanted to really labour that point.  

[jfrey123]

Agree with the above, document the gaps and show how they've been closed.  Part of your investigation can be reviewing the logs and files that weren't reviewed at the prescribed interval, searching for whether any food safety issues were noted on those forms. 

 

When you find things were missed outright, like those 3 weeks of incoming material inspections, investigate why they were not performed and document a corrective action.  Add in review of the production records to see if things normally caught by incoming material inspection were found later in the process (example: if incoming inspection checks for moldy ingredients, check the production and hold records to see if anything was placed on hold for mold).

 

These investigations and CAPAs should be small and independent to the program you've noted them through, but there should be one bigger encompassing CAPA recorded that the facility overall did not keep up on QA related checks.  Root cause is lack of qualified individual, corrective action is hiring you, preventative action is your ongoing review and designation of a backup QA person.  What needs to be cleanly addressed in this CAPA is that the company going forward won't drop the QA ball just because the one-person department is unstaffed for a short period.  Whether that's the owner wearing a QA hat while they fill the role, hard to say in a 10 person operation, but someone needs to be named to do the job in the absence of a QA manager.  You may still take a hit in the audit, but the whole point of a functional QA department is to find the issues and fix them in-house and it should only truly become a finding if they think your preventative action isn't functioning.

[MDaleDDF]

+1 on the CA having you training a backup so this doesn't happen again.   I think that's the first thing the auditor will want to see.  If that had been done, this would all be moot.

I also agree with you just being honest about it with the auditor.   They're going to find it anyway, may as well tell them up front.   If you do that they'll likely work with you.   Whenever we've gotten hit on things I tell the auditor we do our best in here every day to follow the system, and if we're not, we want to know so we can fix our issues.    They'll respond well to that I think.