5 replies to this topic

[Wowie]

(This may not be the best forum to ask this in. If not, my apologies!) 

 

Good day, All!

 

I mentioned in another post that I have recently changed companies (to be closer to home and family!   ). The company I came to was without a QA manager (no HACCP coordinator position) for about a year. None of the internal audits or verification activities (aside from daily monitoring and paperwork verification) for the last 7 months have been completed. This includes GMP/facility, Glass and Brittle Plastic, Sanitation, Master Cleaning Verification, and some specific equipment audits that are performed quarterly.

 

As I'm doing these audits/verifications before the end of the month and getting them completed, I was also drafting a reassessment document to prepare with the Food Safety team. I'm gathering available information from Maintenance, swabs results, FM findings, and other audits performed by other departments to show, to the best of our ability, that all other spokes in the wheel were still in place since July.

 

Would anyone address it this way, or just do the audits, document that due to lack of management available the audits were not performed (I don't like that idea at all) and move one?

 

 

 

[Rajengovender]

Hi,

I would raise non conformances for information missing or not addressed clearly indicating the root cause, corrective actions & preventative measures. This will get you focused & show that you are approaching the issues in a constructive manner, amongst others, prevent a re-recurrence of this unfortunate situation . Any food safety issues must be highlighted to senior management (be critical!!!) & hold them accountable going forward.

[QAGB]

(This may not be the best forum to ask this in. If not, my apologies!) 

 

Good day, All!

 

I mentioned in another post that I have recently changed companies (to be closer to home and family!   ). The company I came to was without a QA manager (no HACCP coordinator position) for about a year. None of the internal audits or verification activities (aside from daily monitoring and paperwork verification) for the last 7 months have been completed. This includes GMP/facility, Glass and Brittle Plastic, Sanitation, Master Cleaning Verification, and some specific equipment audits that are performed quarterly.

 

As I'm doing these audits/verifications before the end of the month and getting them completed, I was also drafting a reassessment document to prepare with the Food Safety team. I'm gathering available information from Maintenance, swabs results, FM findings, and other audits performed by other departments to show, to the best of our ability, that all other spokes in the wheel were still in place since July.

 

Would anyone address it this way, or just do the audits, document that due to lack of management available the audits were not performed (I don't like that idea at all) and move one?

 

 

 

 

Hi Wowie,

 

That's a very unfortunate situation. I would address it the way you are doing it, because you're doing everything you can to assess the situation.

 

If you just document the lack of management, you would most definitely see non-conformances in the provisions of proper resources/staffing area (management commitment), and the internal auditing areas you mentioned as well.

 

If you do your reassessment, the auditor will obviously know there was a lack of proper resources. However, the auditor is more likely to be understanding if you are assessing and addressing internal non-conformances prior to the audit.

 

 

QAGB

[Wowie]

Hi,

I would raise non conformances for information missing or not addressed clearly indicating the root cause, corrective actions & preventative measures. This will get you focused & show that you are approaching the issues in a constructive manner, amongst others, prevent a re-recurrence of this unfortunate situation . Any food safety issues must be highlighted to senior management (be critical!!!) & hold them accountable going forward.

 

 

Yep! I was going to do the RCA/CAPA in the reassessment document, and have members of the Food Safety team present in a meeting, review, sign, etc. I agree, this is likely the best way to go, but there was a bit of "Is all that necessary?" grumblings as I was scouring around for documentation from six months ago.

[QAGB]

Yep! I was going to do the RCA/CAPA in the reassessment document, and have members of the Food Safety team present in a meeting, review, sign, etc. I agree, this is likely the best way to go, but there was a bit of "Is all that necessary?" grumblings as I was scouring around for documentation from six months ago.

 

It's hard to explain the importance of assessments when people don't understand what it takes to maintain your FS certification and the seriousness of not completing the proper verification records.

 

I think your reassessment is a great idea, and should be a useful tool as it shows you all are aware of the non-conformances and are currently working on corrective and preventive actions.

 

 

QAGB

[Wowie]

 

Hi Wowie,

 

That's a very unfortunate situation. I would address it the way you are doing it, because you're doing everything you can to assess the situation.

 

If you just document the lack of management, you would most definitely see non-conformances in the provisions of proper resources/staffing area (management commitment), and the internal auditing areas you mentioned as well.

 

If you do your reassessment, the auditor will obviously know there was a lack of proper resources. However, the auditor is more likely to be understanding if you are assessing and addressing internal non-conformances prior to the audit.

 

 

QAGB

 

 

It is unfortunate. For the last few days since I've discovered the issue, the missing documentation has been the first thing on my mind when I wake up. 

 

Thank you for your advice! I'll push forward with gathering the information. It's nice to have a place to come ask questions that you think have an obvious answer, but everyone around you is making you feel loopy.