3 replies to this topic

[Alexxx]

Hi everyone,

I've noticed during a few occasions that our bread slicer was not perfectly clean and I can still see a few crumbs (nothing alarming). As I do my pre-operational inspection, I am always confused if I should mark it as non-confroming and followup with a corrective action (which is always asking an employee to take a few moments and clean it) or should I always do a CAPA? 

 Thank you for your help in advance.

[kfromNE]

What do you have in your cleaning SOP. 

 

It's rare not to find things for us. QC pre-ops then the item re-cleaned/sanitized. It's all marked on the pre-op sheet. 

It's part of our process. If there is an area that is repetitively dirty - I let sanitation know. 

 

As for a CAPA - no. It has to be major to do so. For example, my QC found a blade that was sheared off. Product from the prior day was put on hold and discarded out of precaution. 

[nwilson]

There is a difference between, correction, corrective action, & preventive action when a non-conformance is raised.  

 

Correction can be applied at the time of the finding.  Similar to your instance of a dirty piece of equipment.  You found it, had someone re-clean and release for usage.  This should be documented in your pre-op inspection.  Things happen.  

 

Corrective action takes it to the next level.  If you see this equipment dirty each time you inspect it then there is a trend and this should be addressed with a root cause analysis.  Why is this always dirty?  Formally correcting and addressing the issue.  

 

Preventive action is stating how do we prevent reoccurrence once and for all.  Training, further evaluating the SOP, etc.  More of a systematic approach.  

 

Corrective action and preventive action can be one straight through process, we found an issue, we corrected it, reviewed root cause, then found a way to prevent in the future.  

 

All are documented, but a formal CAPA is more detailed as this is stating things have escalated to an unwarranted or unsafe level.  

[GMO]

NWilson did a cracking answer here.  I agree.  There are times I have a chat with operations team members and say "sort that out!"  Have a bit of a joke and we move on.  The next time I see it, then we probably get our heads together and say "why is this happening?"  I'd normally not raise a NC if I think they're taking it seriously.  Third time I'd suggest I would but would also support in getting to preventive action.

 

I probably seem like the biggest softie in the world but honestly, my relationships with operations teams are critical to my success and have been throughout my career.  Often saying "look, I trust you to get this sorted" is more effective than doing the whole paperwork thing because people see it as punishment, even if it's not.