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Corrective action for Allergen recall

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VictoriaRK

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Posted 10 December 2024 - 06:31 PM

We recently had our packaging department find a peanut shell in one of our raw materials. The item was a resin, packaged and sold as food but most commonly used to burn as incense. 

 

We initiated a recall, and it wasn't too bad, we had only sold about 40 units of this material, so it was pretty straightforward.

 

The peanut shell did not come from our facility and was present in the bag of raw material from our supplier. They have investigated, they sorted and sifted their remaining stock, and send a compositbe sample for testing and no peanut issues were found. They are not recalling the product as they have sold a large amount of it, and had no other complaints and could not find any peanut issues. They have said it is likely an issue from the farm where the raw material was sourced in Egypt. (maybe some guy harvesting it was eating peanuts for a snack?)

 

My question is, how do I handle the corrective actions for this that I have to submit to SQFI? Our inspection process worked and we caught the fragment (but only after we had already packaged other bags from this lot). I have confirmed our suppliers allergen control SOP, and I feel like they responsed appropriately, but I'm sort of at a loss on what to put for corrective and preventative actions. This is just a weird isolated incident. 

 

Anyone have any advice? (Also this is my first recall I'm handling.......)


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KellyQA

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Posted 10 December 2024 - 06:47 PM

First, I would suspend that supplier and not use them until they are able to provide an adequate corrective action for this issue. This is an allergen, not a tiny piece of cardboard. Honestly, I hope you have a back-up supplier. I would never use that supplier again. 

 

For SQFI, I would include in the CAPA everything that the supplier is providing you and what you are going to do about it. Your company followed your procedures and did the right thing. To get you started, Deviation: peanut shell observed in raw material. Root cause: insert supplier information here. Corrective action: recall product with that lot code. notified supplier, regulatory, and SQF, etc. Line/equipment cleaned, etc. Preventative action: supplier has been suspended; use new/exisiting back-up supplier. (ensure the approval process is completed). 

 

Hope this helps. 


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G M

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Posted 10 December 2024 - 07:49 PM

... They are not recalling the product as they have sold a large amount of it, and had no other complaints and could not find any peanut issues. They have said it is likely an issue from the farm where the raw material was sourced in Egypt. (maybe some guy harvesting it was eating peanuts for a snack?)

...

 

Their conclusion isn't great, but importantly it says nothing about what will be done to prevent it happening again. 

 

Without some kind of testing or preventative procedure they're telling you the product will randomly be contaminated with allergens in the future and they plan to do nothing about it.


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VictoriaRK

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Posted 11 December 2024 - 03:27 PM

I have requested their corrective action report from them, I would hope that they had done one internally. I'm hoping it will have more answers for me.


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matthewcc

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Posted 11 December 2024 - 09:28 PM

I would add to the preventive action that, now that you know peanut is a hazard in this raw material, you need to put in a preventive control/CCP against peanut, such as in the form of an inspection process every time you receive the raw material.  That's important for in case you have the same issue with a different supplier.


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