8 replies to this topic

[asaeger]

If a hose breaks with food grade hydraulic oil and oil sprays all over and there are droplets on the food, but it is unknown how much is this disposed of?  Does this fall under the definition of incidental contact?

[jaredD]

I'm guessing you are getting pressure to save the product rather then the high cost of disposal and losing the product, understandable. Lets say you do consider this "incidental" and put the product on the market. Lets also say someone gets sick from the consumption of this product. Is it really worth the risk of potential suits payouts or loss of consumer trust?  I would say no, I also get paid to say no to things like this and I'm guessing you do to.

 

What do your plans say how you should react? If you are documenting everything and an auditor finds it during an audit like everyone should. Can you justify it to them with all your plans and controls? 

 

Overall its just not worth any of the potential outcomes to put this in the market.       

[QAGB]

I'm guessing you are getting pressure to save the product rather then the high cost of disposal and losing the product, understandable. Lets say you do consider this "incidental" and put the product on the market. Lets also say someone gets sick from the consumption of this product. Is it really worth the risk of potential suits payouts or loss of consumer trust?  I would say no, I also get paid to say no to things like this and I'm guessing you do to.

 

What do your plans say how you should react? If you are documenting everything and an auditor finds it during an audit like everyone should. Can you justify it to them with all your plans and controls? 

 

Overall its just not worth any of the potential outcomes to put this in the market.       

 

I agree with the entirety of this response. I also second the part about your auditor finding this.

 

We have had auditors come in and review our hold list and our CAPAs, and want to reconcile the information in both. They would likely object to you selling this material, and could potentially be a big issue. If this is a private label and a 2nd party (customer) audit, you can bet they won't be happy and might consider pulling business from you.

 

Ultimately just not worth the risk of putting this food out there. It's better to be safe than sorry.

[asaeger]

You both echoed my stand.  Thank you!

[Charles.C]

To specifically answer the OP,  IIRC, "incidental" is explained/defined within the related Standards.

 

Additionally, "Food Grade OIl", per se, afaik does not exist other than for items like soyabean oil.

[asaeger]

What standards are you referring to Charles?

[majoy]

These are the things we have to fight daily in our QA career and as ironic, this is what we are paid to do. 

 

Management will then say, what's the use of purchasing food grade oil or lubricant when an incidental droplet will render the food not for consumption or not allowed for commerce? there i go and already walking out the door...

[QAGB]

These are the things we have to fight daily in our QA career and as ironic, this is what we are paid to do. 

 

Management will then say, what's the use of purchasing food grade oil or lubricant when an incidental droplet will render the food not for consumption or not allowed for commerce? there i go and already walking out the door...

 Yup! I've had very similar arguments with management. In the end, the risk assessment usually wins. Would you rather lose this customer and their millions they bring in (and potentially have a withdrawal).....or would you rather scrap this one run which is worth maybe 1/100th of their annual business?

[Charles.C]

What standards are you referring to Charles?

 

For example -

 

 H1 Brochure_KroonOil_ENG.pdf   992.05KB   14 downloads

 nfc_int_regulations_food_grade_lubricants.pdf   955.04KB   16 downloads

 

https://iselinc.com/...tions-h1-h2-h3/

 

@ asaeger, an additional query to yr OP might have been as to what was the "H" grade of yr oil ? Regardless, offhand, the event in yr OP sounds like an unacceptable "contamination".

Edited by Charles.C, 24 August 2019 - 03:12 AM.
added