5 replies to this topic

[shwetakumari]

I have a Risk Assessment Matrix from PCQi training. Here’s the situation:

 

Q1) In our risk assessment, for some raw materials (e.g., vinegar), the biological hazard is rated as a 21 (which means "not expected to occur" for likelihood) and customer complaint for severity. This places it in the low-risk (green) category. We consider low-risk items as having "no food safety risk."

 

However, our supplier approval program requires QA documentation (e.g., specifications, logs, GFSI certification) for each ingredient. How do we justify applying supply chain preventive controls (PC) for vinegar, which is low-risk? Or should we adjust the risk classification for vinegar's biological hazard to the yellow (moderate) range, where supply chain preventive controls are required?

Thanks for your help!

[nwilson]

If you look into the Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry Draft Guidance the table on page 526 for vinegar does not have any associated hazards per the guidance.  If you mean to state that collecting QA documentation is a supply chain preventive control I do not see this a control more just a part of your approved supplier program.   I would keep your risk low and no supply chain preventive control needed as the supplier isn't providing a control more that the material already is inherently hazard free.  Unless through review of the documentation from the supplier they are not screening the vinegar for a foreign material control, which you would need to control or push back on the supplier.

 

Sure collect a COA for quality reasons, and maintain your approved supplier docs, these are needed for assurances and to make sure you are receiving the correct material.   

 

https://www.fda.gov/...100002/download

[kingstudruler1]

Your supplier approval procedure should also be based on risk.   Are you saying that viengar is high risk in supplier approval and low risk in preventive controls plan.  

 

Sqf requires that you have a supplier approval program for everything.   FSMA only requires supply chain control for those with risk.   

 

Its ok is you want to say that you are going to apply the same scrutiny to a low risk food in your supplier approval program as you would to a high risk food in your preventive controls plan.   Perhaps unneccesary,  but it is not really a contridiction in most cases.   

 

The better plan would be to say that a low risk ingredient in supplier approval only requires "X", but IF they meet the requiments of a medium or high risk ingredients, that is also exceptable.   

[shwetakumari]

"Sqf requires that you have a supplier approval program for everything.   FSMA only requires supply chain control for those with risk.   " this helps a lot.

[jfrey123]

Solid advice here, we do the same for our facilities/ingreidnets that all suppliers must be GFSI certified, provide specifications (or agree to ours), LoG, etc. merely as part of our Supplier Approval process. 

 

Preface that I know very little about vinegar except that my wife uses it in baking and as a fabric softener alternative:

While you're not finding a reason to apply a PC to your vinegar, I would disagree where you state low-risk means no-risk, only that any perceived hazards are unlikely to occur.  Vinegars (mainly balsamic) have been tested and FDA warned for contamination with lead and arsenic.  I don't know enough about vinegar nutritional off hand, but if one white vinegar can be made with different ingredients enough to affect concentration or sodium content, a control to ensure the correctly spec'd vinegar is used should be considered.

[shwetakumari]

I gave the example of vinegar, but sure you are right most ingredeints which come inside the door has some kind of hazard. Biological : • Potential contamination during manufacturing, storage, and transportation in the supply chain; Chemcial: Potential contamination of toxic chemicals (PFAS, BHA etc.)

•Inadequate allergen control during manufacturing, storage, and transportation in the supply chain; or Physical • Inadequate control of foreign material contamination during manufacturing, storage, or transportation in the supply chain