2 replies to this topic

[SauceManinKS]

I recently got a non-conformance from an FDA auditor for this:   Ingredient Hazard analysis did not identify the following processing hazards for Chili Powder: Bacterial Survival of a Lethal Treatment, Recontamination with Environmental Pathogens, Undeclared Allergens - Incorrect Label, Undeclared Allergens - Cross-Contact, Chemical Hazards due to Mis formulation, and Metal. 

I need help on where to start with tackling this issue. We did not break down each specific ingredient and bulked all of our minor ingredients in our HACCP plan. the auditor did not like this and wants us to be very specific. Any help from our community with this would be appreciated. Thanks guys.

You Guys ROCK!

[kingstudruler1]

I agree with them.   You should have a hazard analysis / risk assessment for each raw material.   There may be opportunity for combining, but its best to do them individually.   In the case of spices, i'm not sure everyone understands the risk (which is probably their take as well).   Not all spices have undergone a lethality step prior to purchase.   Thus, a lethality step is required prior to consumption.  Spices have been the source or many food safety issues (pathogens, allergens, FM, etc).  Either your supplier or your facility should be addressing these risks.  

 

It appears they are referencing the FDA Appendix 1 hazards.  

 

At the top of my hazard analysis (before processing steps), I include all of the ingredients.    You could create a separate HA for ingredients as well.   If you are unfamiliar with the risks the FDA appendix 1 is a good reference.   

[jcieslowski]

Well, it sounds like the auditor is being very prescriptive and I would go ahead and follow that prescription.  I'm wondering if the auditor was concerned about an overall lack of understanding of preventative controls and thus was trying to make sure you had all the bases covered.   

 

What I think he's really saying is:  Where's your SOP on lethal treatment of bacteria (the control for bacteria), where's your environmental control program, where's your allergen program, where's your label verification program, where is your formulation program, and where is your metal / foreign material control program?

 

Those are the programs that you would implement to control the identified risks.