13 replies to this topic

[rwilliams]

Recently went through an audit where they found a non-conformance for 2.4.3.7 which is 

 

"The food safety team shall identify and document all food safety hazards that can reasonably be expected to occur at each step in the processes, including raw materials and other inputs."

 

I have all of the process steps taken care of by using the FDA food safety plan builder but the auditor found that I did not have anything for raw materials, ingredients, and primary packaging materials.

 

He had said I needed a risk assessment of all of those items listed above. My problem is I don't know how exactly to go about it. Do you write an SOP for it or do you do a hazard analysis by using a matrix?

 

If anyone has some guidance, an example, or a template I would appreciate it greatly!

[Scotty_SQF]

You should conduct a hazard analysis for all raw materials, ingredients, packaging, etc., you use to make your product.  It should go through the steps of HACCP/HARPC and be in a similar format as your process hazard analysis.  

[kingstudruler1]

I like to include them in the Hazard Analysis.  I include them above the first processing step.  if you are unsure about the hazards, I like to reference appendix 1.  Cheesy example attached.  

Attached Files

•  ingredient HA.docx   15.58KB   96 downloads

[Scampi]

Hazard analysis is missing

 

Here's another great reference tool

https://active.inspe...introe.aspx?i=1

[G M]

In addition to the standard HACCP documents I also have a policy document called "Known Hazards" and just list a bunch of things for different inputs and types of processing we use.  It was added just to avoid the sort of auditor pedantry problem rwilliams is having.

[PennDairy]

Opening up this old thread. 

 

I received a non-conformance for this same thing. SQF Non-Conformance is "Hazard assessment for raw material was observed not completed."

 

My original HA had three process steps included as incoming materials:

 

* Receive Ingredients (Shelf-Stable, Refrigerated, Frozen)

* Receive Raw Milk

* Receive Packaging Materials

 

These aren't specific enough, so I submitted the attached as my revised HA (yellow section is new). The auditor responded with:

 

"The attached Hazard assessment form includes an assessment for receiving and storage of raw and packaging material. The site to submit Hazard Analysis of Incoming material."

 

When I asked for clarity, she responded with:

 

"The site submitted hazard assessment, it is for processing steps (receiving and storage of raw material). The non-conformance was issued due to missing Hazard assessment of raw material. The site to submit raw material hazard assessment."

 

I'm at a loss to understand what she's asking for. I feel I've met the requirements of the code. Any feedback?

[PennDairy]

Opening up this old thread. 

 

I received a non-conformance for this same thing. SQF Non-Conformance is "Hazard assessment for raw material was observed not completed."

 

My original HA had three process steps included as incoming materials:

 

* Receive Ingredients (Shelf-Stable, Refrigerated, Frozen)

* Receive Raw Milk

* Receive Packaging Materials

 

These aren't specific enough, so I submitted the attached as my revised HA (yellow section is new). The auditor responded with:

 

"The attached Hazard assessment form includes an assessment for receiving and storage of raw and packaging material. The site to submit Hazard Analysis of Incoming material."

 

When I asked for clarity, she responded with:

 

"The site submitted hazard assessment, it is for processing steps (receiving and storage of raw material). The non-conformance was issued due to missing Hazard assessment of raw material. The site to submit raw material hazard assessment."

 

I'm at a loss to understand what she's asking for. I feel I've met the requirements of the code. Any feedback?

 

Forgot the attachment:

 

 NC 2.4.3.7 Revised Hazard Analysis (Changes Highlighted).pdf   506.83KB   23 downloads

[Scampi]

You have said NO to any biological or chemical chemical hazards, that doesn't sound correct to me, particularly when you have not even listed your supplier approval program as a control

 

You've also lumped them all together, I find it odd, as whey powder wouldn't have the same hazards as say, dehydrated strawberry powder (as an example)

 

YOu're missing some important things (IMHO) like

C - Presence of mycotoxins mold
Yes 


  C - cross contamination if transported with chemicals
Yes  C - Contamination by non-food chemicals residues (e.g., cleaners, sanitizers, lubricants, agricultural chemicals)
partially controlled - see form 9 P- Physical contamination from extraneous material on the egg                                                                       Yes    C - Presence of environmental contaminants ( such as insecticides and other pesticides )
No

 

This link is an amazing resource for determining hazards  https://active.inspe...introe.aspx?i=1

[PennDairy]

You have said NO to any biological or chemical chemical hazards, that doesn't sound correct to me, particularly when you have not even listed your supplier approval program as a control

 

You've also lumped them all together, I find it odd, as whey powder wouldn't have the same hazards as say, dehydrated strawberry powder (as an example)

 

YOu're missing some important things (IMHO) like

C - Presence of mycotoxins mold
Yes 


  C - cross contamination if transported with chemicals
Yes  C - Contamination by non-food chemicals residues (e.g., cleaners, sanitizers, lubricants, agricultural chemicals)
partially controlled - see form 9 P- Physical contamination from extraneous material on the egg                                                                       Yes    C - Presence of environmental contaminants ( such as insecticides and other pesticides )
No

 

This link is an amazing resource for determining hazards  https://active.inspe...introe.aspx?i=1

 

Thanks for the feedback, this is very helpful.

 

However, the auditor didn't issue a non-conformance for an incorrect raw material HA. She issued a non-conformance for not having a raw material HA at all.

 

I have no problem admitting that my raw material HA could be stronger, that's why annual reviews are required, to keep us in a constant state of improvement. But I do have a problem being told that my raw material HA is nonexistent. Hope this makes sense.

 

I feel like I'm being audited based on my formatting. I feel that she has a specific format in mind of what she wants the raw material hazard analysis to look like and I'm not doing it that way. How am I supposed to provide a correction for something that's subjective??

[kingstudruler1]

I Believe she wants to see a HA for each individual ingredient.  she should probably do a better job of clarifing.  

 

The food safety team shall identify and document all food safety hazards that can reasonably be expected to occur at each step in the processes, including raw materials and other inputs.

 

the standard does seem to separate process from raw  ingrdients.   I always include individual ingredients at the beginning of the HA.   this may be what she wants, again she should clarify.   

[PennDairy]

She actually told me that it was not necessary to have each ingredient listed, but that broader categories was fine.

 

It may be worth noting that I do have a food fraud risk analysis for each ingredient, which she approved. 

[jfrey123]

She might be looking for something more akin to this:  Draft Guidance for Industry Hazard Analysis and Risk-Based Preventive Controls for Human Food: Appendix 1 (January 2024)

 

We've gone through and specifically listed each raw ingredient and transposed over the known hazards associated with them.  Our raw material HA is separate from our HACCP flow and HA, where we reference the RM-HA when we describe our receiving steps for the ingredients.  When we state "Biological - NONE" on our HACCP HA, it's because we can point to our RM-HA and say we've reviewed all potential pathogens and find none are common or likely to occur.

 

Take brownies/cookies on page 32 for example:  The one detail for brownies/cookies changing from pre-bake frosting or topping versus post-bake frosting adds a staph hazard to the post-bake frosted version.  That's a detail many could miss in their HACCP HA if they just consider all baked goods fine to start.

 

I agree grouping like items on your HACCP HA is fine, it's a RM-HA that lets you prove the grouping is consistent.  Example: dry powders from a vendor who has a CCP kill step are low risk, but you can't lump them together with untreated spice powders because of pathogen concerns shown in your RM-HA.

 

Her complaint could also be that your groupings don't show what the things being grouped are.  She could be wanting to see "Dry Powders (list of which powders you're using)" and then "Receive refrigerated flavors/colors (list of which items are in this category)".

[kingstudruler1]

She actually told me that it was not necessary to have each ingredient listed, but that broader categories was fine.

 

It may be worth noting that I do have a food fraud risk analysis for each ingredient, which she approved. 

 

Im stumped then.  

 

Jfrey provided a much better explaination of what I was thinking - 

 

As i recall, the standard says the food fraud risk items can be grouped.  So, im glad that was not an issue for you.   

[PennDairy]

Thanks everyone, I think I understand now. I need a hazard analysis that identifies any potential hazards inherent to my ingredients. This is different than identifying hazards that could occur during processing.

 

For example:

Raw Milk Potential Hazards: pathogens, antibiotic residues, foreign objects

Raw Milk Receiving: growth of pathogens if not properly kept cold, residual cleaning chemicals on equipment, foreign material from powder addition

 

Appreciate all the feedback!