7 replies to this topic

[TheFinalFlame]

Hello! I'm working through updating some of the information surrounding my company's FSPs, and I wanted to make sure that I'm on the right track.

 

We're a USDA/FDA -regulated facility, but we were USDA-regulated first, so most programs lean into that verbiage. That being said, for our FDA products that don't fall under juice/seafood HACCP, we still use HACCP plans. If we have all of the surrounding programs that meet the HARCP requirements (allergen program, sanitation procedures, recall plan, etc.) and call them out as preventative controls in the plan as a part of the control measures, is this sufficient, or do we need to re-write the HACCP programs to have sections specifically for these controls? Additionally, in these programs, we do still call out certain steps as CCPs, since this meshes better with the USDA/FDA HACCP wording that we use in our SOPs (i.e., the post-packaging lethality step is a CCP, rather than a preventative control).

 

Our HACCP/FSP plans currently have the following sections: an introduction (describing HACCP/the sections of the FSP), a product description, the flow chart, the hazard analysis, the CCP determination, monitoring activities, verification activities, and the revisions page. 

 

We have been inspected by the FDA multiple times since the 2016 FSMA deadline, and they've never commented on it, but I don't want to wait until we get a 483 to find out that the way we're doing this is unacceptable. 

[BirdTalon]

This is how its laid out in my facility as well, but I am not even under USDA. Our food safety plan takes majority inspiration from traditional HACCP and even has critical control points. I am interested to see what others add to this topic.

[GMO]

I adapted my UK HACCP plans to be FSMA compliant and we got through an FDA audit. No idea if it was good enough, it was a few years back so I'm sure I'd change some things now.

 

One thing I did was look through which prerequisites could be preventive controls and made sure they particularly had more thorough verification and record keeping. I also made sure that in my introduction to my HACCP plan, I included things like radiological hazards within chemical as a category and there was one ingredient which had a (low) risk so I made sure that was mentioned in the hazard analysis. I can't honestly remember a great deal of other change to be fair. We were already doing things like sanitation validation anyway. We already had supplier controls in place and trace.

 

I do realise though that USDA HACCP is not the same as the rest of the world approach to HACCP so my approach might not be ok for them.

[tahoeskier]

If your products fall under FSMA they should have a food safety plan. I have been to several sites that were issued 483 for non compliance. Most dual jurisdiction plants have both HACCP and food safety plans dependent on the product.

[PieGuy191]

We are a FDA regulated pie manufacturer.  We had all the FSMA required programs 10 years before FSMA came out as our management team all spent years in USDA facilities before coming here.  When they got here they put together HACCP, Recall, Sanitation, and Allergen programs.  So when HARPC became a thing we just changed the name of the HACCP Hazard Analysis to HARPC and then created separate Preventive Control sections for Process, Allergen, Sanitation, and Supply Chain.  We put them in a notebook along with the Recall and Environmental Monitoring Programs.  Wrote an introductory section and included a sign off page and titled it our Food Safey Plan.  Food Safety Plan Cover Page-Table of Contents-Overview Version 11-19-2025.docx   46.08KB   10 downloads  Blank Forms.xlsx   53.42KB   11 downloads[

Edited by PieGuy191, 23 July 2026 - 02:49 PM.

[GMO]

If your products fall under FSMA they should have a food safety plan. I have been to several sites that were issued 483 for non compliance. Most dual jurisdiction plants have both HACCP and food safety plans dependent on the product.

 

So even though HACCP and FSMA will get you to the same controls, you'd have two totally separate plans? Why? Where in the legislation does it say that's necessary?

[Setanta]

So even though HACCP and FSMA will get you to the same controls, you'd have two totally separate plans? Why? Where in the legislation does it say that's necessary?

 

IIRC we did the same thing at a previous employer.I think it had to do with the language in the initial HARPC roll out.

FDA and USDA are competing entities.

Does it make sense, no. Does anything make sense in bureaucracy? Not often

[kfromNE]

So even though HACCP and FSMA will get you to the same controls, you'd have two totally separate plans? Why? Where in the legislation does it say that's necessary?

 

It doesn't. For multijurisdictional plants - very little is said. HACCP and FSMA fall under different rules. USDA says you need to use HACCP. FDA says you need to use FSMA. The rules are slightly different. That being said Seafood HACCP also has different rules. So each must be done. It is easier at times to do them separately to avoid calling things multiple things. Plus the FDA could argue that having meat in the hazard analysis, flow chart etc. would then make it not a FDA item. Thus being wrong. 

 

When you are dual inspections, the rules do allow you to follow one set of food safety rules if they are slightly different from each other. One example - rules on cooling products. We use USDA guidelines for all products.