HACCP and FSMA - combined or separate?
Not wanting to hijack another thread, I thought I'd start a new one.
Many years back when the first FSMA regs came in, I got PCQI qualified but as I'd "grown up" with HACCP in the UK and EU, the most obvious thing to do to me was to combine the two. I'm not writing two plans just for compliance purposes and as I'm UK based and only about 10% of my turnover was US export, I was prepared to die on that hill. And as I have had up to about 10 customers at a time I've been very much used to adapting things that don't always want to go together to mush it all in and make it work.
Now it was news to me today that some US plants don't do this. They have separate FSMA and HACCP plans.
Please, somebody, tell me why??? My mind is blown.
And perhaps most importantly, how on earth that helps food safety compliance in your plant which is (once all is said and done) surely the most important thing?
I think most facilities do combine them. It SEEMS to me like it is usualy the facilities that are BOTH FDA and USDA regulated that like to keep them separatated.
Process preventive controls are equal to a traditional CCP. Sanitation, allergen, and supply chain preventive controls are not equal to a CCP, nor could they be in my opinion. IMO they were created by the FDA as a way to regulate and place requirements on what should be normally occuring prerequisite programs.
Adding the extra sanitation, allergen, and supply chain preventive controls to a traditional HACCP makes all of those programs readily available to an auditor Which some people have an issue with. Dont give them more than they need / want.......
Fear that the auditor, regulator, customer that doesnt understand FSMA Preventive Controls will attempt to equate preventive controls (other than process) to a CCP. The hazard analysis is essentially the same. You are essentially saying there is a risk that needs to be controlled. Yet you are controlling it with something short of a traditional CCP. IE preventive controls (other than process) dont require validation, etc
The other concern is that there are differences between USDA FSIS HACCP and FDA HARPC food safety requirements. For dual jurisdiction facilities, when you combine the programs, you will be held to all the components of them during a regulatory inspection/review, whether they are required by that regulatory body or not. You may be able to notate certain points as specific only to USDA or FDA, but that may just cause more confusion and wasted time explaining what is going on...
When I was in a dual jurisdiction facility, we had separate programs but used combined forms on the floor.
Keith
The other concern is that there are differences between USDA FSIS HACCP and FDA HARPC food safety requirements. For dual jurisdiction facilities, when you combine the programs, you will be held to all the components of them during a regulatory inspection/review, whether they are required by that regulatory body or not. You may be able to notate certain points as specific only to USDA or FDA, but that may just cause more confusion and wasted time explaining what is going on...
When I was in a dual jurisdiction facility, we had separate programs but used combined forms on the floor.
Keith
This is why we do it. To keep the USDA inspectors out of the programs written specifically to cover FDA regs, and the reverse.
And yes, its a pain in the ***.
Fear that the auditor, regulator, customer that doesnt understand FSMA Preventive Controls will attempt to equate preventive controls (other than process) to a CCP. The hazard analysis is essentially the same. You are essentially saying there is a risk that needs to be controlled. Yet you are controlling it with something short of a traditional CCP. IE preventive controls (other than process) dont require validation, etc
Ooh that's news to me that non process preventive controls don't need validation. Is there a reference you can share on that? That must be super confusing for people.
This is why we do it. To keep the USDA inspectors out of the programs written specifically to cover FDA regs, and the reverse.
And yes, its a pain in the ***.
Not going to comment on current politics because there is enough of that. Suffice it to say, I do not agree what's going on right now, however, that is ****ing nuts maintaining two systems just because of auditing not because it makes food safer.
Ooh that's news to me that non process preventive controls don't need validation. Is there a reference you can share on that? That must be super confusing for people.
I was too lazy to go get the regulations. Attached is a screen shot from the approved training mainual.
Attached Files
Not going to comment on current politics because there is enough of that. Suffice it to say, I do not agree what's going on right now, however, that is ****ing nuts maintaining two systems just because of auditing not because it makes food safer.
Its nothing new regarding politics. its been messed up forever. The USDA has been around for ≈160 years. The FDA ≈ 120 years. Why we ever thought we need two separtate departments that cover different types of foods, I dont know.
I was too lazy to go get the regulations. Attached is a screen shot from the approved training mainual.
Helpful, thank you. But again, mind is BLOWN! Sanitation doesn't need validation... That's just stupid. Sorry. But it is! It's so fundamental to validate design and cleanability!
Sorry what is that manual? I'm happy to search for it.
Sorry what is that manual? I'm happy to search for it.
This is the old one.
https://d1vy0qa05cdj...V1.2_public.pdf
The new one you have to purchase now.
Helpful, thank you. But again, mind is BLOWN! Sanitation doesn't need validation... That's just stupid. Sorry. But it is! It's so fundamental to validate design and cleanability!
There techinically is some validation in the verification section. Visual inspection, atp, etc.
I sent you the manual you willl have to check it out.
GMO - another thing to consider with this all. USDA - on site everyday. Our plans, paperwork, facility, etc - get looked at everyday. I've had relief inspectors (inspectors that fill-in for an inspector for a day while they are on vacation) spend ours of the day looking over our HACCP plans. FDA - depending on the risk - every 3 or so years.
Most USDA inspectors will pre-op weekly. So check how well rooms are cleaned/check sanitation. Most won't tell you what day they plan on doing pre-op or which room either. Depending on the inspector - they will write non-compliances if not up to their standards - subjective.
Wowzers. Lots of oversight. Is it helpful oversight though?
Wowzers. Lots of oversight. Is it helpful oversight though?
Depends on the inspector like in everything. We have the same inspector for 6 months. Then it changes. Some jurisdiction areas see the same one for a long time.
It's helpful that they know the facility. They can see changes (for good or bad). I don't have to spend a bunch of time going over paperwork and answering the same questions with them. A meeting is done weekly. So the inspector is made aware of any changes. Ours last under 20 minutes or less depending on what's going on.
Also helpful - some inspectors will give verbal suggestions for minor deviations - a warning vs being formally written up especially if the facility is trying to do the right thing. One example - they see a new employee make a minor mistake. They'll let us know vs writing us up.
It feels bonkers to someone on the outside of it all I have to admit. If you don't integrate the two, how is someone going to understand what they're doing, especially if they don't have the same first language?
I get it but doesn't it encourage a real delivery to comply with the standard rather than delivering the controls to comply with food safety approach?
You have to remember as well that sites outside of the US who supply into the US need to comply with FSMA. And I know of nobody who has said "I will write another plan" in answer to that challenge.
Different mindsets, perhaps as you say driven by the litigious culture of the US.