We are an exporter to the US for single percentage points of our turnover. I'm trying to get my head around the FSMA and I'm coming up on a few headscratchers.
One; is there a blooming standard anywhere; i.e. this is what we want; bang.
The second is HARPC. I mean how do you even pronounce that? If I understand this correctly, and I don't want to be rude but is it just the FDA saying "we implemented HACCP really badly so now we need to call it something else?"
Take this from AIB:
What is HARPC?
o Is it HACCP?
- No. It is very similar to HACCP, but it includes additional elements.
- The FDA requires either HACCP (juice and seafood) or HARPC depending on product type. They do not require both.
- Customers and foreign governments may require a HACCP program and may not accept a HARPC program. In these cases, it may be in a company’s best interest to maintain both.
Erm no, I'm not implementing both... To implement both would be to admit that the food safety system is not applied. You can't have two food safety systems working in one factory. Come on people!
So my intention is to build it in to HACCP with a few mentions to HARPC to keep FDA happy but not too many to annoy the 90+% of rest of the world governments and retailers I have to comply with. Has anyone had any success with FDA in doing this?
I was thinking of including in the scope what is included in the chemical category and biological category to make it clear I'm considering parasites, toxins etc, include in the hazard analysis where applicable (to be honest it's already there); adding a radiological category (I already have a separate allergen category and have for about 8 years). Then I was going to reference my threat and vulnerability plan for the deliberate attack. Do I need to do any more? Will I get a sniffy FDA auditor annoyed that I still call it HACCP?
Then what on earth are all the GMP requirements? Trying to find online...