3 replies to this topic

[staci mccarvey]

With all of the new FSMA requirements, our business is constantly being asked to provide private documents such as HACCP plan. We are also being asked to provide a Description of our Allergen Control, Metal Detection, Foreign Material Programs, etc. Is everyone providing an entire copy of these or what seems to be acceptable? Thank you!

[SQFconsultant]

What used to be considered "private" documents are no longer looked at that way.  Being transparent will win you more customers than not.

 

It is quite standard now for customers to ask their suppliers for these items and get them.  

 

You'll find that more and more will also be asking for your GMPs for your employees, visitors and contractors as well.

[leah]

From my understanding, under FSMA, the FDA can access just about anything they want. This includes all records relating to manufacturing and processing, packing, distribution, receipt, holding, and importation; any records in plain sight (e.g. sitting on a desk); records related to interstate commerce (shipping and receiving records and traceability records); records associated with any SAHCODHA situation. So basically everything. 

Also, unless you fall under juice or seafood, you're no longer dealing with HACCP but HARPC, which is regulated by the FDA. They have begun doing PC (preventive control) inspections and will really be delving into your food safety plan (regardless of what you call it). 

But yes. The FDA just about has full reign now. I wouldn't give them anything they don't ask for, but there's not much they "aren't allowed" to see anymore.

[leah]

For our most recent FDA inspection (it was not a PC inspection), they looked at a facility map, Allergen Policy and Procedure (single document), interstate commerce records, full food safety plan (spent a lot of time on hazard analyses), ingredient PO's and BOL's, org chart, MSS, and a few other things.

 

They took copies of almost everything (except for full HARPC plan) they asked for with them, and I kept a side-by-side copy for my reference.