My facility is a tamale manufacturer that is both regulated by FDA & USDA. We are 'experimenting' with a new product (ramp up expected in the next 1-2 weeks) involving wrapping beef franks in masa for a new customer. Our only product currently is tamales (a wide variety of) and the addition of this new product would bring us to a total of 2 product types. The franks are going to be purchased from a distributor (who manufactures chili products) and not directly from the manufacturer. We will continue to make the masa in-house and will have to modify our process to enclose the franks in masa because they cannot be ran through our current set up (extrusion of meat and filler into tamales). From my understanding of co-manufacturers this new product/process would fall under the category of a co-manufacturer. Is this correct?
Our facility is not GFSI certified. Our annual GMP/Food Safety Audit requires "A written program has been established for approving all co-manufacturers. The program includes a master list of approved co-manufacturers and meets all applicable and current regulatory requirements."
My Questions
1) Would the manufacturer of the franks be considered our co-manufacturer?
2) What are some requirements/verification activities companies should perform when setting up new co-manufacturers. (FSMA Supplier Preventative Control)
My facility is a small establishment and this is not something I have set up before. I am looking at keeping our approved supplier program requirements (LOGs, COI, Prdt Specification, 3rd Audit and/or Cert) as requirements for co-manufacturers but I feel that there are other requirements that we need to check and verify. Thoughts?