FDA has some new proposed rules for traceability that look like they'll be going into effect early 2023 (seems like a done deal to me anyway).
I'm leading a meeting next week to review this for my company. Probably 98% of our products will be affected by the rule, judging by the items listed on the food traceability list (FTL). In typical governmental fashion, the acronyms are flying all over the rule and making things sound more complicated than they are in real life practices, but I wanted to get everyone's thoughts on how this rule will change your operation.
My take? Critical Tracking Events (CTEs) are pretty straightforward, basically anytime you receive raw ingredients and then process them and ship them, you need to document the Key Data Element (KDE) at that step. To me, that's making sure incoming lot numbers are properly recorded, along with the "traceability product description" on the raw materials (which means your receivers need to actually match the item description on their receiving logs if they were previously a bit lazy and just wrote the commodity). Documenting the raw input lot/name on your processing paperwork when you end up changing it into a WIP or finished good with either a lot or internal tracking number, etc for finished goods.
It feels to me like company already running a solid traceability program should be mostly ready to comply with this. Some of the standouts are a requirement to provide a sortable spreadsheet if requested as part of a recall or outbreak, as well as needing to maintain a full list of all documents that capture the KDE's as the material flows through your plant.
I'd love to start a dialogue on this and get everyone's impressions on just how big a deal this might end up being. I'm not seeing a whole lot that we're not already mostly compliant with.