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FSMA 204: Transaction Capture Midstream (Processor/Manufacturer/Distributor/Wholesaler)

Once I’m nicely packed up at my Initial Packing facility, my journey doesn't stop there. Depending on the scenario, I sometimes move through the supply chain without any further packaging changes all the way to your local grocery store. At other times I take different paths to your home like being processed as part of a delicious salad kit, a sandwich, or sometimes even getting repackaged into a different pack with a few new tomato friends.

Transformation Event: Processing (Salad Kit Example)

If you find me in a salad kit, I most likely would have been shipped from my Initial Packer to the Salad Processor who would dice me up and add me to this beautiful salad along with my iceberg lettuce, arugula and other healthy friends. My Initial Packer would first need to share the following info with the salad processor:

Initial Packer Shipping KDEs: (Tracee Shipping)

  • My Traceability Lot Code (Assigned by the initial packager)

  • My quantity and unit of measure

  • My description

  • Location description for my Salad Processor and for the location from where I was shipped (the Initial Packer)

  • My shipping date

  • Location description for the traceability lot code source (In this case the Initial Packer)

  • Reference document type and number

My Salad Processor also needs to capture the above info as part of their Processor Receiving KDEs (Tracee Receiving).

Once my Processer family completes my receiving formalities, they need to prepare delicious ol’ me for their salad kits. As part of this process, which is considered a Transformation event by FSMA 204, the following data needs to be captured:

Transformation KDEs: (Salad Kit Creation)

  • New Traceability Lot Code for the salad kit

  • Location description of the salad processing facility (traceability lot code source)

  • Date processing was completed

  • Product description for the salad kit

  • Salad Kit quantity and unit of measure

  • Reference document type and number

Most of you buy me as a whole tomato from your local store, but even then, my packaging info (Traceability Lot Code & other details) could be different from what was created at my initial packager. The reason for this is a possible “Repackaging” which is the process of someone in the supply chain (wholesaler, other) taking my original packing off and repacking me into new packages with new identification (TLC/Other). These “Repacking KDEs" are the same as the ones above for a processing transaction (like creating a salad kit). The main difference here is that I’m not undergoing a physical change (sliced or diced) but just going into a new package with a new TLC and other supporting identifiers. And if I’m getting a new TLC, the FDA considers this a transformation event.

Midstream data capture requires more process maturity besides just capturing shipping & receiving KDEs. We also need to address the transformation event which may involve multiple ingredients and their supporting data which then transform into a new product with new identification (TLC & other). To capture, store and share all this info across your supply chain, you definitely need to ensure process maturity and leveraging an advanced traceability system like TagOne.