Your quality manager just got the call. An auditor will be on-site Thursday. The plant is clean, your team knows their jobs, and your HACCP plan is current — but pulling the traceability documentation together is a project unto itself.
FSMA 204 changed what auditors expect to see from food manufacturers handling products on the Food Traceability List. The compliance deadline has been extended to July 20, 2028, but the requirements haven’t changed. If you’re handling FTL products, the expectation is that you’re building your system now.
What FSMA 204 Actually Requires
The FDA’s Food Traceability Rule requires food facilities to maintain Key Data Elements (KDEs) at each Critical Tracking Event (CTE) for foods on the Food Traceability List. In practice, this means documenting specific data points when you receive ingredients, when you transform them through production, and when you ship finished goods.
For receiving, that means recording the traceability lot code assigned by your supplier, the quantity and unit of measure, the date you received it, and the location where it was received.
For production, you’re capturing what went into the batch, what came out, the new traceability lot code you assigned to the finished product, and when the transformation happened.
For shipping, it’s the lot code, quantity, date, ship-to location, and the immediate subsequent recipient.
None of this is optional. And all of it must be producible in electronic, sortable format within 24 hours of an FDA request.
The Difference Between Having the Data and Producing It
Most food manufacturers already capture some of this information. The problem isn’t usually that the data doesn’t exist — it’s that it exists in six different places and nobody has ever tried to assemble it under time pressure.
Your receiving logs are in a binder by the dock door. Production records are in a spreadsheet on the production manager’s laptop. Shipping documentation lives in the accounting system. When an auditor asks you to trace a specific lot of finished product back to every ingredient lot that went into it, you need all of those data points connected. Not available in separate systems — connected.
Where Most Operations Fall Short
The gaps tend to show up in the same places:
- Traceability lot codes aren’t consistent. Many operations use internal lot numbers that don’t match what their supplier assigned, creating a break in the chain.
- Production transformation records are incomplete. Receiving and shipping records tend to be stronger because they involve existing paperwork. But production transformation KDEs require documenting which input lots became which output lots.
- Records aren’t electronic or sortable. A binder of handwritten production sheets doesn’t meet the standard. A PDF scan doesn’t either — PDFs aren’t sortable.
- Forward traces take too long. Backward traces are usually easier. Forward traces require connecting production output to shipping records across multiple orders.
How to Build an Audit-Ready Traceability System
Step 1: Map your Critical Tracking Events. Walk your operation from dock to dock. Identify every point where FTL products change state.
Step 2: Define your KDE capture points. For each CTE, list the specific KDEs required. Cross-reference the FDA’s published requirements. Identify where each data point is currently captured — or where it isn’t.
Step 3: Establish traceability lot code discipline. Every FTL product you receive needs its supplier-assigned TLC recorded and linked to your internal lot system.
Step 4: Digitise your records. Your current approach needs to produce exportable, sortable data. The FDA’s 24-hour window assumes electronic access.
Step 5: Run mock traces monthly. Pick a random finished product lot. Run a full backward trace. Then pick a random ingredient lot and run a forward trace. Time it.
The Mock Trace: Your Best Preparation Tool
Mock traces reveal problems that documentation reviews miss. A monthly mock trace — timed, with realistic conditions — is the single most effective audit preparation activity you can perform.
Pick a product at random. Assign someone other than your QA manager. Set a timer. Document what’s missing. Fix the process that created the gap, not just the individual record.
How FlexiBake Helps
FlexiBake captures FSMA 204 Key Data Elements automatically as your team receives ingredients, runs production batches, and ships finished goods. KDEs are recorded as part of normal operations — your team doesn’t fill out separate traceability forms.
When an auditor asks for a trace, you generate it on screen. Forward and backward traces complete in seconds. The output is electronic, sortable, and exportable.