Critical Tracking Events
Harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation — the points where a lot changes hands or changes state.
FDA Food Traceability Rule
GDST / EPCIS aligned
Passive traceability for FSMA 204
The FDA's Food Traceability Rule asks for an Electronic Sortable Spreadsheet within 24 hours of a request. Most operations can only produce one by reconstructing it from binders and memory. Passive traceability removes the reconstruction step: the record was already captured, correctly, at the moment the event happened.
TLC EVENT QTY STATUS
2291 Receiving 41.6 ✓ valid
2291 Transform 38.2 ✓ valid
2292 Receiving 52.0 ✓ valid
2292 Shipping 52.0 ✓ valid
2293 Receiving — ! weight missing
2294 Receiving … capturing
- Events today
- 1,284
- Flagged
- 3
- Export
- Ready
What the rule asks for
Critical Tracking Events, Key Data Elements, and a 24-hour clock.
FSMA 204 applies to foods on the FDA's Food Traceability List. At each Critical Tracking Event you must record a defined set of Key Data Elements, tie them to a Traceability Lot Code, and be able to hand the FDA a sortable electronic file on request. The hard part was never the format — it's capturing the data reliably in the first place.
Key Data Elements
Lot code, quantity and unit of measure, product description, location identifiers, dates, and the reference document for each event.
The 24-hour export
An Electronic Sortable Spreadsheet, delivered on request. One file, one action — not a week of cross-referencing paper against invoices.
Active vs passive capture
The difference is who does the work.
Active capture — the default
A person pauses, finds the device, reads the label, keys the values, and hopes they got the lot right. Capture rate tracks how busy the shift is.
- Competes with production for time
- Gets backfilled from memory
- Fails silently — you find out during the audit
Passive capture — what we build
Cameras already pointed at the work recognise the event and write the record. Nobody changes what they do; the register fills in behind them.
- Capture rate independent of crew workload
- Timestamped at the moment of the event
- Gaps flagged the same day, not at audit time
- Video evidence sits behind every row
Observe the state change
We map where lots physically change state at your site, then cover exactly those points — dock, grader, transformation station, outbound. Coverage is scoped to the traceability model, not to "more cameras".
Recognise the event and its data
Models trained on your product read the crate, the label, the scale, the container and the movement. Where a value can't be read visually we bridge to the scale, the sensor or the existing scan.
Validate before it enters the register
Layered checks catch impossible weights, duplicate lots, out-of-sequence events, and missing Key Data Elements — so bad rows are flagged for a human while the shift is still on site.
Export on demand
FDA Electronic Sortable Spreadsheet, GDST/EPCIS event stream, CSV, or a direct feed into your ERP or food-safety platform.
Reference implementation
CrabTrace: the model, built end to end.
Our shellfish-aquaculture traceability platform is where the architecture was proven: an operations feed, environmental monitoring with threshold alerting, harvest history, a full FSMA 204 lot register with one-click FDA export, a GDST/EPCIS event stream, a five-layer data-quality system, and a natural-language assistant over the record set.
It was designed for stone crab. It generalises to anything that moves through a process in lots — finfish, oysters, leafy greens, soft cheese, cold-chain distribution.
Capability set
- Live operations feed across sites and tanks
- Environmental monitoring with threshold alerts
- Harvest history and yield tracking
- FSMA 204 lot register + one-click FDA export
- GDST / EPCIS event stream for buyers
- Five-layer error-catching data-quality system
- Natural-language assistant over the register
Built as a working system, not a slide. We can demonstrate the capture-to-export
loop against your event model.
Worth being clear about
What software can and can't do for you
No vendor can sell you compliance. FSMA 204 compliance is a programme — your traceability plan, your procedures, your records, and your people. What technology can do is make the record complete and the export instant, so the programme rests on something solid. We'd rather say that up front than in the kick-off meeting.
Questions
FSMA 204, answered plainly
What are Critical Tracking Events under FSMA 204?
Critical Tracking Events are the points in a food's journey where records must be kept: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation. Each event requires its own defined set of Key Data Elements.
What is a Traceability Lot Code?
It's the identifier assigned to a lot of food on the Food Traceability List. It links every downstream record back to a specific batch — the key that makes a recall traceable rather than a guess about which pallets to pull.
Why cameras instead of scanners or tablets?
Scanners and tablets still require a person to stop and act, so capture quality drops exactly when the operation is busiest. Cameras observe work that's already happening. We don't replace barcode or RFID where they work well — passive vision fills the gaps where scanning is impractical, and cross-checks the rest.
Can this run alongside our existing ERP or food-safety system?
Yes. The event register is built to export and integrate: FDA Electronic Sortable Spreadsheet, GDST/EPCIS event streams, CSV, or a direct API feed. It's a capture layer, not a replacement for your system of record.
What does a first engagement look like?
A traceability gap assessment: we map your Critical Tracking Events, look at your existing camera and network coverage, and identify where the record actually breaks. You get a written model of what passive capture would cover and what it wouldn't — whether or not you go further with us.
Find out where your records break.
A traceability gap assessment maps your Critical Tracking Events against what's actually being captured today.