Lot Traceability and Recall Readiness in a U.S. Warehouse
What device distribution records must capture, how to design a usable trace trail, and how to run a mock recall that actually tests the system.
Recall readiness is judged on the day it is needed, but it is built in every receiving and shipping transaction beforehand. The question a regulator or a customer will ask is narrow: which units of this lot did you hold, and where did each one go? A warehouse that can answer in hours is in a different position from one that starts reconstructing from paper.
What traceability has to capture
- Lot, batch or serial number at receipt, linked to the supplier and quantity received.
- Expiration date and storage location at put-away and on every move.
- Customer, order and ship date for every outbound unit.
- Any relabeling, kitting or rework performed on the unit.
- Returns and their disposition, so a returned unit is never silently reshelved.
Designing a trail you can actually use
Traceability fails when the identifier exists but the relationship does not. Recording a lot number in a free-text field is not traceability, because nothing links it to a transaction. The record needs to be relational: receipt, location, order, customer, shipment. That is a system design decision, made before the first pallet arrives.
Running a mock recall that tests something
A useful mock recall starts with a real lot, from a real customer, and asks for the full path in both directions: forward to every consignee, backward to the inbound receipt. Time it, and write down what had to be hunted. If the exercise only confirms that the report exists, it has tested the report, not the recall.
Need this applied to your device?
We run U.S. entry, warehousing, fulfillment and post-market support for medical device manufacturers. Bring the specifics and we will map the steps.