Recall Management and Batch Traceability

Why recalls need traceability

When a batch must be withdrawn, the goal is to identify and locate exactly the affected units — no more, no less. Without batch traceability, a recall means pulling everything (costly) or risking missed stock (dangerous). With it, the recall is precise.

How batch traceability works

GS1 barcoding captures each unit's batch and expiry at receipt and tracks it through storage and dispatch. Combined with a documented movement history, this means a warehouse can answer, for any batch: what do we hold, and where has it gone.

Recall support at SFIMS

SFIMS's GS1 barcoding and documented movement history mean a recall can be executed quickly and accurately — protecting patients and the customer's standing with regulators.

Not every recall moves at the same speed

Recalls vary in urgency according to the risk the defect presents, and the difference is operational rather than theoretical.

At the most urgent end, the requirement is to stop the product reaching patients immediately, which can mean contacting customers within hours, at night and at weekends. At the least urgent, the action may be a controlled withdrawal at the next delivery.

The practical consequence is that a recall process has to work outside office hours. A procedure that depends on one person with the customer list, reachable only on a weekday, is not a recall procedure. Contact routes should be documented, current and known to more than one person.

Rehearsing before you need it

A mock recall is the only way to discover whether the system works, and it takes an afternoon.

Choose a batch dispatched some months ago. Without warning the team, ask three questions: how much of this batch did we receive, where is any remaining stock now, and exactly which customers received the rest and in what quantity. Time the answers.

What the exercise reveals is usually not that data is missing but that it is scattered — part in the warehouse system, part in despatch notes, part in somebody’s spreadsheet. Better to find that on a quiet afternoon than during a genuine recall, and the results give a defensible figure to quote when an auditor asks how quickly you could respond.

After the recall

Retrieving the stock is the middle of the process, not the end.

Returned units are quarantined separately from ordinary returns and reconciled against what was despatched, so it is clear how much is unaccounted for. That reconciliation is the number regulators ask about. Disposal follows a documented route with evidence retained.

Then the harder part: establishing how the defect reached the point it did, and whether anything in your own handling contributed. A recall that ends when the stock comes back has recovered the product but learned nothing, and the same failure remains available.