Product Withdrawal and Recall Procedure

Purpose. Sets out how the business decides on, conducts and closes a product withdrawal or recall, and how the recall team is exercised through mock recalls.

1.Recall team

The recall team consists of the chief executive as recall coordinator, the quality manager, the site manager for the affected site, the warehouse and logistics manager and the customer service lead. The team must be able to be assembled within two hours at any time. Contact details are held on the recall contact card kept by each team member and in the quality office.

2.Deciding to withdraw or recall

When a food safety, labelling or quality issue is identified that could affect product already dispatched, the quality manager must assess the risk and brief the recall coordinator on the same day. A withdrawal will be used where product has not reached consumers and a recall where it has. The decision, the reasons and the scope will be recorded.

3.Traceability

The team must identify every batch affected using the batch record system and the goods receipt records, trace one step back to the raw material lots and one step forward to every customer and quantity dispatched. The trace must be completed within four hours and the reconciliation of quantities produced, in stock and dispatched must be recorded.

• Identify affected batches and raw material lots
• List every customer, quantity and dispatch date
• Reconcile produced, in stock and dispatched
• Place all stock on hand on hold

4.Notification

The recall coordinator will notify the regulator, the customers and, for a consumer level recall, the public using the templates in the recall kit. The pharmaceutical site will follow the uniform recall procedure agreed with the therapeutic goods regulator. All communication must be logged with the time and the person contacted.

5.Retrieval and disposition

Returned product will be received into quarantine, counted, reconciled against the quantities dispatched and dispositioned under a documented decision. The root cause will be investigated and corrective and preventive action recorded in the non-conformance register.

6.Mock recalls

A mock recall will be conducted at least twice a year at each site, alternating between a raw material trace and a finished product trace. The mock recall will be timed, the reconciliation checked and any gap recorded as a non-conformance.