DISCLAIMER: This blog post solely represents my own opinion based on experience and/or interpretations.
A mock recall is an exercise in which the process for executing a recall is demonstrated in a theoretical setting.
The mock recall process should be linked to the field actions process.
Motto ‘Practice makes perfect’
Mock recalls are routine exercises conducted by manufacturers, distributors and other trading partners in the supply chain to assess their recall process’ effectiveness and responsiveness.
Ultimately, mock recalls are about mitigating risk and measuring your ability to react to an emergency event with as much precision as possible.
Mock recalls are often described as most valuable practice and should in my opinion be part of your internal audit plan. Based on the criticality of the process I would advice to perform a mock recall once a year or every two-years depending on your internal audit process. If however, your company was involved in an official recall in that timeframe that documentation and exercise can be used to verify the effectiveness and responsiveness of the process.
The first thing you should do is designate a recall team and make it clear who will be responsible for each task in the process.
The recall team will participate in the activities associated with the mock recall process.
A recall team consists mostly out of:
- Recall coordinator;
- Qualified Person (if required);
- QA representative;
- Other required stakeholders.
The coordinator is responsible for the documentation related to the recall, initiation of the recall request, identification of corrective actions for any deficiencies and/or observation.
Qualified Person (if appropriate)
The qualified person will help identify the release date(s), impacted clients, quantities shipped, and retain sample quantity and location.
The QA representative will help identify the release date(s), impacted clients, quantities shipped, and retain samples.
Will try to resolve all issues discovered during the mock recall exercise and document them in the related documentation for knowledge management and ensure that appropriate corrective actions are taken.
Will provide the necessary input.
Process: Raw Material
- The recall coordinator must pick a random Raw Material.
- Identify all the batches produced on-site with the selected raw material lot and record them in the related documentation.
- Select preferable two batches and record them into the related documentation. The batches selected should be on the market at the time of the mock recall.
- Create a recall notification letter containing the product identification and batch numbers.
- The notification letter must be communicated to the quality representative and Qualified Person (if appropriate).
- Verify the reception of the notification letter with electronic or paper-based signing.
- The quality representative in close cooperation with the Qualified Person (if appropriate) will identify the release date(s), impacted clients, quantities shipped, and retain sample quantity and location.
- A theoretical reconciliation is made (full batch/lot traceability should be verified).
- A root cause investigation for the mock deviation leading to the mock recall is performed and an action plan to prevent recurrence is defined.
- The mock recall coordinator and quality representative must resolve all issues discovered during the mock recall exercise and document them in the related documentation for knowledge management and ensure that appropriate corrective actions are taken.