In the cosmetic manufacturing sector, a robust product recovery system is not a recommendation, it is a mandatory requirement for compliance with ISO 22716:2007. Section 14 specifically addresses the management of complaints and recalls, emphasizing that a system must be in place to ensure the safety of the end-consumer.
The Technical Definition
Under ISO 22716, a Recall is the process of retrieving a product from the distribution chain because it has been identified as non-conforming or potentially hazardous. This differs from a “Withdrawal,” which typically occurs before the product reaches the final consumer. But both would be expected to have controls in place to manage
Factual Requirements for Section 14 Compliance
To meet the standard during an assessment, the following technical data must be present:
- Designated Responsibility: A clear identification of the personnel authorized to initiate and coordinate the recall process.
- The Recall Procedure: A documented SOP outlining how the recall is triggered, who is notified, and how the product is physically sequestered.
- Progress Monitoring: A methodology for reconciling the quantities of products “shipped” vs. “recovered.”
- Mandatory Mock Recall: Evidence of a periodic “Recall Simulation” to verify the system’s effectiveness. This includes a report showing the percentage of product accounted for and the time taken to identify its location.
The Auditor’s Perspective
A common misunderstanding involves the scope of a recall simulation. A factual audit will verify if the simulation can trace the product through all stages: from goods in to goods out and to retailers or distributors, including the specific batch numbers and quantities involved.
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