Complaints, Recalls & Vigilance — Overview

No matter how well you manufacture, complaints and safety signals will occur. Having a documented, practised procedure for handling them is a legal requirement in most markets and a critical protection for consumers.

What this section covers

• Complaint handling procedure — receiving, logging, investigating, and closing complaints
• Distinguishing a complaint from an adverse event (AE) or serious adverse event (SAE)
• Adverse event reporting — when and how to notify the regulator
• Product defect assessment — deciding whether a defect warrants a recall
• Product recall procedure — classification, execution, and communication
• Mock recall exercise — testing your traceability and recall capability annually
• Post-market surveillance — ongoing monitoring of product safety signals
• Trend analysis — spotting patterns across complaints before they become crises