FDA: Complaint Handling

A high number of complaints is not necessarily indicative of poor device quality. There could be many reasons for large number of complaints. Customers may be dissatisfied when they have expectations beyond the capability of what a device can do. There could be a requirements mismatch. A manufacturer may have return policies that inadvertently encourage customers to return their devices for a newer one. Or there could be real problems with the device itself which were not discovered before shipment.

Whatever the complaint reasons, the FDA requires that complaints be processed in a uniform and timely manner.  Too often, companies opt for a quick closure at the expense of customer satisfaction.  Maybe it is time to take a fresh look at your complaint handling process.  There may be opportunities to minimize closure times while maximizing the customer experience.

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