Complaint management is a very important process for a medical device manufacturer. You ship, to the best of your knowledge, only devices that conform to the requirements. You have processes in place to ensure confirmation. One, for example, is reviewed of the DHR before release for distribution.A complaint is an allegation of the deficiency. Somebody asserts that, despite your QMS controls, you shipped a device that doesn't meet a requirement.Clearly, you want to obtain as much information from the complainant as possible. In the old days, we would send a certified letter, return receipt requested, to the complainant. The return receipt provides the objective evidence of an attempt to obtain the information. This keeps the regulators happy but doesn't really solve the investigation problem.Start by classifying the complaint based on the -ilities in a consolidated QSR/13485 definition. The -itilies include reliability, usability, etc.Because you have a process map, determine where in the process a deficiency in the -ilitie could occur. Look at all the associated documentation.Review the DHR for any hints. While the initial review may have been OK, you now have more information.In the end, you want to determine reason for the allegation of a deficiency. The reason may lead to a correction, a corrective action, or both.The long term goal is to drive the complaint rate to zero. Unfortunately you may not receive all the information desired from the complainant.
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