Effective complaint handling is fundamental to life-sciences quality management, with implications for operations, product design, risk management, and more.

It’s also critical to ISO 9001, FDA Quality System Regulation (QSR), and EU Medical Device Regulation (MDR) compliance.

Manufacturers that get complaint management right can use it to improve products and reduce risk to patients and the company. Those that get it wrong, however, run the risk of future product failures, recalls, and regulatory penalties.

With that in mind, this article looks at how life-sciences companies can strengthen complaint management with an automated quality management system (QMS). Included are considerations for building your workflow and how to incorporate risk into the process for better decision making and patient protection.

The basics of an effective complaint management workflow

Each manufacturer will have its own complaint-handling workflows, which may differ based on inputs like issue type or source. That said, there are several common elements that organizations typically build their workflow around in the QMS.

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