Risk Management and Quality Intelligence

Kris Kelly on the Advantu blog brought to my attention a February post he wrote titled “Medical Device Recalls – Do You See the Pattern…?“

While specific in intent to medical devices, the content is very relevant to my last post. Risk Management is a major enabler of quality system, and a big part of risk assessments is moving beyond the expected to find the unexpected.

The other part of the article that stood out to me was how this was a great example of regulatory intelligence as a part of knowledge management. Kris took a trend of medical device recalls and evaluated the need for action. And you should too. Regulatory intelligence should be informing your quality system, it needs to be an input to decision making from design through change management activities and every step of the way. Regulatory intelligence should be an input to your organization. This idea can be expanded to quality intelligence, which also looks at best practices, pharmacopeias and a whole assortment of inputs from agencies to industry associations to benchmarking with other companies.

To bring this post around to one of my long-term preoccupations, change management, the following request is found in 3 of the drug cGMP warning letters on the FDA website since the 01Mar2018.

A comprehensive, independent evaluation and remediation of your change management system. The evaluation should include, but not be limited to, assuring changes are appropriately justified, approved by your quality unit, and evaluated for effectiveness. Also, include a retrospective assessment of all changes executed outside an appropriate change management process.

Is your quality system strong enough? Have you evaluated the risks of your change management system? Are you prepared for your next regulatory inspection? How do you ensure you are evaluating these trends as they develop? Do you have a process in place to make sure you are not surprised?