As expressed in the blog 3 Functional Ways Risk is Critical to Quality Management by LNS Research, an organization’s approach to enterprise quality management should never remain stagnant. 

For medical device manufacturers, having a product that functions as designed is critical, as a person’s health—or even their life—could be at risk. It’s one thing if my Alexa won’t respond to a voice command to remind me of a task, but it may be life threatening if my asthma inhaler won’t give me the medication I need when I’m struggling to breathe.

In today's increasingly competitive manufacturing environment, the need to investigate and track quality related events is a crucial factor in the day-to-day manufacturing operations.