Risk Management
What can we learn about human intelligence by studying how machines “think?” Can we better understand ourselves if we better understand the artificial intelligence systems that are becoming a more significant part of our everyday lives?
These questions may be deeply philosophical…
Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden. Entrenched legacy systems compound the problem as organizational inertia and complacency lead companies to make do…
The arrival of artificial intelligence (AI) in quality management has been met with a mixture of hype and skepticism. Is it just a faster anomaly detector, or is it truly transformative?
The answer depends on how we frame the problem. If we see AI merely as a way to speed up…
When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality. While these functions are critical, starting there can be a misstep. Without the right…
My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason for warning letters, and also introduces the role of failure mode effects analysis (FMEA) in preventing trouble in the first place. The U.S. Food and…
I had a great conversation with a friend of mine. He was bemoaning the fact that his company was almost completely dependent on one huge customer. He saw the inherent risks in that relationship but confessed that his organization had a bad habit it couldn’t kick. It had succumbed to the…