Standards
The U.S. Food and Drug Administration’s April 2, 2026, warning letter to Purolea Cosmetics Lab is making the rounds, mostly under some version of “FDA cracks down on AI in manufacturing.”
That’s the wrong way to read this. If you build medical devices, treating this issue as an AI…
Here’s a scenario that should make any quality leader in pharma or medical devices uncomfortable: A software team building a diagnostic support tool uses an AI coding assistant to generate a data-processing module. The module looks correct, passes validation testing, and ships. Eighteen months…
For more than 30 years I’ve audited management systems in manufacturing, automotive, laboratory, service, and nuclear environments. During that time I’ve watched internal auditing change shape several times. Paper checklists gave way to process-based auditing. Filing cabinets gave way to digital…
The food manufacturing industry has spent the last two years trying to figure out where AI fits: Vision inspection systems? Predictive maintenance? Yield optimization? Contamination detection? The applications are real, but they’re expensive, technically complex, and often require significant…
The pressure is on. Throughout industries and regions, organizations are being asked the same question—not whether they care about the environment, but what they are doing about it.
The landscape for sustainability in business is tightening. Environmental responsibility is no…
A significant change in ISO 9001:2026 involves separate actions to address risks and opportunities. In her article “Brainstorming: The Ultimate Risk Management Tool,” Jenna M Schoettker writes, “Think of risk as two sides of a coin. On one side we have our negative risk, while the other side…