Lean
They may seem simple, but standard operating procedures (SOPs) are surprisingly tricky. On the surface, they describe how a specific process is carried out at your organization. Pretty straightforward, right?
In reality, there are a lot of requirements for writing a good SOP, and…
A quality team’s supplier toolbox is deep. Supplier questionnaires, PPAP, supplier scorecards, incoming inspection, audits, corrective action—the list goes on.
In my years of experience as a quality leader, the challenge I see is matching each one to the right stage in the…
A new Financial Times analysis reports that U.S. technology companies have cut nearly 140,000 jobs in 2026 while pouring record sums into artificial intelligence infrastructure. The obvious story is that AI is replacing workers. The more important story is that executives are using AI to justify…
On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to Purolea Cosmetics Lab, reference 722591-04022026. By now, most of you have heard the story. The company had used AI agents to write drug product specifications, procedures, and master production records. No…
For decades, reverse engineering was a tool reserved for large manufacturers. Aerospace manufacturers leaned on it to keep aging fleets in service when computer-aided design (CAD) data were missing. Defense contractors relied on it to re-create components that had long outlived their original…
Consider an AI tool that delivers consistently accurate results and demonstrates impressive capabilities. If the people who are expected to rely on it can’t understand how decisions are reached or challenge outcomes that appear wrong, why would they trust it with an important decision? Would an…