Lean
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…
Walk any well-run plant and you’ll find statistical process control doing quiet, faithful work: control charts on the critical dimensions; capability studies before a line change; gage R&R before anyone trusts a measurement; out-of-control signals investigated; root causes found; corrective…
Manufacturing has a people problem, but not in the way we usually talk about it.
We talk about the skilled-labor shortage. We talk about retirements. We talk about doing more with fewer people. Usually those are treated as separate problems.
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The real test of a quality system isn’t what happens when everything works. It’s what happens when something doesn’t.
Recently, two of my cameras failed. They were newer versions of models whose older predecessors still worked, so I contacted the manufacturer to report the problem…