In the larger organizations I worked for as a quality leader, supplier auditing was almost always calendar-driven. Sometimes supplier audits happened once a year; in other places, they might happen twice. I’d build the schedule to accommodate that, and the system would just run.

Over time, I shifted to a risk-based approach where how deeply and how often I audited a supplier…

FDA inspectors don’t just check your records. They bring their own thermometer.

And when their reading doesn’t match six months of logged data from the sensor on your cold room wall, the honest explanation is one nobody wants to say: The monitoring system was compliant; the measurement just wasn’t accurate anymore.

I know because I’ve been in that room.

Working…

Researchers at the U.S. Department of Energy’s (DOE) Oak Ridge National Laboratory (ORNL) have created a new tool that can catch and correct potential mistakes in real time while 3D-printing large plastic parts.

The automated system could help U.S. manufacturers produce large, custom parts with fewer defects, potentially reducing waste, lowering costs, and strengthening domestic…