Field notes

Short pieces on how US plants really run, built only on public sources. Every note links its sources.

layered process audit5 min read

In a layered process audit, which layer should find the most?

A 2012 rule of thumb from the Elsmar Cove quality forum says the line should find the most. What practitioners have said about clean first-layer sheets since 2005, read as questions for whoever runs the program.

repeat findings5 min read

Why a repeat finding costs more than a new one

The grading scale used in the Medical Device Single Audit Program adds a grade when a nonconformity comes back, FDA warning letters read repeat failures as a leadership problem, and forum members explain why a repeat can point to the corrective action process.

calendar4 min read

Where quality, CI and operations people meet: October 2026 to June 2027

Ten US conferences, in date order, where the people who run quality, continuous improvement and operations in plants go to hear from each other.