When moving to commissioning or volume production, rigorous control of first-of-run products (the first new products to come off the line) is vitally important. The production department must control first-of-run products in such a way that defectives are neither produced nor shipped.
Figure “A Typical First-of-Run Product Control System” shows a typical first-of-run-product control system, in which the QA department initiates first-of-run-product control when the volume-production drawings are issued. The system ensures that quality is built into the product by making it impossible for any product to be shipped until the production department has carried out a process FMEA, implemented and checked countermeasures, and locked them down.