PV1b
Process validation includes validation of equipment install (IQ) and development of a robust process window (OQ & PQ).
PV2
Process development uses appropriate design of experiment techniques to define the process window.
PV3b
A robust process window must be tolerant to changes in process inputs.
PV4
Process window confirmed by running process at OQlo and OQhi.
PV5
Example of robust process window developed for a polymer sheet welding process.
PV6
Design for manufacturability improvement plan developed using process scorecard.