Thorough data collection to support statistical process control and direct measurements to identify deviations, allowing action limits to be established before a product fails to meet final specifications. This approach reduces scrap and rework. Additionally, documentation is provided to demonstrate that the process was effectively controlled, which is essential for validation and regulatory filings.

Establish the frequency, location, and number of samples that require more intensive sampling than routine production to ensure statistical confidence and reliability in determining process capability.

Testing to support production runs that demonstrate a process consistently produces products meeting specifications.