Product/ process qualification is integrated into the project management process. It starts from the early stages of the design and ends up at the mass production kick-off.
Product qualification aims to check that the product complies with all specifications, customer requirements and wishes.
Process qualification aims to check that everything in the product/ process design will lead the product to remain sustainably compliant.
product/ process qualification plans definition
Risk analysis, prevention plans (tests and monitoring plans)
Management of a risks and problem list
Integration of the product/ process qualification plan into the supplier’s organisational structure