Ensure design validation process meets all customer and regulatory requirements.
Assess the implementation of the design validation process and verify that it is completed and that there is objective evidence of its completion.
Evaluate proposed design data (objective evidence) to ensure compliance to existing engineering standard work.
Ensure that risk mitigation plans are established to manage variations in the design, which have not been previously produced (variations to standard work), using control processes as appropriate.
Based on the positive results of validating new design requirements, update engineering standard work.