To verify that the design validation process is completed and that there is objective evidence of its completion. The design validation process must ensure the design meets all customer and regulatory requirements. If there are variations in the design that have not been previously produced, risk mitigation plans must be developed (variations to standard work).
To the extent a supplier/partner performs design work, such work must be validated and risk mitigation plans developed as required. Objective evidence of compliance to engineering standard work shall be established and maintained.
Knowledge and Skills Requirements:
Ability to ensure design validation process meets all customer and regulatory requirements. Ability to assess the design validation process and verify that it is completed and that there is objective evidence of its completion. Ability to recognize variations in design standard work. Ability to ensure that variations in design standard work have risk mitigation plans.