3.4. Design Changes
Design/process changes include corrective actions, changes implemented to solve the original issue, changes to turn features on and off for customers, and design documents updated to reflect the changed design.
Design Change Analysis
FAIs
V&V (Verification and Validation)
Evaluation of the impact of any proposed design changes on the product's performance, safety, and compliance.
First Article Inspections to verify the conformance of the initial production unit after a design change.
Independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.