ABSTRACT
Design and development changes are changes to the features and characteristics of a product, service or process. Design changes can occur at any stage in the design process from the stage at which the requirement is agreed to the final certification that the product, service or process is proven for production or service provision. Development changes can occur at any time in the life cycle of a design that extends until the product, service or process is superseded. Depending on the nature of the change, the verification may range from a review of calculations to a repeat of the full design verification programme. As modifications are changes to products resulting from design changes, the identity of modifications needs to be visible on the product that has been modified. Information on design changes needs to be retained to verify that the changes are being faithfully implemented and the change procedures have been followed correctly.
