Design validation

This is performed after the final design verification described in the previ­ous paragraphs, under the operating conditions of pre-operational test per­formed during the commissioning phase. It is carried out to confirm by examination and provision of objective evidence that an item conforms to the specified requirements.

Design outputs and change control

The final product of the design process is reflected in the design output documents that shall be adequately identified, stored and retained. A typical list of documents contains the following:

• Specifications

• Drawings

• Verification and validation records

• Technical analysis and safety evaluations.

Changes to design output, including changes to requirements, shall be justi­fied, documented and controlled. Special consideration should be given to the impact of changes on other areas.