7.3.7 Control Of Design and Development Changes

Purpose

To identify the procedure used to control the change process for design and development.

Procedure

Any changes to the design of a product may be identified and proposed by:

• [enter-your-company-name-here]
• The Customer
• The Design Consultants engaged in the design and development process
• Representatives of any external parties who have jurisdiction over the design

Then:

• Proposed changes are reviewed, verified and validated, as appropriate, and approved before implementation. Participants in the review, verification and validation processes shall include top management, representatives of the customer, all relevant functions associated with design and development and representatives of Sales, Finance and Operations as appropriate.
• Final approval for the design change shall be given after all activities associated with this procedure, including changes to drawings, production processes etc., are completed.
• Any review of proposed changes to design shall include careful evaluation of the effect of these changes on constituent parts and product that may be already delivered.
• The review is fully documented in the form of a report, citing the reasons for the change and any actual or potential effects that the change will cause to constituent parts and product that may be already delivered.
• The report shall contain details of the methodology used, and the results obtained, during the verification and validation processes. 
• The documentation shall be stored in accordance with the procedure 4.2.4 – Control of records