To perform GAP analysis and verify if planned changes in your design and development process are carried out in a controlled way, and actions are taken to mitigate any adverse effects, you should:

1. Review Change Control Procedures

Examine your documented procedures for managing changes during the design and development stages. Check that these procedures include steps for identifying, authorizing, and controlling changes. Verify that there is a clear, consistent process in place to assess each planned change before implementation, ensuring it is well-defined and includes criteria for approving or rejecting changes based on potential impacts.

2. Evaluate Impact Assessment and Mitigation Actions

Confirm that, as part of your change control process, you assess any potential adverse effects that the change might have on product or service conformity. Look for evidence that your team evaluates risks associated with each change and determines appropriate actions to mitigate those risks. This should include records showing that any necessary mitigation actions were identified and implemented effectively to prevent negative outcomes.

3. Verify Retention of Documented Information

Check if records of each change, including impact assessments, approvals, and actions taken, are retained as part of your documented information. These records should detail each stage of the change process, from authorization through review and final action, to demonstrate that changes are consistently managed and controlled according to ISO 9001 requirements.

By following these steps, you can verify whether changes to your design and development are systematically controlled, with adequate steps to mitigate any adverse impacts on quality.