As9100 Clause 8.3.6 – Design and Development Changes

AS9100 8.3.6 Design and Development Changes requires organizations to control changes to the design and development of products and services. This includes identifying, reviewing, and approving changes, as well as ensuring that the changes are properly implemented.

The following are some of the key requirements of AS9100 8.3.6:

• Identify changes: Changes to the design and development of products and services must be identified as soon as possible.
• Review changes: Changes must be reviewed to ensure that they meet the requirements of the product or service.
• Approve changes: Changes must be approved by a qualified person before they are implemented.
• Implement changes: Changes must be implemented in a controlled manner to ensure that they do not adversely affect the product or service.
• Maintain documentation: The organization must maintain documentation of all changes to the design and development of products and services.

By following these requirements, organizations can help to ensure that changes to the design and development of products and services are controlled and that the products and services continue to meet customer requirements.

Here are some additional tips for controlling design and development changes:

• Use a formal change control process: A formal change control process will help to ensure that changes are properly identified, reviewed, approved, and implemented.
• Involve all stakeholders: All stakeholders should be involved in the change control process, including customers, engineers, and manufacturing personnel. This will help to ensure that the changes are appropriate and that they do not adversely affect the product or service.
• Use appropriate tools and techniques: The organization should use appropriate tools and techniques to support the change control process. This could include tools such as computer-aided design (CAD), finite element analysis (FEA), and risk management software.
• Communicate effectively: The organization should communicate effectively with all stakeholders throughout the change control process. This will help to ensure that everyone is aware of the changes and that any concerns are addressed.

By following these tips, organizations can help to ensure that design and development changes are controlled and that the products and services continue to meet customer requirements.