AS9100 Clause 8.3.4 – Design and Development Controls

AS9100 Clause 8.3.4 – Design and Development Controls requires organizations to implement controls to ensure that the design and development of products and services meet customer requirements. These controls should include:

• Planning: The organization should plan the design and development process, including the identification of input requirements, the development of outputs, and the verification and validation of results.
• Reviews: The organization should conduct reviews at appropriate stages of the design and development process to ensure that the outputs meet the input requirements.
• Verification: The organization should verify the design and development outputs to ensure that they meet the input requirements.
• Validation: The organization should validate the design and development outputs to ensure that they meet the requirements for the intended use.
• Control of changes: The organization should control changes to the design and development outputs to ensure that they are properly authorized and implemented.
• Documentation: The organization should document the design and development process and the results of the reviews, verification, and validation activities.

By implementing these controls, organizations can help to ensure that their products and services meet customer requirements and are fit for purpose.

Here are some additional tips for implementing AS9100 Clause 8.3.4:

• Involve all relevant stakeholders: The design and development process should involve all relevant stakeholders, including customers, engineers, and manufacturing personnel. This will help to ensure that the final product or service meets the needs of all stakeholders.
• Use risk-based thinking: The design and development process should be risk-based, meaning that the organization should identify and assess the risks associated with the product or service. This will help the organization to prioritize its efforts and focus on the areas where the risks are highest.
• Use appropriate tools and techniques: The organization should use appropriate tools and techniques to support the design and development process. This could include tools such as computer-aided design (CAD), finite element analysis (FEA), and risk management software.
• Establish a process for managing changes: The organization should establish a process for managing changes to the design and development outputs. This process should ensure that changes are properly authorized and implemented, and that the impact of changes is assessed.
• Maintain documentation: The organization should maintain documentation of the design and development process and the results of the reviews, verification, and validation activities. This documentation should be accessible to all relevant personnel.

By following these tips, organizations can help to ensure that they are in compliance with AS9100 Clause 8.3.4 and that their products and services meet customer requirements.