ISO 9001 Clause 8.3.6 addresses the controlled management of changes made during the design and development phase to reduce the possibility of unfavorable effects on the finished good or service. Often, a design change can impact purchasing (change in materials or material specification), production (drawings, work instructions, or testing), shipping (change in packaging), or quality (change in testing). Therefore, it is essential to ensure that everyone is always on the same design revision.
ISO 9001 Clause 8.3.6 Design and Development Changes
This clause emphasizes the need for a structured approach to identify, review, and control changes made during or after the design and development of products and services. The key elements are:
- Identification of Changes: The organization must have a system for identifying changes in the design and development phase, including modifications made during or after the initial design process. This may start with an Engineering Change Order (ECO).
- Review of Changes: Changes must be systematically reviewed to assess their impact. The organization must evaluate whether these changes (ECOs) adversely affect the conformity to requirements. This involves a comprehensive examination of the potential consequences.
- Control of Changes: The organization must implement controls to manage the changes effectively. This could involve obtaining approvals, updating relevant documentation, using existing inventory, and ensuring that the changes are applied consistently across the organization.
- Documented Information: The organization must maintain documented information related to design and development changes.
This includes:
- Details of the changes themselves.
- The outcomes of the reviews (the impacts of the requested change).
- Authorization records for the changes.
- Actions taken to prevent the adverse effects.
Example of Clause 8.3.6 Design and Development Changes
Imagine a software development project where a change is proposed to the application’s user interface after completing the initial design. The organization would need to identify this change, conduct a review to understand its impact on user experience and functionality, control the implementation of the change, and document the entire process. This ensures that the alteration doesn’t negatively affect the quality and conformity of the software.
- Change Identification: In a software development project, the initial design phase has been completed, and the team is working on coding based on that design. During a team meeting, a developer proposes changing the database schema to enhance the application’s performance.
- Review of Changes: The proposed change triggers a review process. The development team and the project manager assess this change’s impact on the overall system. They consider factors such as potential improvements in performance, compatibility with existing modules, and any potential risks or drawbacks.
- Control of Changes: The team decides to proceed after determining that the change is beneficial and won’t adversely affect other parts of the system. The change is documented, and necessary approvals are obtained from the project manager and other relevant stakeholders. The version control system is updated, ensuring that everyone working on the project uses the latest design specifications.
- Documented Information: The organization maintains documentation of this change. This includes records of the initial proposal, the review process, approvals obtained, and the updated design specifications. This information is stored in a centralized repository accessible to relevant team members and can be referred to in the future for auditing or knowledge transfer purposes.
ISO 9001:2015 Clause 8.3.6 Design and Development Changes
Clause 8.3.6 ensures that changes in the design and development phase are not haphazard but rather a controlled process that considers potential impacts and involves proper documentation and authorization. It’s about managing modifications to the design and development phase in a controlled manner, minimizing the risk of adverse effects on the final product or service.
