April 11, 2023

Design Plans: Clearly Identify Design Team Members/Contributors

It’s important to be mindful that ISO TC/210 and FDA expect the design team and its members’ roles to be very clearly defined (i.e., in the design plan).  FDA says that, “The importance of defining responsibilities with clarity and without ambiguity should be recognized.”  ISO TC/210 says, “It needs to be clear who has responsibility and authority for design and development. Generally, as different groups or functions within your organization are involved in design and development, clear and effective communication with distinct assignment of responsibilities across your organization is important….The design and development plan should identify the review, verification and validation methods to be used, including who is to carry them out…” [emphasis added].  This alludes to the pitfalls of arguing against a regulatory authority who seeks inclusion of the various personnel contributions as being part of the design team.