FDA’s Design Controls regulation has no clear mandate as to the purpose of design reviews. Rather, they are concerned with seeing evidence these reviews are conducted at regular intervals by appropriate parties. Determining what data comes out of a design review is ultimately up to your organization’s needs and objectives.
This can become an issue every time a review is completed; the data and insights necessary to close this stage of the design controls process are variable. Without a well-defined scope and guidelines for design review results, your development teams can struggle with next steps and follow-through.
There are solutions for this issue, however. They involve asking the right questions after your design reviews are completed. How you select them varies, but some common questions are worth incorporating into your design review processes.
This question may not seem immediately relevant as a concern for design reviews, but it can actually lead to significant discoveries. Upon reviewing the data collected during the review, try to pinpoint things that may be missing or unexplored. If an anticipated result is missing, there could be serious cause for concern. Similarly, if any results stray from expected outcomes, that discrepancy likely needs to be investigated.
Who takes charge of fixing any detected issues in the product design? This is an essential question to ask, as it promotes accountability and makes design issue resolution more concrete. It also prioritizes your development activities; the more serious the deficiency, the higher priority resolution needs to be. Post-review activities should have a clear enough roadmap to avoid confusion and steer development work appropriately.