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.
1. What did we find?
What results did you come out of the review with, and what do they mean? This question is simple enough, and ideally should be your starting point once your design reviews are completed. It’s worth noting, too, that this question is not just about finding data points at the end of the review process. Being able to extrapolate data from the collected information is critical as well. Without the context around what is discovered during your design reviews, making plans for managing it can be a challenge.
2. What didn’t we find?
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.
3. Were there deficiencies in the design?
As stated earlier, FDA doesn’t specifically call out the purpose of design reviews and what they are intended to identify. However, many organizations use them to flag and take care of deficiencies in product design. Asking explicitly if there were design issues is therefore a worthwhile avenue of investigation. From a compliance perspective, being transparent and up-front about any detectable issues during the development process may satisfy regulators’ expectations, as well as promote safety and effectiveness in your life science product.
4. Who is responsible for addressing these deficiencies?
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.
5. What is the timeline for resolving them?
Asking about timelines for design deficiency resolution seems like a question that doesn’t need to be asked. However, being deliberate about this post-review activity helps in the long run. Structuring how and when issues get resolved cuts down on chaos in your product development process. When thoroughly documented, this shows regulatory bodies that your organization is committed to quality, safety, and effectiveness.
