The next requirement for the design process is the Design Review. This is set up as a milestone(s) during product development, and is used to evaluate the design in relation to the previously identified requirements. These checks will help to identify issues before committing to further work on the product. Per the FDAs definition in § 820.3(h), “Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.”
The manufacturer must have procedures in place that address the formal design review process. The procedure(s) should cover the topics of evaluation of the design, how concerns are to be resolved, and how to implement any corrective actions taken.
Internal procedures are also required to identify the necessary participants for each design review. This team will include individuals from all stages of the product design process, individual(s) not directly responsible for the design stage being reviewed, along with any specialists needed. The reviews along the way will evolve as the product develops. Initially, the discussions will revolve around design input requirements. From there, evaluations of the solutions offered from the design team will take center stage. Eventually, review topics will cover the choice of materials and methods for production will be discussed, and the final review will be regarding verification, validation, and production.
The results of each review meeting will be retained in the design history file. Information included will consist of identification of the design, the date of the meeting, and individuals in attendance.
Let’s talk biological indicators!
Talk with one of our experts to get your questions answered and see how we can help you solve your BI pain points.
