This is the fourth in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device marketplace. Because the design process is controlled and driven by a cross-functional group of individuals, the review of data and the progress of the design project is instrumental in organizing and orchestrating the opening and closing of the various stage gates throughout the evolution of the new product and supporting systems.
What are the basic requirements for and the purpose of design reviews?
Design reviews are formal and intended to provide a systematic assessment of design results, including the device design and the associated designs for production and support processes. This feedback to designers and manufacturing personnel on existing or emerging problems will eventually confirm whether that the project is ready to move on to the next stage of development or not. Because of the formality associated with true design reviews, the following requirements are noteworthy:
- Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development.
- The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed plus an individual who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed.
- The individual(s) performing the review shall be documented in the design history file.
Design reviews may have both an internal and external focus. The internal focus centers upon design feasibility and produceability with respect to manufacturing and support capabilities. The external focus is on the user requirements; that is, the device design is viewed from the perspective of the user needs and intended use. Absorbing user needs into the design process with the initial goal of identifying design inputs and (then outputs) can be accomplished at an early externally-focused design review, i.e. taking sometimes subjective user requirements and morphing them into measureable design inputs. This approval of these requirements (inputs) is best organized and presented at design review meetings.
During the initial design stages, issues related to design input requirements will claim the majority of the agenda items. Next, the main function of the reviews may be to evaluate or confirm the choice of solutions being offered by the design team. Following that, issues such as the choice of materials and the methods of manufacture become more important. During the final stages of fulfilling the design plan, issues related to the verification, validation and the transfer of the design into manufacturing will be addressed. These reviewed phase gates can be then approached in a logical progression of content, authority and release actions.
Design assessment activities during the life-cycle of new product development commonly meet the definition of formal design reviews, in that they are intended to be comprehensive, definitive and multidisciplinary in their scope. For example, each design document that constitutes the formal output, or deliverable, of a design task is normally subject to evaluation activities, sometimes referred to as technical reviews. These activities, while they may be called reviews, are often considered to be just verification activities with a purpose to confirm that design output meets design input. Verification activities affect and add to the design output, and are themselves subject to subsequent design review. Companies may conduct routine or ad hoc meetings to discuss an issue, coordinate activities or assess development progress. Decisions from such meetings may not require formal documentation; however, if a significant issue is resolved, this should be documented using design reviews as a vehicle for compliance.
Control of the design review process is achieved by developing and implementing a formal design review process consistent with quality system requirements.
There is a requirement to proceduralize the design review process. What should I include in this procedure?
The manufacturer should have documented formal design review procedures addressing the following:
- Evaluation of the design (including identification of concerns, i.e., issues and potential problems with the design)
- Resolution of concerns
- Implementation of corrective actions
Due to the far-reaching ramifications of these design reviews, this procedure should include strategic and tactical linkages with the quality management system, as well as post-production implications having to do with redesign arising from adverse events and functionality issues, systemic process issues with causation imbedded in input requirements being inadequately met, validation results that do not address intended use and poorly conceived and documented transfer (to manufacturing).