I agree with the responses so far. One of the aspects that I think design controls help to bring out in the product development process is risk management. This is a way to take the policies, procedures, and practices to the responsibilities of identifying, analyzing, controlling and monitoring risk. Also, with framework is helpful to managing risk and how it is effected in the design process. It all begins during the development process with the design input and as it evolves, new risks arise and are more evident. By keeping track of risk, it is easier for the project team to work on risk mitigation and adjust accordingly to minimize any change cost. An example of this is an exposure control system for a general purpose x-ray system. The control function was allocated to software. Late in the development process, risk analysis of the system uncovered several failure modes that could result in overexposure to the patient. Because the problem was not identified until the design was near completion, an expensive, independent, back-up timer had to be added to monitor exposure times.

http://www.fda.gov/downloads/MedicalDevices/…/ucm070642.pdf

Luisa