21 CFR Part 820 did not always incorporate design controls and other QA practices. In 1997 they were added by the FDA. See their reasoning, below.
"To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the revision is the addition of design controls."
The FDA must recognize that shortcomings in risk management, failure modes, reviews and change control are hazardous in early phases. Being amplified and more dangerous downstream calls for more discipline and precision at the beginning.
Menlo Park Project risk management, FMEA failure mode data collection and planning are professional grade and integrated with all project issues. They can start early, get the attention they deserve, and be continually tracked, in 3D.
Build your methods as sets of procedures comprised of goals, decisions and questions. Use one to start each project. Then add assumptions, commitments, constraints and dependencies to help manage the project. Following initial planning, add risks and failure modes. And, during the project add problems, CAPA's, deviations and requests as needed. Add meetings for reviews and change control in all stages, not just design, development, verification and validation.
Risks, failure modes, CAPA activity and other issues will be tracked for the life of the project. All the while generating reports for history files.
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