In terms of risk management, demonstrating the use of risk tools like Failure Mode Effects Analysis (FMEA), risk registers or decision trees will verify that decisions incorporate risk-based thinking. Manufacturers must show additional evidence that risk management is part of the end-to-end product lifecycle, which goes beyond just a CE approval.
Companies will want to make sure FMEAs are living documents that support the overall risk management process. They’ll need to include legacy products as well as new products, using a closed-loop change control process from complaints to product design. For example, an initial count indicates that the new GSPR Checklist would have more than 220 items to review.
