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merzkrashed replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 8 years, 1 month ago
As we have learned, Risk Management is done on multiple areas of a project, not just one:The product, The product design, and The manufacturing process.
A method to analyze risk
Looks at:
HOW something can fail
SEVERITY of the consequences
PROBABILITY that it will fail
you also can apply DFMEA – Design Failure Mode and Effect Analysis
Apply APQP= Advanced Product Quality Planning and Control