Risk Management

Case for Quality: Risk Management

The purpose of a risk management program or system is to establish a process to identify, evaluate and reduce risk.

We have gathered several examples from member companies who have established successful risk management practices. These examples are listed below in “Related Resources.”

Risk Management Lessons Learned

Below is a list of general learnings based on the examples collected from AdvaMed member companies:

  • Start early in the product lifecycle (don’t wait for launch). Should be a living document, not thought of as an event and forms to be completed.
  • Prior to risk analysis, insist on a clear intended use statement.
  • Focus is on Health and Safety.
  • Consistency through the product lifecycle using a standardized list of hazards and harms from design to process.
  • FMEA Risk Priority Numbers are used to prioritize action and do not quantify hazard/patient risk.
  • All hazards, hazardous situations and harms must be addressed in the Risk Trace Matrix (Hazard Analysis).
  • Safety is ultimately provided by risk control measures and going beyond compliance.
  • All harms (pre- or postmarket) should be assessed by medical/clinical personnel with appropriate expertise.
  • Horizontally deploy risk management learnings.