Risk Management is Key Component to Quality Management Systems

06 June 2011

Risk management principles shall be applied to the life cycle of medical devices. But why? These principles must be applied in order to maintain pace with changes in technology and to better address safety issues arising from age, intended use or foreseeable misuse, work environment, and production (or post-production) complaints.

There are three phases that comprise the risk management process. Each of these phases should be performed in the following order and repeated throughout the lifecycle of the device as new hazards are identified:

  • Risk Analysis - determining hazards, chains of action, and potential harms that might occur due to intended use or foreseeable misuse;
  • Risk Estimation – evaluating whether the risk is acceptable compared to risk acceptability criteria, set by the Risk Management Policy; and
  • Risk Control Measures – eliminating or reducing risk by establishing specific actions to take when each hazard occurs.

The Risk Analysis and Risk Estimation phases are commonly referred to as the Risk Assessment.

The results of all three phases shall be recorded in the Risk Management File.

On June 20, this blog will explore the importance of how a company's quality team needs to work in tandem with the engineering team for RMF requirements in Third Edition.

To learn more about Third Edition and or to speak with an Intertek expert on this subject matter, e-mail us at ThirdEdition@intertek.com.