Quality Risk Management

What is Quality Risk Management?

Quality Risk Management (QRM) systematically uses risk as a marker for efficient deployment of resources to correct conditions that may otherwise compromise the quality of a process. As ICH-Q9 cites, the two primary principles of quality risk management are:
  • The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and
  • The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk

 

Click Here to visit ICH-Q9 document cited above.