Quality Risk Management (QRM): Part III – An Approach for Understanding and Either Accepting or Mitigating the Results of a QRM Analysis

by Mark F. Witcher, PhD
Volume 16, Issue 1 (Spring 2017)

Accepting any identified and evaluated risk is “taking a smart risk.” The acceptance decision, before or after mitigation, is a complex and sometimes difficult choice that is based on the information generated during the ICH Q9 quality risk management (QRM) exercise along with many subjective viewpoints impacted by previous experience, knowledge, risk appetite, and bias. This paper provides an approach for understanding and making acceptance decisions centered around the risk-rating methods that define the severity (harm) and uncertainty (likelihood) of the risk’s consequence occurring. It also builds on concepts developed in the first two parts of this QRM series to provide an overall framework for identifying, evaluating, managing, and accepting a wide variety of biopharmaceutical development and manufacturing risks...

Witcher MF. Quality risk management (QRM): part III – an approach for understanding and either accepting or mitigating the results of a QRM analysis. BioProcess J, 2017; 16(1): 25–31. https://doi.org/10.12665/J161.Witcher.Q.

Posted online May 8, 2017.