New article from James Vesper and Keven O’Donnell published in Pharmaceutical Engineering, Nov-Dec 2016.
From the content:
"The intent of QRM is to make data-driven and scientifically sound decisions proactively, not to justify an action or a decision that has already been taken"
"Formal risk assessments sometimes fail to add value or clarity to a situation because risk assessments often only superficially address root cause analysis, resulting in ineffective risk-control actions"
"Some firms have not yet seen that hazard identification and risk assessment tools can be used together synergistically"