A | IF THIS IS THE PERVASIVE FIRST REACTION to a deviation, management should look at themselves in the mirror if they want to know where root cause fault lies. It is too easy to blame a deviation on simply operator error. Doing so usually means you do not find the real root cause. We execute all of our investigations starting with the presumption of “no harm/no foul.” Even if the first element of cause is an operator mistake, I want to first know “why?” Lack of proper training? An outdated SOP? A too complex SOP? Training that only expects rote adherence to the SOP with no real understanding of why the SOP is written the way it is?
ANDREW SKIBO is the head of global biologics operations and global engineering at MedImmune/AstraZeneca.