Deviation management is the formal process for documenting, investigating, and resolving departures from approved GxP procedures , with root cause analysis and proportionate corrective action.
Definition
Deviation management is the formal process for identifying, documenting, investigating, and resolving departures from approved procedures, specifications, or validated states in a GxP environment. Deviations are classified by severity , minor, major, critical , and require root cause analysis and corrective action proportionate to the risk. Unresolved or inadequately investigated deviations are a top finding in FDA and EMA inspections.
What this means when you're hiring
How a candidate talks about deviation management tells me a lot about their quality mindset. Engineers who treat deviations as administrative burdens to close quickly are a risk in regulated environments. The ones I want to place are those who see deviations as quality intelligence , data that tells you something about your process or system that needs fixing.
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