Question 1 of 6 Fundamentals Concept
How do corrective and preventive actions differ?
Short answer
Corrective action addresses a cause of an observed problem to prevent recurrence. Preventive action addresses a credible potential problem before it occurs, though CAPA programs often handle both using risk-based processes.
Why
If a mislabeling event occurs, containment first protects affected lots while investigation seeks why the control failed. A corrective action might redesign the label verification step after an established scanner-bypass cause. A preventive action might apply the same failure analysis to another line before it experiences the defect.
The labels are less important than a traceable rationale connecting risks, root causes, actions, verification and effectiveness. The quality system should distinguish immediate correction of an individual record from removing a systemic cause. Scope and terminology differ between pharmaceutical, medical device and other regulated sectors.
In 2026, FDA device QMSR integrates ISO 13485, but that device rule should not be presented as the automatic legal basis for drug CAPA.
Common mistakes
- Calling correction of a single bad label the same as corrective action on its root cause
The interviewer might ask next
What would be preventive rather than corrective in a related product line?