CPGP · Question #473
Which document describes how a deviation was evaluated?
The correct answer is C. Deviation investigation. A Deviation Investigation (C) is the document specifically created to record and evaluate an unexpected departure from an approved procedure or specification - it captures the event description, root cause analysis, impact assessment, and conclusions about what happened and…
Question
Which document describes how a deviation was evaluated?
Options
- AChange control form
- BCAPA report
- CDeviation investigation
- DSOP
How the community answered
(30 responses)- A17% (5)
- B3% (1)
- C73% (22)
- D7% (2)
Explanation
A Deviation Investigation (C) is the document specifically created to record and evaluate an unexpected departure from an approved procedure or specification - it captures the event description, root cause analysis, impact assessment, and conclusions about what happened and why. A Change Control Form (A) manages planned, prospective changes to processes or systems, not unplanned deviations. A CAPA Report (B) documents Corrective and Preventive Actions taken after a problem is analyzed - it's a response to findings, not the evaluation itself. An SOP (D) is a Standard Operating Procedure that defines how a process should be performed, not how a deviation from it was assessed.
Memory tip: Think "D for Deviation, D for Document - the investigation lives where it happened." The deviation investigation is the birth record of the problem; CAPA is what you do about it afterward.
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