In CBM T6 environmental monitoring, what triggers CAPA?

• A. Deviations in monitored parameters.
• B. Routine checks with no deviations.
• C. Scheduled maintenance with no issues.
• D. Customer feedback alone.

Answer: (A)

CAPA is started whenever the environmental monitoring data show deviations from the established acceptance criteria, signaling that the process or environment is not under control and could affect product quality. In practice, that means when results fall outside permitted limits or display unusual trends that warrant investigation, root-cause analysis, and actions to correct the issue and prevent recurrence. The aim is to bring the process back into control and verify that the fix is effective.

Routine checks that come back within spec don’t initiate CAPA because they indicate the controls are functioning as intended. Planned maintenance with no issues also isn’t a trigger, since it’s a scheduled activity that doesn’t reflect a deviation in the monitored environment. Customer feedback alone isn’t automatically CAPA-triggering in this context unless it points to a verifiable issue detected by monitoring or related to process control; otherwise it’s not the direct trigger. The defining trigger here is clear deviations in monitored parameters.