Which statement best defines a nonconforming event vs a corrective action?

Which statement best defines a nonconforming event vs a corrective action?

• A. CAPA is the event that triggers the process.
• B. Nonconforming event is the occurrence; CAPA is the action plan to mitigate; nonconformity triggers CAPA process.
• C. Nonconforming event means everything is within spec.
• D. Nonconforming event is the final report.

Answer: (B)

In a quality system, a nonconforming event is the actual deviation from requirements or specifications—the thing that happened. CAPA, on the other hand, is the formal plan of corrective and preventive actions developed to address that deviation, fix the root cause, and prevent recurrence. The key relationship is that detecting a nonconformity starts the CAPA process. So, the best choice captures that distinction: the nonconforming event is the occurrence itself, CAPA is the action plan put in place to remedy and prevent future issues, and the nonconformity triggers the CAPA process to begin. For example, if a batch fails a potency test, that failure is the nonconforming event; the CAPA plan would include investigating why it happened, correcting the current issue, and implementing changes to stop it from recurring.

In a quality system, a nonconforming event is the actual deviation from requirements or specifications—the thing that happened. CAPA, on the other hand, is the formal plan of corrective and preventive actions developed to address that deviation, fix the root cause, and prevent recurrence. The key relationship is that detecting a nonconformity starts the CAPA process.

So, the best choice captures that distinction: the nonconforming event is the occurrence itself, CAPA is the action plan put in place to remedy and prevent future issues, and the nonconformity triggers the CAPA process to begin. For example, if a batch fails a potency test, that failure is the nonconforming event; the CAPA plan would include investigating why it happened, correcting the current issue, and implementing changes to stop it from recurring.