CAPA CAPA Process & Documentation 3

Question 1

In a CAPA system, 'trend analysis' is best described as:

Accepted Answer

Monitoring data over time to detect patterns that may indicate systemic issues

Answer

Trend analysis involves monitoring quality data over time to identify recurring patterns or worsening conditions that may signal systemic problems requiring preventive action.

Question 2

Which CAPA documentation practice best supports traceability during an FDA inspection?

Accepted Answer

Cross-referencing CAPAs to related complaints, audits, and change controls

Answer

Cross-referencing CAPAs to related records such as complaints, audit findings, and change controls creates a traceable chain of evidence that inspectors can follow.

Question 3

A CAPA is classified as 'closed' when:

Accepted Answer

All actions are implemented and effectiveness has been verified

Answer

A CAPA can only be closed after all planned actions are implemented and the effectiveness check confirms the root cause has been eliminated and recurrence prevented.

Question 4

What is the purpose of a CAPA log or tracking register?

Accepted Answer

To provide a summary view of all open and closed CAPAs for management oversight

Answer

A CAPA log provides management with an at-a-glance summary of all CAPAs, their status, risk levels, and owners, enabling oversight and resource allocation.

Question 5

When a CAPA investigation reveals multiple contributing causes, the best documentation approach is to:

Accepted Answer

Document all identified contributing causes and address each in the action plan

Answer

All contributing causes identified during investigation should be documented and addressed in the action plan to ensure the CAPA is comprehensive and effective.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA CAPA Process & Documentation 3