Define CAPA and outline the 5-phase lifecycle used in CBM T6 standards?

• A. CAPA = Corrective Action and Process Analysis; Plan, Do, Check, Act, Close
• B. CAPA = Corrective Action and Preventive Action; Identify problem/nonconformance; Investigate/root cause; Determine corrective and preventive actions; Implement actions; Verify effectiveness and close
• C. CAPA = Corrective Action and Prevention Audit; Identify, Design, Deploy, Document, Close
• D. CAPA = Compliance Action; Initiate, Review, Approve, Implement, Close

Answer: (B)

CAPA is the process of Corrective Action and Preventive Action used to address a problem and stop it from happening again. In the CBM T6 standards, the five-phase lifecycle follows a clear sequence: first, identify the problem or nonconformance; next, investigate and determine the root cause; then decide on corrective and preventive actions; after that, implement those actions; and finally verify that the actions are effective and formally close the CAPA. This structure emphasizes finding the root cause, taking targeted actions to fix the issue and prevent recurrence, and confirming effectiveness before closing.

The other options mix up what CAPA stands for or present a different lifecycle (like Plan-Do-Check-Act), which isn’t the CBM T6 CAPA workflow.