How are nonconformance reports (NCRs) used in CBM T6?

• A. File deviations for archival purposes only.
• B. Approve deviations without investigation.
• C. Close out issues without triggering actions.
• D. Document deviations, trigger investigations and CAPA actions.

Answer: (D)

Nonconformance reports are the formal mechanism for capturing deviations from requirements and starting the problem-solving process. When a deviation is found, an NCR records what happened, where, when, who observed it, and the impact on quality, safety, or compliance. That documentation provides the factual basis for a root-cause investigation and for taking corrective and preventive actions (CAPA). The goal is not just to archive something or to approve a deviation without looking into it, and it’s not to close out the issue without taking steps to prevent recurrence. By documenting the deviation and triggering investigations and CAPA actions, you create a traceable, accountable workflow that addresses the root cause and reduces the likelihood of repeat problems. For example, if a component doesn’t meet specification, the NCR prompts investigation, containment if needed, disposition decisions, and actions to fix the process and prevent future nonconformances.