Which actions are required when a CCP is not within limit?

• A. Immediate containment, disposition of affected product, investigation, corrective plan to prevent recurrence, and documentation
• B. Ignore the deviation if small
• C. Re-run the batch with same parameters
• D. Only document and proceed

Answer: (A)

When a CCP is not within limit, the priority is to stop the hazard and control the situation immediately. This means containing the process right away, holding or discarding affected product as appropriate, and preventing any further production or distribution of that batch. After containment, you investigate to identify the root cause of the deviation and develop a corrective action plan to bring the CCP back into control and to prevent recurrence. Documentation is essential throughout this process so you have a traceable record of the deviation, actions taken, and verification of effectiveness. The other options don’t fit because ignoring the deviation, re-running the batch with the same parameters, or simply documenting and proceeding would fail to protect safety and would not address the root cause or prevent recurrence.