What is a nonconformity (NCR) in the context of SOPs, and what steps follow its detection?

• A. NCR means new customer requirement.
• B. NCR stands for Nonconformity Corrective Report and is optional to document.
• C. A deviation from requirements; document NCR, investigate root cause, initiate CAPA, update SOPs, retrain staff, verify effectiveness.
• D. NCR is a type of audit.

Answer: (C)

A nonconformity in SOP practice is a deviation from required specifications or approved standards. When such a deviation is found, you first document it in a nonconformity report (NCR). This creates a formal record of what went wrong, when, and who observed it, which is essential for traceability and responsibility.

Next, you investigate the root cause to understand why the deviation occurred, not just what happened. This leads into the CAPA process—you implement corrective actions to fix the specific issue and prevent its recurrence, and you may also put preventive actions in place to reduce the chance of similar problems arising elsewhere. Because the goal is lasting improvement, you update the relevant SOPs to reflect the new learning, and you retrain staff so everyone follows the revised procedures.

Finally, you verify the effectiveness of the actions taken to ensure the problem is truly resolved and won’t recur. Only after this verification is successful do you close the NCR.

The other statements miss important aspects: NCRs are not new customer requirements, they are records of deviations; documenting them is not optional in a proper quality system; and an NCR is not a type of audit.