In a regulatory control action, what is the noncompliance record (NR)?

• A. Written notification of the regulatory action.
• B. A certificate of compliance.
• C. A product specification sheet.
• D. A supplier contract.

Answer: (A)

In regulatory control actions, a noncompliance record is the formal written notification that a regulatory authority issues to document a failure to meet requirements and to outline the action being taken. This document serves as the official communication and record of the enforcement step, ensuring there’s a traceable, auditable note of what was found and what will happen next. It isnures that everyone involved understands the noncompliance and the regulatory response, and it typically drives subsequent steps like corrective actions, timelines, and follow-up inspections.

It’s not a certificate of compliance, which would indicate that requirements have been met; nor is it a product specification sheet, which details product requirements, nor a supplier contract, which governs business terms. The noncompliance record specifically captures the regulatory action and the notice given about the nonconformance.