Which statement correctly describes the procedures for associating noncompliance in an NR?

• A. The most recent NR number and date plus the specific further planned action/corrective measures that were either not implemented or were ineffective at preventing recurrence of the noncompliance in the description of the noncompliance (block 10)
• B. The reason for associating the noncompliance is recorded in PHIS
• C. The NR description should be translated into the local language
• D. No prior NR numbers are referenced in the NR description

Answer: (A)

Associating noncompliance relies on linking the current NR to prior NR events to show recurrence and to document whether corrective actions have worked. The correct approach is to include in the NR description (block 10) the most recent NR number and date, plus the specific further planned action or corrective measures that were not implemented or were ineffective at preventing recurrence. This creates a clear audit trail that shows the history of the issue and what remains unresolved, which is essential for enforcement and for guiding corrective action plans.

Recording the reason in PHIS isn’t the formal NR description requirement for association, and translating the NR description into a local language isn’t part of the association procedure. Additionally, not referencing any prior NR numbers would break the link to the issue’s history and recurrence.