CAPA Implementation & Tracking Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 CAPA Implementation & Tracking flashcards as text
During a CAPA audit, you find that corrective actions were implemented but the problem recurred six months later. What does this most likely indicate?
Answer: The root cause was not correctly identified
Recurrence of a problem after corrective action typically indicates that the true root cause was not identified and the action addressed only symptoms.
Which metric is MOST useful for tracking the effectiveness of a CAPA system over time?
Answer: Recurrence rate of corrective actions
Recurrence rate directly measures whether corrective actions eliminated root causes, making it the best effectiveness indicator.
An organization closes a CAPA without completing the effectiveness check. Under ISO 9001, this is BEST described as:
Answer: A nonconformity against clause 10.2 requirements
ISO 9001 clause 10.2.1(f) explicitly requires reviewing the effectiveness of corrective actions taken, making omission a nonconformity.
When tracking preventive actions under ISO 9001:2015, an auditor should note that:
Answer: Risk-based thinking in clause 6.1 has absorbed the preventive action concept
ISO 9001:2015 replaced the explicit preventive action clause with risk-based thinking embedded throughout the standard, particularly in clause 6.1.
A CAPA tracking system shows 45 open corrective actions, with 30 past their due date. What should an auditor recommend first?
Answer: Review prioritization criteria and assess risk of overdue items
Reviewing prioritization and risk assessment ensures that the most critical overdue CAPAs are addressed first rather than just reducing the number.
Which of the following BEST demonstrates that a CAPA process is truly preventive rather than reactive?
Answer: Trend analysis of near-misses triggers CAPAs before failures occur
Using trend analysis of near-misses to initiate CAPAs represents proactive prevention, which is the intent of risk-based thinking in ISO 9001:2015.
During CAPA implementation, an auditor observes that corrective actions are consistently assigned to individuals without authority to change the process. This is MOST likely to cause:
Answer: Ineffective corrective actions and recurring nonconformities
Assigning CAPAs to people without process authority means they cannot implement systemic changes, leading to superficial fixes and recurrence.