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
A quality manager wants to demonstrate CAPA system improvement to leadership. Which data presentation is MOST compelling?
Answer: Trend charts showing declining recurrence rates over 12 months
Declining recurrence rates over time directly demonstrate that corrective actions are eliminating root causes and improving the quality system.
Under ISO 9001:2015, when a nonconformity is detected, what is the FIRST required action?
Answer: React to the nonconformity and control it
Clause 10.2.1(a) requires organizations to first react to the nonconformity by taking action to control and correct it before proceeding to root cause analysis.
An auditor finds that an organization uses the same corrective action (retraining) for every type of nonconformity. This suggests:
Answer: Inadequate root cause analysis leading to generic fixes
Defaulting to retraining regardless of root cause indicates root cause analysis is not being performed or used to drive appropriate corrective actions.
Which of the following sources of data would MOST likely trigger a preventive action under risk-based thinking?
Answer: Analysis of process performance trends showing gradual degradation
Trend analysis revealing gradual degradation enables proactive intervention before a nonconformity occurs, embodying preventive intent under risk-based thinking.
During a surveillance audit, an auditor verifies a previously closed CAPA and finds the problem has recurred. What should the auditor do?
Answer: Raise a new nonconformity for ineffective corrective action
Recurrence after closure indicates the corrective action was ineffective, which is a nonconformity against ISO 9001 clause 10.2 requirements for effective action.
What is the PRIMARY purpose of linking CAPAs to specific clauses of ISO 9001 in a tracking system?
Answer: To identify systemic weaknesses in specific QMS elements
Linking CAPAs to ISO clauses enables trend analysis to reveal which QMS elements have recurring weaknesses, guiding systemic improvement efforts.
An organization's CAPA procedure states that all actions must be completed within 30 days regardless of complexity. An auditor should flag this as:
Answer: A potential risk of superficial fixes due to arbitrary time constraints
Rigid universal timelines can pressure teams into superficial fixes for complex issues rather than thorough root cause elimination.