CBA Corrective & Preventive Action (CAPA) Management Flashcards
7 cards from real CBA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 CBA Corrective & Preventive Action (CAPA) Management flashcards as text
What role does risk assessment play in prioritizing CAPA actions within a biomedical quality system?
Answer: It determines the urgency and resource allocation based on the severity, probability, and detectability of potential harm
Risk assessment guides CAPA prioritization by evaluating severity, probability, and detectability of harm, ensuring the most critical issues receive immediate attention and appropriate resources.
Which metric BEST measures the overall effectiveness of an organization's CAPA system?
Answer: Rate of recurrence of nonconformities from previously closed CAPAs
Recurrence rate directly measures whether corrective actions truly addressed the root cause; a low recurrence rate is the most meaningful indicator that the CAPA system is functioning effectively.
What is the purpose of a 'containment action' in the CAPA process?
Answer: To immediately isolate or control the impact of a nonconformity while root cause analysis is being conducted
Containment actions are immediate, short-term measures taken to limit the spread or impact of a nonconformity while the organization investigates and develops a permanent corrective action.
How does a Nonconformance Report (NCR) typically relate to the CAPA system in a medical device organization?
Answer: An NCR documents a detected nonconformity and may trigger a CAPA if the issue is significant, recurring, or poses patient risk
NCRs capture individual nonconformity events and, based on risk level, recurrence, or significance criteria, may trigger a CAPA investigation to address underlying root causes.
In CAPA effectiveness verification, what does recurrence of a previously corrected nonconformity indicate?
Answer: The corrective action failed to adequately address the root cause and the CAPA must be reopened
Recurrence confirms that the implemented corrective action did not fully eliminate the root cause, requiring the CAPA to be reopened and the investigation to be expanded or revised.
Which ISO standard includes CAPA requirements specifically harmonized with FDA regulations for the medical device industry?
Answer: ISO 13485
ISO 13485 is the international quality management standard specifically designed for medical devices and includes CAPA requirements closely aligned with FDA 21 CFR Part 820.
What distinguishes a systemic corrective action from a point correction (immediate fix) in CAPA management?
Answer: A systemic corrective action modifies the underlying process or system to prevent recurrence organization-wide, while a point correction only addresses the immediate instance
Systemic corrective actions change the underlying system, procedure, or process to prevent the nonconformity from occurring at any point in the organization, while point corrections only fix the single immediate instance.