CBA CBA Corrective & Preventive Action (CAPA) Management 3

Question 1

What role does risk assessment play in prioritizing CAPA actions within a biomedical quality system?

Accepted Answer

It determines the urgency and resource allocation based on the severity, probability, and detectability of potential harm

Answer

It replaces the need for formal root cause analysis when time constraints are critical

Answer

It is required only for CAPA actions involving Class III medical devices

Answer

It is performed only after the CAPA has been fully implemented and closed

Question 2

Which metric BEST measures the overall effectiveness of an organization's CAPA system?

Accepted Answer

Rate of recurrence of nonconformities from previously closed CAPAs

Answer

Average number of calendar days required to close a CAPA from initial opening

Answer

Total number of new CAPAs opened within a given fiscal year

Answer

Percentage of CAPAs that were closed within their originally scheduled due date

Question 3

What is the purpose of a 'containment action' in the CAPA process?

Accepted Answer

To immediately isolate or control the impact of a nonconformity while root cause analysis is being conducted

Answer

To permanently eliminate the root cause of a nonconformity through process redesign

Answer

To document the full scope of a nonconformity for submission in a regulatory report

Answer

To prevent future nonconformities by redesigning the process after effectiveness verification

Question 4

How does a Nonconformance Report (NCR) typically relate to the CAPA system in a medical device organization?

Accepted Answer

An NCR documents a detected nonconformity and may trigger a CAPA if the issue is significant, recurring, or poses patient risk

Answer

An NCR is generated only after a CAPA has been fully completed and closed out

Answer

NCRs and CAPAs are completely independent quality records with no procedural linkage

Answer

Every NCR automatically and mandatorily generates a corresponding full CAPA for each identified issue

Question 5

In CAPA effectiveness verification, what does recurrence of a previously corrected nonconformity indicate?

Accepted Answer

The corrective action failed to adequately address the root cause and the CAPA must be reopened

Answer

The same product lot was inadvertently inspected twice during post-market surveillance

Answer

A second, separate CAPA was opened for a related but distinctly different quality issue

Answer

The corrective action exceeded its originally scheduled completion date before being implemented

Question 6

Which ISO standard includes CAPA requirements specifically harmonized with FDA regulations for the medical device industry?

Accepted Answer

ISO 13485

Answer

ISO 9001

Answer

ISO 14971

Answer

ISO 15189

Question 7

What distinguishes a systemic corrective action from a point correction (immediate fix) in CAPA management?

Accepted 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

Answer

A point correction requires management review and approval while a systemic corrective action does not need leadership sign-off

Answer

A systemic corrective action is required only for Class III medical device nonconformities by FDA regulation

Answer

A point correction eliminates the root cause permanently while a systemic action manages and monitors symptoms over time