CBA CBA Corrective & Preventive Action (CAPA) Management 2

Question 1

Which of the following best describes a 'systemic' root cause in a CAPA investigation?

Accepted Answer

A flaw in a process, procedure, or system that could affect multiple products or outcomes

Answer

A cause limited to a single nonconforming product lot or batch

Answer

A cause related solely to a single employee's individual human error

Answer

A cause identified exclusively through statistical process control chart analysis

Question 2

What is the primary purpose of an effectiveness check in the CAPA process?

Accepted Answer

To verify that the implemented corrective action has eliminated the root cause and prevented recurrence

Answer

To confirm that the corrective action was completed within the originally scheduled timeline

Answer

To obtain formal regulatory approval before the corrective action is considered valid

Answer

To calculate the cost savings achieved as a result of the corrective action

Question 3

Under FDA 21 CFR Part 820, which specific section outlines the CAPA requirements for medical device manufacturers?

Accepted Answer

Section 820.100

Answer

Section 820.50

Answer

Section 820.75

Answer

Section 820.120

Question 4

Which of the following types of evidence is MOST critical to document in a CAPA effectiveness check?

Accepted Answer

Objective evidence that the identified nonconformity has not recurred after implementation

Answer

The total cost incurred to implement the corrective action across all affected areas

Answer

Customer satisfaction survey scores collected following the corrective action implementation

Answer

The number of personnel who received training on the corrective action procedure

Question 5

Which root cause analysis technique involves iteratively asking 'Why?' — typically five times — to trace a symptom to its underlying cause?

Accepted Answer

5 Why analysis

Answer

Fault tree analysis

Answer

Failure Mode and Effects Analysis (FMEA)

Answer

Statistical process control (SPC)

Question 6

Preventive actions in a CAPA system are BEST initiated based on which of the following inputs?

Accepted Answer

Trend data, audit findings, or risk assessments indicating potential future nonconformities

Answer

Customer complaints confirming that existing products are already defective

Answer

FDA warning letters received by the organization requiring immediate remediation

Answer

Failures detected during final product inspection before shipment

Question 7

According to quality management best practices, when should a CAPA be escalated to management review?

Accepted Answer

When the CAPA involves significant risk to product quality, patient safety, or regulatory compliance

Answer

Only when the CAPA has remained open for more than 90 calendar days without resolution

Answer

Automatically after every corrective action is implemented and verified for effectiveness

Answer

Only when escalation is formally requested by an external auditor during a surveillance audit