CBA CBA Corrective & Preventive Action (CAPA) Management 2 — Questions and Answers
Question 1: Which of the following best describes a 'systemic' root cause in a CAPA investigation?
- A flaw in a process, procedure, or system that could affect multiple products or outcomes (Correct answer)
- A cause limited to a single nonconforming product lot or batch
- A cause related solely to a single employee's individual human error
- A cause identified exclusively through statistical process control chart analysis
Correct answer: A flaw in a process, procedure, or system that could affect multiple products or outcomes
Systemic root causes indicate weaknesses in broader processes, procedures, or systems, meaning the problem has the potential to affect multiple products, processes, or outcomes across the organization.
Question 2: What is the primary purpose of an effectiveness check in the CAPA process?
- To verify that the implemented corrective action has eliminated the root cause and prevented recurrence (Correct answer)
- To confirm that the corrective action was completed within the originally scheduled timeline
- To obtain formal regulatory approval before the corrective action is considered valid
- To calculate the cost savings achieved as a result of the corrective action
Correct answer: To verify that the implemented corrective action has eliminated the root cause and prevented recurrence
An effectiveness check provides objective evidence that the implemented CAPA successfully addressed the root cause and the nonconformity has not recurred.
Question 3: Under FDA 21 CFR Part 820, which specific section outlines the CAPA requirements for medical device manufacturers?
- Section 820.100 (Correct answer)
- Section 820.50
- Section 820.75
- Section 820.120
Correct answer: Section 820.100
21 CFR Part 820.100 specifically outlines all CAPA requirements, including investigating nonconformities, identifying corrective and preventive actions, verifying effectiveness, and documenting results.
Question 4: Which of the following types of evidence is MOST critical to document in a CAPA effectiveness check?
- Objective evidence that the identified nonconformity has not recurred after implementation (Correct answer)
- The total cost incurred to implement the corrective action across all affected areas
- Customer satisfaction survey scores collected following the corrective action implementation
- The number of personnel who received training on the corrective action procedure
Correct answer: Objective evidence that the identified nonconformity has not recurred after implementation
Objective evidence of non-recurrence directly demonstrates whether the corrective action successfully eliminated the root cause and is the most critical component of the effectiveness check.
Question 5: Which root cause analysis technique involves iteratively asking 'Why?' — typically five times — to trace a symptom to its underlying cause?
- 5 Why analysis (Correct answer)
- Fault tree analysis
- Failure Mode and Effects Analysis (FMEA)
- Statistical process control (SPC)
Correct answer: 5 Why analysis
The 5 Why technique sequentially asks 'why?' to drill through symptoms to the true root cause, typically resolving the causal chain within five iterations.
Question 6: Preventive actions in a CAPA system are BEST initiated based on which of the following inputs?
- Trend data, audit findings, or risk assessments indicating potential future nonconformities (Correct answer)
- Customer complaints confirming that existing products are already defective
- FDA warning letters received by the organization requiring immediate remediation
- Failures detected during final product inspection before shipment
Correct answer: Trend data, audit findings, or risk assessments indicating potential future nonconformities
Preventive actions are proactively triggered by data trends, risk analysis, or audit observations that indicate a potential nonconformity before it actually occurs.
Question 7: According to quality management best practices, when should a CAPA be escalated to management review?
- When the CAPA involves significant risk to product quality, patient safety, or regulatory compliance (Correct answer)
- Only when the CAPA has remained open for more than 90 calendar days without resolution
- Automatically after every corrective action is implemented and verified for effectiveness
- Only when escalation is formally requested by an external auditor during a surveillance audit
Correct answer: When the CAPA involves significant risk to product quality, patient safety, or regulatory compliance
CAPAs involving significant risks to patient safety, product quality, or regulatory compliance require leadership visibility and resource allocation, necessitating management review escalation.
CBA CBA Corrective & Preventive Action (CAPA) Management 2
Which of the following best describes a 'systemic' root cause in a CAPA investigation?