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

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?

Accepted Answer

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

Answer

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?

Accepted Answer

Section 820.100

Answer

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?

Accepted Answer

Objective evidence that the identified nonconformity has not recurred after implementation

Answer

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?

Accepted Answer

5 Why analysis

Answer

The 5 Why technique sequentially asks 'why?' to drill through symptoms to the true root cause, typically resolving the causal chain within five iterations.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA CBA Corrective & Preventive Action (CAPA) Management 2