CBA CBA Corrective & Preventive Action (CAPA) Management 1

Question 1

What is the primary purpose of a Corrective Action in a biomedical quality management system?

Accepted Answer

To eliminate the root cause of a detected nonconformity to prevent recurrence

Answer

Corrective action targets the root cause of an existing nonconformity specifically to prevent it from recurring in the future.

Question 2

What distinguishes Preventive Action from Corrective Action in a CAPA system?

Accepted Answer

Preventive action addresses potential nonconformities before they occur, while corrective action addresses existing ones

Answer

Preventive action is proactive, addressing potential problems before they occur, while corrective action is reactive to nonconformities that have already been identified.

Question 3

Which federal regulation requires medical device manufacturers to maintain a documented CAPA system?

Accepted Answer

21 CFR Part 820

Answer

21 CFR Part 820 (the Quality System Regulation) mandates CAPA procedures for medical device manufacturers specifically under Subpart J, Section 820.100.

Question 4

What is the FIRST step in initiating a CAPA following identification of a nonconformity?

Accepted Answer

Problem identification and definition

Answer

The CAPA process must begin with clearly identifying and defining the problem before any analysis or corrective measures can be properly scoped and executed.

Question 5

Which root cause analysis tool uses a fishbone-shaped diagram to visually categorize potential causes of a problem?

Accepted Answer

Ishikawa (Cause-and-Effect) diagram

Answer

The Ishikawa (fishbone) diagram categorizes potential causes into categories such as people, process, equipment, and environment, visually mapping their relationship to the problem.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA CBA Corrective & Preventive Action (CAPA) Management 1