CBA CBA Corrective & Preventive Action (CAPA) Management

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

To identify potential nonconformities before they occur

Answer

To document the occurrence of a nonconformity for regulatory reporting

Answer

To retrain personnel on proper procedures after an incident

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

Corrective action is required by regulation while preventive action is optional for small manufacturers

Answer

Preventive action is initiated only after a confirmed customer complaint is received

Answer

Corrective action applies only to equipment failures, not to process or documentation issues

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 11

Answer

21 CFR Part 50

Answer

21 CFR Part 803

Question 4

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

Accepted Answer

Problem identification and definition

Answer

Root cause analysis

Answer

Implementation of the corrective action

Answer

Effectiveness verification of the solution

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

Pareto chart

Answer

Fault tree analysis

Answer

Failure Mode and Effects Analysis (FMEA)

Question 6

According to FDA 21 CFR Part 820.180, what is the minimum record retention period for quality records including CAPA documentation?

Accepted Answer

2 years from the date the device was released for distribution

Answer

1 year from the date of manufacture

Answer

5 years from the date the CAPA was closed

Answer

Until the next scheduled FDA inspection

Question 7

In root cause analysis, what is an 'escape point'?

Accepted Answer

The stage in the process where a defect could have been detected but was not caught

Answer

The physical location where a nonconforming product left the manufacturing facility

Answer

The regulatory deadline for completing and closing a CAPA

Answer

The management approval step at which a corrective action is formally accepted