CBA CBA Corrective & Preventive Action (CAPA) Management 1 — Questions and Answers
Question 1: What is the primary purpose of a Corrective Action in a biomedical quality management system?
- To eliminate the root cause of a detected nonconformity to prevent recurrence (Correct answer)
- To identify potential nonconformities before they occur
- To document the occurrence of a nonconformity for regulatory reporting
- To retrain personnel on proper procedures after an incident
Correct answer: To eliminate the root cause of a detected nonconformity to prevent recurrence
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?
- Preventive action addresses potential nonconformities before they occur, while corrective action addresses existing ones (Correct answer)
- Corrective action is required by regulation while preventive action is optional for small manufacturers
- Preventive action is initiated only after a confirmed customer complaint is received
- Corrective action applies only to equipment failures, not to process or documentation issues
Correct answer: Preventive action addresses potential nonconformities before they occur, while corrective action addresses existing ones
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?
- 21 CFR Part 820 (Correct answer)
- 21 CFR Part 11
- 21 CFR Part 50
- 21 CFR Part 803
Correct answer: 21 CFR Part 820
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?
- Problem identification and definition (Correct answer)
- Root cause analysis
- Implementation of the corrective action
- Effectiveness verification of the solution
Correct answer: Problem identification and definition
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?
- Ishikawa (Cause-and-Effect) diagram (Correct answer)
- Pareto chart
- Fault tree analysis
- Failure Mode and Effects Analysis (FMEA)
Correct answer: Ishikawa (Cause-and-Effect) diagram
The Ishikawa (fishbone) diagram categorizes potential causes into categories such as people, process, equipment, and environment, visually mapping their relationship to the problem.
Question 6: According to FDA 21 CFR Part 820.180, what is the minimum record retention period for quality records including CAPA documentation?
- 2 years from the date the device was released for distribution (Correct answer)
- 1 year from the date of manufacture
- 5 years from the date the CAPA was closed
- Until the next scheduled FDA inspection
Correct answer: 2 years from the date the device was released for distribution
Under 21 CFR Part 820.180, quality records must be retained for at least 2 years from the date the device was released for distribution, or for the expected useful life of the device.
Question 7: In root cause analysis, what is an 'escape point'?
- The stage in the process where a defect could have been detected but was not caught (Correct answer)
- The physical location where a nonconforming product left the manufacturing facility
- The regulatory deadline for completing and closing a CAPA
- The management approval step at which a corrective action is formally accepted
Correct answer: The stage in the process where a defect could have been detected but was not caught
An escape point identifies where in the process the defect should have been detected, helping organizations strengthen detection controls to prevent future escapes.
CBA CBA Corrective & Preventive Action (CAPA) Management 1
What is the primary purpose of a Corrective Action in a biomedical quality management system?