CBA Corrective & Preventive Action (CAPA) Management Flashcards
7 cards from real CBA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 CBA Corrective & Preventive Action (CAPA) Management flashcards as text
What is the primary purpose of a Corrective Action in a biomedical quality management system?
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.
What distinguishes Preventive Action from Corrective Action in a CAPA system?
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.
Which federal regulation requires medical device manufacturers to maintain a documented CAPA system?
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.
What is the FIRST step in initiating a CAPA following identification of a nonconformity?
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.
Which root cause analysis tool uses a fishbone-shaped diagram to visually categorize potential causes of a problem?
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.
According to FDA 21 CFR Part 820.180, what is the minimum record retention period for quality records including CAPA documentation?
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.
In root cause analysis, what is an 'escape point'?
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.