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
Which of the following best describes a 'systemic' root cause in a CAPA investigation?
Answer: A flaw in a process, procedure, or system that could affect multiple products or outcomes
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.
What is the primary purpose of an effectiveness check in the CAPA process?
Answer: To verify that the implemented corrective action has eliminated the root cause and prevented recurrence
An effectiveness check provides objective evidence that the implemented CAPA successfully addressed the root cause and the nonconformity has not recurred.
Under FDA 21 CFR Part 820, which specific section outlines the CAPA requirements for medical device manufacturers?
Answer: Section 820.100
21 CFR Part 820.100 specifically outlines all CAPA requirements, including investigating nonconformities, identifying corrective and preventive actions, verifying effectiveness, and documenting results.
Which of the following types of evidence is MOST critical to document in a CAPA effectiveness check?
Answer: Objective evidence that the identified nonconformity has not recurred after implementation
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.
Which root cause analysis technique involves iteratively asking 'Why?' — typically five times — to trace a symptom to its underlying cause?
Answer: 5 Why analysis
The 5 Why technique sequentially asks 'why?' to drill through symptoms to the true root cause, typically resolving the causal chain within five iterations.
Preventive actions in a CAPA system are BEST initiated based on which of the following inputs?
Answer: Trend data, audit findings, or risk assessments indicating potential future nonconformities
Preventive actions are proactively triggered by data trends, risk analysis, or audit observations that indicate a potential nonconformity before it actually occurs.
According to quality management best practices, when should a CAPA be escalated to management review?
Answer: When the CAPA involves significant risk to product quality, patient safety, or regulatory compliance
CAPAs involving significant risks to patient safety, product quality, or regulatory compliance require leadership visibility and resource allocation, necessitating management review escalation.