What is the purpose of root cause analysis in the CAPA process?
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Root cause analysis is used to identify the underlying cause of a nonconformity to prevent recurrence.
Which of the following tools is commonly used in root cause analysis?
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The Fishbone Diagram helps visualize and categorize possible causes of a problem, supporting systematic analysis.
Which technique is used to drill down through layers of symptoms to find the root cause?
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The '5 Whys' technique involves asking 'why' multiple times to explore the cause-and-effect relationships.
What is the benefit of a multidisciplinary team in CAPA investigations?
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A multidisciplinary team brings diverse perspectives and expertise, improving the accuracy and completeness of the investigation.
Which factor is most important when selecting a root cause analysis method?
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The complexity of the issue should guide the choice of RCA method to ensure it effectively uncovers the true root cause.
After identifying a root cause, what should be done next in the CAPA process?
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Developing corrective and preventive actions based on the root cause ensures the problem is addressed and future issues are avoided.