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Root Cause Analysis & Investigation Techniques Flashcards

6 cards from real CAPA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 Root Cause Analysis & Investigation Techniques flashcards as text
  1. What is the purpose of root cause analysis in the CAPA process?

    Answer: Find the underlying reason for a problem

    Root cause analysis is used to identify the underlying cause of a nonconformity to prevent recurrence.

  2. Which of the following tools is commonly used in root cause analysis?

    Answer: Fishbone Diagram

    The Fishbone Diagram helps visualize and categorize possible causes of a problem, supporting systematic analysis.

  3. Which technique is used to drill down through layers of symptoms to find the root cause?

    Answer: 5 Whys

    The '5 Whys' technique involves asking 'why' multiple times to explore the cause-and-effect relationships.

  4. What is the benefit of a multidisciplinary team in CAPA investigations?

    Answer: Ensures broader analysis of issues

    A multidisciplinary team brings diverse perspectives and expertise, improving the accuracy and completeness of the investigation.

  5. Which factor is most important when selecting a root cause analysis method?

    Answer: Issue complexity

    The complexity of the issue should guide the choice of RCA method to ensure it effectively uncovers the true root cause.

  6. After identifying a root cause, what should be done next in the CAPA process?

    Answer: Develop corrective and preventive actions

    Developing corrective and preventive actions based on the root cause ensures the problem is addressed and future issues are avoided.

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