Deviation Report: Root Cause Analysis
Quiz
•
English
•
Professional Development
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Practice Problem
•
Medium
Kelly Zepp
Used 2+ times
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5 questions
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1.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
What does the Investigation section of a deviation report include?
Steps taken to document the deviation and its impact
Results of the historical review
Identified CAPA plan
Technical justification for impact analysis
All of the above
2.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
What is the purpose of the Root Cause section in a deviation report?
To document the impact assessment and historical review
To identify the fundamental reason or cause for the deviation
To outline the CAPA plan
To provide technical justification for the deviation
3.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
When should a root cause analysis tool be used in the deviation investigation?
For all deviations regardless of severity
Only for deviations with recurring issues
Only for major or critical deviations
Only for deviations involving human errors
4.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
What are some factors or conditions that may contribute to a deviation?
Equipment malfunctions or failures
Human errors or mistakes
Deficiencies in training or knowledge
All of the above
5.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
What is the purpose of implementing preventive actions in response to a deviation?
To address the root causes and prevent recurrence
To evaluate the effectiveness of the corrective actions
To track the progress of the implementation
To identify the contributing factors to the deviation
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