Deviation Report: Root Cause Analysis

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

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

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

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

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