Elements of a deviation report

How many sections are there in a deviation report?

• 5

• 7

• 9

• 11

Match the section of the deviation report to its definition.

• This section investigates and identifies the underlying causes of the deviation.

• Root Cause Analysis

• This section contains information such as the title of the report, the date it was generated, etc.

• Header

• In this section, the actual or potential impact of the deviation is assessed.

• Impact Assessment

• This section provides a detailed account of the deviation incident.

• Initial Description

• This section highlights the actions taken immediately after the occurrence of the deviation.

• Immediate Corrective Action

Match the section of the deviation report to its definition.

• This section provides a comprehensive evaluation of the actual or potential impact of the deviation

• Final Impact Assessment:

• This section serves as a summary and closing statement that encapsulates the key findings, actions t

• CAPA

• This section contains This section provides an overview of any past incidents or similar deviations

• Historical Review

• This section outlines the specific corrective actions taken to address the immediate issue and preve

• Conclusion

CAPA stands for which of the following:

• Cute and Pretty Animals

• Cause and Predictive Analysis

• Corrective and Preventive Actions

• Corrective and Protective Assessment

According to the 6M cause and effect framework, which of these is not a potential root cause?

• manpower

• methods

• machines

• materials

• modality

According to the 6M cause and effect framework, which of these is not a potential root cause?

• Measurements

• Monitoring

• Mothers Nature

• Management

• Maintenance