When issuing the deviation, details of the deviation such as

• Name of the Deviation Observer
• Time of the Observation
• Initial Reaction to the Deviation
• Possible Causes
• Details of the Procedure or Standard Deviated

are included in the description of the deviation.

Detailing the description of the deviation is specially challenging and can even become tedious.

But no matter how unpleasant it might be, a detailed description is the most crucial step in the deviation management sequence.

Deviation Entry and Sequencing

The Quality Assurance Department should maintain a database of all deviations raised, this should provide a summary of the following information about each deviation:

• Deviation Reference Number
• Date Deviation Occurred
• Date Deviation Recognized
• Date Deviation Reported
• Brief Description of Deviation
• Procedures Affected
• Departments Affected
• Product(s)/Batch(es) Affected
• Reported By
• Deviation Categories
• Corrective and Preventative Action (CAPA) Plan
• Location of Deviation Report
• The Closure Date