Deviation Management

Test Protocol Deviations

When the actual results of a test step in a Test Protocol do not match the expected results, this is called a Deviation.

Protocol Deviation Reporting

Deviation reports should include:

• Description – How the actual results differ from the expected results
• Root Cause – What caused the deviation
• Corrective Action – What changes were made to the testing protocol or the system to correct the deviation

Deviations should be reviewed and the solution approved by the System Owner and Quality Assurance. Deviations do not necessarily need to be separate documents, but a system should be in place to ensure that all deviations are addressed before a validation project is resolved. An organization’s control over their deviation process is often reflective of their Quality organization as a whole; thus, regulatory auditors will often focus on the deviation process.