When the actual results of a test step in a Test Protocol do not match the expected results, this is called a Deviation.
Deviation reports should include:
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.
Deviation Management is a central feature of the FastVal software. Deviations are captured in real time, with associated screenshots and tester notes added to the record. Additional information, such as as root cause and corrective actions, can be added as they are identified. Deviation summaries are generated automatically, and tracking and metrics tools allow for continual process improvement and enhanced Quality Control.