Periodic Review and Requalification

Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained in a qualified state throughout the life-cycle of the utility or equipment. Utilities and equipment should be maintained in a qualified state throughout the life-cycle of the utility or equipment. Utilities and equipment should be reviewed periodically, to confirm that they remain in a qualified state or to determine the need for requalification. Where the need for requalification is identified, this should be performed. Principles of risk management should be applied in the review and requalification and the possible impact of small changes over a period of time should further be considered (such as, through change control). Principles of risk management may include factors such as calibration, verification, maintenance data and other information. The qualification status and periodic requalification due dates should be documented, for example, in a qualification matrix, schedule or plan. In case a utility or equipment in use is identified that has not been subjected to qualification, a qualification protocol should be prepared where elements of URS, design specifications, operation and performance are verified for acceptability. The outcome of this qualification should be recorded in a report.