SOP on Operational Qualification

1.0 Objective: This document determines that the equipment operates according to specifications laid down and to record the data for its proper functioning.

2.0 Scope: Operational Qualification is to be performed after the completion of installation, modification or relocation of the equipment.

3.0 Responsibilities: Service engineer & Quality Assurance staff are responsible to perform the operational qualification and record the information.

1. List of calibration equipment required.

2. Materials needed to perform the operational qualification.

3. SOPs and data sheets for normal operations of the equipment under test.

4. Training records documenting that operators have been trained.

5. Manual for equipment. 

5.1 Test and record calibration data for equipment.

5.2 Test and record operative condition of control points and alarms.

5.3 Test and record outputs.

5.4 List of calibration requirements for the equipment under test and records of the calibration of the equipment.

5.5 Measure and record the results of specific challenge to the system in normal and worst case situation where appropriate.

5.6 Record any deviations to the procedures performed.

5.7 Prepare a deviation report including the justification of acceptance and impact on the operation.

5.8 Prepare an operational qualification report.