Operational Qualification Protocol for Conductivity Meter in QC Laboratory

Objective: To validate the Conductivity Meter used in the QC laboratory for accurate conductivity measurement, ensuring compliance with URS Annex11.

Scope: This protocol applies to the Operational Qualification of the Conductivity Meter utilized in the QC Lab for direct product impact measurements.

Responsibilities:

• Validation Team: Execute the OQ protocol and document results.
• Quality Assurance: Review and approve the OQ protocol and results.
• Laboratory Personnel: Ensure proper operation and maintenance of the Conductivity Meter.

Prerequisites:

• Conductivity Meter must be installed and calibrated.
• All personnel must be trained on the use of the Conductivity Meter.
• Relevant SOPs must be reviewed and available.

Equipment Description:

The Conductivity Meter is an instrument designed for measuring the conductivity of solutions in the QC laboratory. It is critical for ensuring product quality and compliance with specifications.

Detailed Test Cases:

Test Case OQ-01: Verify Accuracy Calibration

Objective: To ensure the Conductivity Meter provides accurate measurements.

Procedure: Use standard conductivity solutions to verify calibration.

Acceptance Criteria: Calibration must be within ± 1% of the known standard values.

Evidence: Document results in calibration report.

Test Case OQ-02: Check Audit Trail Functionality

Objective: To confirm that the Conductivity Meter maintains a complete audit trail.

Procedure: Conduct multiple measurements and review the audit trail.

Acceptance Criteria: The audit trail must show all measurement entries with timestamps and user IDs.

Evidence: Document results in audit trail report.

Deviations:

Any deviations from the acceptance criteria must be documented and investigated. A CAPA (Corrective and Preventive Action) process should be initiated as necessary.

Approvals:

Prepared By: ______________________ Date: ___________

Approved By: ______________________ Date: ___________