Document Number: OQ-VD-001
Version: 1.0
Effective Date: YYYY-MM-DD
Review Date: YYYY-MM-DD
Operational Qualification Protocol for Viscometer/Rheometer in NDDS Analytics
Objective: To establish the operational qualification for the Viscometer/Rheometer used in critical NDDS analytics to ensure compliance with specified performance criteria.
Scope: This protocol applies to the Operational Qualification of the Viscometer/Rheometer utilized in the QC/R&D area for viscosity and rheology measurements impacting product delivery performance.
Responsibilities:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the OQ protocol and results.
- Equipment Owner: Ensure equipment is maintained and calibrated prior to OQ execution.
Prerequisites:
- Equipment must be installed and calibrated according to manufacturer’s specifications.
- All personnel involved must be trained on the operation of the Viscometer/Rheometer.
- Relevant Standard Operating Procedures (SOPs) must be available and followed.
Equipment Description:
The Viscometer/Rheometer is an instrument designed to measure the viscosity and rheological properties of fluids. It is critical for assessing delivery performance in NDDS applications.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Perform accuracy test using standard viscosity solutions. | Accuracy within ±2% of expected values. | Calibration report and test results. |
| OQ-002 | Conduct repeatability test across three separate runs. | Standard deviation < 1% of mean viscosity. | Statistical analysis report. |
| OQ-003 | Verify audit trail functionality during testing. | Complete audit trail for all test runs. | Audit log printout. |
Detailed Test Cases:
Test Case OQ-001: Accuracy Test
Objective: To verify the accuracy of the Viscometer/Rheometer.
Procedure: Use standard viscosity solutions of known values and measure viscosity with the instrument.
Acceptance Criteria: Accuracy within ±2% of expected values.
Evidence: Calibration report and test results to be documented.
Test Case OQ-002: Repeatability Test
Objective: To assess the repeatability of the viscosity measurements.
Procedure: Perform three consecutive measurements on the same sample and calculate the standard deviation.
Acceptance Criteria: Standard deviation < 1% of mean viscosity.
Evidence: Statistical analysis report detailing results.
Test Case OQ-003: Audit Trail Verification
Objective: To ensure the audit trail functionality is operational.
Procedure: Execute a test run while monitoring the audit trail functionality.
Acceptance Criteria: Complete audit trail for all test runs.
Evidence: Printout of the audit log for review.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented.
Approvals:
- Validation Team Lead: ________________________ Date: __________
- Quality Assurance Manager: ___________________ Date: __________
- Equipment Owner: ____________________________ Date: __________
Data Integrity Checks:
- Verify data entry against source data for accuracy.
- Check for any unauthorized changes in the audit trail.
- Ensure backup of data is performed regularly.