Document ID: IQ-PWST-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Installation Qualification Protocol for Purified Water Storage Tank
Objective: To establish and document the Installation Qualification (IQ) of the Purified Water (PW) Storage Tank to ensure it meets the specified requirements for storing purified water.
Scope: This protocol applies to the Installation Qualification of the PW Storage Tank located in the Utilities area, utilized for storing purified water with a direct impact on product quality.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is maintained and operational during the qualification process.
Prerequisites:
- Completion of the Design Qualification (DQ) for the PW Storage Tank.
- Installation of the PW Storage Tank as per manufacturer specifications.
- Availability of necessary tools and instruments for testing.
Equipment Description: The PW Storage Tank is designed to store purified water, ensuring microbial integrity and maintaining temperature levels critical for product quality. The tank is constructed from stainless steel and equipped with temperature sensors and monitoring systems.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against the URS Annex 15 requirements. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-02 | Check temperature level monitoring system functionality. | Temperature readings within specified range. | Calibration certificate and logs. |
| IQ-03 | Verify microbial integrity of the system. | No microbial contamination detected. | Microbial test results. |
Detailed Test Cases:
- Test ID IQ-01: Review installation documentation and physical inspection of the PW Storage Tank. Ensure all components match the specifications outlined in the URS Annex 15.
- Test ID IQ-02: Conduct a functional test of the temperature monitoring system. Document the temperature readings against the acceptance criteria.
- Test ID IQ-03: Perform microbial testing on the water stored in the tank to confirm the absence of contaminants. Document the results in the validation report.
Deviations: Any deviations from the acceptance criteria must be documented and evaluated for impact on product quality. Appropriate corrective actions must be initiated.
Approvals:
- _______________________ [Validation Team Lead]
- _______________________ [Quality Assurance Representative]
- _______________________ [Maintenance Supervisor]