Document Control
Document Number: IQ-AVI-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Automated Visual Inspection System
Objective: To establish and document the Installation Qualification (IQ) of the Automated Visual Inspection (AVI) System used for particulate and cosmetic inspection in NDDS Packaging.
Scope: This protocol applies to the installation of the Automated Visual Inspection System in the Production area for NDDS Packaging, focusing on critical parameters that impact product quality.
Responsibilities:
- Validation Team: Prepare and execute the IQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Maintenance Team: Ensure proper installation of the equipment.
Prerequisites:
- All site preparation activities completed.
- Installation team trained on equipment handling.
- Availability of necessary documentation (URS, technical specifications).
Equipment Description: The Automated Visual Inspection (AVI) System is designed for high-speed inspection of packaging integrity and cosmetic defects. It employs advanced detection sensitivity and reject logic to ensure product quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-AVI-001 | Verify installation against manufacturer specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-AVI-002 | Check detection sensitivity settings. | Settings meet URS Annex11 criteria. | Calibration report. |
| IQ-AVI-003 | Review reject logic functionality. | Reject logic operates correctly per specifications. | Functional test report. |
| IQ-AVI-004 | Verify audit trail functionality. | Audit trail logs all activities accurately. | Audit trail verification report. |
Detailed Test Cases:
- Test Case ID: IQ-AVI-001
- Objective: Ensure all components are installed correctly.
- Procedure: Inspect each component against the installation checklist.
- Expected Result: All components installed as specified.
- Test Case ID: IQ-AVI-002
- Objective: Validate detection sensitivity settings.
- Procedure: Measure sensitivity settings using standard test objects.
- Expected Result: Sensitivity settings align with URS Annex11.
- Test Case ID: IQ-AVI-003
- Objective: Confirm reject logic functionality.
- Procedure: Run test objects that should be rejected and verify system response.
- Expected Result: System rejects the specified test objects.
- Test Case ID: IQ-AVI-004
- Objective: Ensure audit trail logs are accurate.
- Procedure: Review audit trail for accuracy and completeness.
- Expected Result: Audit trail reflects all activities accurately.
Deviations: Any deviations from the protocol must be documented and justified. A deviation report should be submitted for review.
Approvals:
- Prepared By: ________________________ Date: ___________
- Approved By: _______________________ Date: ___________