Installation Qualification Protocol for Automated Visual Inspection Machine
Document Number: IQ-AVI-001
Version: 1.0
Effective Date: 2023-10-01
Prepared By: [Your Name]
Reviewed By: [Reviewer Name]
Approved By: [Approver Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Automated Visual Inspection (AVI) Machine is installed correctly and operates according to the specified requirements for the inspection of sterile eye drops and eye ointments.
Scope
This protocol applies to the Installation Qualification of the Automated Visual Inspection Machine used in the production area for the inspection of particulates and cosmetics in ophthalmic products. The protocol will cover the verification of critical parameters, including detection sensitivity, reject logic, and audit trail functionality.
Responsibilities
The following personnel are responsible for the execution and oversight of this protocol:
- Validation Engineer: Responsible for protocol execution and documentation.
- Quality Assurance: Responsible for review and approval of the protocol.
- Production Manager: Responsible for operational oversight and support.
Prerequisites
- Completion of equipment installation.
- Availability of all necessary documentation, including User Requirement Specifications (URS) and manufacturer’s manuals.
- Training of personnel on the operation of the AVI machine.
Equipment Description
The Automated Visual Inspection Machine is designed to inspect sterile eye drops and eye ointments for particulates and cosmetic defects. The machine features advanced detection sensitivity, reject logic, and an audit trail to ensure compliance with industry standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer’s specifications. | All components installed as per the manual. | Installation checklist signed off. |
| IQ-02 | Test detection sensitivity with standard test samples. | Machine detects all specified particulates. | Test report with results. |
| IQ-03 | Check reject logic functionality. | Reject logic operates as per specifications. | Operational log and test records. |
| IQ-04 | Verify audit trail functionality. | Audit trail captures all relevant actions. | Audit trail report. |
Detailed Test Cases
Test Case ID: IQ-01
Procedure: Verify installation according to manufacturer’s specifications.
Acceptance Criteria: All components installed as per the manual.
Evidence: Installation checklist signed off by validation engineer.
Test Case ID: IQ-02
Procedure: Test detection sensitivity with standard test samples.
Acceptance Criteria: Machine detects all specified particulates.
Evidence: Test report with results indicating detection sensitivity.
Test Case ID: IQ-03
Procedure: Check reject logic functionality.
Acceptance Criteria: Reject logic operates as per specifications.
Evidence: Operational log and test records confirming reject logic performance.
Test Case ID: IQ-04
Procedure: Verify audit trail functionality.
Acceptance Criteria: Audit trail captures all relevant actions.
Evidence: Audit trail report demonstrating functionality.
Deviations
Any deviations from the acceptance criteria must be documented, including the reason for the deviation and any corrective actions taken.
Approvals
All test results must be reviewed and approved by the Quality Assurance department prior to final acceptance of the Automated Visual Inspection Machine for use in production.