Operational Qualification Protocol for Automated Visual Inspection Machine
Document Control:
- Document Number: OQ-AVIM-001
- Version: 1.0
- Effective Date: [Insert Date]
- Reviewed by: [Insert Name]
- Approved by: [Insert Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Automated Visual Inspection Machine operates in accordance with its intended use and meets the acceptance criteria defined in the User Requirements Specification (URS) Annex 11.
Scope
This protocol applies to the qualification of the Automated Visual Inspection Machine used in the production area for inspecting prefilled syringes and cartridges.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Team: Execute the qualification tests and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary support and access to the machine.
Prerequisites
Before executing this protocol, the following must be completed:
- Installation Qualification (IQ) must be successfully completed.
- All relevant standard operating procedures (SOPs) must be in place and accessible.
Equipment Description
The Automated Visual Inspection Machine is designed to inspect prefilled syringes and cartridges for visual defects. It utilizes advanced imaging technology to ensure inspection accuracy and maintain an audit trail of inspection results.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify inspection accuracy | Inspection accuracy ≥ 99% | Test report and logs |
| OQ-02 | Test reject logic | Reject logic functions correctly | Test report and logs |
| OQ-03 | Verify audit trail logs | All actions logged correctly | Audit trail report |
Detailed Test Cases
Test Case OQ-01: Verify Inspection Accuracy
Procedure: Run a set of known defect samples through the machine. Document the inspection results.
Acceptance Criteria: The machine must accurately identify ≥ 99% of defects.
Test Case OQ-02: Test Reject Logic
Procedure: Simulate a defect and ensure the machine rejects the sample accordingly.
Acceptance Criteria: The machine must reject the defected sample without error.
Test Case OQ-03: Verify Audit Trail Logs
Procedure: Review the audit trail logs post-inspection for completeness and accuracy.
Acceptance Criteria: All actions must be logged with timestamps and user IDs.
Deviations
Any deviations from the acceptance criteria must be documented and addressed according to the deviation management SOP.
Approvals
This protocol has been reviewed and approved by:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________