Document Control
Protocol Number: OQ-DEV-INS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Name]
Approved By: [Name]
Operational Qualification Protocol for Device Inspection System
Objective: To validate the Device Inspection System for inspecting coating defects and dimensions of drug-eluting stents, ensuring compliance with established acceptance criteria.
Scope: This protocol applies to the Operational Qualification of the Device Inspection System used in the QC/R&D area for drug-eluting stents and coated devices.
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:
- Device Inspection System is installed and operational.
- Calibration of the Device Inspection System is completed and documented.
- All personnel involved are trained on the use of the Device Inspection System.
Equipment Description:
The Device Inspection System (Vision/Microscopy) is designed to inspect the coating defects and dimensions of drug-eluting stents. It utilizes advanced imaging technology to ensure high detection accuracy.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Calibration Verification | Calibration data must show accuracy within ±5% of known standards. | Calibration report |
| OQ-02 | Image Quality Assessment | Images must be clear, with no distortion or artifacts. | Sample images |
| OQ-03 | Defect Detection Test | Must correctly identify at least 95% of defects. | Test results report |
| OQ-04 | Data Integrity Check | Data must be retrievable and unchanged post-analysis. | Data integrity report |
Detailed Test Cases:
Test Case OQ-01: Calibration Verification
- Procedure: Verify calibration using standard reference materials.
- Expected Result: Calibration data shows accuracy within the specified limits.
Test Case OQ-02: Image Quality Assessment
- Procedure: Capture images of the device under standard conditions.
- Expected Result: Images are clear and free from distortions.
Test Case OQ-03: Defect Detection Test
- Procedure: Test system on known defective and non-defective samples.
- Expected Result: System identifies at least 95% of defects correctly.
Test Case OQ-04: Data Integrity Check
- Procedure: Perform checks to ensure data is intact and retrievable.
- Expected Result: Data remains unchanged and accessible.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan must be developed and approved by the Quality Assurance team.
Approvals:
__________________________
Prepared By: [Name]
Date: [Insert Date]
__________________________
Approved By: [Name]
Date: [Insert Date]