Document Control Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver Name]
Design Qualification Protocol for Device Inspection System
Meta Description: This document outlines the Design Qualification Protocol for the Device Inspection System used in inspecting drug-eluting stents and coated devices, ensuring compliance with critical quality standards.
Tags: Equipment Validation, Drug-Eluting Stents, Quality Control, R&D
Objective
The objective of this Design Qualification (DQ) Protocol is to validate the Device Inspection System used for inspecting coating defects and dimensions of drug-eluting stents and coated devices, ensuring it meets the required specifications and regulatory standards.
Scope
This protocol applies to the Device Inspection System (Vision/Microscopy) utilized in the QC/R&D area for direct impact on the product quality of drug-eluting stents and coated devices.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Equipment Owner: Responsible for ensuring the Device Inspection System is maintained and calibrated.
Prerequisites
- Completion of User Requirement Specification (URS) as per Annex 11.
- Calibration of the Device Inspection System.
- Training of personnel on 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 and coated devices, ensuring compliance with specified standards. The system includes advanced imaging capabilities to detect minute defects and measure critical dimensions accurately.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Calibration of detection accuracy | Calibration data integrity maintained; accuracy within ±0.1mm | Calibration report |
| DQ-001-02 | Verification of defect detection | Detection rate ≥ 95% for known defects | Test results log |
| DQ-001-03 | Data integrity check | No data loss; all records retrievable | Data integrity report |
Detailed Test Cases
Test Case: DQ-001-01
Objective: Validate the calibration of detection accuracy.
Procedure: Perform calibration checks using known standards. Record the measurements and compare them against the predefined criteria.
Acceptance Criteria: Calibration data integrity maintained; accuracy within ±0.1mm.
Evidence: Calibration report.
Test Case: DQ-001-02
Objective: Verify the system’s defect detection capability.
Procedure: Introduce known defects to the system and assess the detection rate.
Acceptance Criteria: Detection rate ≥ 95% for known defects.
Evidence: Test results log.
Test Case: DQ-001-03
Objective: Ensure data integrity during operation.
Procedure: Conduct checks to confirm that all data is accurately recorded and retrievable.
Acceptance Criteria: No data loss; all records retrievable.
Evidence: Data integrity report.
Deviations
Any deviations from the acceptance criteria or procedures must be documented and justified. A root cause analysis should be conducted, and corrective actions must be implemented.
Approvals
This protocol must be reviewed and approved by the Quality Assurance team and the equipment owner prior to execution.