Document Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Design Qualification Protocol for Vision System in Nasal & Otic Products
Meta Description: This document outlines the Design Qualification (DQ) Protocol for the Vision System used in the packaging and inspection of Nasal and Otic Products.
Tags: Equipment Validation, Design Qualification, Nasal Products, Otic Products, Vision System
Objective
The objective of this Design Qualification Protocol is to verify that the Vision System used for packaging and inspection of Nasal and Otic Products meets the specified requirements and operates effectively to ensure product quality.
Scope
This protocol applies to the Vision System utilized in the packaging and inspection area for both sterile and non-sterile Nasal and Otic Products. It encompasses the verification of printed data accuracy and compliance with established standards.
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 maintaining the Vision System in accordance with operational standards.
Prerequisites
- Completion of User Requirements Specification (URS) as per Annex 11.
- Installation Qualification (IQ) of the Vision System.
- Training of personnel on the Vision System operation.
Equipment Description
The Vision System is a critical equipment used in the packaging and inspection of Nasal and Otic Products. It is designed to verify printed data with a focus on accuracy and compliance. The system includes features for read rate reject logic and maintains an audit trail for all operations.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify read rate accuracy | Read rate ≥ 99% | Read rate report |
| DQ-02 | Check reject logic functionality | Reject logic triggers correctly | Test log |
| DQ-03 | Audit trail verification | Audit trail logs maintained | Audit trail report |
Detailed Test Cases
Test Case DQ-01: Verify Read Rate Accuracy
Procedure: Conduct a series of tests to measure the read rate of the Vision System.
Acceptance Criteria: The read rate must be equal to or greater than 99%.
Evidence: Documented read rate report showing results.
Test Case DQ-02: Check Reject Logic Functionality
Procedure: Simulate conditions that should trigger the reject logic and verify response.
Acceptance Criteria: The system must correctly reject non-compliant printed data.
Evidence: Documented test log with results of the reject logic test.
Test Case DQ-03: Audit Trail Verification
Procedure: Review the audit trail logs for completeness and accuracy.
Acceptance Criteria: All operations must be logged with timestamps and user IDs.
Evidence: Audit trail report showing logged operations.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team. A root cause analysis may be required for significant deviations.
Approvals
Prepared by: [Name]
Signature: ____________________
Date: [Date]
Reviewed by: [Name]
Signature: ____________________
Date: [Date]
Approved by: [Name]
Signature: ____________________
Date: [Date]