Document Number: DQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Design Qualification Protocol for Vision System in IV Infusions
Meta Description: This document outlines the Design Qualification protocol for the Vision System used in IV Infusions for label and code verification.
Tags: Equipment Validation, Design Qualification, Vision System, IV Infusions
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Vision System used for code and label verification in IV Infusions meets all specified requirements and functions as intended within the packaging and inspection area.
Scope
This protocol applies to the Vision System utilized in the verification of labels and codes on LVP/SVP bags and bottles. It covers all aspects of the system’s functionality, including performance, usability, and compliance with regulatory 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.
- Operations: Responsible for providing necessary resources and support during the DQ process.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) completed and approved.
- Access to relevant Standard Operating Procedures (SOPs).
Equipment Description
The Vision System is a critical piece of equipment used for verifying the accuracy of labels and codes on IV infusion bags and bottles. It features advanced optical technology to ensure high read rates and includes reject logic and audit trail capabilities.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Read Rate Verification | Read rate ≥ 99% | Read rate report |
| DQ-02 | Reject Logic Functionality | Reject logic operates correctly with < 1% false rejects | Test results log |
| DQ-03 | Audit Trail Verification | Audit trail captures all events accurately | Audit trail report |
Detailed Test Cases
Test Case DQ-01: Read Rate Verification
Objective: To verify that the Vision System achieves the required read rate.
Procedure: Test the system with a sample of 100 labels. Record the number of successful reads.
Acceptance Criteria: Read rate must be ≥ 99%.
Evidence: Documented read rate results.
Test Case DQ-02: Reject Logic Functionality
Objective: To ensure that the reject logic functions as designed.
Procedure: Test the system with known defective labels and measure the reject rate.
Acceptance Criteria: Reject logic must result in < 1% false rejects.
Evidence: Log of test results.
Test Case DQ-03: Audit Trail Verification
Objective: To confirm that the audit trail accurately captures all relevant events.
Procedure: Review the audit trail for recorded events during the test phase.
Acceptance Criteria: All events must be logged without omission.
Evidence: Copy of the audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented with a justification and submitted for approval. A corrective action plan should be developed as necessary.
Approvals
All results and documentation must be reviewed and approved by the Quality Assurance team before the Vision System can be deemed qualified for use in the production environment.