Document Control
Document ID: DQ-AVIM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Automated Visual Inspection Machine
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Automated Visual Inspection Machine meets the specified requirements for inspecting prefilled syringes and cartridges, ensuring compliance with industry standards and regulations.
Scope
This protocol applies to the Automated Visual Inspection Machine used in the production area for the inspection of prefilled syringes and cartridges.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Production Team: Responsible for providing operational support during the DQ process.
Prerequisites
- Installation Qualification (IQ) completed.
- Operational Qualification (OQ) completed.
- Relevant Standard Operating Procedures (SOPs) in place.
Equipment Description
The Automated Visual Inspection Machine is designed to inspect prefilled syringes and cartridges for defects. It utilizes advanced imaging technology to ensure inspection accuracy and includes features for reject logic and audit trail logs.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify Inspection Accuracy | 99.5% accuracy | Test Results Report |
| DQ-002 | Test Reject Logic | 100% compliance with reject criteria | Logic Test Report |
| DQ-003 | Audit Trail Logs Verification | Complete and accurate logs | Log Review Report |
Detailed Test Cases
Test Case DQ-001: Verify Inspection Accuracy
Procedure: Run a set of samples through the machine and record the inspection results. Compare against known defect rates.
Acceptance Criteria: The machine must demonstrate an inspection accuracy of 99.5% or higher.
Evidence: Documented results and statistical analysis report.
Test Case DQ-002: Test Reject Logic
Procedure: Introduce known defects into the inspection process and verify that the machine correctly rejects these items.
Acceptance Criteria: The machine must reject 100% of defective items based on defined criteria.
Evidence: Summary of rejected items and compliance report.
Test Case DQ-003: Audit Trail Logs Verification
Procedure: Review the audit trail logs generated by the machine for completeness and accuracy.
Acceptance Criteria: All logs must be complete and accurately reflect the inspection process.
Evidence: Log review report and any discrepancies noted.
Deviations
Any deviations from the acceptance criteria must be documented and addressed through appropriate corrective actions. All deviations will be reviewed by the Validation Team and Quality Assurance.
Approvals
Prepared by: ______________________ Date: ___________
Approved by: ______________________ Date: ___________
CSV Data Integrity Checks
- Ensure data input validations are in place to prevent incorrect data entry.
- Implement regular audits of the CSV data to ensure integrity and compliance.
- Maintain a log of all changes made to the CSV files, including timestamps and user identification.