Document Control
Document Number: OQ-AVI-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Operational Qualification Protocol for Automated Visual Inspection System
Meta Description: This document outlines the Operational Qualification protocol for the Automated Visual Inspection System used in NDDS Packaging and Integrity.
Tags: Equipment Validation, Operational Qualification, NDDS, Automated Visual Inspection, Quality Assurance
Objective
The objective of this protocol is to establish and document the Operational Qualification (OQ) of the Automated Visual Inspection (AVI) System used for particulate and cosmetic inspection in NDDS packaging.
Scope
This protocol applies to the Automated Visual Inspection System utilized in the Production area for NDDS packaging. It encompasses the validation of the system’s capability to detect particulates and cosmetic defects that could impact product integrity.
Responsibilities
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the AVI system according to SOPs.
Prerequisites
- Completion of Installation Qualification (IQ).
- Training of personnel on the operation of the AVI system.
- Availability of test samples and reference materials.
Equipment Description
The Automated Visual Inspection (AVI) System is designed to perform real-time inspection of NDDS packaging for particulates and cosmetic defects. Key features include:
- Detection sensitivity
- Reject logic
- Audit trail capabilities
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-AVI-01 | Verify detection sensitivity using standard test particles. | Must detect 95% of particles. | Test report and logs. |
| OQ-AVI-02 | Evaluate reject logic functionality. | Reject logic must activate for detected defects. | System logs and audit trail. |
| OQ-AVI-03 | Check audit trail integrity. | Audit trail must log all actions accurately. | Audit trail report. |
Detailed Test Cases
Test Case OQ-AVI-01: Detection Sensitivity
Objective: To verify the detection sensitivity of the AVI system.
Procedure: Conduct a series of tests using standard test particles of various sizes. Document the detection rates.
Acceptance Criteria: The system must detect at least 95% of the test particles.
Expected Outcome: A report confirming detection rates with supporting data.
Test Case OQ-AVI-02: Reject Logic
Objective: To evaluate the functionality of the reject logic.
Procedure: Introduce defects in the test samples and observe the system’s response.
Acceptance Criteria: The system must activate the reject logic for all detected defects.
Expected Outcome: Evidence of rejects logged in the system.
Test Case OQ-AVI-03: Audit Trail Integrity
Objective: To ensure the integrity of the audit trail.
Procedure: Review the audit trail for accuracy and completeness after conducting tests.
Acceptance Criteria: All actions must be logged accurately without discrepancies.
Expected Outcome: A comprehensive audit trail report.
Deviations
Any deviations from the established acceptance criteria must be documented and reviewed by the Validation Team and Quality Assurance. Justifications for deviations should be provided, along with proposed corrective actions.
Approvals
Prepared By: ______________________ Date: ____________
Reviewed By: ______________________ Date: ____________
Approved By: ______________________ Date: ____________