Document Control Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Operational Qualification Protocol for Manual Inspection Booth
Meta Description: This document outlines the Operational Qualification protocol for the Manual Inspection Booth used in the production of nasal and otic products, focusing on illuminance contrast requirements.
Tags: Equipment Validation, OQ, Manual Inspection Booth, Nasal Products, Otic Products
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Manual Inspection Booth operates within the specified parameters to ensure effective manual inspection of nasal and otic products under controlled lighting conditions.
Scope
This protocol applies to the Manual Inspection Booth used in the production area for the manual inspection of both sterile and non-sterile nasal and otic products. The focus is on confirming that the equipment meets the illuminance contrast requirements as defined in the User Requirements Specification (URS).
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance (QA): Responsible for reviewing and approving the OQ documentation.
- Production Personnel: Responsible for operating the Manual Inspection Booth during the qualification process.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of the Manual Inspection Booth in the production area.
- Training of personnel on the operation of the Manual Inspection Booth.
Equipment Description
The Manual Inspection Booth is designed for manual inspection of products under controlled lighting conditions. It features adjustable lighting to meet the specified illuminance contrast requirements for effective visual inspection.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Measure illuminance levels at various points within the booth. | Illuminance levels must meet the requirements specified in the URS. | Illuminance measurement report. |
| OQ-002 | Verify contrast levels during product inspection. | Contrast levels must be within acceptable limits as per the URS. | Contrast measurement report. |
Detailed Test Cases
Test Case OQ-001
Objective: To measure the illuminance levels within the Manual Inspection Booth.
Procedure: Use a calibrated illuminance meter to measure light levels at multiple points in the booth. Record the values.
Acceptance Criteria: All measurements must meet the specifications set forth in the URS.
Evidence: Provide a report detailing the measurements taken and their compliance with the URS.
Test Case OQ-002
Objective: To verify the contrast levels during product inspection.
Procedure: Conduct a visual inspection of a sample product under the lighting conditions of the booth and assess the contrast.
Acceptance Criteria: Contrast levels must be within the acceptable limits defined in the URS.
Evidence: Document the results of the visual inspection and any observations made during the process.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals
Prepared by: ___________________ Date: _______________
Reviewed by: ___________________ Date: _______________
Approved by: ___________________ Date: _______________