Design Qualification Protocol for Manual Inspection Booth in Production
Document Control:
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Manual Inspection Booth meets the specified requirements for conducting manual inspections of Nasal and Otic products under controlled lighting conditions, thereby ensuring product quality and compliance with regulatory standards.
Scope
This protocol applies to the Manual Inspection Booth utilized in the production area for the inspection of both sterile and non-sterile Nasal and Otic products. It encompasses all aspects of the equipment’s functionality, including the verification of illuminance contrast requirements.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Lead: Oversee the validation process and ensure compliance with protocols.
- Quality Assurance: Review and approve the DQ protocol and results.
- Production Staff: Conduct the manual inspections as per the established procedures.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the Manual Inspection Booth.
- Training of personnel on the use 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 specific illuminance contrast requirements, ensuring that the quality of Nasal and Otic products is maintained.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify illuminance levels in the inspection booth. | Illuminance levels must meet the URS specifications. | Calibration report and measurement logs. |
| DQ-001-02 | Confirm contrast requirements during manual inspection. | Contrast must be within specified limits as per URS. | Inspection records and photographic evidence. |
Detailed Test Cases
Test Case DQ-001-01
Objective: To verify that the illuminance levels in the inspection booth meet the specified requirements.
Procedure: Use a calibrated light meter to measure the illuminance levels at various points within the booth.
Acceptance Criteria: Illuminance levels must be within the range specified in the URS.
Evidence: Calibration report and measurement logs will be maintained for review.
Test Case DQ-001-02
Objective: To confirm that the contrast requirements during manual inspection are met.
Procedure: Conduct a visual inspection of sample products under the booth lighting and assess contrast against established criteria.
Acceptance Criteria: Contrast must be within the limits specified in the URS.
Evidence: Inspection records and photographic evidence will be documented.
Deviations
Any deviations from the acceptance criteria must be documented and reported to the Validation Lead for evaluation. Corrective actions will be implemented as necessary.
Approvals
This protocol requires approval from the following personnel:
- Validation Lead: ___________________ Date: __________
- Quality Assurance: ___________________ Date: __________
- Production Manager: ___________________ Date: __________