Document Number: OQ-TPB-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for Top Pan Balance in QC Laboratory
Objective: To validate the operational performance of the Top Pan Balance used for weighing bulk samples in the QC Laboratory.
Scope: This protocol applies to the Top Pan Balance utilized in the QC Lab for weighing purposes, impacting product quality directly.
Responsibilities:
- Validation Team: Prepare, execute, and document the OQ protocol.
- Quality Assurance: Review and approve the OQ protocol and results.
- Laboratory Personnel: Operate the Top Pan Balance and report any anomalies.
Prerequisites:
- Installation Qualification (IQ) must be completed.
- All personnel must be trained on the use of the Top Pan Balance.
Equipment Description: The Top Pan Balance is an electronic instrument designed for precise weighing of bulk samples in the QC Laboratory. It is critical for ensuring accurate measurements that directly affect product quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-TPB-01 | Verify accuracy using certified weights. | Accuracy within ±0.01g of certified weight. | Calibration report. |
| OQ-TPB-02 | Check repeatability by weighing the same sample multiple times. | Standard deviation ≤ 0.005g. | Weighing log. |
Detailed Test Cases:
- Test Case 1: Use a certified weight of 100g to check accuracy. Record the balance reading and calculate the deviation from the certified weight.
- Test Case 2: Weigh a 50g sample five times consecutively and calculate the standard deviation to ensure repeatability.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be initiated if criteria are not met.
Approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________