Document ID: OQ-CFM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Automatic Capsule Filling Machine
Objective: To validate the operational performance of the Automatic Capsule Filling Machine to ensure it meets specified requirements for capsule filling in production.
Scope: This protocol applies to the Operational Qualification of the Automatic Capsule Filling Machine used in the production area for capsule filling processes.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Team: Responsible for ensuring the equipment is available and maintained during the OQ process.
Prerequisites:
- Installation Qualification (IQ) must be completed and documented.
- All personnel involved must be trained on the equipment and validation processes.
- Necessary materials and resources must be available for testing.
Equipment Description:
The Automatic Capsule Filling Machine is designed for efficient filling of capsules with powder or granules. It features programmable logic control (PLC) for precise operation and monitoring of critical parameters such as fill weight, speed, and reject rates.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify Fill Weight Accuracy | Fill weight within +/- 5% of target | Calibration report, weight data |
| OQ-02 | Check Speed Settings | Speed settings match PLC input | PLC configuration report |
| OQ-03 | Evaluate Reject Rate | Reject rate < 2% | Production log, reject report |
Detailed Test Cases:
- Test Case OQ-01: Weigh 10 filled capsules and calculate the average fill weight. Verify against target weight.
- Test Case OQ-02: Set the machine to various speed settings and monitor via PLC. Document settings and actual output.
- Test Case OQ-03: Run the machine for a set period and record the number of rejected capsules. Calculate the reject rate.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be conducted, and corrective actions must be implemented.
Approvals:
Validation Team Lead: ______________________ Date: ___________
Quality Assurance Manager: _________________ Date: ___________
Data Integrity Checks:
- Regular backups of PLC data logs.
- Access controls to limit who can modify settings.
- Audit trails for all changes made to the system.