JSA for Safe Operation of Tablet Metal Detector
| JSA Number | JSA/OralDosage/023/2025 | Department | Oral Dosage |
|---|---|---|---|
| Revision Number | V 1.0 | Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 | Review Date | 05/02/2026 |
1. Purpose
The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Tablet Metal Detector. This equipment is used in pharmaceutical manufacturing to detect and remove metal contaminants from tablets, ensuring product quality and patient safety. Proper handling and operation are essential to prevent safety risks, contamination, and mechanical hazards.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Tablet Metal Detector in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with electromagnetic exposure, mechanical movement, and calibration errors.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Tablet Metal Detector.
- Ensure the machine is properly set up and calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) when handling rejected tablets.
- Monitor the machine operation and ensure proper rejection of contaminated tablets.
- Regularly inspect and clean the reject collection bin.
- Perform post-operation cleaning and maintenance as per SOP.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine inspections
of metal detector equipment and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure proper shielding is in place to reduce electromagnetic exposure.
- Verify that operators are trained in handling rejected tablets safely.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, safety glasses).
- GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
- LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.
5. Procedure
| Step | Task Description | Potential Hazard | Risk Level (L/M/H) | Control Measures |
|---|---|---|---|---|
| 1 | Machine setup and calibration | Electrical hazards, incorrect calibration | Medium | Ensure proper grounding and calibration before operation. |
| 2 | Starting the detection process | Electromagnetic exposure, misalignment | Medium | Verify sensor shielding; ensure proper conveyor belt alignment. |
| 3 | Tablet inspection | Contamination risk, improper rejection | High | Regularly test machine with calibration tablets; monitor rejection bin. |
| 4 | Handling rejected tablets | Cross-contamination, manual handling strain | Medium | Use dedicated gloves and separate waste collection for rejected tablets. |
| 5 | Cleaning and maintenance | Electrical hazards, dust exposure | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor exposure to electromagnetic fields | Low |
| Possible | Misalignment causing rejection errors | Medium |
| Likely | Cross-contamination from rejected tablets | High |
7. Emergency Procedures
- In case of machine malfunction, shut down the unit and report to maintenance.
- For incorrect rejection, recalibrate and conduct test runs before restarting.
- In case of electrical failure, ensure the unit is powered off before performing troubleshooting.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Gloves: Prevents contamination when handling rejected tablets.
- Safety glasses: Shields eyes from dust and particles.
- Protective clothing: Prevents tablet contamination from operators.
- Grounding system: Ensures safe operation and reduces static electricity.
- Calibration tablets: Used to verify correct operation of the detector.
9. References
- OSHA 1910.97 – Non-Ionizing Radiation Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tablet quality inspection.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |