JSA for Safe Operation of Oscillating Granulator
| JSA Number | JSA/OralDosage/007/2025 | 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 Oscillating Granulator used in the production of solid oral dosage forms.
2. Scope
This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Oscillating Granulator in the Oral Dosage department.
3. Responsibilities
Operators:
- Ensure the machine is operated per SOPs.
- Wear appropriate Personal Protective Equipment (PPE).
- Report any malfunctions or safety concerns immediately.
Supervisors:
- Ensure compliance with safety guidelines.
- Monitor risk control measures and address safety violations.
Safety Officers:
- Conduct regular safety audits.
- Provide training on hazard mitigation and emergency response.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, goggles, ear protection).
- LOTO: Lockout/Tagout – Procedure to isolate hazardous energy.
- Risk Assessment: A process to evaluate and control hazards.
5. Procedure
| Step | Task Description | Potential Hazard | Risk Level (L/M/H) | Control Measures |
|---|---|---|---|---|
| 1 | Machine setup and calibration | Pinching, crushing injuries | High | Use guards, follow SOP |
| 2 | Loading raw materials | Dust exposure, inhalation | Medium | Wear dust mask and gloves |
| 3 | Granulation process | Mechanical failure, noise exposure | High | Regular maintenance, use ear protection |
| 4 | Unloading granules | Repetitive strain injury | Medium | Use ergonomic posture, take frequent breaks |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor injury | Low |
| Possible | Noise-induced hearing loss | Medium |
| Likely | Severe injury from machine failure | High |
7. Emergency Procedures
- In case of injury, seek medical assistance immediately.
- If a mechanical failure occurs, stop operation and inform maintenance.
- For dust exposure incidents, move to fresh air and use eyewash if needed.
- All incidents must be reported and logged.
8. Required PPE & Safety Controls
- Safety gloves: Protect hands from crushing and sharp edges.
- Ear protection: Prevents hearing damage due to noise exposure.
- Face mask: Reduces inhalation of dust particles.
- Safety goggles: Protects against dust and debris.
- Machine guard: Must always be in place during operation.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- ISO 45001 – Occupational Health & Safety Standards.
- Manufacturer’s Operation Manual for Oscillating Granulator.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |
11. Revision History
| Version | Date | Description of Changes | Approved By |
|---|---|---|---|
| V 1.0 | 01/02/2025 | Initial Release | [Name] |