JSA for Safe Operation of Compression Tooling Inspection Machine
| JSA Number | JSA/OralDosage/024/2025 | 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 Compression Tooling Inspection Machine. This equipment is used in pharmaceutical manufacturing to inspect punches, dies, and tooling components for wear, damage, or contamination, ensuring the quality and consistency of compressed tablets. Proper handling and operation are essential to prevent mechanical hazards, contamination, and handling injuries.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Compression Tooling Inspection Machine in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with sharp tooling, moving parts, and improper handling of heavy components.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while using the Compression Tooling Inspection Machine.
- Ensure the machine is properly set up and calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to protect against sharp edges.
- Monitor the machine operation and inspect tooling components thoroughly.
- Handle punches and dies carefully to prevent damage and injuries.
- Perform post-operation cleaning and maintenance as per SOP.
Supervisors:
- Ensure compliance with GMP
and workplace safety regulations.
Monitor inspection processes to maintain accuracy and efficiency.
Conduct routine inspections of the machine and record maintenance schedules.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure proper handling techniques are followed to avoid injuries.
- Verify that PPE, such as cut-resistant gloves and safety glasses, are used correctly.
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 | Loading compression tooling for inspection | Manual handling strain, sharp edges | Medium | Use lifting aids; wear cut-resistant gloves. |
| 3 | Adjusting inspection parameters | Mechanical hazards, improper settings | High | Ensure hands are clear of moving parts; follow SOP for adjustments. |
| 4 | Tooling inspection process | Finger injuries, misalignment errors | High | Ensure tooling is properly positioned; do not touch moving parts. |
| 5 | Unloading inspected components | Cross-contamination, ergonomic strain | Medium | Use appropriate handling techniques to prevent damage and contamination. |
| 6 | Cleaning and maintenance | Electrical shock, dust exposure | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor handling injuries | Low |
| Possible | Cut injuries from sharp tooling | Medium |
| Likely | Tool misalignment leading to damage | High |
7. Emergency Procedures
- In case of hand injuries, clean the wound and seek medical attention.
- If an electrical issue arises, shut down the machine and report to maintenance.
- For tool misalignment, stop the process and recalibrate before resuming.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Cut-resistant gloves: Protects hands from sharp tooling edges.
- Safety glasses: Shields eyes from metal particles.
- Protective clothing: Prevents contamination and tool handling injuries.
- Tool holding fixtures: Ensures safe and stable positioning of components.
- Calibration standards: Used to verify accuracy of the inspection process.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tooling inspection in pharmaceutical production.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |