JSA for Safe Operation of Tablet Inspection System
| JSA Number | JSA/OralDosage/043/2025 | 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 Inspection System. This equipment is used in pharmaceutical manufacturing to visually and mechanically inspect tablets for defects such as cracks, discoloration, weight variation, and surface irregularities. Proper handling and operation are essential to ensure accurate defect identification, maintain quality standards, and prevent cross-contamination.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Tablet Inspection System in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with moving parts, exposure to fine dust, and improper sorting mechanisms.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Tablet Inspection System.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent contamination and exposure to airborne particles.
- Monitor the quality of inspected tablets and adjust machine settings as needed.
- Ensure proper cleaning and maintenance to prevent cross-contamination.
- Report any machine malfunctions immediately to the supervisor.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine inspections of the Tablet Inspection System and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that dust control and material handling procedures are followed.
- Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, safety glasses, respirators).
- 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 tablets into the inspection conveyor | Manual handling strain, tablet contamination | Medium | Use clean handling tools; wear gloves and mask. |
| 3 | Adjusting inspection parameters | Misalignment, incorrect sorting | High | Follow SOP guidelines for setting inspection thresholds. |
| 4 | Inspection process | Moving parts hazards, tablet breakage | High | Ensure safety guards are in place; do not reach into moving parts. |
| 5 | Unloading and sorting tablets | Cross-contamination, handling errors | Medium | Follow GMP cleaning procedures and use designated collection containers. |
| 6 | Cleaning and maintenance | Electrical shock, residual powder exposure | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor tablet misalignment | Low |
| Possible | Tablet rejection due to incorrect parameters | Medium |
| Likely | Entrapment due to moving parts | High |
7. Emergency Procedures
- In case of tablet contamination, stop the machine and notify the supervisor.
- If the system malfunctions, shut it down and report to maintenance.
- For equipment entrapment, activate the emergency stop and seek immediate assistance.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Respiratory mask: Prevents inhalation of airborne powder from broken tablets.
- Safety glasses: Shields eyes from dust exposure.
- Protective gloves: Prevents direct contact with tablets.
- Machine guards: Ensures safety from moving parts.
- Designated sorting bins: Prevents cross-contamination.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tablet inspection and handling.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |