Procedure for Handling Emergency Stops in Machines
| Department | Production/Engineering/Quality Assurance (QA)/Safety |
|---|---|
| SOP No. | SOP/Ointment/049 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a structured approach for handling emergency stops in machines used in ointment manufacturing. Proper emergency stop procedures ensure personnel safety, prevent equipment damage, and maintain compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel involved in operating, maintaining, and monitoring manufacturing machines in the ointment production facility.
3. Responsibilities
- Production Supervisor: Ensures personnel are trained in emergency stop procedures.
- Machine Operator: Identifies emergency situations and activates emergency stops.
- Engineering Technician: Assesses and repairs equipment after an emergency stop.
- Quality Assurance (QA) Personnel: Verifies GMP compliance and records incidents.
- Safety Officer: Conducts safety audits and ensures adherence to emergency protocols.
4. Accountability
The Production, Engineering, and QA Managers are accountable for ensuring that emergency stop procedures are followed, recorded, and reviewed regularly.
5. Procedure
5.1 Identifying Emergency Situations
- Equipment malfunction (e.g., overheating, abnormal noise, or vibration).
- Operator injury or entrapment.
- Electrical failure or short circuit.
- Product leakage or contamination.
- Fire or chemical spill in the vicinity of the equipment.
5.2 Activating Emergency Stops
- Press the Emergency Stop Button immediately if an emergency arises.
- Ensure the machine comes to a complete stop.
- Alert nearby personnel and supervisors about the situation.
- Isolate power supply to the affected machine if necessary.
5.3 Post-Emergency Stop Actions
- Inspect the machine visually for any visible hazards.
- Verify if the emergency stop was triggered due to a system fault or operator error.
- Lock out and tag out (LOTO) the equipment to prevent unintended restart.
- Document the event in the Emergency Stop Log.
5.4 Troubleshooting and Restarting the Machine
5.4.1 Engineering Assessment
- The Engineering team must inspect the equipment and diagnose the issue.
- Identify the cause of the emergency stop and implement necessary repairs.
- Confirm that all safety measures are in place before restarting.
5.4.2 QA Verification
- QA personnel must conduct a post-incident inspection.
- Ensure no contamination or product loss has occurred.
- Approve the restart only after compliance verification.
5.4.3 Machine Restart
- Remove LOTO after Engineering and QA clearance.
- Ensure the emergency stop button is reset before restarting.
- Gradually start the machine and monitor for abnormalities.
- Resume normal production only after confirming stability.
5.5 Reporting and Documentation
- Record the incident in the Emergency Stop Log (Annexure-1).
- Conduct a root cause analysis for repeated emergency stops.
- Implement corrective and preventive actions (CAPA) if necessary.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- LOTO – Lockout/Tagout
- CAPA – Corrective and Preventive Action
7. Documents
- Emergency Stop Log (Annexure-1)
- Incident Investigation Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- OSHA Lockout/Tagout Standard (29 CFR 1910.147)
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Emergency Stop Log
| Date | Machine ID | Reason for Stop | Action Taken | Restart Approved By |
|---|---|---|---|---|
| 01/02/2025 | EM-101 | Overheating | Cooling system repaired | QA Officer |
| 02/02/2025 | EM-102 | Product leakage | Seal replaced | QA Officer |
Annexure-2: Incident Investigation Report
| Date | Machine ID | Incident Description | Root Cause | Corrective Action | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | EM-101 | Emergency stop due to overheating | Blocked air vents | Air vents cleaned | QA Head |
| 02/02/2025 | EM-102 | Leak detected at filling station | Defective gasket | Gasket replaced | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |