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