the quality of the product, and verifying that the machine operates within the required specifications after repairs.

Health and Safety Officer: Ensures that all safety procedures are followed when troubleshooting and repairing machines, particularly for machines operating under pressure or using hazardous substances.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that any troubleshooting efforts are effective and documented. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Common Machine Issues

1. Regularly monitor machine performance and identify any issues that may arise, such as:
   • Inconsistent filling volumes or weights (for filling machines)
   • Improper crimping or sealing (for crimping machines)
   • Valve failure or leakage (for valve testing machines)
   • Pressure fluctuations or temperature variations
   • Unusual sounds, vibrations, or machine stoppages
2. Report any issues immediately to the Maintenance Team for further investigation and troubleshooting.
3. Log all issues in the Machine Issue Report (Annexure-1) to track recurring problems and their resolutions.

5.2. Diagnosing the Problem

1. Once the issue is reported, the Maintenance Team should perform a visual inspection of the machine to check for obvious signs of malfunction, such as:
   • Damaged parts
   • Leaks or pressure loss
   • Unusual wear on moving parts
   • Loose connections or settings
2. If no obvious cause is found, use diagnostic tools such as:
   • Pressure gauges
   • Flow meters
   • Temperature sensors
   • Electrical testing equipment
3. Check the machine’s error codes or fault logs if applicable to identify specific problems.
4. Consult the machine’s manual for troubleshooting guidelines and possible solutions for identified issues.
5. Record the diagnostic steps and results in the Diagnostic Report (Annexure-2).

5.3. Implementing Corrective Actions

1. Once the problem is identified, implement the appropriate corrective actions. These may include:
   • Replacing or repairing damaged components
   • Recalibrating the machine
   • Adjusting machine settings (e.g., pressure, temperature, speed)
   • Re-aligning or cleaning components
   • Fixing electrical or pneumatic issues
2. After performing the corrective actions, restart the machine and perform a test run to verify that the issue has been resolved.
3. Ensure that the machine is performing within the required parameters before resuming full production.
4. Document the corrective actions taken in the Corrective Action Report (Annexure-3).

5.4. Post-Troubleshooting Performance Verification

1. Once the troubleshooting process is complete, conduct a series of tests to ensure the machine is operating at optimal performance. These tests should include:
   • Checking the product quality (e.g., filling volume, crimping integrity)
   • Verifying that the machine operates without interruptions or errors
   • Monitoring machine parameters such as temperature, pressure, and speed to ensure they meet specifications
2. Verify that the machine is producing products within acceptable quality standards and operational limits.
3. Log the results of the post-troubleshooting verification in the Post-Troubleshooting Report (Annexure-4).

5.5. Continuous Monitoring and Feedback

1. After troubleshooting, continue to monitor the machine’s performance during the production run to ensure that the issue does not recur.
2. If the issue reappears, investigate further to identify whether additional corrective actions are needed, or if the problem is related to an underlying cause that was not addressed initially.
3. Provide feedback to the Maintenance Team regarding any recurring issues or performance concerns for further analysis and potential improvements to the troubleshooting process.
4. Document all ongoing monitoring and feedback in the Continuous Monitoring Log (Annexure-5).

5.6. Documentation and Record-Keeping

1. Ensure that all troubleshooting activities, diagnostic steps, corrective actions, and post-troubleshooting verification results are documented in the appropriate logs and reports.
2. Store all records in compliance with the company’s document retention policy for easy access during audits or regulatory inspections.
3. Ensure that all records are complete, accurate, and up to date to maintain traceability and accountability for the troubleshooting process.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Machine Issue Report (Annexure-1)
2. Diagnostic Report (Annexure-2)
3. Corrective Action Report (Annexure-3)
4. Post-Troubleshooting Report (Annexure-4)
5. Continuous Monitoring Log (Annexure-5)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Machine Issue Report

Machine ID	Issue Description	Reported By	Time
F-12345	Underfilling issue	Rajesh Patel	06/02/2025

Annexure-2: Diagnostic Report

Machine ID	Diagnostic Steps	Operator Name	Result
F-12345	Pressure check, sensor calibration	Rajesh Patel	Pressure sensor adjusted

Annexure-3: Corrective Action Report

Batch No.	Corrective Action	Operator Name	Completion Date
12345	Recalibrated filling volume	Rajesh Patel	06/02/2025

Annexure-4: Post-Troubleshooting Report

Machine ID	Test Results	Operator Name	Time
F-12345	Passed all tests	Rajesh Patel	06/02/2025

Annexure-5: Continuous Monitoring Log

Machine ID	Parameter	Value	Operator Name	Time
F-12345	Filling Volume	200ml	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated troubleshooting procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures