Standard Operating Procedure for Troubleshooting Electrical Failures in Machines in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/160/2025 |
| Supersedes | SOP/ELX/160/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for systematically identifying, isolating, rectifying, and documenting electrical failures in machines used within the Elixir Department to ensure equipment uptime, process continuity, and electrical safety.
2. Scope
This SOP covers all elixir manufacturing machines such as mixers, transfer pumps, filling units, and control panels that operate on electrical systems, including power distribution panels and automation circuits.
3. Responsibilities
- Production Operator:
- Immediately stop the equipment and notify engineering upon detecting an electrical fault.
- Ensure no attempt is made to reset or troubleshoot on their own.
- Engineering Electrician/Technician:
- Perform troubleshooting and corrective action using appropriate PPE and lockout/tagout procedures.
- Document root cause, repairs, and testing status.
- QA Officer:
- Review and approve equipment release post-troubleshooting for GMP resumption.
4. Accountability
The Engineering Head is accountable for electrical fault resolution. The Production Head ensures proper communication and stoppage. The QA Head is
responsible for validation and batch impact review.
5. Procedure
5.1 Initial Response
- Operator shall:
- Stop the machine immediately using the emergency stop (E-STOP) if needed.
- Switch off main power and display “DO NOT OPERATE” tag.
- Inform Engineering and QA teams.
5.2 Troubleshooting by Engineering
- Ensure lockout/tagout is applied before panel or component access.
- Inspect:
- MCBs, fuses, relays, and contactors for tripping or burnout
- Loose wires, faulty connectors, moisture, or damaged cables
- PLC/HMI faults and system diagnostic logs
- Use multimeter, continuity tester, or IR thermometer for diagnostics.
- Replace damaged components with spares from approved list.
- Conduct test run after corrective action with power ON, without product batch.
5.3 Documentation and Reporting
- Fill the Electrical Fault Log (Annexure-1) with:
- Date, time, equipment ID, nature of failure
- Root cause analysis and corrective actions
- Name of technician and QA reviewer
- Update the Equipment History Card with service details.
- Attach photos of damaged components, if applicable.
5.4 Post-Repair Equipment Release
- QA shall verify functionality, cleanliness, and system calibration.
- If batch was interrupted, perform impact assessment before restarting process.
- Resume batch operations only after QA signs off the Equipment Release Form.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- MCB: Miniature Circuit Breaker
- PLC: Programmable Logic Controller
- HMI: Human Machine Interface
7. Documents
- Electrical Fault Log (Annexure-1)
- Equipment History Card
- Equipment Release Form
8. References
- 21 CFR Part 211 – Equipment Maintenance Requirements
- IS 5216 – Electrical Safety Practices
- WHO TRS 1010 – Pharmaceutical Utilities and Equipment Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Electrical Fault Log
| Date | Equipment ID | Nature of Fault | Root Cause | Corrective Action | Technician | QA Review |
|---|---|---|---|---|---|---|
| 11/04/2025 | MXR-ELX-07 | HMI Not Powering On | Loose Connector | Reseated & secured | Ramesh Nair | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added photos and technician acknowledgment fields | Improved Documentation | QA Head |