Creams: SOP for Handling Equipment Breakdowns during Cream Manufacturing – V 2.0

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Creams: SOP for Handling Equipment Breakdowns during Cream Manufacturing – V 2.0

Standard Operating Procedure for Handling Equipment Breakdowns during Cream Manufacturing

Department Creams
SOP No. SOP/CRM/101/2025
Supersedes SOP/CRM/101/2022
Page No. Page 1 of 6
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to establish a standardized procedure for handling equipment breakdowns during cream manufacturing. The goal is to ensure minimal disruption to the production process, safeguard personnel, and maintain product quality during equipment malfunctions.

2. Scope

This SOP applies to all equipment used in the cream manufacturing process. It includes procedures for identifying, reporting, troubleshooting, and resolving equipment breakdowns, as well as documenting corrective actions.

3. Responsibilities

  • Production Team: Responsible for identifying equipment breakdowns, reporting them immediately, and ensuring that the equipment is safely shut down if necessary.
  • Maintenance Team: Responsible for diagnosing and repairing equipment breakdowns and ensuring that the equipment is restored to operational condition.
  • Quality Control (QC): Ensures that product quality is not compromised during the breakdown and that all processes are returned to the approved operating standards after the repair.

4. Accountability

The Maintenance Manager is accountable for overseeing the repair of equipment breakdowns and ensuring that all necessary corrective actions are taken. The Head of Production is accountable for ensuring that production is not unduly delayed and that the equipment is restored to operation as quickly as possible.

5. Procedure

5.1 Identifying the Breakdown

  1. Production personnel should immediately stop the equipment if a breakdown occurs, ensuring that no further damage is done to the equipment or product.
  2. Identify the specific equipment that has malfunctioned. Common signs of breakdowns may include unusual noises, poor performance, overheating, or visible damage to components.
  3. Check the control panel or error messages (if applicable) for diagnostic information regarding the fault.
  4. If the issue cannot be quickly identified or resolved, notify the Maintenance Team immediately for further troubleshooting.
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5.2 Reporting the Breakdown

  1. Report the equipment failure to the Maintenance Team via the breakdown reporting system, phone, or direct communication. Provide the following information:
    • Equipment ID and type
    • Nature of the problem
    • Any relevant error messages or symptoms observed
    • Any actions taken so far
  2. Complete the breakdown report in the Equipment Breakdown Log (Annexure-1).
  3. Ensure that a full description of the issue and any interim solutions are included in the report for accurate documentation.

5.3 Safety and Immediate Action

  1. Ensure that the affected equipment is isolated and does not pose any immediate safety risks. Use emergency stop buttons, circuit breakers, or disconnect switches as required to secure the area.
  2. Ensure that all personnel in the vicinity are safe and that any potential hazards (e.g., electrical, mechanical) are controlled.
  3. If the breakdown causes a contamination risk or unsafe environment, follow emergency procedures and evacuate personnel if necessary.

5.4 Troubleshooting and Diagnosis

  1. The Maintenance Team will assess the equipment to diagnose the problem. They may perform the following actions:
    • Visually inspect equipment for obvious signs of wear or malfunction.
    • Review machine logs and error codes to identify potential faults.
    • Perform tests on electrical systems, mechanical components, or control systems to isolate the issue.
  2. If the issue is beyond the scope of routine maintenance, the Maintenance Team may consult external technical support or the equipment manufacturer.
  3. Document all findings and steps taken in the Equipment Maintenance Log (Annexure-2).
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5.5 Repair and Restoration

  1. Once the fault has been diagnosed, the Maintenance Team will carry out the necessary repairs or replace faulty components as needed.
  2. If spare parts are required, the Maintenance Team will source the necessary components from the spare parts inventory or order them from external suppliers.
  3. After repairs are completed, the equipment will undergo functional testing to ensure it is operating according to specifications.
  4. Once the equipment is restored to operational status, the Maintenance Team will notify the Production Team to resume operations.

5.6 Post-Repair Testing and Monitoring

  1. Before returning the equipment to full operation, conduct a thorough testing phase to ensure the issue has been fully resolved.
  2. Monitor the equipment during initial operation after repairs to ensure that no additional issues arise.
  3. Record the results of the testing phase and any observations in the Equipment Maintenance Log (Annexure-2).

5.7 Documentation

  1. Document all equipment breakdowns, diagnostics, repairs, and post-repair monitoring in the Equipment Breakdown Log (Annexure-1).
  2. Ensure that all corrective actions taken during the repair process are recorded and tracked for future reference.
  3. Ensure that the production team documents any potential impact on product quality during the downtime or repair process.

5.8 Post-Breakdown Review

  1. After the equipment is fully operational, conduct a review to analyze the root cause of the breakdown and identify any process improvements that could prevent future occurrences.
  2. Evaluate whether any training or procedural changes are needed to avoid similar breakdowns in the future.
  3. Document the post-breakdown review and any corrective actions taken to improve equipment reliability in the Continuous Improvement Log (Annexure-3).
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6. Abbreviations

  • GMP: Good Manufacturing Practices
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Annexure-1: Equipment Breakdown Log
  2. Annexure-2: Equipment Maintenance Log
  3. Annexure-3: Continuous Improvement Log

8. References

  • Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
  • International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • Manufacturer’s Manual for Equipment

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Breakdown Log

Equipment ID Breakdown Date Description of Issue Reported By Corrective Action
EQP-001 21/01/2026 Motor failure, overheating John Doe Replaced motor, recalibrated system

Annexure-2: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Type Operator Comments
EQP-001 21/01/2026 Inspection, motor replacement Jane Smith Successfully repaired, back in operation

Annexure-3: Continuous Improvement Log

Issue Identified Root Cause Improvement Action Responsible Person
Motor overheating Insufficient maintenance, poor ventilation Increase maintenance frequency, improve ventilation system Maintenance Manager

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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