and upcoming schedules.
– Include space for recording issues, resolutions, and responsible personnel.

4.1.3 Training
– Train operators and maintenance personnel on proper machine usage, maintenance tasks, and safety procedures.

4.2 Routine Maintenance
4.2.1 Daily Checks
– Inspect machines for visible wear, loose components, or abnormal sounds before starting operations.
– Ensure that lubrication levels, fluid levels, and power connections are within the specified ranges.
– Document daily inspections in the maintenance log.

4.2.2 Weekly Maintenance
– Clean machine components using approved cleaning agents to remove dust, debris, and residue.
– Inspect belts, hoses, and connections for signs of damage or wear and replace if necessary.
– Test machine safety features, such as emergency stops and interlocks.

4.2.3 Monthly Maintenance
– Conduct detailed inspections of mechanical and electrical components, such as motors, sensors, and controllers.
– Calibrate critical instruments to ensure accuracy and compliance with production specifications.
– Update the maintenance log with findings and actions taken.

4.3 Preventive Maintenance
4.3.1 Scheduled Intervals
– Perform preventive maintenance at predefined intervals (e.g., quarterly, semi-annually) based on machine specifications.
– Replace parts prone to wear, such as bearings, seals, or filters, even if they appear functional.

4.3.2 Performance Testing
– Conduct performance tests, such as load tests, speed tests, and precision measurements, to verify equipment reliability.
– Record test results in the maintenance log.

4.3.3 Lubrication and Cleaning
– Apply appropriate lubricants to moving parts to reduce wear and extend machine life.
– Clean machine interiors and exteriors thoroughly to prevent contamination.

4.4 Troubleshooting and Repairs
4.4.1 Identifying Issues
– Monitor machine performance for signs of malfunction, such as irregular noise, reduced output, or error codes.
– Log reported issues in the maintenance log, including the time and nature of the problem.

4.4.2 Initial Assessment
– Perform an initial assessment to determine whether the issue is mechanical, electrical, or software-related.
– Isolate the machine to prevent further damage and ensure operator safety.

4.4.3 Diagnostic Testing
– Use diagnostic tools, such as multimeters, oscilloscopes, or software diagnostics, to pinpoint the root cause of the problem.
– Test individual components, such as motors, switches, or sensors, to identify failures.

4.4.4 Corrective Actions
– Replace or repair defective components using approved spare parts.
– Recalibrate the machine after repairs to ensure it meets operational specifications.
– Conduct a test run to verify that the issue has been resolved.

4.4.5 Documentation
– Document the issue, troubleshooting steps, and resolution in the maintenance log.
– Include photographs or diagrams, if applicable, to aid future troubleshooting efforts.

4.5 Emergency Situations
4.5.1 Major Equipment Failure
– Shut down the affected machine immediately and notify the maintenance team and supervisors.
– Assess the impact on production and implement contingency plans, such as using backup equipment.

4.5.2 Safety Incidents
– If a machine malfunction poses a safety risk, secure the area, and follow emergency response protocols.
– Investigate the root cause of the incident and update safety procedures if necessary.

4.6 Quality Assurance and Documentation
4.6.1 QA Review
– QA personnel must review maintenance logs and repair records to ensure compliance with specifications.
– Approve machines for use only after verifying that all maintenance and repair activities meet quality standards.

4.6.2 Record Retention
– Retain maintenance records for the minimum period required by regulatory agencies, typically five years or more.
– Ensure records are easily accessible during audits or inspections.

5) Abbreviations

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents

– Maintenance Logbook
– Machine Calibration Records
– Diagnostic Test Reports
– Repair and Replacement Logs
– Preventive Maintenance Schedules

7) Reference

– ISO 13485: Medical devices – Quality management systems
– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 14971: Application of Risk Management to Medical Devices

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Maintenance Log Template

Machine ID	Maintenance Date	Task Performed	Performed By	Remarks
Machine ID	DD/MM/YYYY	Maintenance Details	Technician Name	Comments

Annexure 2: Troubleshooting Log Template

Date	Issue Reported	Root Cause	Action Taken	Technician
DD/MM/YYYY	Issue Description	Root Cause Details	Resolution Details	Technician Name