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Updated Procedure For Maintenance

This document outlines the procedure for maintaining equipment and infrastructure in the production of medical devices, detailing responsibilities, maintenance schedules, and record-keeping requirements. Key roles include the Maintenance Supervisor, QA Department, Equipment Users, and Calibration Technician, each with specific duties to ensure compliance and safety. The procedure emphasizes preventive and corrective maintenance, calibration control, and proper documentation to uphold product quality and regulatory standards.

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rengasri13953
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11 views2 pages

Updated Procedure For Maintenance

This document outlines the procedure for maintaining equipment and infrastructure in the production of medical devices, detailing responsibilities, maintenance schedules, and record-keeping requirements. Key roles include the Maintenance Supervisor, QA Department, Equipment Users, and Calibration Technician, each with specific duties to ensure compliance and safety. The procedure emphasizes preventive and corrective maintenance, calibration control, and proper documentation to uphold product quality and regulatory standards.

Uploaded by

rengasri13953
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Procedure for Maintenance

1. Purpose
The purpose of this procedure is to define the methods and responsibilities for
maintaining equipment and infrastructure to ensure continued conformity with product
requirements, regulatory compliance, and safety standards.

2. Scope
This procedure applies to all production, testing, and monitoring equipment used in the
manufacture and control of medical devices within the organization.

3. Responsibilities
 Maintenance Supervisor: Responsible for planning, scheduling, and overseeing
maintenance activities.
 QA Department: Ensures calibration records and maintenance logs are reviewed and
up to date.
 Equipment Users: Report any faults or issues and ensure cleanliness and proper use of
equipment.
 Calibration Technician: Performs calibration as per schedule and updates records.

4. Procedure
1. 4.1 Maintenance Schedule and Periodicity

 Develop and document a maintenance schedule for each piece of equipment.


 Maintenance intervals shall be based on manufacturer recommendations, usage
frequency, and criticality.
 Schedules must be reviewed annually and updated as necessary.

2. 4.2 Preventive and Corrective Maintenance

 Perform preventive maintenance as per the documented schedule.


 Corrective maintenance shall be initiated immediately after fault detection.
 All maintenance activities must be logged in the equipment maintenance register.

3. 4.3 Calibration Control

 Ensure all measuring and monitoring devices are calibrated at defined intervals.
 Use traceable calibration standards and retain calibration certificates.
 Remove or label equipment as 'Out of Calibration' if calibration is overdue or
failed.

4. 4.4 Equipment Checkpoints


 Define checkpoints for inspection, cleaning, lubrication, and safety checks.
 Conduct pre-operation inspections before each use to ensure equipment integrity.
 Document findings and actions taken during equipment checks.

5. 4.5 Breakage and Repair Register

 Maintain a 'Breakage Register' for recording equipment faults, damage, and


repairs.
 Include details such as equipment ID, nature of issue, date reported, repair action,
and personnel involved.
 Analyze data periodically to identify recurring issues and improve reliability.

6. 4.6 Equipment Tagging and Status Indication

 Clearly tag equipment with its current status: Available, Under Maintenance, Out
of Calibration, etc.
 Ensure visibility of tags to prevent use of non-compliant equipment.

7. 4.7 Documentation and Record Keeping

 Maintain all maintenance, calibration, inspection, and repair records for a defined
retention period.
 Ensure records are signed, dated, and reviewed regularly by responsible
personnel.

5. Records
 Maintenance Schedule Log
 Preventive and Corrective Maintenance Records
 Calibration Certificates
 Equipment Checkpoint Inspection Sheets
 Breakage and Repair Register
 Equipment Status Tagging Log

6. References
 ISO 13485:2016 - Medical devices — Quality management systems — Requirements
for regulatory purposes
 Manufacturer Equipment Manuals
 Internal Calibration and Maintenance SOPs

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