Maintain a dedicated logbook for each tool and die, including details of maintenance history, repairs, and inspections.
– Ensure records are easily accessible for audits and inspections.

4.1.3 Training
– Train maintenance personnel on handling, inspecting, and maintaining specific tools and dies.
– Provide operators with basic training on identifying wear and damage during use.

4.2 Routine Maintenance
4.2.1 Daily Inspections
– Inspect tools and dies visually for cracks, wear, or surface damage before and after use.
– Clean tools and dies to remove debris, residue, or lubrication build-up using approved cleaning agents.

4.2.2 Lubrication
– Apply suitable lubricants to moving parts and contact surfaces to minimize wear and friction.
– Ensure that excess lubricant is wiped off to prevent contamination during production.

4.2.3 Minor Adjustments
– Tighten loose components, such as screws, bolts, or clamps, as needed.
– Perform minor reshaping of edges or surfaces using approved equipment if slight wear is observed.

4.3 Preventive Maintenance
4.3.1 Scheduled Inspections
– Perform detailed inspections of tools and dies at regular intervals (e.g., monthly or quarterly) based on the maintenance schedule.
– Use magnifying equipment or non-destructive testing (NDT) methods to detect subsurface cracks or defects.

4.3.2 Reconditioning
– Recondition worn surfaces by polishing, grinding, or other approved methods to restore functionality.
– Replace small components, such as springs, pins, or inserts, as part of preventive maintenance.

4.3.3 Alignment and Calibration
– Check the alignment of dies and tools to ensure they are properly positioned relative to the machine.
– Calibrate tools that require precise measurements, such as cutting tools or molds, to restore accuracy.

4.3.4 Documentation
– Record all preventive maintenance activities, including findings, actions taken, and the name of the technician, in the maintenance log.

4.4 Troubleshooting and Repairs
4.4.1 Identifying Issues
– Monitor production output for signs of tool or die malfunction, such as inconsistent cuts, misalignments, or surface defects.
– Report abnormalities immediately and isolate the affected tools or dies for inspection.

4.4.2 Root Cause Analysis
– Conduct a root cause analysis to identify the source of the problem, such as improper handling, overloading, or material incompatibility.

4.4.3 Repairs
– Perform repairs using approved methods, such as welding, reshaping, or component replacement.
– Test repaired tools and dies for functionality and precision before returning them to production.

4.4.4 Documentation
– Document the issue, repair process, and resolution in the maintenance log.
– Include photographs or diagrams, if applicable, for future reference.

4.5 Emergency Situations
4.5.1 Major Failures
– In the event of a major tool or die failure, halt production immediately to prevent further damage or defects.
– Notify supervisors and initiate contingency plans, such as using backup tools or rescheduling production.

4.5.2 Safety Concerns
– If tool or die failure poses a safety risk, secure the area and follow emergency response protocols.
– Investigate the incident and update safety procedures to prevent recurrence.

4.6 Inspection and Quality Control
4.6.1 Post-Maintenance Inspection
– QA personnel must inspect tools and dies after maintenance or repairs to ensure they meet design specifications.
– Perform functional tests, such as test runs, to validate performance.

4.6.2 Precision Checks
– Use precision measuring instruments, such as micrometers or coordinate measuring machines (CMM), to verify dimensions and tolerances.

4.6.3 Documentation
– Record inspection results in the quality control log and attach supporting documents, such as calibration certificates.

4.7 Record Retention and Compliance
4.7.1 Maintenance and Repair Records
– Retain all maintenance and repair records for a minimum of five years or as required by regulatory agencies.
– Ensure records comply with data integrity standards, such as ALCOA+ principles.

4.7.2 Audit Preparation
– Organize records for easy retrieval during audits or inspections by internal or external parties.

5) Abbreviations

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– NDT: Non-Destructive Testing
– CMM: Coordinate Measuring Machine

6) Documents

– Maintenance Schedules
– Maintenance Logbook
– Inspection Reports
– Repair Records
– Calibration Certificates

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

Tool/Die ID	Maintenance Date	Task Performed	Technician	Remarks
Tool/Die ID	DD/MM/YYYY	Details of Maintenance	Technician Name	Comments

Annexure 2: Inspection Checklist Template

Date	Tool/Die ID	Inspection Criteria	Results	Inspector
DD/MM/YYYY	Tool/Die ID	Criteria Description	Pass/Fail	Inspector Name