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Manufacturing Process & Transfers

Freudenberg Medical’s customer centric manufacturing process ensures that needs and expectations are explicitly documented, translated into requirements and manufacturing transfer project plans are executed on-time and within budget, from a single product line to a full facility transfer.

1

Transfer Opportunity Analysis

  • Determine Project Scope
  • Execute Technical Assessment
  • Perform Financial and Schedule Assessment
  • Customer Review of Project Proposal and Costs
2

Transfer Planning

  • Confirm Project Charter
  • Develop a Detailed Project Schedule
  • Assign a Cross-Functional Manufacturing Transfer Team
  • Establish a Communication Plan Between Project Teams
  • Establish Quality System Plan
  • Identify Regulatory Needs and Support
  • Implement a Risk Management Strategy
  • Optimize Supply Chain
  • Establish Tooling and Fixture Strategy
  • Assess Design for Manufacturability (DFM)
  • Customer Review of Project Changes and Improvements
3

Design and Process Improvements

  • Implement Design and Process Improvements
  • Run Prototype and Evaluate Changes
  • Perform and Document Testing to Support
  • Design and Process Changes
4

Manufacturing Line Install

  • Build or Transfer Tooling
  • Perform Installation Qualification (IQ)
  • Perform Product Equivalency Build
  • Finalize Manufacturing Procedures
  • Initiate Test Method and Validation
5

Process Validation

  • Execute Operational Qualifications (OQ)
  • Execute Performance Qualifications (PQ)
  • Execute Product Performance Qualifications (PPQ)
  • Finalize Testing Methods and Validations
  • Support Regulatory Needs
  • Release for Commercial Sales
  • Perform Line Audit for Manufacturing Kick Off
6

Scale Up

  • Build and Manage Safety and Close Out Stock
  • Confirm Capacity Ramp-Up Plan and Metrics
  • Monitor Line Metrics
7

Sustaining

  • Utilize Continuous Improvement
  • Methodologies (GROWTTH®)
  • Establish On-Going Quarterly
  • Business Review Meetings