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