Design Transfer Checklist

Project:____________________ Project Manager/Team Leader:_____________________ Date:_________

Item Required Complete Reason if not required

Y/ N Y/N
Manufacturing Feasibility Review /
Contract Review
Review Product Documentation
BOM; Drawings and Specifications
Product, packaging/ handling and
labeling
Inventory and shipping requirements
Environmental requirements
Design FMEA
Determine Project plan, timeline, budget
and project team
Verify quotes/ cost cards and transfer price
Select vendors and qualify as required
Document Approval Matrix
Process design
Process flow, line layout, routing and work
instructions
Equipment use, calibration requirements
and maintenance instructions
Inspection and testing procedures
Training
Quality Planning
Determine Product Quality Plan
Process FMEA
Develop Master Validation Plan
Develop Validation protocols
Inspection Instructions
Environmental requirements
Tooling, Equipment and Fixture
Development
Specify, design, build test
IQ & OQ
Calibration Plan
Set-up supply chain
Order long lead items
Order materials for validation and pilot runs
Order materials based on production
forecast
Process Validation
Run pilot build and test against protocols
Refine process as required
Conduct Design Review prior to validations
Conduct validation; kit, build, sterilize, test
Sterilization validation
Packaging validation/ transportation testing
Accelerated aging testing
Complete DMR
Final Design Review

Form MSC-04.14 Rev. 0 DAR 02-012 Approval Date: 9/23/02 Effective Date: 9/30/02