Transfer to Manufacturing

Whether manufacturing will take place in-house or with an outside vendor or group of vendors there are a number of different paths a production plan can take. These paths are dependent on variables such as: product complexity, material & process selection, number of parts, assembly requirements, number of units ordered, quality assurance requirements, etc. The successful transfer to manufacturing will require that the innovator work closely with the internal development group or outside vendor(s) to ensure that there is excellent communication and that each party understands and agrees to their roles and responsibilities. A complete manufacturing plan should be developed with all respective vendors.    

The smooth transition to manufacturing ensures that all parties understand and take responsibility for their roles. Regulatory and Quality Assurance requirements must be documented and met.

If there are components or subassemblies that may critically affect the company’s ability bring the technology to market, alternative vendors should be identified as a back up.

This module will explore the process of Transfering the product to Manufacturing:

• Work with vendor to ensure communication and define responsibilities
• Document and meet regulatory and quality assurance requirements
• Inspect the first article of individual components, lots, and assemblies
• Ensure that all quality and regulatory documentation is up to date