The purpose of Phase 5 - Process Installation & Optimization is to establish a manufacturing process and equipment capable of consistently producing a product that meets the required specifications.  This may include procurement, installation and qualification of equipment, and tooling as well as process flow layouts and optimization.  All required manufacturing documentation (DMR) is released by the end of this phase.


  • Develop a detailed manufacturing plan (facilities, equipment and materials)

  • Finalize supplier selection

  • Conduct Design Review(s)

  • Procure production equipment, fixtures, and tooling

  • Perform Installation Qualification(s) (IQ) on equipment

  • Establish and optimize process parameters

  • Perform Operational Qualification(s) (OQ)

  • Complete Device Master Record (DMR)

  • Close Design History File (DHF) if applicable

  • Phase Review


  • Manufacturing plan

  • Master validation plan

  • Completed IQ protocols and test reports

  • Completed OQ protocols and test reports

  • Device Master Record (DMR)

  • Design History File (DHF)

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