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
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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