Phase 0: Initial Feasibility

The purpose of this Phase is typically to ascertain if specific capability(s) can be demonstrated that a product concept or objective “works” proposed at the opening of the Phase and then demonstrate an assembly capability. The form of Test results and prototypes are required to close the Phase. 

Phase 1: Optimization

Processes, materials, and tooling will be developed & selected. The deliverable is a delicate procedure with combining these practices, recipes, tooling, and equipment necessary to demonstrably fabricate the desired product with consistency and cost that meets the business needs. This package is suitable for the process validation activities of Phase 2 with minimal, if any, changes.  pFMEA started.

Phase 2: Process Validation

Covers the process validation required to bring the manufacturing process to preproduction status. pFMEA finalized and generated the process control plan.  OQ & PQ Protocols written and executed.

Phase 3: Preproduction

A relative transition state where production-level practices are followed while some of the Quality deliverables and documentation will be completed. First Article Inspection Report (FAIR) completed, and reports submitted to the Customer for approval.

Phase 4: Production Build

At this final Phase, the processes to fabricate an assembly have been developed, validated, and fully documented to the satisfaction of the Customer and Amtech Microelectronics. The only activity is to accept orders, build products, track yields and report to the Customer as agreed upon.

Manufacturing Process Development of a New Medical Device