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At GEMÜ, projects comprise five phases. The end of each phase is a milestone; it contains a review as well as the release point for the next phase. Customer solutions primarily begin in phase three.
The requirements for the new product are defined in the user specification. Design and concept variants are then created. Patent suitability is clarified and the preliminary regulatory strategy and risk and cost analyses are compiled.
For more detailed project planning, the user specification is developed into a performance specification. Once approval is given, product development begins. CAD data is generated and prototypes are constructed. The production process (including test planning) is planned. The marking and packaging of the product are defined.
In the process development phase, the tools, fixtures and models are designed, manufactured and sampled. At the same time, the qualification processes are implemented. Production guidelines are drawn up and staff are given appropriate training. The process development phase ends when the functional capability of the tools, fixtures and plant has been qualified.
The proof phase starts with the design, the document freeze and commencement of change management. Process proof is provided using three validation runs. Here, 0-series production parts are manufactured and tested in accordance with the process documentation in a batch size that is similar to series production levels. If required, a larger test scope can be set up. Following validation, the product is registered and released for production.
Following the final project review, the product is introduced to the market.