| Popis: |
In the search to maintain the integrity of all systems and components over the span of the product’s life, a tightly integrated risk management process and system shall enable a discrete but frequent enough calculation method. The challenge is finding a methodology where risk management is living, concomitant process throughout the lifecycle, which is cumulative, so the risk assessments refine with the product’s definition while adhering to a tightly regulated enviroment for medical devices. This process needs be fully embedded in the PLM processes so it is able to accompany the product at any change throughout its life. The Multi-interfaces Entity Model (MIEM) was introduced integrated with a summative risk management concept that allows an incremental risk analysis, while the entities in the MIEM are refined. The results were a recursive methodology that supported with a PLM integrated risk management, can be automated to make sure the risk assessment is complete, re-usable and configurable as an additional PLM function. The focus of this paper lies on the generation of the functional structure of a product which is connected with the Multi-interfaces Entity Model. This allows to create a configured design structure, applying recursively the same cumulative properties of the risk assessment where a new configuration would create new interfaces. |
