In my last article, I explained the two possible ways of project management and also presented the combination of both ways as a hybrid approach.
For some time now, we at MOBA have been combining both paths in suitable projects to form a hybrid development process in which individual functionalities are defined, programmed and also fully tested in the lower phases of the V-Modell in the form of individual sprints. The big advantage of this is that test versions that have a defined and functional scope can be released relatively quickly.
This procedure has also been tested by TÜV Nord with regards to functional safety and compliance with the relevant standards DIN EN 13849 and IEC 61508 and the MOBA development concept has been confirmed.
It is important that the development process is fully documented, starting with the specification, the risk assessment and the safety concept. An overview of the modules required to fulfill the specification of the product is presented with a so-called greybox and the individual modules are specified from all sides (hardware, mechanics and software) and a module FMEA is carried out. This results in functionalities, but also in measures to maintain functional safety, which must be implemented accordingly.
After the functionalities have been implemented and tested in individual sprints (1-2 weeks), a first functional sample of the product is created during the development process, with which further integration and system tests are carried out. After the full functional scope has been achieved and succesfully tested, including the qualification measures defined in the specification, the field test can be carried out with a CE-compliant device.
Finally, the product file with operating instructions, safety manual and data sheet is completed and the product receive series status.
When a series device is modified, MOBA change management comes into the play and all necessary steps are taken, from specification of the change, the complete documentation and implementation and the necessary final tests and qualifications.