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Elicitation of user needs for the production process and production facilities of IVD sensors
Projektdauer: 1 Jahr, 2 Monate
Kurzbeschreibung
The customer's project is part of a program that defines the production of an IVD sensor for a newly developed IVD device. In detail, the project includes the definition of the production processes and production lines from assembly to packaging of the finished sensor. PTA supports the user team in eliciting the needs that different user groups regarding the production process. PTA develops a requirements concept, interviews the users and together with them, elicits and documents the user requirements. As the production process is to be automated in contrast to the production of similar sensors at the production site, a particular focus is placed not only on modeling the system context but also on assigning the process steps to the planned production lines and modeling the corresponding process sequences for these lines.
Ergänzung
Classic requirements and system engineering methods are used. Context, process and system models are modeled in Lucidchart and archived in an ALM tool (codebeamer). Requirements are collected in the ALM tool. This guarantees complete traceability of the elicitation process and proper documentation of the requirements. A technical chapter structure is created based on the production process and the system context, which serves as a guide for interviews with users in order to understand tasks and restrictions. The requirements derived from this are recorded in the form of user stories. Particularly important is the associated rationale, which describes the reason or purpose for a requirement and thus represents the justification for the requirement. The advantage of this approach is that the user and stakeholder needs are documented in the problem space without restricting the solution space in the subsequent concept and design phase.
Fachbeschreibung
The main objectives of the project revolve around a future-proof production concept and the provision of the necessary space, infrastructure and production facilities. Production should be able to be operated profitably, with a high yield and low downtime. It should be flexible, modular and scalable so that production can be adapted to changes in demand with minimal effort. It should also be integrated into existing production structures and adjacent processes so that the quality required by regulations can be guaranteed and documented.
IT-Projektdaten
- Branchen Medizintechnik
- Fachaufgaben consulting, documentation, IVD (in-vitro-diagnostics), questionaires, Requirements Engineering, requisitions, System Engineering
- DV-Aufgaben Requirements Engineering
- Systemumgebungen organizational consulting
- Vorgehensmodell customer standard
- Betriebssysteme Intland Codebeamer
Projektzeitraum01.04.2023 - 31.05.2024
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