Functional Safety Requirements

These are defined by the following standards, depending on the product type and intended use: Medical devices: ISO 60601, 62304 Automotive: IATF 16949 Industry: ISO 61508, ISO 13489

Integrated System Sample (System increments)

System increments are partial or full integrations of system versions that are verified by internal or external tests and (depending on the degree of regulation) by user or market tests. System increments are often created at cluster level, i.e. by integrating sub-products from the various Teams in a Cluster. For the System increment, P4 has…

Feasibility

Eine der wichtigsten K-Gaps in der physischen Produktentwicklung ist die physische “Machbarkeit”.  Diese enthält Fragen wie Gibt es geeignete Wirkprinzipien und welche sind das? -> (Optionen) Gibt es geeignete Materialien?

Cluster Management Circle

A Cluster within the product development Organization is managed by a group of managers. The Cluster Product Owner, the Cluster System Engineer and the Cluster Scrum Master form the Cluster Management Circle following the principal of separating powers. They support and complement each other in the decision-making of topics that reach their level or have been…

Usable Knowledge & Documented Decisions

Usable and documented knowledge is the basis of any system development. It makes it possible to make conscious design decisions. Usable Knowledge also represents the first stage of reuse (see principles). At a higher level, however, they also represens knowledge of the possibilities and limitations of integrated system solutions (Limits and Trade-offs). To achieve this,…

Product Development

  1. Elicit System Functions and Features –Define Context & Scope (Intended use, environments, markets) –Stakeholders & Needs, external interfaces –Quality Attributes, System Use Cases 2.Model a coarse System Architecture/Concept incl. test and production systems (Multiple options maybe necessary) –Output: Components and interfaces 3.Determine maturity of concepts, components and interfaces by gatherings K-Gaps (unknown concepts,…

Product Vision / Business Case

The product vision describes in compact form … the Intended Use, for which users, in which markets the product is intended, which are the basic requirements and standards what are the main functions of the product how the product fits into the application context and what interfaces it has with surrounding systems. There are different…

Risk impact

In every product development, there are design decisions that make the whole concept fly or make it impossible. These naturally have the greatest (risk) impact and should therefore be made first. The decision tree answers the question of the importance and influence of Knowledge Gaps, and thus the order of processing and solution in the…