CMMI (Capability Maturity Model Integration) is a process improvement approach that provides organizations with the essential elements of effective processes, which will improve their performance. CMMI focuses on traceability, repeatability and reporting topics. Companies like Accenture, Boeing, BMW, Nokia, Samsung, KPMG, and Bosh (to name a few) are using CMMI.
ISO 26262 is a Functional Safety standard, titled "Road vehicles -- Functional safety". Like its parent standard IEC 61508, ISO 26262 is risk based safety standard, where the risk of hazardous operational situations are qualitatively assessed and safety measures are defined. ISO26262 focuses on Requirements Management and Electrical and/or Electronic (E/E) systems and that are installed in series production passenger cars. A PLM system can be instrumental in fulfilling these compliance standards.
The international standard IEC 62304 – medical device software – provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of Medical Device Software. This standard provides requirements for each life cycle process.
PLM can enable industry standard traceability requirements.
An example of this is using ENOVIA Requirements Central and DS’ Reqtify product together. ENOVIA Requirements Central enables global development organizations to drive consistency in a shared environment when capturing customer, regulatory standards and market-driven requirements. Requirements can be defined and decomposed into a hierarchy, and fulfilled through the design, implementation and testing of final products to provide traceability throughout product development.
Reqtify acquired from Geensoft in 2010 is the best-in-class solution for Requirement Traceability and Impact Analysis. Reqtify has over 60 3rd-party application plug-ins to various sources of requirements data (e.g. – DOORS, CaliberRM, ReqIF, etc.). When Reqtify is used with ENOVIA Requirements Central, users can:
- Manage requirements from various sources
- Allocate requirement to numerous artifacts
- Export Requirements in ReqIF format
- Create reports in numerous formats
These capabilities are essential to comply with ISO 26262
PLM can promote use of templates to comply with industry standards
A great example of this is ENOVIA Program Central being used to manage a phase/gate development process based upon industry standard templates. Moreover, ENOVIA Program Central allows companies to benefit from a deliverables-driven project management approach. As an example, the release of requirements can drive the completion of tasks, gates or milestones. These capabilities are essential to comply with CMMI.
I would be interested in knowing other examples of how customers have used PLM to comply with these standards.
