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Case study: Shift-Left – Integrating Product Risks in New Product Development using FMEA

Shift-Left – Integrating Product Risks in New Product Development using FMEA

Overview

A leading semiconductor company—operating 32 global sites and generating over $25B in revenue—partnered with Omnex to embed risk management early in its product development lifecycle. By adopting a “Shift-Left” approach, the organization improved product quality, reduced waste, and achieved real-time visibility into product risks using FMEA and Omnex’s enterprise NPI platform.

The Challenge

To remain competitive, the customer needed to refine their Product Realization Process by integrating risk management early in the development phase. Key challenges included:

  • Integration Complexity: Navigating 18 disparate applications spanning legacy systems, homegrown solutions, and COTS software, which fragmented data workflows.
  • API Limitations: Frequent updates and data model changes made real-time insights difficult, as static API pull-based integrations couldn’t support dynamic decision-making.
  • Evolving Change Management: Transitioning between various enterprise change platforms (Metastorm, K2, and FCM) further complicated seamless data exchange and compliance.

Omnex Solution

Omnex implemented a real-time data (RTD) integration strategy within its EwQIMS platform to:

  • Enable push-based, real-time risk data visibility
  • Seamlessly connect change management and NPI systems
  • Automate FMEA updates post-change approval

Impact at a Glance

Omnex implemented a real-time data (RTD) integration strategy within its EwQIMS platform to:

  • Early product risk detection
  • Reduced scrap and rework
  • Unified risk data across 32 sites
  • Scalable, maintenance-free integration

Conclusion

By embedding real-time risk insights into their development lifecycle, this semiconductor leader successfully adopted a “Shift-Left” strategy. The Omnex Enterprise NPI & RTD solution not only enhanced product quality and operational efficiency but also paved the way for sustained industry leadership.

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