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

CASE STUDY · SEMICONDUCTOR

A leading semiconductor company — operating 32 global sites and generating over $25B in revenue — set out to integrate risk management early in its Product Realization Process.

The Challenge

To remain competitive, the customer needed to refine its 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.

The Solution

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

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

The Results

Early detection

Early product risk detection in the development phase.

Less scrap & rework

Reduced scrap and rework across operations.

32 sites unified

Unified risk data across 32 sites.

Scalable integration

Scalable, maintenance-free integration.

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