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 

• 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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Speaker

Antony John

Antony John is the Vice President of Omnex Systems. He has 19 years of experience transforming technology businesses across global markets and different customer industry segments, for profitable growth. Antony also possesses strong experience working in the Information Technology, Automotive, Aerospace, Oil & Natural Gas, and Insurance industries. He currently leads the Product Development of EwQIMS, a revolutionary software solution for managing Enterprise Quality for APQP, Integrated Management Systems / QHSE, and Supplier Quality used by Fortune 500 companies, OEMs, top automotive manufacturers, and large semi-conductor organizations across the globe.