Quality Risk

Because you take pride in quality

Today the pace of innovation is relentless, and excellence in design and manufacturing drives you to invest in continuous improvement for your products and processes. A standardized process is essential to manage inherent quality risks in design and manufacturing.


Fault Tree Analysis

Quality Risk Training


Lock in a consistent approach to products and processes

Our Quality Risk solution helps you strengthen and improve your quality processes. It provides you with the platform you need to create knowledge-driven, data-centric quality specifications and control plans that are consistent across the enterprise and helps you effectively conduct proactive risk assessment methodologies such as Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).

More importantly, the solution offers a holistic approach using standard libraries and templates to promote standardization and a common language, while providing the flexibility to link and connect information together – for example dFMEA and pFMEA, Process Flow Diagram/Chart, pFMEA and Control Plan. This allows you to perform quality risk assessment activities more efficiently and effectively, accelerating productivity and ensuring data integrity.

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Our Quality Risk Management solution allows you to:

  • Eliminate complex and dispersed risk documents and spreadsheets that proliferate your organization

  • Create a central knowledge base to retain critical expert data

  • Reduce engineering time to perform FMEAs and accelerate time to market for new product introductions

  • Seamlessly link FMEA information across the design and process stages (DFMEA, PFMEA) to reduce siloed risk assessments and increase productivity

  • Maintain consistent and systematic measurement of all product quality risks

  • Improve efficiency and reduce product quality risk by cascading changes through the APQP process

Quality Risk Management

Empower your people to meet customer demands for product quality excellence.

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Global Pharma Case Study

Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

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Quality Risk Infographic

What is the cost of poor quality? How can you improve your quality risk processes?

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Stature Quality Risk Management

Stature enterprise risk management platform enables you to drive better visibility and consistency.

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Bring your Pharma Quality Management System to Life

Global healthcare company Baxter shares insights and best practices on Quality by Design to engineer risk out of your processes.

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Quality Risk Case Studies

Customer Success Stories for Advancing Operational Excellence in Quality Risk Management.

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Pharma Risk Management

Link risk analysis across lifecycle stages from clinical hazard analysis to PFMEAs to Control Plans.

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Why FMEA-Pro?

Learn more about FMEA-Pro … Why is it the right tool for the job? How does it facilitate your risk assessments? What makes it like the human brain?

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Semiconductor Case Study

Semiconductor Manufacturer Reduces Product Defects and Lost Profits through Consistent Risk Assessment

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