Failure Mode and Effects Analysis

Stay consistent to eliminate risks

A standardized and consistent process is essential to manage inherent risks in design and manufacturing.

Failure Modes and Effects Analysis (FMEA) is a risk methodology that identifies potential failure modes based on experience with similar products and processes – or based on common physics of failure logic. It is widely used in development and manufacturing industries as well as in the Life Science industry in various phases of the product life cycle.


Quality Risk Training

Meet customer demands for product quality excellence

The Sphera Quality Risk solution is a global risk management platform designed to support a wide range of risk assessment methodologies. It supports FMEA, PFMEA, DFMEA methodologies amongst many others.

With Sphera’s proven enterprise software, content and domain expertise you can strengthen and improve risk visibility across teams, business lines, product families or locations and sites. Ultimately gain the insight you need to make better decisions and better products.

The solution offers a holistic approach where libraries and templates are used to promote standardization and a common language, but also, it provides 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 risk assessment activities more efficiently and effectively – accelerating productivity and ensusring data integrity.

Our Risk Assessment solution allows you to:

  • Accelerate time to market by enabling knowledge transfer across design and production teams

  • Reduce product re-work by creating a system of record for risk information

  • Create a standardized and robust knowledge base so lessons learned can be leveraged to drive continuous improvement

Quality Risk Management

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

Download Brochure

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?

Download Brief

Quality Risk Case Studies

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

Read Case Studies

Global Pharma Case Study

Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

Read Case Study

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.

Watch Webinar

Semiconductor Case Study

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

Read Case Study

Stature Quality Risk Management

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

Watch Video

Quality Risk Infographic

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

View Infographic