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
Global Pharma Case Study
Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory RequirementsRead Case Study
Stature Quality Risk Management
Stature enterprise risk management platform enables you to drive better visibility and consistency.Watch Video