Quality Risk

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Did You Know,

  • 80% of all quality issues are repeated events
  • 42% of knowledge workers’ time is spent seeking, processing and sharing information
  • 30% of total R&D spend is wasted, duplicating research and work done previously*

It really is no wonder as, according to an IHS Pulse of Engineering survey, 32% of companies lack formal knowledge management systems and processes to identify, capture, manage, and share critical documents and information.

A standardized process is essential to managing inherent quality risks in design and manufacturing. It helps to prevent costly failures and recalls and ensures product quality demanded by customers.

Sphera’s robust, centralized Quality Risk Assessment framework, configurable methodologies, and risk assessment workflows will help your organization standardize and record risk assessment data and ensure proper controls are in place. Our libraries and templates promote standardization in a common language while providing the flexibility to link information together – for example, dFMEA and pFMEA, Process Flow Diagram/Chart, pFMEA, and Control Plan. This allows companies to perform quality risk assessment activities more efficiently and effectively, accelerating productivity and ensuring data integrity.

  • Eliminate complex and dispersed risk documents and spreadsheets
  • 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 MFEA 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

Our Advanced Risk Assessment solution for Quality Risk comes prepackaged with a number of templates:

Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a leading framework in manufacturing industries for delivering high quality, reliable products faster, safer, and more efficiently. Sphera’s FMEA solution supports AIAG and VDA methodologies. It links critical quality information metrics across decentralized design and manufacturing processes in complex supply chains, to ensure consistent product quality demanded by customers.

Fault Tree Analysis

Fault Tree Analysis (FTA) is a top-down approach for analyzing pre-event failures with systems in development — beginning with the top event (the potential failure), then determining all the ways it can occur. Similarly, post-event failures can be analyzed to find the root cause of the failure. Although FMEA and FMECA are very powerful tools, specific recommendations can be vague, so identifying high-risk situations may warrant specific investigation using the FTA methodology.

*National board of Patents and Registration (PRJ), WIPI, IFA

Learn How Sphera Can Help Your Business

Are you ready to learn more? Tell us a little about your needs and a Sphera representative will get in touch.

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