Quality Risk Management Software

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Prevent Costly Rework, Scrap, Failures and Recalls

Risk-based decision-making has become a cornerstone in many industries – especially those as critical as manufacturing medical devices, life sciences, automotive, and semi-conductors. There’s risk running straight through these industries due to intellectual property, trade secrets, and the need to deliver quality products to customers.

What’s more, monitoring quality risk is difficult. And while compliance with quality regulations, standards, and customer mandates is a requirement, it’s not enough.

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*

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

To remain competitive, manufacturing organizations must transform and improve the efficiency of their quality management processes. They need to reduce time looking for and accessing risk assessment data. They need to consistently conduct risk assessments, access lessons learned and recommendations and improve traceability.

Companies need a standardized process and formal knowledge management systems and processes to identify, capture, manage and share critical documents and information. This is critical for managing inherent quality risks, preventing costly failures and recalls, and ensuring product quality demanded by customers.

Build Stronger Processes & Better Quality Programs

Sphera’s robust, centralized Quality Risk Management software, 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, 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 FMEA information across the design and process stages 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
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Sphera’s Quality Risk Management Software Helps

Effectively Conduct Risk Assessments

Uncover hidden risks in a consistent, standard format.

Centralize Risk Knowledge

Access risk assessment libraries and share lessons-learned information to help achieve compliance and control.

Comply with Regulations and Industry Standards

An audit trail helps prove compliance with governing regulations and risk legislation.

Understand Root Causes

Analyze root causes, and implement corrective actions to prevent major accidents, quality issues, and equipment failures.

Maximize System Investments

With Sphera’s Control of Work, teams can use a single, shared solution to approve maintenance work and see a breakdown view of the schedule – including required operational activities and inspection-related tasks.

Latest Resources

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Quality Risk Management Best Practices

Quality risk management is always important, but it’s especially so during these challenging times.

Our Quality Risk Management Software 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.

Bow-Tie Risk Analysis

The Bow-Tie methodology is a qualitative risk assessment method that provides a visual representation of the causes of unintended events, likely outcomes, and measures in place to mitigate or control hazards. It is often conducted after an initial PHA and has been adopted in industries such as mining, oil & gas, chemicals, and pharmaceuticals. Due to its graphic nature, Bow-Tie analysis is easily understood by all levels of operations and management and provides critical information that allows you to improve the safety of your processes and make better business decisions.

Process Hazard Analysis

Process Hazard Analysis (PHA) provides visibility of materially impactful risks so your organization can make decisions and implement controls that improve the safety of its processes.

Count on Sphera’s Managed Services and Customer Care to Maximize Your Investment

Implementation

Sphera’s expert services teams will configure our solutions to fit your unique business needs.

Maintenance

Streamlined, no-hassle delivery of software upgrades.

Support

Superior 24/7/365
customer care during and after your implementation.

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Control of Work

Standardize work practices to ensure safe, efficient work execution.

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