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Failure Mode & Effects Analysis (FMEA-Pro)

Efficiently identify, capture, manage and share critical documents and information. Consistent product quality, made possible in even the most complex supply chains. Prevent quality, risk and reliability failures with industry-leading FMEA Software.

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Sphera’s FMEA-Pro software offers a flexible framework for different FMEA methodologies and specialized capabilities for risk data management to ensure that proper controls are in place. It links critical quality information across design and manufacturing processes to help you achieve the quality your customers expect.

Expert Services to Complement Your Team

Our expert facilitators and trainers have extensive experience performing risk assessments based on any methodology, including:

  • Concept FEMA
  • Design FEMA
  • Process FEMA
  • DFMEA with DVP&R
  • And many more.
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ORM Module Graphics_FMEA – Expert Services to Complement Your Team

Streamline your processes to help save money and time

Improve your bottom line with a consistent process to analyze inherent risks thoroughly. Available in multiple languages, it offers key features.

  • Save time with preformatted templates
  • Automatically mirror data across sheets
  • Shorten study time and with centralized libraries
  • Leverage best practices with centralized libraries
  • Expand capabilities with matrix sheets and new techniques
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ORM Module Graphics_FMEA – Streamline your processes to help save money and time

Regulatory Compliance

FMEA-Pro helps organizations with quality, risk and reliability programs based on company or industry standards and guidelines

  • ISO 9001
  • ISO 13485
  • ISO 16949
  • FDA 21 CFR Part 820
  • And 11 More!
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ORM Module Graphics_FMEA – Regulatory Compliance


Efficient Analysis

Quickly assess and analyze current designs and processes.

Knowledge Made Accessible

Apply best practices from historical data and retain critical expert knowledge.

Adaptable Templates

Leverage our preformatted, industry-specific FMEA templates and easily configure them to your preferences.

Over 150 Years of Collective Experience

Our experts have a proven track record of supporting clients as they successfully mitigate risk, manage quality, and meet strict regulatory requirements.


Why FMEA-Pro?

Better analyze product designs and manufacturing processes, dramatically shorten assessment time, and prevent failures from happening in the first place.

Sphera’s leading FMEA solution, provides consistency with quality risk assessments and assists with compliance with industry and company standards.

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Enterprise Advanced Risk Assessment Software Is within reach

Consistently identify, assess and control the impact of operational risk. Sphera’s on-premise and cloud-based deployments features help you improve decision making and performance.


Process Safety Report 2023

In its eighth year, our annual survey takes a deep dive into the state of process safety and operational risk management across various industries.


Assess Risk to Ensure Quality

To preserve the quality of its design from conception to manufacturing this manufacturer performed Failure Mode and Effects Analysis (FMEA).

Our Awards

hydrocarbon processing

Best Digital Twin Technology

Finalist: ORM Digital Twin


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Product of the Year

Safety Category


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Operational Excellence Innovation Awards

Oil & Gas


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Green Quadrant

Leader: Process Safety Management Software


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Operational Risk Management Software


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Request a demo

Fill out the form and we will get back to you to discuss your failure mode & effects analysis needs.



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