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What is FMEA?

Failure Modes and Effects Analysis (or FMEA) is an approach that aims to anticipate and address potential failures in products, processes, or services before they happen.

FMEA follows a structured methodology to spot potential “failure modes” – or ways things go wrong – as well as assessing the risk associated with these failures, and prioritising any action to prevent or mitigate the most serious issues.

Along with its closely related variant, FMECA (Failure Modes, Effects, and Criticality Analysis), FMEA is an approach that allows organisations to form a framework for continuous improvement by helping them systematically address vulnerabilities in their products or processes. This includes efforts specifically targeted to:

  • Reduce risk
  • Improve reliability
  • Reduce warranty costs
  • Improve brand reputation

What are the common procedures in FMEA?

FMEA is usually carried out by a cross-functional team of engineers (representing the design, production, and support of the product or process), as well as quality control and other specialists, depending on the industry or context of the analysis.

Typically, a modern FMEA approach follows a seven-step structure during any stage of product or process development:

  1. Planning and preparation – the team defines the scope and objectives of the FMEA, assembling crucial resources and relevant background information to get a thorough overview.

  2. Structure analysis – the team then identifies which systems, subsystems, and components (or process steps) are the highest priority to be analysed for potential faults. Not every nut and bolt needs to (or can) be analysed. 

  3. Function analysis – after settling on the most relevant items to analyse, teams should detail the primary functions those items must perform for the system or process to operate as intended.

  4. Failure analysis – once functions have been described, the team needs to outline:
     
    • how the system or process could fail to execute those functions,
    • the effects those failures would have on the end user or operator, and
    • the root causes of those failures that could later be addressed by the team. 

  5. Risk analysis – the team evaluates the existing control measures to prevent or detect each failure mode. Risk analysis uses metrics like Severity, Occurrence, and Detection ratings to quantify risks and establish a prioritisation system for ranking risks using Action Priority (AP) or other approaches, letting the team prioritise failures based on their overall risk ratings.

  6. Optimisation – in this step, the team can recommend and track any corrective actions, whether it’s design changes, improvements to quality controls, or adjustments to the process. The overall goal for optimisation is to reduce risk levels to an acceptable range.

  7. Documentation – after all the previous six steps are completed, the final step is to generate a comprehensive report, used as a “living document” to summarise findings, update generic FMEAs, and track any follow-up actions. That way, future teams can add updates over time to add new information and any new risks that may emerge.

Why use FMEA as a risk mitigation tool?

Using FMEA to spot potential failures earlier on in the design stages paves the way for organisations to prevent issues that could compromise safety, quality, or functionality, while also saving time, reducing costs, and improving customer satisfaction.

Whether it’s for product reliability, process efficiency, or overall risk management, FMEA has proven valuable time and time again across a huge range of industries. Industries like automotive, aerospace, and healthcare all have stringent quality and safety requirements, which makes FMEA a critical tool for compliance and continuous improvement.

For example, an organisation can use FMEA on a product to determine how a component failure might compromise safety or performance, and guide design improvements to reduce this risk.

Alternatively, a Process FMEA (PFMEA) might look at potential points of failure within manufacturing, addressing any issues before they can affect production.

No matter what application or industry it’s used for, FMEA has become an invaluable engineering methodology, minimising risks, improving product quality, and producing robust knowledge bases to steer future design and manufacturing processes.

Where did our journey with FMEA begin?

FMEA timeline 01
The timeline of FMEA implementation, from the 1940s to the present day

The history of FMEA begins in the 1940s, when the US armed forces originally formalised its use in the MIL-P-1629 procedure. Originally, FMEA was designed to categorise and mitigate risks in military operations, pre-empting failures that could jeopardise mission success or safety. This would give engineers a systematic way to prioritise issues based on their criticality.

When the Cold War was underway, the aerospace sector – particularly NASA – gained an interest in FMEA to support missions like the Apollo space programme. In these high-stakes missions, where even minor component failures could spell disaster, FMEA became a vital addition, perfect for rigorous risk assessment and proactive planning and helping to save many lives.

Expanding FMEA into other industries
 

Beyond the military, aerospace, and aviation sectors, the automotive industry then became one of the early adopters of FMEA. In the 1970s, American automotive manufacturers faced regulatory and legal scrutiny due to design defects, leading to recalls and public controversy.

In response, automotive giants in the US joined forces to form the Automotive Industry Action Group (AIAG) organisation in 1982, publishing the industry’s first FMEA reference manual. The industry then began integrating and formalising FMEA processes to prevent any similar failures from happening again, establishing FMEA as a standard method in automotive engineering.

Over the decades, FMEA has expanded beyond its military and aerospace origins to industries as wide-ranging as healthcare, food and beverage, semiconductors, oil and gas, and nuclear power, to name a few.

Different adaptations of FMEA now cater to specific industry needs:

  • Design FMEA (DFMEA) looks more at potential design-related failures
  • Process FMEA (PFMEA) focuses more on manufacturing and operational reliability
     

The role of software in improving FMEAs

Early on, the FMEA process involved extensive manual documentation, either on paper or spreadsheets. As FMEA grew in complexity and scope, however, software solutions emerged to help streamline and enhance the process.

One such software solution was ReliaSoft XFMEA. Introduced in 2003, ReliaSoft XFMEA brought unprecedented efficiency and depth to FMEA processes, allowing companies to organise and analyse failure data, track corrective actions, and stay consistent across FMEA documents. Going beyond simple documentation, ReliaSoft XFMEA helped teams with analysing comprehensive data, sharing knowledge, and improving processes.

In more recent years, the introduction of cloud-based solutions has brought about a major transformation of FMEA. Released in 2024, ReliaSoft Cloud is the latest advancement in FMEA technology, enabling real-time collaboration across teams and locations through a web-based, Software-as-a-Service (SaaS) subscription. This provides a simple-to-deploy system for a small team or a global enterprise, with no local software installations.
 

What does the future hold for FMEA?

One of the biggest advancements in technology today is artificial intelligence (AI), with more and more industries turning to AI-driven solutions for complex data analysis thanks to their predictive capabilities.

AI offers the potential to more effectively learn from previous FMEA studies. Processes can be streamlined by using failure modes of similar components more rapidly, saving time and avoiding unexpected issues. This will help teams to learn lessons and reapply them effectively, minimising the loss of engineering knowledge.

AI also has the potential to combine real-world experiences and failure data to better inform future designs and FMEAs. This gives a significant competitive advantage to companies that can truly harness this technology to drive down risk and maximise engineering efficiency.
 

How ReliaSoft Cloud improves the FMEA process

Imagine instant, universal access to FMEA data, without the delays or complications of spreadsheets or even on-premise server systems.

This is a reality with ReliaSoft Cloud.

Building on our long history of reliability engineering and analytics, ReliaSoft Cloud delivers the future of FMEA:

  • Real-time collaboration – engineers can seamlessly communicate and collaborate across teams and locations
  • Global accessibility – instant access to shared documents, data insights, and progress tracking from anywhere in the world
  • Reduced IT maintenance – SaaS cloud computing for rapid, simplified deployment and allowing teams to scale their FMEA practices

As well as providing powerful tools to enable teams to visualise risk data, track design improvements, and streamline decision-making, ReliaSoft Cloud provides AI-powered learning from previous FMEAs. Incorporating AI assistance to help and accelerate FMEAs is a significant stride towards the long-term adoption of artificial intelligence in the risk mitigation process.

Embrace the future of FMEA with ReliaSoft Cloud

With ReliaSoft Cloud, organisations can now enhance their FMEA practices with real-time collaboration, and global accessibility for different teams and locations. This powerful new tool will empower engineering teams to dream bigger, drive innovation, streamline their processes, and improve reliability in ways not previously possible.

Are you ready to learn more about the future of FMEA? Discover how ReliaSoft Cloud will support your FMEA needs and unlock AI-powered, cloud-based FMEA for your organisation.
 

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