Analyze and Reduce Potential Risks. Improve Reliability and the Bottom Line.

The Failure Mode and Effects Analysis (FMEA) method has been used for decades to conduct technical risk analysis, identify, and reduce failures and improve safety in products and processes. The technique varies by industry and application, but the goal is to prevent injury to the end-user and maintain compliance with safety regulations.

Why Perform a Failure Mode and Effects Analysis (FMEA)?

Teams use FMEA to identify potential failures in different phases of product life cycle including product design, manufacturing or assembly process, application, service, etc. It helps to assess the risk associated with those failure modes, rank and prioritize the issues.

FMEA allows teams to take actions to identify, prioritize, eliminate, or reduce failures. Failures are prioritized according to:

  • The severity of their consequences
  • The frequency of their occurrence
  • The ease of detection

The emphasis on prevention helps reduce the risk of harm for both people and businesses. The step-by-step approach is beneficial for identifying issues before implementation and assessing the impact of a proposed change on an existing process.

FMEA begins in the conceptual stages of design and continues throughout the life of the product. It helps document current knowledge and actions for use in continuous improvement.

What Is Failure Mode and Effects Analysis (FMEA)?

FMEA is a systematic method to evaluate and identify where and how a product or process might fail. It is a proactive approach to assess the impact of potential failures and identify the components within the process most in need of change.

“Failure mode” refers to the manner in which failure happens.

“Effects” refers to the undesired effects experienced by the customers (internal and external).

What Are the Different Types of FMEA?

  • System / Functional FMEAs – The highest-level analysis of an entire system that examines the functions of its various subsystems and how they could fail.
  • Design FMEAs – identify potential risks in a new design or a changed design phase of a product/service that could affect user experience.
  • Process FMEAs – identify risks on process changes by looking at manufacturing process steps, its process functions, failure modes, and their effects on the process and the end-user.
  • Service FMEAs – aims to identify and prevent service-related product failures that can occur due to improper installation, maintenance, operation, or repair.
  • Software FMEAs – to assess the system or software design, its ability to perform, identify potential risks that can harm the performance, and react predictably to ensure system safety.
  • Machinery FMEAs – helps to analyze the potential failures in the machinery used in the manufacturing process.

How to Perform FMEA – General Guidance

  • Identify the scope of the FMEA and use product design schematics, process flowcharts, manufacturing steps, etc. to detail the concept, system, design, process, or service.
  • Assemble a cross-functional team of people with diverse knowledge about the process, product, and customer needs.
  • Identify the functions which may include design, quality, manufacturing, testing, maintenance, purchasing (and suppliers), reliability, sales, marketing (and customers), and customer service.
  • Identify the purpose and break the scope into items, parts, assemblies, or process steps.
  • Identify the function of each step and then identify all the ways failure could happen for each function for potential failure modes.
  • Identify the consequences on the systems, processes, products, services, customers, or regulations for each failure mode.
  • The next step is to study the consequences and determine the potential effects of failure and its severity by rating it.
  • Determine the root causes by using analysis tools and list all possible causes for each failure mode on the FMEA form.
  • Determine the occurrence rating or O for each cause and estimate the probability of failure occurring during the product or process lifecycle. List the same on the FMEA table.
  • Identify current process controls for each cause and monitor them to prevent the cause from happening, reduce its occurrence or detect failure after the cause has already happened but before the customer is affected.
  • Determine the detection rating or D for each control. This will help teams to detect the cause or failure mode after occurrence but before the customer is affected. List the same on the FMEA table.
  • Try to find if the failure mode is associated with a critical characteristic that reflects safety or compliance with government regulations and needs special controls.
  • Calculate the risk priority number, or RPN and Criticality to guide potential ranking failures and prioritize them.
  • Identify recommended actions to lower severity or occurrence, which may be design or process changes. Once actions are completed, note the results and the date on the FMEA form.

Sphera’s FMEA-Pro, a leading Failure Mode and Effects Analysis software solution, provides consistency with quality risk assessments and assists with compliance with industry and company standards. It will help you analyze product designs and manufacturing processes better with shortened assessment times.

Learn more about Sphera’s FMEA-Pro and how to prevent failures from happening in the first place.

Further Resources on FMEA

Driving Change in FMEA
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How Quality Soars with FMEA
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Making Risk Assessments Operational

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