What is DFMEA

Guide: Design Failure Mode and Effects Analysis (DFMEA)

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Daniel Croft

Daniel Croft is an experienced continuous improvement manager with a Lean Six Sigma Black Belt and a Bachelor's degree in Business Management. With more than ten years of experience applying his skills across various industries, Daniel specializes in optimizing processes and improving efficiency. His approach combines practical experience with a deep understanding of business fundamentals to drive meaningful change.

Design Failure Mode and Effects Analysis, or DFMEA, is an key risk management strategy in modern product design and development. This technique delves deep into identifying potential failure modes in a product’s design, highlighting its significance in ensuring safety and functionality.

Based on the broader framework of Failure Modes and Effects Analysis (FMEA), DFMEA stands out for its exclusive focus on design-related vulnerabilities. By proactively pinpointing and addressing these vulnerabilities, DFMEA im important in preventing costly and potentially hazardous real-world issues. Its relevance spans across various industries, evident in scenarios like a car manufacturer analyzing a vehicle’s myriad potential failure modes to mitigate risks effectively.

You can learn about conducting an FMEA process with our FMEA Guide.

Table of Contents

What is Design Failure Mode and Effects Analysis (DFMEA)?

Design Failure Mode and Effects Analysis, commonly referred to as DFMEA, is a risk management technique that focuses on identifying potential failure modes within a product design. the DFMEA is a version of the standard Failure Modes and Effect Analysis (FMEA) that is focused on design failure modes. 

It aims to evaluate the consequences, or “effects,” of those failure modes on the overall functionality and safety of the product. The objective is to proactively address design vulnerabilities before they manifest into real-world issues, thus saving time, money, and potentially lives in more serious cases. Take a car manufacturer, for example. There are so many elements and potential failure modes of a car, that they need to analyze how a system of the car might fail and take actions to reduce that risk. 

Systematic and Structured Approach

DFMEA follows a systematic, step-by-step approach, often using a standardized form or software to document the analysis. This structured format ensures that the analysis is thorough and consistent across different projects or industries.

DFMEA Process

A Focus on Product Design

While FMEA can be applied to various areas like processes (PFMEA), systems (SFMEA), and even services, DFMEA specifically targets product design. This focus makes it a vital tool for designers, engineers, and quality assurance professionals involved in creating new products or modifying existing ones.

Risk Assessment

The core function of DFMEA is to act as a risk assessment tool. It helps teams quantify the risk associated with different failure modes by considering factors such as:

  • Severity: How bad is the effect of the failure?
  • Occurrence: How often is the failure likely to happen?
  • Detection: How easy is it to detect the failure before it impacts the customer?
LLS FMEA Failure Modes Effect Analysis RPN Formula LearnLeanSigma

These factors are numerically rated and multiplied together to form a Risk Priority Number (RPN), which helps in prioritizing which failure modes to address first.

This can be seen in the below basic example where insufficient cooling has been identified as the highest RPN failure mode.

FMEA Step 8

Evaluating Potential Failures

In DFMEA, each design element is scrutinized for possible ways it could fail. This includes looking at material choices, tolerances, electrical components, and any other feature that has the potential to fail.

Impact on Functionality and Safety

DFMEA is not just about identifying what could go wrong; it’s about understanding the implications of those failures. Will a failure merely be an inconvenience, or could it result in a safety hazard? These are critical questions that DFMEA helps to answer.

Why is DFMEA Important?

Understanding the significance of DFMEA isn’t just about knowing what it is, but also appreciating why it’s crucial in product design and development. Here are some of the key reasons why DFMEA holds an important place in any design process:

Risk Mitigation

One of the primary advantages of DFMEA is that it allows for the identification of potential design flaws at an early stage. This early identification can be a game-changer, allowing for corrective measures to be taken before the design is finalized and production begins.

By identifying potential risks early, DFMEA allows teams to take preventive rather than corrective actions. This is far more cost-effective and efficient, as it saves the time and resources that would otherwise be spent rectifying issues after they occur.


Discovering a design flaw after a product has gone into production can be a costly mistake. Not only does it require revising the design, but it also often involves scrapping or retrofitting already manufactured units. DFMEA helps in saving costs in such scenarios.

By focusing on potential failure modes that have the highest Risk Priority Numbers (RPN), teams can allocate resources more efficiently, tackling the most critical issues first.

Quality Improvement

A thorough DFMEA process ensures that each aspect of the design has been scrutinized for failure modes, which in turn increases the reliability of the final product.

Products that are reliable and free from design flaws naturally lead to higher customer satisfaction. This can be a significant competitive advantage in the market.


Many industries have stringent regulations that require a systematic approach to risk assessment, of which DFMEA is a key component. Failure to comply can result in penalties and may even prevent the product from entering the market.

DFMEA is often conducted according to industry standards like ISO 9001 for quality management or ISO 14971 for medical devices. This helps in achieving a level of standardization that is globally recognized.

When to Use Design Failure Mode and Effects Analysis (DFMEA)

The timing of when to implement DFMEA is crucial for maximizing its benefits. While it can be tempting to think of DFMEA as a one-time activity, it’s most effective when integrated at multiple stages of the design and development process. Here are some key scenarios when DFMEA should be utilized:

During the Initial Design Phase of a New Product

  1. Conceptual Stage: As soon as the basic concept of a new product is formulated, DFMEA can be introduced to evaluate potential design risks. This early involvement ensures that the product is developed with reliability and safety in mind from the get-go.

  2. Prototyping: Before a physical prototype is developed, a DFMEA can help predict how the design might fail, enabling adjustments that can save both time and resources.

  3. Design Validation: DFMEA can be revisited during design validation to ensure that all identified failure modes have been addressed and that any new failure modes introduced by design changes are assessed.

When Making Significant Changes to an Existing Design

  1. Design Revisions: Whenever there’s a significant change in design—be it in materials, components, or functionality—a new or updated DFMEA should be conducted to assess new potential failure modes.

  2. Feedback Incorporation: Customer feedback, warranty data, or field reports may indicate design weaknesses that need to be addressed. A fresh DFMEA can guide the redesign process effectively.

  3. Technology Updates: Advances in technology can often lead to design updates in existing products. Conducting a DFMEA ensures that the incorporation of new technologies doesn’t introduce unforeseen vulnerabilities.

To Comply with Industry or Regulatory Standards

  1. Regulatory Compliance: In regulated industries like healthcare, automotive, and aerospace, DFMEA is often a mandatory part of the design process. Failure to perform a comprehensive DFMEA can result in regulatory action, including fines or product recalls.

  2. Industry Best Practices: Even in industries where DFMEA is not mandated by law, it is often considered a best practice and can contribute to certifications like ISO 9001 for quality management.

  3. Legal Safeguard: In the unfortunate event of product failure leading to litigation, a well-documented DFMEA can serve as evidence that due diligence was exercised in the design process, potentially safeguarding against legal repercussions.

Common Mistakes in DFMEA and How to Avoid Them

Design Failure Mode and Effects Analysis (DFMEA) is a powerful tool for risk assessment in product design. However, its effectiveness can be compromised if certain common mistakes are made during its implementation. Recognizing and avoiding these pitfalls is crucial for a successful DFMEA process. Here are some of the most common mistakes and how to sidestep them:

Not updating DFMEA:

Many teams consider DFMEA a one-time activity and neglect to update it when design changes occur. This can lead to outdated risk assessments that don’t reflect the current state of the design.

To avoid this mistake you should schedule regular DFMEA review meetings, especially after significant design changes or updates. You should also establish triggers that necessitate a DFMEA update, such as a change in materials, a new manufacturing process, or customer feedback. Finally, maintain a version history of the DFMEA document to track changes over time.

Inadequate Team Composition:

Often, DFMEAs are conducted by teams that lack diversity in terms of skill set and perspective. This can result in a narrow or skewed analysis.

This can be achieved by including professionals from various departments such as design, engineering, quality assurance, and even marketing to get a comprehensive view. Sometimes, bringing in a subject-matter expert from outside the organization can provide new insights. Make sure all team members are trained in the DFMEA methodology to ensure a standardized approach.

Ignoring Low RPN Values:

A RPN is used to prioritize failure modes, and there’s a tendency to ignore issues with low RPN values. However, low RPN doesn’t always mean low risk, especially if the severity rating is high.

This can be avoided by always considering the severity rating independently. Even a rare issue can be catastrophic if it occurs. Instead of solely relying on RPN, look at the risk from multiple angles. For example, consider customer dissatisfaction or brand reputation. Keep an eye on failure modes with low RPN values and reassess them periodically, especially if there are changes in the production volume or customer feedback.


Design Failure Mode and Effects Analysis (DFMEA) is a useful tool in product design, offering a structured and systematic approach to risk assessment and mitigation. By carefully analyzing potential failure modes and their impacts, DFMEA enables designers and engineers to enhance product safety, reliability, and compliance with industry standards.

Its effectiveness, however, relys on proper implementation, inclusive team composition, and ongoing updates to reflect design changes and evolving industry practices. The significance of DFMEA extends beyond mere technical analysis; it represents a commitment to quality, customer satisfaction, and proactive problem-solving in product development. 


A: DFMEA focuses on potential failure modes in the design of a product, while PFMEA looks at potential failures in the manufacturing or assembly process. Essentially, DFMEA is concerned with the “what” (product design), and PFMEA is concerned with the “how” (production process).

A: DFMEA should be considered a living document and should be updated regularly. It is essential to review and revise the DFMEA whenever there are significant changes in the design, new information from customer feedback, or updates in regulations and standards.

A: A DFMEA team should be cross-functional, involving professionals from various departments such as design, engineering, and quality assurance. Sometimes, it may also be beneficial to include external experts or members from marketing or customer service to get a broader perspective.

A: Prioritization is typically done using the Risk Priority Number (RPN), calculated by multiplying the Severity, Occurrence, and Detection ratings. Failure modes with higher RPN values are considered higher priority and are addressed first.

A: While DFMEA is traditionally used for physical products, its principles can be adapted for software design, known as Software FMEA (SFMEA). It helps in identifying potential flaws in the software architecture, logic, or user interface, and assessing their impact on the system’s functionality and reliability.


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Daniel Croft

Daniel Croft is a seasoned continuous improvement manager with a Black Belt in Lean Six Sigma. With over 10 years of real-world application experience across diverse sectors, Daniel has a passion for optimizing processes and fostering a culture of efficiency. He's not just a practitioner but also an avid learner, constantly seeking to expand his knowledge. Outside of his professional life, Daniel has a keen Investing, statistics and knowledge-sharing, which led him to create the website learnleansigma.com, a platform dedicated to Lean Six Sigma and process improvement insights.

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