Design Failure Mode Effects Analysis (DFMEA)

What is Design Failure Mode and Effects Analysis (DFMEA)

To understand DFMEA first, let’s get a quick overview of what failure mode and effects analysis (FMEA) is. FMEA is a systematic process for recognizing and evaluating potential failures of systems, products, or processes. FMEA helps product developers eliminate or mitigate the impact of failures by identifying the effects and outcomes of failures or actions. DFMEA is a subset of FMEA

DFMEA (Design Failure Mode and Effects Analysis) is an approach used for identifying potential risks associated with the design of a product/service. Initially, the Design FMEA recognizes design functions, failure modes, and their effects on the customer. This fetches the corresponding severity ranking/risk of the effect. Then, the causes and mechanisms of the failure mode are determined, and this is how DFMEA works. To prevent or reduce the cause’s impact on the failure mode depends on High probability causes, as indicated by the occurrence ranking. The detection ranking highlights the ability of specific tests to confirm that the failure mode/causes are eliminated. The DFMEA also tracks improvements through Risk Priority Number (RPN) reductions. By comparing the before and after RPN, a history of improvement and risk mitigation can be chronicled. To mitigate the effects of a failure on product reliability or safety, understanding DFMEA is important.  

Initially, FMEA techniques were first developed in the late 1940s by the U.S. military. Then they were adopted by NASA in the 1960s and later by the automotive industry in the 1970s. Throughout the 1980s, the automotive industry put in quite good efforts and helped consolidate and standardize FMEA best practices. This resulted in optimizing the approach as a quality improvement and risk assessment tool were used at various stages of product development. As a critical consideration, today, major industries have adopted the practice of FMEA to meet industry standards to ensure high reliability and product safety for suppliers and product qualifications. Realizing that efficiency by design can contribute to productivity gains by helping in areas such as asset utilization and cost for defects, today every industry started implementing DFMEA to see the positive impact on areas such as product portfolio cycle and time to market. This practice will translate into improved market share.  

Why Perform Design Failure Mode and Effects Analysis (DFMEA)

Without proper analysis rushing a product through development can result in costly mistakes. And anything that hinders a product from operating correctly is considered a “defect.”   

It is a good practice to identify risks in a process as early as possible, as it can serve as a substitute for failure on new / changed designs. Early risk identification serves as the greatest opportunity for verified mitigation before product launch.  

DFMEA is applied when:  

  • A new design with new content is launched.
  • Current design with modifications. This may also include changes due to past failure. 
  • When the current design is being used in a new environment but changes in design. 

Companies perform DFMEA to reduce the number of design defects. This process helps companies prevent any design-related problems from occurring. DFMEA ensures consistent production, manufacturing, and output of high-quality deliverables. Industries like manufacturing, high-end technology, service delivery, and construction are the most likely to use DFMEA.   

But the approach is also used for risk management by companies that manufacture a range of goods and services. DFMEA is an essential component of overall quality management procedures because of these factors.  

DFMEA saves time and money on product development by assisting engineers in identifying and resolving possible design flaws early on. A more robust design with well-defined requirements can also be produced by using the DFMEA approach.  

Think about this: it is far less expensive to fix design-related problems early in the process than it is to wait until later in the production cycle or, worse after the product is in the hands of consumers. For this reason, DFMEA works best when it is included early on in the design process. Early detection and mitigation of possible design problems can greatly lower the likelihood of later, expensive changes and safety concerns.  

How to perform a Design Failure Modes and Effects Analysis (DFMEA) in 10 steps:

  • Define Functional requirements: Outline the functional relationships of the product design into systems and components.  
  • Identify System Failure Modes: Identify the potential failure modes for each system or component.  
  • Assess Failure Effects and Assign Severity Ratings: Describe the effects of each failure mode and rate their severity on a scale of 1 to 10, with 10 being the most severe.  
  • Identify Failure Causes: Investigate the root causes of each failure mode to understand why it occurs.  
  • Specify Prevention Controls and Assign Occurrence Ratings: Develop prevention measures and rate the likelihood of failure occurrence despite these controls on a scale of 1 to 10.  
  • Define Detection Controls and Assign Detection Ratings: Set guidelines to detect failure causes and rate the effectiveness of these controls on a scale of 1 to 10.  
  • Calculate the Risk Priority Number (RPN): Multiply the severity, occurrence, and detection ratings to calculate the RPN for each failure mode.  
  • Develop High-Priority Recommendations: Prioritize failure modes with high RPNs and create recommendations to address them, including specific actions, responsible individuals, and target completion dates.  
  • Document All Actions Taken: Record all actions taken to address failure modes, including completion dates and updates to the DFMEA form.  
  • Re-evaluate RPNs for Decision-Making: After implementing recommendations, re-assess the RPNs to determine if risks have been adequately mitigated and if the design can progress in the development process.  

By following these steps, you can systematically identify, analyze, and mitigate potential failures in your product design. 

Common mistakes in Design Failure Mode and Effects Analysis (DFMEA):

  • Failing to identify failures: Not completely identifying failure modes can result in critical design flaws being missed.  
  • Not involving experts: Cross-functional teams are not involved in overlooking critical failure modes.  
  • Using inaccurate ratings: Incorrect Severity Ratings and RPN Thresholds or lacking predefined thresholds can distort the prioritization of failure modes.  
  • Ineffective detection controls: Overlooking detection controls can allow failure causes to persist.  
  • Incorrect assessment: Neglecting the likelihood of occurrence ratings of failure modes occurring can lead to inadequate risk assessment.  
  • Ignoring Iterative Nature: Not revisiting and updating DFMEA as the design evolves can result in missed risks.  
  • Prioritizing Failures: Lack of Clear Action Plans for prioritizing failure modes can lead to inaction and delays.  
  • Failing to document actions: Not Documenting Actions Taken or Monitoring DFMEA progress can result in incomplete risk mitigation.  
  • Poor Training: Inadequate training in DFMEA can lead to errors and misunderstandings in the process.  

Benefits of DFMEA:

Benefits of DFMEA
  • Enhanced Product Quality and Safety: DFMEA improves product quality and safety, by identifying failure modes and their root causes, ensuring reliability and compliance with standards. 
  • Early Risk Identification: Conducting DFMEA in the very initial stages of development enables teams to identify potential failure modes, causes, and effects. Costs and complexities can be reduced if performed before any escalation happens. 
  • Regulatory Compliance: Identifying issues that could lead to non-compliance, DFMEA aids and ensures that products meet regulatory standards. 
  • Customer Satisfaction: DFMEA results in Higher product quality fewer defects and reliable performance which increases customer satisfaction. 
  • Efficient Resource Allocation: Prioritizing efforts based on severity through DFMEA helps allocate resources effectively, focusing on critical issues. 
  • Improved Decision-Making: DFMEA provides a structured approach for evaluating potential failures, facilitating data-driven decisions on issue resolution. 
  • Continuous Improvement: An iterative process, DFMEA allows for ongoing refinement and improvement as designs evolve and new information

DFMEA is utilized across various industries. The introduction of new products or technologies is frequent and mitigating risks early in the design process is crucial. Industries benefit greatly from DFMEA due to its structured approach to identifying potential failure modes and implementing effective risk mitigation strategies. Some of the industries that extensively use DFMEA include:    

  • Automotive: DFMEA is widely used in the automotive industry to identify and address potential failure modes in vehicle components, systems, and manufacturing processes.  
  • Aerospace: In aerospace, DFMEA plays a vital role in ensuring the reliability and safety of aircraft, spacecraft, and related equipment by proactively identifying and mitigating design risks.  
  • Defense: Defense industries employ DFMEA to assess and manage risks associated with military equipment and systems, ensuring optimal performance and safety in critical applications.  
  • Industrial: Industries involved in manufacturing and process engineering use DFMEA to improve the reliability, quality, and safety of machinery, equipment, and production processes.  
  • Healthcare: In the healthcare sector, DFMEA is applied to medical devices, equipment, and procedures to enhance patient safety, regulatory compliance, and overall product quality.  
  • Software Development: While not traditionally associated with physical products, DFMEA principles can be adapted to software development processes, helping teams identify and mitigate risks in software design, functionality, and performance.  

These industries recognize the value of DFMEA in early risk identification, improved product quality, regulatory compliance, and efficient resource allocation, leading to enhanced customer satisfaction and reduced costs associated with product failures.  

Design Failure Mode and Effects Analysis (DFMEA) Services

Qritrim provides comprehensive Design Failure Mode and Effects Analysis (DFMEA) services. We offer tailored solutions to address your specific DFMEA needs for implementing DFMEA processes in your organization. Our solutions help highlight the value of DFMEA in optimizing your organization’s performance.