Comprehensive Guide to Failure Mode and Effects Analysis (FMEA)

What is FMEA?

Failure Mode and Effects Analysis (FMEA) is a structured risk assessment technique. Primarily, it aims to identify potential failures, their causes, and the consequences of those failures. It enables you to anticipate and address potential issues early in the project life cycle. In addition, FMEA facilitates better decision-making by prioritizing actions based on the severity, occurrence, and detection of failure modes.

Types of FMEA

Failure Mode and Effects Analysis (FMEA) can be categorized into different types based on their application and scope. Each type of FMEA is designed to address specific aspects of processes, products, or systems. Here are the most common types of FMEAs:

1. Design FMEA (DFMEA):

Design FMEA focuses on analyzing and mitigating potential failures during the design phase of a product or system. In other words, it is conducted early in the development process to identify design weaknesses and ensure that potential failure modes are addressed before production begins. Specifically, DFMEA assesses how failures in the design could impact product performance, safety, and customer satisfaction. Ultimately, the goal is to make necessary improvements to the design and reduce potential risks before manufacturing.

2. Process FMEA (PFMEA):

Process FMEA is used to analyze and manage potential failures in manufacturing or operational processes. Generally, it is performed during the production planning stage and aims to identify and address possible failure modes in the production process. Moreover, PFMEA examines how process variations, errors, or malfunctions could affect the quality, efficiency, and reliability of the final product. By proactively addressing process-related risks, manufacturers can enhance product quality and optimize the production process.

3. System FMEA (SFMEA):

System FMEA assesses potential failures and risks within complex systems that involve multiple interconnected components or processes. Therefore, it looks at the interactions between different subsystems and identifies potential failure modes that could compromise the overall system’s performance, safety, or functionality. In addition, SFMEA helps system engineers and designers understand how failures in one subsystem can affect the entire system and allows them to implement effective mitigating measures.

4. Software FMEA (SW-FMEA):

Software FMEA is specifically focused on analyzing software-related failures and risks in systems that heavily rely on software components. Besides, this type of FMEA is commonly used in industries such as automotive, aerospace, and medical devices, where software plays a critical role in the overall system functionality. Specifically, SW-FMEA aims to uncover potential defects, bugs, or vulnerabilities in the software that could lead to system malfunctions or safety issues.

5. Maintenance FMEA (MFMEA):

Maintenance FMEA evaluates potential failures and risks associated with equipment or machinery maintenance activities. It helps maintenance teams identify critical components or systems that require regular maintenance and predict potential failure modes. By understanding the risks associated with maintenance activities, organizations can develop efficient maintenance plans and ensure equipment reliability and longevity.

6. Service FMEA (SERFMEA):

Service FMEA is focused on analyzing potential failures and risks associated with service or repair activities for products or systems after they have been deployed in the field. This type of FMEA is beneficial for industries where products require regular servicing, such as the automotive and healthcare sectors. SERFMEA aims to optimize service processes, reduce downtime, and enhance customer satisfaction.

Each type of FMEA has its unique objectives and methodologies, but the common goal among all of them is to proactively identify and mitigate potential failures, thereby improving the overall performance, reliability, and safety of products, processes, or systems.

How to create an FMEA?

FMEA
  1. Define the Scope:

    Firstly, clearly identify the system, process, or product to be analyzed. Determine the boundaries and objectives of the FMEA study.

  2. Assemble the Team:

    Form a multidisciplinary team of experts and stakeholders who possess knowledge about the system or process being analyzed. Include individuals from different departments or disciplines to ensure a comprehensive assessment.

  3. Identify Failure Modes:

    Next, list all potential failure modes or ways in which the system or process could fail. Generally, this step involves brainstorming and considering various scenarios that could lead to failures.

  4. Determine Effects of Failure:

    Assess the effects or consequences associated with each identified failure mode. While assessing, you should consider the impact on safety, quality, reliability, customer satisfaction, environmental factors, and regulatory compliance.

  5. Assign Severity Ranking:

    Next, assign a severity ranking to each failure mode based on the potential impact of the failure. For this purpose, use a numerical scale or a predefined rating system to determine the severity level.

  6. Identify Causes of Failure:

    Determine the potential causes or sources of each failure mode. By brainstorming, analyze the underlying factors that could lead to the identified failures.

  7. Assign Occurrence Ranking:

    Next, evaluate the likelihood or occurrence probability of each failure mode. For this, consider historical data, expert opinions, and statistical analysis to estimate the likelihood of occurrence.

  8. Detect Failure Modes:

    Identify the existing controls, detection methods, or mechanisms that could potentially detect or prevent the occurrence of each failure mode. Additionally, assess the effectiveness of these controls in detecting failures.

  9. Assign Detection Ranking:

    Next, assign a detection ranking to each failure mode to indicate the effectiveness of the existing controls or detection methods. Also, consider the probability of detection and the reliability of the detection mechanisms.

  10. Calculate Risk Priority Number (RPN):

    Calculate the Risk Priority Number by multiplying the severity, occurrence, and detection rankings. The RPN helps prioritize the failure modes based on their potential impact and likelihood.

  11. Develop Action Plans:

    Prioritize the high-risk failure modes and develop action plans to mitigate or eliminate them. Define specific actions, responsibilities, and timelines for implementation. Consider design improvements, process modifications, training, or additional controls as appropriate.

  12. Implement and Monitor:

    Execute the action plans and monitor their effectiveness. Continuously review and update the FMEA as new information becomes available or when changes occur in the system or process.

By following these key steps, you can systematically analyze and address potential failure modes. Furthermore, you can reduce risks and improve the overall performance, reliability, and quality of your systems, processes, or products.

Example of a Failure Modes and Effects Analysis

FMEA

Let’s create an example FMEA for a hypothetical manufacturing process of a smartphone assembly line. We’ll follow the key steps mentioned earlier:

  1. Define the Scope:

    The scope of our FMEA is the smartphone assembly process, specifically focusing on the step of attaching the screen to the body.

  2. Assemble the Team:

    Our team consists of experts from manufacturing, quality control, design, and engineering departments, as well as representatives from suppliers and customer service.

  3. Identify Failure Modes:

    • Screen misalignment during attachment.
    • Insufficient adhesive application.
    • Damaged screens during the attachment process.
  4. Determine Effects of Failure:

    • Screen misalignment: Poor display quality, and customer dissatisfaction.
    • Insufficient adhesive: Weak bonding, screen detachment, product failures.
    • Damaged screens: Scratched or cracked screens, product rework, or rejection.
  5. Assign Severity Ranking:

    • Screen misalignment: 8/10 (affects usability and customer satisfaction).
    • Insufficient adhesive: 9/10 (critical for product functionality).
    • Damaged screens: 7/10 (affects product quality and customer perception).
  6. Identify Causes of Failure:

    • Screen misalignment: Inaccurate positioning mechanism, human error.
    • Insufficient adhesive: Dispensing equipment malfunction, improper training.
    • Damaged screens: Mishandling during attachment, inadequate protective measures.
  7. Assign Occurrence Ranking:

    • Screen misalignment: 6/10 (occurs occasionally due to human error).
    • Insufficient adhesive: 4/10 (adequate control measures in place).
    • Damaged screens: 5/10 (some incidents due to inadequate handling procedures).
  8. Detect Failure Modes:

    • Screen misalignment: Visual inspection, automated alignment verification.
    • Insufficient adhesive: Weight or pull tests, adhesive inspection.
    • Damaged screens: Visual inspection, quality control checks.
  9. Assign Detection Ranking:

    • Screen misalignment: 2/10 (high probability of detection).
    • Insufficient adhesive: 4/10 (reliable detection methods in place).
    • Damaged screens: 5/10 (moderate detection probability).
  10. Calculate Risk Priority Number (RPN):

    • Screen misalignment: RPN = 8 (severity) × 6 (occurrence) × 7 (detection) = 336.
    • Insufficient adhesive: RPN = 9 (severity) × 4 (occurrence) × 8 (detection) = 288.
    • Damaged screens: RPN = 7 (severity) × 5 (occurrence) × 6 (detection) = 210.
  11. Develop Action Plans:

    • Screen misalignment: Improve alignment mechanism, and provide additional training for operators.
    • Insufficient adhesive: Regularly maintain dispensing equipment, and enhance training programs.
    • Damaged screens: Implement handling guidelines, and introduce protective measures.
  12. Implement and Monitor:

    Action plans are executed, alignment mechanism is upgraded, training programs are conducted, handling guidelines are implemented, and regular equipment maintenance is scheduled. Ongoing monitoring and reviews are conducted to assess the effectiveness of the actions.

This example of FMEA demonstrates how potential failure modes are identified, assessed, and mitigated through the implementation of appropriate action plans.

Conclusion

By following the steps we discussed and using real-life examples, you can apply this technique to various scenarios and identify potential failures before they occur. Remember, FMEA is a proactive approach that empowers you to mitigate risks and improve the reliability and performance of processes, products, or systems.

Scroll to Top