Complete Guide to Risk Analysis FMEA Process

Contents

Introduction to FMEA Process

FMECA, or Failure Mode, Effect and Criticality Analysis , is a systematic methodology used to identify, evaluate and prioritize failure risks within industrial processes. Originating in the aerospace industry in the 1960s, this approach quickly found its way into many sectors due to its ability to significantly improve the reliability and quality of products and systems. By focusing on processes, Process FMEA helps companies optimize their operations, prevent potential failures, and implement effective solutions before those failures occur.

FMEA Fundamentals Process

FMEA aims to identify and evaluate potential failures, their causes and their effects on the performance of a system, product or process. The analysis process goes through a series of checks carried out at different points in the production chain, as well as on the finished product or service.

The FMEA Process is based on three fundamental principles:

Identification :

The first step is to identify all the steps in a process as well as the potential failure modes associated with each step. This includes anything that could go wrong, from hardware errors to human errors.

Analysis :

After identifying potential failures, the analysis focuses on evaluating their effect on the overall process. This involves assessing the severity of each failure, its frequency of occurrence, and the likelihood that it will be detected before causing a problem.

Prioritization :

Finally, Process FMEA prioritizes identified failures based on their criticality, allowing companies to focus their efforts and resources on the most critical issues.

This systematic methodology ensures that improvement efforts are targeted effectively, maximizing the impact on process quality and reliability.

How to Apply FMEA Process in Your Business?

The integration of the FMEA Process into a company's activities is a strategic approach that encompasses training, planning, and rigorous execution through key stages:

Training and Awareness :

First of all, it is crucial to organize training sessions for all staff concerned. The goal is to provide an in-depth understanding of the principles and importance of FMEA in continuous process improvement. This initial step ensures the commitment and active participation of all team members.

Definition of Objectives and Preparation :

Clearly establish the objectives of the FMEA analysis, linked to the strategic ambitions of the company. This preparation phase includes determining the scope of the analysis, specifically choosing which processes to evaluate for maximum impact.

Constitution of the Multidisciplinary Team :

Form a team including experts from various fields relevant to the process being analyzed. This diversity of expertise guarantees comprehensive identification and analysis of potential risks.

Participation schedule for FMEA meetings with a calendar of sessions and list of expected participants

Identification of Failure Modes :

Engage the team in brainstorming sessions or use checklists to list all potential failures at each stage of the relevant processes. This helps capture a wide range of perspectives and expertise.

Analysis of Effects and Determination of Criticality :

Evaluate the consequences of each identified failure on the process, the final product, and the customer. Then calculate the criticality of each failure mode, considering its severity, its frequency of occurrence, and the probability of non-detection.

Development of the Action Plan :

Based on established priorities, develop targeted action plans to mitigate or eliminate risks. This step involves the implementation of preventive, corrective or improvement measures to effectively address critical points.

Implementation and Monitoring :

Implement the defined actions and ensure continuous monitoring to verify the effectiveness of the measures taken. Adjust action plans based on the results obtained and feedback collected.

Use dashboards to monitor Risks evolution and actions implementation.

 

 

Review and Continuous Improvement :

FMEA is not a one-off exercise but an evolving process. Hold periodic reviews to update the analysis based on changes in processes, new information or technology improvements.

This integrated approach, which begins with training and extends to the practical implementation of FMEA, allows companies to significantly strengthen the quality and reliability of their processes, while fostering a culture of continuous improvement and Risk prevention.

    Evaluating Failures with the FMEA Process Evaluation Matrix

    The evaluation of failures within the framework of the FMEA Process is based on the use of detailed evaluation matrices, making it possible to methodically classify and analyze the identified risks. These matrices assign scores on a scale of 1 to 10 for three critical dimensions: the frequency of occurrence of failures, their severity, and the effectiveness of the detection system.

    Detail of Criticality Calculation

    • Frequency (F) : This score reflects the probability that a failure will occur. A score of 1 indicates a very rare occurrence, while a score of 10 means failure is almost certain. 

    • Severity (G) : This score assesses the potential impact of a failure on the customer or the final process. A score of 1 represents a negligible impact, while a score of 10 indicates extremely serious consequences. 

    • Detection (D) : This score measures the probability of detecting the failure before it reaches the customer or impacts the process. A score of 1 means a very high probability of detection, while a score of 10 implies that the failure is very difficult, if not impossible, to detect before it causes a problem. 

    The criticality of a failure is calculated by multiplying these three scores:

    This image illustrates a FMEA scoring grid, used to identify and manage potential risks in manufacturing processes.

    This criticality formula makes it possible to assign a unique score to each potential failure mode identified in the Process FMEA. Higher criticality scores indicate failures that require priority attention because they pose a greater risk to the business in terms of frequency, severity, and low probability of detection.

    By systematically applying this assessment approach, companies can effectively prioritize corrective or preventive actions, targeting the most critical risks to minimize their potential impact on operations and customer satisfaction.

    FMEA Criticality Calculator

    Tools and Software for FMEA Process

    The use of specialized tools and software can greatly facilitate the application of FMEA by automating certain tasks and providing a structured framework for analysis. These tools can help:

    Map processes : Process mapping software makes it possible to visualize each step of the process and more easily identify where failures are likely to occur.

    Identify and analyze failures : Dedicated platforms offer functionality to record failure modes, their causes and effects, as well as calculate criticality.

    Manage corrective actions : Project or quality management systems can be used to track corrective and preventive actions, ensuring that improvements are implemented effectively.

    Popular software for FMEA includes solutions like APIS IQ-Software , ReliaSoft XFMEA , and Isograph Availability Workbench . Choosing the right tool will depend on the specific needs of the company as well as the complexity of the processes to be analyzed.

    Download our free tool - FMEA Excel and Google sheet template and start improving your processes efficiently and quickly. Incorporating different analysis modes, this example model guides you through the steps of detecting and managing potential failures.

    Discover in this video a advanced FMEA model, an essential tool for analyzing in detail the failure modes of a complex multi-product process.

    Challenges and Solutions in Applying the FMEA Process

    Although FMEA is a powerful tool for risk management, its application can encounter certain challenges:

    Complexity of Processes :

    Complex industrial processes can make FMEA analysis tedious. Solution : Start with less complex sections of the process or products to build expertise before tackling more complicated analyses.

    Resistance to change :

    Introducing new methodologies may encounter resistance from employees. Solution : Actively involve teams in the FMEA process and provide adequate training to highlight the benefits of the approach.

    Keeping Data Up to Date :

    Ensuring that the FMEA stays up to date with changes in production processes or conditions can be difficult. Solution : Establish regular FMEA reviews as an integral part of the quality management system.

    To deepen your understanding of FMEA and discover its advanced applications in the industrial sector, we invite you to consult our Complete Guide to FMEA in Industry .

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