Everything you need to know about the FMEA method: Risk analysis

Contents

• What is FMEA?
• The principle of FMEA
• The different types of FMEA
• Integrate FMEA into the company
• How to apply FMEA in your business?
• Evaluate failures with the FMEA evaluation matrix
• FMEA Criticality Calculator
• The advantages of FMEA
• Conclusion

What is FMEA?

FMEA is the acronym for “Failure Mode, Effects and Criticality Analysis”. It is a method recommended for companies seeking to improve the quality of their products and optimize the performance of their processes, with the aim of obtaining a standard or certification. This is essential in the quality approach and operational safety, with significant benefits for the continuous improvement of the production and organization of a company.

The principle of FMEA

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 different types of FMEA

There are different types of FMEA, each suited to a specific area:

• Product FMEA: focused on the analysis of potential failures of a product.
• Process FMEA: focused on failures related to manufacturing and production processes.
• FMEA Means: looks at potential failures of equipment or installations.

It is essential to choose the appropriate type of FMEA based on the specific needs and objectives of your business.

Integrate FMEA into the company

FMEA can transform your business by optimizing production, continually improving the means of production to minimize failures, constantly improving the organization, and setting a quality threshold to be achieved with the means necessary to achieve it. In addition, FMEA promotes a detailed analysis of production defects and the implementation of preventive and corrective measures to eliminate the causes of failure.

How to apply FMEA in your business?

The application of FMEA requires a structured approach to obtain conclusive results. Here are the key steps to implementing FMEA in your business:

• Definition of the object of study: Determine precisely what you want to study: is it a product, a process or a service? This initial step is essential to define the scope of your analysis.
• Formation of a multidisciplinary team: The FMEA approach is collaborative. Assemble a team made up of experts from different fields (quality, production, maintenance, etc.) to carry out a comprehensive analysis.

• Failure Identification: List all potential failures associated with the object of study. Team members' experience and previous feedback are invaluable at this stage.
• Risk assessment: For each failure identified, assess its severity, frequency of occurrence and probability of detection. Prioritize failures using the criticality formula.

• Implementation of preventive measures: Develop actions to avoid or minimize the occurrence of failures. These actions may include design changes, additional verifications or specific training.
• Reviews and monitoring: Once the measures have been implemented, it is essential to monitor their effectiveness and regularly review the FMEA analysis. This allows it to be updated based on feedback from the field and developments in the object studied.

Evaluate failures with the FMEA evaluation matrix

Once the FMEA has been implemented, the results are classified and analyzed using evaluation grids. In these grids, a score between 1 and 10 is assigned for the frequency of failures, the severity of failures and the quality of the detection system. The criticality score is then calculated by multiplying these three scores. The higher the criticality rating, the more important the failure is considered.

Criticality = Frequency × Severity × Detection

FMEA Criticality Calculator

Enter the values ​​for Frequency, Severity and Detection (1-10):

The advantages of FMEA

Using FMEA has several advantages for the company:

• Quality Improvement: FMEA helps identify and rectify weak points in the process or product before they become problematic.
• Cost Reduction: By preventing failures, the company avoids costs associated with repairs, returns and customer complaints.
• Customer Satisfaction: By offering more reliable and higher quality products, customer satisfaction is increased, which can lead to increased sales and customer loyalty.
• Resource Optimization: By identifying potential failures, the business can better allocate its resources to resolve critical issues.

Conclusion

FMEA is a valuable tool for any company looking to improve the quality and reliability of its products or services. By analyzing and evaluating potential failures, you can optimize your production process and provide better value to your customers.

Download this free FMEA Excel and Google sheet template and start improving your processes quickly.

Discover in this video an advanced FMEA model to analyze the failures of a complex multi-product process, also to lead analysis meetings and effectively monitor the implementation of actions.