FMEA Essentials: Prevent Failures & Enhance Quality

What is FMEA?

FMEA (Failure Mode and Effects Analysis) is a methodology aimed at achieving Quality Assurance. Through systematic analysis, it contributes to the identification and prevention of failure modes for both products and processes/services. It is a tool that systematically investigates the potentially weak points of products, processes, and services, quantifying and evaluating their risk of failure.

Objectives of FMEA

• Customer satisfaction
• Introduce the philosophy of prevention to companies
• Analyze the effects and failures that may affect a product or process
• Stipulate the means and procedures for each failure mode, and assign a method of detection for each failure
• Adopt corrective and preventive actions

Types of FMEA

Design FMEA

The study of potential product failures and everything related to their definition (functional non-compliance).

Process FMEA

Analysis of product failures derived from the potential failure of process elements (materials, labor, environment, machine, and methods).

Means & Installation FMEA

Study of the potential failure of means and everything related to their definition and maintenance.

Phases of FMEA Application

1. Conduct a Study and Form a Team: Clearly define the product, delimiting the scope of FMEA application. Form a team (these are not permanent teams, typically 3 to 7 people). Ensure all points of view are considered, and define responsibilities and a moderator.
2. Information Gathering: To ensure FMEA is not performed intuitively, gather comprehensive information.
3. Definition of Functions: Describe the functions of the process being analyzed; exact knowledge is essential. There are three types of function definition:
   • Design FMEA: Using a functional tree to define functions based on customer requirements.
   • Means FMEA
   • Process FMEA
4. Qualitative Analysis: For each function, define potential failure modes, their causes, and their effects. It is also important to identify controls to detect possible failures. There are two main types of controls:
   • Product Controls: Implemented before product validation.
   • Process Controls: Implemented before the product leaves the plant.
5. Quantitative Analysis:
6. Definition and Implementation of Actions: