FMEA for Problem Prevention

What is Failure Mode & Effects Analysis (FMEA)?

Failure Mode and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a process or design to identify where and how it might fail and to assess the relative impact of different failures. The goal is to identify, prioritize, and eliminate or reduce potential failures, starting with the highest-priority ones.

Key components of an FMEA include:

• Failure Modes: The specific ways in which a component, system, or process could fail to meet the design intent.
• Effects of Failure: The consequences of a failure mode on the system, customer, or downstream processes.
• Causes of Failure: The design or process weaknesses, errors, or conditions that could trigger the failure mode.
• Risk Priority Number (RPN): A numerical ranking of the risk associated with each potential failure. It is calculated as: RPN = Severity (S) × Occurrence (O) × Detection (D)
  • Severity (S): The seriousness of the effect of the failure.
  • Occurrence (O): The likelihood that the cause of the failure will occur.
  • Detection (D): The ability of current controls to detect the cause or the failure mode before it reaches the customer.

Brief History of FMEA

The FMEA methodology was first developed by the U.S. military in the late 1940s and documented in military procedure MIL-P-1629. It was designed to evaluate the reliability and safety of military equipment by identifying all possible failure modes and their effects on mission success.

Its value was quickly recognized by the aerospace industry. NASA extensively used FMEA during the Apollo program in the 1960s to mitigate risks and enhance the safety of space missions. In the 1970s, the automotive industry, led by Ford Motor Company, adopted FMEA to improve vehicle safety and quality, popularizing its use in the commercial sector. Today, FMEA is a foundational tool in quality engineering, risk management, and reliability engineering across countless industries, including healthcare, software, and manufacturing.

How to Use This Tool

1. Define Structure: In the "Components" panel, add all the parts or steps of your system/process. Mark items as "External" if they are outside your system boundary (e.g., user, power source).
2. Define Interfaces: In the "Contacts" panel, define the connections and interactions between the components you added.
3. Define Functions: In the "Functions" panel, describe what the system is supposed to do. Assign each function to the specific contacts involved in carrying it out.
4. Visualize: The tool automatically generates a structure chart (network diagram) to help you visualize the system's components, interfaces, and functions. You can drag nodes to rearrange the layout.
5. Generate FMEA Table: Click the "Generate FMEA" button. This will create a pre-populated FMEA table based on the functions you defined.
6. Analyze Failures: For each function in the table, fill in the potential failure modes, their effects, potential causes, and any current controls in place to prevent or detect them.
7. Assess Risk: Use the dropdowns to assign Severity (S), Occurrence (O), and Detection (D) scores. The tool automatically calculates the RPN to help you prioritize.
8. Define Actions & Export: For high-risk items, list recommended actions. When complete, you can export the entire FMEA table to an Excel file for your records.