Contrary to what you might think, and even to what has been previously been posted on this blog, the alignment between AIAG and VDA practices, published in 2019, was not the 5th edition of the FMEA. What we have now is the 1st edition of the FMEA AIAG & VDA.
One key change has been made to the structure, which is now shown as a 7-step approach. See what it is like now and what each step covers.
As we can see in the image, the seven steps are:
- Planning and Preparation
- Structure Analysis
- Function Analysis
- Failure Analysis
- Risk Analysis
- Results Documentation
These steps can be grouped into three phases:
- Steps 1 to 3 represent the “System Analysis” phase of an FMEA study.
- Steps 4 to 6 represent the “Failure Analysis and Risk Mitigation” phase of an FMEA study.
- The third phase, “Risk Communication,” is covered by the results documentation step.
Step 1: Planning and Preparation
The FMEA study starts with a purposeful and careful definition of the scope. The management team is responsible for setting the scope of the study.
Step 2: Structure Analysis
Structure analysis is used to identify and break down the process into sequential steps, interfaces and logistical elements. It uses the boundaries stipulated in the definition of scope done in step 1 in order to identify each stage, interface and logistical element in the process at hand.
Structure analysis is aimed at facilitating complete understanding of the process. Start with the central element of your scope, identify the process it is part of and, finally, indicate all elements related directly to it.
Step 3: Function Analysis
There should be an exploration of what the product should be doing in the Function Analysis step, as well as of what should be executed in the general process (and each one of its activities) and how this functionality is facilitated. Using the Structure Analysis developed in step 2, each element is analyzed separately in terms of its function and corresponding requirements.
Step 4: Failure Analysis
In step 4, the concept of a “failure chain” is used to understand and visualize imperfections in the process. This chain is made up of the mode, effect and cause of the failure.
- A failure mode represents any manner in which an item (the focus element) could fail to meet its intended function.
- A failure effect is the consequence of a failure mode.
- A failure cause is an indication of why a failure mode could occur.
Analyzing failures involves identifying how the focus elements detailed during the Structure Analysis may fail to perform intended functions documented by the Function Analysis. A failure mode leads to a failure effect triggered by a failure cause. Determining potential causes is at the heart of an FMEA.
Step 5: Risk Analysis
In Step 5, the Severity, Occurrence and Detection of each failure chain is evaluated. An action priority level of “High, Medium or Low” is obtained based on evaluations, as indicated by the Action Priority Tables. The action priority tables do not establish a “risk priority,” but rather a priority level for action needed, aimed at reducing the risk of failure to function as intended.
If the level obtained is high, action to improve prevention and/or detection controls (or justification on why current controls are adequate) must be taken.
If it is medium, it is recommended that action be taken to improve prevention and/or detection controls (or justification on why current controls are adequate).
And if it is low, action to improve prevention and/or detection controls may be taken, but are not required.
Step 6: Optimization
The primary objective of the optimization step is to develop actions that reduce risks and increase customer satisfaction, improving the product. Most actions will likely involve lowering the likelihood of the occurrence of failure causes or improving detection controls; either approach leads to a more robust design.
Step 7: Results Documentation
The results of each FMEA study should be fully documented. An FMEA study is not finished until Step 7 has been completed.
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