What is FMEA-Failure Mode and Effects Analysis (FMEA) FMEA is an analytical methodology used to ensure that potential problems have been considered and addressed throughout the product and process development process. Part of the evaluation and analysis is the assessment of risk. The important point is that a discussion is conducted regarding the design (product or process), review of the functions and any changes in application, and the resulting risk of potential failure.
Seven-Step FMEA Process
The revised FMEA process is now represented in seven steps:
- Step 1 | Planning and Preparation
- Step 2 | Structure Analysis
- Step 3 | Function Analysis
- Step 4 | Failure Analysis
- Step 5 | Risk Analysis
- Step 6 | Optimization
- Step 7 | Results Documentation
These seven steps are organized into three phases:
- Steps 1 through 3 represent the “System Analysis” phase of an PFMEA study.
- Steps 4 through 6 represent the “Failure Analysis and Risk Mitigation” phase of an PFMEA study.
- The third phase, Communication, is Step 7, Results Documentation
FMEA-MSR
A new method has been added called the FMEA-MSR is a supplemental “FMEA for Monitoring and System Response.” The FMEA-MSR is intended to maintain a safe state (i.e. safety) or state of regulatory (i.e. environmental) compliance during customer operation.
Elimination of the RPN
In Step 5 of the FMEA Process, Risk Analysis, the “RPN” is eliminated. What??
That is right, the Risk Priority Number (RPN) is replaced with Action Priority (AP) that comes from a series of tables that define the AP based on the Severity, Occurrence and Detection Ratings. The AP is not a risk priority but rather a priority for action (high, medium or low) to reduce the risk of failure to function as intended. While the RPN encouraged ranking potential failures from high to low, the AP tables define an absolute priority for action regardless of how many other items have been identified in the FMEA study.
We too were shocked when we started getting wind of this change to FMEAs. We had a hard time understanding how something that has been a cornerstone to FMEAs, could be done away with. But, as we are becoming more comfortable with the new methodology, it is clear to us that The Action Priority is an improvement over the RPN.
Two Types of Recommended Action
In step 6, Optimization, “Recommended Action” has been changed to two columns: “Preventive Action and “Detection Action.”
AIAG-VDA FMEA download link
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