FMEA- Failure Mode and Effect Analysis
FMEA has been used as a risk identification & mitigation tools for many decades.
Developed by US Military in 1940's.
Used for almost 70 years with relatively small evolutionary enhancement.
In 2019, substantial changes were introduced as AIAG & VDA "Harmonized" their difference for conducting FMEA.
FMEA (Failure Mode & Effect Analysis) is a structured tool to
Identify failure modes for process
Estimate its effect & risk associated with it.
Identify & prioritize probable cause of failure
Prioritize the failures modes based on the action priority.
Evaluate & develop control plan to contain the risk
What is FMEA?
History
System FMEA
Design FMEA
Machinery FMEA
Process FMEA
Reverse FMEA
Types
INTENT: What is or isn't included in the scope of this project & why is the FMEA being undertaken?
TIMING: When will be the FMEA done? (Includes when in the product/process development cycle to conduct the study with deadline for FMEA.
TEAM: who will be the core team & extended team with roles & responsibilities?
TASK: What work to be done by team?
TOOLS: What are the tools required by team to complete the project?
New 7 step Approach (PS 2F RO R)
Revised Severity, Occurrence & detection Rating
Risk Priority Number (RPN) replaced by Action Priority (AP)
New FMEA sheet with color & linkage
PFD is a integral part
Use of 5T & 4M approach
Recommendation Actions replaced by Prevention & Detection Action
Added status of action
Added special characteristic to replace classification.
Key changes in VDA-FMEA
5T
Project Identification
Project Planning
Boundary Analysis
1- Planning & Preparation
Process Flow Diagram
High level process
Breakdown sub-process to single operation
3- Functional Analysis
Identify failure modes
Determine failure effect
Analyze failure cause
4- Failure Analysis
Risk assessment
Prevention & Detection Control
SOD Rating & AP Calculation
5- Risk Analysis
Sort Risk
Make risk mitigation action plan
Assign responsibility & due date
6- Optimization
Update FMEA Results
Action Plans
Approve & Release FMEA