FMEA- failure mode and effect analysis

Team oriented, systematic method which evaluate the potential technical risk of failure of a product
or process, analyze the cause and effects of those failures and recommend action to reduce the risk.
 
Published 4th edition of FMEA in 2008 by AIAG (automotive industry action group)
Latest edition is jointly published by AIAG and VDA (variable dearness allowance) on 1st june 2019 as
1st edition
 
 
When to do FMEA:
 New technology
 ECN (engineering change note) [process, customer/lar requirements, quality issue, HARA,
TARA etc]
HARA (hazard and risk analysis)
Hazards are threat which effect human life and health is called hazards.
TARA (threat assessment and remedial action)
Others than hazard risk, all type of risk is threat.
HIRA- (hazard identification and risk assessment)

Major changes:
 Collaboration of AIAG and VDA
 To provide common foundation
 Supplemental FMEA for monitoring system and response (MSR)
 
Benefits of FMEA:
Direct-
1. Quality
2. Reliability
3. Safety
4. Manufacturability
5. Reducing cost
 
Indirect-
1. Regulatory compliances
2. Strong communications
3. Reduction in wastages
 
Limitations:
 It is qualitative (subjective) not quantitative (measurable)
 It relies on team's level of knowledge which may or may not predict future performance
 
FMEA have 4 types of risk:
 Technical risk
 Financial risk
 Time risk
 Strategy risk
*we only talk about technical risk in PFMEA
 
New FMEA has 7 steps:
1. Planning & preparation
2. Structure analysis
3. Function analysis
4. Failure analysis
5. Risk analysis
6. Optimization
7. Results documentation