FMEA –Failure Mode and Effect Analysis

FMEA is the analysis of potential failure of a product or process that affects the function
partially or completely
Types of FMEA
• DFMEA – Design
• PFMEA – Process
• Others (Concepts, Systems, Service, etc,.)
Design FMEA
• Design FMEA aids in the design process by identifying known and upcoming
Failure modes and then ranking failures according to relative impact on the product.
• Hence Design FMEA focuses on relative impact of the failure mode on the product
Process FMEA
• Process identifies potential process failure modes by ranking failures and helping to establish
Priorities according to the relative impact on the internal or external customer.
• Hence Process FMEA focuses on relative impact of the failure mode on internal or external
Customer.
 Effect Define Cause
Failure mode
S, O, D

Re-calculate Recommended Calculate Control

RPN action, if need. RPN Process

• Severity - Classification of failure by severity of the effects

• Occurrence - How often they occur
• Deduction - How easily can they deducted

RPN (Risk priority number) = Severity X Occurrence X Deduction

• The RPN gives us a relative risk ranking.
• The higher the RPN, the higher the potential risk.
• An organization may decide any RPN above a maximum target of 200 presents
an unacceptable risk and must be reduced.
• Severity will not change, when recalculating RPN.
Stages of FMEA documentation

1) Specifying possibilities 3) Correcting high causes

• Functions • Prioritizing work
• Possible feature modes • Detailing action
• Root causes • Assigning action responsibility
• Effects • Check point on completion
• Deduction / Prevention

2) Quantifying Risk 4) Re-evaluating Risk

• Severity of effect • Recalculation of RPN
• Occurrence of failure (probability of cause)
• Deduction (effectiveness of control to prevent cause)
• RPN (Risk priority number)
 FAILURE MODE AND EFFECTS ANALYSIS

FMEA
Responsibility:
Item: number:
Model: Prepared by: Page :
Core FMEA Date
Rev:
Team: (Orig):

Action Results
Potential Responsibility
Potential Potential Current
Process Cla Cause(s)/ Occu Det Recommended and Target
Failure Effect(s) of Sev Process RPN Actions
Function ss Mechanism(s) of r ec Action(s) Completion Sev Occ Det RPN
Mode Failure Controls Taken
Failure Date
 FAILURE MODE AND EFFECTS ANALYSIS

Item: Drill Hole Responsibility: AAA FMEA number: 123456

Model: Current Prepared by: BBB Page : 1 of 1
FMEA Date
Rev: 1
Core Team: AAA (Engineering), BBB (Production), CCC (Quality) (Orig): 1/1/2021

Action Results
Potential
Potential Potential Cause(s)/ Current Responsibility and
Process Cl Occu Det Recommended
Failure Effect(s) of Sev Mechanism Process RPN Target
Function ass r ec Action(s)
Mode Failure (s) of Controls Completion Date Actions Taken Sev Oc Det RPN
Failure c

Break
Improper
Drill Blind Hole too through Operator training
7 machine 3 3 63 0
Hole deep bottom of and instructions
set up
plate

Incomplete Improper
Hole not Operator training
thread 5 machine 3 3 45 0
deep enough and instructions
form set up
hole Broken Install Tool
Tool life 5 5 None 9 225 BBB 3/1/2021 5 5 1 25
missing Drill Detectors
0 0
0 0
Benefits of FMEA
• Prevent failures before they happen.
• Identifies where to focus
• Improves the quality, reliability, and safety of the process
• Reduces process development time, cost
• Documents and tracks risk reduction activities
• Helps to identify critical-to-quality characteristics
• Provides historical records; establishes baseline
• Helps increase customer satisfaction and safety