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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.

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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

Cause

Failure mode

Effect

Control

Process

Calculate

RPN

Re-calculate

RPN

Recommended action, if need.

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.

Define

S, O, D

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1) Specifying possibilities

Functions
Possible feature modes
Root causes
Effects
Deduction / Prevention

Stages of FMEA documentation

2) Quantifying Risk

Severity of effect
Occurrence of failure (probability of cause)
Deduction (effectiveness of control to prevent cause)
RPN (Risk priority number)

3) Correcting high causes

Prioritizing work
Detailing action
Assigning action responsibility
Check point on completion

4) Re-evaluating Risk

Recalculation of RPN

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					FAILURE MODE AND EFFECTS ANALYSIS

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

Process Function	Potential Failure Mode	Potential Effect(s) of Failure	Sev	Class	Potential Cause(s)/ Mechanism(s) of Failure	Occur	Current �Process �Controls	Detec	RPN	Recommended Action(s)	Responsibility and Target Completion Date	Action Results
Process Function	Potential Failure Mode	Potential Effect(s) of Failure	Sev	Class	Potential Cause(s)/ Mechanism(s) of Failure	Occur	Current �Process �Controls	Detec	RPN	Recommended Action(s)	Responsibility and Target Completion Date	Actions Taken	Sev	Occ	Det	RPN

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					FAILURE MODE AND EFFECTS ANALYSIS

Item:	Drill Hole				Responsibility:		AAA				FMEA number:	123456
Model:	Current				Prepared by:		BBB				Page :	1 of 1
Core Team:	AAA (Engineering), BBB (Production), CCC (Quality)										FMEA Date (Orig):	1/1/2021	Rev:		1

Process Function	Potential Failure Mode	Potential Effect(s) of Failure	Sev	Class	Potential Cause(s)/ Mechanism(s) of Failure	Occur	Current �Process �Controls	Detec	RPN	Recommended Action(s)	Responsibility and Target Completion Date	Action Results
Process Function	Potential Failure Mode	Potential Effect(s) of Failure	Sev	Class	Potential Cause(s)/ Mechanism(s) of Failure	Occur	Current �Process �Controls	Detec	RPN	Recommended Action(s)	Responsibility and Target Completion Date	Actions Taken	Sev	Occ	Det	RPN
Drill Blind Hole	Hole too deep	Break through bottom of plate	7		Improper machine set up	3	Operator training and instructions	3	63							0
	Hole not deep enough	Incomplete thread form	5		Improper machine set up	3	Operator training and instructions	3	45							0
	hole missing	Tool life	5		Broken Drill	5	None	9	225	Install Tool Detectors	BBB	3/1/2021	5	5	1	25
									0							0
									0							0

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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