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ASQ - Design FMEA

This document discusses Failure Mode and Effects Analysis (FMEA) as a tool for identifying risks. It describes how FMEA can be used to identify potential failure modes and their causes and effects. The document provides examples of Process FMEA (PFMEA) and Design FMEA (DFMEA) formats that allow teams to document potential failures, occurrence rates, current controls, detection methods, and priority numbers. The goal of FMEA is to prioritize potential failures and identify actions to address high risks before they impact customers or processes.

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407 views35 pages

ASQ - Design FMEA

This document discusses Failure Mode and Effects Analysis (FMEA) as a tool for identifying risks. It describes how FMEA can be used to identify potential failure modes and their causes and effects. The document provides examples of Process FMEA (PFMEA) and Design FMEA (DFMEA) formats that allow teams to document potential failures, occurrence rates, current controls, detection methods, and priority numbers. The goal of FMEA is to prioritize potential failures and identify actions to address high risks before they impact customers or processes.

Uploaded by

BES
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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RISK

IDENTIFICATION
FMEA

FAILURE MODE
EFFECTS ANALYSIS
FAILURE AT 30,000 FEET

Quality Solutions Jeff Prahst 2


FMEA TOOL IDENTIFIES RISKS

 Risks of Failure in both Design and Process


Identified risks for customers, the business, our personnel
and the environment, etc.
 Tool to help identify and prioritize risks

 Types of FMEA:
• Design FMEA – DFMEA
• Process FMEA - PFMEA
• Implementation FMEAs (for starting new processes)
• Special PFMEA (used as a specific problem solving tool)
Quality Solutions 7
PFMEA - CRITICAL QUESTIONS
• WHAT IN THE PROCESS CAN GO WRONG?
• POTENTIAL FAILURE MODES

• WHEN FAILURE HAPPENS WHAT IS THE EFFECT


ON THE CUSTOMER AND HOW BAD IS AILURE?
• EFFECT AND SEVERITY

• WHY DOES IT HAPPEN AND HOW OFTEN?


• CAUSES AND OCCURRENCE

• HOW WILL FAILURE BE DETECTED AND


CORRECTED BEFORE IT LEAVES THE PROCESS?
• CONTROLS AND DETECTION
Quality Solutions Jeff Prahst 8
RISK IDENTIFICATION
Process Failure Mode and Effect Analysis

Function: Process Step

Effects Failure Mode Controls


Severity Detectability
(1-10) (1-10)

Causes
Occurrence
(1-10)

RPN
RPN =Risk
=Risk Priority
Priority Number
Number
Quality Solutions
RPN
RPN == S
S xx O
O xx D
D == 11 to
to 1000
1000 9
PFMEA FORM
Process Failures Causes Current Controls
Process
Function Potential

Occurrence

RPN
Detection
Criticality
or Step Potential Potential Cause/

Severity
Failure Effect of Mechanism

Class
# Requirements Mode Failure of Failure Detection Prevention

0 0

0 0

0 0

0 0

10
QUALITY BY DESIGN

DFMEA
DESIGN FAILURE MODE
AND EFFECTS ANALYSIS

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DESIGN - DFMEA FORMAT

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BENEFITS - DESIGN FMEA
• AIDS IN DESIGN TO REDUCE RISKS.
• EVALUATES DESIGN REQUIREMENTS /
ALTERNATIVES.
• IDENTIFIES HOW A PRODUCT MAY FAIL TO MEET
ITS INTENDED FUNCTION.
• EXAMINES POTENTIAL CONSEQUENCES OF
FAILURE.
• PRIORITIZES CORRECTIVE ACTIONS NEEDED.
Quality Solutions Jeff Prahst 13
INFORMATION SOURCE
• BOUNDARIES FOR CUSTOMER CHANGE NOTIFICATION
• IDENTIFIES SPECIAL CHARACTERISTICS FOR PFMEA
• RANKS POTENTIAL FAILURE MODES ACCORDING TO
THEIR EFFECT ON THE CUSTOME
• PRIORITIZES RISKS & IMPROVEMENT OPPORTUNITIES
• PROBLEM SOLVING TOOL WHEN ANALYZING
CUSTOMER PRODUCT CONCERNS

Quality Solutions Jeff Prahst 14


TEAM REQUIREMENT ?
• TEAM ACTIVITY
• TEAM LEADER / FACILITATOR
• DESIGN AND DEVELOPMENT ENGINEERS
• PROCESS ENGINEERS
• MANUFACTURING SUPERVISORS AND
OPERATORS
• OTHERS PARTICIPATE AS NEEDED
• QUALITY ASSURANCE
• QUALITY ENGINEERS
• CUSTOMERS OF PRODUCT
• SUPPLIERS OF RAW MATERIALS AND EQUIPMENT
Quality Solutions Jeff Prahst 15
FUNCTION, EXPECTATION,
FAILURE
1. LIST PRODUCT FUNCTIONS
• APPEARANCE, PERFORMANCE, PROCESSABILITY, ...

2. LIST CUSTOMER EXPECTATIONS


• APPEARANCE – LOOKS GOOD; CLEAN; SHINY; NO
DEFECTS...
• PERFORMANCE – RESISTANT TO DAMAGE; STARTS AND
RUNS ...
• PROCESSABILITY – EASY TO USE & EASY TO MAKE...

3. TRANSLATE INTO FAILURE MODES


• LOOKS GOOD – NOT SHINY; DIRTY; NOT AT
EXPECTATIONS ...
Quality Solutions
• NO DEFECTS – SCRATCHES; DENTS; BROKEN PARTS 16...
Jeff Prahst
• STARTS EASY – WILL NOT START; HARD TO START...
FUNCTIONS & FAILURE MODES

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EFFECTS OR CONSEQUENCES

• IDENTIFY EFFECTS AS PERCEIVED BY


CUSTOMER.
• WHAT COULD BE THE RESULT OF FAILURE
MODE?
• DESCRIBE IN TERMS OF WHAT THE
CUSTOMER MIGHT EXPERIENCE OR NOTICE.
• CUSTOMER DISSATISFACTION
• WARRANTY COSTS AND PRODUCTION LINE REWORK

• CONSIDER “CUSTOMER” TO ALSO BE “INTERNAL


CUSTOMERS” AS WELL AS FINAL OR ULTIMATE END USERS.
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SEVERITY RATINGS

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DESIGN MATRIX
• MATERIALS AND PARTS
SELECT MATERIALS, PARTS AND QUANTITY LEVELS
• MATERIAL - FAILURE UNDER 47% TO OVER 58% BY
WEIGHT
• PART - FAILURE UNDER X % TO OVER Z %

• MATERIAL AND PART CHARACTERISTICS


ESTABLISH MATERIAL AND PART SPECIFICATIONS
IDENTIFY SIGNIFICANT PROPERTIES WHICH HAVE A MAJOR
IMPACT ON FINAL PRODUCT PERFORMANCE
• MATERIAL: FAILURE UNDER OR OVER AMOUNTS USED
• PART : FAILURE TO MEET SPECIFICATION (UNDER/OVER
)
Quality Solutions Jeff Prahst 20
DESIGN MATRIX
• PRODUCT CHARACTERISTICS
SELECT TESTS AND SPECIFICATIONS WHICH DETERMINE
THE ULTIMATE PERFORMANCE OF THE PRODUCT.
• TIME TO TEMP.: FAILURE UNDER OR OVER
SPECIFICATION
• SOLIDS - FAILURE UNDER 65% TO OVER 73% BY
WEIGHT
• PRESSURE TEST: FAILURE @ 5 PSI

• PROCESS CONSTRAINTS
IDENTIFY SIGNIFICANT MANUFACTURING CONSTRAINTS
• EQUIPMENT REQUIRED: STAINLESS, SPECIAL TOOLS
• SPACE AND LINE REQUIREMENTS: SQ FOOTAGE;
Quality Solutions HEIGHT Jeff Prahst 21
DESIGN MATRIX
• CONDITIONS FOR USE
IDENTIFY SIGNIFICANT CONSTRAINTS IN THE CONDITIONS
INVOLVED WHEN THE CUSTOMER USES OF THE PRODUCT.
• FILM BUILD - FAILURE UNDER 2.0 MILS.
• BAKE TIME @ 350°F - FAILURE UNDER 20 MINUTES.
• BAKE TEMPERATURE @ 20 MIN. - FAILURE UNDER 350°F.
• SHELF LIFE - FAILURE AFTER SIX MONTH
• STORAGE TEMPERATURE - FAILURE OVER 70°F.
• HUMIDITY - FAILURE OVER 60% RELATIVE HUMIDITY
• TEMPERATURE (PAINT): FAILURE UNDER 50°F TO OVER
120°F

Quality Solutions Jeff Prahst 22


DESIGN MATRIX -

Quality Solutions Jeff Prahst 23


OCCURRENCE TABLE

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DFMEA FORM

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DESIGN CONTROLS
• IDENTIFY DESIGN CONTROLS

 DESIGNED EXPERIMENTS (DOE)


 CUSTOMER VALIDATION TESTS, TRIAL
RUNS
 TEST PROTOCOLS, TEST METHODS
 SUBCONTRACTOR THIRD PARTY TESTING
 ENGINEERING GENERAL PRACTICE
RANGES
Quality Solutions Jeff Prahst 26
DETECTION - CHANCE OF
ESCAPE
• HOW LIKELY WILL DESIGN FAILURES ESCAPE
THROUGH OUR CONTROLS TO CUSTOMER?
• HIGH LIKELIHOOD = HIGH NUMBER
• LOW LIKELIHOOD = LOW NUMBER

• WILL CURRENT DESIGN CONTROLS DETECT


AND STOP THE CAUSES OF FAILURE.
• DESIGNED EXPERIMENTS (DOE)
• MSA AND GAGE R&R RESULTS
Quality Solutions Jeff Prahst 27
DESIGN - DETECTION TABLE

Quality Solutions Jeff Prahst 28


IMPROVEMENT ACTION PLAN
• RECOMMENDED ACTION(S)
• RESPONSIBILITY & TARGET DATES
• ACTIONS TAKEN
• RESULTING RISK ANALYSIS
• SEVERITY
• OCCURRENCE
• DETECTION
• RPN

Quality Solutions Jeff Prahst 29


DFMEA FORM

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“LIVING DOCUMENT”
• SELECT AREAS FOR IMPROVEMENT. (HIGH
RISK)
• FORMULATE PLANS FOR CORRECTIVE ACTIONS.
• IMPLEMENT ADDITIONAL CORRECTIVE ACTIONS.
• RE-COMPUTE THE RISK ASSESSMENT (RPN).

• UP-DATE AND MAINTAIN


• UPDATE AS NEW INFORMATION IS AVAILABLE.
• RECORD ALL CHANGES MADE TO PRODUCT OR
PROCESS.
• REVISE AS EXPERIENCE GROWS.
Quality Solutions Jeff Prahst 31
IMPORTANCE OF PRIORITIZATION

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PRIORITY AND PRACTICALITY

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DFMEA – CUP OF COFFEE

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DFMEA FOR MAKING COFFEE

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FUNCTIONS & FAILURE MODES

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DESIGN MATRIX -

Quality Solutions Jeff Prahst 37


DFMEA FORM

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DESIGN FMEA

Quality Solutions Jeff Prahst 39

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