Risk Identification

FMEA
Failure Mode
Effects Analysis
 Failure at 30,000 feet

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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)

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 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
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 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
RPN
RPN == S
S xx O
O xx D
D == 11 to
to 1000
1000
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PFMEA Form

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 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.

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 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

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 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
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 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 ...
No Defects Scratches; Dents; Broken parts ...
Starts Easy Will not start; Hard to start...

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 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 )
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 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; height

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 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 @ 350F - Failure under 20 minutes.
Bake Temperature @ 20 min. - Failure under 350F.
Shelf Life - Failure after Six Month
Storage Temperature - Failure over 70F.
Humidity - Failure over 60% relative humidity
Temperature (paint): Failure under 50F to over 120F
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 Design Matrix -

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 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

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 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

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 Design - Detection Table

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 Improvement Action Plan

Recommended Action(s)
Responsibility & Target Dates
Actions Taken
Resulting Risk Analysis
Severity
Occurrence
Detection
RPN

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 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.

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 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 -

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 DFMEA Form

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 Design FMEA

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