© TLC, Fmea 42703

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TLC, FMEA 42703
Purpose for Course

This Class was developed to meet the following instructional need: Provide instruction in the principles and best practices associated with Failure Modes and Effects Analysis methodology.
611 Whitby Lane Brentwood, CA 94513 1-925-285-1847 FAX: 1-925-513-9450 drlittle@dr-tom.com www.dr-tom.com
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TLC, FMEA 42703
Audience
Audience: This class is designed for those individuals who work on various aspects of product development and manufacturing. It is assumed they come from many different backgrounds, disciplines, education levels and will be working on a variety of product and process areas across many departments of a company. Prerequisites: None Time: Course requires 8 hours of classroom instruction. Additional time may be needed to complete workshop activities.
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TLC, FMEA 42703
Course Objectives
As a result of the course the participant will be able to: 1. 2. 3. 4. 5. Understand the various types of FMEAs Apply the basic steps for FMEA generation Know when and how to apply FMEA to product designs and internal processes Identify potential design or assembly issues which will impact customer product performance and yields Prioritize and manage improvement opportunities from FMEA results
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TLC, FMEA 42703
Course Outline
Section I Introduction to FMEA
History of FMEA The FMEA method When should FMEAs be developed? Types of FMEAs Benefits
Section II FMEA Preparation

Determine scope and objectives Identify FMEA participants Organize and review relevant data
Section III FMEA Generation

Develop process flow diagram Identify potential failure mode Determine effects of failure modes Identify potential causes of the failure Determine potential controls for causes Determine current containment for failures Compute RPNs for each potential failure
Section IV FMEA Action Plans

Prioritize failure modes Determine recommended actions Assign owners Verify effectiveness with new data Review and update FMEA
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TLC, FMEA 42703
FMEA Introduction
Section I Introduction to FMEA

History of FMEA The FMEA method When should FMEAs be developed? Types of FMEAs System Design Detailed Design Process Equipment Benefits Anticipate problems Fix problems faster Improved process controls
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TLC, FMEA 42703
History of FMEA
Developed by NASA in the 1960's Spread to many different industries: Automotive Aerospace Electronics Petrochemical Pharmaceutical Medical device Semiconductor Assembly and Test Today FMEA is often a customer requirement
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TLC, FMEA 42703
The FMEA Method and Flow
Potential Failure Modes Potential Effects of Failure

System, Design, Process or Equipment
Potential Causes of Failure Current Control(s) in Place Current Containment in Place Action Plans
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TLC, FMEA 42703
FMEA
FMEA Objective, scope and goal(s):
Key Date: System: Subsystem: Component: Design Lead: Core Team:
Potential Failure Mode and Effects Analysis (FMEA) Design
FMEA Type: Design FMEA Number: Prepared By: FMEA Date: Revision Date: Page:
Action Results
of
Item / Function Seals Coolant containment. Hose connection. Coolant fill. M Sensor mount. Seal Sensor mount. Seal
Potential Failure Mode(s)
Potential Effect(s) of Failure
S e v
Potential Cause(s)/ Mechanism(s) of Failure
P r o b
New Prob
Current Design/Process Controls
D E T
R P N
Recommended Action(s)
Responsibility & Target Completion Date
Actions Taken
Compression set Loosen during sensor assembly/service
Leak Leak. Fall inside tank
8 Gasket material 8 Fitting not held in place
7 Pressure cycle w/cold shock. 2 Added rib.
1 1
56 Use imported material 16 Implement holding J.P. Aguire rib in design. New 11/1/95 fitting design. Prototype validation. 10
Sensor mount. Seal Sensor mount. Seal
Damaged internal thread
Cannot install sensor
5 Damaged during installation or transportation 4 Damaged during shipment to piracicaba

8 Over pressure
Damaged external Cannot install wire thread nut

Leak
12 Damaged fitting not used by Piracicaba

J.P. Aguire 11/1/95 E. Eglin 8/1/96 prototype and production validation testing. 135 Obtain GMB vibration J.P. Aguire road tape.
Coolant containment. Crack/break. Burst. Hose connection. Side wall flex. Bad Coolant fill. M seal. Poor hose rete Coolant containment. Crack/break. Burst. Hose connection. Side wall flex. Bad Coolant fill. M seal. Poor hose rete
8 Burst, validation pressure cycle.
64 Test included in
Failed mount
5 Vibration
9 Vibration w/road tapes
New RPN
New Sev
New Det
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TLC, FMEA 42703
When should FMEAs be developed?
When new systems, designs, products, or processes are designed When existing systems, designs, products or processes change for any reason (we need a systematic method to evaluate the change) When new applications are found for current systems, designs, products, or processes When new metrology, test, software or process equipment is evaluated and purchased As a general risk assessment and risk reduction tool
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TLC, FMEA 42703
Types of FMEAs
System Design System design & alternatives FMEAs Main system design FMEAs System software Detailed Design Subassembly FMEAs Component FMEAs Subsystem software Process Process FMEA by operation or process step Equipment Measurement, process equipment, computers, phone systems, test equipment etc.
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TLC, FMEA 42703
Focus of FMEA type
System Design FMEA

Main systems, Major Subsystems
Detailed Design FMEA

Subsystems, Components
Process FMEA
People, Machine, Method, Material, Measurement, Environment
Equipment FMEA
Hardware, Software, Interface, Tooling, Material handling, Performance
Focus:
Minimize failures of the system design
Focus:
Minimize design related failures of the subsystem and components
Focus:
Minimize failures of the process
Focus:
Minimize failures of the process equipment
Goal:
Maximize system quality, reliability, cost and maintainability
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TLC, FMEA 42703
Benefits of FMEA
Proactive approach (does not infer a problem) Eliminate potential causes of failures Select better design and or process alternatives Develop process controls, containment and test methods Develop preventive maintenance programs Develop problem response plans Reactive approach (we have a problem now what?) Analyze known failures due to a specific process step Used as a risk assessment tool Prioritize corrective action to prevent/reduce reoccurrence of failures Strengthen control and containment of current failures Develop problem response plans
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TLC, FMEA 42703
Benefits of FMEA
Process improvement Reduce total process time and down time for better productivity Other uses Preserve, transfer and share knowledge (inter plant/site) As a training tool As a feedback tool to equipment/product suppliers for further improvement
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TLC, FMEA 42703
FMEA Preparation
Section II FMEA Preparation Determine scope and objectives Identify FMEA participants Organize and review relevant data
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TLC, FMEA 42703
Determine Scope and Objective
Type of the FMEA (System, Design, Process or Equipment) Stop and start points (includes, does not include) Objectives of the FMEA Specify desired results (improvement goals or risk assessment) Other considerations Level of design Process flow Level of detail Potential actions
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TLC, FMEA 42703
Identify FMEA Participants
Based on the objective and scope, determine who can effectively contribute to the development of the FMEA
Design experts Process experts Customers Suppliers Technicians Failure analysis QA

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TLC, FMEA 42703
Organize & Review Design or Process Data

Based on the objective, review relevant data Internal data sources: Past product or design failures Yield by product or process operation Defect rates by product or operation Process flow charts Equipment maintenance records Downtime logs External data sources: Functional field failures Customer complaints Returned materials
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TLC, FMEA 42703
FMEA Definition Exercise

FMEA Objective, scope and goal(s):
Key Date: System: Subsystem: Component: Design Lead: Core Team:
Potential Failure Mode and Effects Analysis (FMEA) Design
FMEA Type: Design FMEA Number: Prepared By: FMEA Date: Revision Date: Page:
of
Create an FMEA definition for your project. 1. Create an objective, scope and goal statement for your FMEA. 2. Identify the type of FMEA (System, Design, Process or Equipment). 3. Identify the team you need to help complete the FMEA. 4. Be prepared to share your work.
In Class Exercise: 10 Min
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TLC, FMEA 42703
FMEA Generation
Section III FMEA Generation Develop process flow diagram or WBS Identify potential failure mode Determine effects of failure modes Identify potential causes of the failure Determine current controls for the causes Determine current containment for failures Compute RPNs for each potential failure
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TLC, FMEA 42703
Identify process flow or WBS
Develop Work Breakdown Structure (WBS) for System or Design FMEA. WBS is a way of defining the major subsystems, design elements and components of a product. A product BOM may be useful as well. Develop process flow diagram for process or equipment FMEA Understand the specific operations in the process flow Understand the specific machine functions Identify what specifically the FMEA will focus on Link failure/defect data to the process flow or WBS
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TLC, FMEA 42703
Identify critical design functions or process steps
Design Primary and secondary design functions Features that influence customer satisfaction Design robustness and redundancy for reliability and safety Product appearance and packaging issues
Process Processes that influence customer satisfaction Look for areas that require a heavy dependency on inspection Review all low yielding operations Locate areas with a high WIP Look for redundant equipment Look for cost savings opportunities
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TLC, FMEA 42703
Identify potential failure modes
Identify each potential failure mode For each component, subsystem, system, operation or function It does not mean it will happen, it just can happen List all possible failure modes that can occur and enter them into the FMEA spreadsheet Listing a potential failure mode does not indicate at this point a problem or that it is actionable
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TLC, FMEA 42703
Potential Failure Mode Example
Damaged internal thread Damaged external thread

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TLC, FMEA 42703
Identify Potential Failure Modes Exercise
Potential Failure Modes for your FMEA 1. List the elements of the system, design, process or machine. 2. For each element identify potential failure modes. 3. You may have multiple failure modes per design feature or process operation. Make sure a row is dedicated for each failure mode. 4. Be prepared to share your findings.
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TLC, FMEA 42703
Determine Effects of Failure Mode

Potential Failure Mode(s) Potential Effect(s) of Failure
Item / Function
List potential effects for each failure mode Start with known effects from past history, then brainstorm other possible effects Effects may include: Local effect within the design or subsystem, downtime or defects Downstream effect subsequent product function or process step End effect Test, quality/reliability Assign severity ranking If multiple potential effects, add a row for each
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TLC, FMEA 42703
System Severity Ranking

System FMEA Severity Rating Effect
Hazardous without warning Hazardous with warning Very High High Moderate Low Very Low Minor Very Minor None
SEVERITY of Effect
Very high severity ranking when a potential failure mode affects safe system operation without warning Very high severity ranking when a potential failure mode affects safe system operation with warning System inoperable with destructive failure without compromising safety System inoperable with equipment damage System inoperable with minor damage System inoperable without damage System operable with significant degradation of performance System operable with some degradation of performance System operable with minimal interference No effect
Ranking 10 9 8 7 6 5 4 3 2 1
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TLC, FMEA 42703
General Severity Ranking

Work together as a team to achieve consensus concerning ranking scores
General SEVERITY RANKING TABLE
Rank 10 9 Reliability / Reputation at risk Category Liability External and Internal Effect Failure will affect safety or compliance to law Catastrophic customer impact Moderate to major reliability failures End user recalls Premature end-of-life (wear out) Increased early life failures Intermittent functionality Major customer impact 8 7 Customer quality Minor reliability failures Customer line impact / lines down Impacts the yield of customer Wrong package / part / marking Products performing marginally Damaged the customer's equipment 6 5 Internal yield or special 4 3 2 1 Unnoticed handling required Product assembly error Equipment cross contamination Damaged to down stream equipment Major yield hit Significant line yield loss Minor yield hit Low line yield loss Special internal handling, effort or annoyance Unnoticed either internally or externally
inconveniences Involved customer's special handling
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TLC, FMEA 42703
Severity Ranking Example
S e v
8 8
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TLC, FMEA 42703
Potential Failure Effects and Severity Ranking Identify potential failure effect(s) Exercise #2
Potential Failure Effects for your FMEA 1. Based on your previous work and group 2. Identify potential failure effects: Based on data or brainstorming determine the effects of the failures and write them down 3. Determine the severity ranking of each failure effect 4. Be prepared to share your finding
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TLC, FMEA 42703
Identify Potential Failure Causes

Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure P r o b
List the possible causes of each failure and the probability of failure The following activities may be helpful: Cause & effect diagram (fishbone) 5 Whys Fault tree analysis The cause is known when we have identified the source or origin of the potential failure Proper cause identification requires some understanding of the failure mechanism based on the process, the physics, mechanics or chemistry The cause is verified when we can recreate or manipulate 31 the problem source TLC, FMEA 42703
Use Cause & Effect diagram to Brainstorm Potential Root Cause(s)

QC Tool 7: Cause & Effect Diagram
Cause Cause
Br a nc h
1. Draw a horizontal line with a box connected at the far right. 2. Write the problem or effect in the box. 3. Draw 6 branches off the main stem and categorize them People, Material, Method, Machine, Measurement, and Environment. 4. Cause & Effect diagrams are usually completed in a brainstorming session with team members. 5. One team member acts as a facilitator to guide the brainstorming session to solicit ideas for potential causes from the team members. 6. Use the Cause and Effect checklist to identify problem related issues 7. The facilitator will capture potential causes and put them onto a branch or sub-branch under the correct category.
Sub-branch Effect
Main stem
Cause
Cause
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TLC, FMEA 42703
Cause & Effect Diagram to Identify Failure Modes
People
Machine
Improper cassette loading
Method
Insufficient vacuum
Wrong BOM Wrong cassette Missing cassette
Wrong program
XYZ alignment
too fast
Excessive heat
7% automated placement and insertion errors

CCD Camera calibration for part location
Defective Parts
Environment Material
Measurement
When brainstorming the cause and effect diagram add frequency data to get a more complete picture of the sources of the problem
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TLC, FMEA 42703
5 Whys Example
State the potential failure, then ask why did this problem occur until you reach root cause. Think about where is the source of the failure and where you can affect a controllable solution.
Agent X in the Lot

External Source of the Agent Wrong Material Used Fail to Clean Internal Host Error in Assay
What?/Why? Why? Why? Why? Why?
Residual Material in Bulk Fill
Filter integrity tester shared with multiple products Efficiency of Operation Inadequate Segregation
Insufficient Capacity
Five is not an absolute, could be three, four, five or more whys

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TLC, FMEA 42703
Fault Tree Analysis to find Failure Modes
Why use it? To logically and graphically represent the various combinations of events, both faulty and normal, occurring in a system that leads to the top undesired event. What does it do? Encourages people to expand their thinking Allows for confirmation of logical links & completeness at all levels Helps migrate the team from theory to real world Uncovers the true level of complexity involved in a system
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TLC, FMEA 42703
FTA Symbols
OR
Logical OR add the probabilities
AND
Logical AND multiply the probabilities Major design, machine or process element
Event Basic Fault Event
A source of the fault
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TLC, FMEA 42703
FTA Symbols
Trigger event A fault event that is expected to happen Incomplete event. Not fully developed due to a lack of information
Conditional event. Indicates a restriction or condition to the logic Transfer in from another FTA flow Transfer out to another FTA flow
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TLC, FMEA 42703
FTA Example
Springs broken
Fluid pressure not free to release
Oversized shoes for drum (width)
Brake does not release Weak springs No grease on shoe lands at facing contact
SOURCE: K. E. Case and L.L. Jones, Profit Through Quality: Quality Assurance Programs for Manufacturers, (1978)
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TLC, FMEA 42703
FTA Example
Brake performance marginal
Brake does not work
Fluid low Master cylinder defective (subsystem) Improper installation of shoes, sprgs., whl. cylinder
Foreign material shoes or drum
Poor shoe to drum arc fit Contaminated fluid Drums not true Springs uneven or deformed Shoes improperly bonded Improperly bled brakes
Shoes wet (e.g., water) Fillings not cleaned after drums turned Fluid leak Grease from bearings on shoes or drum
Excessive wear Brake line broken or leaking
SOURCE: K. E. Case and L.L. Jones, Profit Through Quality: Quality Assurance Programs for Manufacturers, (1978)
Bleed zerk loose
Master cylinder leaking
Wheel cylinder leaking (subsystem)

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TLC, FMEA 42703
Assign Probability of Failure Ranking
Referring to probability of failure ranking table, the matrix should be modified based on type and availability of historical data: Field failure data, DPPM, defect frequency Pareto, SPC charts, periodical measurement etc. Evaluate the probability of failure for each cause. One number can also be used to represent all potential causes pick the worst case (1, remote through 10, very high)
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TLC, FMEA 42703
Probability of Failure
PROBABILITY of Failure
Very High: Failure is almost inevitable
Failure Prob Ranking >1 in 2 10

1 in 3
9 8 7 6 5 4 3 2 1
High: Repeated failures
1 in 8 1 in 20
Moderate: Occasional failures
1 in 80 1 in 400 1 in 2,000
Low: Relatively few failures
1 in 15,000 1 in 150,000
Remote: Failure is unlikely
<3.4 in 1,000,000
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TLC, FMEA 42703
Example
S e v
P r o b
7 2
Sensor mount. Seal
5 Damaged during installation or transportation
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TLC, FMEA 42703
Identify Potential Failure Causes

Potential Failure Causes and Probability for your FMEA 1. Based on your previous work and group. 2. Identify potential failure causes: Based on data or brainstorming determine the cause of the failures and write them down 3. Determine the probability of failure ranking of each failure cause.
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TLC, FMEA 42703
Determine Current Controls/Tests
Describe current control in place for each potential cause Control can be either prevent failure from occurring or detect the failure after it occurs Assign control ranking (DET) Detection is the likelihood of the control to detect a failure or prevent failure mode Use one detection number to represent controls per causepick worst case. One detection number to represent all control per failure can also be used-pick worst case (1, effective through 10, ineffective)
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TLC, FMEA 42703
Determine Controls for Causes
Types of Controls
Measurement Based Control
Management Dashboards & Review Statistical Process Control
Test & Inspection

Test Inspection (poor effectiveness and costly)
Documentation
Process Flow Diagrams Product Drawings, Schematics
Periodic Checks
Scheduled Maintenance Scheduled Calibration Training and Operator Certification Audits
View controls from a perspective of six methods for controlling performance Different problems require different types of control
Process Management Plans Written Procedures
Design
Design out Product Problems Mistake Proofing Robust Process Design Design Reviews
Incentives
Measures that are associated with a bonus Measures that are associated with a penalty
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TLC, FMEA 42703
Inspection Effectiveness
Inspection by definition is an incapable process. Under good conditions the inspector will detect the defects correctly only 85% of the time. 15% of the defects will escape from the process. Consider this when rating inspections effectiveness in defect containment.
Defect Rate Inspection Capability Escape Rate 15.00% 85.00% 2.25% 10.00% 85.00% 1.50% 5.00% 85.00% 0.75% 1.00% 85.00% 0.15% 0.10% 85.00% 0.02%
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TLC, FMEA 42703
Detection Ranking Table
Detection
Cannot Detect Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain
subsequent failure mode Very remote chance the design control will detect potential cause/mechanism and subsequent failure mode Remote chance the design control will detect potential cause/mechanism and subsequent failure mode Very low chance the design control will detect potential cause/mechanism and subsequent failure mode Low chance the design control will detect potential cause/mechanism and subsequent failure mode Moderate chance the design control will detect potential cause/mechanism and subsequent failure mode Moderately High chance the design control will detect potential cause/mechanism and subsequent failure mode High chance the design control will detect potential cause/mechanism and subsequent failure mode Very high chance the design control will detect potential cause/mechanism and subsequent failure mode Design control will detect potential cause/mechanism and subsequent failure mode
Ranking Design control cannot detect potential cause/mechanism and 10 9 8 7 6 5 4 3 2 1
Likelihood of DETECTION by Design Control
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TLC, FMEA 42703
Additional Detection Criteria
Detection
Cannot Detect Very Remote Remote Very Low Low Moderate Moderately Hight High Very High Almost Certain
Additional Detection Criteria

Absolute certainty of non-detection of defective product prior to shipment
Rank
10 9 8 7 6 5 4 3 2 1
Test/inspection gates probably will not detect defective product Test/inspection gates will catch all but 25% of defective product Test/inspection gates will catch all but 10% of defective product Test/inspection gates will catch all but 1.00% of defective product Test/inspection gates will catch all but 0.25% of defective product Test/inspection gates will catch all but 500 DPM of defective product Test/inspection gates will catch all but 60 DPM of defective product Test/inspection gates will catch all but 3.4 DPM of defective product Test/inspection gates will catch all but 1 DPB of defective product
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TLC, FMEA 42703
Controls and Detection Example
S e v
P r o b
D e t
1 1
Sensor mount. Seal
5 Damaged during installation or transportation
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TLC, FMEA 42703
Determine Controls for Causes

Controls and Detection Ranking for your FMEA 1. Based on your previous work and group 2. Identify current controls: Evaluate current controls If no control is present state None Brainstorm potential control improvements Determine realistic control points or methods that should be added to the design process, process, equipment, or test sequence 3. Determine the detection (DET) ranking for the control(s) Use one detection number to represent controls per cause - pick worst case. (1, effective through 10, ineffective) if none ranking is 10
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TLC, FMEA 42703
FMEA Action Plans
Section IV FMEA Action Plans Prioritize failure modes Determine recommended actions Assign owners and completion dates Verify effectiveness with new data Review and update FMEA
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TLC, FMEA 42703
Prioritize Actions for Potential Failure Modes
Rank failure modes by RPN score from high to low Based on RPN and engineering judgment determine which of the failure modes require immediate action
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TLC, FMEA 42703
Determine recommended actions
Prioritize actions based on top RPNs Determine actions to reduce RPNs Actions can be devised to: 1) reduce/eliminate occurrence 2) improve control 3) improve containment by increasing the probability of detection Changing the design or process to eliminate the possibility of failure occurrence is always preferred; however, not always possible
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TLC, FMEA 42703
FMEA Worksheet Computes RPNs for each Potential Failure

Calculate Risk Priority Number (RPN) For each potential failure mode RPN= Severity * Probability of Failure * Detection High RPN numbers relative to one another require action RPNs are used to prioritize improvement activities in the design or process Don't use RPNs as relative indicators from one FMEA to another. They are only comparable within the FMEA.
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TLC, FMEA 42703
S e v
P r o b
D E T
R P N
1 1
56 16

8 Over pressure
10

Leak
12
Coolant containment. Crack/break. Burst. Side wall flex. Bad Hose connection. seal. Poor hose rete Coolant fill. M Coolant containment. Crack/break. Burst. Side wall flex. Bad Hose connection. seal. Poor hose rete Coolant fill. M Coolant containment. Crack/break. Burst. Side wall flex. Bad Hose connection. seal. Poor hose rete Coolant fill. M
64
Failed mount
5 Vibration
135
Hose leak
6 Overpressure. Poor clamp
5 Burst, validation pressure cycle w/GMB clamps.
60
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TLC, FMEA 42703
RPN Interpretation
RPN Interpretation RPN Number High Due to prob. of failure High Due to severity High Due to detection Moderate Due to detection Moderate Due to prob. of failure Moderate Due to severity Low All
Change design or process Change design or process Change process control/test method Consider improving present control/test method Consider changing design or process Consider changing design or process Maintain present status
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Compute RPNs for Each Potential Failure

Controls and Detection Ranking for your FMEA 1. Based on your previous work and group 2. Compute RPNs for each potential failure mode. 3. Evaluate the RPN numbers. 4. Which ones require action? 5. What action appears to be appropriate, modification of the design or the control? 6. Be prepared to share your findings.
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TLC, FMEA 42703
Assign owners and completion dates
Identify the owner for for problem solution (Corrective Action) Get commitment from owner on action plans and completion dates Match expertise and availability to the task
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FMEA with Actions

Potential Cause(s)/ Mechanism(s) of Failure P r o b
S e v
D E T
R P N
Recommended Action(s)
Responsibility & Target Completion Date
1 1
56 Use imported material 16 Implement holding J.P. Aguire rib in design. New 11/1/95 fitting design. Prototype validation. 10

8 Over pressure

Leak
12 Damaged fitting not used by Piracicaba

J.P. Aguire 11/1/95 prototype and E. Eglin 8/1/96 production validation testing. 135 Obtain GMB vibration J.P. Aguire road tape.
Coolant containment. Crack/break. Burst. Side wall flex. Bad Hose connection. seal. Poor hose rete Coolant fill. M Coolant containment. Crack/break. Burst. Hose connection. Side wall flex. Bad Coolant fill. M seal. Poor hose rete Coolant containment. Crack/break. Burst. Side wall flex. Bad Hose connection. seal. Poor hose rete Coolant fill. M
64 Test included in
Failed mount
5 Vibration
Hose leak
6 Overpressure. Poor clamp
5 Burst, validation pressure cycle w/GMB clamps.
60 Obtain GMB clamps

and clamping specification.
J.P. Aguire 12/1/95
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Verify Effectiveness with Actions Completed
Complete action plans Gather new data after implementation of recommended action (solution) Recalculate RPNs based on new data or design modification
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Update New RPN based on Design or Process Actions
Action Results New Prob Recommended Action(s) Responsibility & Target Completion Date Actions Taken New RPN New Sev New Det
Use imported material Implement holding J.P. Aguire rib in design. New 11/1/95 fitting design. Prototype validation.
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TLC, FMEA 42703
Compute New RPNs for Each Potential Failure

Controls and Detection Ranking for your FMEA 1. Based on your previous work and group 2. Based on the changes to the design, process or control assign new SEV, PROB, or DET numbers and compute the new RPN. 3. Review the revised NEW RPN numbers. Has the action resulted in reduced risk? 4. Be prepared to share your findings.
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Review and update FMEA
Make changes to FMEA based on new RPNs and continue to work on the next highest ranking RPN Endpoint of exercise is to be determined by the team Keep all revisions of FMEA Review and update FMEA as conditions, processes and performance change
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TLC, FMEA 42703
Summary
FMEA is a powerful tool to examine failure modes and proactively prevent their occurrence Systematic application of FMEA to Products, Designs, Processes and New Equipment will reduce defects and their impact to customer satisfaction Involvement of the right people early in the process and applying a structured FMEA methodology will have the greatest impact on failure reduction FMEA should not be generated in a vacuum. Make sure you have the right data available during the FMEA generation.
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References
Bass, L. 1991. Cumulative supplement to Products liability: Design and manufacturing defects. Colorado Springs, Co.: Shepards, McGraw-Hill. Blanchard, B. S. 1986. Logistics engineering and management. 3d ed. Englewood Cliffs, N.J.: Prentice Hall. Blanchard, B. S., and E. E. Lowery. 1969. Maintainability-Principles and practices. New York: McGraw-Hill. Brassard, M., and D. Ritter. 1994. The Memory Jogger II. First ed. Metheun, MA: Goal/QPC. Chrysler Corporation, Ford Motor Company, General Motors Corporation. (February 1995). Potential failure mode and effects analysis reference manual. Second edition. Eachus, J. 1982. Failure analysis in brief. In Reliability and quality handbook, by Motorola. Phoenix: Motorola Semiconductor Products Sector. Stamatis, D.H 1995. Failure Mode and Effect Analysis: FMEA from Theory to Execution. Milwaukee, WI: ASQC Press. Course materials are copyrighted by Thomas A. Little Consulting. Any duplication or use of these materials or sections of these materials requires the express permission of TLC prior to use. 2003
611 Whitby Lane Brentwood, CA 94513 1-925-285-1847 FAX: 1-925-513-9450 drlittle@pacbell.net www.dr-tom.com
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TLC, FMEA 42703

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1

TLC, FMEA 42703

Purpose for Course

Section II FMEA Preparation

Section III FMEA Generation

Section IV FMEA Action Plans

Section I Introduction to FMEA

The FMEA Method and Flow

Potential Failure Modes Potential Effects of Failure

Key Date: System: Subsystem: Component: Design Lead: Core Team:

Potential Failure Mode and Effects Analysis (FMEA) Design

Potential Failure Mode(s)

Potential Effect(s) of Failure

Potential Cause(s)/ Mechanism(s) of Failure

Current Design/Process Controls

Responsibility & Target Completion Date

Compression set Loosen during sensor assembly/service

Leak Leak. Fall inside tank

8 Gasket material 8 Fitting not held in place

7 Pressure cycle w/cold shock. 2 Added rib.

Sensor mount. Seal Sensor mount. Seal

Damaged internal thread

Cannot install sensor

5 Damaged during installation or transportation 4 Damaged during shipment to piracicaba

Damaged external Cannot install wire thread nut

12 Damaged fitting not used by Piracicaba

8 Burst, validation pressure cycle.

9 Vibration w/road tapes

When should FMEAs be developed?

Focus of FMEA type

System Design FMEA

Detailed Design FMEA

Determine Scope and Objective

Identify FMEA Participants

Design experts Process experts Customers Suppliers Technicians Failure analysis QA

Organize & Review Design or Process Data

FMEA Definition Exercise

Key Date: System: Subsystem: Component: Design Lead: Core Team:

Potential Failure Mode and Effects Analysis (FMEA) Design

In Class Exercise: 10 Min

Identify process flow or WBS

Identify critical design functions or process steps

TLC, FMEA 42703

Identify potential failure modes

Potential Failure Mode Example

Potential Failure Mode(s)

Compression set Loosen during sensor assembly/service

Sensor mount. Seal Sensor mount. Seal

Damaged internal thread Damaged external thread

Identify Potential Failure Modes Exercise

In Class Exercise: 10 Min

Determine Effects of Failure Mode

System Severity Ranking

General Severity Ranking

inconveniences Involved customer's special handling

Severity Ranking Example

Potential Failure Mode(s)

Potential Effect(s) of Failure

Compression set Loosen during sensor assembly/service

Leak Leak. Fall inside tank

Sensor mount. Seal Sensor mount. Seal

Damaged internal thread