FMEA RCM Course - Foundations of Effective FMEA - RS 470 CourseNotes_Rev9.1

Language/Region: English/USADocument Revision: 9.1

©2003-2012 ReliaSoft Corporation - ALL RIGHTS RESERVED

RS 470 Foundations of

Effective FMEAs

1 Course Material Copyright & License Information©2003-2012 ReliaSoft Corporation, ALL RIGHTS RESERVED.

These course materials are provided to you by ReliaSoft in a printed and/or electronic format as part of a training course to enhance your learning experience and are licensed to you for your personal use. ReliaSoft grants you the Licensee (a person, firm,

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mailto:[email protected]

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Welcome

Location and FacilitiesAny questions regarding the location of any facilities.

Make sure we are fully aware of the exits and the most appropriate egress route in case of an emergency.

Meeting point in case of an emergency evacuation.

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About the Course

This course will provide a general overview of FMEA techniques and an introduction to the use of ReliaSoft’s Xfmea software.

It is not intended to provide “facilitation”

for performing FMEAs on specific products or processes.

A related course, RS 471 –

FMEA Facilitation and Application Skills –

uses case study examples to allow attendees to practice FMEA facilitation and application skills. Note on variation:

There is a good deal of variation among practitioners as to the specific analysis procedures, terminology, reporting requirements, etc.

The tool has been adapted in many different ways for many different purposes.

This course will discuss general requirements and common techniques, with the expectation that individuals may identify relevant variations to fit their own experiences/needs.

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9:40 to10:40 am

8:30 to9:30 am

10:50 to11:45 am

1:15 to2:15 pm

2:30 to3:30 pm

3:30 to4:30 pm

LectureSoftware

Demo

Typical Course Timeline (USA) (May be adjusted*)

Lecture Lecture

Lecture

Software Demo & Examples guide Class Exercise & Wrap-Up

* Depending on country/location and venue, alternative start times may be utilized. In such cases, the timeline can be shifted accordingly.

Lunch

11:45 am1:15 pm

Class Exercise

Lecture

Lecture

Software Exercise Lecture

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Attendee Introductions

Name, Company, Position/DutiesWhat is your experience with FMEA/FMECA?

If applicable:What standards have you used?What software/tools have you used?

What do you hope to get out of this class?

1.

None. This is my first exposure to the subject.2.

Peripheral. I have been exposed to some principles.3.

Beginner. I just started working in this area and have some basic training.

4.

Intermediate/Practitioner. I have been involved for some time and use it in my day-to-day work activities.

5.

Subject Matter Expert. I have in-depth knowledge of the subject and applications.

CRP CreditsCRP Credits

This course is eligible for 3 CRP credits.For more information, see: http://www.ReliabilityProfessional.org

http://www.reliabilityprofessional.org/

http://www.reliabilityprofessional.org/index.htm

http://www.reliabilityprofessional.org/index.htm

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Course Objectives

1.

Introduction2.

FMEA and Reliability3.

Fundamental Definitions and Concepts4.

Selection and Timing 5.

Preparation 6.

Procedure 7.

FMEA Action Strategies 8.

Case Studies 9.

FMEA Success Factors 10.

Basic FMEA Facilitation 11.

Implementing an FMEA Process 12.

FMECA 13.

Integration with other Analyses and ProcessesDRBFM, FTA, RCM, Hazard Analysis, Software FMEA

14.

Xfmea User and Administrative Features (integrated throughout course

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EDUCATION

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8

1: IntroductionIntroduction

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Introduction Objectives

Many companies are faced with intense global competition and must shorten product development times and reduce costs. Failure Mode and Effects Analysis (FMEA) is one of the most effective techniques to achieve high reliability during shorter product development timelines and budget constraints.The objectives of this module are to:

Introduce Failure Mode and Effects Analysis.Illustrate how FMEA improves reliability and safety while reducing warranty costs in a variety of industries.

As a result of this module students will understand general information about FMEAs, including why they are an important part of reliability programs.

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FMEA Definition

Failure Mode and Effects Analysis (FMEA) is a methodology designed to:

Identify and fully understand potential failure modes for a product or process.Assess the risk associated with those failure modes and prioritize issues for corrective action.Identify and carry out corrective actions to address the most serious concerns.

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History of FMEA

FMEA was formalized in 1949 by the US Armed Forces in the publication Mil-P 1629

Procedure for performing a failure mode effect and criticality analysis. The objective was to classify failures according to their impact on mission success and personnel/equipment safety.It was later adopted in the Apollo space program to mitigate risk due to small sample sizes. The use of FMEA gained momentum during the 1960s with the push to put a man on the moon and return him safely to earth. Ford Motor Company introduced FMEA to the automotive industry in

the late 1970s for safety and regulatory consideration after the Pinto affair. In the 1980s, the automotive industry began implementing FMEA by

standardizing the structure and procedures through the Automotive Industry Action Group. FMEA is now extensively used in a variety of industries including semiconductor processing, foodservice, plastics, software, automotive and healthcare.

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Published Guidelines

SAE J1739

for the automotive industry.AIAG FMEA and APQP

for the automotive industry.

ISO 16949

quality guidelines for the automotive industry.MIL-STD-1629A

for FMECA.

Cancelled in November, 1984 but still used in some military and other applications.

IEC 60812

from the International Electrotechnical Commission.SAE ARP5580

for non-automotive applications.

BS 5760

from the British Standards Institution (BSI).ISO 14971

for the medical devices industry.

Other industry-specific and/or company-specific guidelines exist.

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FMEA Applications

Usually, the primary objective of an FMEA is to identify and mitigate risks in a product or process in order to improve product or process design. In addition, since the FMEA provides a central location for reliability-related information for the product or process, it can be used as:

A resource when considering modifications to the design in the future.A resource when developing similar designs in the future.A resource for service personnel to identify possible corrective actions when problems occur in the field.A learning tool for new engineers.…

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FMEA Applications (cont’d)

The FMEA can contribute to and/or integrate with other processes and objectives, such as:

Reliability Growth Testing and ManagementFRACAS problem resolutionDesign Review Based on Failure Mode (DRBFM)Design Verification Plans (DVP&Rs) or Test PlansProcess Control PlansReliability Block Diagrams or Fault TreesMaintenance Plans (RCM)…

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FMEA Applications (cont’d)

FMEA is often performed in order to meet a customer requirement or comply with safety and quality regulations, such as:

ISO 9001 / QS 9000 / ISO/TS 16949 ISO 14971FDA Good Manufacturing Processes…Design for Six SigmaDesign for Reliability…

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Why Perform FMEAs?

There are a number of business reasons to implement an effective FMEA process:

When done well, FMEA is a proven tool to reduce life cycle warranty costs.When done well, FMEAs will reduce the number of missed opportunities for design and process improvement during product development.FMEAs can be effective in the identification and resolution of safety issues before a potential catastrophe.It is far less expensive to prevent problems early in product development than to fix problems after launch.

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Benefits of FMEA

Contributes to improved designs and reduced risk for products and processes.

Higher reliability.Better quality.Increased safety.Enhanced customer satisfaction.

Contributes to cost savings.Decreases development time and re-design costs.Decreases warranty costs.Decreases waste, non-value added operations.

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Benefits of Relational Database Software for FMEA

Using relational database software to facilitate FMEA analysis, data management and reporting can:

Provide a keyword searchable “knowledge base”

of your organization’s FMEAs.Make it easy to re-use information from existing FMEAs or from pre-defined phrase libraries.Help to establish consistency throughout the organization and allow multiple users to cooperate on analyses.Provide a feedback loop for corrective actions.Provide reports, queries and charts that facilitate decision making.

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EDUCATION

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2: FMEA and Reliability

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FMEA and Reliability Objectives

FMEA needs to integrate seamlessly into other reliability tasks in order to achieve maximum benefits.The objective of this module is to:

Show how FMEA supports the overall reliability process, including design-for-reliability.

As a result of this module students will understand how FMEA fits into other reliability methods and tasks and the general inputs and outputs of FMEAs.For the purposes of this presentation:

Design for Reliability covers both product and process design.

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FMEA & Design for Reliability (DFR)

To understand why FMEAs are important, we need to begin with the Product Development Process and the tools that support Design for Reliability (DFR).Today’s corporations are facing unprecedented worldwide competition as a result of three continuing challenges:

the mandate to reduce costsfaster development timeshigh customer expectations for the reliability of products and processes

The necessity for reliability testing and process verification are still important…However, there is increasing emphasis on Design for Reliability as a corporate strategy.

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What is Design for Reliability?

In simple terms, whereas reliability analysis methods enable us to compute the reliability of an item…“Design for Reliability”

provides the process of

assuring that the optimum/desired reliability is designed into the item or process.

This process encompasses multiple tools and practices in order to drive reliability into products.

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DFR Philosophy

Three important statements summarize the best practice reliability philosophy of successful companies:

Reliability must be designed into products and processes, using the best available science-based methods.Knowing how to calculate

reliability is important, but

knowing how to achieve

reliability is equally if not more important.Design for Reliability practices must begin early in the design process and must be well integrated into the overall product development cycle.

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Pay Now or Pay More Later

By far, it is more cost effective to design in reliability than to try to test it in after the fact.If reliability cannot fit in the current budget then where can you fit the budget* for fixing field issues, field recalls, lost customers, etc?

“…

and we can save 700 lira by not taking soil tests!”

*Reportedly, in 2007 Microsoft set aside a $1,500,000,000 budget for addressing Xbox®

field issues.

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Implementing Reliability is a Process

Reliability is a long-term process. Proper implementation requires:

Strategic visionProper planningSufficient organizational resource allocationProper implementationIntegration and institutionalization of reliability into the organization

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Factor of 10 RuleIf you discover a reliability problem in this stage…

…it will cost you this much

10x

100x

1,000x

10,000x

100,000x

Stage Gate Process

Feasibility

Design

Development

Testing

Manufacturing

Field

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This illustration is from the book Effective FMEAs, ©

John Wiley & Sons, 2012, all rights reserved.

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Introduction to Bicycle Example

Throughout this presentation, we will demonstrate key FMEA analysis techniques and skills using a fictional example for a new Trail Bike design.

Example slides are identified with the following graphic in the upper left corner:

The information for the trail bike example was developed by Mike Schubert, Carl S. Carlson and ReliaSoft engineers.Although the example is intended to be representative of a real-world analysis scenario, it was prepared for demonstration purposes only and does not represent an actual product or process.

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EDUCATION

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3: Fundamental Definitions and Concepts

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Types of FMEA

FMEA analyses are often referred to by type based on the subject of the analysis and the level of detail. The most common designations are:

SystemDesignProcess

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System FMEA A high-level DFMEA analysis of the entire system.Includes interfaces/interactions among subsystems/components and between the system and the environment or customer.

Design FMEA (DFMEA) focuses on design-related issuesTo analyze a new product design before it goes into full production.Done at the system, subsystem and/or component level.Focuses on potential design related problems (e.g., “incorrect dimensions specified).”

Process FMEA (PFMEA) focuses on process-related issuesTo analyze the manufacturing process before production begins.Focuses on potential process related problems (e.g., “design specifications not met during manufacturing).”

System, Design and Process FMEA

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Other Types of FMEA

Other types of FMEA may include:Machinery FMEA

(a Design FMEA focused on tooling and equipment for a manufacturing plant)

Service FMEA(can be a DFMEA or a PFMEA depending on focus)

Interface FMEA(a Design FMEA focused on the interfaces between assemblies)

Software FMEA(a Design FMEA focused on software)

…

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Importance of Engineering Judgment / Business Judgment

Essentially, FMEA provides a structured framework and documentation for the engineer’s evaluation of products and processes.

Relies heavily on the engineering judgment and business judgment of the individuals who are performing the FMEA.

This is a qualitative

(not quantitative) analysis approach.

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A Living Document

FMEA is most effective when it is a dynamic and iterative process –

a “living”

document.

The team will need to review and update the analysis when:

New information becomes available.Corrective actions are implemented.Design phases progress.Operating conditions change.…

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Overview of the Typical FMEA Worksheet Elements

What is it supposed

to do?

What is it supposed

to do?How could

it fail?

How could it fail?

How bad will it be?

How bad will it be?

What will happen if it

fails?

What will happen if it

fails?

Is the problem likely to occur?

Is the problem likely to occur?

What is the cause of failure?

What is the cause of failure?

Are you likely to detect the problem before it

reaches the user?

Are you likely to detect the problem before it

reaches the user?

What are you doing to detect the problem?

What are you doing to detect the problem?

What are you doing to prevent

the problem?

What are you doing to prevent

the problem?

What did we

do?

What did we

do?

What can we do to improve the design

and reduce the risk?

What can we do to improve the design

and reduce the risk?

What is the risk for this problem?

What is the risk for this problem?

How much were we able to

reduce the risk?

How much were we able to

reduce the risk?

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Introduction to Exercises

Throughout this module, students will be asked to exercise their knowledge about FMEA definitions by identifying and sharing examples of each FMEA element. Each student should select a familiar item, either design-

related OR

process-related. For example:A student who wishes to use a design-related example for the exercises might select an item from their garage, or from their work (non-proprietary), focusing on product design.A student who wishes to use a process-related example for the exercises might also select an item from their garage, or from their work, focusing on the manufacturing process.

Any item that can be used to demonstrate FMEA will suffice.

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Hands-on FMEA ExercisesDemonstration of Xfmea introductory features.Follow along with the demonstration:

Launch Xfmea (using the software defaults).Create a database and project.

Select profile AIAG4Input analysis information into the database for the remaining exercises as directed by your instructor.

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Definition Item

An item is the focus

of the FMEA project: For a System FMEA this is the system itself. For a Design FMEA, this is the subsystem or component under analysis. For a Process FMEA, this is usually one of the specific steps of the manufacturing process under analysis, as represented by an operation description.

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Sample Item Descriptions: DFMEA Example 1

Item: Power steering pump

This example is excerpted from the book Effective FMEAs, ©


Poorly worded example of an Item: System

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Item: Shaft (part of rock grinding equipment)



Additionalexample

for studentreference only

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Item: Projector bulb



Additionalexample


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Sample Item Descriptions: PFMEA Example 1

Process Step: Induction harden vehicle axle shafts using induction-hardening machine



Poorly worded example of a Process Step: Install part A

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Process Step: Clamp upper tube in weld fixture locating the part using self positioning detail and the hand clamp to secure the tube in position.



Additionalexample


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Process Step: Apply lubrication to O-ring using lubricant gun and fixture AF12345



Additionalexample


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Item Description Exercise

Write a description of the item you have identified as the object of your analysis. Enter it in your Xfmea project.The instructor will ask for volunteers or call on you to share what you have written.

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Definition Function

Function is what the item or process is intended to do, usually to a given standard of performance or requirement.

For Design FMEAs, this is the primary purpose or design intent of the item. For Process FMEAs, this is the primary purpose of the manufacturing or assembly operation; wording should consider “Do this [operation] to this [the part] with this [the tooling]”

along with any needed requirement.

There may be many functions for each item or operation.

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Sample Function Descriptions: DFMEA Example 1

Item: Power steering pumpFunction: Delivers hydraulic power for steering by

transforming oil pressure at inlet ([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle speed



Poorly worded example of a Function: Provides hydraulic power

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Item: Shaft (part of rock grinding equipment)Function: Provide mechanical transfer of xx

rotational force while maintaining linear and angular stability



Additionalexample


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Item: Projector bulbFunction: Provide xx

lumens of light for image

transfer for minimum yy

hours of use



Additionalexample


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Sample Function Descriptions: PFMEA Example 1

Process Step: Induction harden vehicle axle shafts using induction-hardening machineFunction: Induction harden shafts using induction-

hardening machine ABC, with minimum hardness Brinell Hardness Number (BHN) “X”, according to specification #123.

Poorly worded example of a Function: Induction harden the shafts



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Process Step: Clamp upper tube in weld fixture locating the part using self positioning detail and the hand clamp to secure the tube in position.Function: Securely clamp upper tube in weld fixture,

without damaging part and without looseness or movement of part in fixture



Additionalexample


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Process Step: Apply lubrication to O-ring using lubricant gun and fixture AF12345Function: Lube O-ring with ABC lubricant, using XYZ

specification



Additionalexample


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Function Exercise

Write a description of a function of the item you have identified as the object of your analysis. Enter it in your Xfmea project.The instructor will ask for volunteers or call on you to share what you have written.

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Definition Failure Mode

Failure Mode is the manner in which the item or operation fails to meet or deliver the intended function and its requirements.

Depending on the definition of failure established by the analysis team, failure modes may include:

failure to perform a function within defined limitsinadequate or poor performance of the functionintermittent performance of a function, and/or performing an unintended or undesired function.

There may be many failure modes for each function.

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Sample Failure Mode Descriptions: DFMEA Example 1

Item: Power steering pumpFunction: Delivers hydraulic power for steering by

transforming oil pressure at inlet ([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle speed

Failure Mode: Inadequate outlet pressure (less than [yy] psi)

Poorly worded example of a Failure Mode: Power steering pump fails



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rotational force

while maintaining linear and angular stabilityFailure Mode: Shaft fractures



Additionalexample


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lumens of light for image transfer for

minimum yy

hours of useFailure Mode: Bulb shatters



Additionalexample


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Sample Failure Mode Descriptions: PFMEA Example 1

Process Step: Induction harden vehicle axle shafts using induction-hardening machineFunction: Induction harden shafts using induction-hardening

machine ABC, with minimum hardness Brinell Hardness Number (BHN) “X”, according to specification #123.

Failure Mode: Shaft hardness less than BHN “X”

Poorly worded example of a Failure Mode: Shaft fails



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Process Step: Clamp upper tube in weld fixture locating the part using self positioning detail and the hand clamp to secure the tube in position.Function: Securely clamp upper tube in weld fixture, without

damaging part and without looseness or movement of part in fixture

Failure Mode: Tube not clamped securely and shifts during processing



Additionalexample


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Process Step: Apply lubrication to O-ring using lubricant gun and fixture AF12345Function: Lube O-ring with 4 grams of

ABC lubricant

evenly around the O-ring, using XYZ specificationFailure Mode: Insufficient lubrication, less than

4 grams applied



Additionalexample


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Failure Mode Exercise

Write a description of a failure mode relating to the function of the item you have identified as the object of your analysis. Enter it in your Xfmea project.The instructor will ask for volunteers or call on you to share what you have written.

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Definition Effect

Effect is the consequence of the failure on the system or end user.

For Process FMEAs, the team should consider the effect of the failure at the manufacturing or assembly level, as well as at the system or end user. There can be more than one effect for each failure mode. However, in most applications the FMEA team will use the most serious of the end effects for the analysis.

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Sample Effect Descriptions: DFMEA Example 1

Item: Power steering pumpFunction: Delivers hydraulic power for steering by transforming oil

pressure at inlet ([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle speed

Failure Mode: Inadequate outlet pressure (less than [yy] psi)Effect (Local: Pump): Low pressure fluid goes to

steering gearEffect (Next level: Steering Subsystem):

Increased friction at steering gearEffect (End user): Increased steering effort with

potential accident during steering maneuversPoorly worded example of an Effect: Unsafe



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Failure Mode: Shaft fracturedEffect (Local: Shaft): No torque output (does

not transfer energy)Effect (Next level: Grinder Subsystem): Rock

grinder teeth do not moveEffect (End user): No rocks are pulverized, and

product order is not filled (loss of sales)



Additionalexample


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lumens of light for image transfer for minimum yy


Effect: No light, with potential for operator injury from broken glass



Additionalexample


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Sample Effect Descriptions: PFMEA Example 1

Process Step: Induction harden vehicle axle shafts using induction-hardening machineFunction: Induction harden shafts using induction-hardening

machine ABC, with minimum hardness Brinell Hardness Number (BHN) “X”, according to specification #123.

Failure Mode: Shaft hardness less than BHN “X”Effect (In plant): 100% scrapEffect (Assembly): Not noticeable during

assemblyEffect (End user): Shaft fractures with

complete loss of performance, and increased potential for loss of vehicle control

Poorly worded example of an Effect: Customer unhappy This example is excerpted from the book Effective

FMEAs, ©


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Process Step: Clamp upper tube in weld fixture locating the part using self positioning detail and the hand clamp to secure the tube in position.Function: Securely clamp upper tube in weld fixture, without

damaging part and without looseness or movement of part in fixture

Failure Mode: Tube not clamped securely and shifts during processing

Effect: (In plant): Tube position incorrect, with potential for defective welds and 100% scrap

Effect: (End user): If upper tubes get out of plant with defective welds, the bicycle frame could collapse, with potential rider injury



Additionalexample


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ABC lubricant evenly around the O-ring, using XYZ specification

Failure Mode: Insufficient lubrication, less than 4 grams applied

Effect: Gas leak at fitting, with potential for operator injury; system inoperable in field use



Additionalexample


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Effect Exercise

Write a description of an effect of the failure mode relating to the function of the item you have identified as the object of your analysis. Enter it in your Xfmea project.The instructor will ask for volunteers or call on you to share what you have written.

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Definition Severity

Severity is a ranking number associated with the most serious effect for a given failure mode, based on the criteria from a severity scale.

It is a relative ranking within the scope of the specific FMEA and is determined without regard to the likelihood of occurrence or detection.

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What severity would be assigned

to a complete

loss of function

using this DFMEA Severity Ranking Scale?

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What severity would be assigned if the product functioned at a reduced level of performance and 100% of production had to be reworked off line

using this PFMEA Severity Ranking Scale?

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Definition Cause

Cause is the specific reason for the failure, preferably found by asking “why”

until the root cause is

determined. For Design FMEAs, the cause is the design deficiency that results in the failure mode. For Process FMEAs, the cause is the manufacturing deficiency (or source of variation) that results in the failure mode. In most applications, particularly at the component level, the cause is taken to the level of the failure mechanism. By definition, if a cause occurs, the corresponding failure mode occurs. There can be many causes for each failure mode.

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Sample Cause Descriptions: DFMEA Example 1

Item: Power steering pumpFunction: Delivers hydraulic power for steering by transforming oil pressure

at inlet ([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle speed

Failure Mode: Inadequate outlet pressure (less than [yy] psi)Effect (Local: Pump): Low pressure fluid goes to steering gearEffect (Next level: Steering Subsystem): Increased friction at

steering gearEffect (End user): Increased steering effort with potential accident

during steering maneuvers

Cause: Fluid incorrectly specified (viscosity too low)

Poorly worded example of a Cause: Outlet pressure too low



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Failure Mode: Shaft fracturedEffect (Local: Shaft): No torque output (does not transfer energy)Effect (Next level: Grinder Subsystem): Rock grinder teeth do not

moveEffect (End user): No rocks are pulverized, and product order is

not filled (loss of sales)

Cause: Shaft not strong enough due to material heat treat incorrectly specified



Additionalexample


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hours of use

Failure Mode: Bulb shattersEffect: No light, with potential for operator injury from broken

glass

Cause: Over pressure due to wrong gas specified



Additionalexample


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Sample Cause Descriptions: PFMEA Example 1

Process Step: Induction harden vehicle axle shafts using induction-

hardening machineFunction: Induction harden shafts using induction-hardening machine ABC,

with minimum hardness Brinell Hardness Number (BHN) “X”, according to specification #123.

Failure Mode: Shaft hardness less than BHN “X”Effect (In plant): 100% scrapEffect (Assembly): Not noticeable during assemblyEffect (End user): Shaft fractures with complete loss of

performance, and increased potential for loss of vehicle control

Cause: Induction machine electrical voltage/current settings incorrect for part number

Poorly worded example of a Cause: Operator error



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Process Step: Clamp upper tube in weld fixture locating the part using self positioning detail and the hand clamp to secure the tube in

position.Function: Securely clamp upper tube in weld fixture, without damaging part

and without looseness or movement of part in fixtureFailure Mode: Tube not clamped securely and shifts during processing



Cause: Excessive wear on clamp tooling locating tips



Additionalexample


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ABC lubricant evenly around the o-

ring, using XYZ specification

Failure Mode: Insufficient lubrication, less than 4 grams appliedEffect: Gas leak at fitting, with potential for operator injury;

system inoperable in field use

Cause: Lubrication gun calibration incorrect due to calibration procedure not followed



Additionalexample


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Cause Exercise

Write a description of a cause of the failure mode relating to the function of the item you have identified as the object of your analysis. Enter it in your Xfmea project.The instructor will ask for volunteers or call on you to share what you have written.

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Definition Occurrence

Occurrence is a ranking number associated with the likelihood that the failure mode and its associated cause will be present in the item being analyzed.

For System and Design FMEAs, the occurrence ranking considers the likelihood of occurrence during the design life of the product. For Process FMEAs the occurrence ranking considers the likelihood of occurrence during production. It is based on the criteria from the corresponding occurrence scale. The occurrence ranking has a relative meaning rather than an absolute value and is determined without regard to the severity or likelihood of detection.

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What DFMEA occurrence ranking would you give to a cause that the team estimates 1 in 500?

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What PFMEA occurrence ranking would you give to a cause that the team estimates 1 in 500?

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Definition Controls

Controls are the methods or actions currently planned, or that are already in place, to reduce or

eliminate the risk associated with each potential cause.

Controls can be the methods to prevent

or detect

the cause during product development, or actions to detect a problem during service before it becomes catastrophic. There can be many controls for each cause.In Design FMEAs, they are called Design Controls.In Process FMEAs, they are called Process Controls.

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Definition Design Controls

Prevention-type Design Controls describe how a cause, failure mode or effect in the product design is prevented

based on current or planned actions. They are:Intended to reduce the likelihood that the problem will occur.Used as input to the occurrence ranking.

Detection-type Design Controls describe how a failure mode or cause in the product design is detected, based on current or planned actions, before the product design is released to production. They are:

Intended to increase the likelihood that the problem will be detected before it reaches the end user.Used as input to the detection ranking.

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Sample Control Descriptions: DFMEA Example 1

Item: Power steering pumpFunction: Delivers hydraulic power for steering by transforming oil pressure at

inlet ([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle speed

Failure Mode: Inadequate outlet pressure (less than [yy] psi)Effect (Local: Pump): Low pressure fluid goes to steering gearEffect (Next level: Steering Subsystem): Increased friction at steering

gearEffect (End user): Increased steering effort with potential accident

during steering maneuversCause: Fluid incorrectly specified (viscosity too low)

Prevention Control: Design guideline #ABC for hydraulic fluid selection

Detection Control: Vehicle durability testing #123Poorly worded example of a Prevention Control: Design guidePoorly worded example of a Detection Control: Vehicle durability test



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Failure Mode: Shaft fracturedEffect (Local: Shaft): No torque output (does not transfer energy)Effect (Next level: Grinder Subsystem): Rock grinder teeth do not

moveEffect (End user): No rocks are pulverized, and product order is



Prevention Control: Heat treat specification #123Detection Control: Pump pressure shock test

#234, cold start durability test #567, broken drive-shaft test #890



Additionalexample


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hours of use

Failure Mode: Bulb shattersEffect: No light, with potential for operator injury from broken

glassCause: Over pressure due to wrong gas specified

Prevention Control: Currently scheduled design review that addresses gas properties

Detection Control: Lamp pressure test #456



Additionalexample


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Definition Process Controls

Prevention-type Process Controls describe how a cause, failure mode or effect in the manufacturing, fabrication

or

assembly

process is prevented, based on current or planned actions. They are:

Intended to reduce the likelihood that the problem will occur.Used as input to the occurrence ranking.

Detection-type Process Controls

describe how a failure mode or cause in the manufacturing, fabrication or assembly

process is detected, based on current or

planned action, before the item is shipped from the manufacturing or assembly plant. They are:

Intended to increase the likelihood that the problem will be detected before it is shipped from the assembly plant.Used as input to the detection ranking.

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Sample Control Descriptions: PFMEA Example 1

Process Step: Induction harden vehicle axle shafts using induction-hardening machine

Function: Induction harden shafts using induction-hardening machine ABC, with minimum hardness Brinell Hardness Number (BHN) “X”, according to specification #123.

Failure Mode: Shaft hardness less than BHN “X”Effect (In plant): 100% scrapEffect (Assembly): Not noticeable during assemblyEffect (End user): Shaft fractures with complete loss of performance, and

increased potential for loss of vehicle controlCause: Induction machine electrical voltage/current settings incorrect for part

number

Prevention Control: Detailed requirement defined in machine setup instructions

Detection Control: Routine daily audit of shaft hardness

Poorly worded example of a Prevention Control: Operator instructionsPoorly worded example of a Detection Control: Audit



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Process Step: Clamp upper tube in weld fixture locating the part using self positioning detail and the hand clamp to secure the tube in

position.Function: Securely clamp upper tube in weld fixture, without damaging part

and without looseness or movement of part in fixtureFailure Mode: Tube not clamped securely and shifts during processing



Cause: Excessive wear on clamp tooling locating tips

Prevention Control: (none)Detection Control: Routine scheduled visual

inspection of clamp tool



Additionalexample


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ABC lubricant evenly around the O-

ring, using XYZ specification




Prevention Control: Documented in-plant lube- gun calibration procedures #RJ3765

Detection Control: 100% End-of-line pressure testing



Additionalexample


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Control Exercise

Write a prevention-type control and a detection-type control for the cause of the failure mode you are working on, keeping in mind the definition of control. Enter it in your Xfmea project.

Students working on a design-related example write down a Design Control example.Students working on a process-related example write down a Process Control example.

The instructor will ask for volunteers or call on you to share what you have written.

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Definition Detection

Detection is a ranking number associated with the aggregate of all current detection-type controls, based on the criteria from the detection scale.

The detection ranking considers the likelihood of detection of the failure mode/cause, according to defined criteria. Detection is a relative ranking within the scope of the specific FMEA and is determined without regard to the severity or likelihood of occurrence.

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What ranking

would you give if you

used virtual analysis that is highly

correlated with actual operating

conditions?

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What ranking

would you give if the operator

used attribute gaging to

check parts after they are produced?

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Definition RPN

RPN (Risk Priority Number) is a numerical ranking of the risk of each potential failure mode/cause, made up of the arithmetic product of the three elements:

Severity of the effect.Likelihood of occurrence of the cause.Likelihood of detection of the cause.

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Example of RPN for Design FMEA

Item: Power steering pumpFunction: Delivers hydraulic power for steering by transforming oil

pressure at inlet ([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle speed

Failure Mode: Inadequate outlet pressure (less than [yy] psi)Effect (Local: Pump): Low pressure fluid goes to steering

gearEffect (Next level: Steering Subsystem): Increased friction

at steering gearEffect (End user): Increased steering effort with potential

accident during steering maneuversCause: Fluid incorrectly specified (viscosity too low)

Prevention Control: Design guideline #ABC for hydraulic fluid selection

Detection Control: Vehicle durability testing #123

Sev = 10(potential injury)

Occ = 4(1 in 10,000)

Det= 6(low likelihood of detection)

RPN = 10 x 4 x 6 = 240

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Example of RPN for Process FMEA

Process Step: Apply lubrication to O-ring using lubricant gunFunction: Lube O-ring with ABC lubricant, using XYZ specification

Failure Mode: Insufficient lubricationEffect: Gas leak at fitting, with potential for operator injury;



Prevention Control: Documented in-plant lube-gun calibration procedures #RJ3765


Sev = 10(potential operator

injury)

Occ = 2(1 in 1000,000)

Det= 3(high likelihood

of detection)

RPN = 10 x 2 x 3 = 60

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Definition Recommended

Actions

Recommended Actions are the tasks recommended by the FMEA team that can be performed to reduce or eliminate the risk associated with potential cause of failure.

Recommended Actions should consider the existing controls, the relative importance (prioritization) of the issue and the cost and effectiveness of the corrective action. There can be many recommended actions for each cause.

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Sample Action Descriptions: DFMEA Example 1

Item: Power steering pumpFunction: Delivers hydraulic power for steering by transforming oil pressure at inlet

([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle speedFailure Mode: Inadequate outlet pressure (less than [yy] psi)

Effect (Local: Pump): Low pressure fluid goes to steering gearEffect (Next level: Steering Subsystem): Increased friction at steering gearEffect (End user): Increased steering effort with potential accident during

steering maneuversCause: Fluid incorrectly specified (viscosity too low)

Prevention Control: Design guideline #ABC for hydraulic fluid selectionDetection Control: Vehicle durability testing #123

Recommended Action: Increase fluid viscosity to standard #xyz

Poorly worded example of a Recommended Action: Change fluid viscosity



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Failure Mode: Shaft fracturedEffect (Local: Shaft): No torque output (does not transfer energy)Effect (Next level: Grinder Subsystem): Rock grinder teeth do not moveEffect (End user): No rocks are pulverized, and product order is



Prevention Control: Heat treat specification #123Detection Control: Pump pressure shock test #234, cold start durability

test #567, broken drive-shaft test #890

Recommended Action: Increase shaft strength by using more rigorous heat-treat standard #ABC



Additionalexample


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Effect: No light, with potential for operator injury from broken

glassCause: Over pressure due to wrong gas specified

Prevention Control: Currently scheduled design review that addresses gas properties

Detection Control: Lamp pressure test #456

Recommended Action: Reduce gas pressure by changing gas properties to material specification #xyz



Additionalexample


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Sample Action Descriptions: PFMEA Example 1

Process Step: Induction harden vehicle axle shafts using induction-

hardening machine

Function: Induction harden shafts using induction-hardening machine ABC, with min. hardness Brinell Hardness Number (BHN) “X”, according to specification #123.

Failure Mode: Shaft hardness less than BHN “X”Effect (In plant): 100% scrapEffect (Assembly): Not noticeable during assemblyEffect (End user): Shaft fractures with complete loss of performance, and increased

potential for loss of vehicle controlCause: Induction machine electrical voltage/current settings incorrect for part number

Prevention Control: Detailed requirement defined in machine setup instructionsDetection Control: Routine daily audit of shaft hardness

Recommended Action: Install machine alert light (red) to let operator know when voltage or current is set too high

Recommended Action: Implement Statistical Process Control (SPC) charts on machine voltage and current

Poorly worded example of a Recommended Action: Implement Statistical Process Control



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Process Step: Clamp upper tube in weld fixture locating the part using self positioning detail and the hand clamp to secure the tube in position.

Function: Securely clamp upper tube in weld fixture, without damaging part and without looseness or movement of part in fixture

Failure Mode: Tube not clamped securely and shifts during processingEffect: (In plant): Tube position incorrect, with potential for defective welds and 100%

scrapEffect: (End user): If upper tubes get out of plant with defective welds, the bicycle

frame could collapse, with potential rider injuryCause: Excessive wear on clamp tooling locating tips

Prevention Control: (none)Detection Control: Routine scheduled visual inspection of clamp toolRecommended Action: Establish a tooling and maintenance plan

that includes scheduled evaluation of wear, and addresses criteria for replacement or repair

Recommended Action: Temporarily use daily scheduled visual inspection of clamping tool wear until SPC charts show routine conformance, with documented process control

Recommended Action: Use increased hardness clamp tool to reduce wear



Additionalexample


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Process Step: Apply lubrication to O-ring using lubricant gun and fixture AF12345

Function: Lube O-ring with 4 grams of

ABC lubricant evenly around the o-ring, using XYZ specification




Prevention Control: Documented in-plant lube-gun calibration procedures #RJ3765


Recommended Action: Use modified lubrication-gun calibration procedure #12345 and update maintenance plan to calibrate every 1000 parts.

This example is excerpted from the book “Effective FMEAs”, ©

John Wiley & Sons, 2012, all rights reserved

Additionalexample


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Recommended Action Exercise

Write a recommended action to address the cause of the failure mode for the exercise you are working on, keeping in mind the definition of recommended action. Enter it in your Xfmea project.The instructor will ask for volunteers or call on you to share what you have written.

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Definition Actions Taken

Actions Taken are the specific actions that are implemented to reduce risk to an acceptable level.

Each Action Taken correlates to the corresponding recommended action.They are assessed as to effectiveness by a revised severity, occurrence, detection ranking and by a corresponding revised RPN.

109

EDUCATION

109

109

4: Selection and Timing

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Selection and Timing Objectives

Few companies have the resources to perform FMEAs on every subsystem and component and manufacturing operation. A workable FMEA selection process is needed. In addition, doing FMEAs during the “window of opportunity”

is important to achieving the best

results.The objectives of this module are to:

Demonstrate the primary selection criteria for FMEA projects.Show at what stage in the product development process the different types of FMEAs are done.

As a result of this module students will understand how to select FMEAs that need to be performed, and when the different types of FMEAs should be done in order to achieve optimum results.

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Selection Criteria for FMEAs

High-level selection criteria for FMEA projects:A Concept FMEA –

when risk due to failure is part of the concept selection process.A System FMEA –

when a new system begins development or when an existing system will be changed sufficiently so that there are concerns about risk. Design FMEAs –

when new designs begin development or when existing designs will be changed sufficiently so that there are concerns about risk. Process FMEAs –

when a new manufacturing or assembly process is being developed or when an existing manufacturing or assembly process will be changed sufficiently so that there are concerns about risk.

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FMEA Project Selection Criteria

A “preliminary risk assessment”

may help to focus the analysis effort on the aspects of the design or process that have the greatest risk and/or have the greatest potential benefit from design improvements. Factors may include:

System FMEA risk identifiedPotential for safety issuesNew technologyNew applications of existing technologyHistory of significant field or plant problems Potential for important regulation issuesSupplier capabilityMission-critical or other applications

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Example Form for Preliminary Risk Assessment

Sample Form –

Other formats are acceptable and may be more appropriate for particular applications

Preliminary Risk Assessment for XXXX1 = Lower Risk 2 = Moderate Risk 3 = Higher Risk

System

FMEA Risk I

dentif

ied

Safety

Concern

s

New Technology

New Applic

ation

Field C

oncerns

Regulation C

oncern

s

Supplier C

oncern

s

OtherTOTAL

SystemSubsystem AComponent A.1Component A.2Subsystem BComponent B.1Component B.2…

Configurablecolumns

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Example of Preliminary Risk Assessment (Performed at the Subsystem Level)

Subsystem Risk

ID by

Sys F

MEA

Safet

y Con

cern

sNe

w Te

chno

logy

New

Appli

catio

ns

Field

Prob

lems

Regu

lator

y Risk

Supp

lier C

once

rns

Othe

r

TOTA

L

Frame Subsys. 3 2 2 3 1 1 1 1 14

Front Wheel Subsys. 3 1 1 1 1 1 1 1 10

Rear Wheel Subsys. 2 1 1 1 1 1 1 1 9

Sprocket Subsys. 1 1 1 1 1 1 2 1 9

Chain Subsys. 1 2 1 1 1 1 2 1 10

Seat Subsys. 2 2 1 1 1 1 1 1 10

Handle Bar Subsys. 1 1 1 1 1 1 1 1 8

Hand Brake Subsys. 3 2 1 1 3 1 2 1 14

Suspension Subsys. 1 2 2 2 1 1 1 1 11

Preliminary Risk Assessment for New Trail Bike Design1=Lower Risk 2=Moderate Risk 3-Higher Risk

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When to Perform an FMEA

FMEAs should be performed during the “window of opportunity”

when they can most

effectively impact the product or process design.

An “up-front”

activity, rather than “after-the- fact.”

Too early and the needed information is not available.Too late and the opportunity to make design or process changes becomes difficult.

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Timing Criteria for FMEA

Concept FMEAs should be performed during the time when concept alternatives are being considered and before design or process concepts have been selected.System FMEA should be started as soon as the system configuration is determined and completed before the system configuration freeze date. Design FMEAs should be started as soon as the design concept is determined and completed before the design freeze date.Process FMEAs should be started as soon as the manufacturing or assembly process is determined at the concept level, and completed before the manufacturing or assembly process freeze date.

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System FMEA

Feasibility

FMEA and Stage Gate Process –

High Level

Requirements Design & Development Qualification Launch

Design FMEAs

Process FMEA

Concept FMEAs

Actions to Improve Product and Process



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EDUCATION

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118

Basic FMEA Analysis Procedure5: Preparation

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Preparation Objectives

Proper preparation is essential to success in any FMEA project.The objectives of this module are to:

Summarize the systematic tasks that need to be done one time

to prepare for future FMEA projects.

Demonstrate the tasks that need to be done for each new

FMEA project.

As a result of this module students will understand the key steps for preparation of each type of FMEA in order to be fully successful with FMEA projects.

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Basic Steps for an FMEA Project

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FMEA Preparation One-Time Tasks

The following tasks need to be done once for a series of FMEA projects:Obtain FMEA software.Select or modify FMEA worksheets and scales. (What will the worksheets look like –

what ranking scales will be

used?)Identify roles and responsibilities.Establish how the designated facilitator will be determined.Provide FMEA team training.Understand legal guidelines for doing FMEAs.

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FMEA Preparation One-Time Tasks (cont’d)

Set-up meeting logistics.Define the system hierarchy (for System and Design FMEAs).Determine how the team will work with interfaces and interactions.Define the process steps (for Process FMEAs).

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For Design FMEAs: Define the System Hierarchy

If you are performing System or Design FMEAs, you should begin by defining the system configuration. For example:

SystemSubsystem A

Component A.1Component A.2

Subsystem BComponent B.1Component B.2

You may choose to perform the analysis at the system, subsystem (assembly) and/or component “indenture level.”

(Reference Preliminary Risk

Assessment)

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For Process FMEAs: Define the Process Steps

If you are performing a Process FMEA, you should begin by defining the process configuration. For example:

LineStation A

Operation A.1Operation A.2. . .

Station BOperation B.1Operation B.2. . .

You may choose to perform Process FMEAs on the entire manufacturing or assembly process or identify specific stations operations for analysis (Reference Preliminary Risk Assessment)

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FMEA Preparation Each New FMEA

The following tasks need to be done for each new FMEA project:Determine the Scope of the AnalysisMake the Scope Visible (for System and Design FMEAs):

FMEA Block DiagramParameter Diagram (P-Diagram)FMEA Interface MatrixFunctional Block Diagram

Make the Scope Visible (for Process FMEAs):Process Flow Diagram (PFD)Process Flow Diagram Worksheet (PFD WS)

Assemble the Correct TeamEstablish the Ground Rules and AssumptionsEstablish the Role of SuppliersGather and Review Relevant InformationPrepare FMEA Software for First Team Meeting

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FMEA Inputs and Outputs

The following two slides show the high- level inputs and outputs for Design and

Process FMEAs

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Design FMEA Inputs and OutputsDesign FMEA Inputs and Outputs



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Process FMEA Inputs and OutputsProcess FMEA Inputs and Outputs



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Determine the Scope

Before you can begin any FMEA, you must decide specifically what you are going to analyze.Determining the scope

of the analysis is an extremely

important step because it helps to identify the boundaries for what issues will be considered and the approach that the analysts will take during the analysis. For example, it could be:

A high-level analysis that focuses generally on the entire system or process, including interfaces and integration.A detailed analysis that focuses intensively on a specific aspect of the system or process.

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Determine the Scope (cont’d)

For System FMEAs, scope typically includes:System-related deficienciesSystem safetySystem integrationInterfaces or interactions between subsystems or with other systemsInteractions with the surrounding environmentHuman interactionServiceOther issues that could cause the overall system not to work as intended.

The exact scope will need to be determined by the System FMEA team.

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For Design FMEAs, scope typically includes:Design-related deficiencies (with emphasis on improving the design and ensuring product operation is safe and reliable during useful life).For subsystems, the scope includes the subsystem itself, as well as the interfaces between adjacent components.For component designs, the scope includes the selected components and parts.

The exact scope will need to be determined by the Design FMEA team.

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For Process FMEAs, scope may include:Manufacturing-related deficiencies (as identified in manufacturing operations)Transporting and handling of materialsShippingIncoming partsStorageConveyorsTool maintenanceLabeling

The exact scope will need to be determined by the Process FMEA team.

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Making the Scope Visible for Design FMEAs: FMEA Block Diagrams

For each individual FMEA that is performed, it is useful to define what components, interfaces and interactions will be included in the analysis.An FMEA Block Diagram shows the physical and logical relationships between the components in the system or assembly. It identifies:

Physical connectionsMaterial exchangesEnergy transfersData exchanges

134

All Terrain System FMEA Block Diagram (with interfaces between subsystems and rider)

Rider

Seat S/S Handle Bar S/S G Gr ro u Rr Wheel S/S n d

Chain‐ Derailleur S/S

Frame S/S

Sprocket‐ Pedal S/S

Suspension S/S ou

Ft Wheel S/S nd

Hand Brake S/S

Physical Connection

Material Exchange

Energy Transfer

Data Exchange

Some of the FMEA Block Diagram elements are intentionally missing. Can you determine what they are?



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Making the Scope Visible for Process FMEAs: Process Flow Diagram

A Process Flow Diagram

(PFD) is a logical, graphical representation of all of the process operations that result in the manufactured or assembled product, and are within the scope of the Process FMEA project. Each of the process operations is represented by a symbol representing the type of operation, such as Fab, Move, Store, Get, Inspect, Rework, Scrap or

Contain, and

the symbols are connected in the precise sequence of the operations in the manufacturing or assembly process.

136



Truncated

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Making the Scope Visible for Process FMEAs: Process Flow Diagram Worksheet

In addition to including symbols and logical sequencing for the entire set of process steps in the manufacturing or assembly process, a Process Flow Diagram Worksheet

provides more information about each of the manufacturing or assembly operations.This includes a detailed description of the process step, called Operation Description, and other information, such as the significant product and process characteristics. The PFD Worksheet can be useful to make visible the steps in the process that will be analyzed in the PFMEA and to determine the functions and critical characteristics that will be considered in the analysis.

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Op-Seq # Fa

b

Mov

e

Stor

e/G

et

Insp

ect

Rew

ork

Scra

p/

Con

tain

Operation Description

Cla

ss(K

PC) Significant Product Characteristics (Outputs) C

lass

(KC

C) Significant Process

Characteristics(Inputs)

1.2 Front Wheel Subassembly Station

1.2.1Get wheel hub from parts presentation device

Correct hub selectedCorrect hub are in presentation device

1.2.2Orient and place wheel hub in wheel assembly fixture

Wheel hub is correctly located in wheel assy fixture

Fixture does not allow incorrect hub placement

1.2.3Get wheel rim from parts presentation device

Correct wheel rim selectedCorrect wheel rims are in presentation device

1.2.4Orient and place wheel rim in wheel assembly fixture

Wheel rim is correctly located in wheel assy fixture

Fixture does not allow incorrect rim placement

1.2.5Get set of wheel spokes from parts presentation device

Correct spoke set selectedCorrect spokes are in presentation device

1.2.6Orient and place wheel spokes in wheel assembly fixture

1. Correct number of wheel spokes 2. Correctly oriented spokes properly connected in wheel assy fixture

1. Correct kit of 36 wheel spokes2. Error-proofed wheel assy fixture (orientation,correct parts)

1.2.7Attach and tighten spokes to wheel rim and wheel hub

KPCSpokes correctly tightened to required specification

KCCSpoke tightening gun correctly calibrated (torque management)

1.2.8Adjust spoke tightness to ensure wheel rim is round to specs

KPCWheel roundness meets specifications

KCCCorrect spoke adjustment procedure

TRUNCATED

A

Example of PFD Worksheet for a portion of the Front Wheel Subassembly Station

This illustration excerpt is from the book Effective FMEAs, ©


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Determining the Scope Exercise

Draw a Functional Block Diagram for the item you have selected, keeping in mind the type of FMEA you are working on and its scope.This exercise may be done in the Xfmea system, or on paper.The instructor will ask for volunteers or call on you to share what you have written.

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Assemble the Correct Team

A critical step in preparing for an FMEA is selecting the right team:

FMEA is a cross-functional team activity.Doing an FMEA by one person, or with an inadequate or incomplete team, is very likely to lead to sub-optimized results that will inevitably result in poor quality.

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Assemble the Correct Team (cont’d)

There are three primary reasons for the necessity to have the correct team when doing an FMEA:

People have “blind spots.”The FMEA analysis requires subject-matter experts from a variety of disciplines to ensure all necessary inputs are considered.Cross talk and synergy between subject-matter experts can discover things that individuals miss.

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Assemble the Correct Team Design FMEA Example

A core team for a System or Design FMEA might include representatives from:

Design EngineeringSystem EngineeringManufacturing EngineeringTest EngineeringField ServiceQuality / Reliability

More than one design representative may be required for large systems or subsystems.Supplier partners may be included for critical parts on a need to know basis. The FMEA core team can invite other experts for specific topics during Design FMEA meetings, when their topic is being discussed.

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Assemble the Correct Team Process FMEA Example

A core team for a Process FMEA might include representatives from:

Manufacturing EngineeringProduct EngineeringAssembly OperationsSupplier QualityEnd-of-line TestMaintenanceQuality / ReliabilityField Service

The FMEA core team can invite other experts for specific topics during Process FMEA meetings, when their topic is being discussed.

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Size of the Analysis Team

The team should be large enough to make sure that relevant viewpoints and knowledge are represented but not too large.If the team is too large:

It will be difficult to have productive discussions during meetings.It will be a waste of an extremely valuable resource –

the time (and patience!) of your

organization’s Subject Matter Experts (SMEs).

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Focus Team Resources Appropriately

A skilled facilitator can help to make sure that team meeting time is used effectively and the analysis is performed correctly.Team members should be familiar with the FMEA analysis process, as it is practiced by the organization.The composition of the team at any particular meeting may vary depending on the focus of the meeting.

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Assemble the Team FMEA Exercise

Brainstorm, identify, and document a list of potential participants (team members) for the exercise you are working on, keeping in mind the type of FMEA you are working on and its scope.Enter this information into Xfmea.The instructor will ask for volunteers or call on you to share what you have written.

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Establish the Ground Rules and Assumptions

Before beginning the analysis, the team should discuss and document the underlying assumptions of the analysis and specific ground rules for how the analysis will be performed.Ground rules are agreements of how meeting business will be handled. These may include:

Standard rules of order will be followed (e.g., Robert’s Rules of order or other).How agreement on issues will be achieved (consensus, majority vote, or other).How approvals for completion are achieved.Etc.

Some of these guidelines may already be determined by the organization’s standard practices for FMEA and some may be specific to the particular analysis project.

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Assumptions are agreements on what the team will take as true for the purposes of the analysis. These may include:

For Design FMEAs, does the FMEA team assume the product will be manufactured or assembled within engineering specifications? For Design FMEAs, does the FMEA team wish to consider an exception, such as the part design may include a deficiency that

could cause unacceptable variation in the manufacturing or assembly process?For Process FMEAs, does the FMEA team assume the design is sound and incoming parts and materials to an operation meet design intent? For Process FMEAs, does the FMEA team wish to consider an exception, such as incoming parts or materials may have variation and do not necessarily meet engineering requirements?

Establish the Ground Rules and Assumptions (cont’d)

Excerpted from the book Effective FMEAs, ©


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Ground Rules and Assumptions Example Questions (cont’d)

What are the assumed environmental conditions?What are the assumed operating profiles?Will the FMEA team assume product abuse by the user? If so, to what levels?What is the definition of failure used in the FMEA?How will the FMEA team use severity rankings and RPNs to prioritize issues for corrective actions?

To help assure you have a complete understanding of ground rules

and assumptions in your FMEA, please refer to the section titled

“Establish the Ground Rules and Assumptions”

in chapter 5 of the book Effective FMEAs.



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Ground Rules & Assumptions FMEA Exercise

For the exercise you are working on, brainstorm, identify and document:

3 or 4 ground rules3 or 4 assumptions

Keep in mind the type of FMEA you are working on and its scope.Enter this information into Xfmea.The instructor will ask for volunteers or call on you to share what you have written.

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Gather Information (Pre-Work)

Taking the time to gather (and review) available information before the analysis meetings begin can help to:

Make the most efficient use of team meeting time.Achieve an analysis that is thorough and accurate.

The appropriate resources will vary depending on the type of FMEA that you are performing and the specific product or process that you are analyzing.

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For Design FMEAs: Gather Information

For System and Design FMEAs, the following is an example of the type of information that should be readily available to the FMEA team:

Bill of MaterialsPast Design FMEAs Current System FMEA (if performing a Design FMEA at the subsystem or component level)Warranty, recalls and other field historyEngineering requirements (functional, performance, operating environments, etc.)Drawings and schematicsApplicable government or safety regulations

For the entire gather information checklist for Design FMEAs please refer to the section titled “Gather and Review Relevant Information”

in chapter 5 of the book Effective FMEAs.Excerpted from the book Effective FMEAs, ©


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For Process FMEAs: Gather Information

For Process FMEAs, the following is an example of the type of information that should be readily available to the FMEA team:

Bill of MaterialsBill of ProcessCurrent and Past Design FMEAs (for the products being analyzed by Process FMEA)Past Process FMEAsOperator InstructionsWarranty, recalls and other field historyManufacturing data (plant incidents, etc.)

For the entire gather information checklist for Process FMEAs please refer to the section titled “Gather and Review Relevant Information”

in chapter 5 of the book Effective FMEAs.Excerpted from the book Effective FMEAs, ©


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Gather Information FMEA Exercise

Brainstorm, identify and document some of the resources the team may wish to consult for the exercise you are working on, keeping in mind the type of FMEA you are working on and its scope.Enter this information into Xfmea.The instructor will ask for volunteers or call on you to share what you have written.

155

EDUCATION

155

155

Basic FMEA Analysis Procedure6: Procedure

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Procedure Objectives

Once the FMEA preparation steps have been properly completed, work can begin with the FMEA team on the FMEA procedure. The objectives of this module are to:

Detail the basic procedure for doing FMEAs, from Items through calculation of Risk Priority Numbers.Provide emphasis on how to apply the fundamental concepts and definitions of FMEA in real-world applications.

As a result of this module students will be able to conduct effective FMEAs up to calculation of RPNs.

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Basic Steps for an FMEA Project

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Procedures for doing FMEAs vary from practitioner to practitioner.

There is no standard methodology for performing the sequence of steps in the FMEA procedure.Approaches range from the use of sticky notes and paper to the use of comprehensive software that minimizes administration.

It is necessary to establish the approach that will be used prior to the first meeting. This is usually done when ground rules and assumptions are defined.

How Meetings are Conducted

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Suggested Practice for Sequence of Steps

Many experienced Design and Process FMEA teams use the following strategy:

Enter all the primary functions for the item under analysis.Beginning with the first function, enter all the failure modes and corresponding effects, with severity rankings for the most serious effect of each failure mode.For each failure mode, enter all of the causes, with occurrence rankings for each cause.

More!



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Suggested Practice for Sequence of Steps (cont’d)

For each cause, enter prevention-type controls and detection-type controls, with detection rankings for the best detection-type control.

(Some practitioners prefer to enter the prevention-type controls before the occurrence rankings as prevention-

type controls can influence the value of the occurrence ranking.)

More!



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Suggested Practice for Sequence of Steps (cont’d)

Enter the next function and continue until all the functions are analyzed through RPNs.Review the high severities and high RPNs, and develop all needed recommended actions that will reduce risk to an acceptable level. Review high-risk FMEA issues, and corresponding recommended actions, with management and proceed to execution steps.



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Remainder of this module is optional

Time permitting, the remainder of this module provides additional experience with FMEA procedure, using the bicycle example. It is optional.If the remainder of this module is skipped, instructor may wish to show the slides covering:

key characteristicsfailure mechanismsfailure mode progressionand the three types of detection risk.

Skip to end of moduleExcerpted from the book Effective FMEAs, ©


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Identify the Function(s)

The function description is about what the item is supposed to do.

For each item under consideration, the FMEA team identifies the primary function(s) and enters the information in the appropriate field.Information that is included in the field provided for the function should be specific and include metrics that define the standard of performance when possible.Metrics can often be found in the technical specifications or product requirements documents. These documents can be attached or linked to the FMEA during the research phase of the analysis for reference as needed during FMEA team meetings.

Definition

Function

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Identify the Function(s)

Functions for DFMEAs and PFMEAs are described in terms of an item/operation’s:

Primary purpose(s).What it’s supposed to do.What it’s not supposed to do.Standard of performance.

Concentrate on the major functions of the item or step and how it will be used:

For DFMEAs and System FMEAs, include ways that the product is commonly misused (i.e., functions that the customer assumes the item has or should have).For System / Subsystem FMEAs, include functions that occur at interfaces.

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Functions Trail Bike Hand Brake Design FMEA



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Identify the Function(s) for Process FMEAs

The function description is about what the operation is supposed to do. It is the primary purpose of the operation being addressed.The description may take the form of:

Do this…

(operation)To this…

(part)With this…

(tooling/equipment)When possible, include metrics that define the standard of performance the function is intended to achieve.

For the trail bike frame assembly process example, the function might read:

Securely clamp upper tube in weld fixture without damaging the part and without looseness or movement of the part in the fixture.

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Functions Wheel Spoke Installation Process FMEA



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Function Information

Existing documents may contain detailed information about the functions that the item or step is intended to perform. For example:

Quality Function Deployment (QFD) or other planning information contains design requirements that should be considered in the DFMEA.Process Flow Diagrams, process planning sheets, and other planning information may contain process operation information that should be considered in the PFMEA.

Function description is input into the FMEA form in the Function field.

To help ensure you have a complete description of functions in your FMEA, please refer to the sections titled “Checklist of Function Types”

and “Thought Starter Questions”


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Identify Function Exercise

Recall your exercise on Functions.Write down two questions you would ask your team when completing the Function field for an item.Enter the two functions you have identified for your selected topic into Xfmea.

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Identify the Failure Mode(s)

The Failure Mode is the manner in which the item or operation fails to meet or deliver the intended function and its requirements. For each item under consideration, the FMEA team identifies potential failure modes and enters the information in the appropriate field.The next step is to determine the failure modes that could occur for each item and function.

Definition

Failure Mode

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Remember!

The failure mode is not merely the antithesis

of the function; rather, it is the manner in which an item/operation potentially fails to meet or deliver the intended function and associated requirements.Limit failure modes to those of concern

to at least one

member of a properly constituted FMEA team. Avoid

failure mode wording that is too general

such as

“doesn’t work”

for Design FMEAs or “mis-build”

for Process FMEAs.

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Failure Modes Trail Bike Hand Brake Design FMEA



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Failure Modes Wheel Spoke Installation Process FMEA



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Identify Failure Modes Exercise

Recall your exercise on Failure Modes.Write down two questions you would ask your team when completing the Failure Mode field for an item.Enter the two Failure Modes you have identified for your selected topic into Xfmea.

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Identify the Effect(s) of Failure

After potential failures have been identified, the next step is to identify potential effectsFor each potential failure mode, determine the consequences that could occur.

A single description of the effect on the entire system/process is one approach

Another is to identify three levels of effects: Local Effect: The effect on the item.Next Higher Level Effect: The effect on the next higher level assembly.End Effect: The effect on the top level item (system) and/or end user.

Definition

Effects

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Local, Next and End Effects

An example of this might be:Running out of gas in your car:

Local effect:Fuel injectors fail to supply gas to the engine

Next higher level effect:Engine stops working

End effect:Car stops running

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For PFMEA, the effect may be with the product or effects on the manufacturing operation. For example:

Station not in operation, production stopped resulting in specific effects to the production process.Component/assembly not to specification resulting in inferior performance or quality issues for the customer.

Identify the Effect(s) of Failure

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Effects Trail Bike Hand Brake Design FMEA



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Effects Wheel Spoke Installation Process FMEA



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Identify Effects Exercise

Recall your exercise on Effects.Write down two questions you would ask your team when completing the Effects field for an item.Enter the Effects for both failure modes of your selected topic into Xfmea.

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Severity of Effect Ranking

Once all of the effects have been identified for a failure mode, it is appropriate to provide a severity ranking.Severity is related to the most serious effect for the identified failure mode.The severity ranking should be agreed upon by the analysis team.

NOTE: In order to reduce the severity ranking, a design change is usually required.

Definition

Severity

RiskRank

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Identify Severity of Effect Exercise

Recall your exercise on Effects.Refer to the default ranking scale for Severity in the Xfmea software and rank the severity of the Effects for your item.

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Use of Classification Column

One of the objectives of FMEA is “to identify significant product or process characteristics.”The classification column can be used to visually display where a significant characteristic is associated with a failure mode or cause. This column can also be used to highlight failure modes or causes for further discussion or for follow up action.

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Key Product Characteristics

Key Product Characteristics (KPCs) are significant product characteristics that are designated by the company for highlighted attention. They require follow up in the Process Control Plan and usually have their own approval process.An example is a shaft with a bending problem, where KPCs can be material hardness and shaft diameter.

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Key Process Characteristics

Key Control Characteristics (KCCs) are a subset of the significant process characteristics, and are designated by the company for highlighted attention. They require follow-up in the Process Control Plan and usually have their own approval process.An example is shaft material hardness problem, where KCCs can be temperature and duration of water quench.

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Cause(s) of Failure

As the effects of each failure mode are identified, it is usually most efficient to move on to the causes.For each potential failure, determine the specific reason for the failure. This may be found by asking “why”

until the

basic mechanism that brings about the failure is determined.In many cases, there are several levels of detail that could be used to describe the cause of failure.In general, it is best to choose the level at which the organization is able to control the condition and/or take corrective action.

Definition

Cause

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Failure Mechanisms

Failure mechanisms are the physical, chemical, thermodynamic or other processes that result in failure.

The actual physical phenomenon behind the failure mode. The process of degradation or chain of events leading to and resulting in a particular failure mode.

All higher risk Failure Modes must be taken to the root cause and failure mechanism level.

Either asking “why”

until root cause is determined.Or, in the case of system FMEAs, using subsystem and component FMEAs to get to the root cause.

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Failure Mode Progression



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Causes Trail Bike Hand Brake Design FMEA



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Causes Wheel Spoke Installation Process FMEA



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Identify Causes Exercise

Recall your exercise on Causes.Write down two questions you would ask your team when completing the Cause field for an item.Enter two Causes for one of the failure modes for your selected topic into Xfmea.

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Current Controls

As the causes are discussed, it is also natural to establish what is currently being done to manage the risk associated with each cause.For each potential cause of failure, identify the methods or actions that are planned or currently in place to reduce or eliminate risk.Current controls can be classified as “Prevention”

or

“Detection:”Prevention Controls

are intended to reduce the likelihood

that the problem will occur. Detection Controls

are intended to increase

the likelihood that the problem will be detected before it reaches the end user.

Definition

Controls

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Current Controls –

DFMEA

For DFMEADesign Controls are design practices that are performed prior to production parts being made.They are typically standards, procedures, virtual analysis, analytical or other pre-testing evaluations used to establish design parameters (prevention).They are used by the design community to establish if design deficiencies exist –

frequently through testing or

analysis (detection).

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Current Controls Trail Bike Design FMEA

Trail Bike -

Bicycle Sub-System



Intentional errors have been

introduced. Can you find them?

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Current Controls –

PFMEA

For PFMEAProcess Controls are ongoing manufacturing operation control practices that are performed during the production process that address and mitigate the potential for non-

conformity.They are typically maintenance procedures, process controls/specs or other ongoing evaluations used to maintain a process such that it is manufacturing parts that meet design requirements (prevention).They are used by the manufacturing community on an ongoing basis to assure that parts being produced are meeting design requirements through inspections or conformance audits (detection).

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Current Controls Wheel Spoke Installation Process FMEA



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Identify Controls Exercise

Recall your exercise on Controls.Write down two questions you would ask your team when completing the Controls field for an item.Enter one preventive type control and one detection type control for one of the causes into Xfmea.

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Occurrence Ranking

Once the current controls have been identified for each failure mode, it is appropriate to rank the likelihood of occurrence of the cause.Each failure mode may have several potential causes. Rank the likelihood of occurrence for each cause.

Prevention type controls are input to the occurrence ranking.

The Occurrence rating should be based on:History with previous similar designs.Level of change from baseline design.Prevention controls in place.

Definition

Occurrence

RiskRank

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From AIAG FMEA-4 (2008)

Recall your exercise on Causes and Controls.Refer to the default ranking scale for Occurrence in the Xfmea software and rank the occurrence for one of the causes.Remember to consider the preventive-type controls when ranking the occurrence.

Identify Occurrence of the Cause Exercise

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Detection Ranking

Once the current controls have been identified for each failure mode, and the occurrence ranking has been established, it is appropriate to rank the likelihood of detection.The detection risk ranking is based on three potential factors:

The likelihood of detection by the identified controls.The timing of the opportunity for detection.The type of test.

Rank the detection risk using the ranking scales established for this purpose.

Definition

Detection

RiskRank

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Likelihood of Detection

The first factor to consider in establishing ranking for detection is the likelihood of the control to detect the cause/failure mechanism.

Strong detection capabilityModerate detection capabilityWeak detection capability

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Opportunity for Detection

The second factor is the timing (opportunity) of detecting the potential cause/failure mechanism.For DFMEA this includes:

Virtual analysis during the design developmentPrior to design freezePost design freeze but prior to launch

For PFMEAIn stationDuring processingPrior to shipment

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Opportunity for Detection

For DFMEA, the third factor to consider is the type of test (quality of test):

Degradation Test to FailurePass/Fail

For PFMEA, the third factor is the ability to detect:Automatically, such as an automated system that stops production or sounds an alarm when a deficiency is detected.Manually, such as audit inspection.Visually, that relies on human visual acuity.

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Detection Summary

The amount of risk associated with the detection is a combination of the ability to detect the cause/failure mechanism, the amount of time available to react to the detection if found and the type of control that will be used.

Typically, the FMEA team will want to take the worst of the three factors in assessing the Detection ranking. For example, if the likelihood of detection is high (lower risk), but the timing of the control is late (higher risk), the detection risk remains high.

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From AIAG FMEA-4 (2008)

Recall your exercise on Causes and Controls.Refer to the default ranking scale for Detection in the Xfmea software and rank the detection for one of the causes.Remember to consider the detection-type controls when ranking the detection. No detection control results in a ranking of 10.

Identify Detection of the Cause Exercise

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RPN

Once the initial ranking for an item is completed, the associated RPN is calculated based on the product of the three rankings:

RPN = S x O x DRisk Priority Number is the product of the Severity,

Occurrence, & Detection ratings.

At this point it is appropriate to go to the next function, address failure modes and continue this process until all the functions are analyzed through to determination of the initial RPN.

Definition

RPN

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RPNs -

Trail Bike Hand Brake DFMEA

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RPNs –

Wheel Spoke Installation PFMEA

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RPN Rating Scales

RPN rating scales usually range from 1 to 10 or from 1 to 5, with the higher number representing the higher seriousness or risk. In other words, 10 is worse than 1. For example:

Severity = 10 indicates that the effect is very serious and is worse than Severity = 1.Occurrence = 10 indicates that the likelihood of occurrence is very high and is worse than Occurrence = 1.Detection = 10 indicates that the failure is not likely to be detected before it reaches the end user and is worse than Detection = 1.

1 5 1 5 1010

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Risk Priority Numbers Exercise

What are the Risk Priority Numbers for your example?The instructor will ask for volunteers or call on you to share what you have written.

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Final Thoughts

The goal is not to just fill out the FMEA worksheet...

You’re likely to get better results if you:Use the FMEA worksheet as a tool

for a

meaningful examination of the risks associated with your product or process design.Focus on things that can be done to improve the design

of the product or process.

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Basic Xfmea DemonstrationDemonstration of Xfmea basic features.Follow along with the demonstration:

Launch Xfmea (using the software defaults).Review of basic features including queries, views, filters, import, export, reports.Students will exercise features using the bicycle example.

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7: FMEA Action Strategies

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FMEA Action Strategies Objectives

Developing effective actions strategies to reduce risk is one of the most important tasks in FMEA projects.The objectives of this module are to:

Teach students how to prioritize issues for corrective action.Identify and implement the most effective action strategies.Remove roadblocks to successful execution of FMEAs.

As a result of this module students will be able to address both high-severity and high-RPN issues with effective actions that reduce risk to an acceptable level.

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Prioritizing Issues for Corrective Action

Risk Prioritization Task # 1The FMEA team must adequately address all high-severity problems. If the team is using a severity scale of 1 to 10, this means addressing all 9s and 10s at a minimum.

Risk Prioritization Task # 2In addition to addressing all high severities, the FMEA team needs to review and prioritize the high RPNs.

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Addressing High Severity Issues

If using a severity scale of 1 to 10, address all 9s and 10s at a minimum:

High Severity issues have potential safety, legal, regulatory and/or major performance consequences, even with low occurrence.First focus of the should be on reducing Severity risk to the lowest possible level (design change).

If this is not possible, take all actions necessary to achieve the lowest possible occurrence and detection rankings; then obtain management’s concurrence and support before determining that no further action is required.

Strategies to reduce severity risk are covered in the next section.

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Addressing High RPN Issues

There are at least four ways companies use RPN to determine which issues to address:

1.

RPN Thresholds, where company guidelines require certain actions when RPN is above a threshold value –

this method has significant pitfalls.

2.

Begin with the highest RPN and work down the list, addressing lower and lower RPNs given available resources and program goals.

3.

Rank the RPNs and then address an agreed upon percentage of total issues.

4.

Use guidelines for each combination of severity, occurrence and detection to determine appropriate action.

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RPN Limitations

It is enticing for management to use thresholds for RPN values and require defined action if the RPN value exceeds the given threshold.

In most cases, this is a flawed approach, as it can easily become a numbers game. If RPN thresholds are used at all, they should only trigger a heightened level of review, not specifically mandated action.

RPN ratings tend to be subjective in nature and cannot be used to compare risk objectively across analyses.Even two identical RPN values can have different levels of risk.

For example, a severity of 1, occurrence of 8 and detection of 8

has the same RPN value as a severity of 8, occurrence of 4 and detection of 2. Clearly, there is very different risk associated between these two examples.

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Risk Priority Numbers Exercise

What priority order would you give these four line items from the Trail Bike example?



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Develop Effective Recommended Actions

Now that the higher risk items have been identified, recommended actions are developed that will reduce risk to an acceptable level.

Remember!•

It usually takes multiple actions to reduce high severity or high RPN risk.

•

Use the entire array of quality and reliability tools to develop strategies.

•

Always coordinate with management on high risk

severity and RPN issues.

Definition

Recommended

Actions

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Identify and Assign Actions

Starting with the first item identified on the priority list, establish actions to mitigate the risk.

When identifying a recommended action, the FMEA team should consider existing controls and the relative importance (priority) of the issue.They should drive design or process improvements.Cost and effectiveness of corrective actions should be considered.Recommended Actions should be detailed and executable.

To help ensure you have a complete understanding of how to develop effective action strategies in your FMEA, please refer to the sections titled “Action Strategies to Reduce Severity Risk,”

“Action Strategies to Reduce Occurrence Risk”

and “Action Strategies to Reduce Detection Risk”


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Recommended Actions Exercise

Recall your exercise on RPNs.Write down two questions you would ask your team when completing the Recommended Actions field for your highest risk item.Enter two recommended actions to address one of the causes.Enter the Recommended Actions for your high risk item into Xfmea.

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Example of Recommended Actions Trail Bike Hand Brake DFMEA



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Example of Recommended Actions Wheel Spoke Installation PFMEA



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Implement Recommended Actions

Once recommended actions have been developed, they need to be assigned owners and timing.Determine the task owner for action item.Determine the task timing requirement.Implement the recommended actions.Follow-up to assure that actions are completed to an acceptable lever.Document the actions taken.Re-rank severity, occurrence and detection.

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Execution is Everything

FMEA has little value unless the recommended actions are fully executed.Follow up each recommended action to ensure:

Completion to satisfaction of FMEA team and management.Risk eliminated or mitigated to an acceptable level.

Bring problems with execution back to management.Update action status and risk reduction in the FMEA database.

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Document Actions Taken

The FMEA team documents the specific actions taken to implement the recommended actions. Care should be taken to ensure that the correct actions were implemented and that the risk is reduced to an acceptable level.

Definition

Actions Taken

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Execution Enablers

The following are key elements for ensuring timely execution of FMEA recommended actions: 1.

Recommended actions are well defined.2.

Recommended actions include specific information.3.

Recommended actions are energetically followed up.4.

Execution problems are quickly identified and resolved.5.

Management reviews all high-severity and high-RPN issues.6.

The FMEA team remains actively involved until all FMEA recommended actions have been executed.

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Advance Xfmea DemonstrationDemonstration of Xfmea advanced features. Follow along with the demonstration:

Launch Xfmea (using the software defaults).Review of advanced features including user settings, database set-up, help feature, my portal, configurable settings, revision management.Students will exercise features using the bicycle example.

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Basic FMEA Analysis Procedure8: Case Studies

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Case Studies Objectives

It is helpful to see actual FMEAs and for students to learn by evaluating and critiquing such FMEAs.The objectives of this module are to:

Share real-world FMEA applications.Offer students an opportunity to evaluate and critique actual FMEAs.

As a result of this module students will better understand how FMEA is applied and gain experience in evaluating actual FMEAs.

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Case Studies

See Effective FMEAs

book, Chapter 8:DMFEA example 8.7 (Projector Lamp) and corresponding end of chapter problem 8.7PFMEA example 8.1 (Shock Absorber) and corresponding end of chapter problem 8.1

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Basic FMEA Analysis Procedure9: FMEA Success Factors

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FMEA Success Factors Objectives

Much can be learned by observing mistakes companies have made in doing FMEAs. Certain common mistakes show up repeatedly. The objective of this module is to:

Outline the most common FMEA mistakes and describe how to avoid them.

As a result of this module students will be able to recognize common mistakes and ensure that the FMEAs they are doing meet defined quality objectives.

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FMEA Key Success Factors

There are four primary focus areas that are critical to uniformly successful FMEA application:

1.

Become skilled in the theory and application of FMEA methodology (Modules 1 through 8).

2.

Meet the FMEA quality objectives (Module 9).3.

Become an excellent FMEA facilitator (Module 10 and RS 471).

4.

Solicit management support (Module 11).

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Maxim

“Good judgment comes from experience and experience comes from poor judgment”

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Questions to Consider

What are the experiences that resulted in “best practice”

FMEA methods?

What are the poor judgments to avoid?

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Level of Detail How will you establish the proper level of detail in your FMEAs?How will you keep your FMEA team focused on risk?

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Becoming an Expert in the FMEA Methodology

Becoming an expert in the methodology of FMEA is a path, not a single event. The path includes:

Basic courses in FMEA (RS 470 and RS 471).Participating or leading many FMEAs.Getting feedback on the quality of FMEAs.Continuing to improve one’s personal FMEA skills.

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Experience

There is no limit to the number of ways that FMEA definitions can be goofed up.There is no substitute for learning and applying correctly the definitions.This is one of the keys to getting actionable recommendations with minimum effort.

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Meet the FMEA Quality Objectives

Learning the FMEA procedure is not enough to be a successful FMEA practitioner.Performing successful FMEAs requires understanding and implementing the key factors for effective FMEAs:

What are the primary ways that FMEA can be done wrong? (Mistakes)What are the key factors that make for effective FMEAs? (Quality Objectives)

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Mistake #1

Failure to Drive Design or Process Improvements:

Some FMEAs do not drive any action at all.Some FMEAs drive mostly testing.Some FMEAs drive ineffective action.

Quality Objective #1:The FMEA drives product or process design improvements as the primary objective.

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A Note on Quality Objective #1

Reliability engineering has a multitude of tools to choose from in driving design or process improvements.The key is to use the FMEA “Recommended Actions”

field to identify and execute best

practice tools that can optimize designs.This is one of the reasons that reliability engineers need to participate on FMEAs.

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FMEA Drives Design ImprovementsHow will you know if your FMEA drives design improvements as the primary objective?

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Failure to Address All High Risk Failure Modes:

Risk thresholds can be defined by FMEA Team or set as company policy.In addition to high RPN or criticality, high severity must be addressed.Some companies fail to take effective action on all higher risk failure modes.

Quality Objective #2:The FMEA addresses all high risk failure modes, as identified by the FMEA team, with executable action plans.

Mistake #2

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The emphasis on this quality objective is to ensure that all of the higher risk failure mode/causes are adequately addressed with effective actions.Company policy or the FMEA team will define which RPNs or Criticality will rise to the level of high risk.The key is effective

action that reduces or

eliminates the risk.

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High Risk Failure ModesHow will you know if your FMEA addresses all high risk failure modes?

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Mistake #3

Failure to Improve Test/Control Plans:Some companies miss the opportunity to improve Test Plans or Process Control Plans based on failure modes from the FMEA.Some FMEA teams do not include representatives from the test department.The result is inadequate testing or control plans.

Quality Objective #3:The Test Plan or the Process Control Plan considers the failure modes from the FMEA.

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The FMEA team will often discover Failure Modes/Causes that were not part of the Design Controls or Test Procedures.The key is to ensure that the test plan (DVP&R) or Control Plan is impacted by the results of the FMEA.This can be done by including test/control membership on FMEA team or through well-

written actions.

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Improve Test and Process PlansHow will you ensure your FMEA improves test or process plans?

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Mistake #4

Not Including Interfaces in FMEA:Empirical data shows that at least 50% of field problems can occur at interfaces.Some companies focus on part or subsystem failures and miss the interfaces.

Quality Objective #4:The FMEA scope includes integration and interface failure modes in both block diagram and analysis.

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Interfaces can be included as part of the item by item analysis or as a separate analysis.It is recommended that the preliminary FMEA Block Diagram clearly show the interfaces that are part of the FMEA scope.

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InterfacesHow will you ensure that your FMEA includes interfaces?

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Mistake #5

Disconnect from Field Lessons Learned:Some companies provide no linkage between FMEAs and field data.It takes concerted effort to integrate problem resolution databases with FMEA.Otherwise serious problems repeat.

Quality Objective #5:The FMEA considers all major “lessons learned”

(such as high warranty, campaigns, etc.) as input to failure mode identification.

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Field failure data can be brought into generic FMEAs on a regular basis.Then, when new program-specific FMEAs are started, they benefit from field lessons learned.If generic FMEAs are not used, new FMEAs should be seeded with potential field problems and show how they will not repeat in the new design/process.The key is to hold the FMEA team responsible to ensure that major field problems do not repeat.

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Lessons LearnedHow will you integrate your FMEAs with field lessons learned so that high risk failure modes are not repeated?

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Wrong Level of Detail in the Analysis:Some FMEAs go into too much detail

Making it difficult to focus on areas of higher risk.“Missing the forest for the trees.”

Some FMEAs go into too little detailMaking it difficult to determine root cause and effective corrective actions.

Quality Objective #6:The FMEA provides the correct level of detail in order to get to root causes and effective actions.

Mistake #6

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Good FMEA facilitation keeps the team focused on areas of risk that lead to root causes and corrective actions. FMEA discussion should be limited to areas of concern by team members, and avoid lengthy discussions on low-risk issues. The higher the risk the more important and in depth should be the discussion. Lower risk issues should receive less, but appropriate, discussion.

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Level of DetailHow will you assure that your are working to the proper level of detail for your analysis?

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Mistake #7

Doing FMEAs Late:Many companies do FMEAs late, and this reduces their effectiveness.FMEAs should be completed by design or process freeze dates, concurrent with the design process.

Quality Objective #7:The FMEA is completed during the “window of opportunity”

where it can most effectively impact

the product or process design.

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The key to getting FMEAs done on time is to start

the FMEAs on time.

FMEAs should be started as soon as the design or process concept is determined.Exception is FMEAs done during trade-off studies, which can be started earlier.

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TimingWhen should your FMEAs be done to maximize their value?

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Mistake #8

Inadequate Team Composition:Some FMEA teams do not have the right experts on the core team.Some FMEA teams do not have good attendance.Some FMEA team members just sit in their chairs and don’t contribute to team synergy.

Quality Objective #8:The right people participate on the FMEA team throughout the analysis, and are adequately trained in the procedure.

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People have blind spots (scotomas).Key is to get the people who are knowledgeable and experienced about potential failures and their resolutions actually showing up at the meetings.Attendance takes management support.Team size is best between 4 to 8 people.If team gets too large, consider breaking into additional limited scope FMEAs.

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Analysis TeamHow will you ensure that the correct people show up at all FMEA meetings?

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Mistake #9

Improper Procedure:There are hundreds of ways to do FMEAs wrong.Some companies do not encourage or control proper FMEA methodology.Training, coaching, reviews are all necessary to success.

Quality Objective #9:The FMEA document is completely filled out “by the book,”

including “Action Taken”

and final risk

assessment.

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One of the most common FMEA errors is to fail to get to the root cause.Expert input is necessary.Follow up actions based on poorly defined causes will not work and FMEA will not be successful.

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FMEA ProcedureHow will you know if your FMEAs are done with correct procedure?

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Mistake #10

Lack of Efficient Use of Time:Some companies mandate FMEAs, then do not ensure the time is well spent.Pre-work must be completed, meetings well run and efficient follow up of high risk issues.Ask FMEA team if there time is well spent, and take action to address shortcomings.

Quality Objective #10:The time spent by the FMEA team, as early as possible, is an effective and efficient use of time with a value added result.

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If this objective is met, then future FMEAs will be well attended and supported by subject matter experts and management.

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Time ManagementHow will you know if the time spent on FMEAs by subject matter experts is time well spent?

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FMEA Quality Objectives

DESIGN IMPROVEMENTS FMEA primarily drives Design Improvements.

HIGH RISK FAILURE MODES FMEA addresses all high risk Failure Modes.

DVP&R/CONTROL PLAN Comprehends failure modes from the Design/Process FMEA.

INTERFACES FMEA scope includes integration and interface failure modes.

LESSONS LEARNED Warranty, field issues, “hardy perennials”

included.

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FMEA Quality Objectives (cont’d)

LEVEL OF DETAILThe FMEA provides the correct level of detail in order to get to

root causes and effective actions.

TIMING The FMEA is completed during the “window of opportunity.”

TEAM The right people participate as part of the FMEA team.

DOCUMENTATION FMEA document is completely filled out “by the book.”

TIME USAGE Effective and efficient use of time by FMEA Team.

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Meeting FMEA Quality Objectives

Make FMEA quality objectives part of FMEA training.Review them at each meeting.Participate in FMEA quality audits.Keep FMEA open until quality objectives are met.

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Step-by-Step Examples in GuideThe examples guide provides examples with step-by-step instructions that you can work through at your own pace.Feel free to ask any questions as you work through the guide.After 1 hour, we will have a brief class discussion to explore what you learned.

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Basic FMEA Analysis Procedure10: Basic FMEA Facilitation

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Basic FMEA Facilitation Objectives

FMEA teams need to be led by someone who is skilled in team leadership and facilitation. The objective of this module is to:

Provide a brief overview of the primary principles of excellent FMEA facilitation.

RS 471 will cover this subject in much more detail including:

The primary FMEA facilitation skills that ensure success in FMEA applications.The central elements for conducting effective meetings.Techniques to resolve difficult facilitation problems.Techniques to maximize team creativity. and The unique roles and responsibilities of the FMEA facilitator in performing each of the steps of the FMEA procedure.

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Successful FMEA Facilitation

FMEA facilitation is a different subject than FMEA methodology.FMEA Facilitators must be well trained in effective meeting facilitation techniques.FMEA Facilitators must be proficient in FMEA basics, procedures and the use of software.

FMEA team members need to be trained in an overview of the FMEA procedures.

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Successful FMEA Facilitation (cont’d)

Good facilitation is key to prevention of high risk problems without wasting time.The simple fact is most FMEA teams will not achieve a high quality result without expert facilitation.

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Primary FMEA Facilitation Skills

Brainstorming and Probing QuestionsEncouraging ParticipationActive ListeningControlling DiscussionMaking DecisionsConflict ManagementManaging Level of DetailManaging Time

RS 471 will teach these skills and how to apply them to FMEA projects.

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Basic FMEA Analysis Procedure11: Implementing an FMEA Process

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Implementing an FMEA Process Objectives

In order to be fully successful, FMEA teams require persistent and energetic support from management as well as involvement

with specific strategies and

organized reviews. The objectives of this module are to:

Share a company-wide FMEA process that will result in effective implementation of FMEA projects.Outline the specific roles and responsibilities of management.Explain how FMEA teams should interact with management to maximize opportunities for success in FMEA projects.

As a result of this module students will understand the important role of management in assuring successful FMEA programs, and the specific tasks that are needed to enable that support.

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What is an FMEA Process?

It is company-wide systems and tasks essential to support development of high reliability products and processes through timely accomplishment of well done FMEAs.

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Develop a Strategy for Your Organization

Although the basic analysis technique is usually very similar, the manner in which FMEA is implemented (the process) may be somewhat different by an individual organization depending on a variety of factors, such as:

Organizational culture/traditionCustomer or regulatory requirementsParticular characteristics of the products/processes that are being analyzedThe consequences of failure

If your organization does not already have an overall FMEA strategy in place, there are a number of decisions that may need to be made before analysis teams begin performing individual FMEAs.

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Management Roles and Responsibilities in an FMEA Process

The importance of broad support from management in implementing an Effective FMEA process cannot be overstated. Here is a short list of key management responsibilities: Champion the subject of FMEA with management and employees.Provide agreement on FMEA strategy and support needed resources.Implement an effective FMEA training program.Vigorously implement each of the steps of the FMEA process, as covered in this chapter.



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Management Roles and Responsibilities in an FMEA Process (cont’d)

Define roles and responsibilities for all FMEA participants, and integrate with employee work instructions.Assist in integrating FMEA with other business processes, including Design Reviews, Design Verification Plans, Process Control Plans and others.Provide effective reviews of high-risk failure modes and recommended actions. Support attendance of expert FMEA team members.Help ensure FMEAs are fully executed.Establish an FMEA audit process to continuously improve the quality of FMEAs.



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Management Review of High Risk Items

Management review of high risk items is essential.All FMEA high risk issues and recommended actions should be regularly reviewed with management (to ensure understanding, buy-in, support and execution).FMEA reports/charts should be generated per FMEA strategic plan (use Xfmea).Feedback from management goes back to FMEA teams for review and incorporation.

Further development of Managing the FMEA process is beyond the scope of this training. To better understand how management best participates in the process, please see the book Effective FMEAs, Chapter 11 ‘Implementing an Effective Company-Wide FMEA Process’.

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Basic FMEA Analysis Procedure12: FMECA

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FMECA Objectives

Although MIL-STD-1629A for FMECA was cancelled in November, 1984, it is still used in some military and other applications.Some companies may choose to add (or are mandated to add) a Criticality Analysis to the FMEA procedure, according to specific procedures. The objectives of this module are to:

Introduce FMECA and explain how it differs from FMEA.Explain both Quantitative and Qualitative Criticality Analysis.

As a result of this module students will become aware of the primary elements of FMECA and its procedure.

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FMECA Definition

Failure Mode, Effects and Criticality Analysis (FMECA) is the combination of:

FMEA AnalysisCriticality Analysis

Method to evaluate the seriousness of the issues that are identified through FMEA.

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Choosing Criticality Analysis

You might choose Criticality Analysis in addition to, or instead of, RPNs because:

Your customer requires an analysis in the MIL-STD-1629A format (e.g.,

military and

aerospace clients).You have quantitative reliability data that you want to take directly into account.You want to use criticality values to compare components for inclusion in a new design.You want to focus more on severity and likelihood of occurrence and less on ability to detect.…

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Two Types of Criticality Analysis

MIL-STD-1629A describes two types of Criticality Analysis:

QuantitativeIncorporates the item’s unreliability and failure mode apportionments.

QualitativeUses pre-defined rating scales.

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Quantitative Criticality Analysis

To use Quantitative Criticality Analysis to evaluate risk and prioritize corrective actions:

Define the reliability/unreliability for each item in order to estimate the expected number of failures at a given time (with the exponential distribution, this is t but it is estimated differently for other lifetime distributions).Identify the portion of the item’s unreliability (in terms of expected failures) that can be attributed to each potential failure mode.Rate the probability of system loss if the failure occurs.

Mode Criticality

= Expected Failures x Mode Ratio of Unreliability x Probability of LossItem Criticality

= SUM of Mode Criticalities

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Mode Criticality

Mode Criticality = Expected Failures x Mode Ratio of Unreliability x Probability of Loss

Expected FailuresThe expected number of failures for the item at a given time.

Failure Mode Ratio of UnreliabilityThe probability that a failure will be due to the failure mode under consideration; the portion of the item’s unreliability due to the given mode.

Probability of LossThe probability that a failure will cause a system failure (or a

serious “loss”). More detail is available on FMECA in Chapter 12 in the book Effective FMEAs,

‘Failure Mode Effects and Criticality Analysis (FMECA)’.

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13:DRBFMFTARCM

Hazard Analysis Concept FMEA

Software FMEA

Other FMEA Related Applications

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Other FMEA Related Applications Objectives

Many variants of FMEA build on basic FMEA principles for unique applications. The objectives of this module are to:

Introduce DRBFM, Fault Tree Analysis, Reliability-Centered Maintenance, Hazard Analysis, Concept FMEA and Software FMEA.Show how each of these applications builds on the fundamentals of FMEA.

As a result of this module students will become aware of unique applications of FMEA and understand when they are used.

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Introduction to DRBFM Objectives

Many companies are incorporating Design Review Based on Failure Mode

(DRBFM) in addition to

FMEA. The objective of this module is to:

Introduce the DRBFM methodology.Explain how it is different from FMEA, when it should be used and briefly how it is done.

As a result of this sub-module students will become aware of DRBFM and how it is done.

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DRBFM and FMEA

A well-done baseline FMEA should precede a DRBFM project. Subsequent changes to the design or the process can be evaluated by proper DRBFM procedure to ensure that all concerns are surfaced and addressed. Many of the elements of FMEA provide input to the DRBFM analysis.Xfmea supports this integration between DRBFM and FMEA.

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DRBFM General Information

DRBFM is customer focused and intended to flush out all concerns (buds of problems) while supporting daily engineering activity.DRBFM is focused on changes –

functions,

material properties (size, shape, strength), supplier, environment, etc. –

and interactions

(physical parts, electrical and software).DRBFM is driven by engineering knowledge and detailed discussion to support engineering decisions and is backed up by data.

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DRBFM General Information (cont’d)

DRBFM is:A combination of Design Review and FMEA.It includes a discussion by subject matter experts of all concerns without limitations:

Design concernsValidation and verification concernsProcess concernsManufacturing concernsSupplier concernsCustomer expectationsCost and deliveryMaintenance

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DRBFM Methodology

DRBFM includes three stages:DRBFM PreparationDRBFM ProcedureDRBFM Action Closure

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DRBFM Preparation

A DRBFM project begins with “Change Point Analysis.”Change Point Analysis begins with the baseline design and identifies specific changes and includes changes as:

Product designManufacturing or assemblySupplierSupplier design or processUsage environmentInterfacesSpecificationsPerformance requirementsOr any other changes

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DRBFM Preparation (cont’d)

The next preparation step is similar to preparation for FMEA and includes gathering documents such as:

Bill of MaterialsPast FMEAs Warranty, recalls and other field historyEngineering requirements (functional, performance, operating environments, etc.)Drawings and schematicsApplicable government or safety regulationsTest proceduresPreliminary Design Verification PlanPreliminary test data (if available)Actual parts (similar to design intent)Other documents and information that highlight the nature of the

design concept

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DRBFM Worksheet

Once the preparation is complete, the two step Procedure begins:Step one

The responsible engineer completes the first portion of the DRBFM worksheet and provides a draft to the team for their review prior to the team meeting. This step focuses on changes to the existing design and is defined in detail in the first column (directly from the preparation document).The worksheet documents:

“Points of concern”“Effects to the customer”“Detailed causes (circumstances of concerns)”“Actions taken to eliminate concern.”

Some variations in the structure of the worksheet.

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DRBFM Worksheet (cont’d)

Step twoThe team discusses the area of change and interfaces. The engineer explains changes to the existing design and reviews the detailed analysis.Experts from required areas participate to make sure nothing was

missed by the responsible engineer.The Experts identify additional “points of concern,”

“effects to the customer,”

“detailed causes,”

and “actions taken to eliminate concern.”The team provides detailed actions (design, validation, manufacturing) to address all causes of concerns.

This process tends to reduce the time spent in team meetings by experts.

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Example of DRBFM

Shimizu, Hirokazu, Yuichi Otsuka, and Hiroshi Noguchi, Design review based on failure

mode to visualize reliability problems in the development stage of mechanical products.

International Journal of Vehicle Design, 2010. Volume 53 (Issue 3): p. pages 149 to 165.

Truncated

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DRBFM Action Closure

In order to prove the identified cause is not present, the detailed data is reviewed from validation and verification testing.

All design related actions reviewed and approved and documented in DRBFM worksheet.All validation and verification testing reviewed and approved and documented in DRBFM worksheet.All manufacturing, assembly and supplier related actions are closed and approved and documented in DRBFM worksheet.

If engineering data is not acceptable the proposed change should be denied.

For comprehensive examples of DRBFM, please see the book Effective FMEAs: Chapter 13 ‘Introduction to Design Review Based on Failure Mode (DRBFM).’

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Introduction to FTA Objectives

Undesirable events or other high-risk situations can have numerous and complex potential contributors. There are times when Fault Tree Analysis

(FTA)

should be used in addition to FMEA. The objective of this module is to:

Provide a brief overview of FTA and explain how it relates to FMEA.

As a result of this module students will be aware of when FTA should be used to augment FMEA projects. Further training on FTA is needed to become proficient in its application.

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Definition of FTA

A Fault Tree Analysis can be described as an analytical technique whereby an undesired state of the system is analyzed in the context of its environment and operation to find all credible ways in which the undesired event can occur. The fault tree itself is a graphical model of the various parallel and sequential combinations of faults that will result in the occurrence of the predefined undesired event. The faults can be events that are associated with component hardware failures, human errors or any other pertinent events that can lead to the undesired event. A fault tree thus depicts the logical interrelations of basic events that lead to the undesired event –

which is the top

event of the fault tree.Excerpts from Fault Tree Handbook, by the U.S. Nuclear Regulatory Commission.

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FTA and FMEA

The primary differences between FTA and FMEA include: FTA is a graphical representation of the complex relationships in the system leading to the unwanted event, whereas FMEA is worksheet based.FTA considers the interactions between unwanted events and multiple contributors, such as two or more contributors that each must be present in order for the unwanted event to manifest. FMEA usually considers each contributor separately. FTA has the capability of incorporating the probabilities for each of the contributors and the complex interactions and interrelationships with the top-level unwanted event. FMEA does not usually support the probability calculation of a top-level unwanted event.



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FTA and FMEA (cont’d)

The subject of FTA is outside the scope of RS 470 FMEA training.Further information about FTA can be found in ReliaSoft's System Reliability training.Modeling Fault Trees can be done with ReliaSoft's BlockSim software.

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FTA Example

Export from BlockSim file ‘Bicycle FTA’

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Introduction to RCM Objective

“Reliability-Centered Maintenance

(RCM) is an analytical process used to determine preventive maintenance (PM) requirements and identify the need to take other actions that are warranted to ensure safe and cost-

effective operations of a system.”The objective of this module is to:

Provide a brief overview of RCM and explain how it relates to FMEA.

As a result of this module students will be aware of when RCM should be used to augment FMEA projects. Further training on RCM is needed to become proficient in its application.

* Excerpt from NAVAIR 00-25-403 Guidelines for the Naval Aviation Reliability-Centered Maintenance Process, Naval Air Systems Command.

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Reliability Centered Maintenance: Relationship to Traditional FMEA

FMEA is a major component of RCM.Well-done equipment FMEA(s) can be a substantial foundation from which to perform an RCM analysis. RCM is unique from traditional FMEA in the following ways:

Selection of the specific equipment items.A unique worksheet, with some different definitions.A set of failure-effect-categorization logic diagrams.Maintenance task selection logic charts to help select the tasks for the preventive maintenance plan.

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Reliability Centered Maintenance: Relationship to Traditional FMEA (cont’d)

Different definitions for some of the terms are frequently used:

“Function”

for FMEA maps to “Function”

for RCM.“Failure Mode”

for FMEA maps to “Functional Failure”

for RCM.“Effect”

for FMEA maps to “Effect”

for RCM.

“Cause”

for FMEA maps to “Failure Mode (Cause)”

for RCM.

* Approaches and practices for RCM vary significantly among practitioners as do definitions and terms used in the practice. Different approaches can be seen when reviewing standards.

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Reliability Centered Maintenance: Relationship to Traditional FMEA (cont’d)

The decision logic requires that the following be considered for each failure mode being analyzed:

Consequences of failure (safety, environmental, operational, economical).Whether the functional failure is evident or hidden to the operating crews.Evidence of reduced resistance to failure.Age-reliability characteristics of each item.Trade-off analyses comparing various maintenance tasks for optimum handling of a failure mode.

Maintenance tasks are selected that minimize risk and provide the desired level of availability for the minimum cost.

Based on NAVAIR 00-25-403 Guidelines for the Naval Aviation Reliability-

Centered Maintenance Process, Naval Air Systems Command.

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Reliability Centered Maintenance (RCM) Example

An example of RCM, as implemented in the aircraft industry’s MSG-3 guidelines, involves:

Identifying Maintenance Significant Items (MSIs).Identifying the functions, failures, effects and causes for each MSI (FMEA).Evaluating the potential effects of failure.Selecting the appropriate maintenance tasks to address potential causes of failure.

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Reliability Centered Maintenance More Information

RCM Publications and ProceduresReliability-Centered Maintenance, by F. Stanley Nowlan and Howard Heap, 1978.ATA MSG-3 Operator/Manufacturer Scheduled Maintenance Development, 2003.NAVAIR 00-25-403 Guidelines for the Naval Aviation Reliability-Centered Maintenance Process, 2001.SAE JA1011 Evaluation Criteria for Reliability-Centered Maintenance (RCM) Processes, 1999.SAE JA1012 A Guide to the Reliability-Centered Maintenance (RCM) Standard, 2002.Reliability-Centered Maintenance, Second Edition, by John Moubray, 1997.Practical Application of Reliability-Centered Maintenance, by the Reliability Analysis Center, 2003.MIL-STD-2173(AS) Reliability-Centered Maintenance Requirements for Naval Aircraft, Weapons Systems and Support Equipment, 1986.

The theory and application of RCM that go beyond FMEA are taught in ReliaSoft's RCM training.

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Reliability Centered Maintenance Example



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Reliability Centered Maintenance Example (cont’d)



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Reliability Centered Maintenance Example (cont’d)



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Hazard Analysis

“Hazard analysis is the process of examining a system throughout its life cycle to identify inherent safety related risks.”

(excerpt from FAA System

Safety Handbook, chapter 7)

A hazard is defined by the Department of Defense in Mil Std 882D as “Any real or potential condition that can cause injury, illness, or death to personnel; damage to or loss of a system, equipment or property; or damage to the environment.”

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Hazard Analysis Relationship to Traditional FMEA

The primary difference with a Hazard Analysis is that it focuses entirely on safety hazards, whereas the scope of an FMEA covers safety as well as performance, quality and reliability. There are other procedural and worksheet differences, such as:

Unique scales and worksheet.Focus on various types of hazards, including hardware, material, software, procedural, human factors, environmental and interface.

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Hazard Analysis More Information

Hazard Analysis References and Standards:ANSI/GEIA-STD-0010-2009, Standard Best Practices for System Safety Program Development and Execution.FAA System Safety Handbook, Chapter 7: Integrated System Hazard Analysis, 2010.FAA System Safety Handbook, Chapter 8: Safety Analysis/Hazard Analysis Tasks, 2010,IEEE STD-1228-1994 Standard for Software Safety Plans.ISO 14971:2007,

Medical devices -

Application of risk management to medical devices.SAE ARP4761, Guidelines and Methods for Conducting the Safety Assessment Process on Civil Airborne Systems and Equipment, 1996.Mil-Std 882D, STANDARD PRACTICE FOR SYSTEM SAFETY, 2000.U.S. Food and Drug Administration, Hazard Analysis and Critical Control Point Principles and Application Guidelines, adopted 1997.

http://www.iso.org/iso/rss.xml?csnumber=38193&rss=detail

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Hazard Analysis Example

TruncatedAvailable from: http://www.mech.utah.edu/ergo/pages/Educational/safety_modules/Pha/PHA_ns.pdf

intended for use in the fourth year mechanical engineering design sequence, Department of Mechanical

Engineering.

http://www.mech.utah.edu/ergo/pages/Educational/safety_modules/Pha/PHA_ns.pdf

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Concept FMEA

A Concept FMEA

is a short version of FMEA to aid in selecting optimum concept alternatives or to determine changes to system design specifications. It increases the likelihood that potential failure modes and resulting effects of a proposed concept are considered before the final concept is determined and actual design work proceeds.

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Concept FMEA Relationship to Traditional FMEA

The Concept FMEA includes the following elements from a traditional FMEA.

Item(s)Function(s)Failure mode(s)Effect(s)Severity ranking of the most serious effectCause(s)Occurrence ranking of primary cause(s)Design control(s)

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Concept FMEA Example



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Software FMEA

“Software FMEA assesses the ability of the system design, as expressed through its software design, to react in a predictable manner to ensure system safety.”

Excerpt from “Software FMEA Techniques”

in Proceedings of the Annual Reliability and Maintainability Symposium. 2000, by Peter Goddard.

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Software FMEA Relationship to Traditional FMEA

FMEA methodology applies very well to software as well as hardware. It is possible to include software functionality in the System FMEA as part of the functional descriptions. However, especially for complex software functionality such as embedded control systems, it may be useful to perform a separate software FMEA.

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Software FMEA Relationship to Traditional FMEA (cont’d)

Here are some possible objectives for software FMEA:

Identifying missing software requirements.Analyzing output variables.Analyzing a system’s behavior as it responds to a request that originates from outside of that system.Identifying (and mitigating) single point failures that can result in catastrophic failures.Analyzing interfaces in addition to functions.Identifying software response to hardware anomalies.

There is no universally agreed-upon standard for performing software FMEAs.

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Software FMEA Function Level Example

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Software FMEA Logic Level Example

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Software FMEA Code Level Example

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Basic FMEA Analysis Procedure14: Selecting FMEA Software

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Selecting FMEA Software Objectives

Using good relational-database software is an essential element for an effective FMEA program. The objectives of this module are to:

Present the key attributes of good FMEA software.Show why they are essential to FMEA project success.

As a result of this module students will be aware of the most important characteristics of good FMEA software.

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Benefits of Relational Database Software for FMEA

Using relational database software to facilitate FMEA analysis, data management and reporting can:

Provide a keyword searchable “knowledge base”

of your organization’s FMEAs.Make it easy to re-use information from existing FMEAs or from pre-defined phrase libraries.Help to establish consistency throughout the organization and allow multiple users to cooperate on analyses.Provide a feedback loop for corrective actions.Generate from a common database the various reports, queries and charts that facilitate decision making.Link other processes to FMEA.

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Time Savings

Xfmea provides a number of features to help analysts find and re-use relevant information from existing FMEAs and failure mode libraries.

This can significantly reduce the overall FMEA time, both in and out of meetings.

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Reports and Charts

Xfmea makes it easy to “slice and dice”

your data in a variety of different ways (beyond the traditional tabular spreadsheet).

Broad variety of pre-defined print-ready reports.Broad variety of graphical charts.Query utility for customized search and reporting.Can aggregate reports, charts and queries across multiple FMEAs.

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All Major Standards Supported

Xfmea supports all major standards.Military standardsCommercial standardsIndividual company standards

Worksheet are easily tailored.Can enforce consistency within the organization.

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Linkage to Other Processes

Linkage to Reliability ToolsReliability block diagramsLife data distributions

Transfer FunctionsDesign FMEAs transfer to Process FMEAsDesign FMEAs transfer to DVP&RsProcess FMEAs transfer to Process Control Plans and Process Flow Diagrams

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Advanced Hands-on FMEA ExerciseSelect an FMEA project.Divide into small groups.Each group will perform an FMEA for a specific portion of the overall project, using Xfmea to record the results.Each group selects one person to report the results to the rest of the class.The entire class will critique

each FMEA according to the FMEA quality objectives, correct definitions and procedures.

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ReferencesReferences

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References

Automotive Industry Action Group (AIAG), Potential Failure Mode and Effects Analysis. (February 1993, February 1995, July 2001 and June 2008).Automotive Industry Action Group (AIAG), Advanced Product Quality Planning and Control Plan (APQP). (June 1994 and July 2008).Crowe, Dana and Alec Feinberg, Design for Reliability, Ch. 12 “Failure Modes and Effects Analysis.”

CRC Press, Boca Raton, FL, 2001. Dhillon, B.S., Design Reliability: Fundamentals and Applications, Ch. 6 “Failure Modes and Effects Analysis.”

CRC Press, Boca Raton, FL, 1999.Kececioglu, Dimitri, Reliability Engineering Handbook Volume 2. Prentice-Hall Inc., Englewood Cliffs, New Jersey, 1991. Pages 473-506.

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References (cont’d)

McCollin, Chris, “Working Around Failure.”

Manufacturing Engineer, February 1999. Pages 37-40.McDermott, Robin E., Raymond J. Mikulak and Michael R. Beauregard, The Basics of FMEA. Productivity Inc., United States, 1996. Palady, Paul, Failure Modes & Effects Analysis: Author’s Edition. Practical Applications…Quality & Reliability, United States, 1998. Shimizu, Hirokazu and Imagawa, Toshiyuki, “Reliability Problem Prevention Method for Automotive Components: Development of the GD3 Activity and DRBFM,”

JSAE 20037158 SAE 2003-01-

2877, 2003.Stamatis, D.H., Failure Mode and Effect Analysis: FMEA from Theory to Execution. American Society for Quality (ASQ), Milwaukee, Wisconsin, 1995.

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References (cont’d)

Society of Automotive Engineers (SAE), Aerospace Recommended Practice ARP5580, "Recommended Failure Modes and Effects Analysis (FMEA) Practices for Non-Automobile Applications," June 2000. Society of Automotive Engineers (SAE), Surface Vehicle Recommended Practice J1739, Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA). July 1994, August 2002 and August 2008. U.S. Department of Defense, MIL-STD-1629A, Procedures for Performing a Failure Mode Effects and Criticality Analysis. November 1974, June 1977, November 1980. (Cancelled in November, 1984).

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Worldwide Headquarters (North America)

ReliaSoft Corporation 1450 S. Eastside Loop

Tucson, AZ 85710-6703, USA

Phone: (+1) 520-886-0410 (USA/Canada Toll Free: 1-888-886-0410)

Fax: (+1) 520-886-0399 E-mail: [email protected]

Web site: www.ReliaSoft.com

South America

ReliaSoft Brasil

São Paulo, Brasil

Europe and Middle East

ReliaSoft Corp. Poland Sp. z o.o. Warsaw, Poland

India ReliaSoft India Private Limited Chennai, India

Asia Pacific

ReliaSoft Asia Pte Ltd Singapore

Regional Centers

See http://Directory.ReliaSoft.com

for complete contact info.

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mailto:[email protected]

http://www.reliasoft.com/

http://directory.reliasoft.com/

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Reference Material

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Making the Scope Visible for Design FMEAs: Other Tools

In addition to the FMEA Block Diagram, there are other tools available to the Design FMEA team to make the scope visible:

Parameter Diagram (P-Diagram)FMEA Interface MatrixFunctional Block Diagram

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Making the Scope Visible for Design FMEAs: Parameter Diagram

The Parameter Diagram (P-Diagram) takes inputs from a system/ customer and relates those inputs to desired outputs of a design, considering non-

controllable outside influences.It is a useful tool in brainstorming and documenting:

Input signalsNoise factorsControl factorsError statesIdeal response

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Making the Scope Visible for Design FMEAs: FMEA Interface Matrix

An FMEA Interface Matrix is a chart with the subsystems and/or components (depending on the scope of the FMEA) on both the vertical and horizontal axes. The chart shows which interfaces must be considered in the analysis and the type of interface.There are four primary types of interfaces:

A physical connectionA material exchangeEnergy transferData exchange

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Making the Scope Visible for Design FMEAs: Functional Block Diagram

A Functional Block Diagram is a visual tool to describe the operation, interrelationships and interdependencies of the functions of a system or equipment. Each primary (high level) function is placed in a “block”

and visually laid out in the sequence

performed. Inputs and outputs are added for clarity.

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Functional Block Diagram for a flashlight operation



Documents

FMEA RCM Course - Foundations of Effective FMEA - RS 470 CourseNotes_Rev9.1