Failure Mode and Effects Analysis (FMEA) : Classroom Training 2-Day Course

Failure Mode and Effects Analysis
(FMEA)
CLASSROOM TRAINING
2-Day Course
1-1
Failure Mode and Effects Analysis
(FMEA)
Welcome!
1-2
Classroom Courtesy
Emergency exits and restrooms
Breaks
Electronic devices
Be fully present
Have FUN!!
July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-3

Participant Introductions
Your name?
Your role at Whirlpool?
How long with Whirlpool?
Something interesting about yourself.
Your expectations of the course. / How will FMEA

be applied to your job role?

Course Objectives
Upon completion of this course, you will be able to:
Describe the importance and use of the FMEA

process at Whirlpool.
Complete an FMEA per Whirlpool’s Product
Quality System (WPQS) requirements with limited
assistance.
Understand how to use the information generated
from the FMEA to assist in the design of better
products and processes.

Course Outline
Lesson 1: Course Introduction
Lesson 2: FMEA Project Preparation
Lesson 3: The Form: Customer Focus Section
Lesson 4: The Form: Engineering Focus Section
Lesson 5: The Form: Issue Resolution Section
Lesson 6: Course Conclusion

Lesson 1
Course Introduction
1-7
Lesson 1 - Objectives
Upon completion of this lesson, you will be able to:
Define FMEA.
Understand Whirlpool’s intent for using FMEA.
Understand how the FMEA fits into key Whirlpool

processes.
Understand when an FMEA is required.

FMEA Definition
Failure Mode and Effect Analysis is…

A methodology used to identify, assess, manage, and reduce risk
associated with failures or potential failures of a design or a
manufacturing process. The failures are documented and
prioritized. Action plans are developed and carried out to prevent
failures – BEFORE they occur!

Types of FMEA
Design FMEA (DFMEA)

• Helps identify potential design failure
modes, their effects and the causes,
prior to releasing the product to production.
• Generates actions that drive design improvement.
• Helps in the development of design specifications.
• Aids in the planning of thorough and more efficient design development &
design verification plans.
• Assumes that the component/assembly is made to print.

However, the design team should consider the fabrication / assembly
process in the DFMEA, and specify a design that the design can be made
and assembled consistently.

Types of FMEA
Process FMEA (PFMEA)

• Helps identify potential manufacturing
/ assembly process failure modes,
their effects & the causes, prior to
shipment of the product.
• Generates actions that drive manufacturing

/ assembly process improvement.
• Helps identify areas of the process to focus process control efforts.
• Aids in the planning of thorough and more efficient process development

& process corrective action plans.
• Assume that purchased component / assemblies are made to print.

However, Process teams may list purchased assembly issues if their team
has the power to drive improvements to these issues.

Exercise 1
Filling in the Global Whirlpool FMEA Form
• Given the WPQS procedure and work instruction:
– Select a project and a project team to complete one (1) or two

(2) rows of the form.
– Work on a current project or an office door hinge.
– You will be given 45 minutes for this exercise.

Exercise 1
Summary and Conclusion

• Each group will review their FMEA and discuss the following
questions:
– Question: What were your project objectives? Did you

struggle? Why?
– Question: Why are there so many different responses to the

FMEA forms?
– Question: Is there any group that has combined a process

and design FMEA to one form?
– Question: What are the pros and cons to combining a process

and design FMEA into one form?

Intent of FMEA
The intent of the FMEA process at Whirlpool Corporation:
• Efficiently and effectively identify, document, and resolve

critical failure modes and their causes.
• Create a common global process used to drive customer

satisfaction and product safety.
• Drive improved product quality and customer-focused test

plans.

Key Points
What are some elements of Whirlpool’s new FMEA

process that are intended to control variation?
• The use of a global ________ ________.
• ________ Severity, Occurrence & Detection ________ ________.
• ________ ________ of FMEA to projects.
• Correct use of ________ to and ________ of the FMEA.
Answer Choices:
FMEA process inputs
common outputs
rating scale common application

Legal Implications of an FMEA
FMEAs are important engineering tools with potential

legal implications.
• FMEAs provide evidence that appropriate due diligence was

applied during the product & process development.
• Legal implications vary by global region / country / location.
• Depending upon local law, fines or imprisonment are

possible if the FMEA is not conducted, not conducted
completely or is conducted inadequately.

Whirlpool’s Safety and Legal
Requirements
Whirlpool’s Safety and Legal Departments have defined
the following FMEA requirements:
• An FMEA shall be completed for any product design and/or

process change that affects functional parts* of a product.
• Use of an FMEA to document safety issues should reflect

fact-based descriptions of the potential product hazards,
their consequences, actions and closure references.
*Functional Parts: Components that are critical to the product’s essential function, a component that, if
missing or broken, renders the product non-operational or creates a potential hazard, i.e.: motors,
switches, compressors, heaters, valves, shelf, handle, software, etc.

Whirlpool’s Safety and Legal
Requirements (continued)
• Approval for production will only be granted when all issues
that require action are closed.
• FMEAs need to be an accurate data source, not contradicted

by other documents like test reports, PHMs, etc.
• Expectations with respect to FMEAs are the same for any

product or component whether licensed, purchased, or
created within Whirlpool Corporation.
• All Design FMEAs under revision control, will be stored for 26

years.
• All Process FMEAs are to be retained for 5 years after the

process is obsolete or the process is superseded by a new
process.

Whirlpool’s Product Quality System
(WPQS)
What is WPQS?
WPQS is the quality management system’s set of activities carried

out within Whirlpool to satisfy the expectations of our customers.
– WPQS is a "business" system with coordinated activities to direct
and control an organization with regard to quality.
– WPQS is based on international standard ISO/TS 16949 for quality
management systems.
– ISO/TS 16949 and ISO (International Organization for
Standardization) is the world's largest developer of technical
standards.
Design FMEA and Process FMEA are two activities required by
WPQS.
Design teams will be audited to WPQS procedures when WPQA
comes live.

Whirlpool’s Product Quality System
WPQS
(Whirlpool Product Quality System)
International Standard: This international standard

ISO/TS16949 requires Design and Process
FMEAs.
Level 1 Whirlpool’s FMEA intent is reflected within

Defines Approach & this common global policy.
Quality
Responsibility Manual The global FMEA procedure defines
(Policies) FMEA roles & responsibilities, FMEA
Level 2
training materials and describes FMEA
Defines Who, What, When Procedures linkage to C2C.
Level 3 The global FMEA work instruction
Answers How Job Instructions
provides instructions for filling in
(Work Instructions)
Level 4 the FMEA form.
Recording of information, e.g.
Other Documentation Provides a common global
forms, tags, labels.
FMEA form.

C2C, RPD, and FMEA
What is the link between C2C, RPD & FMEA?
• Customer-to-Customer (C2C) is the global business process for the

development and launch of products that begins and ends with the
customer.
• Robust Product Design (RPD) is a Global Product Development

process that supports C2C. RPD is a technical, functional process
that links to C2C through Technical Design Previews (TDPs) and
tollgate.
• Many different tool serve as inputs to the RPD process. FMEA is

one of those critical tools. An FMEA is a cross-functional
communication and risk assessment tool that starts with the
customer.

FMEA and TDPs
Technical Design Preview (TDP) Tollgate:
• Concept Selection Milestone (CSM)

– Demonstrate if and how the DFMEA methodology is being used
as input to the concepts selected. DFMEAs updated through
Severity.
• Concept Evaluation Tollgate (CET)

– DFMEA’s are updated through SOD, prioritized and associated
recommended actions developed.
– Demonstrate how the PFMEA methodology is being used to

drive the evaluation of the process concepts.
Note: Although some lower level FMEAs (ie., system, sub-system, component OR sub-
assembly lines, individual assembly stations OR fabrication FMEAs) may lag the requirements
listed here, all teams are expected to work on hierarchical FMEAs in parallel .

FMEA and TDPs
Business Evaluation Tollgate (BET)/Design Release

Milestone (DRM)
• DFMEAs updated through Actions Taken and updated

SODs are meeting project requirements.
• Production approval test plans finalized.
• PFMEAs updated through SOD, prioritized, and associated

action plans developed.

FMEA and TDPs
Production Release Milestone (PRM)
• SODs confirmed through Product Approval and verification

testing – all codes, safety, and relevant technical and quality
issues resolved.
• PFMEAs complete through corrective actions with updated

SOD’s meeting project requirements.
• Production control plans finalized.
Note: DFMEAs and PFMEAs are to be updated with knowledge gained during development.

Measuring FMEA
20 Keys to RPD Excellence:
• A global measurement system to assess RPD embedment

and excellence.
• The 20 Keys to RPD Excellence may include:
– Customer Focus
– Risk Management
– Safety
– Specifications
– Translation Effectiveness
– FMEA

Measuring FMEA (continued)
5 Elements within the FMEA Key include:

• Timing
• Linkage
• Intent
• Content Development and
Review
• Risk Quantification
Each of the 5 elements of the FMEA Key has a rating

scale of 1-5, ranging from a Traditional to a Best-in-
Class approach
Note: The FMEA Key is written primarily to address DFMEAs (at this time).

Traditional Learning Leading World Class Best-in-Class
No process or ineffective, Awareness and Implementation of preferred Effective and efficient use Effective and efficient use
inefficient approach understanding of preferred approach with regular use of preferred approach and of preferred approach and
approach with basic worthy of internal worthy of external
proficiency benchmarking benchmarking
Level Element
1 2 3 4 5
Element Score
Not used Used Drives Manages Predicts
- at the applicable TDP - at the appropriate C2C - usage at the appropriate - continuously during the - continuously during the
tollgate time C2C time project project
- not driving project work, - project work, planning, - risk assessment - risk assessment
1 Timing planning, communication,
documentation
communication,
documentation
- project work
- planning
- outcomes
- manage project work 1
- communication - planning
- documentation - communication
- documentation
None Design-only Linkage Design + Safety Integrated Fully integrated and

- none, independent - Product/ Linkage - Product/ system/ interdependent
system/component - Product/ component FMEAs to - Product/ system/
FMEAs to system/component - customer requirements component/process/equip
- supplier FMEAs to - resources ment FMEAs
- manufacturing - supplier - test plan - customer requirements
- manufacturing - suppliers - resources
- the RPD 5-step
2 Linkages - safety audit
- PHM's translation
- test plan
- suppliers
1
- Safety Audit - the RPD 5-step
- PHMs translation
- process control plans
- manufacturing
- equipment
- Safety Audits
- PHMs
Noncompliance Compliance Driving Design Prioritization Risk Management
- to RPD/C2C process - to RPD/C2C process - to RPD/C2C process - used iteratively based - continuously iterated,
- created at a single point - updated for TDP's - updated for TDP's on knowledge gained updated and documented
in time but not revisited - used iteratively based - driving design function - driving design function
on knowledge gained - driving design validation - driving design validation
3 Intent - driving design function - drives resource planning
and work
- resource planning and
work
1
- risk management
- integration (design,
process, supplier and
equipment FMEAs)

Traditional Learning Leading World Class Best-in-Class

No process or ineffective, Awareness and Implementation of preferred Effective and efficient use Effective and efficient use
inefficient approach understanding of preferred approach with regular use of preferred approach and of preferred approach and
approach with basic worthy of internal worthy of external
proficiency benchmarking benchmarking
Level Element
1 2 3 4 5
Element Score
None Limited Cross-functional Comprehensive Integrated
- individual contribution by - contributions by Project - contributions by cross- - contributions by cross- - contributions by cross-
Design Engineer Team functional team functional team functional team and other
- no review of content - reviewed by - reviewed by - facilitated development subject matter experts
- Project engineer - Project engineer with FMEA expert - facilitated development
- lab - lab - reviewed by with FMEA expert
- manager/RTL - Project engineer - reviewed by
- updated or plan to update - lab - Project team
Content through KLT - manager/GTL - design
4 Development and
Review
- service - manufacturing 1
- manufacturing - marketing
- updated or plan to update - sales
through KLT with p - procurement
Individual Project Team Previous Previous data Current project data

knowledge knowledge information - FMEA - experiments
- engineering knowledge of - FMEA - experiments - lab test results
the project team - observational/historical - lab test results - reliability testing
5 Risk Quantification data - reliability test results - EFT 1
- cross-functional project - SIR - process capability
team input - cross- functional project - cross-functional project
team input team input

FMEA Competencies
FMEA is a Key Competency in the RPD
A Master of FMEA,
understands the role FMEA in
RPD, the use of FMEA,
application of the FMEA tools,
and ability to teach FMEA.
An individual Proficient with

FMEA is capable of leading
FMEA creating and they
understand the FMEA
Process.
An individual that understands

the basic principles of FMEA
and participates in creating
FMEAs is considered to have
a Basic competency level.

Lesson 1 - Summary
In this lesson you learned the following:
The definition of FMEA

• Identifies Failure Modes and Causes
• Assesses risk
• Documents Action Plans and the results of the Action Plans
When an FMEA is required

• For any product design and/or process change that affects functional parts of a product
Whirlpool’s intent for using FMEA

• Efficiently and effectively identify, document, and resolve critical failure modes and
their causes.
• Create a common global process used to drive customer satisfaction and product
safety.
• Drive improved product quality and customer-focused test plans.
How the FMEA fits into key Whirlpool processes

• WPQS provides an FMEA Procedure and Work Instructions
• Integral part of C2C and RPD
• Measured by the FMEA element of the 20 Keys to RPD Excellence

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Failure Mode and Effects Analysis

Emergency exits and restrooms

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-3

Your role at Whirlpool?

How long with Whirlpool?

Something interesting about yourself.

Your expectations of the course. / How will FMEA

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-4

Upon completion of this course, you will be able to:

Describe the importance and use of the FMEA

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-5

Lesson 1: Course Introduction

Lesson 2: FMEA Project Preparation

Lesson 3: The Form: Customer Focus Section

Lesson 4: The Form: Engineering Focus Section

Lesson 5: The Form: Issue Resolution Section

Lesson 6: Course Conclusion

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-6

Upon completion of this lesson, you will be able to:

Understand Whirlpool’s intent for using FMEA.

Understand how the FMEA fits into key Whirlpool

Understand when an FMEA is required.

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-8

Failure Mode and Effect Analysis is…

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-9

Design FMEA (DFMEA)

• Generates actions that drive design improvement.

• Helps in the development of design specifications.

• Assumes that the component/assembly is made to print.

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-10

Process FMEA (PFMEA)

• Generates actions that drive manufacturing

• Helps identify areas of the process to focus process control efforts.

• Aids in the planning of thorough and more efficient process development

• Assume that purchased component / assemblies are made to print.

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-11

Filling in the Global Whirlpool FMEA Form

• Given the WPQS procedure and work instruction:

– Select a project and a project team to complete one (1) or two

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-12

Summary and Conclusion

– Question: What were your project objectives? Did you

– Question: Why are there so many different responses to the

– Question: Is there any group that has combined a process

– Question: What are the pros and cons to combining a process

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-13

The intent of the FMEA process at Whirlpool Corporation:

• Efficiently and effectively identify, document, and resolve

• Create a common global process used to drive customer

• Drive improved product quality and customer-focused test

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-14

What are some elements of Whirlpool’s new FMEA

• ________ Severity, Occurrence & Detection ________ ________.

• ________ ________ of FMEA to projects.

• Correct use of ________ to and ________ of the FMEA.

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-15

FMEAs are important engineering tools with potential

• FMEAs provide evidence that appropriate due diligence was

• Legal implications vary by global region / country / location.

• Depending upon local law, fines or imprisonment are

July 2006 Version 1.0 Copyright 2005-2006 Whirlpool Corporation 1-16

• An FMEA shall be completed for any product design and/or

• Use of an FMEA to document safety issues should reflect

• Severity, Occurrence & Detection .

• of FMEA to projects.

• Correct use of to and of the FMEA.