RISK

REV VING UP RISK RECOGNITION

Better identify risk in product and service designs with system, component,
assembly and application DFMEA by Matthew Barsalou

Huber & Starke/Toa55/pagadesign via Getty Images

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JUST THE FACTS

Organizations should use

different types of design fail-
ure mode and effects analysis
(DFMEA) to better identify
risk in a new or changed
product or service design.
The four types of DFMEA are
system DFMEA, component
DFMEA, assembly DFMEA
and application DFMEA.

The author details how to

perform DFMEA, including
incorporating boundary
diagrams and parameter
diagrams, and considering
special characteristics.

A DFMEA is a living
document that provides
lessons learned about past
failures and can be used as a
template for future DFMEAs.

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T here are multiple types of failure mode and effects analysis (FMEA): process FMEA (PFMEA),
service FMEA (for a service that will be performed), machine FMEA, system FMEA (for early
development design concepts) and design FMEA (DFMEA).1 There also is application FMEA
for the specific application the product will be used in,2 as well as FMEA for project manage-
ment.3 Other uses can be found for FMEA, such as assessing environmental risks.4
An organization should consider using different types of DFMEA to better identify risk in a new or changed
product design. A system DFMEA should be created to evaluate new concepts in which operating conditions
often are unknown. The component and assembly DFMEAs should follow as components and assemblies
are developed, and an application DFMEA should be created to evaluate the risks in a specific customer
application. A DFMEA may only consider the usual operating conditions for a part, so if a customer uses
the component in unusually harsh conditions, for example, the additional risks would be considered part
of the application DFMEA.
These DFMEAs also should be inputs for the PFMEAs. The failure modes and prevention and detection
actions will differ, but the consequence of a failure—the failure effect—often is the same. A poorly selected
nominal and tolerance value for bracket thickness, for example, can have the same failure effect as a bracket
with insufficient thickness due to a manufacturing failure.
iStock.com/cosmin4000

DFMEAs
Start the DFMEA after a concept has been created for a part, assembly or system. The objective is to identify
risks as early as possible in the development process—the cost to correct failures is less when the failure is found
early in the development process. Changing a tolerance when the concept only exists as a technical drawing,

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FIGURE 1

DFMEA form

Responsible and due date

Recommended action
Current controls:
Classification
Component/

requirement

Occurrence

Occurrence
Prevention

Detection

Detection
Function/
assembly

Current
Severity

Severity
Failure Failure Failure Actions

RPN

RPN
controls:
mode effect cause taken
Detection

DFMEA = design failure mode and effects analysis RPN = risk priority number

for example, costs relatively little compared to changing The failure cause for a component or assembly DFMEA
the tolerance after tooling has been completed or the first should be an aspect found in a drawing or specification.
parts are available. An organization new to using DFMEA The true root cause may be “engineer selected wrong toler-
must create DFMEAs for existing products, which then can ance,” for example, but “wrong tolerance” is better for the
be used as templates for future products. Figure 1 depicts a DFMEA because it pertains to something typically found
generic DFMEA form. on a drawing.
Ideally, a new concept should have a system DFMEA. Ideally, failure causes should be phrased in terms of
Finalized technical drawings seldom exist for an early design location regarding which component or assembly is causing
concept, so failure causes in a system DFMEA should pertain the failure, or which drawing or specification requirement
to failures related to the basic concept, such as the material is causing the failure, and how the drawing or specification
selected or the approach used to solve a characteristic causes the failure. “Rod length
design problem. This DFMEA should be too long,” for example, tells us the failure
used as an input for the component and is at a rod, the problem is length, and it
assembly DFMEAs. is a problem because the specification
One approach is to perform a resulted in the rod being too long.
component DFMEA for failures A DFMEA may be for a generic
that happen only in individual part or assembly, an application
parts. Assembly DFMEAs are DFMEA should be created for
created for assembly-level An organization should customer use. Many of the
failures. Here, failure causes consider using different failure modes and effects
may include a combination types of DFMEA to from the DFMEA can
of parts, such as when a be carried over to the
failure mode occurs as
better identify risk application DFMEA
the result of a stack-up of in a new or changed if they are relevant to the
tolerances from two or more product design. application project where the
components. Coordination is product will be used. Generic
required if different engineers are failure causes are considered in
responsible for the separate compo- the DFMEA, so the application
nents in an assembly. The assembly DFMEA should concentrate on failure
DFMEA provides a method to ensure causes unique to the specific application,
this coordination is carried out. such as “operating temperature too high.”

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FIGURE 2

Relationship between DFMEAs

Component DFMEA
For failure causes resulting
from single component

System DFMEA Application DFMEA

For design concepts For customer application
specific failure causes, failure
modes and failure effects

Assembly DFMEA
For failure causes resulting
from multiple components

DFMEA = design failure mode and effects analysis

Figure 2 shows the relationship between system FMEAs, DFMEAs should exist for current products, leaving the team
component and assembly DFMEAs, and application DFMEAs. free to concentrate on any differences in new variants as well
as completely new products. If this is not the case, DFMEAs
Performing DFMEA should be completed for current products. Although this takes
Creating a DFMEA requires a team approach. The exact resources, DFMEAs completed properly will be available for
composition of the team will vary among organizations, future use, and generic aspects will not need to be considered
but the team generally should include the person responsible every time a variant is developed.
for the component or assembly and representatives from the The relevant bill of materials and technical drawings
quality department. The person who will test the component should be present during the initial DFMEA meeting.
or assembly also should be involved. Hardware—​i f it exists—also should be present during
Have at least a few meetings with somebody from DFMEA meetings so team members can better understand
the department responsible for producing the part and what is being discussed. Otherwise, any renderings, sketches
somebody who can serve as an interface to the customer or 3D views of the product should be available to the team.
receiving the product. Lessons learned from comparable components or assem-
A DFMEA moderator also is needed. The moderator blies should be reviewed. Lessons learned include customer
knows DFMEAs and can act as a team facilitator. He or complaints, internal failure reports and older DFMEAs.
she may be a dedicated moderator who supports multiple These also should be reviewed.
DFMEA teams or an experienced team member.
DFMEA sessions can be draining and should be limited Boundary diagram
in duration.5 A one-hour session may be too brief to accom- A boundary diagram, also known as a block diagram, is a graph-
plish much, while sessions more than four hours could ical depiction of a system that displays the interactions and
wear down the team. Ideally, a session should last two to interfaces among various components or assemblies in a system.
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four hours, and there should be a brief break if the session It is used to identify the scope of the DFMEA.7
is longer than two hours. A boundary diagram can be useful for determining where
Conducting a DFMEA can be time consuming. One option failure effects will occur, as well as identifying components
to increase efficiency is to deemphasize older known items that could have a failure cause resulting in the failure mode
and focus on new, unique and difficult items.6 Ideally, complete in an assembly.

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FIGURE 3

Boundary diagram
Component
E

Component Component
B D

Component Component
A C

Figure 3 depicts a simple boundary diagram with the focus and prevention actions to make transferring to the DFMEA
element in the center. The dotted lines indicate the component easier. The error states can be considered as failure causes,
in the box is the focus element, which is the part that is in the failure modes or failure effects. Although there may be
DFMEA scope. The arrows indicate that there are interactions one list of error states, the error states also can be divided
that cross the boundary. These arrows can be color coded to into subcategories.
indicate physical contact, fluid transfer and signals that cross
the boundary, for example. Special characteristics
The form for a DFMEA often has a classification column.
Parameter diagram This is for the use of any special characteristics required
A parameter diagram (p-diagram) is used to assess a system’s by customers. Even if they’re not required by customers,
inputs and outputs as well as noise factors, control factors8 special characteristics still should be considered because
and potential error states. Inputs include electrical signals, they provide a method for identifying high risks in the
and the transmission of force and fluids. The output is what DFMEA. Using special characteristics allows engineers to
the system is intended to deliver, such as a given flow rate of communicate unique risks to internal production or assem-
water for a water pump. bly departments, or external suppliers.
The error state is how things could go wrong. Control Special characteristics in the DFMEA are considered
factors often are influences that are controlled, such as possibilities and used as inputs for the engineering drawing
dimensions. For a DFMEA, however, the control factors and the PFMEA when special characteristics should be con-
also can be the prevention and detection actions that can sidered for additional control actions.
or will be taken. Noise factors are uncontrolled influences There generally are two types of special characteristics:
on the system. Common categories of noise factors include 1. Potential critical characteristic—typically affects safety
piece-to-piece variation, changes over time, use, environment or violates legal requirements or government regulations.
and system interactions with other systems. A p-diagram is 2. Potential significant characteristic—has a high severity
depicted in Figure 4 (p. 18). but is below the level of a potential critical characteristic.9
The system output in the p-diagram can be used as the It often affects functionality.
function or requirement in the DFMEA. Control factors There are many ways to identify special characteristics.
can be divided into subcategories consisting of detection Ford Motor Co., for example, uses “YC” for critical characteristics

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FIGURE 4

P diagram
Noise factors

Piece-to-piece variation Changes over time Use Environment System interaction

Input System Output

Error state

Control factors

P = parameter

and “YS” for significant characteristics in the DFMEA, Criteria for identifying potential significant and potential
and “CC” for significant characteristics and “SC” for special critical characteristics vary among standards, customers and
characteristics in the PFMEA. DaimlerChrysler AG uses “DS” authors. One set of guidance is to use severities of nine or 10 as
for documentation requirements due to safety and “DT” for potential critical characteristics because either a law may be
documentation requirements due to certifications. Additional broken or a person could be harmed. A product’s functionality
company-specific letters are used, as well as a shield or a dia- may be heavily affected by failure effects with a severity of four
iStock.com/Julia Garan

mond symbol. The German Verband der Automobilindustrie to eight, so a severity of four to eight together with an occur-
standard uses “BM S” for safety-related characteristics, “BM Z” rence greater than three can be used for identifying potential
for characteristics that involve laws, and “BM F” for functional significant characteristics.11 Although occurrence ratings can
and requirement-related characteristics.10 be used when considering special characteristics, it is important

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to remember that the occurrence rating is for design-related performed. The current controls were either insufficient
failures and has no bearing on the occurrence of process-​ or the ratings were incorrect if the failure already was listed
related failures. in the DFMEA. In either case, a reevaluation is necessary,
Although severity ratings should and the resulting improvement actions
be considered when identifying special must be implemented.
characteristics, engineering judgment Completed DFMEAs can be used
also should be used. Unless otherwise as templates for future comparable
required by an industry standard or components or assemblies. If used
customer requirement, an organi- as a template, a full review of the
zation should select criteria that Using special DFMEA by the new DFMEA
fit the organization’s needs. team is critical because the
characteristics
One possible approach is new product may be differ-
to select higher severity allows engineers to ent from the one used to
effects for additional communicate unique create the template. QP
consideration, with the risks to internal REFERENCES
DFMEA team deciding
production or 1. D.H. Stamatis, Failure Mode and
whether a special charac- Effects Analysis: FMEA From Theory
teristic is needed based on assembly departments, to Execution, Quality Press, 2003.
the related drawing characteris- or external suppliers. 2. Carl S. Carlson, Effective FMEAs:
tic’s sensitivity to variation in the Achieving Safe, Reliable and Economical
Products and Processes Using Failure Mode
manufacturing process as well as and Effects Analysis, John Wiley & Sons Inc, 2012.
the effect if the characteristic is out 3. Thomas A. Carbone and Donald D. Tippett,
of specification. “Project Risk Management Using the Project Risk
Having too many special character- FMEA,” Engineering Management Journal, Vol. 16,
istics increases manufacturing costs due No. 4, 2004, pp. 28-35.
4. Willy W. Vandenbrande, “How to Use FMEA to Reduce the Size of Your Quality
to increased control activities, while having too few char- Toolbox,” Quality Progress, November 1998, pp. 97-100.
acteristics increases the risk of failure. The DFMEA should 5. T.M. Kubiak, “3.4 Per Million: Conducting FMEAs for Results,” Quality Progress,
only consider design-related failures, not production process-​ June 2014, pp. 42-45.
related failures. 6. Gary G. Jing, “A Fundamental FMEA Flaw,” Quality Progress, May 2019, pp. 26-33.
Critical characteristics do, however, provide a method for 7. Carlson, Effective FMEAs, see reference 2.
8. Kai Yang and Basem S. El-Haik, Design for Six Sigma: A Roadmap for Product
the DFMEA team to communicate to the PFMEA team about Development, second edition, McGraw Hill, 2008.
which drawing characteristics are especially critical due to 9. Ibid.
the potential failure effect if they are out of specification. 10. Martin Werdich, editor, FMEA—Einführung und Moderation: Durch System-
The special characteristics in the DFMEA should be trans- atische Entwicklung zur Übersichtlichen Risikominimierung (inkl. Methoden
ferred to the PFMEA, and that team should decide which im Umfeld), second edition, Springer Hachmedian, 2012.
11. D.H. Stamatis, The ASQ Pocket Guide to Failure Mode and Effect Analysis
special characteristics to transfer into the control plan. (FMEA), Quality Press, 2015.
12. Russell T. Westcott, editor, The Certified Manager of Quality/Organizational
A DFMEA is a living document Excellence Handbook, fourth edition, ASQ Quality Press, 2013.
12
A DFMEA is a form of lessons learned. It is “a living 13. Govind Ramu, “FMEA Minus the Headache,” Quality Progress, March 2009,
document”13 and should be updated as needed. Suppose pp. 36-42.
a new type of failure occurs a few months after the prod-
EDITOR’S NOTE
uct goes into production and the root cause is found to be
For part two of this article, check out “DFMEA Made Simple” in the February 2023
design related. The DFMEA should be updated with the issue of QP. The article provides a concise review of the actions required to perform
failure, new current controls should be developed and a successful DFMEA to help readers understand the process and objectives of such
a new risk priority number (RPN) evaluation should be an analysis.

Matthew Barsalou is an extramural researcher at Poznan University of Technology. He has a master’s degree in business administration
and engineering from Wilhelm Büchner Hochschule in Darmstadt, Germany, and a master’s degree in liberal studies from Fort Hays State
University in Hays, KS. Barsalou is an associate academician in the International Academy for Quality, an ASQ fellow and was the 2021 chair
of ASQ’s Statistics Division. He is a certified lean Six Sigma Master Black Belt and an ASQ-certified Six Sigma Black Belt, manager of quality/
organizational excellence, quality technician and quality engineer.

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