Design FMEA Example
Design FMEA Example
The DFMEA can also take into consideration the technical and physical limits of product serviceability and
recycling once the product has entered field use, for example:
Tool access
Diagnostic capability
Material classification symbols (for recycling)
Materials/chemicals used in the manufacturing processes
The DFMEA focuses on the design of the product that will be delivered to the final customer (End User). The
prerequisite tasks for an effective analysis of the product design include: assembling a team, determining scope,
creating block diagrams or P-diagrams depicting product function and requirements. A clear and complete
definition of the desired product characteristics better facilitates the identification of potential failure modes.
The DFMEA process can be mapped to the customer or organization‟s product development process. A
DFMEA should begin with the development of information to understand the system, subsystem, or component
1
being analyzed and define their functional requirements and characteristics. In order to determine the scope of
Page
What processes, mating components, or systems does the product interface with?
Are there functions or features of the product that affect other components or systems?
Are there inputs provided by other components or systems that are needed to perform intended functions
of the product?
Do the product‟s functions include the prevention or detection of a possible failure mode in a linked
component or system?
These are some of the tools that may be applied, as appropriate, to assist the team in developing the DFMEA.
The block diagram of the product shows the physical and logical relationships between the components of the
product. There are different approaches and formats to the construction of a block diagram.
The block diagram indicates the interaction of components and subsystems within the scope of the design. This
interaction may include: flow of information, energy, force, or fluid. The objective is to understand the
requirements or inputs to the system, the activities acting on the inputs or function performed, and the
deliverables or output. The diagram may be in the form of boxes connected by lines, with each box
2
corresponding to a major component of the product or a major step of the process. The lines correspond to how
Page
the product components are related to, or interface with each other. The organization needs to decide the best
The P-Diagram is a structured tool to help the team understand the physics related to the function(s) of the
design. The team analyzes the intended inputs (signals) and outputs (responses or functions) for the design as
well as those controlled and uncontrolled factors which can impact performance. The inputs to the product and
outputs from the product, i.e., the intended and unintended functions of the product, are useful in identifying
error states, noise factors, and control factors. The error states correspond to the Potential Failure Modes in the
DFMEA.
Functional Requirements:
Another step in the DFMEA process is a compilation of the functional and interface requirements of the design. This list
may include the following categories such as General (This category considers the purpose of the product and its overall
design intent), Safety, Government Regulations, Reliability (Life of the Function), Loading and Duty Cycles such as
Customer product usage profile, Quiet Operations such as Noise, vibration and harshness (NVH), Fluid Retention,
Ergonomics, Appearance, Packaging &Shipping , Service and Design for assembly & manufacturing.
3
Page
Other tools and resources that may help the team understand and define the design requirements may include:
The use of these tools, supported by engineering experience and historical information, can assist in defining a
comprehensive set of requirements and functions. The example used with the sample form deals with a Front Door
assembly. The product has several functional requirements:
The final DFMEA would include analysis of all these requirements. The example includes part of the analysis of them
requirement: “Maintain integrity of inner door panel”.
4
Page
Prepared By (H)
Enter the name and contact information including the organization (company) of the engineer responsible for
preparing the DFMEA.
Item (a 1)
Enter the items, interfaces, or parts which have been identified through block diagrams, P-diagrams, schematics
and other drawings, and other analysis conducted by the team. The terminology used should be consistent with
customer requirements and with those used in other design development documents and analysis to ensure
traceability.
Function (a1)
Enter the function(s) of the item(s) or interface(s) being analyzed which are necessary to meet the design intent
based on customer requirements and the team‟s discussion. If the item(s) or interface has more than one
function with different potential modes of failure, it is highly recommended that each of these functions and
associated failure mode(s) is listed separately. Function becomes a2 if Item and Function are split.
Requirements (a2)
An additional column, “Requirements”, may be added to further refine the analysis of the failure mode(s). Enter
the requirement(s) for each of the functions being analyzed (based on customer requirements and the team‟s
discussion). If the function has more than one requirement with different potential modes of failure, it is highly
recommended that each of the requirements and functions are listed separately.
A large number of failure modes identified for a single function may indicate that the requirement is not well
Page
defined. The assumption is made that the failure could occur, but may not necessarily occur, consequently the
Severity (d):
Severity is the value associated with the most serious effect for a given failure mode. Severity is a relative
ranking within the scope of the individual FMEA. The team should agree on evaluation criteria and a ranking
system and apply them consistently, even if modified for individual process analysis. It is not recommended to
modify criteria ranking values of 9 and10. Failure modes with a rank of severity 1 should not be analyzed
further.
Criteria
Effect Rank
Severity of Effect on Product(Customer Effect)
Failure to Meet Potential failure mode affects safe vehicle operation and/or involves noncompliance 10
Safety and/or with government regulation without warning.
Regulatory Potential failure mode affects safe vehicle operation and/or involves noncompliance
9
Requirements with government regulation with warning.
Loss or Loss of primary function (vehicle inoperable, does not affect safe vehicle operation) 8
Degradation of Degradation of primary function (vehicle operable, but at reduced level of
7
primary function performance)
Loss or Loss of secondary function (vehicle operable, but convenience functions inoperable). 6
Degradation of Degradation of secondary function (vehicle operable, but comfort /convenience
5
secondaryfunction functions at reduced level of performance).
Appearance or Audible Noise, vehicle operable, item does not conform and noticed
4
by most customers (> 75%)
Annoyance
Appearance or Audible Noise, vehicle operable, item does not conform and noticed
3
by many customers (50%).
Appearance or Audible Noise, vehicle operable, item does not conform and noticed
2
No effect by discriminating customers (< 25%)
No discernible effect. 1
Example of DFMEA Severity Evaluation criteria
8
Page
Occurrence (g)
Occurrence is the likelihood that a specific cause/mechanism will occur resulting in the failure mode within the
design life. The likelihood of occurrence ranking number has a relative meaning rather than an absolute value.
A consistent occurrence ranking system should be used to ensure continuity. The occurrence number is a
relative ranking within the scope of the FMEA and may not reflect the actual likelihood of occurrence. The
team should agree on evaluation criteria and a ranking system and apply them consistently, even if modified for
individual process analysis. Occurrence should be estimated using a 1 to 10 scale. In determining this estimate,
questions such as the following should be considered:
Prevention:
11
Eliminate (prevent) the cause of the mechanism of failure or the failure mode from occurring, or reduce its rate
Page
of occurrence.
Identify (detect) the existence of a cause, the resulting mechanism of failure or the failure mode, either by
analytical or physical methods, before the item is released for production.
The preferred approach is to first use prevention controls, if possible. The initial occurrence rankings will be
affected by the prevention controls provided they are integrated as part of the design intent. Detection control
should include identification of those activities which detect the failure mode as well as those that detect the
cause. The team should consider analysis, testing, reviews, and other activities that will assure the design
adequacy such as:
Prevention Controls
Benchmarking studies
Fail-safe designs
Design and Material standards (internal and external)
Documentation — records of best practices, lessons learned, etc. from similar designs
Simulation studies — analysis of concepts to establish design requirements
Error-proofing
Detection controls
Design reviews
Prototype testing
Validation testing
Simulation studies — validation of design
Design of Experiments; including reliability testing
Mock-up using similar parts
Failure
Cause Preventive Control Detection Control
Mode
Mechanical linkage break due to Designed per material Environmental stress test
inadequate corrosion protection standard MS-845 03 -9963
Master cylinder vacuum lock due to Carry-over design with Pressure variability
seal design same duty cycle testing — system level
Vehicle requirements
does Loss of hydraulic fluid from loose Designed per torque Vibration step stress test
not stop hydraulic line due to incorrect requirements -3993 18-195O
connector torque specification
Loss of hydraulic fluid due to Designed per Material Design of Experiments
hydraulic lines crimped/compressed, standard MS-1178 (DOE) — tube resiliency
inappropriate tube material specified
Examples of Prevention and Detection Design Controls
12
Page
Likelihood
Opportunity for Criteria:
Rank for
Detection Likelihood of Detection by Design Control
Detection
No detection Almost
No current design control; Cannot detect or is not analyzed. 10
opportunity Impossible
Design analysis/detection controls have a weak detection
Not likely to Very
capability; Virtual Analysis (e.g., CAE, FEA, etc.) is not correlated 9
detect at any stage Remote
to expected actual operating conditions.
Product verification/validation after design freeze& prior to launch
with pass/fail testing (Subsystem or system testing with acceptance 8 Remote
criteria such as ride and handling, shipping evaluation, etc.)
Post Design Product verification/validation after design freeze and prior to
Freeze and launch with test to failure testing (Subsystem or system testing until 7 Very low
prior to launch failure occurs, testing of system interactions, etc.).
Product verification/validation after design freeze and prior to
launch with degradation testing (Subsystem or system testing after 6 low
durability test, e.g., function check).
Product validation (reliability testing, development or validation
tests) prior to design freeze using pass/fail testing (e.g., acceptance 5 Moderate
criteria for performance, function checks, etc.)
Prior to Design Product validation (reliability testing, development or validation
Moderately
Freeze tests) prior to design freeze using test to failure (e.g., until leaks, 4
high
yields, cracks, etc.)
Product validation (reliability testing, development or validation
tests) prior to design freeze using degradation testing (e.g., data 3 High
trends, before/after values, etc.)
Virtual Design analysis/detection controls have a strong detection
Analysis - capability. Virtual analysis (e.g. CAE, FEA, etc.) is highly
2 Very High
Correlated correlated with actual or expected operating conditions prior to
design freeze.
Detection not Failure cause or failure mode cannot occur because it is fully
Almost
13
The initial focus of the team should be oriented towards failure modes with the highest severity rankings. When
the severity is 9 or 10, it is imperative that the team must ensure that the risk is addressed through existing
design controls or recommended actions. For failure modes with severities 8 or below the team should consider
causes having highest occurrence or detection rankings. It is the team‟s responsibility to look at the information
identified, decide upon an approach, and determine how to best prioritize the risk reduction efforts that best
serve their organization and customers.
Within the scope of the individual FMEA, this value can range between 1 and 1000.
The use of an RPN threshold is NOT a recommended practice for determining the need for actions. Applying
thresholds assumes that RPNS are a measure of relative risk (which they often are not) and that continuous
improvement is not required (which it is). For example, if the customer applied an arbitrary threshold of 100 to
the following, the supplier would be required to take action on the characteristic B with the RPN of 112.
In this example, the RPN is higher for characteristic B, but the priority should be to work on A with the higher
severity of 9, although the RPN is 90 which is lower and below the threshold. Another concern with using the
threshold approach is that there is no specific RPN value that requires mandatory action. Unfortunately,
establishing such thresholds may promote the wrong behavior causing team members to spend time trying to
justify a lower occurrence or detection ranking value to reduce RPN. This type of behavior avoids addressing
the real problem that underlies the cause of the failure mode and merely keeps the RPN below the threshold. It
is important to recognize that while determining “acceptable” risk at a particular program milestone
(e.g., vehicle launch) is desirable, it should be based on an analysis of severity, occurrence and detection and
14
not through the application of RPN thresholds. Use of the RPN index in the discussions of the team can be a
useful tool. The limitations of the use of RPN need to be understood. However, the use of RPN „thresholds to
Page
Only a design revision can bring about a reduction in the severity ranking. High severity rankings can
sometimes be reduced by making design revisions that compensate or mitigate the resultant severity of failure.
For example: The requirement for a tire is to “retain applied air pressure under use”. The severity of the effect
of the failure mode “rapid loss of air pressure” would be lower for a "run flat" tire. A design change, in and of
itself, does not imply that the severity; will be reduced. Any design change should be reviewed by the team to
determine the effect to the product functionality and process. For maximum effectiveness and efficiency of this
approach, changes to the product and process design should be implemented early in the development process.
For example, alternate materials may need to be considered early in the development cycle to eliminate
corrosion severity.
A reduction in the occurrence ranking can be effected by removing or controlling one or more of the causes or
mechanisms of the failure mode through a design revision. Actions such as, but not limited to, the following
should be considered:
The preferred method is the use of error/mistake proofing. An increase in design validation/ verification actions
should result in a reduction of the detection ranking only. In some cases, a design change to a specific part may
be required to increase the likelihood of detection (i.e., reduce, the detection ranking). Additionally, the
following should be considered:
Design of Experiments (particularly when multiple or interactive causes of a failure mode are
present)
Revised test plan
If the assessment leads to no recommended actions for a specific failure mode/cause/control combination,
15
indicate this by entering “None” in this column. It may be useful to also include a rationale if “None” is entered,
Page
especially in case of high severity. For design actions consider using the following:
After the action has been implemented, enter a brief description of the action taken and actual completion date.
Page
17
Page