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- Review the design—Use a
blueprint or schematic of the design/product to identify each
component and interface.
- Brainstorm potential failure modes—Review
existing documentation and data for clues.
- List potential effects of failure—There
may be more than one for each failure.
- Assign Severity rankings—Based
on the severity of the consequences of failure.
- Assign Occurrence rankings—Based
on how frequently the cause of the failure is likely to occur.
- Assign Detection rankings—Based
on the chances the failure will be detected prior to the
customer finding it.
- Calculate the RPN—Severity
x Occurrence x Detection.
- Develop the action plan—Define
who will do what by when.
- Take action—Implement
the improvements identified by your DFMEA team.
- Calculate the resulting RPN—Re-evaluate
each of the potential failures once improvements have been made
and determine their impact on the RPNs.
Reasons for the review:
- Help assure
all team members are familiar with the product and its design.
- Identify each of the main components of the design and determine the
function or functions of those components and interfaces between
them.
- Make sure you are studying all components defined in the
scope of the DFMEA.
Use a print or schematic for the review.
- Add
Reference Numbers to each component and interface.
Try out a
prototype or sample.
- Invite a subject matter expert to answer
questions.
- Document the function(s) of each component and
interface.
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-
Consider potential
failure modes for each component and interface.
- A potential
failure mode represents any manner in which the product component
could fail to perform its intended function or functions.
- Remember
that many components will have more than one failure mode. Document
each one. Do not leave out a potential failure mode because it
rarely happens. Don’t take shortcuts here; this is the time to be
thorough.
Prepare for the brainstorming activity.
- Before you
begin the brainstorming session, review documentation for clues
about potential failure modes.
- Use customer complaints, warranty
reports, and reports that identify things that have gone wrong, such
as hold tag reports, scrap, damage, and rework, as inputs for the
brainstorming activity.
- Additionally, consider what may happen to
the product under difficult usage conditions and how the product
might fail when it interacts with other products.
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The effect is related
directly to the ability of that specific component to perform its
intended function.
- An effect is the impact a failure could make
should it occur.
- Some failures will have an effect on customers;
others on the environment, the process the product will be made on,
and even the product itself.
The effect should be stated in terms
meaningful to product performance. If the effects are defined in
general terms, it will be difficult to identify (and reduce) true
potential risks.
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The ranking scales are mission
critical for the success of a DFMEA because they establish the basis
for determining risk of one failure mode and effect relative to
another.
The same ranking scales for DFMEAs should be used
consistently throughout an organization. This will make it possible
to compare the RPNs from different FMEAs to one another.
- The
severity ranking is based on a relative scale ranging from 1 to 10.
A “10” means the effect has a dangerously high severity leading to a
hazard without warning. Conversely, a severity ranking of “1” means
the severity is extremely low. The scales provide a relative, not an
absolute, scale.
- See
FMEA Checklists
and Forms for an example DFMEA
Severity Ranking Scale.
The best way to customize a ranking scale
is to start with a standard generic scale and then modify it to be
more meaningful to your organization.
- By adding
organization-specific examples to the ranking definitions, DFMEA
teams will have an easier time using the scales. The use of examples
saves teams time and improves the consistency of rankings from team
to team.
- As you add examples specific to your organization,
consider adding several columns with each column focused on a topic.
One topic could provide descriptions of severity levels for customer
satisfaction failures and another for environmental, health, and
safety issues. However, remember that each row should reflect the
same relative impact, or severity, on the organization or customer.
- See
FMEA Checklists
and Forms for an example of Custom DFMEA Ranking Scales.
(Examples of custom scales for severity, occurrence, and detection
rankings are included in this Appendix.)
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We need to know the
potential cause to determine the occurrence ranking because, just
like the severity ranking is driven by the effect, the occurrence
ranking is a function of the cause.
- The occurrence ranking is
based on the likelihood, or frequency, that the cause (or mechanism
of failure) will occur.
- If we know the cause, we can better
identify how frequently a specific mode of failure will occur.
The
occurrence ranking scale, like the severity ranking, is on a
relative scale from 1 to 10.
- An occurrence ranking of “10” means
the failure mode occurrence is very high; it happens all of the
time. Conversely, a “1” means the probability of occurrence is
remote.
- See
FMEA Checklists
and Forms for an example DFMEA Occurrence
Ranking Scale.
Your organization may need to customize the
occurrence ranking scale to apply to different levels or
complexities of design. It is difficult to use the same scale for a
modular design, a complex design, and a custom design.
- Some
organizations develop three different occurrence ranking options
(time-based, event-based, and piece-based) and select the option
that applies to the design or product.
- See
FMEA Checklists
and Forms for an examples
of Custom DFMEA Ranking Scales. (Examples of custom scales for
severity, occurrence, and detection rankings are included in this
Appendix.)
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To assign detection rankings,
consider the design or product-related controls already in place for
each failure mode and then assign a detection ranking to each
control.
- Think of the detection ranking as an evaluation of the
ability of the design controls to prevent or detect the mechanism of
failure.
Prevention controls are always preferred over detection
controls.
- Prevention controls prevent the cause or mechanism of
failure or the failure mode itself from occurring; they generally
impact the frequency of occurrence. Prevention controls come in
different forms and levels of effectiveness.
- Detection controls
detect the cause, the mechanism of failure, or the failure mode
itself after the failure has occurred BUT before the product is
released from the design stage.
A detection ranking of “1” means
the chance of detecting a failure is almost certain. Conversely, a
“10” means the detection of a failure or mechanism of failure is
absolutely uncertain.
See Appendix 6 for the “Standard” (AIAG)
DFMEA Detection Ranking Scale.
To provide DFMEA teams with
meaningful examples of Design Controls, consider adding examples
tied to the Detection Ranking scale for design related topics such
as:
- Design Rules
- DFA/DFM (design for assembly and design for
manufacturability) Issues
- Simulation and Verification Testing
See
FMEA Checklists
and Forms for examples of Custom DFMEA Ranking Scales.
(Examples of custom scales for severity, occurrence, and detection
rankings are included in this Appendix.)
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The RPN is the Risk Priority Number.
The RPN gives us a relative risk ranking. The higher the RPN, the
higher the potential risk.
The RPN is calculated by multiplying
the three rankings together. Multiply the Severity Ranking times the
Occurrence Ranking times the Detection Ranking. Calculate the RPN
for each failure mode and effect.
- Editorial Note: The current FMEA
Manual from AIAG suggests only calculating the RPN for the highest
effect ranking for each failure mode. We do not agree with this
suggestion; we believe that if this suggestion is followed, it will
be too easy to miss the need for further improvement on a specific
failure mode.
Since each of the three relative ranking scales
ranges from 1 to 10, the RPN will always be between 1 and 1000. The
higher the RPN, the higher the relative risk. The RPN gives us an
excellent tool to prioritize focused improvement efforts.
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Taking action means reducing
the RPN. The RPN can be reduced by lowering any of the three
rankings (severity, occurrence, or detection) individually or in
combination with one another.
- A reduction in the Severity Ranking
for a DFMEA is often the most difficult to attain. It usually
requires a design change.
- Reduction in the Occurrence Ranking is
accomplished by removing or controlling the potential causes or
mechanisms of failure.
- And a reduction in the Detection Ranking is
accomplished by adding or improving prevention or detection
controls.
What is considered an acceptable RPN? The answer to that
question depends on the organization.
- For example, an organization
may decide any RPN above a maximum target of 200 presents an
unacceptable risk and must be reduced. If so, then an action plan
identifying who will do what by when is needed.
There are many
tools to aid the DFMEA team in reducing the relative risk of those
failure modes requiring action. The following recaps some of the
most powerful action tools for DFMEAs.
Design of Experiments (DOE)
- A family of powerful statistical improvement techniques that can
identify the most critical variables in a design and the optimal
settings for those variables.
Mistake-Proofing (Poka Yoke)
- Techniques that can make it impossible for a mistake to occur,
reducing the Occurrence ranking to 1.
- Especially important when
the Severity ranking is 10.
Design for Assembly and Design for
Manufacturability (DFA/DFM)
- Techniques that help simplify assembly
and manufacturing by modularizing product sub-assemblies, reducing
components, and standardizing components.
Simulations
- Simulation
approaches include pre-production prototypes, computer models,
accelerated life tests, and value-engineering analyses.
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The Action Plan outlines what steps are
needed to implement the solution, who will do them, and when they
will be completed.
A simple solution will only need a Simple
Action Plan while a complex solution needs more thorough planning
and documentation.
- Most Action Plans identified during a DFMEA
will be of the simple “who, what, & when” category. Responsibilities
and target completion dates for specific actions to be taken are
identified.
- Sometimes, the Action Plans can trigger a fairly
large-scale project. If that happens, conventional project
management tools such as PERT Charts and Gantt Charts will be needed
to keep the Action Plan on track.
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This step in a DFMEA
confirms the action plan had the desired results by calculating the
resulting RPN.
To recalculate the RPN, reassess the severity,
occurrence, and detection rankings for the failure modes after the
action plan has been completed.
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