En PLATO E1ns E-Learning - Lesson 3 - FMEA Methodology Steps 5-7 With Practical Example

E-Learning Course for PLATO e1ns
Lesson 3: FMEA methodology and

practical example
(continued)
06.01.2021
1
Lesson 3, part 1:
Creating the FMEA in 7 Steps
according to AIAG/VDA - Steps 5-7
06.01.2021
2
Watch this lesson as a video
Online videos for lesson 3
There are two videos available for this lesson. You can find both on the training content page
for this e-learning course:
▪ Part 1 – FMEA methodology steps 5-7 (in the video the following slides are explained in detail)
▪ Part 2 – Practical example for steps 5-7 (the video shows the practical example "live", without slides)
06.01.2021 © PLATO AG, e1ns Training
3
Methodology continued:
Step 5: Risk Evaluation
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Risk evaluation in the FMEA form
Product (design) or
Effects of the failure What are the actual
operation (process)
on the upper level. measures to remove
requirements. With
the problem?
characteristics.
Function/ Current AP1/RPN1

Failure Effect Cause SxOxD
Process step actions
...
Derived of the Why does the What is the

function: which failure occur? current risk?
problems can occur?
© PLATO AG
Actual Target
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Risk evaluation by key figures: Risk Priority Number “RPN”
„Classic“ FMEA Risk Evaluation by RPN (Risk Priority Number)
▪ S Severity of potential failure effect (FE)

▪ O Occurrence of potential failure cause (FC)
▪ D Detection of potential failure mode (FM) or potential failure cause (FC)
▪ S, O and D must be evaluated in each case from 1 ... 10.

(1 = low risk, 10 = high risk)
© PLATO AG
▪ RPN = S x O x D = 1 ... 1000

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Risk evaluation by key figures: Risk Priority Number “RPN”
The problem with RPN…
© PLATO AG
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Risk evaluation by key figures: Risk Matrix “SxO”
„Classic“ FMEA Risk Evaluation by Risk Matrix (SxO)
© PLATO AG
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Risk evaluation by key figures: Action Priority “AP”
„Modern“ FMEA Risk Evaluation by AP (Action Priority)
Example: AP for S10 – O8 – D2 = H
AP=H (high)
The team must define appropriate actions to improve
occurrence and/or detection. Or they have to document and
justify why existing actions taken are sufficient.
AP=M (medium)
The team should define appropriate actions to improve
occurrence and/or detection. Or they have to document and
justify why existing actions taken are sufficient.
© PLATO AG
AP=L (low)
The team can identify appropriate actions to improve
occurrence and/or detection.
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„Modern“ FMEA Risk Evaluation by AP (Action Priority)
© PLATO AG
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Risk Evaluation for Design-FMEA
Preventive actions
Preventive actions start with the causal avoidance of problems, reduce the probability of
occurrence (O) of a failure cause in the risk assessment and require a corresponding reference to
the document, which comprehensibly describes the avoidance measures.
Examples
• System design according to simulation or prototype
• Reliability rates of similar systems (experience with product reference)
• reinforcements
• material selection
• tolerance calculation
© PLATO AG, e1ns Training
• Comply with standards / guidelines XYZ

• Redundant components
• Data manuals, warranty databases
• Experience from the field ...
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Risk Evaluation for Design-FMEA
Detective actions
Detective/inspection actions start with problem identification, improve the probability of detection (D) of
failure causes or failures in the risk assessment, confirm the effectiveness of the prevention actions and
require a corresponding reference to the document that comprehensibly describes the measure.
Examples
▪ Function check acc. to test plan xzy
▪ Tolerance sample inspection acc. to G-456
▪ Endurance test according to document 123
▪ Simulation method SV9000
▪ Laboratory tests according to LV-No. 1235 ...

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Evaluation Catalog for Design-FMEA
Severity, Occurrence, Detection
Severity Occurrence Detection
1 No discernible effect. Failure is eleminated through preventive control. Failure cause or failure mode can not occur because it is
fully prevented through design solutions…
2 Appearance or Audible Noise … noticed by customers No observed failures associated with almost identical Design/detection controls have a strong detection
(<25%). design... 1 in 1,000,000 capability. Virtual analysis (e.g. CAE, FEA, etc.) …
3 Appearance or Audible Noise … noticed by customers Only isolated failures associated with almost identical Product validation (reliability testing, development or
(50%). design… 1 in 100,000 validation tests) prior to design freeze using
degradation testing …
4 Appearance or Audible Noise … noticed by customers Isolated failures associated with similar design or in Product validation (reliability testing, development or
(>75%). design simulation and testing. 1 in 10,000 validation tests) prior to design freeze using test to
failure testing …
5 Degradation of secondary function (comfort / Occasional failures associated with similar design or in Product validation (reliability testing, development or
convenience). design simulation and testing. 1 in 2,000 validation tests) prior to design freeze using pass/fail
testing …
6 Loss of secondary function (comfort / convenience). Frequent failures associated with similar design or in Product verification/validation after design freeze and
design simulation and testing. 1 in 500 prior to launch with with degradation testing …
7 Degradation of primary function (reduced level of Failure is uncertain with new design, new application, or Product verification/validation after design freeze and
performance). cahnge in duty cycle/operating conditions. 1 in 100 prior to launch with with test to failure testing …
8 Loss of primary function (vehicle inoperable, does not Failure is likely with new design, new application, or Product verification/validation after design freeze and
affect safe vehicle operation). cahnge in duty cycle/operating conditions. 1 in 50 prior to launch with with pass/fail testing …
9 Noncompliance with government regulation with warning. Failure is inevitable with new design, new application, Design analysis/detection controls have a weak
or cahnge in duty cycle/operating conditions. 1 in 20 detection capability …
10 Safe vehicle operation affected / Life in danger. New technology/new design with no history. >/= 1 in 10 No current design control: Cannot detect or is not
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analyzed.
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Risk Evaluation for Process-FMEA
Preventive actions
Preventive actions serve the optimal process planning and decrease in the risk assessment the
probability of occurrence (O) of a failure possibility and need a corresponding reference to the
document, which describes the action comprehensible.
Examples
▪ Discovery of possible design flaws of the production plant by test runs acc. to regulation ABC
(process planning)
▪ Discovery of defective parts in the manufacturing plant or at the test site
▪ Use of a particular device
▪ Avoidance of the error by POKA YOKE

▪ Two-hand operation on machines
▪ Following part can not be mounted
▪ shape-bound positioning
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Risk Evaluation for Process-FMEA
Detective actions
Detective/inspection actions start with problem identification, improve the probability of detection (D) of
failure causes or failures in the risk assessment, confirm the effectiveness of the prevention actions and
require a corresponding reference to the document that comprehensibly describes the measure.
Examples
▪ Visual inspection according to test instruction ABC
▪ Tolerance sample inspection acc. G-456
▪ Dimension check with check tool XYZ
▪ attributive exam with Tool 2500 ...
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Evaluation Catalog for Process-FMEA
Severity, Occurrence, Detection
Severity Occurrence Detection
1 No discernible effect. Failure is eleminated through preventive Error (Cause) prevention as a result of fixture design, machine design
control. or part design. Discrepant parts cannot be made …
2 Slight inconvenience to process, operation, operator. 1 in 1,000,000 (incidents per Error (Cause) detection in-station by automated controls that will
items/vehicles) detect error and prevent discrepant part from being made.
3 A portion of production run may have to be reworked in- 1 in 100,000 (incidents per items/vehicles) Failure Mode detection in-station by automated controls that will
station before it is processed. detect discrepant part and automatically lock part in station to prevent
further processing.
4 100% of production run may have to be reworked in- 1 in 10,000 (incidents per items/vehicles) Failure Mode detection post-processing by automated controls that
station before it is processed. will detect discrepant part and automatically lock part in station to
prevent further processing.
5 A portion of production run may have to be reworked off 1 in 2,000 (incidents per items/vehicles) Failure Mode or Error (Cause) detection in-station by operator through
line and accepted. use of variable gauging or by automated controls in-station that will
detect discrepant part and notify operator (light, buzzer, etc.).
6 100% of production run may have to be reworked off line 1 in 500 (incidents per items/vehicles) Failure Mode detection post-processing by operator through use of
and accepted. variable gauging or in-station by operator with attribute gauging.
7 A portion of production run may have to be scapped. 1 in 100 (incidents per items/vehicles) Failure Mode detection in-station by operator through
Deviation from primary process including decreased line visual/tactile/audible means or post-processing through use of
speed or added manpower. attribute gauging.
8 100% of production run may have to be scrapped. Line 1 in 50 (incidents per items/vehicles) Failure Mode detection post-processing by operator through
shutdown or stop ship. visual/tactile/audible means.
9 May endanger operator (machine or assembly) with 1 in 20 (incidents per items/vehicles) Failure Mode and/or Error (Cause) is not easily detected (e.g. random
warning. audits).
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10 May endanger operator (machine or assembly) without >/= 1 in 10 (incidents per items/vehicles) No current process control; Cannot detect or is not analyzed.
warning.
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Result in the DFMEA Form: Steps 3 to 5
© PLATO AG
1/6/2021
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Step 6: Optimization
Reducing the risk in the FMEA form
Which measures are Which target date has The true Which status is
suitable to reduce the been fixed? implementation date connected to the
risk? of the action action (bundle)?
Target Action
Recomm. Completion AP2/RPN2
Responsibility completion
SxOxD
Status
action taken date
... date
Who is making
Which actions have Which risk level
the decision and
been realized? does exist after
is responsible
© PLATO AG
optimization?
for realization?
Actual Target
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Examples for optimization criteria to reduce the risk
▪ First criteria is the AP!
▪ Critical value optimization

Value exceeding at single key figure (e.g. S=9), single product (e.g. SxO) and/or RPN
(e.g. RPN > 120) must be optimised.
Use the Risk Matrix SxO as a tool for visualizing.
▪ Top-3 (or 5, or 10) Optimization

The three (fife, ten, etc.) highest rated risks are optimized.
▪ Old „FORD principle“

Priorities for preventive actions will be calculated as follows:
1st high severity figure,
2nd high S*O value,
3rd high RPN value
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Recognizing weaknesses in Design and Process and optimizing them through measures
Priority for optimization should be as follows:

prevention before reaction!
1. Prevention of occurance (failure cause)

2. Minimization of occurance (failure cause)
3. More effective detection of failures or failure causes
Next you have to…

▪ Define new actions/measures

▪ Define responsible Manager, schedule deadline dates
▪ Perform activities and reevaluate
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Result in the DFMEA Form: Steps 3 to 6
© PLATO AG
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Step 7: Documentation and Presentation
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The results of the FMEA analysis shall be documented and reported to the relevant audience.
This could be inside the company or to suppliers or customers.
AP Graph Risk graph: Actual SxO2

▪ Summary in a report
▪ Scope of consideration of the FMEA
▪ S-O-D Evaluation catalogs
▪ Action priorities
▪ Results and conclusions of the
analysis
▪ Graphical visualization Risk graph: Actual AP No. Of causes RPN1 vs RPN2
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Use e1ns.output to generate documentation files. For example when a development gate is reached.
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Use e1ns.documents to store the documentation of your projects.
▪ Central file storage

▪ Structure-based
▪ Workflow for release and versioning
▪ See changes in Audit Trail
▪ Comment function
Status Rev. Title Modification Date Size Editor Options
Draft
Released
Released
Released
Archived
1/6/2021
Released
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And now…
Let‘s jump into the software and learn how to conduct the last steps no. 5 to 7!
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End of lesson 3, part 1
06.01.2021
28
Lesson 3, part 2:
Practical example
Steps 5-7 according to AIAG/VDA
06.01.2021
29
Watch this lesson as a video
Online videos for lesson 2
There are two videos available for this lesson. You can find both on the training content page
for this e-learning course:
▪ Part 1 – FMEA methodology steps 5-7 (in the video the following slides are explained in detail)
▪ Part 2 – Practical example for steps 5-7 (the video shows the practical example "live", without slides)
The following applies to this lesson as well:

The next exercises are explained in detail in the accompanying video. You can play it and work
on your training environment at the same time.
If you would like it to be a little more challenging, then just try to do the exercises on your own
first!
30
06.01.2021 © PLATO AG, Training exercises
31
Module: e1ns.methods
Exercise 8: e1ns.methods - Specifications
Add specifications for design characteristics:

▪ On the system element „Pen with cap“ for the function
"Ensure durability":
Write cycles >= 1000 <sc>
▪ On the system element „Refill“ for the function

"Dispense appropriate amount of ink":
Amount of ink per meter = 0,815 ml (+/- 0,1) <cc>
Add specifications for process characteristics :

▪ On the system element „Final assembly pen“ for the process step
"Insert refill in housing":
Assembly pressure = 50 N (+/- 5) <cc>
32
Exercise 8: e1ns.methods - Specifications
▪ Solution:
33
Exercise 9: e1ns.methods – Design-FMEA
Design-FMEA for component "Refill“
Current Risk:
▪ Go to e1ns.methods into the form "TeamFMEA“
▪ Complete the evaluation for the severity of the effect (S)
▪ Complete current prevention and detection actions
▪ Complete the evaluations for O and D
Optimization:
▪ Define two recommended actions for the cause "Viscosity too low".
For example:
Supplier audit (P)
Viscosity test (D)
▪ Define the responsible person etc. and re-evaluate the risk
34
Exercise 9: e1ns.methods – Design-FMEA
▪ Solution:
35
Exercise 10: e1ns.methods – Process-FMEA
Process-FMEA for "Final assembly pen“
Current Risk:
▪ Go to e1ns.methods into the form "TeamFMEA"
▪ Complete the evaluation for the severity of the effect (S)
▪ Complete current prevention and detection actions
▪ Complete the evaluations for O and D
▪ Add a new cause: "Assembly with too much pressure".
→ Please connect properly afterwards by using e1ns.architect!!!
Optimization:
▪ Define recommended actions for the two causes.
For example:
Staff/Operator training (P)
Poka Yoke Design (P)
▪ Define the responsible person etc. and re-evaluate the risk
36
Exercise 10: e1ns.methods – Process-FMEA
▪ Solution:
37
Exercise 11: Documentation of Results
Use the respective e1ns module to generate the following outputs:
e1ns.output:
▪ Use the "Sample Product File" output format at the product level for all relevant sub-elements
and generate a PDF document.
e1ns.documents:
▪ Share the generated PDF document directly with e1ns.documents. Save any other documents
there.
e1ns.dashboard:
▪ Use the "3x3 Risk Graph" for the assembly of the “Refill" as well as for the process of the “Final
assembly".
▪ Create an overview of AP values via “Action Priority > AP Graph".
▪ Create an Excel document via "FMEA Maturity" that allows you to perform a variety of data
38 analyses.
Exercise 11: Documentation of Results
▪ Solution:
39
Quiz for lesson 3
Online self-test
▪ Click here to start a quiz for lesson 3. Good luck!

06.01.2021
40
End of lesson 3
... continue with lesson 4!
06.01.2021
41

En PLATO E1ns E-Learning - Lesson 3 - FMEA Methodology Steps 5-7 With Practical Example

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E-Learning Course for PLATO e1ns

Lesson 3: FMEA methodology and

Function/ Current AP1/RPN1

Derived of the Why does the What is the

„Classic“ FMEA Risk Evaluation by RPN (Risk Priority Number)

▪ S Severity of potential failure effect (FE)

▪ S, O and D must be evaluated in each case from 1 ... 10.

▪ RPN = S x O x D = 1 ... 1000

• Comply with standards / guidelines XYZ

▪ Laboratory tests according to LV-No. 1235 ...

▪ Avoidance of the error by POKA YOKE

▪ First criteria is the AP!

▪ Critical value optimization

▪ Top-3 (or 5, or 10) Optimization

▪ Old „FORD principle“

Priority for optimization should be as follows:

1. Prevention of occurance (failure cause)

Next you have to…

▪ Define new actions/measures

AP Graph Risk graph: Actual SxO2

▪ Central file storage

Status Rev. Title Modification Date Size Editor Options

The following applies to this lesson as well:

Add specifications for design characteristics:

▪ On the system element „Refill“ for the function

Add specifications for process characteristics :

Design-FMEA for component "Refill“

Process-FMEA for "Final assembly pen“

Use the respective e1ns module to generate the following outputs:

▪ Click here to start a quiz for lesson 3. Good luck!

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