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E-Learning Course for PLATO e1ns

Lesson 1:
FMEA history and first steps
06.01.2021

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Lesson 1, part 1:
History and development of FMEA
06.01.2021

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Watch this lesson as a video
Online videos for lesson 1

There are two videos available for this lesson. You can find both on the training content page
for this e-learning course:

▪ Part 1 - History and development of FMEA (in the video the following slides are explained in detail)

▪ Part 2 - First steps in e1ns (the video shows the practical example "live", without slides)
06.01.2021 © PLATO AG, e1ns Training

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What is FMEA?

FMEA: Failure Mode and Effects Analysis

▪ Preventive method to analyse products and processes to prevent


potential failures

▪ Predominantly used in Development and Production

▪ Discover potential weak spots, causes and effects


© PLATO AG, e1ns Training

▪ Goal - Failure prevention instead of failure adjustment (early use!)


- Faultless Products → customer satisfaction
1/6/2021

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A brief history of FMEA

1940... 1949: US-Millitary published FMEA Method as US Military Procedure (MIL-P-1629 )

Target
Guideline for military and suppliers to classify failures and defects in relation
to their influence on the success of a mission.

1960... 1963: NASA initiated FMEA to Apollo-Project


1965: Innovated by the aerospace industry in the USA
© PLATO AG, e1ns Training

Target
Development of faultless products. Focus especially on parts which
are difficult to repair or maintain.
1/6/2021

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A brief history of FMEA

1970... 1975: Applied to the Nuclear Technology,


1977: Applied to the automotive industry in 1977 (AIAG)

1980... in 1980 standardized by the VDA (Association of the German automotive industry)
from 1986 on enforced use in german automotive industry

1990... Applied to chemical and pharmaceutical industry, medical technology


and software development.
New FMEA form (VDA, 1996)

2000... The increasingly frequent request for the application of FMEA


© PLATO AG, e1ns Training

(ISO 9000:2000; FDA; GMP etc.) results in an increased use in


pharmaceutical industry, food industry and medical technology.

2019 New handbook for harmonized FMEA standards of AIAG and VDA.
1/6/2021

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FMEA – A Method Conquers the World
FORD “Pinto”
06.01.2021 © PLATO AG, e1ns Training

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FMEA – A Method Conquers the World
Initial Situation – The Scandal

Ford Pinto†
1970-1980
06.01.2021 © PLATO AG, System-FMEA nach VDA 4.2 Teil 1 - Methodik

✓ Most successful small car – competitor to VW Beatle


✓ Ford sells millions of cars in the 1970s
✓ Scandal because of heavy design defects
✓ Fuel tank in the back of the car exploded when car was hit in the trunk because of wrong
construction design
✓ 60 dead burn victims and more than 120 persons heavily injured
✓ Total cost for lawsuit: some million USD
✓ Huge damage for the image of FORD
✓ High risk for Ford to go bankrupt because of damage claims (Schadensersatzforderungen) in lawsuits

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FMEA – A Method Conquers the World
The Solution – Standards

Ford Pinto†
1970-1980
06.01.2021 © PLATO AG, System-FMEA nach VDA 4.2 Teil 1 - Methodik

1977 1978
AIAG standard by Re-call of >1,5 million cars
Ford/Chrysler/GM ✓ New fuel filler pipe
✓ Installation of protective plates

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Motivation for FMEA
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Why FMEA?
Because of…

Standards Laws
▪ DIN EN ISO 9001 ff ▪ Product liability act
(German: „Produkthaftungsgesetz“)
▪ IATF 16949 (2016)
▪ DIN EN ISO 14971
▪ Equipment and Product Safety Act
(German: “Geräte- und Produktsicherheitsgesetz”)

FMEA is recommended in ISO 9001 as a proof for your duty


of care („Sorgfaltspflicht“) Acknowlegment of FMEA as exoneration („Entlastung“) and proof of
your duty of care

FMEA
Guide Lines Economic efficiency
06.01.2021 © PLATO AG, e1ns Training

▪ VDA/AIAG ▪ Warranty/good will


▪ SAE J 1739 ▪ Avoid recalls
▪ EU-GMP ▪ Avoid loss of customers
▪ Avoid costs for late changes in design
Recommends/demands FMEA ▪ Do knowledge management

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Failure Formation and Removal

Failure formation Failure removal

75% of all failures 80% of all failures are


occur before the start Start of
removed after start
serial
of serial production production of serial production
Failure rate

➢ 40% of all warranty expenses are because of conceptual reasons


➢ 60% of all failures are repetetive failures
© PLATO AG, e1ns Training

Product Development Production Production Test Use


definition planning

Phases during product life cycle


1/6/2021

(Source: Siemens Study with University RWTH Aachen, 1997)


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Rule of Ten
failure prevention failure correction

Entwickeln und Planen manufacturer


Beschaffen und Herstellen Prüfen und customer
Vertreiben
„An undetected failure does lead to
failure removal costs which are
increasing tenfold in each product life
cycle phase„
100.00 €
(Source: Daimler Benz/FhG-ITP, Aachen)
costs per failure
© PLATO AG, e1ns Training

10.00 €

1.00 €
0.10 €

planning design development production test application


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Conclusion “Why FMEA?”

Because FMEA is an established method to ensure that required product features are
met.

▪ Early detection and evaluation of possible failures during the design phase

▪ Prioritized handling of problems

▪ Definition of counter actions (prevention or detection)


06.01.2021 © PLATO AG, e1ns Training

▪ The FMEA documents the generated knowledge and avoids repetition of


failures

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End of lesson 1, part 1
06.01.2021

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Lesson 1, part 2:
Getting to know e1ns
Some simple first steps
06.01.2021

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Watch this lesson as a video
Online videos for lesson 1

There are two videos available for this lesson. You can find both on the training content page
for this e-learning course:

▪ Part 1 - History and development of FMEA (in the video the following slides are explained in detail)

▪ Part 2 - First steps in e1ns (the video shows the practical example "live", without slides)
06.01.2021 © PLATO AG, e1ns Training

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Getting to know e1ns
First steps – Goal: filling the FMEA form manually
06.01.2021 © PLATO AG, e1ns Training

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Getting to know e1ns
First steps – how to log in

Please use the web address of the training cloud which you have received by PLATO.
You will also receive your access data with username and password.
Your login page will look similar to this example:

1. Web address

2. Username

3. Password: plato
06.01.2021 © PLATO AG, e1ns Training

4. Database: DemoEng

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Getting to know e1ns
Video Tutorial

Follow this link to open a PLATO video on Youtube which demonstrates the basic handling
of e1ns and how to fill data into an empty FMEA form.

▪ https://youtu.be/ftdmxAPZqbA
06.01.2021 © PLATO AG, e1ns Training

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And now…

Let‘s jump into the software and learn some basic handling of e1ns!
06.01.2021 © PLATO AG, e1ns Training

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Quiz for lesson 1
Online self-test

▪ Click here to start a quiz for lesson 1. Good luck!


06.01.2021

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End of lesson 1
... continue with lesson 2!
06.01.2021

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