FMEA is a technique designed to systematically analyze and review components, assemblies and subsystems to find possible failure modes and the cause and effects of malfunctions. Developed in the 1950s to study problems arising in military systems, FMEA is foremost used as a system reliability study and for the means of quality control and failure prevention.
The basic concept is to identify and evaluate the causes of potential errors in the concept phase rather than using error detection and correction. Preventive, rather than reactive, FMEA seeks to improve products and processes during the inspection phase. Thus, error-tracking costs that may otherwise occur in the production phase or even after delivery can be avoided. Errors, more severe the later they are found, can have varying degrees of costs concerning financial and existential consequences as well as damaging a company’s reputation. Various graphs display these costs as well as explanations and benefits of FMEA are attractively represented for easy comprehension. The FMEA template set also outlines the development stage, work preparation, production planning and sourcing phases. Variants of FMEA are incorporated such as the Kepner-Tregoe Method (KT-Method), and also different analysis tables and form sheets.
3. AGENDA
BASIC CONCEPT
Definition– what is FMEA?
WHY FMEA?
BENEFITS And TARGETS OF
FMEA
TYPES OF FMEA
PROCEDURE
Key FIGURES
LAUNCH And TRAINING OF
FMEA
Phase model DAMUK
FMEA Form SHEET
4. BASIC CONCEPT
The later an error is detected, the more difficult
and expensive is to correct
Instead of using error detection and correction, avoid
errors all together by identifying and evaluating the
causes of potential errors in the concept phase
Thus, inspection or error-tracking costs that would
otherwise occur in the production phase or even after
delivery can be avoided and overall costs reduced
Through past findings, the repetition of defects in
new products and processes is avoided
The principle of error prevention plays the key role
The quality awareness of every employee is the focus
Quality control is no longer an area of expertise, but
should
be of common knowledge for each and everyone
5. DEFINITION – WHAT IS FMEA?
The important methodic
instrument of reliability
technology is used to detect
possible product and process
errors and their causes and
consequences at an early stage
ANALYSISMETHOD
Possible errors are evaluated
with a key figure regarding their
relevance for the customer,
their probability of occurrence
and detection
KEY FIGURES
Within quality and safety
management, FMEA is applied to
increase technical reliability
especially in the development and
planning phase of new products
and processes
TECHNICAL RELIABILITY
FMEA is used to monitor the
maturity level of products and
processes and is therefore an
important managing instrument
to support interdisciplinary
teamwork
MATURITY MONITOR
6. WHY FMEA?
Extending the term
“quality” to services and
intra-company cooperation
requires modern quality
management within the
whole company
Being aware that lacking
quality means less profit
has led to the fact that
quality has top priority
within corporate goals
Orientation towards
requirements of internal
and external customers
increases competitiveness
Aim to create an awareness
for the fact that flawless
products and services can
only be reached by
continuous improvement
7. UNPLEASANT DRIVING
EXPERIENCE
THE STEERING WHEEL
IS VIBRATING
THE CAR IS VIBRATING
THE AXIS IS VIBRATING
THE WHEEL IS BEATING
THE TIRE IS IMBALANCED
THE MECHANIC DID NOT
BALANCE THE TIRES
SE 0
CAR
SE 1
VEHICLE
SE 2
AXIS
SE 3
WHEEL
SE 4
TIRE
SE 5
DEALER
Effect
Error Effect
Cause Error Effect
Cause Error Effect
Cause Error Effect
Cause Error Effect
Cause Error
SYSTEM level
ERror
EXAMPLE
8. BENEFITS AND GOALS OF FMEA
Recognizing risks
that are
connected with
products or
processes
in the company
Avoiding or
decreasing costs
for quality
control,
reworking and
error correction
Designing
processes in such
a way that they
run smoothly
Assuring
functionality,
safety and
reliability to
minimize liability
claims
Developing
products
from the start, so
that no errors,
quality defects or
damages arise
9. TYPES OF FMEA
Makes early assessment of
the manufacturing suitability
of a product
Considers systematic failures
during the construction
phase
Possible breakdowns and
errors that can occur on
separate parts of the system
are regarded and proactively
avoided
Detects error causes usually
arising in the construction
and manufacturing phase
Is directed by a responsible
engineer
Construction plans are the
basis
Explores the interaction of
subsystems or components
of an entire system
Aims to identify potential
weaknesses, that could arise
at the interaction of single
components
Considers random and
systematic failures during
operation
Analyzes procedures of the
considered system
Is based on results from the
Construction FMEA and
determines possible
weaknesses in the
production process
Examines the process
related to
error causes
Thus, process suitability,
reliability and quality are
ensured at an early stage
Is guided by a responsible
employee of the production
Design drawings are the
basis
HardwareFMEASYSTEM FMEAprocess FMEA
Same purpose as Hardware
FMEA, but for generated
program codes
Aims to analyze, evaluate
and eliminate risks from the
hardware and electronic
fields
CONSTRUCTION FMEA
SoftwareFMEA
System FMEA, Construction, Hardware and Software FMEA have been combined to PRODUCT FMEA,
which investigates functional correlations in the considered system.
10. TYPES OF FMEA
Application areas of product and process FMEA
concept development Process Planning PRODUcTION SERIEs
Systematic analysis of product and process
Elimination of error causes and risks in
development and planning taking all departments
into account
Principle of error prevention
Product FMEA
System analysis
Product FMEA
Consideration of functions
Product FMEA
Consideration of construction
Process FMEA
Manufacturing process
Process FMEA
Assembly process
11. problem
CAUSE-AND-EFFECT-DIAGRAM
Cause EFFECT
MACHINE
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MEASUREMENT
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MATERIALS
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MOTHER NATURE
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METHOD
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MAN
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12. PROCEEDING IN 5 STEPS
StructureAnalysis
Function Analysis
error Analysis
RISKevaluation
Optimization
RPI*
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S SIGNIFICANCE
D DETECTION
P PROBABILITY
*Risk Priority Index
13. KEY FIGURES
P: occurrence probability of error causes
S: significance for the customer
D: detection probability of the error or its cause
Key figures P, S and D are basis for evaluating the risk
Can take integer values between 1 and 10
RPI: with the Risk Priority Index a risk ranking can be
generated
It results from the multiplication of P, S and D and can
therefore take values between 1 and 1,000
The benefit is still questioned, as the same results
could have been emerged in different ways
RPI* = p × s × d
*Risk Priority Index
14. IMPLEMENTATION AND TRAINING OF FMEA
1. Decision of the Management
Turning away from the commonly practiced crisis
management and shift to a preventive quality
management in the whole company
Due to the long-term and comprehensive
importance of a reorientation, only the
management can make the decision to introduce
FMEA and implement it
Active support during the introduction phase
and common interest in future results are
essential aspects of the management’s
fundamental decision
15. FMEA – PHASE MODEL DAMIC
Guideline for an efficient implementation of FMEA Methods in the Company
Definition: preparation
and system definition
Analysis: systematic
determination of demands
and risks; conduct FMEA in
the team
Measurement decision:
define measures and
procedures
Implementation: realizing
and evaluating through
verification, validation and
monitoring
Communication: present,
inform and communicate
Ico
ns
Analysisimplementation
Measures
decision
Definition
communication
16. VARIANTS OF FMEA
Bow Tie
Method developed by Shell to solve
problems in the off-shore sector
Graphic method that depicts causes on one
side, effects on the other side, and the error
itself in between
Between causes and effects, barriers are
planned in order to avoid errors and
reduce error consequences
For each error, this results in an image that
resembles a bow tie
Barriers that have not been implemented
can be introduced with the help of a
measure plan
17. VARIANTS OF FMEA
HAZOP – Hazard-Operability
H POZAIn the chemical industry,
Process FMEA is often
replaced or added by the
Hazard Operability
Method
Whole process facilities
are divided into
subsystems based on
installation plans, work
instructions, and
formulations (e.g.)
For each plant unit,
target functions are
listed; for every target
function, possible
disturbances are
searched for and
appropriate counter
measures are planned
A HAZOP Analysis is
performed by a group
of project and process
engineers, as well as
experts of work safety,
environment protection
and fire protection
An experienced
moderator motivates the
group for creative work
and is responsible for the
preparation and follow-
up of discussions
18. VARIANTS OF FMEA
Kepner-Tregoe Method (KT-Method)
This method doesn’t stop at the collection
of random results, but sets a specific
structure of analyzing problems
Thereby, comparable problems from the
past are considered as former findings
might help solve current problems
In 1970, the method was applied by NASA
to save flight Apollo 13
The saying: “Houston, we have a problem.”
is the first step to solve a problem with the
KT-Method
Simplified description of the method:
Naming the problem (with the help of
the 5W-Technique or Fish Bones Technique)
Describing the problem and analyzing the
cause
Examining the cause analysis
Finding the solution
19. 1. Master data
Information on the FMEA type, the considered unit or system and people
involved
The considered system and the associated FMEA number have to be clearly
recognizable
2. System element / function / task
Description of the considered object (system, module, product, component)
List of all features and functions which the object has to fulfill
During a Process FMEA, the planned work sequence is described in detail
3. Possible error consequences
Successively, each possible error is regarded and treated as if it had occurred
The particular impact on the entire system is described in such a way as the
customer would recognize it
FMEA FORM SHEET
Explanations
20. FMEA FORM SHEET – VARIANTS
Function:
Text:
Function:
Text:
Possible error
consequences:
Significance:
Systemelement
/Function:
Possible
error/malfuncti
on:
Possible error
causes:
Current state: Proposed
correction
measures:
Responsible
person /
Deadline:
FAILURE-MODE-AND-EFFECT-ANALYSIS
FMEA
Product name: Product no.:
Model/System/Production: Techn. Revision state:
Created by (Name/Dep.): Created:
Occurrence:
RPI:
RPI:
Avoidance measures: Detection
measures:
Taken
measures:
Significance:
Occurrence:
RPI:
Improved state:
Revised: Effort (in hrs):
Detection:
Function:
Text:
Design FMEA Process FMEA
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