Sie sind auf Seite 1von 36

Quality Management – Prof.

Schmitt Lecture 09

Lecture Quality Management


09 The Early Phases of Quality Management –
Focus: Deviation

Prof. Dr.-Ing. Robert Schmitt


© WZL/Fraunhofer IPT

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 0
Quality Management – Prof. Schmitt Lecture 09

Contents

 Introduction

 DR – Design Review

 QA – Quality Assessment

 FTA – Fault Tree Analysis

 FMEA – Failure Mode and Effects Analysis

 DRBFM – Design Review Based on Failure Mode

 Rapid Quality Deployment

© WZL/Fraunhofer IPT Page 1

Literature:
DGQ (Hrsg.): FMEA – Fehlermöglichkeits- und Einflussanalyse. In: DGQ Band 13-11, 2. Aufl., Berlin:
Beuth, 2001
Norm DIN EN ISO 9004 (Dezember 2000). Qualitätsmanagementsysteme – Leitfaden zur
Leistungsverbesserung
Norm DIN EN 60812 (November 2006). Analysetechniken für die Funktionsfähigkeit von Systemen –
Verfahren für die Fehlzustandsart- und -auswirkungsanalyse (FMEA)
Norm DIN 25424-1 (April 1990). Fehlerbaumanalyse. Methode und Bildzeichen
Norm DIN 25424-2 (April 1990). Fehlerbaumanalyse. Handrechenverfahren zur Auswertung eines
Fehlerbaums
Technische Spezifikation ISO/TS 16949 (August 2002). Qualitätsmanagementsysteme. Besondere
Anforderungen bei Anwendung von ISO 9001:2000 für die Serien- und Ersatzteil-Produktion in der
Automobilindustrie
Pfeifer, T.; Schmitt, R.: Masing - Handbuch Qualitätsmanagement. 5. Aufl. München: Hanser, 2007
Pfeufer, H.-J.: FMEA, Fehler-Möglichkeits- und Einflussanalyse, Kurzüberblick. München: BMW AG, 1993
Richtlinie VDI 2247(1994). Qualitätsmanagement in der Produktentwicklung. Qualitätskontrolle in der
Automobilindustrie. Berlin: Beuth, 1994
VDA (Hrsg.): VDA Band 4, Sicherung der Qualität. 2. Aufl., Frankfurt am Main: VDA Verband der
Automobilindustrie e. V., 2003.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 1
Quality Management – Prof. Schmitt Lecture 09

Challenge
 E.g. Mattel
News/ press release 08-14-07:
The Barbie manufacturer Mattel had to call back several
million toys due to poor reliability. Germany is also affected by
the greatest call-back in history of Mattel, says Mattel
announcer Michael Rust. Short time ago another call-back
from Mattel contained 1.5 million toys. The current call-back
includes - according to Mattel - 18.2 million toys worldwide.

“We have immediately established a three level controlling


system: First we demand that only exclusive colours of
certified suppliers are used and that every colour batch has to
be tested. Colours which don’t pass the test will not be used.
The second point is the intensification of the production Source: www.mattel.de
inspections and the increase of not announced random
inspections at our suppliers. In the end we test every
production run before it reaches our customers in order to
assure the fulfilment of the defined standards [...]”, says Jim
Walter, Mattel’s Senior Vice President of Worldwide Quality
Assurance.
© WZL/Fraunhofer IPT Page 2

The Early Phases of QM – Focus: Deviation


The main concern of product developers is to identify every product failure as soon as possible and to
define suitable solutions, which guarantee the product success. This lecture introduces methods to
support the user in failure prevention.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 2
Quality Management – Prof. Schmitt Lecture 09

Design Changes Before Job #1


 European and American Idea to product Process to Product in

Frequency of the constructive changes to the product


companies change the design product/ process use
of their products more often development
and later than Japanese
companies.
 An early and rigorous
design freeze increases
the reliability of technical
systems by a reduced
error rate.

Key:
Japanese companies benchmark
U.S.- and European companies

SOP
-24 months -3 months +3 months
Source: Sullivan, L.P. in QZ 36 (1991) 23

© WZL/Fraunhofer IPT Page 3

Design Changes Before Job #1


Approx. 70-80% of all product failures can be traced back to disabilities during product planning phases.
Responsible for most of them are the developing and engineering departments.
In general, failure identification and prevention starts predominantly in later phases, after the start of
production or sale.
The result of these facts is the need to apply preventive measures to secure quality standards in
developing and engineering.
- In early developing and engineering phases the modifying potential of product characteristics is large
and on the other hand the modification expenses are small due to the fact that engineering
modifications do not have any influence on the production.
- By engineering modifications at an early stage, it is possible to present a fixed product design long
before production starts. This offers the opportunity to concentrate on quality needs in production.
- Modifications at an early stage enable a short time-to-market, however, delays are quite frequent
especially in the automotive industry.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 3
Quality Management – Prof. Schmitt Lecture 09

Methodologies and Tools For the Quality Assurance Before Serial


Production

Quality Function Deployment

System – FMEA Product


S.–FMEA Process

Fault Tree Analysis


In this lecture
Quality Assessment

Design Review

Design Review based on Failure Mode

Statistical Tolerance Analysis

Customer to Process Manufacturing


Idea to product
innovation development release

© WZL/Fraunhofer IPT Page 4

Methodologies and Tools for the Quality Assurance Before Serial Production
To assure the quality of a product it is necessary to integrate suitable methods in developing and
engineering phases. This chapter presents the following methods in detail:
- Design Review (DR)
- Quality Assessment (QA)
- Fault Tree Analysis (FTA)
- System-FMEA Product and Process (FMEA)
- Design Review based on Failure Mode (DRBFM)

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 4
Quality Management – Prof. Schmitt Lecture 09

Contents

 Introduction

 DR – Design Review

 QA – Quality Assessment

 FTA – Fault Tree Analysis

 FMEA – Failure Mode and Effects Analysis

 DRBFM – Design Review Based on Failure Mode

 Rapid Quality Deployment

© WZL/Fraunhofer IPT Page 5

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 5
Quality Management – Prof. Schmitt Lecture 09

DR – Design Review
Definition/ Preliminary Notes

DR is a method to formally check the accordance of the


product development with its definition/ standards/ proceeding.
DR can cover the whole product lifecycle process.
Besides DR, further similar methods like Quality Assessment (QA) are in use.
Other methods like FMEA, FTA, QFD can be integrated into DR
or can be used to prepare a DR.

 Objectives:
- Ensure that the product meets the customer demands
- Improve product quality
- Recognise failures at an early stage
- Reduce the number of design changes
- Decrease development times
© WZL/Fraunhofer IPT Page 6

Design Review (DR)


Definition
- Design Review is a documented, extensive and systematic examination of a design that is carried out
to assess its ability to meet the quality requirements, to identify any existing problems and to make
suggestions relating to the development of solutions to the problems.
- A Design Review may be conducted at any stage of the development, but should always be carried
out on completion of the developing process.
Functions
- Utilise the experience of all those involved
- Improve interdepartmental communications
- Ensure that results are documented in a verifiable manner

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 6
Quality Management – Prof. Schmitt Lecture 09

DR – Classification by the Type of Realisation

Design Review

Walk through Document control


oral written

CHECKLISTS

© WZL/Fraunhofer IPT Page 7

DR – Classification by the Type of Realisation


In general, DR can be separated in two different approaches because of varieties in realization:
1. Verbal DR (walk through) will be applicable if the DR is limited to a few people. This type of DR is
characterised by critical verification of the inspection object and by documenting the results in a test
log.
2. Characteristic for written DR (document control) are experts of different divisions who collect written
objections and suggestions in a fixed period of time. These notes will be distributed to all team
members before the team meeting starts. All concerned departments or developers have to reply to
these notes before the DR-meeting.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 7
Quality Management – Prof. Schmitt Lecture 09

DR – Phase Model for the Product Development Process


Project Finalize Decision for Release of Release of
start functional spec. a draft prototype series

Definition Development Qualification Pre-series Series Usage

MDR
CDR
SDR
PDR

FDR
DR:

Pilot lot
Item: Functional Lab-sample Prototype
spec. Production process

Key:
Quality-Gate/ Milestone
DR Design Review CDR Critical DR PDR Preliminary DR
MDR Manufacturing DR SDR System DR FDR Finalfacturing DR

© WZL/Fraunhofer IPT Page 8

DR – Phase Model for the Product Development Process:


Five different DR types can be separated:
1. Preliminary Design Review in the „Definition“ phase
2. System Design Review in the „Development“ phase
3. Critical Design Review in the “Qualification” phase
4. Manufacturing Design Review in the “Pre-series” phase
5. Finalfacturing Design Review in the “Pre-series” phase
Design Reviews are realised quality gate- or milestone-oriented according to a certain project schedule
(network plan).

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 8
Quality Management – Prof. Schmitt Lecture 09

DR – Procedure at the Design Review


Nominate Constitute Establish Execute reviews
project manager for Design Review team Design Review plan
Design Review Preparation:
- Compose documents
- Work sharing

Execution:
- Problem treatment
- Problem formulation
Quality assurance - Problem solution
Production - Selection and
Development Design Process planning assessment
Marketing - Measures

Post processing:
- Measures control
- Allocation of status
- Documentation

© WZL/Fraunhofer IPT Page 9

DR – Procedure at the Design Review


- One result of the stipulated procedure is an improvement of interdisciplinary communication between
departments.
- Considerable detail planning, in form of a binding DR-plan, is required for the execution of a design
review.
- The project manager and his team are responsible for the DR execution. Team members are selected
on the basis of the functions involved. Members of the development/design, manufacturing and
process planning departments are always involved.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 9
Quality Management – Prof. Schmitt Lecture 09

DR – Extract of a Design Review checklist


Review-Checklist Revision: 01/2008
Excellent Tyres Ltd. Elaboration phase Object: Off-road tyre
SW: SUV Article-Nr.: 1234
No. Checkpoint yes no Remarks
1 Customer changes to the program since
last review? X
2 Speed test (180 km/h + 5%) passed? X Durability Test AASHTO1
3 No hydroplaning at 80 km/h
(Water depth 10mm)? X
4 Wear behaviour? X (Tread 4mm after 30Tkm)
5 Dimensions in tolerance? X
6 Maximum load adequate? X
7 Tread suitable for heavy terrain? X (Traction force > 2.800 N)
8 Homologation process initiated
and promising? X

1
American Association of State Highway and Transportation Officials
© WZL/Fraunhofer IPT Page 10

DR – Extract of a Design Review Checklist


- Checklists are used to analyse the subject of investigation. These checklists are worked out by the
team members specifically for the project. Question catalogues build the basis for these checklists.
- This catalogue of questions must be developed in accordance to the requirements and continually
checked and updated. The Design Review results should be evaluated critically concerning defects on
precursor products.
- When the checklist is available, the team members receive a documentation which is as complete as
possible relating to the subject of the investigation some weeks before the actual review meeting.
Problems identified at this time are solved by the developer or other involved experts prior to the
meeting.
- The main goal of the DR meeting is to review the subject formally and completely on the basis of the
checklist. The meeting results are documented in a written form.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 10
Quality Management – Prof. Schmitt Lecture 09

Contents

 Introduction

 DR – Design Review

 QA – Quality Assessment

 FTA – Fault Tree Analysis

 FMEA – Failure Mode and Effects Analysis

 DRBFM – Design Review Based on Failure Mode

 Rapid Quality Deployment

© WZL/Fraunhofer IPT Page 11

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 11
Quality Management – Prof. Schmitt Lecture 09

QA – Process of the Quality Assessment (QA) in Three Steps

QA 2: QA 3:
QA 1:
Development prototype Release of
Concept selection
contract series production

Review item: Review item: Review item:


Concept Development prototype Intermediate and first prototype

Activity: Activity: Activity:


Theoretical preview of function Test and trial Test of ability for serial
and safety manufacturing

Reasons for Quality Assessment (QA):


• New application for existing products Series manufacturing
• Increased quality risk
• New development
• New materials or processes
• Use of parts that are obliged to documentation

© WZL/Fraunhofer IPT Page 12

Quality Assessment (QA)


QA accompanies the development of a product through different stages.
Objective: detection and assessment of failures by systematically questioning the departments involved in
the product developing process at an early stage prior to production start.
Evaluation in three steps:
1st Stage: Theoretical preliminary investigation of the design’s ability to meet its
functional and reliability requirements, also in relation to other products.
2nd Stage: Assessment of the development prototype; the function and reliability of the
prototype are evaluated on the basis of tests and trials.
3rd Stage: Assessment regarding the capability for serial production by testing
pre-series test samples and prototypes; also samples produced under conditions of mass
production environment.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 12
Quality Management – Prof. Schmitt Lecture 09

QA – Extract of a Quality Assessment Checklist


QA 3
Symbols: QA 1 QA 2
(start serial
Unproblematic
Assessment (concept) (concept prototype)
production)
I Function
Probably E.g. Statutory instructions, standards 1 1/ 3 4
unproblematic E.g. Customer requirements 1 1/ 3 5
II Reliability
Probably 5
E.g. Static and dynamic strength 1 2
problematical
E.g. permanent (operation) behaviour 1 5 5
Very problematical III Typical features
E.g. Maintenance 1 3 5
Indices: E.g. Ease of repair 1 3 5
1 - Theoretical View IV Quality preview
Prognosis of the failure quotes in the field
2 - Function sample according to the % of delivery advised
50 ppm 20 ppm
3 - Trial sample - during warranty period
- after warranty period 1000 ppm 300 ppm
4 - First sample
V Total evaluation
5 - Own trial Product complies with requirements
- in all scope
- with restriction +
- insufficient
© WZL/Fraunhofer IPT Page 13

QA – Extract of a Quality Assessment Checklist


- Checklists are provided for the quick determination of problems.
- Repeated application at different times helps to identify weak points of a product prior to start of
production.
- To fulfil the evaluation at each stage the required documents must be determined in
advance to make them available in time.
- A quality preview is drawn up when all three evaluation steps passed through. This quality preview
predicts the expected failure rate in the series within a defined period. The quality preview supports
companies in detecting irregularities in manufacturing processes or in Quality Assessment itself.
Example in picture:
In each field, a combination of the evaluation method (or basis) and the evaluation result are shown as an
symbol/ index combination. Example:
+ 1/ 3: evaluated as “unproblematic” by theoretical view and trial sample

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 13
Quality Management – Prof. Schmitt Lecture 09

Contents

 Introduction

 DR – Design Review

 QA – Quality Assessment

 FTA – Fault Tree Analysis

 FMEA – Failure Mode and Effects Analysis

 DRBFM – Design Review Based on Failure Mode

 Rapid Quality Deployment

© WZL/Fraunhofer IPT Page 14

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 14
Quality Management – Prof. Schmitt Lecture 09

FTA – Fault Tree Analysis


Fehlerbaumanalyse (engl: FaultDefinition/ Preliminary
Tree Analysis, FTA) Notes

FTA is a method to determine all logical combinations of


component or system failures that lead to an unwanted event.

Logical Combinations of Inputs/ Outputs (Boolean Logic)

Starting out from an unwanted event (TOP), all potential causes are identified
(Top-Down)

Quantitative, objective calculation of system reliability characteristics

Preventive and retrospective execution possible

 Objectives:
- Recognise failures at an early stage
- Calculate system reliability characteristics
- Avoid failure causes
© WZL/Fraunhofer IPT Page 15

Fault tree analysis and related methods


Objectives
- Determination of the behaviour of a system regarding the occurrence of defined failures
- Estimation and calculation of system reliability characteristics
- Avoid failure causes

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 15
Quality Management – Prof. Schmitt Lecture 09

FTA – Procedure of Fault Tree Analysis


1 System analysis

Definition of unwanted events and Bang!!


2
failure criteria
Definition of relevant reliability P at
3
parameters and time intervals 2.5 m km

Determination of the types of failure


4
of the components

5 Creation of a fault tree

Evaluation of the inputs of the fault tree


6
with failure rate, time of failure, etc.

7 Calculation and interpretation of fault tree data


8 Determination of measures 

© WZL/Fraunhofer IPT Page 16

FTA – Fault Tree Analysis Process


Structure
1. A system Analysis should be conducted with the aim of gaining precise knowledge about the technical
system.
2. The unwanted event for which the Fault Tree is developed must be defined (differentiation: breakdown
of system/ breakdown of system function). Definition by clear and unambiguous breakdown criteria.
3. Reliability indicators, such as breakdown frequency or non-availability, and the time period have to be
specified.
4. Definition of breakdown modes of components
(can be linked with a FMEA).
5. Fault Tree generation.
6. Evaluation of all inputs of the Fault Tree (Determination of the expected breakdown frequencies).
7. Calculation and interpretation of results regarding the unwanted event.
8. Determination of appropriate measures incl. due dates, responsibilities and targets. Following:
Checking the measure effectiveness.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 16
Quality Management – Prof. Schmitt Lecture 09

FTA – Procedure of System Analysis

System analysis Components tree

„Component Determination of system functions


oriented view“ System as “Black Box”
- I/O-behaviour
- Performance aim
- Description
- Tolerable variations - Input
- Operation phase - Output
- Performance
Iteration Determining environmental cond. - Purpose
for all - Operation
components Examine resources phase

Identify components Organization and


behaviour

- Interaction of components
„Total view“ - Environmental influences
- Reaction to failures
© WZL/Fraunhofer IPT Page 17

FTA – System Analysis Process


System Analysis as basis for Fault Tree Analysis
One of the main requirements for performing a Fault Tree Analysis is the System Analysis of the technical
system.
System Analysis is divided into two main steps:
- Setting up of the component tree (component-oriented analysis)
- Description of the organisation and characteristics of the system (total investigation)
Component-oriented analysis (iterative approach):
- Description of the function(s) of each component by I/O interfaces
- Indication side conditions and support components
- Dividing components into sub-components, which are analysed again, if necessary
Total investigation/ analysis …
- of component contribution to the total system functions
- of environmental influences and their impact on the overall system
- in which way the entire system reacts to internal breakdowns (fault-propagation
mechanisms)
- of operator’s influence on the system

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 17
Quality Management – Prof. Schmitt Lecture 09

FTA – Symbols to Represent a Fault Tree According to DIN 25424

Standard signs for Fault Tree Analysis

Standard input Secondary input Transfer


Comment
(Primary fault) (Secondary fault) in- and output

Logical Combinations of Inputs/ Outputs (Boolean Logic)

O O O
& 1 >1
I1 I2 I I1 I2
AND-combination
AND-combination NOT-combination
NOT-combination OR-combination
OR-combination

Key: I = Input; O = Output


© WZL/Fraunhofer IPT Page 18

FTA – Symbols to Represent a Fault Tree According to DIN 25424


Faults are divided into:
- Primary faults (faults under proper use); symbol: Standard input
- Secondary faults (faults under improper use); symbol: Secondary input
Primary faults don’t have to be further investigated within Fault Tree Analysis (e.g. supplied parts). The
failure causes of the other categories must be further investigated.
Usage of standard signs (according to Boolean logic)
- AND - combination
- OR - combination
- NOT - combination
- Transfer in-/ output as a link to other Fault Trees (e.g. linking the root of one Fault Tree to the transfer
input of another tree).

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 18
Quality Management – Prof. Schmitt Lecture 09

FTA – Example for a Component Tree


Technical system Component Tree
R
Safety valve Manometer F1 F2
Compressed air system
Dischar-
cing
P
Pneumatics Electrics
K1
K2
Pressure Compres-
tank sor S2 - Safety valve - Motor M1

M
M1 - Manometer - Switch S2
1~
K2
K1
- Discharging - Relay K1
Drainage valve Mp
- Pressure Tank - Relay K2
The pressure system will be started by pressing switch
S2. Relay K1 works as self abiding relay. K2 is closing. - Compressor - Pressure
Thereby the motor starts. If the maximum pressure is Switch P
reached, pressure switch P is opening and K2 relapses. - ... - ...
Whereby the motor stops.
© WZL/Fraunhofer IPT Page 19

FTA – Example for a Component Tree


Desired results:
- List of all failure combinations that may lead to the unwanted event.
- Evaluation of the frequency of occurrence of the unwanted event.
Various methods to analyse Fault Trees; choice of method depends on complexity and task. Complex
technical systems require the usage of analysis software.
Example of a Component Tree: compressed air system - determination of the Component Tree from
technical documentation.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 19
Quality Management – Prof. Schmitt Lecture 09

FTA – Example for a Fault Tree


Technical system Fault Tree
Safety valve
R Bursting of pressure tank
Manometer
F1 F2

Dischar-
≥1
cing

P Pressure tank Operation con-


K1 failure ditions exceeded
Pressure Compres-
tank sor S2
≥1
M
M1
1~
K2 Overpressure Non-acceptable
Drainage valve
Mp & conditions

The pressure system will be started Safety valve does Fill up to


by pressing switch S2. Relay K1 works not open highest pressure
as self abiding relay. K2 is closing. ≥1 &
Thereby the motor starts. If the
maximum pressure is reached, Safety valve Wrong P-switch Compressor
pressure switch P is opening malfunction valve-setup does not open is working
and K2 relapses.
Whereby the motor stops. X2 X3
© WZL/Fraunhofer IPT Page 20

Evaluation of a FTA
To calculate the failure combinations the frequencies of occurrence (FO) have to be combined as
described below:
AND- combination: FO (A and B) = FO (A) * FO (B)
NOT- combination: FO (not A) = 1 – FO (A)
OR- combination: FO (A or B) = 1 – [(1 – FO (A)) * (1 – (FO (B))]

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 20
Quality Management – Prof. Schmitt Lecture 09

Contents

 Introduction

 DR – Design Review

 QA – Quality Assessment

 FTA – Fault Tree Analysis

 FMEA – Failure Mode and Effects Analysis

 DRBFM – Design Review Based on Failure Mode

 Rapid Quality Deployment

© WZL/Fraunhofer IPT Page 21

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 21
Quality Management – Prof. Schmitt Lecture 09

FMEA – Failure Mode and Effects Analysis


Definition/(engl:
Fehlerbaumanalyse Preliminary
Fault TreeNotes
Analysis, FTA)

FMEA is a method to determine the effects and causes of potential


failures of products or processes

Modern QM-standards like ISO/ TS 16949 do explicitly mention FMEA as


the state-of-the-art method for fault prevention

FMEA is the most frequently used Quality Management method in the industry

 Objectives :

- Recognise possible failures at an early stage


- Prioritisation of risks
- Avoid failure causes by implementing appropriate measures

© WZL/Fraunhofer IPT Page 22

FMEA – Failure Mode and Effects Analysis


- FMEA is standardised in Germany by DIN 25448 (usable up to 09-03-01)/ DIN EN 60812 (since 06-11-
01).
- A FMEA can also be used to collect empirical knowledge which is available in the company relating to
correlations between failures and factors that influence quality and to make it accessible throughout the
company.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 22
Quality Management – Prof. Schmitt Lecture 09

FMEA – Task Area


Failure Mode and Effects Analysis
in teamwork

Input information Methodology Output information


Weak points:
Product data - Determination of failures, risks ...
potential failures

- Determination of Actions:
Mechanical drawing
possible failure causes modifications, optimisations ..
and their effects

Working plan - Evaluation of Inspection features


potential failures

- Use and evaluation of ...


...
actions

© WZL/Fraunhofer IPT Page 23

FMEA – Task Area


The first FMEA stage is to identify potential failures, their causes and effects. In the second stage these
three elements are evaluated and in the last stage suitable measures are defined. After running these
three stages, the resulting risk potential is evaluated again.
- The input information refers to the current state of product/ process data.
- Besides the aim to discover and prioritise failures, the FMEA results can be used for further tasks in
an integrated QM (e.g. determination of inspection features).

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 23
Quality Management – Prof. Schmitt Lecture 09

FMEA in the Aachen Quality Management Model

Management

Quality Stream
Requirements
Forderungen

Product Process
Production Produkte
development development
System-FMEA System-FMEA
Produkt Prozess

Felddaten
Quality Backward Chain

Ressourcen & Dienste

© WZL/Fraunhofer IPT Page 24

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 24
Quality Management – Prof. Schmitt Lecture 09

FMEA – Classification of Types of FMEA in the Product Structure


Structure Main
Compo- Subcom- Process Process
level System compo- Module Part Feature
nent ponent step parameter
nent
Engine Throttle Diameter Calibration,
Vehicle
Example Engine breaking breaking Throttle Valve of the Grinding disturbance
(Truck)
system system valve variable
Failure Vehicle
Engine
Throttle Throttle
Engine breaking Valve Diameter Grinding Tool, fixing,
character- breaks breaking valve does
breaks down power is jarns too big failure etc.
istics down power lacks not open
too low

FE F FC Level I
Key: FE = Failure Effect
System Level II F = Failure
FE F FC
FC = Failure Cause
FMEA Level III
FE F FC
Product
FE F FC Level IV

Level V
FE F FC (until 1996: Design-FMEA)

Connection System-FMEA
System Product and Process
FMEA
Level VII FE F FC
Process
© WZL/Fraunhofer IPT Page 25

FMEA – Classification of Types of FMEA in the Product Structure


Starting from a failure (F) in one system structure level, the failure effects (FE) within one structure level
above and the failure causes (FC) within one structure level below are considered.
Types of FMEA
Due to different focuses, FMEA is divided in two different types (System-FMEA Product; System-FMEA
Process)
- The function of the System-FMEA Product is to analyse potential failures from the system’s or
construction’s point of view.
- The function of the System-FMEA Process is to analyse potential failures from the manufacturing’s
point of view.
- The differences between these two types of FMEA lies in the objects that are analysed. Nonetheless,
there is a relationship between them.
- The objective of System-FMEA Product with focus on the system (Level I-IV) is to
evaluate the final result of handing over failures across all product levels. Depending on the complexity
of a system or product, several FMEAs on different levels can be performed.
- The System-FMEA Product with focus on design (Level V) follows the completion of a design. The
objective is to obtain a failure-free design from the engineering point of view.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 25
Quality Management – Prof. Schmitt Lecture 09

FMEA Evaluation Concept


 Risk assessment of the FMEA is based on the evaluation of 3 risk circumstances for
each combination of FE, F, FC

Failure effect Failure Failure cause

Probability of Probability of
Severity Detection Occurrence

Rn S RnD Rn O

 Risk assessment is rated from 1-10 by means of risk figures (RnX)

 Identification of an overall risk figure (RPN) by multiplication:


RPN= RnS x RnD x RnO = [1...1000]

© WZL/Fraunhofer IPT Page 26

FMEA Evaluation Concept


- The failure effects are evaluated in reference to their meaning (RnS).
- The failure causes are evaluated in reference to the Probability of Detection (RnD) and the Probability
of Occurrence (RnO).
- In contrast, several companies do not evaluate the failure causes but the failure in reference to the
Probability of Detection. This is contrary to the principle of Quality Management which is to declare the
causes of a problem.
With increasing probability both values RnD and RnO run against each other:
- The higher the Probability of Detection, the lower the RnD value
- The higher the Probability of Occurrence, the higher the RnO value

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 26
Quality Management – Prof. Schmitt Lecture 09

FMEA – Example of a Template


Excellent Tyres Ldt. Failure Mode and Effects Analysis FMEA-No:
X System-FMEA Product System-FMEA Process Page:
Type/model/manufacture/batch: Subject No.: Responsibility.: Dept:
90 HF M. Schmidt Development
Offroad Ranger 4x4
Status: Company: Date:
A/369 438/KC ET Ltd. 28.08.2007
System No./ System element: Subject No.: Responsibility: Dept:
Steel belt
Function/Task: Status: Company: Date:

Possible Poss. Poss. Remedial Detection


No. RnS RnO RnD RPN Resp / Due date
Effect Failure Causes Measures Measures
Belt Belt diameter too Stress D. Beckham
01 Tyre explodes 9 breaks small (dimensioning) simulation
3 Design Review 5 135 17.09.2007
Belt Belt diameter too Supplier Incoming T. Edison
02 Tyre explodes 9 breaks small (supplier) audit
5 inspection 4 180 10.09.2007
Belt Material strength Stress Recalculate H. Newton
03 Tyre explodes 9 breaks too low simulation
3 dimensioning 3 81 Done 30.08.2007
Belt Fatigue J. Watt
04 Tyre explodes 9 breaks
Fatigue of material
calculation
3 Fatigue test 2 54 31.08.2007
No assembly on Belt too Belt diameter too Assembly D. Beckham
05 rim possible 5 stiff Small (dimensioning) trial
2 Design Review 5 50 17.09.2007

Legend: S = Severity D = Probability of Detection A = Probability of Occurrence


1 (no S.) - 10 (paramount S.) 1 (probable) - 10 (improbable) 1 (improbable) - 10 (probable)

© WZL/Fraunhofer IPT Page 27

FMEA – Example of a Template


Example of a FMEA form (VDA 96)
Beside the VDA version other company-specific forms are in use; the differences in using them are only
marginal.
Way of reading:
- FMEA for the system element: steel belt (of an off-road tyre).
- Possible failure “Belt brakes” is caused by 4 different failure causes (line 01 – 04), that all lead to the
same effect (tyre explodes).
- For each failure cause, appropriate remedial detection measures are shown, incl. risk
evaluation numbers and responsibilities.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 27
Quality Management – Prof. Schmitt Lecture 09

FMEA – Conduction in Teamwork


Task of the Moderator

- Project planning and -organisation


FMEA-team - Documentation, evaluation
- Assure methodological correctness
- Moderation of conversation

System FMEA - Product System FMEA - Process

FMEA - level FMEA - level FMEA - level


System/Component Component Process

Constantly Temporary Constantly Temporary Constantly Temporary


Responsible Responsible Responsible
involved involved involved involved involved involved
Production-
Development Moderator Customer Design Moderator Development Moderator Design
planning
Production- Technical
Procurement Distribution Procurement Production
planning Function
Quality Quality
Design
Assurance Assurance

© WZL/Fraunhofer IPT Page 28

FMEA – Conduction in Teamwork


- Fundamentally, FMEA is an interdepartmental method. Employees from various departments in a
company cooperate with one another to perform the FMEA. The reason for this is that the knowledge
relating to a product is generally distributed among many employees working in different departments.
Almost every department affects the quality of a product.
- The team meetings are conducted by a moderator, whose function is to ensure that FMEA is run
efficiently and methodically correct. The moderator leads and moderates the team discussion.
- The inclusion of suppliers/ customers knowledge gains increasingly significance for performing the
FMEA. This particularly applies to companies with a low vertical manufacturing range like the
automotive industry.
- The successful execution of the FMEA not only requires a motivated but also a well informed (about
the methodological principles) team. Therefore, it is essential that the introduction of FMEA method in a
company is planned seriously.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 28
Quality Management – Prof. Schmitt Lecture 09

FMEA – Computer Support for Realisation

Knowledge-based
EDP-System

Problem-related proposals
Systematic acquisition
Computer aided,
data based
concepts

Computer aided
template concepts
Conventional
concepts
(template-sheet)

Fill out the template

© WZL/Fraunhofer IPT Page 29

FMEA – Computer Support for Realisation


It is helpful to use computer-assisted tools when conducting and maintaining FMEAs, because these tools
can help minimising the costs when performing the analysis. A further advance of computer-assisted tools
is the possibility to utilise stored FMEA knowledge efficiently.
Generally, the existing systems can be divided in two different types:
– The word processing system mainly contains routines for completing the FMEA forms but these
systems cannot support the user in structuring the various content of the comment boxes.
– Database systems offer support for a systematic implementation of FMEA. FMEA data is memorised
and structured within a database.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 29
Quality Management – Prof. Schmitt Lecture 09

Contents

 Introduction

 DR – Design Review

 QA – Quality Assessment

 FTA – Fault Tree Analysis

 FMEA – Failure Mode and Effects Analysis

 DRBFM – Design Review Based on Failure Mode

 Rapid Quality Deployment

© WZL/Fraunhofer IPT Page 30

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 30
Quality Management – Prof. Schmitt Lecture 09

DRBFM – Design Review Based on Failure Mode


Definition/(engl:
Fehlerbaumanalyse Preliminary
Fault TreeNotes
Analysis, FTA)

DRBFM is a method to determine the effects of product or process changes.

DRBFM is the main method of the Mizenboushi-GD³, the actual quality concept from
Japan.

In contrary to the practice of FMEA creative approaches are emphasised, teamwork is


supported and formalism is reduced.

DRBFM is not strictly orientated to the structure of the product.

 Objectives :
- Recognise possible failures of product or process changes
- Bring together participants and concerned
- Avoid failure causes by implementing appropriate measures

© WZL/Fraunhofer IPT Page 31

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 31
Quality Management – Prof. Schmitt Lecture 09

DRBFM – General Information

high
Basic
development

Grade of innovation
Platform project

product
Variantenprojekt
Variant project
Increased
application
Application of DRBFM
projekt
project

low
low Grade of innovation high

project
DRBFM is a method which is focused on the changes within a design in the process of
development. Variant and application development projects provide the highest
potentials and benefit for DRBFM.
Source: QZ 10/2005

© WZL/Fraunhofer IPT Page 32

DRBFM – General Information


- DRBFM is used as a team method.
- In practice, it is common to work directly on the product or process - without the help of software within
the creative phase.
- The possible problems/ failures are noted in a pre-structured working sheet (greater DIN A0).
- Software is only used from the measure phase on.
- Focuses of DRBFM are application und variant projects which modify existing results of development.

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 32
Quality Management – Prof. Schmitt Lecture 09

DRBFM – Work Sheet (cp. Noguchi et al. 2003)


1 2 Concerns Regarding Change When and How Concern 5
(Failure Mode) Points appear?

Functions and
Requirements
Effect to
Component

Concerned 3 4
Changes

Customer
Name

(System)

Evaluation
Potential Weitere Weitere
Any other Any other
Failure Mode Probleme? Causes Ursachen?
Concerns? Causes?
due to Change (DRBFM) (DRBFM)

6 Empfohlene
Recommended Maßnahmen
Actions 10
(Results
(Resultate
of Design
von DRBFM)
Review)

Action Results
7 8 9
Termin, and

Termin, and
Verantwortlichkeit

Verantwortlichkeit
Verantwortlichkeit

Termin, and
Current Design

Aktion
Status
Versuche
Responsibility

Responsibility
Steps to avoid

Responsibility

Deadline
Deadline
Konstruktive Items to reflect Items
Prozess-
to reflect
Concerns Items to reflect und
Maßnahmen in inänderungen
„Production
in „Design“ Tests

Deadline
(DRBFM) „Evaluation“ Process“
(DRBFM)
(DRBFM)

„creative FMEA“ (Phase 1) Design Review (Phase 2)


© WZL/Fraunhofer IPT Page 33

DRBFM – Work Sheet (cp. Noguchi et al. 2003)


The following questions are the most important:
1. Which changes are to be considered?
2. Which systems and functions are affected by the change?
3. Which potential problems (failures) for the system and functions are caused by the change?
4. Which causes for those problems exist and which system do they come from?
5. What is affected by the problem regarding to system and client?
6. Which actions are recommended?
7. - 10.: Measure tracking

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 33
Quality Management – Prof. Schmitt Lecture 09

Contents

 Introduction

 DR – Design Review

 QA – Quality Assessment

 FTA – Fault Tree Analysis

 FMEA – Failure Mode and Effects Analysis

 DRBFM – Design Review Based on Failure Mode

 Rapid Quality Deployment

© WZL/Fraunhofer IPT Page 34

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 34
Quality Management – Prof. Schmitt Lecture 09

Rapid Quality Deployment –


Modules of Different Quality Management Methods
QFD FMEA DRBFM Target
GD³
Costing

Change
analysis
Demand Demand
analysis analysis
Determine techn. Determine Determine Determine
characteristics functions functions functions
Determine Determine Determine Determine
system system system system
Risk Risk Target cost
analysis analysis splitting
Risk Cause Cost
assessment minimization minimization
Risk Product/ process
minimization evaluation

© WZL/Fraunhofer IPT Page 35

Modules of Different Quality Management Methods


Use of synergies between methods
The integrated coverage of the product development process needs a tightly
focused use of methods, which is in line with the different phases of product
development. Rapid Quality Deployment aims at the efficient use of
synergies between these methods, which can be achieved by modularization.
Implementing e.g. a FMEA, because ISO TS 16949 explicitly demands it, the
modules “determine functions” and “determine system” are processed. Once
processed the results of these modules can also be used for QFD or Target
Costing. This helps to reduce the effort for these methods to 33% (QFD).

© WZL/IPT
Quality Management in early phases – Focus: Deviation L 09 Page 35