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Quality Management – Prof. Schmitt Lecture 09

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

© WZL/Fraunhofer IPT

Lecture Quality Management09 Quality Management in early phases – Focus: Deviation

Prof. Dr.-Ing. Robert Schmitt



Seite 1© WZL/Fraunhofer IPT

IndexIntroduction

DR - Design Review

QA - Quality Assessment

FTA - Fault tree analysis

FMEA - Failure Mode and Effects Analysis

DRBFM – Design Review based on Failure Mode

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




ChallengeE.g. Mattel

News/ press release 08-14-07:

The Barbie manufacturer Mattel had to callback several million of toys due to poor reliability. Germany is also affected by thegreatest 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. Every colour charge must been tested. Colours which don’t pass the test will not be used. The second point is the intensification of the production inspections and the increase of the not announced random inspections at our suppliers. In the end we test every production run before itreaches our customers in order to assure the fulfilment of the defined standards [...]”, says Jim Walter, Mattel´s Senior Vice President of Worldwide Quality Assurance.

Source: www.mattel.de

QM at the early phases – Focus: Deviation The main concern of product developers is to identify every product fault as soon as possible and to define suitable solutions, which guarantee the product success. This lecture introduces methods to support the user in fault prevention.




Design changes before job #1idea to product process to

product/ processdevelopment

Product inuse

Freq

uenc

y of

the

cons

truct

ive

chan

ges

to th

e pr

oduc

t

-24 months -3 months +3 months

Legend:

European and American companies change the design of their products more often and later than Japanese companies.

An early and rigorousdesign freeze increases the reliability of technical systems by a reduced error rate.

Source: Sullivan, L.P. in QZ 36 (1991) 23 SO

P

U.S.- and European companiesJapanese companies benchmark

Design changes before job #1Approx. 70-80% of all product defects can be traced back to disabilities during product planning phases. Responsible for most of them are the developing and engineering departments.In general, fault identification and prevention starts predominantly in later phases, after start of production or sales.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 modification 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, though especially in the automotive industry delays are quite frequent.




Methodologies and tools for the quality assurance before serial production

S.–FMEA ProcessSystem – FMEA Product

Fault Tree Analysis

Quality Assessment

Design Review based on Failure Mode

Quality Function Deployment

Design Review

In this lecture

Customer to innovation Idea to product Process

developmentManufacturing

release

Statistical Tolerance Analysis

Methodologies and tools for the quality assurance before serial productionTo 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)




DR – Design Review

Definition/ Preliminary Notes

DR is a method to formally check the accordance of a product development to its definition/ standards/ its 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 be used to prepare a DR.

Objectives:- Ensure that the product meets the customer requirements- Enhance product quality - Recognise faults at an early stage- Reduce the number of design changes- Decrease development times

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 in the development, but should always be carried out on completion of the developing process.

Functions- Utilize the experience of all those involved- Improve interdepartmental communications- Ensure that results are documented in a verifiable manner




DR – Classification by the type of realization

Design Review

Document controlwritten

Walk throughoral

CHECKLISTS

DR – Classification by the type of realizationIn 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

characterized 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 department or developers have to reply to these notes before the DR-meeting.




DR – Phase model for the product development process

Legend:Quality-Gate/ Milestone

DR Design Review CDR Critical DR PDR Preliminary DRMDR Manufacturing DR SDR System DR FDR Finalfacturing DR

Functional spec. Lab-sample Prototype

Pilot lot

Development

Finalize functional spec.

Qualification

Decision for a draft

Pre-series

Release of prototype

Series

Release of series

Definition

Project start

Utili-sation

DR:

Item:

PDR

SDR

CD

R

MD

R

FDR

Production process

DR – Phase model for the product development process:Five different DR types can be separated:1. Preliminary Design Review in the „Definition“ phase2. System Design Review in the „Development“ phase3. Critical Design Review in the “Qualification” phase 4. Manufacturing Design Review in the “Pre-series” phase5. Finalfacturing Design Review in the “Pre-series” phaseDesign Reviews are realized quality gate- or milestone-oriented according to a project schedule (network plan).




DR – Procedure at the Design Review

ConstituteDesign Review team

EstablishDesign Review plan

Execute reviews

Preparation:- Compose documents- Work sharing

Execution:- Problem treatment- Problem formulation- Problem solution- Selection and

assessment- Measures

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

Process planning

ProductionDesign

Quality assurance

DevelopmentMarketing

Nominate project manager for

Design Review

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.




DR – Extract of a Design Review checklist

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? X6 Maximum load adequate? X7 Tread suitable for heavy terrain? X (Traction force > 2.800 N)8 Homologation process initiated

and promising? X

Excellent Tyres Ltd.Review-Checklist Revision: 01/2008Elaboration phase Object: Off-road tyreSW: SUV Article-Nr.: 1234

No. Checkpoint yes no Remarks

1 American Association of State Highway and Transportation Officials

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 most complete documentation 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.




QA – Process of the Quality Assessment (QA) in three steps

Reasons for Quality Assessment (QA):• New application for existing products• Increased quality risk• New development• New materials or processes• Use of parts that are obliged to documentation

Review item:Concept

Activity:Theoretical preview of function and safety

Review item:Development prototype

Activity:Test and trial

Review item:Intermediate and first prototype

Activity:Test of ability for serial manufacturing

QA 1:Concept selection

QA 2:Development prototype

contract

QA 3:Release of

series production

Series manufacturing

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:1. Stage: Theoretical preliminary investigation of the design’s ability to meet its

functional and reliability requirements, also in relation to other products.2. Stage: Assessment of the development prototype; the function and reliability of the

prototype are evaluated on the basis of tests and trials.3. Stage: Assessment regarding the capability for serial production by testing

preseries test samples and prototypes; also samples reduced under conditions of mass production environment.




QA – Extract of a Quality Assessment checklistSymbols:

Unproblematic

Probablyunproblematic

Probablyproblematical

Very problematical

Indices:

1 - Theoretical View

2 - Function sample

3 - Trial sample

4 - First sample

5 - Own trial

EvaluationI Function

e.g. Statutory instructions, standardse.g. Customer requirements

V Total evaluationProduct complies with requirements- in all scope- with restriction- insufficient

IV Quality previewPrognosis of the failure quotes in the fieldaccording to the % of delivery advised- during warranty period- after warranty period

III Typical featurese.g. Maintenancee.g. Ease of repair

II Reliabilitye.g. Static and dynamic strengthe.g. permanent (operation) behaviour

QA 1(concept)

QA 2(concept prototype)

QA 3(start serial production)

50 ppm1000 ppm

20 ppm300 ppm

+

11

1/ 31/ 3

45

55

25

11

55

33

11

QA – Extract of a Quality Assessment checklist- Checklists are provided for the quick determination of problems.- Repeated application at different times helps to identify product weak points prior to start of production.- To fulfil the evaluation at each stage of 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




FTA – Fault tree analysis

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

FTA is a method to determine all logical combinations ofcomponent or system faults that lead to an unwanted event.

Objectives:- Recognise faults at an early stage- Calculate system reliability characteristics - Avoid failure causes

Logical Combinations of Inputs/ Outputs (Boolean Logic)

Starting from the unwanted event (TOP), all potential causes are listed up (Top-Down)

Quantitative, objective calculation of system reliability characteristics

Preventive and retrospective execution possible

Fault tree analysis and related methodsObjectives- Determination of the behaviour of a system regarding the occurrence of defined faults- Estimation and calculation of system reliability characteristics- Avoid failure causes




FTA – Fault tree analysis process

Determination of measures8

Calculation and interpretation of fault tree data7

Evaluation of the inputs of the fault treewith failure rate, time of failure, etc.6

Creation of a fault tree5

Determination of the types of failureof the components4

Definition of relevant reliabilityparameters and time intervals

P in3000 h

3

System analysis1

Definition of unwanted events andfailure criteria2 Bang!!

FTA – Fault tree analysis processStructure1. 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.




FTA – System analysis process

System analysis

„Componentoriented view“

Determination of system functionsSystem as “Black Box”- I/O-behaviour- Performance aim- Tolerable variations- Operation phase

Determining environmental cond.

Examine resources

Identify components

- Interaction of components- Environmental influences- Reaction to failures

Iterationfor all

components

„holistic view“

Components tree

Organization andbehaviour

- Description- Input- Output- Performance- Purpose- Operation

phase

FTA – System analysis processSystem analysis as basis for Fault Tree AnalysisOne 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 the component tree (component-oriented analysis)- Description of the organisation and characteristics of the system (holistic investigation)Component-oriented analysis (iterative approach):- Description of the function(s) of each component by I/O interfaces- Indication of the site conditions and support components- The component is then divided into its sub-components, which are analysed again, if

necessaryHolistic 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




FTA – Symbols to represent a fault tree according DIN 25424

Standard signs for fault tree analysis

AND-combination

Transfer In- and OutputCommentStandard-Input

(Primary fault)

NOT-combination OR-combination

Logical Combinations of Inputs/ Outputs (Boolean Logic)

Secondary-Input(Secondary fault)

Legend: I = Input; O = Output

I2I1

AND-combination NOT-combination OR-combinationI I2I1

OO

&

O

1 > 1

FTA – Symbols to represent a fault tree according DIN 25424Faults are divided into:- Primary fault (fault under proper use); symbol: Standard-Input- Secondary fault (fault under improper use); symbol: Secondary-InputPrimary faults don’t have to be further investigated in the course of 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).




FTA – Example for a component tree

The pressure system will be started by pressing switchS2. Relay K1 works as self abiding relay. K2 is closing.Thereby the motor starts. If the maximum pressure is

reached, pressure switch P is opening and K2 relapses.Whereby the motor stops.

Pneumatics

- PressureSwitch P

Component tree

Compressed air system

Electrics

- Safety valve

- Manometer

- Extraction valve

- Pressure Tank

- Compressor

- Motor M1

- Switch S2

- Relay K1

- Relay K2

- ... - ...

Technical System

Safety valve Manometer

Dischar-cing

Pressuretank

Drainage valve

R

F1 F2

K2

S2

K1

M1~

Mp

P

Compres-sor

K1

K2M1

FTA – Example for a component treeDesired 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.




FTA – Example for a fault tree

Compressor is working

Technical System

The pressure system will be startedby pressing switch S2. Relay K1 works

as self abiding relay. K2 is closing.Thereby the motor starts. If themaximum pressure is reached,pressure switch P is opening

and K2 relapses.Whereby the motor stops.

Fault TreeBursting of pressure tank

Pressure tankfailure

Operation con-ditions exceeded

Overpressure Non-acceptableconditions

Safety valve doesnot open

Fill up tohighest pressure

Safety valvemalfunction

Wrongvalve-setup

P-switchdoes not open

≥1

&

&

≥1

≥1

X2 X3

Safety valve Manometer

Dischar-cing

Pressuretank

Drainage valve

R

F1 F2

K2

S2

K1

M1~

Mp

P

Compres-sor

K1

K2M1




FMEA – Failure Mode and Effects Analysis


FMEA is a method to determine the effects and causes of potentialfailures of products or processes

Objectives :

- Recognise possible faults at an early stage- Prioritisation of risks- Avoid failure causes by implementing appropriate measures

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 industry

FMEA – Failure Mode and Effects Analysis- FMEA is standardised in Germany in DIN 25448 (usable up to 09-03-01)/ DIN EN 60812 (since 06-11-

01).- A FMEA can also be used to collate empirical knowledge available in the company relating to

correlations between faults and factors that influence quality and to make them accessible throughout the company.




FMEA – Task area

- Determination of potential failures

- Determination of possible failure causes and their effects

- Valuation of potential mistakes

- Use and valuation ofactions

Input informations Methodology Output informations

Working plan

Product dataWeak points:

failures, risks ...

Actions:modifications, optimizations ..

...

Inspection features

...

Failure Mode and Effects Analysisin teamwork

Mechanical drawing

FMEA – Task areaThe first FMEA stage is to identify potential faults, 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.- Input information is the current issue of product/ process data.- Besides the target, to discover and prioritise faults, the FMEA results can be used for further tasks in

an integrated QM (e.g. determination of inspection features).




FMEA in product lifecycle process

System FMEAproduct

System FMEA process

manufacturing Gebrauch

process failures

product in use

planning datadesign data

process planningdesign

design failures

FMEA in product lifecycle process- The FMEA provides short control loops by preventing the handover of faults to the

following process steps.- The only identification of faults after production or product use is insufficient, due to long response time.




FMEA – Classification of types of FMEA in the product structure

Connection System-FMEAProduct/ Process

Tool, fixing, etc.

Grinding failure

Diameter too big

Valve jarns

Throttle valve does not open

Throttle breaking

power lacks

Engine breaking power istoo low

Engine breaks down

Vehicle breaks down

Calibration, disturbance

variableGrinding

Diameter of the valve

ValveThrottleThrottle breaking system

Enginebreakingsystem

EngineVehicle(Truck)

Structure level

Example

Failure character-

istics

Process parameter

Process stepFeaturePartModuleSubcom-

ponentCompo-

nent

Main compo-

nent

System FMEA

Product

FE F FC Level II

FE F FC Level III

FE F FC Level IV

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

System FMEA

Process FE F FCLevel VII

FE F FC Level I Legend: = Failure Effect= Failure= Failure Cause

FFC

FE

System

FMEA – Classification of types of FMEA in the product structureStarting from a failure (F) in one system structure level, the failure effects (FE) in the structure level one above and the failure causes (FC) in the structure level one below are considered.Types of FMEAFMEAs differ in analysis object emphasis and objectives, thus 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 system or construction

point of view.- The function of the System-FMEA Process is to analyse potential failures from

manufacturing point of view.- The differences between the types of FMEA manifest themselves in the analysed objects. But

nonetheless there is a relationship between the different FMEA types.- The objective of System-FMEA Product with focus on systems (Level I-IV) is to

evaluate the final technically possible effect of the fault propagation across all product levels. Depending upon complexity of a system or product, several FMEAs on different levels can be made.

- The System-FMEA Product with focus on design (Level V) follows on the completion of a design. The objective is to obtain a faultless design from an engineering point of view.




FMEA evaluation conceptRisk 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

RnS RnD RnA

Severity Probability of detection

Probability of appearance

!

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 RnA = [1...1000]

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 appearance (RnA).- Differing of this 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 rising probability both figures RnD and RnA run against each other:- The higher the Probability of detection, the lower the RnD- The higher the Probability of appearance, the higher the RnA




FMEA – Example of a template

Dept.:Development

Responsibility:M. Schmidt

Subject No.:90HF

Type/model/manufacture/batch:

Offroad Ranger 4x4 Date:28.08.2007

Company:ET Ltd.

Status:

A/369 437/KCDept.:Responsibility:Subject No.:System no./System element:

Steel belt

FMEA-No:Page:

Failure Mode and Effects AnalysisExcellent Tyres Ltd.System-FMEA ProcessSystem-FMEA Product

Date:Company:Status:Function/Task:Resp./ Due dateRPNRn

DDetection Measures

RnO

Remedial Measures

Poss.Causes

Poss. Failure

RnSPossible EffectNo

X

Gurt zufest

05

„04

„03

„02

Gurtreißt

01

5Unkomforta-bles Abrollen

9„

9„

9„

9Reifenexplodiert

Gurtdurchmesser zugroß

Materialermüdung

Materialfestigkeitzu gering

Gurtdurchmesserzu gering (Lieferant)

Gurtdurchmesserzu gering (Ausleg.)

2Belastungs-test

3Ermüdungkalkulieren

3Belastungs-simulation

5Lieferanten-audit

3Belastungs-simulation

Tyre explodes

D. Beckham17.09.2007

505Design ReviewAssembly trial

Belt diameter too big (dimensioning)

Belt too stiff

No assembly on rim possible

J. Watt31.08.2007

542Fatigue testFatigue calculation

Fatigue of material

H. NewtonDone 30.08.2007

813Recalculatedimensioning

Stress simulation

Material strength too low

T. Edison10.09.2007

1804Incoming inspection

Supplier audit

Belt diameter too small (supplier)

D. Beckham17.09.2007

1355Design ReviewStress simulation

Belt diameter too small (dimensioning)

Belt breaks

S = Severity evaluation grade1 (no S.) - 10 (paramount S.)

D = Detection grade1 (probable) - 10 (improbable)

O = Occurrence evaluation grade1 (improbable) - 10 (probable))

Legend:

FMEA – Example of a templateExample of a FMEA form (VDA 96)Beside the VDA version further 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, an appropriate remedial and detection measure is shown, incl. the risk

evaluation numbers and responsibilities.




FMEA – Conduction in teamworkTask of the Moderator

- Project planning and -organisation- Documentation, evaluation- Assure methodological correctness- Moderation of conversation

System FMEA - Product System FMEA - Process

FMEA - level System/Component

FMEA - levelComponent

FMEA - levelProcess

responsible constantlyinvolved

temporaryinvolved

Development Moderator

Procurement

Customer

Distribution

Design


temporaryinvolved

Design Moderator

Production-planningQuality

Assurance

Development

Procurement


temporaryinvolved

Production-planning Moderator

Production TechnicalFunction

QualityAssurance

Design

FMEA-team

FMEA – Conduction in Teamwork- FMEA is fundamentally an interdepartmental method. Employees from various departments in a

company cooperate with one another to draw up 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 drawing up the FMEA. That particularly applies to companies with a low vertical manufacturing range like the automotive industry.

- The successful execution of the FMEA requires not only a motivated but also a well informed (about the methodological principals) team. Therefore it is essential that the introduction of FMEA method in the company is planned seriously.




FMEA – Computer support for realization

conventionalconcepts

(template-sheet)

Fill out the template

prob

lem

- re l

ated

pro

pos a

ls

syst

emat

ic a

cqui

sitio

n

knowledge-basedEDP-System

computer aided,data basedconcepts

computer aidedtemplate concepts

FMEA – Computer support for realizationIt is helpful to use computer-assisted tools when conducting and maintaining FMEAs, because these tools can help minimising the costs when drawing up the analysis. A further advance of computer-assisted tools is the possibility to utilise saved FMEA knowledge efficiently.Generally the existing systems can be divided in two different types:– The word processing systems contains mainly 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 in a database.




DRBFM – Design Review Based on Failure Mode


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

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

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

In contrary to the practice of FMEA creative appendages are accentuated, teamwork is raised and formalism is reduced.

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




DRBFM – General information

Source: QZ 10/2005

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.

high

projekt

Variantenprojekt

platform project

basicdevelopment

grad

e of

inno

vatio

npr

oduc

t

low high

low

project

variant project

grade of innovationproject

application

Increased application of DRBFM

DRBFM – General information- DRFBM is used as a team method.- In practice it is common to work directly at the product or process - without the help of software in the

creative phase.- The possible problems/ failures are noted in an pre-structured working sheet (greater DIN A0).- Software is used only from the measure phase on.- Focus of DRBFM are application und variant projects which modify existing results of development.




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

WeitereUrsachen?(DRBFM)

CausesCom

pone

ntN

ame

Cha

nges

Con

cern

edFu

nctio

ns a

nd

Req

uire

men

ts

Concerns Regarding Change (Failure Mode)

Potential Failure Mode

due to Change

WeitereProbleme? (DRBFM)

When and How Concern Points appear?

KonstruktiveMaßnahmen

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Term

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Versucheund

Tests(DRBFM)

Prozess-änderungen

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Akt

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Empfohlene Maßnahmen(Resultate von DRBFM)

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Current Design Steps to avoid

Concerns

Any other Causes?

Any other Concerns?

Items to reflect in „Design“

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Items to reflect in „Production

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Act

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Res

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Recommended Actions(Results of Design Review)

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

1 2

3 4

6

5

Effect to Customer (System)

7 8 9

10

DRBFM – Work Sheet (cp. Noguchi et al. 2003)Those questions are the most important:1. Which changes are to be considered?2. Which systems und 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 from which system do they come?5. What is affected by the problem regarding to system and client?6. Which actions are recommended?7. - 10.: Measure tracking




Modules of different quality management methods

Determination of functions and system can be used overall methods

FMEAQFD Target Costing

Determinefunctions

Determine system

Determinefunctions

Target cost-splitting

Costminimisation

Determine system

Determine system

Demand Analysis

Determine techn. characteristics

Riskminimisation

Risk assessment

Risk analysis

Modules of different quality management methodsUse of synergies between methodsThe 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. an FMEA, because ISO TS 16949 explicitly claims it, the modules “determine functions” and “determine system” are being worked on. Using these modules for other methods, editing can be reduces to one module for a QFD compilation or two modules for Target Costing.

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