lecture quality management - · pdf filenorm din en 60812 (november 2006). analysetechniken...

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 The Early Phases of Quality Management –

Focus: Deviation

Prof. Dr.-Ing. Robert Schmitt



Page 1© WZL/Fraunhofer IPT

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

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 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 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.

Source: www.mattel.de

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.




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

Key:

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 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.




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)




Contents

Introduction











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

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




DR – Classification by the Type of Realisation

Design Review

Document controlwritten

Walk throughoral

CHECKLISTS

DR – Classification by the Type of RealisationIn 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.




DR – Phase Model for the Product Development Process

Key: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

Usage

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 realised quality gate- or milestone-oriented according to a certain 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 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.




Contents

Introduction










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: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 massproduction 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

AssessmentI 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 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




Contents

Introduction











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

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

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

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

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




FTA – Procedure of Fault Tree Analysis

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 in15.000 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 – Procedure of System Analysis

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

„Total 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 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 necessaryTotal 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 to 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)

Key: I = Input; O = Output

I2I1

AND-combination NOT-combination OR-combinationI I2I1

OO

&

O

1 > 1

FTA – Symbols to Represent a Fault Tree According to DIN 25424Faults are divided into:- Primary faults (faults under proper use); symbol: Standard input- Secondary faults (faults under improper use); symbol: Secondary inputPrimary 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).




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

- Discharging

- 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 TreeTechnical 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.

Safety valve Manometer

Dischar-cing

Pressuretank

Drainage valve

R

F1 F2

S2

M1~

Mp

P

Compres-sor

K2M1

K1

Compressor is working

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




Contents

Introduction












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

Objectives :

- Recognise possible failures 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 the industry

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.




FMEA – Task Area

- Determination of potential failures

- Determination of possible failure causes and their effects

- Evaluation of potential failures

- Use and evaluation ofactions

Input information Methodology Output information

Working plan

Product dataWeak points:

failures, risks ...

Actions:modifications, optimisations ..

...

Inspection features

...

Failure Mode and Effects Analysisin teamwork

Mechanical drawing

FMEA – Task AreaThe 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).




FMEA in Product Lifecycle Process

System FMEAproduct

System FMEA process

Manufacturing Gebrauch

Process failures

Usage of product

Planning dataDesign data

Process developmentDesign

Design failures

FMEA in Product Lifecycle Process- The FMEA provides short control loops by preventing the handover of failures to the

following process steps.- Only identifying failures after production or product usage is insufficient, due to long response time.




FMEA – Classification of Types of FMEA in the Product Structure

Connection System-FMEAProduct and 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 Key: = 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) within one structure level above and the failure causes (FC) within one structure level below are considered.Types of FMEADue 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.




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 RnO

Severity Probability of Detection

Probability of Occurrence

!

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]

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




FMEA – Example of a Template

S = Severity1 (no S.) - 10 (paramount S.)

D = Probability of Detection1 (probable) - 10 (improbable)

A = Probability of Occurrence1 (improbable) - 10 (probable)

Legend:

Failure Mode and Effects Analysis FMEA-No:Page:

Excellent Tyres Ldt.

Type/model/manufacture/batch:

Offroad Ranger 4x4Subject No.:90 HF

Status:A/369 438/KC

Responsibility.:M. Schmidt

Company:ET Ltd.

Dept:Development

Date:28.08.2007

System No./ System element:Steel beltFunction/Task:

Subject No.:

Status:

Responsibility:

Company:

Dept:

Date:

No. Possible Effect RnS Poss.

FailurePoss.Causes

Remedial Measures RnO

01 Tyre explodes 9 Belt breaks

Belt diameter too small (dimensioning)

Stresssimulation 3


Belt diameter too small (supplier)

Supplieraudit 5


Material strength too low

Stresssimulation 3

04 Tyre explodes 9 Belt breaks Fatigue of material Fatigue

calculation 3

05 No assembly onrim possible 5 Belt too

stiffBelt diameter too Small (dimensioning)

Assemblytrial 2

DetectionMeasures RnD RPN

Design Review 5 135

Incominginspection 4 180

Recalculatedimensioning 3 81

Fatigue test 2 54

Design Review 5 50

Resp / Due date

D. Beckham17.09.2007T. Edison10.09.2007H. NewtonDone 30.08.2007J. Watt31.08.2007D. Beckham17.09.2007

System-FMEA Product System-FMEA ProcessX

FMEA – Example of a TemplateExample 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.




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- 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.




FMEA – Computer Support for Realisation

Conventionalconcepts

(template-sheet)

Fill out the template

Pro

ble m

-re l

ated

pro

pos a

ls

Sy s

tem

atic

acq

uis i

tion

Knowledge-basedEDP-System

Computer aided,data basedconcepts

Computer aidedtemplate concepts

FMEA – Computer Support for RealisationIt 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.




Contents

Introduction












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

Objectives :- Recognise possible failures 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 approaches are emphasised, teamwork is supported 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

Gra

de o

f inn

ovat

ion

prod

uct

low high

low

project

Variant project

Grade of innovationproject

Application

Increased application of DRBFM

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.




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

(DRBFM) Term

in,

Vera

ntw

ortli

chke

it

Term

in,

Vera

ntw

ortli

chke

it

Versucheund

Tests(DRBFM)

Prozess-änderungen

(DRBFM) Term

in,

Vera

ntw

ortli

chke

it

Akt

ion

Stat

us

Empfohlene Maßnahmen(Resultate von DRBFM)

Eval

uatio

n

Current Design Steps to avoid

Concerns

Any other Causes?

Any other Concerns?

Items to reflect in „Design“

Res

pons

ibili

ty a

nd

Dea

dlin

e

Res

pons

ibili

ty a

nd

Dea

dlin

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Items to reflect in

„Evaluation“

Items to reflect in „Production

Process“

Res

pons

ibili

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nd

Dea

dlin

e

Act

ion

Res

ults

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)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




Contents

Introduction










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. 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).

lecture quality management - · pdf filenorm din en 60812 (november 2006). analysetechniken...

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