Quality Management

International Technology Transfer Management Summersemester 2004
Quality Management Prof. Sondermann Lecture Notes by Phillip Kern
Quality Management
Content
CONTENT ................................................................................................................................ 1 1 TERMS.............................................................................................................................. 3 1.1 1.2 2 3 4 5 2.1 QUALITY ..................................................................................................................... 3 QUALITY MANAGEMENT.............................................................................................. 3 HOUSE OF QUALITY .................................................................................................... 4
QFD QUALITY FUNCTION DEPLOYMENT......................................................... 4 KANO MODEL OF SATISFACTION .......................................................................... 6 TQM .................................................................................................................................. 6 ISO 9000 ............................................................................................................................ 7 5.1 5.2 ISO 9001..................................................................................................................... 7 9004............................................................................................................................ 9
EXAMPLE PROCESS FMEA ........................................................................................ 10 ASSIGNMENT OF PROBABILITIES ................................................................................ 11 RPN RISE PRIORITY NUMBER ................................................................................... 13 EXERCISE FOR FMEA ............................................................................................... 13
FMEA FAILURE MODE AND EFFECTS ANALYSIS......................................... 10 6.1 6.2 6.3 6.4
7 8 9
ISO CONTROL CYCLE............................................................................................... 14 CONTROL PLAN.......................................................................................................... 15 PROCESS CONTROL AND CAPABILITY .............................................................. 15 9.1 9.2 PROCESS CAPABILITY ................................................................................................ 16 MEASUREMENT ......................................................................................................... 18
10 SYSTEMATIC INSPECTION METHODOLOGY AS MEASURE OF QUALITY ASSURANCE ......................................................................................................................... 22 10.1 10.2 10.3 10.4 11 11.1 11.2 12 12.1 12.2 OPERATIONAL CURVE (OC)....................................................................................... 22 LARSON NOMOGRAMM........................................................................................... 23 DURCHSCHLUPF CURVE (ESCAPE-CURVE) .............................................................. 24 ATI (AVERAGE TOTAL INSPECTION)......................................................................... 24 SHEWART-CONTROL-CHART ..................................................................................... 26 NON-SHEWARD CONTROL CHARTS ........................................................................... 27 RATING RESULTS & FOLLOWING ACTIVITIES............................................................. 29 CERTIFICATION AND AUDITING ................................................................................. 30 1/41
CENTRAL LIMITING THEOREM............................................................................ 26
QUALITY CAPABILITY ............................................................................................. 28
12.3 12.4 13 13.1 13.2 13.3 13.4 13.5 13.6 13.7 13.8 13.9 13.10 13.11 13.12 14 15
POTENTIAL ANALYSIS ............................................................................................... 31 QUALITY CONTROL CHARTS ..................................................................................... 32 DATA COLLECTION ................................................................................................... 33 CHECK SHEETS .......................................................................................................... 33 HISTOGRAM .............................................................................................................. 33 PARETODIAGRAM ...................................................................................................... 33 ISHIKAWA/FISHBONE/CAUSE-EFFECT-DIAGRAM ...................................................... 33 SCATTERED DIAGRAM............................................................................................... 33 (CONTROL CHART).................................................................................................... 33 AFFINITY DIAGRAM .................................................................................................. 33 RELATION DIAGRAM ................................................................................................. 33 TREE DIAGRAM ..................................................................................................... 33 MATRIX DIAGRAM ................................................................................................ 33 RADAR CHART ...................................................................................................... 33
BASIC TOOLS FOR QM.............................................................................................. 33
USING OF METHODS - MATRIX DIAGRAM ........................................................ 34 QUALITY ENGINEERING METHODS STRUCTURE .......................................... 35 15.1 15.2 POKA-YOKE .............................................................................................................. 35 DOE.......................................................................................................................... 36
16 17 18
REQUIREMENTS FOR POTENTIAL ANALYSIS (OF SUPPLIERS).................. 37 STAGES OF QUALITY................................................................................................ 40 SUMMARY FOR EXAM.............................................................................................. 41
LINKS: www.vfh.de/qm user: QMDMT03 pw: sonn-! automotive recalls: www.nhtsa.dot.gov
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1 Terms
1.1 Quality
concerns: - products - process - company
TQM(Total Quality Management)
Definition: Degree to which a set of inherent characteristics fulfils requirements.
1.2 Quality management
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1st layer
2nd layer
3rd layer: Objects 4th layer: Methods
House of Quality 5th layer: documents (HoQ)
2 QFD Quality Function Deployment

www.vfh.de/qm LE08
team-based methods to develop customer focused specification for products and processes Documentation House of Quality (HoQ)
2.1 House of Quality

Translates the voice of the customer into the voice of the company.
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(1) (2)
Customer requirements Degree of importance (1..5 or 1...10) - e.g. by paired comparison (by matrix) (3) Service complaints (4) Customer rating (5) Design requirements (6) Maximize, minimize or achieve target goal (7) Correlation (8) Relation matrix (9) Technical difficulties (10) Technical comparison (11) Technical objectives - must be measurable Fill in by Symbols. Assign values to the symbols! symbol value Value (preferred by Prof. Sondermann)
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Strong relationship Medium relationship Weak relationship
5 3 1
9 3 1 2004-04-01
3 KANO Model of satisfaction
example railway: - basic: safety - performance: just in time - additional: comfort, food service
4 TQM
Company Goals Formerly(Quality Inspection) - better products - production cost reduction - batch optimization Product Strong quality department Today and Tomorrow (TQM) - better company - customer satisfaction - high flexibility Market Quality: part of al activities
Basic orientation Organization of quality assurance
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2004-04-06
5 ISO 9000
LE02
5.1 ISO 9001

Basis of business certificate for QMS effectivness doing the right things belongs to integrated management Systems ISO 14001 ecological management system working safety & health protection (SCC) QS9000 VDA 6.1 TS16949 enhanced Management systems
5.1.1 Characteristics of ISO 9001 process orientation
aiming at the ability of an organization to assure conformity of products (to requirements) striving at fulfilling requirements with customer satisfaction continuous improvement According to this declarations one need processes!!! Q-Objectives: - general o policy - specific o time & quantity relations 7/41
5.1.2 structure of ISO 9001

0 Einleitung Enthlt Hinweise auf: - Den Prozessorientierten Ansatz - Die Beziehung zur DIN EN ISO 9004 - Die Vertrglichkeit mit anderen Managementsystemen (z.B. fr Umwelt, Arbeitssicherheit und Gesundheitsschutz) - Die Nichtunterstellung, dass einheitlich strukturierte und dokumentierte QM-Systeme verlangt werden
1 Anwendungsbereich 2 Normative Verweisungen 3 Begriffe 4 Qualittsmanagementsystem Enthlt Ausfhrungen zu: - Dokumentationsanforderungen - Lenkung von Dokumenten und Aufzeichnungen Definiert Anforderungen, die die Leitung verpflichten, - Eine Qualittspolitik und Qualittsziele festzulegen und - Mittel und adquate Organisations- und Kommunikationsstrukturen bereitzustellen, mit dem Ziel, dass Kundenbedrfnisse und -erwartungen erfllt werden. Enthlt Anforderungen: - Zur Bereitstellung von Mitteln zur Umsetzung und Verbesserung des QM-Systems - Zu Personalfragen wie adquate Aufgabenzuordnung und Schulung Anforderungen werden aufgestellt zur: - Planung der Produktrealisierung - Kundenbezogenen Ermittlung der Anforderungen an das Produkt - Gestaltung des Entwicklungsprozesses mit Verifizierung und Validierung der Entwicklungsergebnisse - Beschaffung inklusive der Verifizierung beschaffter Produkte - Produkt- und Dienstleistungserbringung sowie - zur Lenkung von berwachungs- und Messmitteln Enthlt Anforderungen: - zur Messung der Kundenzufriedenheit - fr interne Audits - zur berwachung und Messung von Produkten und Prozessen - zur Datenanalyse - zur kontinuierlichen Verbesserung, Korrektur- und Vorbeugemanahmen
5 Verantwortung der Leitung
6 Management der Ressourcen
7 Produktrealisierung
8 Messung, Analyse und Verbesserung
standardized is the WHAT not the HOW! 8/41
5.2 9004
refers to improvement of efficiency (guideline) approaches - step to TQM - as addition 6Sigma-Approach
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2004-04-08
6 FMEA Failure Mode and Effects Analysis

LE09
Failure and defect prevention analytical method team based (inter-disciplinary) used for (single) parts not for (complete) systems
based on preliminary but evaluable designs of processes of products
6.1 example Process FMEA

Target: Assembly of a new car System / Design Operation Process
search for potential failures (by experience) FMEA doesnt ask in the first time whether a defect can occur, but how a defect would look like look for effects of these failures evaluate the effects
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6.2 Assignment of probabilities

RPZ = A x B x E Die folgenden Schemata geben praxisrelevante Werte wieder. Die Tabellen sind aber dennoch unternehmensspezifisch zu hinterfragen und ggf. anzupassen. 1. Zuordnungsschema fr die Bewertung der Auftretenswahrscheinlichkeit A
Prognostizierte Prozesssituation (max.) Auftretenswahrscheinlichkeit A in % Punktezuordnung A
Fehlerauftreten unwahrscheinlich Beherrschter Prozess mit cp >= 1,33 bzw. Fehleranteil (vor Prfung) < 1/20000 Beherrschter Prozess mit 1,0 <= cp >= 1,33 bzw. Fehleranteil zw. 1/2000 bis 1/20000 Beherrschter Prozess mit 0,8 <= cp >= 1,00 bzw. Fehleranteil zwischen 1/200 bis 1/1000 Beherrschter Prozess mit cp <= 0,8 bzw. Fehleranteil zw. 1/100 bis 1/50 Nicht beherrschter Prozess mit Fehleranteil zwischen 1/10 bis 1/2
gegen 0 0,005
1 2
0,05
0,1 0,2 0,5 1 2 10 50
4 5 6 7 8 9 10
2. Zuordnungsschema fr die Bewertung der "Bedeutung (Auswirkung, Fehlerfolge)" B

Prognostizierte Bedeutung der Fehlerauswirkung (f. Kunden) Punktezuordnung
Nicht wahrnehmbare Auswirkung Unbedeutende Fehlerauswirkung Geringfgige Beeintrchtigung Geringfgige Belstigung 11/41
1 2 3 4
Unzufriedenheit des Kunden Verrgerung des Kunden (Werkstattbesuch, Reklamation, Beschwerde, nicht fahrbereites Kfz) Funktionsverlust mit besonderer Verrgerung und Risiken fr Kunden (Liegenbleiben mit dem Kfz) Sicherheitsgefhrdung
5 6 7 8 9 10
3. Zuordnungsschema fr die Ermittlung der "Entdeckung" bzw. des "Risikos der Nichtentdeckung" E
Prognostizierte Mglichkeiten der Fehlerentdeckung (max.) Wahrscheinlichkeit der Entdeckung E in % Punkte(max.) Nichtzuordnung entdeckungsE wahrscheinlichkeit in %
Sichere Entdeckenswahrscheinlichkeit Hohe Entdeckenswahrscheinlichkeit
99,999 99,99 99,95 99,9 99,7 99,5 99 98 > 90
0,001 0,01 0,05 0,1 0,3 0,5 1 2 10
1 2 3 4 5 6 7 8 9
Mige Entdeckenswahrscheinlichkeit Geringe bis sehr geringe Entdeckens wahrscheinlichkeit Keine Entdeckensmglichkeit (nicht geprftes bzw. prfbares Merkmal)
100
10
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2004-04-15
6.3 RPN Rise Priority Number

RPN = Occurance * Detectability * (1..10) (1..10) Range RPN 11000 Effect(=Severity) (1..10)
no absolute risk measurable not comparable between teams
Example: Occ. =5 ; Det.= 5; Sev.=5 RPN=125
!!!But RPN is not always objective to judge about failures!!! e.g. O=2 * S=9 * D=3 RPN=54 O=3 * S=6 * D=3 RPN=54 but the first is much more risky because of much higher severity!
6.4 Exercise for FMEA

necessary: - Name of Process - Process Objectives - Process owner (efficiency & effectiveness) - Trigger - Input - Resources - Procedure - Measurements/Controls - Output - Reactionplan in case of failures(irregularities)
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2004-04-20
7 ISO Control Cycle
ISO 9001
5 Management Responsibility 6 Resource Management 7 Product Realization
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2004-04-27
8 Control Plan
Ishikawa:
2004-04-29
9 Process control and Capability

Processes should be under statistical control and should be capable. Processes can produce parts(components) and services or software etc. Industrial processes should be analysed in order to state the ability to meet requirements. Def.: Industrial processes is under control if - the parameter of distribution (e.g. & in case of quality characteristics are following a Gaussian distribution) do not change overtime or - change in a predictive manner or - vary in know boundaries in other words: you must be able to assign a so called theoretical process-time-model to process outcome Process-time-model A1 (according to DIN) samples: Gaussian distributed process: Gaussian distributed & : constant Process-time-model A2 (according to DIN) samples/process non Gaussian characteristic variables: constant 15/41
9.1 Process capability

- is capable if quality is guaranteed without e.g. additional sorting processes
case 1: , are constant upper and lower specification level (USL/LSL) are outside the sample distribution Process is capable case 2: , are constant upper and lower specification level (USL/LSL) are inside the sample distribution process predictable, theoretical level is assignable process is under control (not directly linked to requirements) but not capable (directly linked to requirements) 2004-05-04 9.1.1 Process capability index cP, cPK machine capability index cm, cmK measurement (equipment) capability index cg, cgA (g=gauge)
cp = T/p =Tolerance width/Process width USL LSL = 1,33(!) 6
(6 = +/-3 area) +/-1 area corresponds to 68,26% of all samples +/-2 area corresponds to 95,4% of all samples +/-3 area corresponds to 99,73% of all samples
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TV Target Value p=8 (presumption) difference between minimum & maximum sample is 8 assuming that +/-3 covers all my samples (99,73%): =p/6=4/3
cp
= T/p = 10/8 = 1,25
(too low, should be 1,33 in automotive industry)
cp does not take the position of the process into account (red curve) cpK Value is taking into account the position(mean) of the process either as deviation from target value or its approximation to the specification limits (1) c pK = (1 k ) c p
k= TV T 2
USL LSL ; (2) c pK = Min 3 3

Cases: cpK < 0 cpK = 0 cpK = cp ^ is outside the specification level ^ is equal to USL or LSL k=0 =TV centred process
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2004-05-06
9.2 Measurement
Characteristics: 1. Resolution R requirement: R 0,05 T T = USL LSL
R should be smaller than 5% of your tolerance width 2. Correctness (bias) xc is a known standard (e.g. sample for calibrating) e.g. xc = 20,039 x = 20,045 = 0,006
3. precision, repeatability measure for precision 4. accuracy correctness + precision 5. reproduceability Measurement for reproduceabilities xOP1 is measured by an other technique than xOP3 4 area
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6. linearity A measurement is linear if the between the samples and the means is constant. (in case of different techniques or different samples) 7. stability A measurement is stable if is not varying over time.
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2004-05-11 9.2.1 Index Cg
cg =
0,2 T ! 1,33 4S g
cg =
0,2 T 4S g
! 1,33
same as
cg =
0,15 T ! 1,0 4S g
If not met by measurement device
lack of resolution 20/41
c gk =
0,1 T ( x g xc ) 2S g
! 1,33
[ xg xc = bias ]
example: Weight Measurement Device standard 10mg ( xc) specification 100.6[mg] LSL = 9.4mg USL = 10.6mg
xg = 10.006 sg=0,04242426 |Bi| = |xg xc| = 0.00600 cg= 0,2 *1,2/(4 * 0,042426) =1,41 cgk= (0,1 *1,2-0,006) / (2 * 0,042426) =1,34
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2004-05-13
10 Systematic Inspection Methodology as Measure of Quality Assurance

LE14 Stichprobensysteme
(DIN) ISO 2859 Part 1 3 basis for establishing acceptance tests or inspection (lot inspection) simple inspection plans o decision of acceptance and rejection based on the results of 1 sample only o form: n-c (n=sample size; c=acceptance number) or n-c/d where d = c+1 (d=rejection number) double inspection plans o results of sample inspection are treated in following: defects c1 accept (c1 = acceptance number) defects > d1 reject (d1 = rejection number) defect rate of 1st sample > c1 an < d1 2nd sample needed o form: n-c1/d1-c2/d2 where c2/d2 is the combined defection rate of 1st & 2nd sample example: 20-2/5-4/5 (1st sample: accept in case of 2 or less failures reject in case of 5 or more failures 2nd sample in case of 3 or 4 2nd sample: accept in case of 4 or less failures at all (1st + 2nd sample) reject in case of 5 or more failures at all (1st + 2nd sample) and others
10.1 Operational curve (OC)

PA p AQL LQ Probability of Acceptance failures per lot size Acceptable Quality Level up to this level you accept (otherwise test 100%) limited Quality causes troubles
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2004-05-18
10.2 Larson Nomogramm

x n i n i binomial distribution G ( x; n, p ) = i p (1 p ) i =0
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10.3 Durchschlupf curve (Escape-curve)

D (Durchschlupf) = AOQ (Average Outgoing Quality)
AOQ = p PA
example for n-c = 50-1: p 0 0,011 0,02 0,03 0,04 0,05 0,06 0,07 PA 1 0,9 0,74 0,56 0,4 0,275 0,18 0,12 AOQ 0 0,0099 0,0148 0,0168 0,016 0,01375 0,0108 0,0084
0,018 0,016 0,014 0,012 0,01 0,008 0,006 0,004 0,002 0 0 0,011 0,02 0,03 0,04 0,05 0,06 0,07 failure rate p Average Outgoing Quality AOQ
AOQ - curve
Values from Larson - Nomogramm
highest AOQ at p = 3% !!! operational curve for this example:

Operational Curve
1,1 1 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0 0 0,05 0,1 failure rate p[%] 0,15 0,2 Acceptance Probability PA[%]
10.4 ATI (Average Total Inspection)

Calculated for the average of parts inspected either on sample base or (plus) those lots which are 100% inspected after a lot was stopped.
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ATI = n +
( N n) (1 PA ) lots
n = sample size; N = lot size
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2004-05-27
11 central limiting theorem

based on U-Transformation table
95,4%
u=
182 180 =2 1
178
S=1 180 182
is population standard deviation (over all) s is the standard deviation of one sample
[cm]
UCL LCL
AE
99% distribution limit of x taken out of a process
AE = UWL LWL
UCL/LCL UWL/LWL
u u
AW
95% distribution limit of x taken out of a process
Upper/Lower Control Level Upper/Lower Warning Level
example: typical sample sizes n-sample 3 5 7 10 20 AE 1,487 1,152 0,974 0,815 0,576 AW 1,132 0,877 0,741 0,620 0,438
Out of these values it is possible to establish a control chart. for a full control chart, additional information are necessary (e.g. frequency of samples)
11.1 Shewart-Control-Chart
notes missing! relevant for exam!!! Interaction Ping fragen!
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-Risk -Risk
the risk to interfere a process, where it is not necessary = 1% because we defined 99% of distribution are inside UCL and LCL 2004-06-01
Whats wrong with these samples? They do not follow the distribution on what control and warning levels are based. (There should also be some samples close to the levels.) Possible Reason: The process was improved but the levels were not adopted. This can be a problem because samples that would be outside of new levels will not be discovered by these levels. This process is not capable.
11.2 Non-Sheward Control Charts

- no middle line (value) - no Warning-Levels - based on Tolerance Levels not on Levels based on process statistics
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2004-06-03
12 Quality Capability
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2004-06-10
12.1 Rating Results & following activities
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12.2 Certification and Auditing
Documents:
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12.3 Potential Analysis

12.3.1 Auditing and Evaluation process
12.3.2 Evaluation/grading
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12.4 Quality Control Charts

Prerequisites for Control Charts: process must be capable and under control !!! are the limits process(statistical Experience) or product(ToleranceLevel) oriented? Process distribution Process moved but maybe will not be recognized because most parts are still inside specification levels (only focused on tolerance)
Sample distribution By defining Control Lines/levels you will recognize this process shift!
Quality Control Charts are an excellent tool to support JIT
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2004-06-08
13 Basic Tools for QM

Copy BASIC TOOLS FOR QUALITY MANAGEMENT AND PROCESSIMPROVEMENT (ISO 9004-DRAFT)
13.1 Data Collection

WHY, WHAT, WHEN, WHO, WHERE, BY WHAT, HOW
13.2 Check Sheets 13.3 Histogram

to check the kind of distribution
13.4 Paretodiagram
sort different characteristics by occurance
13.5 Ishikawa/Fishbone/Cause-Effect-Diagram 13.6 Scattered Diagram 13.7 (Control Chart)

not really a basic tool, because to complicated
13.8 Affinity Diagram

e.g. based on Brainstorming to classify the ideas/results
13.9 Relation Diagram

to find root cause(s) elements with only outgoing errors
13.10 Tree Diagram 13.11 Matrix Diagram

e.g. House of Quality
13.12 Radar Chart

e.g. Mr. Mbius Slides of Part- & Component-Suppliers
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2004-06-15
14 Using of Methods - Matrix Diagram

Quality Lead times Productivity Costs Teamwork graphs Pareto Cause-effect-diagram Check lists Histogram Control Chart (Streuungsdiag.) Brainsttorming(METAPLAN) Relationship diagram Tree diagram Matrix diagram Net plan (CPM)
Overall Improvements Methods Improvement steps

(1) Estimation of Problem size Understanding the situation Defining problem Assessment of scattering of data Timely scattering Layering and comparision of data Discussion of importance of problems Discussion of difference of problems Assessment of importance Estimation about possibility of improvement Potential factors (identification) Choose of most important factors selection Test relation Time relation Generation and structuring of ideas Selection of improvements steps/actions Evaluate Estimate of improvement results Improvement plan Realize the Plan (execution) Collecting data after improvement Check effectiveness Check data variations Confirm results lead improvement to persist Detect deviations Report
(2) Defining Improvement objective (3) Analysis of influencing factors
(4) Finding & Discussion of improvements
(5) Realization of improvements (6) Test of improvement results (7) Improvement lasting
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2004-06-17
15 Quality Engineering Methods Structure
FTA = Fault Tree Analysis MEOST to take care of interactions between different environment conditions
15.1 Poka-Yoke
Main principle: Prevent errors to become defects.
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2004-06-22
15.2 DOE
first define problem define factors (conditions)
15.2.1 Full Factorial (Vollstndiger Versuch) example: 2 parameters A, B 1. Matrix for experiment A B + + - + + - Conditions for experiment + high level of parameters (e.g. estimated improvement) - low lever of parameters(e.g. actual state of parameter) Lk
No. of experiments 2. Analyse matrix A B AB + + + - + + - - +
(L=no. of levels; k=no. of parameters)
Result Trail1 Trail2 24 22 11 12 20 19 9 11
Result is measuring of the value what you want to improve
3. Impact of the factors Impact of A I(A): A(+)=24+22+20+19=85 A(-)=11+12+9+11=43 I(A)=|A(+)-A(-)|=42 Impact of B I(B): B(+)=24+22+11+12=49 B(-)=20+19+9+11=59 I(B)=|B(+)-B(-)|=10 Impact of AB I(AB): AB(+)=24+22+9+11=66 AB(-)=11+12+20+19=62 I(AB)=|AB(+)-AB(-)|=4
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16 Requirements for Potential Analysis (of suppliers)

read pages 43-75 from the VW.pdf document!
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2004-06-24
17 stages of quality
see copies! additionally to stage 2:
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2004-06-29
18 Summary for exam

Basic principle process under control (see definition) Capable can produce parts to specification without sorting mechanism 1. ISO 9000 o structure o difference 9001 9004 o effectiveness efficiency o QM page 4 o QFD o process approach write down typical ISO process (management review or supplier evaluation or Internal Audit, Design review) Process Audit (Input Control Plan, Operation/specification documents); Output report o 2. Process Capability & Control o calculation of Capability Index o 3. Measurement system capability 4. FMEA 5. paired comparison (open book question) 2004-07-06 6. tree structure page 4 7. what to do to become a potential supplier (p.43-75 in VW.pdf) 8. QFD 9. HoQ 10. Larsson 11. no shewart control chart
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International Technology Transfer Management Summersemester 2004