An Introduction To ISO/TS 16949:2002: by George Tao

An Introduction to
ISO/TS 16949:2002
By George Tao
1 5th Mar. 2006
ORIENT INDUSTRY 1
Learning objectives
6 App
reciating key aspects of ISO/TS 16949 + market
drivers
6 Comparing ISO/TS 16949:2002 with ISO 9001 :2002
6 Approaches to assessing where you are now
6 Appreciating the techniques to support ISO/TS 16949;
6 Statistical Analysis
6 Statistical Process Control
6 Measurement Systems Analysis
6 FMEA
6 Control Plans
ORIENT INDUSTRY 2
6 i i t xt t
·hat is ISO/TS 16949:2002?
TS 16949 is a Technical Standard e pressing

å articular requirements for the a lication of ISO
9001:2000 for automotive roduction and relevant
service art organizations´
...which means...
ISO 9001:2000 requirements lus additional requirements

specific to automotive production
In the standard document ISO 9001:2000 te t is shown in bo es
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·here did ISO/TS 16949:2002 come from?
Prepared by International Automotive Task Force (IATF)

+ Japan Automobile Manufacturers Assoc. (JAMA)
EAQF
AVSQ ISO/TS ISO/TS
Autom otive
VDA 6.1 16949:1999 16949:2002
QS 9000
ISO 9000
ISO 9001 :1994 ISO 9001:2000
series
1994 1999 2000 2002

·ho contributed - through IATF/JAMA?
6 All major automotive OEMs

6 US, European + Japanese supplier
organizations
6 Some
USA Tier
UK 1 suppliers
France Germany Italy Ja an
OEMs Ford PSA V· Fiat Nissan

GM Renault BM· Toyota
Daimler Honda
Chrysler
National SMMT FIEV VDA ANFIA JAMA

Su lier
Org¶ns
Su liers Bosch GKN Faurecia Bosch Magneti

USA Marelli
ORIENT INDUSTRY 5
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Key Aspects ± Scope & goal
SCOPE: ³This
technical specification is applicable to
sites of the organization where roduction and/or service arts
s ecified by the customer are manufactured...
...throughout the su ly chain.´
GOAL: ³The goal of this specification is the develo ment of a quality

management system that provides for;
6 continual im rovement,
6 em hasizing defect revention and
6 h r du ion o ri ion nd w in h u l h in .´
O IE T I ST Y 8
Key Aspects ± Overview
6 Top management involvement including;

implementing a business plan linked to defined
measurable quality objectives
6 Clear definition of responsibilities including;

6 Authority to stop production to correct quality problems
6 Top management review of the performance of the

quality system including;
6 reporting and evaluation of the cost of poor quality
ORIENT INDUSTRY 9
6 Focus on Human Resource management including
6 processes for defining competence
requirements,
6 providing training (including on the job training for
employed,
temporary and agency personnel),
6 A process to motivate employees to
6 achieve quality objectives,
6 make continual improvement,
and
6 create an environment to promote
6 A process to measure the e tent to which personnel are
aware of the relevance & importance of their activities - how
they contribute to achieving the quality objectives
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6 Focus on product & process design to meet requirements
6 Use of automotive core tools

6 Statistical Process Control (SPC),
6 Measurement System Analysis (MSA)
6 Failure Mode Effect Analysis (FMEA)
6 Controlling production processes by use of

6 control plans
6 work instructions
6 Ensuring effective control of internal & e ternal laboratories
ORIENT INDUSTRY 11
6 Focus on process for measurement of customer
perception and satisfaction
6 All processes need to take into account any customer

specific requirements
6 Development of suppliers using ISO/TS16949: 2002
6 Focus on continual improvement

6 Undertaking effective system, process & product audits
6 Effective analysis of data to drive improvement
6 Evidence of continual improvement throughout the
organisation¶s
processes, not just manufactu
ORIENT ring
INDUSTRY 10
Key Aspects ± 8 QM principles
6 Proc
ess A roach o 4.1, 5.1.1 ]
6 Customer focus o 5.1, 5.2, 5.6.1.1, 8.2.1, 8.3.3 ]
6 Leadership o 5.3, 5.4.1 ]
6 Involvement of people o 5.5.3, 6.2.2.4 ]
6 System approach o 4.1, 5.1.1, 5.4.1, 5.6.1 ]
to management
6 Continual improvement o 5.1, 5.3, 8.5.1 ]
6 Factual approach o 5.6.1, 8.2.2, 8.4 ]
to decision making
6 Mutually beneficial o 7.4.1.2 ]
K A t P f
li l ti i
Process ± ³any activity or set of activities that uses
resources to transform inputs into outputs.
o4.1] ³The organisation shall

6 identify processes needed for the quality management
system and their application throughout the
organisation
6 determine the sequence and interaction of these
p rocesses
6 measure, monitor and improve these processes.
ORIENT INDUSTRY 15
K A t P f
6 Ex m l fµ t m i t t ¶
6 Bi /T ,O / t
6 P ti
6 P t/P ti ifi ti
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ccc
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O IE T I ST Y
Key Aspects ± Process focus
Management & support processes ± e amples
6 Management Review & Business Planning

6 Internal Audit
6 Production Engineering
6 Quality
6 Purchasing
6 Finance
6 Maintenance
6 Human Resources
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6 Customer measures of process effectiveness
6 Delivered part quality performance
6 Customer disruptions including field returns
6 Delivery schedule performance (including instances of
premium freight)
6 Customer notification of quality or delivery issues
6 Organisation measures of process effectiveness

6 Reports & reviews of performance against objectives
6 Evaluation of the cost of poor quality
Key Aspects
Key Aspects ±± Customer
Process focus
focus
6 Cust
omer specific requirements are included in an
audit for ISO/TS 16949
6 ³Customer specific quality management system
requirements supplemental to ISO/TS 16949 shall be
included in the audit in order to obtain customer
recognition of such certification
6c
c c c c c
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Key aspects ± required documents
6 Quality olicy & objectives [4.2.1] + Quality manual [4.2.2]

6 Procedures & documents to ensure effective lanning, o eration
and control of rocesses + records [4.2.1]
6 Procedure for document control [4.2.3]
6 Procedure for identifying training needs and achieving competence of all
personnel performing activities affecting product quality o6.2.2.2]
6 Procedure for internal audits, re orting results & kee ing records
[ .2.2]
6 Procedure for control of nonconforming roduct + res onsibilities
[ .3]
6 Procedure for reviewing nonconformities, determining causes wi th
action to revent recurrence [ .5.2]
6 Procedure for determining nonconformities & causes,
action to revent occurrence [ .5.3]
Bold = from ISO 9001:2000
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Market Drivers ± the goal
³The goal of this Technical Specification is the

development of a quality management system that
provides for;
- continual improvement
- emphasising defect prevention and
- the reduction of variation and waste in the supply
chain.
Process approach of ISO 9001:2000 complements

ISO/TS 16949:2000 ± many common requirements
(less paper?)
ORIENT INDUSTRY 22
M t i OEM & Ti imt
ISO/TS i tl t t f ll i :
BMW, iml l , Fi t, F , GM i l O l V x ll , PSA
P t it ë , lt SA, VW.
OEM¶ li f Ti li i i ISO/TS :
6 lt l
6 iml l l
6PSA P t it ë
6F & GM
T f ll i a b d m nu ur r À i i t tÀi t:
BMW G ;F M t m ; K; ;
i M t M f
ti K; Pt Mt m ; ll

Mt & Btl Mt ; GK ; M il Oil.
O IE T I ST Y
Market Drivers ± OEM requirements
ISO/TS 16949:2002 or ? Customer S ecific Requirements
OEM
Audi/Volkswagen ISO/TS 16949:2002 or VDA 6 o Quality Cap. Suppliers 4 th Ed ]
BMW Contact customer o Supplied Parts Quality Mgmt ]
Daimler Chrysler ISO/TS 16949:2002 o Daimler Chrysler Customer specific Requirements for use
with ISO/TS 16949: 2000 ]
Ford Motor Co. ISO/TS 16949:2002 (QS 9000 / Q1) Contact customer
General Motors ISO/TS 16949:2002 o ISO/TS 16949:2002 Customer Specific Requirements ]
Honda Contact customer o Honda Supplier Quality Manual ]
Isuzu Contact customer o Supplier Quality Manual ]
Mazda Contact customer Contact customer
Mitsubishi Contact customer o SMITQA-003 ]
Nissan Contact customer o Supplier Quality Manual / Alliance Supplier Guide ]
PSA Peugeot-Citroën ISO/TS 16949:2002 Contact customer
Renault ISO/TS 16949:2002 Contact customer
Rover Contact customer o RG2000 Supplier Management System ]
Saab Contact customer Contact customer
Subaru Contact customer o Subaru Supplier Manual ]
Toyota Contact customer o Supplier Quality Assurance Manual ]
ORIENT INDUSTRY 20
Market Drivers ± Tier 1 requirements
ISO/TS 16949:2002 or ? Customer S ecific Requirements
Tier 1
Dana Corporation Contact customer Contact customer
Delphi Contact customer o Supplier Standards ]

Johnson Controls Contact customer o Global Supplier Standards Manual ]
Navistar (International) Contact customer o Navistar Quality Requirements ]

Visteon QS-9000, Section II Contact customer
ohttp://www.industryforum.co.uk/pdf/FordCustomerReqSpec.doc]
uc c
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Comparing ISO/TS 16949 with ISO 9001
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Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000
Applying to
6 Quality Management System
6 Management Res onsibility
6 Resource Management
6 Product Realisation
6 Measurement, Analysis and Im rovement
o http://www.smmt.co.uk/downloads/comparisons.pdf
also shows comparison to QS9000 ]
ORIENT INDUSTRY 27
ºm i ISO/TS itÀ ISO
ddi ion l imt f ISO/TS : ISO :
Qu li M n g m n m
6 t i i ilit f ll t

o..]
6 i
tm ii
ifi
ti &
À
itÀi o.. .]
6 ºtl
f l t
tm imt
o...]
O IE T I aT Y 8
Additional Requirements of ISO/TS 16949:2002 vs ISO 9001 :2000
Management Res onsibility
6 Top management shall review product realisation and support

processes o5.1.1]
6 Top management shall define quality objectives in the business
plan and their use to deploy quality policy o5.4.1(.1)]
6 Managers responsible for corrective action shall
6 be promptly informed of products or processes that do
not
conform to requirements.
6 appoint µquality representatives¶ with authority to stop
production (all shifts) to correct quality problems o5.5.1.1]
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Management Res onsibility (cont¶d)
6 Top management shall appoint µcustomer representatives¶ with

specific responsibility to ensure compliance with customer
requirements, including selection of special characteristics,
corrective/preventative actions and design/development. o5.5.2.1]
6 Management reviews shall include;

6 monitoring of performance trends, the cost of poor quality,
the achievement of quality objectives, o5.6.1.1]
6 review of actual and potential field failures. o5.6.2.1]
ORIENT INDUSTRY 30
ddiion l imt f ISO/TS : ISO :
our M n gmn
6 P l itÀ
t i i ilit À ll
mtt
t
Ài i imt ill i li
l tl
t
Ài . o...]
6
mt
f itifi t ii
Àii

mt
f l o...]
6 Pi tÀj t ii, i
li tÀ

t tÀ

tm f
fmiti o... ]
6
t mti t ml t;
Ài lit
j
ti , m
ti l immt &
t i ti
imt. o...]
O IE T I aT Y
our M n gmn on¶d

6 E ll ill t ff i tÀ f
t il i
ii l t
l t À li mtÀ ; i
l l m f
t i
miimm i & miimm mmt f t o. .]
6
ti
l f m
it ti tÀ t
l ff
t

tm imt , i
li f il,
mmi
ti
f il, m ti l t l f il, imt f il,
l Àt À li t
t. o. .]
6 E tÀ t tÀ l t l t i mtÀ i
itÀ ft t ml i mi. o..]
6 E tÀ t l
ti i tl
l . o..]
O IE T I aT Y
Product Realisation
6 Include customer requirements and reference to spec.s in the
planning of product realisation o7.1(.1)]
6 Define and approve acceptance criteria with the customer o7.1.2]
6 Ensure confidentiality of customer contracted products and product
information during design & development and production. o7.1.3]
6 Have change control process that;
6 prevents any change to product, materials or processes without
customer approval,
6 includes testing the validation or effectiveness of the change
before implementation.
For a proprietary design, review impact on form fit and function
with the customer. o7.1.4]
Product Realisation (cont¶d)

6 Obtain customer approval for any waiving of a review of
requirements related to the product o7.2.2.1]
6 Review manufacturing feasibility within contract review o7.2.2.2]
6 Communicate necessary information in a customer specified
language and format o7.2.3.1]
6 Document and include the following in µ roduct design in ut¶
6 customer requirements including performance and special
characteristics
6 e perience from previous products
6 targets for product quality, life, reliability, durability,
maintainability, timescales and cost. o7.3.2.1]
6 Product Realisation (cont¶d)
6 Document and include the following in µ manufacturing

design in ut¶
6 product design outputs that have to be met by
manufacturing
6 e perience from previous products
6 targets for productivity, process capability and cost.
o7.3.2.2]
6 Identify special characteristics o7.3.2.3]
ORIENT INDUSTRY 35
6 Product Realisation (cont¶d)
6 Document and include the following in µ roduct design out ut¶

in ways that demonstrate that all design inputs have been met
6 design FMEAs including diagnostic guidelines to
predict
failure modes
6 reliability results
6 special characteristics
6 an analysis of error proofing
6 product drawings, specifications and calculations
6 product design reviews o7.3.3.1]
ORIENT INDUSTRY 32
6 Document and include the following in µ manufacturing design

out ut¶ in ways that demonstrate all design inputs have been met
6 design FMEAs including diagnostic guidelines to predict
failure modes
6 a control plan, specifications, drawings, instructions and
flowcharts
6 plant & workstation layouts
6 an analysis of error proofing
6 manufacturing process validity and approval method including
acceptance criteria o7.3.3.2]
ORIENT INDUSTRY 37
6 Report measurements of design & development at management

review o7.3.4.1]
6 Perform validation in accordance with customer requirements
o7.3.6(.1)]
6 Prototype programme required using manufacturing processes
o7.3.6.2]
6 Approval procedure required as recognised by the customer
o7.3.6.3]
6 All purchased products shall conform to regulatory requirements
o7.4.1.1]
ORIENT INDUSTRY 3
Produ liion on¶d

6 W i t Ài itÀ li t l tÀ li lit
m mt tm. ºfmit t ISO : i i.
o...]
6 A
ifi i tÀ
t
t,
f
À
m ti l o... ]
6 Mit tÀ lit f
À
t m f tÀ
flli;
6 l ti f tÀ t ti ti
l t
i fm tÀ li
6
ii i
ti
6 t it itÀ
f
t l li
fm

6 t l ti i t l t o.. .]
O IE T I aT Y
6 Monitor supplier performance by;

6 delivered product quality performance
6 customer disruptions that have occurred
6 returns or other feedback from end users
6 delivered schedule performance o7.4.3.2]
6 Use Control Plans to the format specified in Appendi A o7.5.1.1]
6 ·ork instructions for operations that impact on quality are required
o7.5.1.2]
6 Verify job set ups o7.5.1.3]
ORIENT INDUSTRY 36
6 Use predictive and preventative maintenance for key processes

o7.5.1.4]
6 Resources for tool and gauge design, fabrication and verification
are required o7.5.1.5]
6 Schedule production to meet customer requirements e.g. just -in-
time o7.5.1.6]
6 Establish a process for communication of information on service
concerns o7.5.1.7]
6 Verify the effectiveness of any customer service agreements
o7.5.1.8]
ORIENT INDUSTRY 41
ddiionl imt f ISO/TS : ISO :
Produ liion on¶d
6 V li t ll
f
t i
i i t
m t t tÀ ilit f tÀ
t
Ài l
lt À li
l tÀÀ;
6 fi
iti f i l f tÀ

6 l f imt lifi
ti f l
6 f
ifi
mtÀ &

6 imt f

6 li ti o. ..]
O IE T I aT Y
Produ liion on¶d
6 I ll
;
6 itif tÀ
t tÀÀt
t li ti
6 itif tÀ
t t t itÀ
t t miti &
m mt imt
6 À t
ilit i,
tl
i
t
itifi
ti o. . . ]
6 Pm tl m
tm tli
6 A tÀ
iti f t
. A t
t ti FIFO.
ºtl lt t

fmi. o. . .]
6 Pfm t ti ti
l ti m i imt t l
i ti o..]
O IE T I aT Y
6 Maintain calibration records including

6 Equipment identification
6 The standard against which the equipment is calibrated
6 Revisions following changes to equipment
6 Assessments of the impact of out-of-specification
equipment
6 Notifications to customer of any product that may have
been
affected by out-of-specification measuring equiment
6 A positive statement of the acceptance of the calibration
ORIENT INDUSTRY 40
6 Define the scope of any internal laboratory to include its ability to

perform the required duties and be managed by a documented
management system either within or separate from the main
system o7.6.3.1]
6 Use only e ternal laboratories that

6 have a suitable scope
6 are accredited to ISO 17025 or acceptable to the customer
o7.6.3.2]
ORIENT INDUSTRY 45
Measurement, Analysis and Im rovement
6 Identify appropriate statistical tools for each process o8.1.1]

6 Understand statistical concepts o8.1.2]
6 Monitor customer satisfaction and produce performance indicators
o8.2.1 (.1)]
6 Audit the quality management system to verify compliance with the
standard o8.2.2.1]
6 Audit each manufacturing process o8.2.2.2]
6 Include in internal audits all quality management related
processes, activities and shifts o8.2.2.4]
ORIENT INDUSTRY 42
Measurement, Analysis and Im rovement (cont¶d)
6 Internal auditors shall be suitable qualified o8.2.2.5]
6 Perform process capability studies and include the conclusions in

the quality or control plan. Studies shall include the;
6 stability of the process
6 capability of the inspection and test process
6 capability of the reaction plans to contain the effect of any
nonconformity o8.2.3]
ORIENT INDUSTRY 47
6 Conduct product audits o8.2.2.3] and µlayout inspections¶ i.e.

checking every measurement and parameter shown on the
approved design drawings. o8.2.4.1]
6 Conduct appearance inspections on items for which customer
specifies this i.e. checking every aspect of the appearance of the
finished product as perceived by the end user. Maintain master
samples and means of making comparisons. o8.2.4.2]
6 Class product with unidentified status as nonconforming. Make
instructions for rework available. o8.3(.1), 8.3.2]
6 Inform customers promptly if nonconforming product is shipped
o8.3.3]
ORIENT INDUSTRY 4
Murmn, nli nd Im ro mn on¶d

6 O t i
tm

i f
i itÀ ftÀ

i if t m ti l i t fll i

itÀ
imt . TÀi À ll l t
t m ti l till
i
li. o. .]
6 A l t i lit & ti l fm
; t t:
6 m t ll j
ti
6 itif iiti
6 i f
t l i f
i i m i
6 ti
i t i
t lm i i fm tÀ .
E t li À
Àm t m fm
i t

mtit tÀ i t
i
iti .o..]
O IE T I aT Y
6 Define a programme for continual improvement o8.5.1.1]

6 Focus manufacturing improvement on reducing variation o8.5.1.2]
6 Define a process for problem solving o8.5.2.1]
6 Use error proofing methods in the corrective action process
o8.5.2.2]
6 Apply corrective action to other similar processes and products
o8.5.2.3]
6 Minimise the time for corrective action o8.5.2.4]
ORIENT INDUSTRY 46
ORIENT INDUSTRY 51
Assessing where you are now
Techniques to support ISO/TS 16949
Statistical Analysis
- Statistical Process Control (SPC)
- Measurement Systems Analysis (MSA)
ORIENT INDUSTRY 52
Statistical Analysis - SPC
Statistical Process Control (SPC)

³The use of statistical techniques such as control charts to analyse
a process or its outputs so as to take appropriate actions to
achieve and maintain a state of statistical control and to improve
process capability.
6 Detects variation in process measures to enable;

6 reduction of variation, and,
6 prevention of defects / waste.
6 Applied to all processes whose output measures offer

6 Variable data e.g. part dimensions
6 Attribute data ± conforming; yes/no - that can be counted e.g.
parts received on-time
ORIENT INDUSTRY 53
ISO/TS 16949:2002 requirement for Statistical Analysis
6 8.0 Measurement, analysis and improvement
6 8.1.1 Identification of statistical tools
6 8.1.2 Knowledge of basic statistical concepts
6 8.2.3.1 Monitoring and measurement of

manufacturing process
6 8.5.1.2 Manufacturing process improvement
ORIENT INDUSTRY 50
6 Variable data forms a pattern that, if stable, can be

described as a distribution. Distributions, differ in
6 Location
6 Spread
6 Shape ...or any combination of these.
6 If the shape of variable data is µnormal¶ (typical);

6 location is measured by the mean o X ]
6 spread is measured by the range oR] or standard
deviation osd]
6 SPC can be applied to see if variation is unacceptable
ORIENT INDUSTRY 55
6 Variation in variable data can come from

6 Common causes ± natu ral random events ± which
affect all values of process output
6 S ecial causes ± intermittent, often unpredictable
causes making the process output unstable
6 Control charts help identify special causes by showing

6 Values beyond control limits
6 Non±random patterns or trends e.g. 7 points
increasing/decreasing, 7 points one side of the average
ORIENT INDUSTRY 56
6 Befor
e assessing process capability, special causes
must be removed
6 Process Capability then measures
6 How variable the process is o Pp, Cp ]
6 How process variation fits within the specified limits
oPpk, Cpk] - how well it meets a customer requirement
Cpk A rox arts er million out of s ecification

1.00 66,000
. ,
.
. . Six im
Statistical Analysis ± SPC
Attribute data can be analysis using

6 p chart for proportion of nonconforming parts
6 u chart for nonconformities per unit
6 np chart for the number of nonconforming parts
6 c chart for the number of nonconformities
ORIENT INDUSTRY 59
Statistical Analysis ± SPC
Benefits of Statistical Process Control (S PC)
6 Show how successfully a process is adjusted &

controlled to achieve consistent and therefore
predictable outputs e.g. conforming products
6 Flag any special causes of variation which need to be

identified and eliminated by local action
6 Quantify the effects of improvements in quality, leading

to reductions in waste (poor quality costs)
ORIENT INDUSTRY 60
- Statistical Process Control (SPC)
- Measurement Systems Analysis (MSA)
Statistical Analysis - MSA
6 ·hy Measurement System Analysis?

³The purpose of any analysis of a measurement
system should be to better understand the sources of
variation that can influence the results produced by
the system.
6 To quantify and communicate the limitations of

specific measurement systems.
ORIENT INDUSTRY 62
ISO/TS 16949:2002 requirement for Measurement

Systems Analysis (MSA) o7.6.1]
³Statistical studies shall be conducted to analyse the

variation present in the resu lts of each type of
measuring and test equipment system. This
requirement shall apply to measurement systems
referenced in the control plan. The analytical methods
and acceptance criteria used shall conform to those in
customer reference manuals on measurement systems
analysis. Other analytical methods of acceptance
criteria may be used if approved by the customer.
ORIENT INDUSTRY 63
Terminology
Measurement system:
the collection of operations, procedures, gauges and
other equipment, software and personnel used to
assign a number to a characteristic being measured;
the complete process used to obtain a measurement.
Material Man Method
MEASUREMENT SYSTEM
Machine (Time) Environment

ORIENT INDUSTRY 59
Termi nology
6 Gauge: any device used to obtain measurements, frequently

used to refer specifically to the devices used on the shop floor.
6 Calibration: a set of operations that establish under specific

operating conditions, the relationship between a measuring
device and a traceable standard of a known reference and
uncertainty.
6 Reference Value: a reference for comparison, normally

determined under laboratory conditions or using a more
accurate instrument.
Statistical
Analysis -- MSA
MSA
6 Quality of measurement data
6 If measurements are close to the reference value the quality of
the
data is high
6 Measurement systems
6 Must be in statistical control
6 Must have small variability compared with specified tolerance
or
manufacturing process variability*
Descrimination : the amount of change from the reference value that
an instrument can detect and faithfully indicate.
6 Typically the smallest graduation on the scale of the
instrument
6 *Descrimination should be one tenth of the tolerance
range,
however recently the descrimination target is one tenth of the
ORIENT INDUSTRY 61
ORIENT INDUSTRY 66
6 Variability characterised by
6 Location - bias, linearity, stability
6 Width or s read ± repeatability, reproducibility
6 Location Errors Bias: the difference between the mean

ƒ
measurement and the

reference value.
6 Linearity : the difference in bias through the operating range
6 Stability : the total variation in the measurements obtained from a

single characteristic over time (change in bias over time)
6 Check change in characteristic, such as values from Electrical
Test Equipment, between calibration intervals
6 Plot data and take action if bias outside a specified value
Spread Errors (Gauge R & R)
6 Re eatability: variation in measurements obtained with one

measurement instrument, when used several times by one
appraiser while measu ring the identical characteristic on the
same part. (µEquipment Variation¶)
6 Under 10% considered acceptable
6 To improve, instruments may need maintenance
or redesign
6 Re roducibility: variation in measurements obtained with
one measurement instrument, when used by different
appraisers while measuring the identical characteristic on the
same part.
6 Under 10% considered acceptable
6 To improve, appraiser(s) may need training, or more
ease of use
ORIENT INDUSTRY 63
ORIENT INDUSTRY 6
6 Meas
urement System Study
6 Select appraisers ± people already using the instrument
6 Select measurement instrument ± has it the required discrimination
6 Select parts from the process that represent entire operating range
e.g. several days production and number each part.
6 Measurement System Analysis ± Ñ c

6 ³As processes change and improve, a measurement system must
be re-evaluated for its intended purpose
For e ample, when there is a new product, capability improvement,
skill level change, process change e.g. new equipment, change in
imt,
À i t t mtÀ/
.
O IE T I aT Y
Failure Modes & Effects Analysis
ORIENT INDUSTRY 65
Failure Mode and Effects Analysis
Failure Mode and Effects Analysis (FMEA)
6 A systematic group of activities to:

6 Recognize and evaluate potential failures of a product or process
and the effects of failure
6 Identify actions that could eliminate or reduce the chance of the
potential failure occurring
6 Document the above process
6 Evidence from vehicle recalls has shown a fully implemented

FMEA could have prevented many causes
6 Enables action before the event (Prevention),

not after (Detection)
ORIENT INDUSTRY 72
ISO/TS 16949:2002 requirement for FMEA
6 4.2.3.1 Engineering specifications

6 7.3.1.1 Multidisciplinary approach
6 7.3.2.3 Special Characteristics
6 7.3.3.1 Product design outputs
6 7.3.3.2 Manufacturing process design outputs
6 7.5.1.1 Control Plan
ORIENT INDUSTRY 73
C
Item O Current D Responsibility & Action Results
l Potential
Potential S R
Potential a Cause(s)/ Controls Recommended Actions Taken
Effect(s) of c e S O D R
Function Failure Mode s Mechanisms (Prevention / Action(s) Target
Failure e c t P
Requirements s of Failure Detection) Completion Date
v u e N e c e P
r c v c t N
What are the How can What should be

customer What are cause or done, by whom
related the effects? effect be & when?
functions or revented
req ui rements? & detected? -design/ process
change
How
What can bad -special controls,
is it? How good changes in
go wrong? is this procedures/
-No function method at guides
detecting /
-Partial/over/ reventing?
What are
degraded What has
the
fu nction been
causes?
What risks done?
-Intermittent
are highest
fu nction Is there
riority?
How often still a
-Unintended does it riority
fu nction
ha en? risk?
ORIENT INDUSTRY 6
6 Design FMEA
6 Focuses on ? c
cPotential Failures in Product
Design
causing detrimental effects on functional performance
TEAM 6 Applies when products¶ design is created or
EFFORT
revised
6 Uses test, production, quality, supplier & customer
6 Process FMEA
6 Focuses on
cPotential Failures in manufacturing
Process causing detrimental effects on functional performance
6 Applies when manufacturing process is
applied to new product
TEAM or changed
EFFORT
6 Uses test, design, quality, supplier & customer
e perience
ORIENT INDUSTRY 75
Design FMEA used to address potential risks in the design achieving
functional performance, by:
6 Identifying potential design failures, their causes & effects
6 Rating the;
6 Severity of effects; 1 to 10 (10 = most severe),
6 Occurrence of effects; 1 to 10 (10 = most likely),
6 Detection/prevention of effects by current controls eg. analysis, test; 1 to 10
(10 = not likely to be detected/prevented),
using guidance available in DFMEA manuals.
6 Using the Risk Priority Number (RPN)

RPN = Severity rating Occurrence rating Detection rating
...to prioritise action ± focussing on designing out failure
6 Customers may define triggers for action e.g. RPN >100,
Severity> 8 ORIENT INDUSTRY 70
Process FMEA used to address potential risks in the manufacturing
process achieving functional performance, by:
6 Identifying potential process failures, their causes & effects
6 Rating the;
6 Severity of effects; 1 to 10 (10 = most sev ere),
6 Occurrence of effects; 1 to 10 (10 = most likely),
6 Detection/prevention of effects by current controls eg. test; 1 to 10
(10=unlikely to be detected/prevented),
using guidance available in PFMEA manuals.
6 Using the Risk Priority Number (RPN)

RPN = Severity rating Occurrence rating Detection rating
...to prioritise action ± focussing on preventing failure
6 Customers may define triggers for action e.g. RPN >100,
Severity> 8
ORIENT INDUSTRY 77
FMEA is successful as a process & living document,

if:
6 All links to e ternal (& internal) customer requirements
from Design and Process elements are understood and
systematically reviewed for risk of potential failure
6 Informed team approach leads to multidisciplinary
e perience being shared to evaluate risk consistently
6 Actions are planned at an early stage ± before changes
are considered too costly
6 Actions are taken as planned and the resulting effect on
the risk is evaluated and documented
ORIENT INDUSTRY 7
F il M Eff
t A l i
FMEA µiffi

lt¶, c
6 T m t À
6
mm t i f tÀ FMEA

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6 A
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O IE T I aT Y
Control Plans
ORIENT INDUSTRY 74
Control Plans - Overview
Control
Plans
6 summarize the systems used to minimize process and product

variation, guiding manufacturing on how to control the process
and ensure product quality
6 structure the approach to design, selection and implementation of

value-added control methods
6 describe the actions required at each phase of the process to

ensure all process outputs will be in control
6 are living documents - updated as measurement systems and
ORIENT INDUSTRY 1
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O IE T I aT Y 8
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O IE T I aT Y 8
Control Plans - Content
ISO/TS 16949:2002 requirement for Control Plan

content o7.5.1 .1]
³The control plan shall

- list the controls used for the manufacturing process
control,
- include the methods for monitoring of control e ercised
over special characteristics...
- include the customer required information, if any, and,
- initiate the specified reaction plan when the process
becomes unstable or not statistically capable.
ORIENT INDUSTRY 4
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O IE T I aT Y 8
Control Plans - E ample
Control Plan E ample format
minimum elements required by ISO/TS 16949:2002 Annex A
CONTROL PLAN
Prototype Pre-launch Production Key Contact/Phone Date (orig.) Date (Rev.)
Control Plan Number
Part Number / Latest Change Level Core Team Customer Engineering Approval/Date (if Req'd)
Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (if Req'd)
Supplier/Plant Supplier Code Other Approval/Date (if Req'd) Other Approval/Date (if Req'd)
Characteristics Methods
Process Name / Reaction Plan
Evaluation
Part/ Operation Mac hine, Proc ess Special Product/Process Sam ple Sam ple / Corrective
No. Product Measurement Control Method
Proc ess Description Device, Jig, param eters Char. Specification/Tolerance Size Frequency Action
Technique
Num ber Tools for Manuf. C lass
ORIENT INDUSTRY 79
Control Plans
Control Plan Checklist
6 Have customer requirements been adopted in Control Plan
format and preparation?
6 Have all known customer concerns been identified to facilitate
the selection of special product/process characteristics?
6 Are all special product/process characteristics included in the
control plan?
6 Are material specifications requiring inspection identified?
6 Does the control plan address incoming material/components
through processing/assembly including packaging?
6 Are engineering performance testing requirements identified
6 Are gauges and test equipment available as required by the
control plan?
6 If required, has the customer approved the control plan?
6 Are gauge methods compatible between supplier & customer?
ORIENT INDUSTRY 7
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O IE T I aT Y 88
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O IE T I aT Y 8
THANKS
ORIENT INDUSTRY 2
O IE T I aT Y

An Introduction To ISO/TS 16949:2002: by George Tao

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An Introduction to

TS 16949 is a Technical Standard e pressing

ISO 9001:2000 requirements lus additional requirements

In the standard document ISO 9001:2000 te t is shown in bo es

Prepared by International Automotive Task Force (IATF)

1994 1999 2000 2002

6 All major automotive OEMs

OEMs Ford PSA V· Fiat Nissan

National SMMT FIEV VDA ANFIA JAMA

Su liers Bosch GKN Faurecia Bosch Magneti

GOAL: ³The goal of this specification is the develo ment of a quality

6 Top management involvement including;

6 Clear definition of responsibilities including;

6 Top management review of the performance of the

6 Focus on product & process design to meet requirements

6 Use of automotive core tools

6 Controlling production processes by use of

6 Ensuring effective control of internal & e ternal laboratories

6 All processes need to take into account any customer

6 Development of suppliers using ISO/TS16949: 2002

6 Focus on continual improvement

o4.1] ³The organisation shall

Management & support processes ± e amples

6 Management Review & Business Planning

6 Organisation measures of process effectiveness

6 Quality olicy & objectives [4.2.1] + Quality manual [4.2.2]

³The goal of this Technical Specification is the

Process approach of ISO 9001:2000 complements

Delphi Contact customer o Supplier Standards ]

Navistar (International) Contact customer o Navistar Quality Requirements ]

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000

ddi ion l imt f ISO/TS :  ISO :

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001 :2000

Management Res onsibility

6 Top management shall review product realisation and support

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000

Management Res onsibility (cont¶d)

6 Top management shall appoint µcustomer representatives¶ with

6 Management reviews shall include;

ddiion l imt f ISO/TS : ISO :

ddiion l imt f ISO/TS : ISO :

our  M n gmn on¶d

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000

Product Realisation (cont¶d)

6 Product Realisation (cont¶d)

6 Document and include the following in µ manufacturing

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000

6 Product Realisation (cont¶d)

6 Document and include the following in µ roduct design out ut¶

Product Realisation (cont¶d)

6 Document and include the following in µ manufacturing design

Product Realisation (cont¶d)

6 Report measurements of design & development at management

Produ  liion on¶d

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000

Product Realisation (cont¶d)

6 Monitor supplier performance by;

Product Realisation (cont¶d)

6 Use predictive and preventative maintenance for key processes

Produ  liion on¶d

Produ  liion on¶d

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000

ddi ion l imt f ISO/TS : ISO :

ddiion l imt f ISO/TS : ISO :

ddiion l imt f ISO/TS : ISO :

our M n gmn on¶d

Produ liion on¶d

Produ liion on¶d

Produ liion on¶d

Murmn, nli nd Im ro mn on¶d

FMEA µiffi

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