TS16949

An Introduction to
ISO/TS 16949:2002
By George Tao
15th Mar. 2006
ORIENT INDUSTRY 1
Learning objectives
Appreciating key aspects of ISO/TS 16949 + market
drivers
Comparing ISO/TS 16949:2002 with ISO 9001:2002
Approaches to assessing where you are now
Appreciating the techniques to support ISO/TS 16949;
Statistical Analysis
Statistical Process Control
Measurement Systems Analysis
FMEA
Control Plans
Considering the next steps
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What is ISO/TS 16949:2002?
TS 16949 is a Technical Standard expressing

“particular requirements for the application of ISO
9001:2000 for automotive production and relevant
service part organizations”
…which means...
ISO 9001:2000 requirements plus additional requirements

specific to automotive production
In the standard document ISO 9001:2000 text is shown in boxes
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Where 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
Automotive
VDA 6.1 16949:1999 16949:2002
QS 9000
ISO 9000
ISO 9001:1994 ISO 9001:2000
series
1994 1999 2000 2002
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Who contributed - through IATF/JAMA?
All major automotive OEMs

US, European + Japanese supplier organizations
Some Tier 1 suppliers
USA UK France Germany Italy Japan
OEMs Ford PSA VW Fiat Nissan

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

Supplier
Org’ns
Suppliers Bosch GKN Faurecia Bosch Magneti
USA Marelli
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Key Aspects – Scope & goal
SCOPE: “This technical specification is applicable to

sites of the organization where production and/or service parts
specified by the customer are manufactured…
…throughout the supply chain.”
GOAL: “The goal of this specification is the development of a quality

management system that provides for;
continual improvement,
emphasizing defect prevention and
the reduction of variation and waste in the supply chain.”
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Key Aspects – Overview
Top management involvement including;

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

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

quality system including;
reporting and evaluation of the cost of poor quality
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Focus on Human Resource management including
processes for defining competence requirements,
providing training (including on the job training for employed,
temporary and agency personnel),
verifying effectiveness of actions taken
A process to motivate employees to

achieve quality objectives,
make continual improvement, and
create an environment to promote innovation.
A process to measure the extent to which personnel are

aware of the relevance & importance of their activities - how
they contribute to achieving the quality objectives
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Focus on product & process design to meet requirements
Use of automotive core tools

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

control plans
work instructions
Ensuring effective control of internal & external laboratories
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Focus on process for measurement of customer
perception and satisfaction
All processes need to take into account any customer

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

Undertaking effective system, process & product audits
Effective analysis of data to drive improvement
Evidence of continual improvement throughout the organisation’s
processes, not just manufacturing
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Key Aspects – 8 QM principles
Process Approach [ 4.1, 5.1.1 ]

Customer focus [ 5.1, 5.2, 5.6.1.1, 8.2.1, 8.3.3 ]
Leadership [ 5.3, 5.4.1 ]
Involvement of people [ 5.5.3, 6.2.2.4 ]
System approach [ 4.1, 5.1.1, 5.4.1, 5.6.1 ]
to management
Continual improvement [ 5.1, 5.3, 8.5.1 ]
Factual approach [ 5.6.1, 8.2.2, 8.4 ]
to decision making
Mutually beneficial [ 7.4.1.2 ]
supplier relationship
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Key Aspects – Process focus
Process – “any activity or set of activities that uses

resources to transform inputs into outputs.”
[4.1] “The organisation shall

identify processes needed for the quality management
system and their application throughout the
organisation
determine the sequence and interaction of these
processes
measure, monitor and improve these processes.”
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Examples of ‘customer orientated processes’

Bid/Tender, Order/Request
Production
Product/Production verification
For your own operations, consider such processes -

inputs
outputs
possible indicators of process effectiveness from the
customer and/or organisations (internal customer)
perspective
what management/support processes are needed for this
process to work effectively
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Management & support processes – examples
Management Review & Business Planning

Internal Audit
Production Engineering
Quality
Purchasing
Finance
Maintenance
Human Resources
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Customer measures of process effectiveness

Delivered part quality performance
Customer disruptions including field returns
Delivery schedule performance (including instances of
premium freight)
Customer notification of quality or delivery issues
Organisation measures of process effectiveness

Reports & reviews of performance against objectives
Evaluation of the cost of poor quality
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Key Aspects – Customer focus
Customer specific requirements are included in an

audit for ISO/TS 16949
“Customer 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”
What is your process for identifying and using

customer specific quality management system
requirements?
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Key aspects – required documents
Quality policy & objectives [4.2.1] + Quality manual [4.2.2]

Procedures & documents to ensure effective planning, operation
and control of processes + records [4.2.1]
Procedure for document control [4.2.3]
Procedure for identifying training needs and achieving competence of all
personnel performing activities affecting product quality [6.2.2.2]
Procedure for internal audits, reporting results & keeping records
[8.2.2]
Procedure for control of nonconforming product + responsibilities
[8.3]
Procedure for reviewing nonconformities, determining causes with
action to prevent recurrence [8.5.2]
Procedure for determining potential nonconformities & causes,
action to prevent occurrence [8.5.3]
Bold = from ISO 9001:2000
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Market Drivers – the goal
“The 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?)
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Market Drivers – OEM & Tier1 requirements
ISO/TS 16949 is currently supported by the following:
BMW, DaimlerChrysler, Fiat, Ford, GM (incl Opel-Vauxhall), PSA
Peugeot-Citroën, Renault SA, VW.
OEM’s deadlines for (Tier 1) suppliers achieving ISO/TS 16949:2002

Renault 1 July 2004
Daimler Chrysler 1 July 2004
PSA Peugeot-Citroën 15 Dec 2004
Ford & GM 14 Dec 2006
The following UK-based manufacturers have indicated their support:

BMW Group; Ford Motor Company; Honda UK; Jaguar Cars;
Nissan Motor Manufacturing UK; Peugeot Motor Company; Rolls-
Royce Motor Cars & Bentley Motor Cars; GKN; Mobil Oil.
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Market Drivers – OEM requirements
ISO/TS 16949:2002 or ? Customer Specific Requirements
OEM
Audi/Volkswagen ISO/TS 16949:2002 or VDA 6 [ Quality Cap. Suppliers 4th Ed ]
BMW Contact customer [ Supplied Parts Quality Mgmt ]
Daimler Chrysler ISO/TS 16949:2002 [ 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 [ ISO/TS 16949:2002 Customer Specific Requirements ]
Honda Contact customer [ Honda Supplier Quality Manual ]
Isuzu Contact customer [ Supplier Quality Manual ]

Mazda Contact customer Contact customer
Mitsubishi Contact customer [ SMITQA-003 ]
Nissan Contact customer [ 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 [ RG2000 Supplier Management System ]
Saab Contact customer Contact customer
Subaru Contact customer [ Subaru Supplier Manual ]
Toyota Contact customer [ Supplier Quality Assurance Manual ]
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Market Drivers – Tier 1 requirements
ISO/TS 16949:2002 or ? Customer Specific Requirements
Tier 1
Dana Corporation Contact customer Contact customer
Delphi Contact customer [ Supplier Standards ]
Johnson Controls Contact customer [ Global Supplier Standards Manual ]
Navistar (International) Contact customer [ Navistar Quality Requirements ]
Visteon QS-9000, Section II Contact customer
[http://www.industryforum.co.uk/pdf/FordCustomerReqSpec.doc]
+ Your customers?
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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
Quality Management System
Management Responsibility
Resource Management
Product Realisation
Measurement, Analysis and Improvement
[ http://www.smmt.co.uk/downloads/comparisons.pdf
also shows comparison to QS9000 ]
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Quality Management System

Retain responsibility for all outsourced processes [4.1.1]
Review customer engineering specifications & changes
within 2 weeks [4.2.3.1]
Control records of regulatory and customer requirements
[4.2.4.1]
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Management Responsibility
Top management shall review product realisation and support

processes [5.1.1]
Top management shall define quality objectives in the business
plan and their use to deploy quality policy [5.4.1(.1)]
Managers responsible for corrective action shall
be promptly informed of products or processes that do not
conform to requirements.
appoint ‘quality representatives’ with authority to stop
production (all shifts) to correct quality problems [5.5.1.1]
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Management Responsibility (cont’d)
Top management shall appoint ‘customer representatives’ with

specific responsibility to ensure compliance with customer
requirements, including selection of special characteristics,
corrective/preventative actions and design/development. [5.5.2.1]
Management reviews shall include;

monitoring of performance trends, the cost of poor quality,
the achievement of quality objectives, [5.6.1.1]
review of actual and potential field failures. [5.6.2.1]
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Resource Management
Personnel with product design responsibility shall be competent
to achieve design requirements and skilled in applicable tools and
techniques. [6.2.2.1]
Document procedures for identifying training needs and achieving
competence of personnel [6.2.2.2]
Provide on-the-job training, including the consequences to the
customer of nonconformities [6.2.2.3]
Have a process to motivate employees to; achieve quality
objectives, make continual improvements & create an innovative
environment. [6.2.2.4]
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Resource Management (cont’d)

Ensure all skilled staff in the factory are involved in deciding plant
layout and handling methods; include lean manufacture using
minimum work in progress & minimum movement of parts [6.3.1]
Have contingency plans for emergency situations that could affect
customer requirements, including power failure, communication
failure, raw material or parts supply failure, equipment failure,
labour shortage and handling returned product. [6.3.2]
Ensure that the plant layout and working methods are designed
with safety to employees in mind. [6.4.1]
Ensure that workplaces are tidy and appropriately clean. [6.4.2]
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Product Realisation
Include customer requirements and reference to spec.s in the
planning of product realisation [7.1(.1)]
Define and approve acceptance criteria with the customer [7.1.2]
Ensure confidentiality of customer contracted products and product
information during design & development and production. [7.1.3]
Have change control process that;
prevents any change to product, materials or processes without
customer approval,
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. [7.1.4]
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Product Realisation (cont’d)

Obtain customer approval for any waiving of a review of
requirements related to the product [7.2.2.1]
Review manufacturing feasibility within contract review [7.2.2.2]
Communicate necessary information in a customer specified
language and format [7.2.3.1]
Document and include the following in ‘product design input’
customer requirements including performance and special
characteristics
experience from previous products
targets for product quality, life, reliability, durability,
maintainability, timescales and cost. [7.3.2.1]
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Document and include the following in ‘manufacturing

design input’
product design outputs that have to be met by
manufacturing
experience from previous products
targets for productivity, process capability and cost.
[7.3.2.2]
Identify special characteristics [7.3.2.3]
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Document and include the following in ‘product design output’

in ways that demonstrate that all design inputs have been met
design FMEAs including diagnostic guidelines to predict
failure modes
reliability results
special characteristics
an analysis of error proofing
product drawings, specifications and calculations
product design reviews [7.3.3.1]
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Document and include the following in ‘manufacturing design

output’ in ways that demonstrate all design inputs have been met
design FMEAs including diagnostic guidelines to predict
failure modes
a control plan, specifications, drawings, instructions and
flowcharts
plant & workstation layouts
an analysis of error proofing
manufacturing process validity and approval method including
acceptance criteria [7.3.3.2]
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Report measurements of design & development at management

review [7.3.4.1]
Perform validation in accordance with customer requirements
[7.3.6(.1)]
Prototype programme required using manufacturing processes
[7.3.6.2]
Approval procedure required as recognised by the customer
[7.3.6.3]
All purchased products shall conform to regulatory requirements
[7.4.1.1]
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Work in partnership with suppliers to develop the supplier quality
management system. Conformity to ISO 9001:2000 is required.
[7.4.1.2]
As specified in the contract, use approved sources for purchased
material [7.4.1.3]
Monitor the quality of purchased product by one or more of the
following;
evaluation of the statistical data received from the supplier
receiving inspection
2nd or 3rd part audits with records of acceptable delivered
performance
part evaluation by a designated laboratory [7.4.3.1]
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Monitor supplier performance by;

delivered product quality performance
customer disruptions that have occurred
returns or other feedback from end users
delivered schedule performance [7.4.3.2]
Use Control Plans to the format specified in Appendix A [7.5.1.1]
Work instructions for operations that impact on quality are required
[7.5.1.2]
Verify job set ups [7.5.1.3]
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Use predictive and preventative maintenance for key processes

[7.5.1.4]
Resources for tool and gauge design, fabrication and verification
are required [7.5.1.5]
Schedule production to meet customer requirements e.g. just-in-
time [7.5.1.6]
Establish a process for communication of information on service
concerns [7.5.1.7]
Verify the effectiveness of any customer service agreements
[7.5.1.8]
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Validate all processes for product and service provision to

demonstrate the ability of these processes to achieve planned
results – where applicable through;
defined criteria for review and approval of the process
approval of equipment and qualification of personnel
use of specific methods & procedures
requirements for records
revalidation [7.5.2(.1)]
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In all cases;
identify the product throughout product realisation
identify the product status with respect to monitoring &
measurement requirements
where traceability required, control and record unique product
identification [7.5.3(.1)]
Permanently mark customer owned tooling
Assess the condition of stock. Assure stock rotation (FIFO).
Control obsolete stock as nonconforming. [7.5.5.1]
Perform statistical studies on measuring equipment to analyse
variation [7.6.1]
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Maintain calibration records including

Equipment identification
The standard against which the equipment is calibrated
Revisions following changes to equipment
Assessments of the impact of out-of-specification equipment
Notifications to customer of any product that may have been
affected by out-of-specification measuring equiment
A positive statement of the acceptance of the calibration for
the intended purpose [7.6.2]
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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 [7.6.3.1]
Use only external laboratories that

have a suitable scope
are accredited to ISO 17025 or acceptable to the customer
[7.6.3.2]
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Measurement, Analysis and Improvement
Identify appropriate statistical tools for each process [8.1.1]

Understand statistical concepts [8.1.2]
Monitor customer satisfaction and produce performance indicators
[8.2.1(.1)]
Audit the quality management system to verify compliance with the
standard [8.2.2.1]
Audit each manufacturing process [8.2.2.2]
Include in internal audits all quality management related
processes, activities and shifts [8.2.2.4]
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Measurement, Analysis and Improvement (cont’d)
Internal auditors shall be suitable qualified [8.2.2.5]
Perform process capability studies and include the conclusions in

the quality or control plan. Studies shall include the;
stability of the process
capability of the inspection and test process
capability of the reaction plans to contain the effect of any
nonconformity [8.2.3]
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Conduct product audits [8.2.2.3] and ‘layout inspections’ i.e.

checking every measurement and parameter shown on the
approved design drawings. [8.2.4.1]
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. [8.2.4.2]
Class product with unidentified status as nonconforming. Make
instructions for rework available. [8.3(.1), 8.3.2]
Inform customers promptly if nonconforming product is shipped
[8.3.3]
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Obtain a customer concession before proceeding with any further
processing if any part or material is not fully in accordance with
approved requirements. This shall apply to product or material still
being processes by a supplier. [8.3.4]
Analyse trends in quality & operational performance; use data to:
manage progress towards overall objectives
identify priorities
provide a factual basis for decision making
anticipate and predict problems arising from the end users.
Establish benchmarks to measure performance against
competitors or other appropriate recognised criteria.[8.4.1]
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Define a programme for continual improvement [8.5.1.1]

Focus manufacturing improvement on reducing variation [8.5.1.2]
Define a process for problem solving [8.5.2.1]
Use error proofing methods in the corrective action process
[8.5.2.2]
Apply corrective action to other similar processes and products
[8.5.2.3]
Minimise the time for corrective action [8.5.2.4]
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Assessing where you are now
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Techniques to support ISO/TS 16949
- Statistical Process Control (SPC)
- Measurement Systems Analysis (MSA)
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Statistical Analysis - SPC
Statistical Process Control (SPC)

“ The 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.”
Detects variation in process measures to enable;

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

Variable data e.g. part dimensions
Attribute data – conforming; yes/no - that can be counted e.g.
parts received on-time
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ISO/TS 16949:2002 requirement for Statistical Analysis
8.0 Measurement, analysis and improvement
8.1.1 Identification of statistical tools
8.1.2 Knowledge of basic statistical concepts
8.2.3.1 Monitoring and measurement of manufacturing process
8.5.1.2 Manufacturing process improvement
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Variable data forms a pattern that, if stable, can be

described as a distribution. Distributions, differ in
Location
Spread
Shape …or any combination of these.
If the shape of variable data is ‘normal’ (typical);

location is measured by the mean [ X ]
spread is measured by the range [R] or standard
deviation [sd]
SPC can be applied to see if variation is unacceptable
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Variation in variable data can come from

Common causes – natural random events – which
affect all values of process output
Special causes – intermittent, often unpredictable
causes making the process output unstable
Control charts help identify special causes by showing

Values beyond control limits
Non–random patterns or trends e.g. 7 points
increasing/decreasing, 7 points one side of the average
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Before assessing process capability, special causes
must be removed
Process Capability then measures
How variable the process is [ Pp, Cp ]
How process variation fits within the specified limits
[Ppk, Cpk] - how well it meets a customer requirement
Cpk Approx parts per million out of specification
1.00 66,000
1.33 6,000
1.67 233
2.00 4.6 (Six sigma)
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Attribute data can be analysis using

p chart for proportion of nonconforming parts
u chart for nonconformities per unit
np chart for the number of nonconforming parts
c chart for the number of nonconformities
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Statistical Analysis – SPC
Benefits of Statistical Process Control (SPC)
Show how successfully a process is adjusted &

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

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

to reductions in waste (poor quality costs)
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- Statistical Process Control (SPC)
- Measurement Systems Analysis (MSA)
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Statistical Analysis - MSA
Why Measurement System Analysis?

“The 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.”
To quantify and communicate the limitations of

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

Systems Analysis (MSA) [7.6.1]
“ Statistical studies shall be conducted to analyse the

variation present in the results 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.”
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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
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Terminology
Gauge: any device used to obtain measurements, frequently

used to refer specifically to the devices used on the shop floor.
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.
Reference Value: a reference for comparison, normally

determined under laboratory conditions or using a more
accurate instrument.
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Quality of measurement data
If measurements are close to the reference value the quality of the
data is high
Measurement systems
Must be in statistical control
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.
Typically the smallest graduation on the scale of the instrument
*Descrimination should be one tenth of the tolerance range,
however recently the descrimination target is one tenth of the
process variation – significantly less.
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Variability characterised by
Location - bias, linearity, stability
Width or spread – repeatability, reproducibility
Location Errors
Bias: the difference between the mean measurement and the
reference value.
Linearity: the difference in bias through the operating range
Stability: the total variation in the measurements obtained from a

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

measurement instrument, when used several times by one
appraiser while measuring the identical characteristic on the
same part. (‘Equipment Variation’)
Under 10% considered acceptable
To improve, instruments may need maintenance or redesign
Reproducibility: variation in measurements obtained with

one measurement instrument, when used by different
appraisers while measuring the identical characteristic on the
same part.
Under 10% considered acceptable
To improve, appraiser(s) may need training, or more ease of use
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Measurement System Study

Select appraisers – people already using the instrument
Select measurement instrument – has it the required discrimination
Select parts from the process that represent entire operating range
e.g. several days production and number each part.
Measurement System Analysis – when?

“As processes change and improve, a measurement system must
be re-evaluated for its intended purpose”
For example, when there is a new product, capability improvement,
skill level change, process change e.g. new equipment, change in
work environment, change in test method/procedure.
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Failure Modes & Effects Analysis
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Failure Mode and Effects Analysis
Failure Mode and Effects Analysis (FMEA)
A systematic group of activities to:

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

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

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

7.3.1.1 Multidisciplinary approach
7.3.2.3 Special Characteristics
7.3.3.1 Product design outputs
7.3.3.2 Manufacturing process design outputs
7.5.1.1 Control Plan
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C
Item O D Responsibility & Action Results
l Potential Current
Potential S c e R
Potential a Cause(s)/ Controls Recommended Actions Taken
Effect(s) of e c t P S O D R
Function Failure Mode Failure v
s Mechanisms
u
(Prevention /
e N
Action(s) Target
s of Failure Detection) e c e P
Requirements r c Completion Date
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 prevented
& detected? -design/ process
requirements?
change
How
What can bad -special controls,
How good
go wrong? is it? changes in
is this
procedures/
-No function method at
guides
detecting /
-Partial/over/ What are preventing?
degraded the What has
function causes? been
What risks done?
-Intermittent are highest
function Is there
How often priority?
still a
-Unintended does it priority
function happen? risk?
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Design FMEA
Focuses on designing out Potential Failures in Product Design
causing detrimental effects on functional performance
Applies when products’ design is created or revised
TEAM
EFFORT Uses test, production, quality, supplier & customer experience
Assumes manufacturing process would achieve specification
Process FMEA
Focuses on preventing Potential Failures in manufacturing
Process causing detrimental effects on functional performance
Applies when manufacturing process is applied to new product
or changed
Uses test, design, quality, supplier & customer experience
TEAM
EFFORT
Assumes if design made to spec., it would otherwise succeed
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Design FMEA used to address potential risks in the design achieving
functional performance, by:
Identifying potential design failures, their causes & effects
Rating the;
Severity of effects; 1 to 10 (10 = most severe),
Occurrence of effects; 1 to 10 (10 = most likely),
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.
Using the Risk Priority Number (RPN)

RPN = Severity rating x Occurrence rating x Detection rating
…to prioritise action – focussing on designing out failure
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:
Identifying potential process failures, their causes & effects
Rating the;
Severity of effects; 1 to 10 (10 = most severe),
Occurrence of effects; 1 to 10 (10 = most likely),
Detection/prevention of effects by current controls eg. test; 1 to 10
(10=unlikely to be detected/prevented),
using guidance available in PFMEA manuals.
Using the Risk Priority Number (RPN)

RPN = Severity rating x Occurrence rating x Detection rating
…to prioritise action – focussing on preventing failure
Customers may define triggers for action e.g. RPN >100, Severity > 8
ORIENT INDUSTRY 71
FMEA is successful as a process & living document,

if:
All links to external (& internal) customer requirements
from Design and Process elements are understood and
systematically reviewed for risk of potential failure
Informed team approach leads to multidisciplinary
experience being shared to evaluate risk consistently
Actions are planned at an early stage – before changes
are considered too costly
Actions are taken as planned and the resulting effect on
the risk is evaluated and documented
ORIENT INDUSTRY 72
FMEA appears ‘difficult’, if:

Team does not have
common understanding of the FMEA process
agreement/guidance on ratings
multidisciplinary experience – particularly a history of customer
concerns or internal failures to consider in evaluating a new item
time to work through sufficient detail and agree actions
Relationship between Design and Process elements and
external (& internal) customer requirements is not understood
Actions are not
Planned early enough
Followed through to achieve reward in better satisfying customer
ORIENT INDUSTRY 73
Control Plans
ORIENT INDUSTRY 74
Control Plans - Overview
Control Plans
summarize the systems used to minimize process and product

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

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

ensure all process outputs will be in control
are living documents - updated as measurement systems and

control methods are evaluated and improved.
ORIENT INDUSTRY 75
Control Plans - Requirement
ISO/TS 16949:2002 requirement for Control Plans [7.5.1.1]
“The organization shall

- develop control plans (see Annex A)… for the product
supplied…
- have a control plan for pre-launch & production that takes into
account the design FMEA and manufacturing process FMEA
outputs.
Control plans shall be reviewed and updated when any

change occurs…
NOTE Customer approval may be required…”
ORIENT INDUSTRY 76
Control Plans - Content
ISO/TS 16949:2002 requirement for Control Plan

content [7.5.1.1]
“The control plan shall

- list the controls used for the manufacturing process
control,
- include the methods for monitoring of control exercised
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 77
Control Plans - Content
ISO/TS 16949:2002 requirement for Control Plan

content [Annex A]
a) General Data; part no. & name, process step descriptions, etc
b) Product Control; characteristics for control; specif’n tolerance
c) Process Control; process parameters, manuf’g m/cs & tools
d) Methods; evaluation of meas’t technique, sample size & freq.
e) Reaction Plan & corrective actions
ORIENT INDUSTRY 78
Control Plans - Example
Control Plan Example 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
Part/ Machine, Special Evaluation
Operation Process Product/Process Sample Sample / Corrective
Process Device, Jig, No. Product Char. Measurement Control Method
Description parameters Specification/Tolerance Size Frequency Action
Number Tools for Manuf. Class Technique
ORIENT INDUSTRY 79
Control Plans
Control Plan Checklist
Have customer requirements been adopted in Control Plan
format and preparation?
Have all known customer concerns been identified to facilitate
the selection of special product/process characteristics?
Are all special product/process characteristics included in the
control plan?
Are material specifications requiring inspection identified?
Does the control plan address incoming material/components
through processing/assembly including packaging?
Are engineering performance testing requirements identified
Are gauges and test equipment available as required by the
control plan?
If required, has the customer approved the control plan?
Are gauge methods compatible between supplier & customer?
ORIENT INDUSTRY 80
Control Plans - Benefits
Benefits of Control Plans
Improved quality of products during design,
manufacturing and assembly, by identifying sources of
variation
Resources focussed on process and product

characteristics important for customer satisfaction
Communication of
changes in product/process characteristics and their
control & measurement
prepared responses to nonconformities (Reaction Plan)
ORIENT INDUSTRY 81
THANKS
ORIENT INDUSTRY 82

TS16949

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TS16949

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An Introduction to

TS 16949 is a Technical Standard expressing

ISO 9001:2000 requirements plus additional requirements

In the standard document ISO 9001:2000 text is shown in boxes

Prepared by International Automotive Task Force (IATF)

1994 1999 2000 2002

 All major automotive OEMs

OEMs Ford PSA VW Fiat Nissan

National SMMT FIEV VDA ANFIA JAMA

SCOPE: “This technical specification is applicable to

GOAL: “The goal of this specification is the development of a quality

 Top management involvement including;

 Clear definition of responsibilities including;

 Top management review of the performance of the

 A process to motivate employees to

 A process to measure the extent to which personnel are

 Use of automotive core tools

 Controlling production processes by use of

 Ensuring effective control of internal & external laboratories

 All processes need to take into account any customer

 Development of suppliers using ISO/TS16949: 2002

 Focus on continual improvement

 Process Approach [ 4.1, 5.1.1 ]

Process – “any activity or set of activities that uses

[4.1] “The organisation shall

 Examples of ‘customer orientated processes’

 For your own operations, consider such processes -

Management & support processes – examples

 Management Review & Business Planning

 Customer measures of process effectiveness

 Organisation measures of process effectiveness

 Customer specific requirements are included in an

 What is your process for identifying and using

 Quality policy & objectives [4.2.1] + Quality manual [4.2.2]

“The goal of this Technical Specification is the

Process approach of ISO 9001:2000 complements

OEM’s deadlines for (Tier 1) suppliers achieving ISO/TS 16949:2002

The following UK-based manufacturers have indicated their support:

Isuzu Contact customer [ Supplier Quality Manual ]

Delphi Contact customer [ Supplier Standards ]

Johnson Controls Contact customer [ Global Supplier Standards Manual ]

Navistar (International) Contact customer [ Navistar Quality Requirements ]

Visteon QS-9000, Section II Contact customer

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

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

Quality Management System

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

 Top management shall review product realisation and support

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

Management Responsibility (cont’d)

 Top management shall appoint ‘customer representatives’ with

 Management reviews shall include;

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

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

Resource Management (cont’d)

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

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

Product Realisation (cont’d)

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

 Product Realisation (cont’d)

 Document and include the following in ‘manufacturing

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

 Product Realisation (cont’d)

All major automotive OEMs

Top management involvement including;

Clear definition of responsibilities including;

Top management review of the performance of the

A process to motivate employees to

A process to measure the extent to which personnel are

Use of automotive core tools

Controlling production processes by use of

Ensuring effective control of internal & external laboratories

All processes need to take into account any customer

Development of suppliers using ISO/TS16949: 2002

Focus on continual improvement

Process Approach [ 4.1, 5.1.1 ]

Examples of ‘customer orientated processes’

For your own operations, consider such processes -

Management Review & Business Planning

Customer measures of process effectiveness

Organisation measures of process effectiveness

Customer specific requirements are included in an

What is your process for identifying and using

Quality policy & objectives [4.2.1] + Quality manual [4.2.2]

Top management shall review product realisation and support

Top management shall appoint ‘customer representatives’ with

Management reviews shall include;

Product Realisation (cont’d)

Document and include the following in ‘manufacturing

Product Realisation (cont’d)

Document and include the following in ‘product design output’

Document and include the following in ‘manufacturing design

Report measurements of design & development at management

Monitor supplier performance by;

Use predictive and preventative maintenance for key processes

Validate all processes for product and service provision to

Maintain calibration records including

Define the scope of any internal laboratory to include its ability to

Use only external laboratories that

Identify appropriate statistical tools for each process [8.1.1]

Internal auditors shall be suitable qualified [8.2.2.5]

Perform process capability studies and include the conclusions in

Conduct product audits [8.2.2.3] and ‘layout inspections’ i.e.

Define a programme for continual improvement [8.5.1.1]

Detects variation in process measures to enable;

Applied to all processes whose output measures offer

8.0 Measurement, analysis and improvement

8.1.1 Identification of statistical tools

8.1.2 Knowledge of basic statistical concepts

8.2.3.1 Monitoring and measurement of manufacturing process

8.5.1.2 Manufacturing process improvement

Variable data forms a pattern that, if stable, can be

If the shape of variable data is ‘normal’ (typical);

Variation in variable data can come from

Control charts help identify special causes by showing

Show how successfully a process is adjusted &

Flag any special causes of variation which need to be

Quantify the effects of improvements in quality, leading

Why Measurement System Analysis?

To quantify and communicate the limitations of

Gauge: any device used to obtain measurements, frequently

Calibration: a set of operations that establish under specific

Reference Value: a reference for comparison, normally

Linearity: the difference in bias through the operating range