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An Introduction to

ISO/TS 16949:2002
By George Tao
15th Mar. 2006

ORIENT INDUSTRY 1
Learning objectives
ƒ Appreciating key aspects of ISO/TS 16949 + market
drivers
ƒ Comparing ISO/TS 16949:2002 with ISO 9001:2002
ƒ Approaches to assessing where you are now
ƒ Appreciating the techniques to support ISO/TS 16949;
ƒ Statistical Analysis
ƒ Statistical Process Control
ƒ Measurement Systems Analysis
ƒ FMEA
ƒ Control Plans
ƒ Considering the next steps

ORIENT INDUSTRY 2
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

ORIENT INDUSTRY 3
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

ORIENT INDUSTRY 4
Who contributed - through IATF/JAMA?

ƒ All major automotive OEMs


ƒ US, European + Japanese supplier organizations
ƒ 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
ORIENT INDUSTRY 5
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;
ƒ continual improvement,
ƒ emphasizing defect prevention and
ƒ the reduction of variation and waste in the supply chain.”

ORIENT INDUSTRY 6
Key Aspects – Overview

ƒ Top management involvement including;


ƒ implementing a business plan linked to defined
measurable quality objectives

ƒ Clear definition of responsibilities including;


ƒ Authority to stop production to correct quality problems

ƒ Top management review of the performance of the


quality system including;
ƒ reporting and evaluation of the cost of poor quality

ORIENT INDUSTRY 7
Key Aspects – Overview
ƒ Focus on Human Resource management including
ƒ processes for defining competence requirements,
ƒ providing training (including on the job training for employed,
temporary and agency personnel),
ƒ verifying effectiveness of actions taken

ƒ A process to motivate employees to


ƒ achieve quality objectives,
ƒ make continual improvement, and
ƒ create an environment to promote innovation.

ƒ 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
ORIENT INDUSTRY 8
Key Aspects – Overview
ƒ Focus on product & process design to meet requirements

ƒ Use of automotive core tools


ƒ Statistical Process Control (SPC),
ƒ Measurement System Analysis (MSA)
ƒ Failure Mode Effect Analysis (FMEA)

ƒ Controlling production processes by use of


ƒ control plans
ƒ work instructions

ƒ Ensuring effective control of internal & external laboratories

ORIENT INDUSTRY 9
Key Aspects – Overview
ƒ Focus on process for measurement of customer
perception and satisfaction

ƒ All processes need to take into account any customer


specific requirements

ƒ Development of suppliers using ISO/TS16949: 2002

ƒ Focus on continual improvement


ƒ Undertaking effective system, process & product audits
ƒ Effective analysis of data to drive improvement
ƒ Evidence of continual improvement throughout the organisation’s
processes, not just manufacturing
ORIENT INDUSTRY 10
Key Aspects – 8 QM principles

ƒ Process Approach [ 4.1, 5.1.1 ]


ƒ Customer focus [ 5.1, 5.2, 5.6.1.1, 8.2.1, 8.3.3 ]
ƒ Leadership [ 5.3, 5.4.1 ]
ƒ Involvement of people [ 5.5.3, 6.2.2.4 ]
ƒ System approach [ 4.1, 5.1.1, 5.4.1, 5.6.1 ]
to management
ƒ Continual improvement [ 5.1, 5.3, 8.5.1 ]
ƒ Factual approach [ 5.6.1, 8.2.2, 8.4 ]
to decision making
ƒ Mutually beneficial [ 7.4.1.2 ]
supplier relationship

ORIENT INDUSTRY 11
Key Aspects – Process focus

Process – “any activity or set of activities that uses


resources to transform inputs into outputs.”

[4.1] “The organisation shall


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

ORIENT INDUSTRY 12
Key Aspects – Process focus

ƒ Examples of ‘customer orientated processes’


ƒ Bid/Tender, Order/Request
ƒ Production
ƒ Product/Production verification

ƒ For your own operations, consider such processes -


ƒ inputs
ƒ outputs
ƒ possible indicators of process effectiveness from the
customer and/or organisations (internal customer)
perspective
ƒ what management/support processes are needed for this
process to work effectively
ORIENT INDUSTRY 13
Key Aspects – Process focus

Management & support processes – examples

ƒ Management Review & Business Planning


ƒ Internal Audit
ƒ Production Engineering
ƒ Quality
ƒ Purchasing
ƒ Finance
ƒ Maintenance
ƒ Human Resources

ORIENT INDUSTRY 14
Key Aspects – Process focus

ƒ Customer measures of process effectiveness


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

ƒ Organisation measures of process effectiveness


ƒ Reports & reviews of performance against objectives
ƒ Evaluation of the cost of poor quality

ORIENT INDUSTRY 15
Key Aspects – Customer focus

ƒ Customer specific requirements are included in an


audit for ISO/TS 16949
ƒ “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”

ƒ What is your process for identifying and using


customer specific quality management system
requirements?

ORIENT INDUSTRY 16
Key aspects – required documents

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


ƒ Procedures & documents to ensure effective planning, operation
and control of processes + records [4.2.1]
ƒ Procedure for document control [4.2.3]
ƒ Procedure for identifying training needs and achieving competence of all
personnel performing activities affecting product quality [6.2.2.2]
ƒ Procedure for internal audits, reporting results & keeping records
[8.2.2]
ƒ Procedure for control of nonconforming product + responsibilities
[8.3]
ƒ Procedure for reviewing nonconformities, determining causes with
action to prevent recurrence [8.5.2]
ƒ Procedure for determining potential nonconformities & causes,
action to prevent occurrence [8.5.3]
Bold = from ISO 9001:2000

ORIENT INDUSTRY 17
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?)

ORIENT INDUSTRY 18
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


ƒRenault 1 July 2004
ƒDaimler Chrysler 1 July 2004
ƒPSA Peugeot-Citroën 15 Dec 2004
ƒFord & 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.
ORIENT INDUSTRY 19
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 ]

ORIENT INDUSTRY 20
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?

ORIENT INDUSTRY 21
Comparing ISO/TS 16949 with ISO 9001

ORIENT INDUSTRY 22
Comparing ISO/TS 16949 with ISO 9001

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

Applying to
ƒ Quality Management System
ƒ Management Responsibility
ƒ Resource Management
ƒ Product Realisation
ƒ Measurement, Analysis and Improvement

[ http://www.smmt.co.uk/downloads/comparisons.pdf
also shows comparison to QS9000 ]

ORIENT INDUSTRY 23
Comparing ISO/TS 16949 with ISO 9001

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

Quality Management System


ƒ Retain responsibility for all outsourced processes [4.1.1]
ƒ Review customer engineering specifications & changes
within 2 weeks [4.2.3.1]
ƒ Control records of regulatory and customer requirements
[4.2.4.1]

ORIENT INDUSTRY 24
Comparing ISO/TS 16949 with ISO 9001

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

Management Responsibility

ƒ Top management shall review product realisation and support


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

ORIENT INDUSTRY 25
Comparing ISO/TS 16949 with ISO 9001

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

Management Responsibility (cont’d)

ƒ 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]

ƒ Management reviews shall include;


ƒ monitoring of performance trends, the cost of poor quality,
the achievement of quality objectives, [5.6.1.1]
ƒ review of actual and potential field failures. [5.6.2.1]

ORIENT INDUSTRY 26
Comparing ISO/TS 16949 with ISO 9001

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

Resource Management
ƒ Personnel with product design responsibility shall be competent
to achieve design requirements and skilled in applicable tools and
techniques. [6.2.2.1]
ƒ Document procedures for identifying training needs and achieving
competence of personnel [6.2.2.2]
ƒ Provide on-the-job training, including the consequences to the
customer of nonconformities [6.2.2.3]
ƒ Have a process to motivate employees to; achieve quality
objectives, make continual improvements & create an innovative
environment. [6.2.2.4]

ORIENT INDUSTRY 27
Comparing ISO/TS 16949 with ISO 9001

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

Resource Management (cont’d)


ƒ 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]
ƒ 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]
ƒ Ensure that the plant layout and working methods are designed
with safety to employees in mind. [6.4.1]
ƒ Ensure that workplaces are tidy and appropriately clean. [6.4.2]

ORIENT INDUSTRY 28
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation
ƒ Include customer requirements and reference to spec.s in the
planning of product realisation [7.1(.1)]
ƒ Define and approve acceptance criteria with the customer [7.1.2]
ƒ Ensure confidentiality of customer contracted products and product
information during design & development and production. [7.1.3]
ƒ Have change control process that;
ƒ prevents any change to product, materials or processes without
customer approval,
ƒ 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]

ORIENT INDUSTRY 29
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)


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

ORIENT INDUSTRY 30
Comparing ISO/TS 16949 with ISO 9001

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

ƒ Product Realisation (cont’d)

ƒ Document and include the following in ‘manufacturing


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

ORIENT INDUSTRY 31
Comparing ISO/TS 16949 with ISO 9001

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

ƒ Product Realisation (cont’d)

ƒ Document and include the following in ‘product design output’


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

ORIENT INDUSTRY 32
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)

ƒ Document and include the following in ‘manufacturing design


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

ORIENT INDUSTRY 33
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)

ƒ Report measurements of design & development at management


review [7.3.4.1]
ƒ Perform validation in accordance with customer requirements
[7.3.6(.1)]
ƒ Prototype programme required using manufacturing processes
[7.3.6.2]
ƒ Approval procedure required as recognised by the customer
[7.3.6.3]
ƒ All purchased products shall conform to regulatory requirements
[7.4.1.1]

ORIENT INDUSTRY 34
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)


ƒ Work in partnership with suppliers to develop the supplier quality
management system. Conformity to ISO 9001:2000 is required.
[7.4.1.2]
ƒ As specified in the contract, use approved sources for purchased
material [7.4.1.3]
ƒ Monitor the quality of purchased product by one or more of the
following;
ƒ evaluation of the statistical data received from the supplier
ƒ receiving inspection
ƒ 2nd or 3rd part audits with records of acceptable delivered
performance
ƒ part evaluation by a designated laboratory [7.4.3.1]
ORIENT INDUSTRY 35
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)

ƒ Monitor supplier performance by;


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

ORIENT INDUSTRY 36
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)

ƒ Use predictive and preventative maintenance for key processes


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

ORIENT INDUSTRY 37
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)

ƒ Validate all processes for product and service provision to


demonstrate the ability of these processes to achieve planned
results – where applicable through;
ƒ defined criteria for review and approval of the process
ƒ approval of equipment and qualification of personnel
ƒ use of specific methods & procedures
ƒ requirements for records
ƒ revalidation [7.5.2(.1)]

ORIENT INDUSTRY 38
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)

ƒ In all cases;
ƒ identify the product throughout product realisation
ƒ identify the product status with respect to monitoring &
measurement requirements
ƒ where traceability required, control and record unique product
identification [7.5.3(.1)]
ƒ Permanently mark customer owned tooling
ƒ Assess the condition of stock. Assure stock rotation (FIFO).
Control obsolete stock as nonconforming. [7.5.5.1]
ƒ Perform statistical studies on measuring equipment to analyse
variation [7.6.1]
ORIENT INDUSTRY 39
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)

ƒ Maintain calibration records including


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

ORIENT INDUSTRY 40
Comparing ISO/TS 16949 with ISO 9001

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

Product Realisation (cont’d)

ƒ 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]

ƒ Use only external laboratories that


ƒ have a suitable scope
ƒ are accredited to ISO 17025 or acceptable to the customer
[7.6.3.2]

ORIENT INDUSTRY 41
Comparing ISO/TS 16949 with ISO 9001

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

Measurement, Analysis and Improvement

ƒ Identify appropriate statistical tools for each process [8.1.1]


ƒ Understand statistical concepts [8.1.2]
ƒ Monitor customer satisfaction and produce performance indicators
[8.2.1(.1)]
ƒ Audit the quality management system to verify compliance with the
standard [8.2.2.1]
ƒ Audit each manufacturing process [8.2.2.2]
ƒ Include in internal audits all quality management related
processes, activities and shifts [8.2.2.4]

ORIENT INDUSTRY 42
Comparing ISO/TS 16949 with ISO 9001

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

Measurement, Analysis and Improvement (cont’d)

ƒ Internal auditors shall be suitable qualified [8.2.2.5]

ƒ Perform process capability studies and include the conclusions in


the quality or control plan. Studies shall include the;
ƒ stability of the process
ƒ capability of the inspection and test process
ƒ capability of the reaction plans to contain the effect of any
nonconformity [8.2.3]

ORIENT INDUSTRY 43
Comparing ISO/TS 16949 with ISO 9001

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

Measurement, Analysis and Improvement (cont’d)

ƒ 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]
ƒ 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]
ƒ Class product with unidentified status as nonconforming. Make
instructions for rework available. [8.3(.1), 8.3.2]
ƒ Inform customers promptly if nonconforming product is shipped
[8.3.3]

ORIENT INDUSTRY 44
Comparing ISO/TS 16949 with ISO 9001

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

Measurement, Analysis and Improvement (cont’d)


ƒ 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]
ƒ Analyse trends in quality & operational performance; use data to:
ƒ manage progress towards overall objectives
ƒ identify priorities
ƒ provide a factual basis for decision making
ƒ anticipate and predict problems arising from the end users.
Establish benchmarks to measure performance against
competitors or other appropriate recognised criteria.[8.4.1]

ORIENT INDUSTRY 45
Comparing ISO/TS 16949 with ISO 9001

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

Measurement, Analysis and Improvement (cont’d)

ƒ Define a programme for continual improvement [8.5.1.1]


ƒ Focus manufacturing improvement on reducing variation [8.5.1.2]
ƒ Define a process for problem solving [8.5.2.1]
ƒ Use error proofing methods in the corrective action process
[8.5.2.2]
ƒ Apply corrective action to other similar processes and products
[8.5.2.3]
ƒ Minimise the time for corrective action [8.5.2.4]

ORIENT INDUSTRY 46
Assessing where you are now

ORIENT INDUSTRY 47
Techniques to support ISO/TS 16949

Statistical Analysis
- Statistical Process Control (SPC)
- Measurement Systems Analysis (MSA)

ORIENT INDUSTRY 48
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.”

ƒ Detects variation in process measures to enable;


ƒ reduction of variation, and,
ƒ prevention of defects / waste.

ƒ Applied to all processes whose output measures offer


ƒ Variable data e.g. part dimensions
ƒ Attribute data – conforming; yes/no - that can be counted e.g.
parts received on-time

ORIENT INDUSTRY 49
Statistical Analysis

ISO/TS 16949:2002 requirement for Statistical Analysis

ƒ 8.0 Measurement, analysis and improvement

ƒ 8.1.1 Identification of statistical tools

ƒ 8.1.2 Knowledge of basic statistical concepts

ƒ 8.2.3.1 Monitoring and measurement of manufacturing process

ƒ 8.5.1.2 Manufacturing process improvement

ORIENT INDUSTRY 50
Statistical Analysis - SPC

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


described as a distribution. Distributions, differ in
ƒ Location
ƒ Spread
ƒ Shape …or any combination of these.

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


ƒ location is measured by the mean [ X ]
ƒ spread is measured by the range [R] or standard
deviation [sd]
ƒ SPC can be applied to see if variation is unacceptable

ORIENT INDUSTRY 51
Statistical Analysis - SPC

ƒ Variation in variable data can come from


ƒ Common causes – natural random events – which
affect all values of process output
ƒ Special causes – intermittent, often unpredictable
causes making the process output unstable

ƒ Control charts help identify special causes by showing


ƒ Values beyond control limits
ƒ Non–random patterns or trends e.g. 7 points
increasing/decreasing, 7 points one side of the average

ORIENT INDUSTRY 52
Statistical Analysis - SPC
ƒ Before assessing process capability, special causes
must be removed
ƒ Process Capability then measures
ƒ How variable the process is [ Pp, Cp ]
ƒ 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)
ORIENT INDUSTRY 53
Statistical Analysis - SPC

Attribute data can be analysis using


ƒ p chart for proportion of nonconforming parts
ƒ u chart for nonconformities per unit
ƒ np chart for the number of nonconforming parts
ƒ c chart for the number of nonconformities

ORIENT INDUSTRY 54
Statistical Analysis – SPC

Benefits of Statistical Process Control (SPC)

ƒ Show how successfully a process is adjusted &


controlled to achieve consistent and therefore
predictable outputs e.g. conforming products

ƒ Flag any special causes of variation which need to be


identified and eliminated by local action

ƒ Quantify the effects of improvements in quality, leading


to reductions in waste (poor quality costs)

ORIENT INDUSTRY 55
Techniques to support ISO/TS 16949

Statistical Analysis
- Statistical Process Control (SPC)
- Measurement Systems Analysis (MSA)

ORIENT INDUSTRY 56
Statistical Analysis - MSA

ƒ 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.”

ƒ To quantify and communicate the limitations of


specific measurement systems.

ORIENT INDUSTRY 57
Statistical Analysis - MSA

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.”

ORIENT INDUSTRY 58
Statistical Analysis - MSA
Terminology

ƒ 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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Statistical Analysis - MSA
Terminology

ƒ Gauge: any device used to obtain measurements, frequently


used to refer specifically to the devices used on the shop floor.

ƒ 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.

ƒ Reference Value: a reference for comparison, normally


determined under laboratory conditions or using a more
accurate instrument.

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Statistical Analysis - MSA
ƒ Quality of measurement data
ƒ If measurements are close to the reference value the quality of the
data is high

ƒ Measurement systems
ƒ Must be in statistical control
ƒ 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.
ƒ Typically the smallest graduation on the scale of the instrument
ƒ *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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Statistical Analysis - MSA
ƒ Variability characterised by
ƒ Location - bias, linearity, stability
ƒ Width or spread – repeatability, reproducibility

ƒ Location Errors
ƒ Bias: the difference between the mean measurement and the
reference value.

ƒ Linearity: the difference in bias through the operating range

ƒ Stability: the total variation in the measurements obtained from a


single characteristic over time (change in bias over time)
ƒ Check change in characteristic, such as values from Electrical
Test Equipment, between calibration intervals
ƒ Plot data and take action if bias outside a specified value
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Statistical Analysis - MSA
Spread Errors (Gauge R & R)

ƒ 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’)
ƒ Under 10% considered acceptable
ƒ To improve, instruments may need maintenance or redesign

ƒ Reproducibility: variation in measurements obtained with


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

ƒ Measurement System Study


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

ƒ Measurement System Analysis – when?


ƒ “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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Techniques to support ISO/TS 16949

Failure Modes & Effects Analysis

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Failure Mode and Effects Analysis
Failure Mode and Effects Analysis (FMEA)

ƒ A systematic group of activities to:


ƒ Recognize and evaluate potential failures of a product or process
and the effects of failure
ƒ Identify actions that could eliminate or reduce the chance of the
potential failure occurring
ƒ Document the above process

ƒ Evidence from vehicle recalls has shown a fully implemented


FMEA could have prevented many causes

ƒ Enables action before the event (Prevention),


not after (Detection)

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Failure Mode and Effects Analysis

ISO/TS 16949:2002 requirement for FMEA

ƒ 4.2.3.1 Engineering specifications


ƒ 7.3.1.1 Multidisciplinary approach
ƒ 7.3.2.3 Special Characteristics
ƒ 7.3.3.1 Product design outputs
ƒ 7.3.3.2 Manufacturing process design outputs
ƒ 7.5.1.1 Control Plan

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Failure Mode and Effects Analysis
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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Failure Mode and Effects Analysis
ƒ Design FMEA
ƒ Focuses on designing out Potential Failures in Product Design
causing detrimental effects on functional performance
ƒ Applies when products’ design is created or revised
TEAM
EFFORT ƒ Uses test, production, quality, supplier & customer experience
ƒ Assumes manufacturing process would achieve specification

ƒ Process FMEA
ƒ Focuses on preventing Potential Failures in manufacturing
Process causing detrimental effects on functional performance
ƒ Applies when manufacturing process is applied to new product
or changed
ƒ Uses test, design, quality, supplier & customer experience
TEAM
EFFORT
ƒ Assumes if design made to spec., it would otherwise succeed
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Failure Mode and Effects Analysis
Design FMEA used to address potential risks in the design achieving
functional performance, by:

ƒ Identifying potential design failures, their causes & effects

ƒ Rating the;
ƒ Severity of effects; 1 to 10 (10 = most severe),
ƒ Occurrence of effects; 1 to 10 (10 = most likely),
ƒ 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.

ƒ Using the Risk Priority Number (RPN)


RPN = Severity rating x Occurrence rating x Detection rating
…to prioritise action – focussing on designing out failure
ƒ Customers may define triggers for action e.g. RPN >100, Severity > 8
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Failure Mode and Effects Analysis
Process FMEA used to address potential risks in the manufacturing
process achieving functional performance, by:

ƒ Identifying potential process failures, their causes & effects

ƒ Rating the;
ƒ Severity of effects; 1 to 10 (10 = most severe),
ƒ Occurrence of effects; 1 to 10 (10 = most likely),
ƒ Detection/prevention of effects by current controls eg. test; 1 to 10
(10=unlikely to be detected/prevented),
using guidance available in PFMEA manuals.

ƒ Using the Risk Priority Number (RPN)


RPN = Severity rating x Occurrence rating x Detection rating
…to prioritise action – focussing on preventing failure
ƒ Customers may define triggers for action e.g. RPN >100, Severity > 8
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Failure Mode and Effects Analysis

FMEA is successful as a process & living document,


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

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Failure Mode and Effects Analysis

FMEA appears ‘difficult’, if:


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

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Techniques to support ISO/TS 16949

Control Plans

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Control Plans - Overview

Control Plans

ƒ summarize the systems used to minimize process and product


variation, guiding manufacturing on how to control the process
and ensure product quality

ƒ structure the approach to design, selection and implementation of


value-added control methods

ƒ describe the actions required at each phase of the process to


ensure all process outputs will be in control

ƒ are living documents - updated as measurement systems and


control methods are evaluated and improved.

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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…”

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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.”

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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

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Control Plans - Example
Control Plan Example format
ƒ 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

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Control Plans
Control Plan Checklist
ƒ Have customer requirements been adopted in Control Plan
format and preparation?
ƒ Have all known customer concerns been identified to facilitate
the selection of special product/process characteristics?
ƒ Are all special product/process characteristics included in the
control plan?
ƒ Are material specifications requiring inspection identified?
ƒ Does the control plan address incoming material/components
through processing/assembly including packaging?
ƒ Are engineering performance testing requirements identified
ƒ Are gauges and test equipment available as required by the
control plan?
ƒ If required, has the customer approved the control plan?
ƒ Are gauge methods compatible between supplier & customer?

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Control Plans - Benefits
Benefits of Control Plans
ƒ Improved quality of products during design,
manufacturing and assembly, by identifying sources of
variation

ƒ Resources focussed on process and product


characteristics important for customer satisfaction

ƒ Communication of
ƒ changes in product/process characteristics and their
control & measurement
ƒ prepared responses to nonconformities (Reaction Plan)

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THANKS

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