An Introduction to ISOTS 16949:2002

1
An Introduction to ISO/TS 169492002
2
Learning objectives

• Appreciating key aspects of ISO/TS 16949 market
  drivers
• Comparing ISO/TS 169492002 with ISO 90012002
• 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

3
What is ISO/TS 169492002?

• TS 16949 is a Technical Standard expressing
  particular requirements for the application of
  ISO 90012000 for automotive production and
  relevant service part organizations
• which means...
• ISO 90012000 requirements plus additional
  requirements specific to automotive production

In the standard document ISO 90012000 text is
shown in boxes
4
Where did ISO/TS 169492002 come from?

• Prepared by International Automotive Task Force
  (IATF) Japan Automobile Manufacturers Assoc.
  (JAMA)

5
Who contributed - through IATF/JAMA?

• All major automotive OEMs
• US, European Japanese supplier organizations
• Some Tier 1 suppliers

6
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.

7
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

8
Key Aspects Overview

• 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

9
Key Aspects Overview

• 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

10
Key Aspects Overview

• 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
  organisations processes, not just manufacturing

11
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

12
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.

13
Key Aspects Process focus

• 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

14
Key Aspects Process focus

• Management support processes examples
• Management Review Business Planning
• Internal Audit
• Production Engineering
• Quality
• Purchasing
• Finance
• Maintenance
• Human Resources

15
Key Aspects Process focus

• 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

16
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?

17
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 90012000
18
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 90012000 complements
  ISO/TS 169492000 many common requirements
  (less paper?)

19
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.
• OEMs deadlines for (Tier 1) suppliers achieving
  ISO/TS 169492002
• 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.

20
Market Drivers OEM requirements
21
Market Drivers Tier 1 requirements

• http//www.industryforum.co.uk/pdf/FordCustomerRe
  qSpec.doc
• Your customers?

22

• Comparing ISO/TS 16949 with ISO 9001

23
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• 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

24
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• 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

25
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• 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

26
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Management Responsibility (contd)
• 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

27
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• 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

28
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Resource Management (contd)
• 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

29
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• 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

30
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

31
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

32
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

33
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

34
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

35
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• Work in partnership with suppliers to develop the
  supplier quality management system. Conformity to
  ISO 90012000 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

36
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

37
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

38
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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)

39
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

40
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

41
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Product Realisation (contd)
• 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

42
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• 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

43
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Measurement, Analysis and Improvement (contd)
• 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

44
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Measurement, Analysis and Improvement (contd)
• 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

45
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Measurement, Analysis and Improvement (contd)
• 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

46
Comparing ISO/TS 16949 with ISO 9001

• Additional Requirements of ISO/TS 169492002 vs
  ISO 90012000
• Measurement, Analysis and Improvement (contd)
• 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

47

• Assessing where you are now

48
Techniques to support ISO/TS 16949

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

49
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

50
Statistical Analysis

• ISO/TS 169492002 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

51
Statistical Analysis - SPC

• 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

52
Statistical Analysis - SPC

• 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
• Nonrandom patterns or trends e.g. 7 points
  increasing/decreasing, 7 points one side of the
  average

53
Statistical Analysis - SPC

• 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

54
Statistical Analysis - SPC

• 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

55
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)

56
Techniques to support ISO/TS 16949

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

57
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.

58
Statistical Analysis - MSA

• ISO/TS 169492002 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.

59
Statistical Analysis - MSA

• 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.

60
Statistical Analysis - MSA

• 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.

61
Statistical Analysis - MSA

• 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.

62
Statistical Analysis - MSA

• 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

63
Statistical Analysis - MSA

• 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

64
Statistical Analysis - MSA

• 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.

65
Techniques to support ISO/TS 16949

• Failure Modes Effects Analysis

66
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)

67
Failure Mode and Effects Analysis

• ISO/TS 169492002 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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Failure Mode and Effects Analysis
How can cause or effect be prevented detected?
What are the customer related functions or
requirements?

• What should be done, by whom when?
• design/ process change
• special controls, changes in procedures/ guides

What are the effects?
How bad is it?

• What can go wrong?
• No function
• Partial/over/ degraded function
• Intermittent function
• Unintended function

How good is this method at detecting / preventing?
What are the causes?
What has been done?
What risks are highest priority?
Is there still a priority risk?
How often does it happen?
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Failure Mode and Effects Analysis

• 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
• 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
• Assumes if design made to spec., it would
  otherwise succeed

TEAM EFFORT
TEAM EFFORT
70
Failure Mode and Effects Analysis

• 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)
• to prioritise action focussing on designing
  out failure
• Customers may define triggers for action e.g. RPN
  gt100, Severity gt 8

RPN Severity rating x Occurrence rating x
Detection rating
71
Failure Mode and Effects Analysis

• 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 (10unlikely to be
  detected/prevented),
• using guidance available in PFMEA manuals.
• Using the Risk Priority Number (RPN)
• to prioritise action focussing on preventing
  failure
• Customers may define triggers for action e.g. RPN
  gt100, Severity gt 8

RPN Severity rating x Occurrence rating x
Detection rating
72
Failure Mode and Effects Analysis

• 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

73
Failure Mode and Effects Analysis

• 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

74
Techniques to support ISO/TS 16949

• Control Plans

75
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.

76
Control Plans - Requirement

• ISO/TS 169492002 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

77
Control Plans - Content

• ISO/TS 169492002 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.

78
Control Plans - Content

• ISO/TS 169492002 requirement for Control Plan
  content Annex A
• General Data part no. name, process step
  descriptions, etc
• Product Control characteristics for control
  specifn tolerance
• Process Control process parameters, manufg m/cs
  tools
• Methods evaluation of meast technique, sample
  size freq.
• Reaction Plan corrective actions

79
Control Plans - Example

• Control Plan Example format
• minimum elements required by ISO/TS 169492002
  Annex A

80
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?

81
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)

82

• Next Steps