TS 16949 Auditor Course

ISO/TS 16949: 20023 Days Internal Auditor

Certification CourseInstructor / Lecturer:

Mohamed GhorabMarch 2008

2Audience Acquaintance / Ice Breaker:

Introduce yourself

What Company do you work for?

Any previous Quality Management or auditing experience?

Define a process in your company which has a direct impact on the customer (External)

3Basics

Switch mobile phones to the silent mode.

Toilets.

Break.

Material provided.

A written open book final exam

4Is THE Global Group

Established in 1878 - Head Office in Geneva, Switzerland.

42000 employees -1000 Offices and 320 Laboratories in more than 120 Countries.

SGS is recognized as the global benchmark for the highest standards of expertise, quality and integrity.

5We provide leading & innovative services to all industries

Certification Inspection & Verification Outsourcing Risk Management Technical Consulting Testing & Analysis

Trainings :

In the areas of:

ISO/TS 16949: 20023 Days Internal Auditor

Certification Course

6Course Objectives:

Understand and apply the automotive process approach to auditing.

Understand the structure and content of ISO/TS 16949: 2002, the support documents and the automotive core tools.

Who should attend?

A person who has the competence to conduct an audit. Demonstrated personnel attributes and demonstrated ability

to apply knowledge and skills.

7Goal of ISO/TS 16949: 2002

The goal of this Technical 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.

8Course Outline:

Background & Development of ISO/TS& Automotive Process Approach

Internal Auditor Qualification& Customer Specific requirements

APQP & Control Plan Statistical Process Control (SPC) Failure Mode & Effect Analysis (FMEA) Measurement System Analysis (MSA) Rules For Achieving IATF Recognition Written Exam (Open Book)

Day 1

Day 2

Day 3

Session 1

Session 3

Session 4

Session 5

Session 6

Session 2

Session 7

9Session 1:

Background & Development of ISO/TS 16949: 2002

& Automotive Process Approach

10

History of Quality Standards

1979 BS 5750

1987 ISO 9000 series

1994 ISO 9000 revision / QS 9000 issued

11

EAQF

Automotive migration to International Standards

The plan is to have no change before 2008 at the earliest due to alignment with ISO 9001: 2000 update.

1994 200019991997 1998 2002

ISO/TS1st edition

ISO 9001: 1994Based document

ISO/TS2002 edition

ISO 9001: 2000Based document

AVSQ

Automotive sector Quality requirements(With registration variation)

USA

GermanyItaly

France

VDA 6QS 9000

12

IATF Representatives

France Germany Italy USA UK Japan

Car Makers PSA

Renault

VW

BMW

Daimler

Fiat Chrysler

Ford

GMLiaison

(Europe / US)

Opel VW of USA

National Super Organization

FIEV VDA ANFIA AIAG / IAOB

SMMT JAMA

Nissan

Toyota

HondaSuppliers Faurecia Bosch Magneti

Marelli

Bosch USA

GKN

13

Scope of ISO/TS 16949: 2002

This technical specification is applicable to sites of the organization where production and / or service parts specified by the customer are manufactured.

This technical specification can be applied throughout the automotive supply chain.

Also applicable to vehicle manufacturers.

14

Business Planning

Business Plan

Policy

Objectives

Planning

Employee Motivation & Empowerment

Impact Influen

ce

15

Terminology

Process Customer Procedure

ISO/TS 16949: 2002 ISO 9001: 1994

16

8 Quality Management Principles

Customer Focus Leadership Involvement of People Process Approach System Approach to management Continual Improvement Factual Approach to decision making Mutually beneficial supplier relationship

Please find a requirement in ISO/TS which relates to each of the above principles.

17

Process Approach

4 8

7

6

5

18

Process

Any Activity or set of activities that uses resources to transform inputs to outputs

19

A process

A process has a start and an end defined by two limits.

And a chain of activities between these two limits

INPUTCustomer who

has a need

OUTPUTCustomer who has a need met

InputStep

1Step

2StepN

Output

20

Identification of processes

ISO/TS 16949: 2002 requires:The organization shall identify processes needed for

the quality management system and their application throughout the organization.

Determine the sequence and interaction of these processes.

Measure, monitor and improve these processes.

21

Audit Tool: Turtle Diagram

Outputs

Conforming product delivered to customer schedule (8.2.1.1)

Inputs

Customer schedule (7.5.1.6)Raw materials (7.4)

How?Control plans (7.5.1.1)Work instructions (7.5.1.2)Preventive maintenance (7.5.1.4)SPC (8.1.1)Nonconforming product procedure (8.3)Dispatch process (7.5.1.7)Contingency plan (6.3.2)Document control/ records (4.2.3/4)

What Results?Analysis of data (8.4.1)Customer satisfaction (8.2.1)Other Organizational objectives (5.4.1)Maintenance objectives (7.5.1.4)Cost of poor quality (5.6.1.1)Process capability (8.2.3.1)Management review (5.6.1)Continual improvement results (8.5)Audit records (8.2.2)

With Who? Competence criteria (6.2.1)Induction/ training records (6.2.2)Agency/ Contract labour (6.2.2.3)Job responsibilities/ authorities (5.5)Training effectiveness (6.2.2)SPC awareness (8.1.2)Personnel safety (6.4.1)Awareness of policy/ objectives (6.2.2.4)

With What? Plant and machinery (6.3)Process equipment (6.3)Measuring equipment (7.6)Tooling (7.5.1.5)Maintenance (7.5.1.4)Packaging/labeling (7.5.5)Customer property (7.5.4)Transportation (6.3)

(Support Processes)ITHuman resourceLogisticsSalesQualityPreventive maintenance

Process:

Manufacturing Manufacturing Process (7.5)Process (7.5)

22

Turtle Diagram Workshop

In your groups analyze the process allocated by the trainer and create a turtle diagram.

23

Process Improvement (Shewart Cycle)

Plan

What and why?

Do

How, when, and how much?

Check

How will you know it worked?

Act

How do you plan to fully adopt?

Act Plan

Check Do

24

The Dilbert Cycle

Blame someone else for catastrophe

Adopt unproven process or technology

Make wild guess at what is wrong

ACT

25

Plan-Do-Check-Act diagram

Requirement

Plan

CorrectiveAction

Do Check Conforms? Product /Service

Feedback Loop

Yes

No

Continual Improvement

Requirement

Plan

26

The > Cycle and the audit

P

D

CA

Approach >

PDCA feedbacksystem

27

The > Cycle and the audit Cont.

The audit plan must take into account the way the processes should be managed, looking at such items as:

1. Deployment of objectives.

2. Organization.

3. Resources assigned.

4. Worst case operations.

5. Indicators, information feedback.

6. Management of improvement plans (the dinamism)

28

The > Cycle: Follow through the business strategy

Responsibilities shared, responsibilities assigned and responsibilities defined!Management from the top management at

every level!P

DC

ATop ManagementProcess Owners

Participants Participants

Process Owners

Top Management

StrategyPolicy

ObjectivesResources

Risk analysis

Planning the activities

Operations &recording

ReportingImprovement actionsCollect and analyze

Operational information

Strategic thinkingDecisions

Use information

The organization must identify and allocate necessary resources but also ensure continual improvement

29

The CAPDo Logic

Start with a questions about performance, what is expected, what are the indicators and objectives, What is the actual performance?

How is performance being improved?

How was the process planned, does the process design allow performance objectives to be met? Previous Performance results?

Is the process being carried out as designed? Are theMethods being applied in the field? On the shop floor,At the work station?

C

A

P

Do

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Understand the process to audit

Outputs

Conforming product delivered to customer schedule (8.2.1.1)

Inputs

Customer schedule (7.5.1.6)Raw materials (7.4)

How?Control plans (7.5.1.1)Work instructions (7.5.1.2)Preventive maintenance (7.5.1.4)SPC (8.1.1)Nonconforming product procedure (8.3)Dispatch process (7.5.1.7)Contingency plan (6.3.2)Document control/ records (4.2.3/4)

What Results?Analysis of data (8.4.1)Customer satisfaction (8.2.1)Other Organizational objectives (5.4.1)Maintenance objectives (7.5.1.4)Cost of poor quality (5.6.1.1)Process capability (8.2.3.1)Management review (5.6.1)Continual improvement results (8.5)Audit records (8.2.2)

With Who? Competence criteria (6.2.1)Induction/ training records (6.2.2)Agency/ Contract labour (6.2.2.3)Job responsibilities/ authorities (5.5)Training effectiveness (6.2.2)SPC awareness (8.1.2)Personnel safety (6.4.1)Awareness of policy/ objectives (6.2.2.4)

With What? Plant and machinery (6.3)Process equipment (6.3)Measuring equipment (7.6)Tooling (7.5.1.5)Maintenance (7.5.1.4)Packaging/labeling (7.5.5)Customer property (7.5.4)Transportation (6.3)

(Support Processes)ITHuman resourceLogisticsSalesQualityPreventive maintenance

Process:

Manufacturing Manufacturing Process (7.5)Process (7.5)

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Effectiveness of system

Customer measures:

Delivered part quality performance

Customer disruptions including field returns

Delivery schedule performance (including incidents of premium freight)

Customer notification related to quality or delivery issues

Organization measures:

Establishing, reporting and reviewing performance against quality objectives & evaluation of the cost of poor quality

32

SMART

The more the goals reflects the customers needs and expectations, the more successful the project will be.

An effective quality planning goal has five characteristics (SMART):

Specific.

Measurable.

Agreed upon/Achievable.

Realistic

Time-phased.

33

Audits parties levels

Accreditation Body

Certification Body

ORGANIZATION

CUSTUMER

SUPPLIER

3rd p 3rd p3rd p

1st p1st p1st p

2nd p2nd p

4th p

2nd p

34

Why conduct Internal Audits?

To comply with quality management system standards!

To help facilitate continuous improvement of the quality management system

Help in sharing best practices between departments

Provides management information about the state of the business

Helps focus attention on need for system compliance.

35

Phases of an audit

Audit planning and scope Preparation

Documentation

Checklist

Executing the audit

Opening meeting

Collecting evidence

Closing meeting

Audit report preparation / distribution Corrective action follow up / Close out.

36

Audit Planning

The audit program shall be planned taking into consideration:

Status and importance of the processes and areas to be audited.

Results of previous audits.

When internal / external non conformities or customer complaints occur, the audit frequency shall be appropriately increased.

Cover all processes, activities and shifts in accordance with an annual plan.

Prepare an audit plan to satisfy the system and process audit requirements in ISO/TS 16949: 2002

37

The audit approach

Quality management system audit:Verify compliance with ISO/TS 16949 + any additional quality management system requirements.

Manufacturing process audit:Audit of each manufacturing process to determine its effectiveness

Product Audit:Audit of product at appropriate stages of production and delivery to verify conformance to all specified requirements.

38

Manufacturing Process Audit

ISO/TS requirement 8.2.2.2:The organization shall audit each manufacturing

process to determine its effectiveness.

Can be extended to apply to any company business processes.

ISO 9001; 2000 requires a process approach

39

Product Audits

Known in QS-9000 as final product audit (Applied to final packaged product only)

ISO/TS requirement 8.2.2.3Audit product at appropriate stages of production and

delivery to verify conformance to all specified requirements such as product dimensions, functionality, packaging, labeling, at a defined frequency.

40

Product Audits

A product audit is the planning, performance, evaluation and documentation of examinations of - Quantitative and qualitative

characteristics.

on - material products

after - completion of a production stage

by - comparison with reference values

by - an independent auditor

41

Product audit planning

Link to production process audits or run as an independent audit program?

Base frequency on results!

Immediate action required if problems found

Refer to VDA6.5 for guidance

42

Session 2:

Internal Auditor Qualification & Customer Specific Requirement

43

Internal Auditor Qualification

ISO 19011

Auditor: a person who has the competence to conduct an audit.

Competence: Demonstrated personal attributes and demonstrated ability to apply knowledge and skills.

44

Auditor Competence defined in ISO 19011

Quality system knowledge

Personnel attributes

EnvironmentSystem

knowledge

GenericKnowledge

Education Work Experience Auditor training Audit Experience

45

Current techniques

What is your organizations current process for qualifying internal auditors?

How is competence maintained?

46


Auditor Qualification:The organization shall have internal auditors

who are qualified to audit the requirements of this technical specification (See 6.2.2.2 Training)

Ensure that your understand your Customer specific requirements for auditor qualification

E.g. Ford / GM / Peugeot

47

Examples of Customer Specific qualification requirements

Ford (requirement 4.39)

Trained in ISO/TS 16949: 2002, core tools, customer specific requirements and the automotive process approach.

Participate in practice sessions equivalent to one day.

Training delivered by a trainer qualified under the above criteria

Or

Conduct at least 5 internal audits in 24 months, under supervision of an auditor trained as above

48

Examples of Customer Specific qualification requirements

General Motors (Requirement 4.1.10)

Qualified as recommended in ISO 19011 sections 7.1- 7.5

Understand the process approach

Understand core tools (PPAP, APQP, MSA, SPC, FMEA)

Understand GM customer specific requirements

49


What do you think an organization should take into account when selecting and qualifying internal auditors?

Define what you think aCompetency profile should be?

50

Personnel Attributes

Ethical: Fair, truthful, sincere, honest, discreet Open minded: Willing to consider other points of view Diplomatic: Tactful in dealing with people Observant: Actively aware of physical surroundings and

activities Perceptive: Instinctively aware of and able to understand

situations Versatile: Adjusts readily to different situations Tenacious: Persistent, focused on achieving objectives Decisive: Reaches timely conclusions based upon logical

reasoning and analysis Self reliant: Acts and functions independently while

interacting effectively with others

51

Auditor Qualification Criteria

Education Training in ISO/TS 16949: 2002Work ExperienceQuality management experience Demonstrated ability to apply knowledge and

skills

52

Customer Specific Requirements

Overview of Ford Motor Company:

4.4 Control of records:

PPAP, tooling records, purchase orders, and amendments maintained for the length of time for the part plus one year

Production inspection and test results retained for one year after the year when they are created

Internal audit and management review records retained for three years

4.6 Customer representative: Inform Ford within 10 days of any change to senior management

responsible for quality

53

Process Approach to auditing methodology

What are the objective(s) for the process? How do they link to business objective?What activities are carried out in the process?What are the applicable support processes? How is achievement measured?What results are actually being achieved?What actions are planned to ensure

achievement of defined objectives?What improvement efforts are being made?

54

Preparing to audit a process

Ensured scope of audit is clearly defined (i.e. where to start and finish!)

Make logistical arrangements with auditee(timings, agenda, audit scope)

Identify any objectives / measures related to the process and documents used to control the process (may be done by discussion with auditee)

55

Preparing to audit a process

Prepare for a process audit by review of key information gathered which may include:

Relevant performance indicators / objectives

Management review minutes

Previous audit records

Continuous improvement plans

ISO/TS 16949: 2002

Customer specific requirements

Planning is essential for an effective audit

56

Checklist Preparation

ISO/TS 16949: 2002, 8.2.2.4 note states:Specific checklists should be used for each audit

Create your own generic checklists or an individual turtle diagram / checklists for each audit

Use turtle / checklist as a guide and not the only questions to be asked!

57

Undertaking the audit (What, Where, When, How, Why, Who, Show me?)

1. Set the Scene: Opening meeting, Outline the objective of the audit to the auditee.

2. Establish responsibilities: Confirm responsibilities and what happens in the process / area.

3. Analyse the process: Review what actually happens, e.g. follow an audit trail.

58


4. Search for objective evidence & records

Interview relevant employees (Include management)

Look for the evidence of implementation and effectiveness of process, not just procedure compliance!

Look for opportunities for Improvement

59


4. Search for objective evidence & records

Follow process flow

Do not get distracted

Take notes on items to follow up on

Manage time effectivelyOpen questions may take minutesClosed questions may take secondsIt takes time to study dataAllow for the unexpected

60


5. Check back

Confirm understanding & link findings

(e.g. to ISO/TS 16949: 2002 requirement)

6. Close out

Explain audit findings to auditee and agree actions required

61

Reporting Findings

Evidence gathered should be evaluated against requirements defined in ISO/TS 16949: 2002, customer requirements, and organizations management system Confirm decisions,

(Conformity, Non conformity or opportunity for improvement)

Where found, prepare written nonconformities / opportunity for improvement

62

ISO 9000: 2000 definitions

Conformity:Fulfillment of requirement

Nonconformity:Non fulfillment of a requirement

63

ISO/TS 16949 Definitions

Major Nonconformity:

Absence of or total breakdown of a system to meet an ISO/TS 16949 requirement

Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the product or services for their intended purpose.

A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes and products

64

ISO/TS 16949 Definitions

Minor Nonconformity:

A failure to comply with ISO/TS 16949 which based on judgement and experience is not likely to result in the failure of the quality system or reduce its ability to assure controlled processes or products.

65

Opportunities for Improvement

Auditors should identify opportunities for improvement as these become evident.

e.g. Where the situation is compliant but could be undertaken more efficiently.

66

Preparing nonconformities

Typical reporting structure

Report number

Date

Auditor / audit team name and auditee

Process / area audited

ISO/TS requirement / related procedure

Failure observed

Evidence found

Nonconformity grade (Where applicable)

Agreement / signature of auditee

67

Audit reporting

Report content:

Scope & objectives of audit

Details of auditors / auditees

Reference documents against which audit was conducted

Nonconformities and opportunities for improvement

The systems ability to achieve defined quality objectives

Distribution list

68

Corrective action follow up

Auditee is responsible for determining root cause, and initiating corrective and preventive action needed to address nonconformities

Auditors responsibility is to verify corrective and preventive action is effectively implemented within the agreed timescale

69

Audit situation Work shop

Following submission of the nonconformity report to the manufacturing manager, the following response was received by the auditor, within the agreed timescale: Report no. IBW1

Temporary employee trained and leak test now being undertaken at the required frequency

Is this acceptable to close the nonconformance?

70

Nonconformity report

Report #: IBW1 Date raised: May 2004Auditor: I.B. WrightProcess / support: Manufacturing / HR ManagementISO/TS req.: 8.2.3.1, 6.2.2.3Nonconformity:The leak test, specified on the control plan for product A1246, was not

being undertaken at the defined frequency & failures were found at customer.

No evidence was available to demonstrate the temporary employee operating the process was competent to undertake the leak test. Evidence of competency was not seen for other temporary staff.

Grade: MajorSigned: Auditor: I.B. Wright Auditee: U.B. Nhad

71

The End of Day 1

Mohamed [email protected]

72

Session 3:

Advanced Product Quality Planning (APQP) & Control Plan

73

Product Quality Planning Timing Chart

74

1. Plan & Define Program

Outputs: Design goals. Reliability & Quality

goals.

Preliminary bill of Material.

Preliminary process flow chart.

Preliminary listing of special product & process characteristics.

Product Assurance plan. Management Support.

75

2. Product design & development

Outputs: New equipment, tooling & facilities requirements. Special product & process characteristics. Prototype Control Plan. Gages / Testing equipment requirements. Team feasibility commitment and management support.

76

3. Process Design & DevelopmentOutputs:

Packaging Standard. Product / process

quality system review. Process flow chart. Floor plan layout. Characteristics matrix. PFMEA. Pre-launch Control

Plan. Process instructions. Measurement systems

analysis plan. Preliminary process

capability study plan. Packaging

specifications. Management support.

77

4. Product & Process ValidationOutputs:

Production Trial run.

Measurement system evaluation.

Preliminary process capability study.

Production part approval.

Production validation testing.

Packaging evaluation.

Production control plan.

Quality planning sign off & management support.

78

5. Feedback, Assessment & Corrective Action

Outputs: Reduced variation. Customer satisfaction. Delivery & Service.

79

Process analysis

80

Control plan methodology

What: is a formal document that provides a written summary description of the systems, methods and documents used in controlling parts and processes in order to minimize process and product variations

Why: to aid in the manufacture of quality products according to customer requirements

How: by providing a structured approach for the design, selection and implementation of value added control methods for the whole product manufacturing processes

Where: all actions required at each phase of processes including receiving, in-process ,outgoing , and periodic requirements to assure that all process outputs will be in a state of control

81

CP Important notes

The control plan does not replace the information contained in detailed operator instructions but may make reference to.

The control plan should provide the processes monitoring and control methods that will be used to control both product characteristics and process parameters

The control plan represents an integral part of an overall quality system and should be used in conjunction with other related documents

The control plan should be utilized as a living document that responds to continual updating and improvements of processes

Organization should use the control plan format that is most suitable to its type, size and complexity of its manufacturing processes .

A single control plan may apply to a group or family of products that are produced by the same processes at same source.

82

While establishing control plans

use a cross functional (multidisciplinary) team that comprises engineering, design, manufacturing, customer services, quality functions and others as appropriate.

Utilize all the available information to gain a better understanding of the process, such as:

Process flow diagram

PFMEA

Special product characteristics

Lessons learned from similar parts

Team knowledge of the process and experience

Design reviews

83

Benefits of developing and implementing control plans includes

Its an aid to reduce waste and improve the quality of the productsduring design, manufacturing and assembly .

Its a structured discipline that provides a thorough evaluation of the product and process

It helps to identify source of variations (input variables) that cause variation in product characteristics (output variables)

It focus resources on processes and products related to characteristics that are important to the customer , this will help to reduce costs without sacrificing quality ,ultimately enhancing customer satisfaction

As a living document , it identifies and communicates changes inproduct/process characteristics, control methods and corrective actions.

84

Types of control plans

Prototype CP: it is a description of dimensional measurements and material and performance tests that will occur during prototype build

Pre launch CP: it is a description of dimensional measurements and material and performance tests that will occur after prototype and before full production

Production CP: it is a description of dimensional measurements and material and performance tests that will occur during mass production

85

Control Plan Table:

SampleRespo nsible Reaction Plan Documents RecordsSize Frequency

Serial Operation # Material Operation Description CharacteristicsMeasurement

TechniqueClas

s

Machines / Device /

Equipments / Tools

Spec./Tolerance1 2 3 4 5 6 7

89

10 11 12 1413

86

Session 4:

Statistical Process Control (SPC)

87

Objectives

Understand the purpose of statistical process control (SPC) and link to ISO/TS 16949: 2002

Understand variable and attribute data and the types of charts used for each

Understand methods of constructing control charts, calculating control limits and interpreting data

Understand the term process capability

88

Link to ISO/TS 16949: 2002

7.5.1.1: Control Plan 7.5.1.3: Verification of Job setup 7.6.1: Measurement system analysis 8.1.1: Identification of statistical tools 8.1.2: Knowledge of basic statistical concepts 8.2.3.1: Monitoring and measuring of

manufacturing processes

8.5.1.2: Manufacturing process improvement

89

What is Statistical Process Control

The use of statistical techniques such as Control Charts to analyze 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

90

Quality Loss Function; Distribution of Products produced

91

Types of Statistical Quality Control

92

Quality Characteristics

93

Statistical Process Control

Statistical technique used to ensure process is making product to standard.

All process are subject to variability:

Natural causes: random variations.

Assignable causes: correctable problems. Machine wear, unskilled workers, poor material.

Objective: Identify assignable causes. Uses process control charts.

94

Process Control: Three Types of Process Outputs

95

Process Chart

Shows sequence of events in process.

Depicts activity relation ships.

Has many uses:

Identify data collection points.

Find problem sources.

Identify places for improvement.

Identify where travel distances can be reduced.

96

Statistical Process Control (SPC)

Uses statistics & control charts to tell when to adjust process.

Developed by Shewhart in 1920s. Involves:

Creating standards (Upper & Lower limits).

Measuring sample output (e.g. mean wgt.).

Taking Corrective actions (if necessary).

Done while product is being produced.

97

Statistical Process Control Steps

98

Process Control Chart

99

Patterns to look for in Control Charts

100

Process Capability Cpk

101

Meaning of Cpk Measures

102

Capability Indices

If the process data have a normal (bell shape) distribution the following can be used as a guide to interpret Cpk:

Cpk Approx, % out of Spec1.00 66,000 / 1,000,000

1.33 6,000 / 1,000,000

1.67 233 / 1,000,000

2.00 3.4 / 1,000,000

Customer will often specify minimum Cpk

103

Session 5:

Failure Mode & Effect Analysis

104

Requirement for FMEA in ISO/TS 16949

0.5: Goal 4.2.3.1: Engineering specifications 7.3.1.1: Multidisciplinary approach 7.3.2.3: Special Characteristics 7.3.3.1: Product Design Output 7.3.3.2: Manufacturing process design outputs 7.5.1.1: Control Plan

105

Definition of FMEA

A systematic group of activities intended to:

Recognize and evaluate the potential failure of a product / process and the effects of failure

Identify actions that could eliminate or reduce the chance of the potential failure occuring

Document the entire process

106

Vehicle Manufacturing View

Evidence from vehicle campaigns / recalls have shown a fully implemented FMEA could have prevented many cases

Act before the event (Prevention) not after (Detection)

107

Interaction with ISO/TS 16949: 2002

Product Realization

Design & Process FMEA

Design Control

Process Control

Competence / Training

Corrective / Preventive

Action

Continual Improvement

108

Severity

Severity is the rank associated with the most serious effect for a given failure mode

Severity can only be reduced by design change

Team should establish criteria and ranking system

109

Occurrence

Occurrence is the likelihood that a specific cause / mechanism of failure will occur

Rank from 1 to 10

The ranking number has a relative meaning rather absolute value

110

Detection

Detection is the rank associated with the best detection control listed in the process control column

111

Risk Priority Number RPN

RPN is the product of severity, Occurrence and detection ranking

S X O X D = RPN This value can be between 1 and 1000

Customers may define trigger points for action (e.g. RPN > 100 Severity > 8)

112

FMEA Flow Chart

Assign a label to each process or system component

List the function of each component

List potential failure modes

Describe effects of the failures

Determine failure severity

Determine probability of failure

Determine detection rate of failure

Assign RPN

Take action to reduce the highest risk

113

FMEA Worksheet

Potential Failure Mode

Potential Effect of Failure

Sev

Class

Potential Cause of Failure

Occurr

Current Controls

Det

RPN

Recom-mended Action

Responsibility & Completion Date

Actions Taken

Sev

Occ

Det

RPN

Item Function or Purpose

Component:

Failure Mode and Effects Analysis

FMEA Number:

Product or Process Name:

Prepared By: Action Results

Model Number:Design Responsibility:Completion Date:

114

Recommended Actions

Actions should be targeted toward high RPN / high severity

Intent is to reduce ranking by actions

Actions taken should be tracked, recorded and closed

115

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116

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117

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118

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119

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120

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121

ggg

122

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123

ggg

124

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125

Documentation Linkages within the FMEA process

DFMEA

PFMEA & Flow Chart

Control Plan

Work Instruction &Standard Operations

126

The End of Day 2


127

Session 6:

Measurement System Analysis (MSA)

128

Requirement for MSA in ISO/TS 16949; 2002

7.6.1: Measurement System Analysis

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 system analysis. Other analytical methods of acceptance criteria may be used if approved by the customer

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MSA (Definition)

A collection of instruments or gages, standards, operations, methods, fixtures, software, personnel, environment & assumptions used to quantify a unit of measure or fix assessment to the feature characteristic being measured. The complete process used to obtain measurements.

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Calibration

A set of operations that establish, under specified operating conditions, the relation ship between a measuring device and a traceable standard of a known reference and uncertainty.

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Calibration Linkages

National Standard

Reference Standard

Working Standard

Production /gauge

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Measurement System Analysis

MEASUREMENT SYSTEM

Material Man Method

Machine (Time) Environment

Input need to measure

Output Data

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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.

This will allow us to quantify and communicate the limitations of specific measurement systems.

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Quality of Measurement Data

Reference value: A reference for comparison, normally determined under laboratory conditions or using a more accurate instrument.

Accuracy: How close measurements are to the reference value

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Measurement System Properties

Discrimination: The smallest detectable unit of a measurement device. Should be 1/10 of the tolerance to be measured.

Resolution: Capability of measurement system to detect & faithfully indicate even small changes.

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Measurement system variation Location (Mean)

Reference Value

Reference Value

Reference Value

Time 1

Time 2

Bias

Linearity

Stability

Larger BiasSmaller Bias

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Measurement system variation Spread (Mean)

Operator A

Operator C

Reproducibility

Operator B

Repeatability

Repeatability (EV): Common cause random variables resulting from successive trials under defined conditions of measure.

Reproducibility (AV): When 2 or more people measure the same parts or items using thesame measuring technique.

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Gauge R & R Studies

There are 3 principle methods:

Range Method.

Average & Range Method.

ANOVA (Analysis Of Variance) Method.

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Gauge R & R Studies Range Method

Quick Approximation of overall measurement variability.

This has a defined confidence level, e.g. 80% with sample of 5.

Typically uses 2 appraisers & 5 parts for study.

% Gauge R&R = ( Gauge R&R ) X 100%(Process Standard Deviation)

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Gauge R & R Studies Average & Range Method

Summarizes the data gathered in a measurement study, to provide information on the total variation and its components of:

Equipment,

Appraiser,

Equipment / appraiser combined &

Part variation.

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Gauge R & R Studies Average & Range Method Cont.

Select appraisers, should be the same people using the instrument.

Select measurement tool, has the gauge the required discrimination?, if the characteristic variation is 0.01 mm the gauge should be able to read 0.001mm.

Select parts, from the process that represent entire operating range, from several days production, number each part.

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Somebody should facilitate the study. Ensure each appraiser uses the same procedure.Measurements should be made in a random order. Readings should estimate the nearest number to

that which can be obtained.

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Numerical analysis of the study; Gauge repeatability and reproducibility data sheet or specific software, e.g. Minitab.

The study estimates; the variation and percent of process variation for the measurement system and its components.

Repeatability.

Reproducibility.

Part to Part variation.

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Guidelines for Acceptance of Gauge Repeatability & Reproducibility

Under 10%

Generally considered to be acceptable.

10% - 30%

May be acceptable based on importance of application, cost of repairs, etc.

Over 30%

Not acceptable.

Every effort should be made to improve.

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R & R Analysis of results

EV > AV reasons:

Gauge need maintenance.

Gauge need redesigning.

Gauge fixture need to improve.

Excessive within part variation.

AV > EV reasons:

Training appraiser.

Gauge dial / indicator is difficult to read (Parallex).

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Gauge Discrimination (NDC)

< 2 Not Accepted

NDC = 1.41 * (PV / GRR)

> 5 Accepted

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Example:

See next attached work sheets.

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Session 7:

The registration Process Rules for Achieving IATF recognition,

2nd edition

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Scope of ISO/TS 16949: 2002

This technical specification is applicable to sites of the organization where production and / or service parts specified by the customer are manufactured

This technical specification can be applied throughout the automotive supply chain

Site: Where value added manufacturing processes occur

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Definitions (FAQ 1)

Automotive shall be understood as including the following: Cars, Trucks (Light, Medium and Heavy), Buses, Motorcycles

Automotive shall be understood to exclude the following: Industrial, Agriculture, Off-highway (Mining, Forestry, Construction, etc)

See www.iaob.org for latest FAQs and sanctioned interpretations.

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Scope

Scope of registration must include all products / services provided to subscribing customers.

Scope of registration may also include at the decision of the organization, manufacturing meeting the applicability to ISO/TS supplied to customers non subscribing.

Support functions onsite or remote must be included (design, purchasing, sales)

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Registration Process

Audit days for ISO/TS 16949: 2002 defined in Annex 3 of Scheme rules

ISO 9001: 2000 Audit days of recert. Audit

QS9000 / VDA 6.1& ISO 9001: 2000 Max 50% reduction

QS9000 Max 30% reduction

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Registration Process

Select an IATF recognized Certification Body Contract with Certification Body Optional pre-audit / assessment Stage 1 Readiness Review Audit Planning for Stage 2 Stage 2 site audit (Within 90 days of stage 1) Nonconformance closure (90 days max) Certification decision / certificate issue Surveillance audits (years 1 and 2) Recertification (year 3)

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Stage 1 Readiness Review

Scheme rules require the following documents are submitted for review:

Description of processes showing sequence and interaction, including key indicators of performance trends for the previous 12 months, minimum

Evidence that all the requirements of ISO/TS 16949: 2002 are addressed by the organizations processes

Quality Manual (for each site to be audited)

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Stage 1 Readiness Review

Internal audit and management review planning and results from previous 12 months

List of Qualified internal auditors

List of customer specific requirements

Customer satisfaction & complaints status, including customer reports and score cards

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Stage 2 Site Audit

Audit will start with Top Management Auditors will look for evidence of

implementation and effectiveness of processes

Audit will cover all shifts Evidence must include the results of at least

one complete internal audit and managementreview cycle.

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Stage 2 Audit Findings

Certificate cannot be issued with any open nonconformances Any nonconformance must be 100% resolved

within 90 days of the end of stage 2 site audit Any nonconformity identified at registration

assessment will require re-audit Any nonconformity identified on surveillance

will result in suspension process being instigated

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The End of Day 3 & the Course


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TS 16949 Auditor Course

Documents

Transcript of TS 16949 Auditor Course