TS Auditor Course

transcript

ISO/TS 16949: 2002

3 Days Internal Auditor

Certification CourseInstructor / Lecturer:

Mohamed GhorabJuly 2009

Audience 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)

Basics

Switch mobile phones to the silent mode.

Toilets.

Break.

Material provided.

A written open book final exam

Is THE Global Group

Established in 1878 - Head Office in Geneva, Switzerland.

42’000 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.

We 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

Course 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.

Goal 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.

Course 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)

Session 1

Session 3

Session 4

Session 5

Session 6

Session 2

Session 7

Session 1:

Background & Development of ISO/TS 16949: 2002

& Automotive Process Approach

History of Quality Standards

1979 BS 5750

1987 ISO 9000 series

1994 ISO 9000 revision / QS 9000 issued

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

Automotive sector Quality requirements(With registration variation)

Germany

France

VDA 6QS 9000

IATF Representatives

France Germany Italy USA UK Japan

Car Makers PSA

Renault

Daimler

Fiat Chrysler

Liaison

(Europe / US)

Opel VW of USA

National Super Organization

FIEV VDA ANFIA AIAG / IAOB

SMMT JAMA

Nissan

Toyota

Suppliers Faurecia Bosch Magneti

Marelli

Bosch USA

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.

Business Planning

Business Plan

Policy

Objectives

Planning

Employee Motivation

& Empowerment

Impact

Influence

Terminology

Process

Customer

Procedure

ISO/TS 16949: 2002 ISO 9001: 1994

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.

8 Quality Management Principles

Customer Focus (1, 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)

Process Approach (4.1, 5.1.1)

System Approach to management (4.1, 5.1.1, 5.4.1, 5.6.1)

Continual Improvement (Goal, 1, 5.1, 5.3, 8.5.1, 8.5.1.1, 8.5.1.2)

Factual Approach to decision making (5.6.1, 8.2.2, 8.4)

Mutually beneficial supplier relationship (7.4.1.2)

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

Process Approach

Process

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

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

2Step“N”

Output

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.

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)

Turtle Diagram Workshop

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

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

The Dilbert Cycle

Blame someone else for catastrophe

Adopt unproven process or technology

Make wild guess at what is wrong

Plan-Do-Check-Act diagram

Requirement

CorrectiveAction

Do Check Conforms?Product /Service

Feedback Loop

Requirement

The << V >> Cycle and the audit

Approach << Top Down >>

PDCA feedbacksystem

The << V >> 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)

The << V >> Cycle:Follow through the business strategy

Responsibilities shared, responsibilities

assigned and responsibilities defined!

Management from the top management at every level!P

ATop Management

Process 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

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?

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)

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

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.

Audits parties’ levels

Accreditation Body

Certification Body

ORGANIZATION

CUSTUMER

SUPPLIER

3rd p 3rd p3rd p

1st p1st p1st p

2nd p2nd p

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.

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.

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

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.

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

Product Audits

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

ISO/TS requirement 8.2.2.3

Audit 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.

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

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

Session 2:

Internal Auditor Qualification& Customer Specific Requirement

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.

Auditor Competence defined in ISO 19011

Quality system knowledge

Personnel attributes

EnvironmentSystem

knowledge

GenericKnowledge

Education Work Experience Auditor training Audit Experience

Current techniques

What is your organizations current process for qualifying internal auditors?

How is competence maintained?

Auditor Qualification (8.2.2.5):

“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

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

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

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

Define what you think a

“Competency profile” should be?

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

Auditor Qualification Criteria

Education

Training in ISO/TS 16949: 2002

Work Experience

Quality management experience

Demonstrated ability to apply knowledge and skills

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

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?

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)

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

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!

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.

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

4. Search for objective evidence & records Follow process flow Do not get distracted Take notes on items to follow up on Manage time effectively

Open questions may take minutes

Closed questions may take seconds

It takes time to study data

Allow for the unexpected

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

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

ISO 9000: 2000 definitions

Conformity:

Fulfillment of requirement

Nonconformity:

Non fulfillment of a requirement

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

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.

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.

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

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

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

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?

Nonconformity report

Report #: IBW1 Date raised: May 2004

Auditor: I.B. Wright

Process / support: Manufacturing / HR Management

ISO/TS req.: 8.2.3.1, 6.2.2.3

Nonconformity:

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: Major

Signed: Auditor: I.B. Wright Auditee: U.B. Nhad

The End of Day 1

Mohamed GhorabMohamed.ghorab@sgs.com

Session 3:

Advanced Product Quality Planning (APQP) & Control Plan

Product Quality Planning Timing Chart

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.

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.

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.

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.

5. Feedback, Assessment & Corrective Action

Outputs:

Reduced variation. Customer satisfaction. Delivery & Service.

Process analysis

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

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.

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

Benefits of developing and implementing control plans includes

It’s an aid to reduce waste and improve the quality of the products during design, manufacturing and assembly .

It’s 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 in product/process characteristics, control methods and corrective actions.

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

Control Plan Table:

SampleRespon

sibleReaction Plan Documents Records

Size Frequency

SerialOperation #

Material

Operation Description

CharacteristicsMeasurement

TechniqueClas

Machines / Device /

Equipments / Tools

Spec./Tolerance

1 2 3 4 5 6 78

10 1112 1413

Session 4:

Statistical Process Control(SPC)

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

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

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”

Quality Loss Function; Distribution of Products produced

Types of Statistical Quality Control

Quality Characteristics

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.

Process Control: Three Types of Process Outputs

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.

Statistical Process Control (SPC)

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

Developed by Shewhart in 1920’s.

Involves: Creating standards (Upper & Lower limits). Measuring sample output (e.g. mean wgt.). Taking Corrective actions (if necessary).

Done while product is being produced.

Statistical Process Control Steps

Process Control Chart

Patterns to look for in Control Charts

Process Capability Cpk

Meaning of Cpk Measures

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 Spec

1.00 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

Session 5:

Failure Mode & Effect Analysis

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

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

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)

Interaction with ISO/TS 16949: 2002

Product Realization

Design & Process FMEA

Design Control

Process Control

Competence / Training

Corrective / Preventive

Action

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

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

Detection

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

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)

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

FMEA Worksheet

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

Documentation Linkages within the FMEA process

PFMEA & Flow Chart

Control Plan

Work Instruction &Standard Operations

FORD Q1 – 2002 requirements

Annual Review: To prioritize improvement activity to achieve lower RPN figures.

Pareto analysis:To prioritize actions to drive improvements by the following analysis breakdown: Severity Severity X Occurrence

Identify High RPN – (Top 10) focus on actions to reduce.

The End of Day 2

Session 6:

Measurement System Analysis(MSA)

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”

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.

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.

Calibration Linkages

National Standard

Reference Standard

Working Standard

Production /gauge

Measurement System Analysis

MEASUREMENT SYSTEM

Material Man Method

Machine (Time) Environment

Input need to measure

Output Data

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.

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

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.

Measurement system variationLocation (Mean)

Reference Value

Time 1

Time 2

Linearity

Stability

Larger BiasSmaller Bias

Measurement system variationSpread (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 the same measuring technique.

Gauge R & R Studies

There are 3 principle methods:

Range Method.

Average & Range Method.

ANOVA (Analysis Of Variance) Method.

Gauge R & R StudiesRange 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)

Gauge R & R StudiesAverage & 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.

Gauge R & R StudiesAverage & 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.

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.

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.

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.

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).

Gauge Discrimination (NDC)

< 2 Not Accepted

NDC = 1.41 * (PV / GRR)

> 5 Accepted

Example:

See next attached work sheets.

Session 7:

The registration Process Rules for Achieving IATF recognition,

2nd edition

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

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 FAQ’s and sanctioned interpretations.

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)

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 (is not existing) Max 30% reduction

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)

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 organization’s processes

Quality Manual (for each site to be audited)

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

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 management review cycle.

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

The End of Day 3 & the Course