1

Presents an:

Employee Overview of

ISO/TS 16949:2009

Presented by:

Your Organization

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Today you will learn ...

•

What TS 16949 is all about

•

Why Your Organization wants to implement it

•

How you can help

–

develop and improve the quality system

–

prepare for the quality system audit

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TS 16949 Is . . .

•

A process approach for:

–

Implementing an effective quality management system, and

–

Enhancing customer satisfaction

through continual improvement

•

Based on ISO 9001:2008

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Continual Improvement of theQuality Management System

The Process-Based QualityManagement System

ManagementResponsibility

ProductRealization

ResourceManagement

MeasurementAnalysis &

Improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Product

Input Output

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the ISO 9000 ‘family’

of standards include ...

ISO 9000:2005Quality Management Systems -Fundamentals and Vocabulary

ISO 9004:2009Managing for the sustained success of an

organization – A quality management approach

ISO 9001:2008Quality Management Systems -

Requirements

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TS 16949:2009 incorporates all ISO 9001:2008 requirements and ...

Customer ‘Core Tools’ Manuals•Advanced Product Quality Planning (APQP) & Control Plan•Potential Failure Mode Effects Analysis (FMEA)•Production Part Approval Process (PPAP)•Fundamental Statistical Process Control (SPC)•Measurement Systems Analysis (MSA)

ISO/TS 16949:2009Quality Management Systems - particular requirements for the application of ISO

9001:2000 for automotive production and relevant service part organizations

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Goals for TS 16949:2009

•

Achieve quality by managing the processes that create products and services …

with an emphasis on:

–

preventing problems–

reducing variation

•

Give the customer confidence

that products and

services will consistently meet requirements

•

Give the organization confidence

that it can achieve

its objectives

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Your Organization is Adopting ISO/TS 16949:2009 to …

•

COMPLY: Your key customers have said Your Organization must demonstrate compliance to TS 16949 to keep its status as a Tier 1 supplier

•

SELL: Many future customers will require compliance before considering Your Organization as a possible supplier

•

COMPETE: Most of Your Organization’s competitors will seek TS 16949 registration as a means of getting more business

•

IMPROVE: All companies adopting TS 16949 have reported that it has provided many benefits and improvements

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A Quality System must be …

“

SEDA”

•Suitable

•Documented

Words of wisdom from Victor Schur (Sears)

• Effective

• Auditable

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The Basis of a Quality System is to ...

say what you do,

do what you say,

record what you did,

check the results, and

act on the difference

Words of wisdom from Ian Durand(US Technical Advisory Group to ISO TC 176)

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ISO 9001/TS 16949 “Quality Management Principles”

•

Customer Focus

•

Leadership

•

Involvement of People

•

Process Approach

•

System Approach

•

Continual Improvement

•

Factual Approach to Decision Making

•

Mutually Beneficial Supplier Relationships

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Customer Focus

•Organizations depend on their customers and therefore should:

–

understand current and future customer needs;

–

meet customer requirements; and

–

strive to exceed customer expectations.

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Customer related processes are vital to business success ...

• Advertising and Inquiry Handling

• Offer, Quote and Contract Processing

• Customer Complaint Handling

• Customer Feedback = Customer Satisfaction ?

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Leadership•Leaders should:

–

establish unity of purpose and

direction

of the organization, and

–

create and maintain the internal environment in which people can become fully involved

in achieving

the organization’s objectives.

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Your Organization’s Goals are Captured in its Quality Policy

•

The quality policy was developed by top management to:

–

tell customers what Your Organization’s quality goals are, and

–

tell all employees what they should strive for

•

Do you know Your Organization’s quality policy?

“Insert Quality Policy Statement Here”

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Your Organization’s Goals are Deployed through Objectives

•

Our key corporate objectives are to:

–

CI Objective #1:

–

CI Objective #2:

–

CI Objective #3:

•

Do you know you contribute to achievement of our key corporate objectives?

(discuss and/or give examples)

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Performance Against ‘Desired Results’

• Actions are taken when management or customer objectives are NOT achieved:

–

‘Zero Defects’

(PPM)

–

Capability (Cpk, Ppk)

–

Efficiency (thruput, scrap, waste)

–

On-Time Delivery (schedule adherence)

–

‘Expediting’

Costs (premium freight)

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Process Approach

• Monitor more than process output: (typically through inspection activities)

• Monitor inputs and transformation activities as well: (i.e. define/control input, develop controls and mechanisms to manage the activity, and define/measure output in terms of desired results that are linked to established the organizations performance and improvement objectives)

ACTIVITY OUTPUTINPUT

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a simple process ‘model’

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Production and Service processes must be...

•Capable

•Effective

•Efficient

•Continually Improved

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Product/Service Quality must be …

•Planned (APQP)

•Validated (PPAP)

•Monitored (SPC)

•Verified (Inspection/Test)

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System Approach

• Identify, understand, and manage interrelated processes (system)

–

the output of one process is the input to one or more subsequent processes in the “system”

–these interfaces must be managed to ensure the outputs of a process meet the input requirements of related process(es) that follow

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Involvement of People

• People at all levels are the essence of an organization, and–

their full involvement enables . . .

–

their abilities

to be used . . .

–

for the organization’s benefit

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Continual Improvement

•

Continual improvement of the organization’s overall performance should be a permanent objective:

–

improvement activities must planned

(take action to achieve a

desired result)

and monitored

for effectiveness

Continual Continuous

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Potential and Actual Problems must be identified and eliminated ...

•Process Monitoring

•Internal Audits

•Complaint Processing

•Nonconforming Product Control

•Corrective/Preventive Action

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Plan Do

Act Check

QMS

Results

Baseline Performance

Improvement Objective

Improve Processthrough PDCA Cycle

Measure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed

to Achieve and Sustain Desired Results

The QMS must be used for continual improvement ...

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Factual Approach to Decision Making

• Effective decisions are:

–

based on the analysis of

data

and information.

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Mutually Beneficial Supplier Relationships

•An organization and its suppliers are inter-dependent so:

–

a mutually beneficial relationshipenhances the ability of both to create value.

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Purchased materials and services must be what’s needed ...

• Purchase Document and Data Control

• Supplier Evaluation and Monitoring

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A TS 16949 QMS Benefits You

•

You get good materials and correct data and information to work with

•

The equipment and tools you use are suitable and in good condition

•

You receive the necessary instructions and training to do your job

•

You are able to quickly find things and obtain the information you need

•

Should there be anything that prevents you from doing a good job, you are able to report the problem and get help to do something about it

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A TS 16949 QMS Benefits the Entire Organization

•

The customer’s needs and requirements are well understood

•

Vendors and subcontractors supply high quality materials and services

•

All activities, from taking orders to shipping finished goods, are planned and coordinated

•

Rejects and rework rates are decreased, saving materials and time while improving efficiency and productivity

•

All functions and personnel can identify problems affecting quality and find and implement solutions

•

The organization supplies better quality products and wins new customers and markets

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You can help implement an effective QMS ...

•

Learn how the quality system works

•

Help define and implement your portion of the quality system (i.e. YOUR PROCESSES):

–

Say what you do (document)

–

Do what you say (implement)

–

Prove it (keep records)

–

Improve it (communicate and participate in quality audits)

•

Help maintain document control

•

Report problems

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You can help prepare for the TS 16949 audit ...

•

Know the organization’s quality policy

•

Check your documents and records

•

Clean up your work area

•

Prepare to demonstrate to the auditors how you use the QMS to manage YOUR PROCESSES:

–

Say what you do

–

Do what you say

–

Prove it

–

Improve it

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Employee Handout for today’s Overview of TS 16949

TS 16949 Benefits the Organization

•

The customer’s needs and requirements are well understood

•

Suppliers provide high quality materials and services

•

All activities, from taking orders to shipping finished goods, are planned and coordinated

•

Rejects and rework are decreased

•

Everyone gets involved in improvement

•

The Organization supplies higher quality products and wins new customers

TS 16949 Benefits You ...

You get good materials and correct data and information to work with

The equipment and tools you use are suitable and in good condition

You receive the necessary instructions and training to do your job

You are able to quickly find things and obtain the information you need

Should there be anything that prevents you from doing a good job, you are able to report the problem and get help to do something about it

You Can Help Implement it ...

Learn how the quality management system works

Help develop procedures and work instructions for your portion of the system … i.e. your processes...

Say what you do

Do

what you say

Prove

it

Improve

it

Help maintain document control

Report problems

Participate in internal audits and process improvement activities