Implementing ts strategic-choices_5_2003

Implementing ISO/TS 16949:2002

- Strategic ChoicesSan Jose, CaliforniaChad Kymal

Agenda

• Basic Facts About ISO/TS 16949:2002• Transitioning from QS-9000 – Key

Differences• Importance of the Customer and

Customer Specific Requirements• Important Deadlines• Getting Value from ISO/TS 16949:2002

Implementations• Strategic Choices

ISO/TS 16949:2002 Basic Facts

ISO/TS 16949:2002 Basics – What is ISO/TS 16949:2002?

• Incorporates ISO 9001:2000• Replaces US, and European Standards

– QS-9000, VDA, etc.• Document reflecting worldwide automotive

requirements – US, Europe, and Asia• Customized for Semiconductor Industry with ISO/TS

16949:2002 Semiconductor Supplement

ISO/TS 16949:2002 Basics –Documents Auditors and Implementers need to Know

• ISO/TS 16949:2002 Technical Standard

• ISO/TS 16949:2002 Guidance Document

• Rules for Automotive Certification Scheme

• Quality System Checklist

• Customer Specific Requirements

• ISO/TS 16949:2002 Semiconductor Supplement

ISO/TS 16949:2002 Semiconductor Supplement

• Adds requirements to the ISO/TS 16949:2002

• Required to be included in documented system

• Needs to be audited in QMS by internal auditors

• Needs to be audited by registrar

• Included in Scope of audit

ISO/TS 16949:2002 Third Party Registration Scheme

ISO/TC176

OthersUKAS

ANSI/RAB

OthersBSI

AQSR

OthersCompany B

Company A

Organizations

Registrars

NationalAccreditationBodies

Quality ManagementandQuality Assurance Technical Committee

U.S.U.K.

IATFInternationalAutomotiveTask Force

IAOB

InternationalAutomotiveOversightBureau

ISO 9001:2000 ISO/TS 16949:2002

IATF View on ISO/TS 16949:2002

• Automotive Industry – Value added requirements• Global Quality System Content• Global Recognition Certificate• Common Registration Requirement and Oversight Body for

registrars• Reduced number of registrars- one contract and certification

committee centralized in one office• Common Auditor Qualification

Process Approach to auditing is key to the transition from QS-9000 to ISO/TS 16949:2002!

Comparison of ISO/TS 16949 and QS-9000

• QS-9000– Released in 1994– 22,500

Certifications– 174 Registrars

with multiple offices

– 22 Accreditation Bodies

• ISO/TS 16949– First edition

released in 1999– 1724 Certifications– 48 Registrars– 5 Regional Offices

for Accreditation

Transitioning from QS-9000 to ISO/TS 16949:2002

Key Differences

Key Transition Challenges

• Process Approach – COPs, MOPs, and SOPs

• Customer Focus

• Objectives Deployment

• Management (Business) Review

• Human Resources and Competency

CustomersCustomers

CustomersCustomers

Managementresponsibility

Measurement,analysis andimprovement

Resourcemanagement

Requirements

Satisfaction

ProductProductrealization

Input Output

Continual improvement of the qualitymanagement system

Continual improvement of the qualitymanagement system

Key

Value-adding activities

Information flow

Organization

O

I

This is a processŸ An interface Organizational/External environment input (I)Ÿ An interface Organizational/External environment output (O)

Notice how this is a literalapplication of the process model.

Check inputagainstoutput.

Customer Oriented Processes

Process Characteristics

• A process can be identified by a series of unique, but consistent, characteristics. There are six characteristics of a process that are mandatory for effective quality management.– A process owner exists– The process is defined– The process is documented– The linkages of the process are established– The process is monitored and improved– Records are maintained

OMNEX’s View of the Processes

• OMNEX believes there are four types of processes.– Customer Oriented Processes (COPs)– Management Oriented Processes (MOPs)– Support Processes (SOPs)– ISO/TS 16949:2002 Related Processes

Process Approach – Omnex’s View

• Process Map

• Process List (linkage from Process Map (processes) to Documentation)

• BMS Control Plan

• Alignment Chart

Customer Expectations

Customer Requirements

Quality/Business Objectives

Quality/Business Planning

Processes

Customer Focus - Align Expectations, Objectives and and Processes

BMS ALIGNMENT

ProductQuality

EliminateReworks

Owner

No IncomingInspections

GM

ImproveProblemSolving

Ford

ExternalQuality

20 PPM Date

InternalQuality

Rejects per1000 pieces

ExternalQuality

PPM perPart

QualityAssurance

ProcurementProcess

Engineering

PoorProcessDesign

ProblemsNot

Resolved

PoorIncomingProduct

Customer Expectations Category

Result Measurables

Potential Causes

Process Measurables

InternalQuality

99.95% FOADate

Quality Objectives

ProcessCapability

%Cpk<1.33

ProblemSolving

# RecurringProblems

MaterialQuality

Ton Rejected

QMS Processes

5 4 4

Key Transition Challenges (cont’d)

• Design and Development for Manufacturing Processes

• Purchasing• Customer Satisfaction Supplemental

Requirements• Process Approach to Auditing

Auditing ISO/TS 16949:2002 – Key Approach Differences as Viewed by IATF

• Process Approach to Audit

– Customer Oriented Process- These processes start with customer requirements and then end with output. The input and output need to be checked against each other to see if the output satisfies the input. They want all the COPs identified in the organization. They want to the process to have a clear line of sight from the customer to the organization

• The Audit Plan should have key processes instead of elements

– Needs to identify the key processes and COPS from Readiness Review

• Performance

– Linked to common metrics for organization and supplier• Oversight – Adherence to the “rules” and Common Global Process• Throw away the checklist and use the organization’s procedure to do the audit• Use the checklist to make sure you are through, but not as the list of questions.

Auditing Approach (cont’d)

• They stressed the definition of remote location (not being able to get certificates) and that the site being production and manufacturing.

• Sites should supply Automotive to get ISO/TS 16949:2002 certificates

• Each of the OEMs will have links to their websites where the customer specific documents can be gotten.

How Much Training for Auditors?

• Omnex View– If they have already attended RAB-certified internal or lead

auditor training, then take the transition training with one day readiness and customer specific training

– If they are new auditors, then the RAB certified internal auditor training for ISO/TS with one day readiness and customer specific training

– If they are lead auditors for the system audit or the lead implementers, then the RAB certified lead auditor training for ISO/TS

Importance of Customer and Customer Specific

Requirements

Importance of Customer Specific Requirements

• Understanding and Implementing Customer Specific Requirements is key to ISO/TS 16949:2002

• Customer names will be included in the Scope of the Certificate

Part

Commodity

Division

Company

Sector

Fundamental

MoreSpecific

MoreGeneric

IS0 9001

ISO/TS 16949

Customer Specific Requirements

• Customer specific requirements will fundamentally change the following:– Documentation requirements– Auditor requirements– Many other requirements

• For Example Ford Additional Requirements adds the following:

– ISO 14001 mandatory requirements– Manufacturing Plant Requirements – 10 requirements –

affecting everything from FMEA to PPAP– Phased PPAP requirements– APQP requirements– MMOG Requirements

Customer Specific Requirements – Visteon and Delphi

• Currently being worked on

• Adds many new requirements to ISO/TS 16949:2002

• Needs to be included in documented system

• Needs to be audited in internal audit by trained auditors

Customer Requirements for Internal Auditors

• Curriculum requirements– Pretest requirements– Training and testing requirements– Practice session equivalent to one day

• Trainer requirements equivalent to Registrar Auditor Certification Requirements (with some latitude)

Important Deadlines

Facts About ISO/TS 16949:2002

• QS-9000 goes away 2006, Dec. 15– Note: DCX deadline is July, 2004

• Past Dec. 15, 2003 the organization needs to get QS-9000 audits and ISO 9001:2000 audits to maintain ISO standing– Chad’s note: If you are going to implement QS with ISO

9001:2000, why then not go directly to ISO/TS 16949:2002. Imagine the conflicts between the ISO 1994 version and the ISO 2000 version.

• Includes Vehicle Assembly Centers

For all practical purposes, ISO/TS 16949:2002 deadline is Dec. 15, 2003.

What happens after Dec. 15, 2003?

• ISO 9001:1994 will no longer be a certifiable standard• QS-9000 will become a stand alone certificate

– Note if you seek ISO 9001:2000 registration you must get a separate certification

• ISO/TS 16949:1999 will end in 2004• Visteon and Delphi will announce their own deadlines

Getting Value from Implementations

Getting Value from Your Implementation

• Set Objectives for your ISO/TS 16949:2002 Implementations– Find crucial senior management problems to work

on – SAVE Money with the implementation

• For example:– Setting business objectives and a management process– Implement Six Sigma or Lean as a part of the continual

improvement process – Save Money– Process and documentation Commonization– Improved Problem solving with lead time and cost savings

target

• Become Process focused – Follow the Omnex approach

Getting Value from Your Implementation (cont’d)

• Use the alignment methodology to become customer focused

• Train your implementation team and Auditors– Use the idea of a BMS and not a QMS

• Use software which has prescribed Best In Class Methods – Use to optimize the implementation and make it easy. Use web based software– Documentation– Customer Focus and Continual Improvement– APQP and PPAP– Process Mapping and Process Flows

• Get your top management involved in the implementation

Getting Value from ISO/TS 16949:2002

• Disciplined product development and product approval process

• Disciplined problem solving approach• Common customer satisfaction metrics• Common Process Approach – COPS, MOPS etc.• Higher quality registrar audit worldwide• FMEA/Control Plans/Work Instructions• Emphasis on Statistical methods and process

improvement• Emphasis on Measurement Systems Analysis

Strategic Choices

Strategic Choices

• How to implement ISO/TS 16949:2002– Site vs. remote location– Implement everywhere or just implement in

automotive plants/design groups– Setting overall objectives for success

• Choose your registrar for worldwide registration• Commonization of processes and documentation• Documentation decisions for customization• How to integrate customer specific requirements?• What to do with the supply base?• Planning the involvement of top management