ISO/TS 16949:2002

Expiration of QS-9000

ISO (Geneva, Switzerland) has stated that QS-9000 has been extended by 3 years, and will expire on 14 December, 2006

ISO has indicated that there is virtually no chance of additional extensions, nominally, the ISO 9000:1994 standard embedded within QS-9000 will expire 15 December, 2003.

Two Key Organizations

International Automotive Task Force

International Automotive Oversight Bureau

Purpose of the IATF

Develop consensus for international quality system requirements (automotive)

Develop policy & procedure for registration Provide appropriate training Serve as formal liaison

IATF Members

Authoring Organization of ISO/TS 16949 includes: Vehicle manufacturers: BMW, DaimlerChrysler, FIAT,

Ford Motor, GM, PSA, Renault, Volkswagen Industry trade organizations: AIAG, ANFIA, FIEV,

SMMT, VDA Guest members: JAMA

IATF Oversight

ANFIA, IAOB, IATF-France, SMMT, VDA-QMC Implementation of IATF registration scheme and rules

via a common process Witness audits Auditor qualification training and exam Monitor CB/auditor performance

Apply and implement IATF policy and decisions Coordinate special projects and work teams Develop sanctioned interpretations and

recommendations for improvement Database management

Purpose of IAOB

Implement and manage 16949 registrations Manage and coordinate with IATF Europe Support further global consistency Develop and maintain central database

Which Car Manufacturers Will Accept ISO / TS 16949?

The users of -

QS-9000 - US Big 3

VDA 6.1 - German

AVSQ - Italian

EAQF - French

Why Upgrade to TS?

From the OEM subscriber’s view: TS 2nd is based on the current ISO 9001:2000

Includes Customer Specifics to achieve conformity

Improved control of the auditing process Reduced audit variation Better control of certification and its value

Why Upgrade to TS?

From the supplier’s point of view: Reciprocal recognition (one size fits all) Vocabulary is consistent with ISO 9001:2000 Process audit is aligned with the way the

automotive business is run Continual improvement from earlier requirements

documents (e.g., TS 1st, QS-9000, EAQF, AVSQ, VDA 6.1)

Closer oversight – greater value in certification

ISO/TS 16949:2002 Addresses Significant QS-9000 issues

• The Oversight process

- Tighter registrar control than with QS-9000 Accreditation Body method, and higher quality auditors

• International recognition of ISO/TS 16949:2002

- The Multinational OEM authoring group reduces the number of certification requirements in Europe, and therefore cost

• ISO/TS 16949:2002 is based on and includes ISO 9001:2000- ISO 9001:2000 includes strengthened management reporting,

continuous improvement and customer satisfaction metrics (aligned with Q1 2002)

Eight Principles

Customer focus

Leadership

Involvement of people

Process approach

System approach to management

Continual Improvement

Factual approach to decision making

Mutually beneficial supplier relationships

Introduction

The goal of this Technical Specification: development of a quality management system provide for continuous improvement emphasize defect prevention reduction of variation and waste in the supply

chain

“The intent of this international standard is to encourage the adoption of the process approach to manage an organization.”

Process approach - “for organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes. The systematic identification and management of the processes employed within an organization and particularly between such processes is referred to as process management.

Through industry standards - ISO9001:2000 & ISO/TS16949:2002.

How Will the Audit Change?

Process audit approach Automotive application Line of sight from the organization to the customer

Audit plan Identification of key processes impacting the customer Based on the processes as defined by the organization

Performance Linked to common metrics for

Organization Supplier

Oversight Adherence to the “Rules” and Common Global Process

Management

Responsibility

Resource

Management

Product

Realization

Measurement,

Analysis

& Improvement

Inputs Product

C

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Outputs

R

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Q

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M

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T

S

C

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M

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C.I.

Continual Improvement Cycle

Scope and Applicability

ISO / TS 16949

Applicable to production and service part supplier sites that are providing: Parts or materials Heat treating, painting, plating, other finishing services Other customer specific products

May also be applied throughout supply chain

What’s New (and Different)

Based on ISO 9001:2000 not ISO 9001:1994 Greater focus on the customer and customer

satisfaction New focus on the “Process” approach vs. the

“elemental” approach Clarification of requirements for continual

improvement

New and Different (Cont.)

Greater emphasis upon the role of top management

Measurable quality objectives Reduced emphasis on documented

procedures

New and Diff. (Cont.)

Modification in the purpose of internal audits Use the “Deming Cycle” of Plan, Do, Check,

and Act as a basic methodology Process Conrol and improvement is

expanded from product to include all activities of the organization.

ISO 9001 Supply Chain Terms

C ustom er

O rgan iza tion

SU PPL IE R Was Subcontractor in QS-9000

Was Supplier in QS-9000

Adds sector terminology Control plan Design responsible org. Error proofing Laboratory Laboratory scope Outsourcing Predictive maintenance Premium freight Remote location & “site” Special characteristics

Modifies ISO terms Continual improvement Manufacturing

Automotive Specific Terminology

ISO 9001 Core Sections

Permissible ExclusionsISO / TS 16949

The only permitted exclusions may be in 7.3• Where the organization is not responsible for product design and

development• Permitted exclusions do NOT include manufacturing process

design • Justified with details in the quality manual• Conformity should not be claimed otherwise

Only IATF will prescribe authorized exclusions for vehicle assembly plants

Mandatory Procedures

ISO 9001:2000 Control of Documents Control of Records Internal Audit Control of

Nonconforming Product Corrective Action Preventive Action

ISO/TS 16949:2002 Laboratory Field Service (i.e.

Warranty) Training

Key Differences between QS-9000 & TS16949

TS16949 focuses on the business processes required to satisfy customer requirements (The “Process Approach”).

QS-9000 follows the 20 elements (The “Conformity Approach”)

Process audit (TS16949) vs. documentation audit (QS-9000)

Contrast between QS-9000 & TS-16949:2002

Procedures Are: Driven by task completion

Issued

May be completed by different departments with different objectives

Are segmented

Satisfy the standard

Define the sequence of steps to perform a task

Static

Processes Are: Driven by desired output

Managed

May be completed by different departments with the same objectives

Flow to conclusion

Satisfy the stakeholders

Transform inputs into outputs

Dynamic

QS-9000(Procedure Based)

TS-16949:2002(Process Based)

1 2 3 4

Functional Goals

A FUNCTIONAL ORGANIZATIONWITH PROCESS OVERLAYS…

Management of Processes

Process 2

1

2

3

4

Process 1

Process 3

Process 4 Proc

ess

goal

s

• All work is performed to achieve some objectives

• The objective is achieved more efficiently when related resources and activities are managed as a process

• Objectives of the organization which serve to meet its mission will be met more effectively when the organization is managed as a system of interrelated processes.

Recognizes:

The Process Approach

InputsInputs OutputsOutputsProcessProcess

ObjectivesObjectives

ResultsResults

RisksRisks

PurposePurpose

• Stakeholder Wants & Needs • Specifications• Schedule/Timing• Market Data• Industry Trends• Economic Conditions

• Products • Information

Process Mapping

Forms and Form Instructions

Supporting Instructions

Program Planning & Launch

Manufacturing

Marshall Key Processes

Shipping

LRP/OPManufacturing

RoadmapInformation

ManagementCorrective

ActionInternal Auditing Preventive Action

Document Control

Business Processes

Management Review / Continuous

Improvement

Quality Objectives

CQR/CQA

Support Processes

Asset Management Human Resource Management

Materials Management Capacity Planning Purchasing

DFMSupplier

Management

Non-conforming Material

Laboratory Records Retention

Component Quality

Customer Support 5S Audit

Process Mapping

• How do I get started mapping????• First map out our processes at your location at

the macro level• Identify the process owner• Map out your processes at the micro level that

support the processes at the macro level

Process Mapping

You will need to identify• The inputs to your processes• The outputs of your processes• And then map out the activities in between that

define the processesYou might find sub processes

• Identify metrics to measure the effectiveness of your processes (must tie to the process objective)

Process Mapping

Identify your customers and your process objectives/outputs (TS16949 section 4.2.2.c)

• Internal (other processes) and External customers

• Show interactions between the various processes

Process Mapping

Identify your customers and your process outputs (TS16949 section 4.2.2.c)

• Physical products• Documents• Information• Services• Decisions• On time to schedule• Meet profit margins

Process Mapping

Identify suppliers to your process (internal and external) (TS 16949 section 4.2.2.c)

• What are their inputs to your processOther processesLaborMaterial Ideas InformationEnvironmentProcedures, Forms, Documents, Records

Process Mapping

Identify support to your processes (TS16949 section 4.2.2.c)

• Human Resources• Training• Purchasing• Finance• Quality Assurance• Etc.

Process Mapping

Establish a goal against which to measure your metrics• You will need to monitor your metrics and implement

corrective actions if you don’t meet your goal• Look for opportunities of continual improvement to

improve your processes

Process Mapping

Identify risks to the process and the objectives• Compressed Timing• Failure to meet schedule timing• Incomplete customer requirements• Test/performance failures• Rejected approvals (appearance, PPAP)• Underestimated costs• Premium freight

Process Mapping

Flow chart the process.

Note:

Indicating forms/records to be filled out at each step of the process can eliminate or reduce the need for procedures to document activities at each step.

A well done flow chart can eliminate the need for a procedure to describe the process.

Questions to Help with Mapping

Purpose

• Why does this process exist?• What is the purpose of this process?• What is the outcome?

Outputs• What product does this process make?• What are the outputs of this process?• At what point does this process end?

Customers• Who uses the products from this

process?• Who are the customers of this process?

Inputs/Suppliers• Where does the information or

material you work on come from? Who are your suppliers?

• What do they supply?• Where do they affect the process

flow?• What effect do they have on the

process and on the outcome? Process steps

• What happens to each input?• What conversion activities take

place?

Process Objective: Support Processes:

Configuration Management

Manufacturing

Program Management

Purchasing

Inputs Outputs Rules/Responsibilities

(5) If parts are required, parts may be ordered by Engineering, Sales or supplied internally from a TRW manufacturing facility.

(6) Prototypes built in accordance to build checklist, drawings & specifications.

(7) Engineering to coordinate deviation or customer concurrence.

(8) Quality Assurance performs & documents inspections using inspection standards or prototype control plans, depending upon the specific customer requirements.

(9) Quality Assurance coordinates any required deviations using the specific customer forms.

(10) Quality Assurance documents results using the specific customer paperwork and maintains copies for future reference. Paperwork may be sent with the prototype parts or forwarded to the customer via mail or fax depending upon specific customer requirements.

(11) Shipping Department packas parts and coordinates develivery. Sales isrwponsbile for alerting shipping in advace if expidated develiry will be require3d.

(12) Finance Department coordinates billing and collection. Sales Department may assist in overdue collection through direct customer contact.

(3) Team usually can consists of Engineering, Quality, Sales, Program Mgt., Manufacturing.

(1) Sales Department.

(2) Sales Department.

Document No./ Release No.

345643/ERD 2345

Process

Process Name / Level:

Prototype Process - Farmington Hills (Level 2)

Build and deliver on-time, prototype parts that meet

customer design & performance requirements.

1. On-time delivery.

(4) Sales Department.

Process Measurables:Process Risks:

1. M issed delivery date to the customer.

2. Parts do not meet customer requirements in quality or performance. 2. Prototype rejections by the customer.

Customer Order

(1) Receive Customer P.O., EDI, Phone, Fax,

Mail

Prototype Parts

Order Issues ?

No

Yes

Drawings

(2) Enter order into SAP System

(3) Review Order Requirements with Prototype Team

Specifications

(4) Resolve with Customer

Revised P.O.

Req'd?Yes

(5) Components Inventory CheckNo

(6) Build Prototypes

Functionally Test Prototypes

Prototype Paperwork

(7) Resolve with the

Customer

Test Issues ?

(8) Quality Inspection

No

Quality Issues ?

No

(11) Packing & Shipping

(10) Complete Prototype Paperwork

(9) Resolve with the

Customer

(12) Issue Billing to Customer

Customer Invoice

Components

Yes

Yes

Document No. Revision

MPM0078 AProcess Objective: Support Processes:

Material Management

Document ControlNon-Conforming Material

Inputs Outputs Rules/Responsibilities/Comments

1. Shipping instructions.

2. Government Regulations

3. Customer Requirements

6. Customer requirements not met. 6. Finished Goods Accuracy

4. Customer not notified (no ASN) 4. Customer Quality5. No invoice or not correct. 5. Finished Goods Inventory

Governing Documents

Process Measurables:

3. P remium Freight.

1. Shipping Associate

Process

Process Nam: Back to Marshall Key Processes

Marshall Shipping Process

Ship quality product per customer requirements.

1. On-time delivery performance report (internal).

3. The shipment is not on time to the customer schedule.

Process Risks:

1. On-line system goes down and customer orders are missed.2. The wrong quantities are shipped. 2. On-time delevery performance report (external)

Report and Move to

Finished Goods

Pull Signal to Manufacturing

Assemble/Verify Shipment

Invoice Customer

Warehouse Storage

Ship Product

Document No. Revision

MPM0079 AProcess Objective: Support Processes:

Materials ManagementDocument ControlNon-Conforming Material

Inputs Outputs Rules/Responsibilities/Comments

1. Shipping Associate2. Shipping C lerk

1. Customer Packaging Specifications2. Delivery Note

3. Honda Delta System

4. DCX SMART System5. Ford DDL6. MMOG

4. Customer not notified (no ASN)5. Dropped parts.

4. Customer Quality5. Finished Goods Inventory

Process Risks:

1. On-line system goes down and customer orders are missed.2. The wrong quantities are shipped. 2. On-time delevery performance report (external)

Process

Process Nam: Back to Marshall Key Processes

Assemble / Verify Shipment

Ship quality product per customer requirements.

1. On-time delivery performance report (internal).

3. The shipment is not on time to the customer schedule.

Process Measurables:

3. P remium Freight.

6. Finished Goods Accuracy

Governing Documents

Delivery Note from Customer

Service

Place on truck

Review Pick List

Is all stock available?

Shipment Configuration

Stored Finished Goods

Assemble order per customer

directives

Consult SAP inventory screen.

Contact Manufacturing or Customer Service

Pull Order

Is stock in the correct quantity?

Reference on-hand inventory screen when picking shipment

Is container within the two week window

of stock

Is another box required?

Identify out of rotation or missing box and forward to inventory analyst. (2)

Yes

No

YesNo

No

Yes

Yes

No

Is the box damaged or dropped?

No

Warehouse Nonconformance

Yes

What About the AIAG Reference Manuals?

The AIAG reference manuals (PPAP, FMEA, MSA, APQP & SPC are still viable documents.

References to these manuals will be included in DCX, Ford and GM’s respective customer specifics for TS16949.

Certification to TS16949 also includes the requirements defined in the AIAG reference manuals.

Questions?Questions?