AUTO-TECH 2004

Introduction
Speakers:
Terri Pratt
Delphi Corporation
Kelli Rogers American Axle and
Manufacturing, Inc.

2003 AIAG

CQI-7

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AUTO TECH 2003

www.AIAG.ORG

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Steps to Implementation
1

Identify & Understand

What is New

Determine the Scope of

QMS

Develop Transition /
Certification Plan

Determine
Documentation Strategy

10

NO

Are
ISO/TS
16949:2002
Requirements
Met?

YES

YES

Revise, Reference or
Create Documentation

Perform Gap
Analysis

Does QMS
Reflect a Process
Approach?
NO
Align QMS to Reflect
Process Approach

Train Employees on
QMS

11
Implement QMS

Conduct Internal Audit

12

13

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Correct Deficiencies &

Verify Effectiveness of
Solutions

Conduct Management
Review

AUTO TECH 2003

1.0 Overview

zIATF ISO/TS16949:2002 publications

ISO/TS 16949:2002 Technical Specification
Automotive Certification Scheme for ISO/TS
16949:2002
IATF Guidance to ISO/TS 16949:2002
Quality System Assessment Checklist
(May be purchased through www.aiag.org)

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1.0 Overview

zCore Tools
PPAP
APQP
MSA
SPC
FMEA
z (May be purchased through www.aiag.org)

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1.0 Overview

z ISO 9001:2000 Base Standard

ISO 9001:200 Quality management systems Requirements
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including
those needed to meet requirements for product (see 7.1 a) are
established at relevant functions and levels within the
organization. The quality objectives shall be measurable and
consistent with the quality policy.
5.4.1.1 Quality objectives Supplemental
Top management shall define quality objectives and
measurements that shall be included in the business plan and
used to deploy the quality policy

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1.0 Overview

z www.iso.com

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1.0 Overview

z International Automotive Oversight Bureau

www.IAOB.ORG
FAQS,
Sanctioned Interpretations,
Customer Specifics

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www.IAOB.ORG

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2.0 Whats New and Different

Base Standard
Changes in Intent
Shalls
Documentation
Auditing

Change in Terms
Format
Focus
Customer Specifics
Accreditation Function

Global Accreditation Process

Site Certification Process
De-certification Process
Who can be registered
COPS Customer Oriented Processes

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2.1 Customer Oriented Process (COPs)

In ISO/TS 16949:2002, the IATF has adopted a concept called
Customer Oriented Processes, or COPs. COPs are referred to in the
Checklist to ISO/TS 16949:2002.
The IATF;
9 Expects auditors to audit based upon the Customer Oriented
Processes (COP).
9 Refers to the fact that any organization needs customer input to
comply to specified and expected needs of the customer (output) in
order to achieve customer satisfaction.
9 Accomplished by value adding processes of product realization and
appropriate support processes, both enabled by management
processes and provided resources.

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2.2 New Requirements (n=15)

5.1
5.1.1
5.4.1
5.5.2.1
5.5.3
6.2.2.4
6.3
7.2.3
7.3.2.1
7.3.2.2
7.3.3.2
7.4.3.2
8.1
8.2.2.5
8.5.1.2
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Management commitment
Process efficiency
Quality objectives
Customer representative
Internal communication
Employee motivation and empowerment
Infrastructure
Customer communication
Product design input
Manufacturing process design input
Manufacturing process design output
Supplier monitoring
Measurement, analysis and improvement General
Internal auditor qualifications
Manufacturing process improvement
AUTO TECH 2003

Steps to Implementation
1

Identify & Understand

What is New

Determine the Scope of

QMS

Develop Transition /
Certification Plan

Determine
Documentation Strategy

10

NO

Are
ISO/TS
16949:2002
Requirements
Met?

YES

YES

Revise, Reference or
Create Documentation

Perform Gap
Analysis

Does QMS
Reflect a Process
Approach?
NO
Align QMS to Reflect
Process Approach

Train Employees on
QMS

11
Implement QMS

Conduct Internal Audit

12

13

14

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2003 AIAG

Correct Deficiencies &

Verify Effectiveness of
Solutions

Conduct Management
Review

AUTO TECH 2003

Step 5 - Process Approach

QS-9000
z Documented quality system document what you do,
do what you document
ISO/TS16949
z Customer satisfaction and measures of process
effectiveness

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QS-9000

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ISO/TS 16949 Process Approach

(Process Approach)

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What is a process?

z Set of interrelated or interacting activities

which transforms inputs to outputs

INPUTS

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PROCESS STEPS

OUTPUTS

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Building Blocks of a Process

z Management Responsibility
z Resource Management
z Product Realization
z Measurement, Analysis and Improvement

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Model of a Process-Based Quality

Management System
Continual Improvement of the
Quality Management System

Management
Responsibility

Customers

Requirements

Resource
Management

Input

Customers

Measurement,
Analysis,
Improvement

Product
realization

Satisfaction

Product
Output

Quality Management
System
Key:
Value-adding activities
Information flow

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Setting up the Quality Management

System

z Process Identification
z Process Mapping
z Effectiveness
z Auditing
z Documentation to Certification Body

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Process Identification

z Market Analysis/Customer Requirements

z Bid/Tender
z Order/Request
z Product and Process Design
z Product and Process Verification/Validation
z Product Production
z Delivery
z Payment
z Warranty/Service
z Post Sales/Customer Feedback
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Process Identification Tool

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Process Mapping
With What?

With Who?

(Materials/Equipment)

(Competence/Skills/Training)

Inputs

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Process

Outputs

How Many?

How?

(Measurement/
Assessment)

(Methods, Procedures,
Techniques)
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Example - Process Mapping

Supplier Database
Shipping Database

Supplier Quality Assurance

Management (inbound)
Customer Service Manager
(outbound)
PC&L Supervisor (internal)

ISO/TS 16949
Customer
Specifics
Schedule

Delivery
Report
Delivery

SPDP
Customer
Satisfaction

Adherence to Schedule
Supplier Development
Tracking
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SPDP Procedures
PC&L Procedures
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Example - Process Mapping

Process Auditing Approach
WHAT is used in the process?

WHO is involved?
Competence/Skills/Training

Materials/Equipment
4.1 General Management Requirements
4.2 Documentation Requirements
5.3 Quality Policy
5.4 Planning Quality Objectives
6.3 Infrastructure
7.1 Planning & Product Realization
7.2 Customer Related Processes
7.3 Design & Development
7.4 Purchasing
7.5 Production & Service

Inputs
(Customer inputs to process, such as
QMS requirements, customer
requirements, regulatory & safety, product
reliability. Inputs may be a document,
materials, tooling, schedule, etc.)

(examples: skills, matrix, temporary employees, OJT, Quality

Auditor qualifications)
4.1 General Management Requirements
4.2 Documentation requirements
5.3 Quality Policy
5.1 Management Commitment
5.5 Responsibility, authority, communication
6.2 Human Resources Training
7.3 Design/development
7.3.1.1 Multi-disciplinary
6.1 Provision of Resources

Process

Outputs

(Process Owner must be

identified and interviewed)
(Transformation of inputs into outputs
analyzed in general terms)

(Outputs to customer, both internal or

external customer satisfied. Outputs may
be a product, document, and should be to
actual measure of effectiveness)

HOW MANY What measurements are used to

HOW is the process done?
Methods/Procedures/Techniques
(including preventive maintenance)
4.1 General Management Requirements
4.2 Documentation Requirements
5.3 Quality Policy
4.2.2 Quality Manual
6.3 Infrastructure
6.4 Work Environment
7.1 Product Realization
7.3 Design & Development
7.5 Product & Service
7.6 Control of Monitoring and Measuring Devices
8.3 Control of Nonconforming Material

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report the process?

Measurement and Analysis
(examples: PPM, delivery, uptime, scrap, efficiencies, customer
disruptions, field returns)
4.1 General Management Requirements
4.2 Documentation Requirements
5.3 Quality Policy
5.2 Customer Focus
5.6 Management Review
7.6 Control of Inspection, Measuring and Test Equipment
8.1 statistical concept
8.2 Monitoring and measuring
8.3 Control of Nonconforming material
8.4 Analysis of Data
8.5 Improvement - MSA SPC Internal Audits

AUTO TECH 2003

Effectiveness

z Compare outputs to inputs

z Compare outputs to objectives
z Analyze metrics being used
z Determine metrics to be used
z Track progress
z Take actions to drive continual improvement

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Benefits of Using the Process Approach

z Improved understanding of interfaces and

interactions
z Alignment of organization activities to
customer metrics
z Customer feedback through metrics provides
customers perspective of effectiveness
z Common language
z Improved organizational efficiency
z Audits tailored to individual organizations
z Audits focused on activities and objectives
most important to customer satisfaction
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AUTO TECH 2003

Steps to Implementation
1

Identify & Understand

What is New

Determine the Scope of

QMS

Develop Transition /
Certification Plan

Determine
Documentation Strategy

10

NO

Are
ISO/TS
16949:2002
Requirements
Met?

YES

YES

Revise, Reference or
Create Documentation

Perform Gap
Analysis

Does QMS
Reflect a Process
Approach?
NO
Align QMS to Reflect
Process Approach

Train Employees on
QMS

11
Implement QMS

Conduct Internal Audit

12

13

14

29
2003 AIAG

Correct Deficiencies &

Verify Effectiveness of
Solutions

Conduct Management
Review

AUTO TECH 2003

Step 8 Documentation Strategies

z Matrix Approach
z Revise Current Documentation
z Revamp System

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Matrix Approach
A matrix that shows the linkage between the
requirements of ISO/TS 16949 and the organizations
current policies, procedures and work instructions
(example Process Identification Tool)

z Advantages:
Saves time and resources by not having to recreate
documentation
Potentially reduces training needed since team
members are already familiar with the QMS.

z Disadvantages
Promotes an elemental approach based QMS
Creates another layer of documentation
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Revise Current Documentation

Updating current policies, procedures and work
instructions to reflect sequence, interaction and
effectiveness based on the process approach

z Advantages;
Evaluates and deletes unnecessary documentation

z Disadvantages
Existing documentation may retain the format of an
elemental approach

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Revamp System
The organization focuses on customer satisfaction
metrics and creates a QMS around these

z Advantages
Allows an organization to take a fresh, unbiased look
at each requirement
Gain a better understanding of its business
processes, eliminate unnecessary steps and reduce
excess documentation

z Disadvantages
Requires the most time and resources

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Steps to Implementation
1

Identify & Understand

What is New

Determine the Scope of

QMS

Develop Transition /
Certification Plan

Determine
Documentation Strategy

10

NO

Are
ISO/TS
16949:2002
Requirements
Met?

YES

YES

Revise, Reference or
Create Documentation

Perform Gap
Analysis

Does QMS
Reflect a Process
Approach?
NO
Align QMS to Reflect
Process Approach

Train Employees on
QMS

11
Implement QMS

Conduct Internal Audit

12

13

14

34
2003 AIAG

Correct Deficiencies &

Verify Effectiveness of
Solutions

Conduct Management
Review

AUTO TECH 2003

Step 12 - Audits

Product Audit
Manufacturing Process Audit
Quality Management System Audit

Internal Audit Plan

2003 AIAG

Quality Management System Audit

z Review list of customers & customer specific

requirements
z Identify process owners
z Review process measurements
z Compare business goals and objectives to
customers
z Understand basic business processes and
follow the process
z Review linkages and interactions

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Quality System Audit Process

Auditing Report Database
Process Mapping

Trained Auditors to ISO/TS

16949 and customer specific
(such as core tools)

ISO/TS 16949
ISO 19011
Customer
Specifics

Audit Report

Quality System
Auditing Process

QMS Manuals

Revised
Schedule

Schedule

Adherence to Schedule

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QMS Procedures for

Auditing

Tracking Processes Audited

to include all requirements

Process Audit Approach

Trend analysis

AUTO TECH 2003

Manufacturing Process Audit

z Each manufacturing process

z What are planned activities?
z Does actual practice follow those planned
activities?
z Do the customer metrics indicate the control
plan is effective?

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Manufacturing Process Audit Focus

z Customer ratings and customer complaints

z Internal nonconformity reports
z Process flow charts, PFMEA, control plans,
work instructions
z Internal communication
z Employee competency
z Quoted production capacity
z Preventive/predictive maintenance

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Product Audit
Product Audit
Management Responsibility:
Responsible management review of results
Resources assigned to perform audits

Resource Management:
Qualified Auditors
Appropriate Measurement and Test Equipment
Databases for inputting results

Product Realization:
Product sampling & Product inspection
List number of parts examined and those found
nonconforming

Measurement Analysis
& Improvement:
Audit Report
Customer Complaints
Control of Nonconforming Product

Measurements taken:

Inputs:
Drawings
Specifications
Work Instructions
Inspection Instructions
Visual Aids
FMEA
Control Plan
Approved
Internal Nonconformities
Customer Complaints

Marking/Identification
Packaging according to specification
Dimension inspection (selected dimensions
according to the customer or organizations
drawing)
Visual inspection

Outputs:
Audit Report
Corrective Actions (if
needed)

Gauging
Physical properties (such as torque, Newtons,
heat)
Chemical properties (material inspection reports)
List of any nonconformities (if found)
Corrective Action Follow-up Recommendation
(if necessary)

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Steps to Implementation

15

Certification Body
Conducts Document
Review
16

YES

Pre-Audit
Desired?

17
Conduct
Pre-Audit

18

NO
Conduct
Certification Audit

19

Conduct
Surveillance Audits
At Appropriate
Intervals

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Conduct
Re-Certification
Audit

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Step 15 - Documentation to Certification

Body
z Number of employees, address, etc.
z Scope of certification
z Product design responsibility
z Sites to be registered
z Remote activities
z Quality management systems certifications obtained
z Quality manual
z Internal audit and management review planning and
results from previous 12 months
z List of customer specific requirements
z Customer complaint status
z Operational performance trends for the previous 12
months minimum
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Pitfalls to Avoid

z Pre-Audit
Selecting a Certification Body
Switching Certification Bodies
Timeliness of Certification
Scheduling of Multiple Sites

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Pitfalls to Avoid

z Preparing the QMS

Measuring the Processes
Customer Requirements

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Pitfalls to Avoid

z During the audit

Management responsibility
Competence, Awareness & Training

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Pitfalls to Avoid

z 3rd Party Auditors

Value added audits
Auditor qualifications

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Pitfalls to Avoid

z Post Audit Activities

Follow-up of nonconformances

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Appendices

z Comparison of ISO/TS 16949:2002 and QS-9000

z Process Identification tool
z Process Examples
z QMS and Process Audit examples
z 4 pack Explanation
z Training Recommendations
z Contact Information

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Conclusion

z Guide to transition between QS-9000 and

ISO/TS 16949:2002
z Helps companies understand the structure and
importance of the process approach
z Focuses on Customer Satisfaction
z In addition to the guide, utilize sources such as
the IAOB, ISO, AIAG and others that have
successfully transitioned.

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The End
Questions

2003 AIAG