1. ISO/TS Challenges Johannes A. M. Roovers (“Yon”)
President, Jan Roovers Associates, Inc.
Located in Charlotte, North Carolina
Providers of Training and Consulting Services:
Quality Management Systems
Organizational Development 1
Jan Roovers Associates, Inc.

2. ISO/TS 16949:2002 is Based on Eight 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 relationships 5
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3. 1. Customer Focus
Organizations depend on their Customers and therefore should
Understand current and future Customer needs
Meet Customer requirements
Strive to exceed Customer expectations 6
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4. 2. Leadership
Leaders establish unity of purpose and direction of the organization. They should
create and maintain the internal environment in which people can
become fully involved in achieving the organization’s objectives 7
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5. 3. 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 8
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6. 4. Process Approach A desired result is achieved more efficiently when
activities and related resources
are managed as a process
(Will be discussed in great detail later) 9
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7. 5. System Approach to Management
Identifying, understanding and managing interrelated process as a system
contributes to the organization’s effectiveness and efficiency in
achieving its objectives
(Will be discussed in great detail later) 10
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8. 6. Continual Improvement
Continual improvement should be a permanent objective of the organization 11
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9. 7. Factual Approach to Decision Making
Effective decisions are based on the analysis of data and information 12
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10. 8. Mutually Beneficial Supplier Relationships
An organization and its suppliers are interdependent and
a mutually beneficial relationship enhances the ability of both
to create value 13
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11. The Process Approach 17
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12. Change in Focus QS-9000:1998 based QMS: ISO/TS 16949:2002 based QMS:
Requirements driven
Conformance to requirements
ISO/TS 16949:2002 based QMS:
Customer (and organization’s) needs and expectations driven
Performance of the QMS and its processes must be demonstrated 18
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13. Change in Focus QS-9000:1998 based QMS: ISO/TS 16949:2002 based QMS:
Develop procedures based on the 20 elements in the standard
Focus was on requirements
ISO/TS 16949:2002 based QMS:
Develop procedures based on customer (and organization’s) needs and expectations
Focus must be on processes 19
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14. Process Approach
ISO/TS 16949:2002 promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.
Re: Clause 0.2 Process approach 20
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15. Process Approach Quality Management Principle #4
A desired result is achieved more efficiently when activities and related resources are managed as a process
Key benefits:
Lower costs and shorter cycle times through effective use of resources
Improved, consistent and predictable results
Focused and prioritized improvement opportunities 21
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16. Process Approach Quality Management Principle #4
Applying the principle of process approach typically leads to:
Systematically defining the activities necessary to obtain a desired result
Establishing clear responsibility and accountability for managing key activities
Analyzing and measuring of the capability of key activities
Identifying the interfaces of key activities within and between the functions of the organization 22
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17. Process Approach Quality Management Principle #4
Applying the principle of process approach typically leads to: (Cont’d)
Focusing on the factors - such as resources, methods and materials - that will improve key activities of the organization
Evaluating risks, consequences and impacts of activities on customers, suppliers and interested parties 23
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18. CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
(and other
interested
parties) C U S T O M E R
(and other
interested
parties)
Management
Responsibility R E Q U I M N T S S A T I F C O N
Measurement,
Analysis, and
Improvement
Resource
Management
Product
Realization
Product
Input
Output
Model of a Process-based Quality Management System 24
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19. The QMS must be used for continual improvement ...
Improve Processes
through PDCA Cycle
Results: - Quality
- Productivity
- Competitive Position
Baseline Performance
Plan Do
Act Check
Measure/monitor results against objectives - Improve process and change QMS as needed to achieve and sustain desired results
QMS
Improvement Objective 25
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20. The organization shall:
Identify the processes needed for the quality management system and their application throughout the organization
Determine the sequence and interaction of these processes
Determine criteria and methods needed to ensure that both the operation and control of these processes are effective
Ensure the availability of resources and information necessary to support the operation and monitoring of these processes
Re: Clause 4.1 General requirements 26
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21. The organization shall:
Monitor, measure and analyze these processes, and
implement actions necessary to achieve planned results and continual improvement of these processes
These processes shall be managed by the organization in accordance with the requirements of this International Standard
Re: Clause 4.1 General requirements 27
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22. The Organization Shall
Identify the processes needed for the quality management system and their application throughout the organization 28
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23. ISO 9001:2000 ISO 9001:2000 identifies four categories of processes:
Management responsibility-related processes
Resource management-related processes
Product realization-related processes
Measurement, analysis and improvement-related processes 29
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24. Management Responsibility
CONTINUAL IMPROVEMENT OF THE QMS C U S T O M E R
Management Responsibility C U S T O M E R
Operational Management
QMS Planning and Objectives
Quality Policy - Business Planning
QMS Performance Analysis
Management Review
Internal Communication
Control of Documents
Control of Records
Human Resources
Training Development
Training Delivery
Employee Motivation
Maintenance
Environmental
Safety Compliance
IT Services
Resource Management
Customer Issues
Internal Auditing
Inspections, Testing
Control of NC Product
Data Analysis
Improvement Projects
Corrective Action
Preventive Action
Measurement, Analysis, Improvement
Product Realization
Process Planning
Sales-Marketing
Product Design
Process Design
Scheduling
Manufacturing
Assembly
Testing
PPAP
Shipping
Purchasing
Supplier Relations
Receiving
Storage
Inventory Control
Calibration and MSA
ID/Traceability
Production Tooling
Laboratory
Contract Mgt.
Require- ments
Realization Processes
Support Processes
Satis- faction
Parts
Input
Output
Acme Auto Parts Corp. Quality Management System 30

25. The Process Approach per IATF/IAOB31
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26. IATF IATF suggests three categories of processes:
Customer-oriented Processes (COPs)
Support Processes
Management Processes 32
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27. Octopus Diagram COPs Output Input Input Output Output Input Input33
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28. Customer Oriented Process “COP”
A process that begins with a customer requirement, specification, expectation or implied contract (input) and ends with a fulfillment of the requirement and/or expectation being met (output). 34
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29. Customer Oriented Processes (Suggested by IATF)
Market Analysis/Customer Requirements
Bid/Tender
Order/Request
Product and Process Design
Product and Process Verification/Validation
Product Production
Delivery
Payment
Warranty/Service
Post Sales/Customer Feedback 35
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30. Activity that transforms INPUT into OUTPUT
What is a Process?
Activity that transforms INPUT into OUTPUT
Activity
Input
Output
Resources:
People
Facilities/Equipment
Material
Methods
Environment
Results:
Products
Services
Performance 36
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31. PROCESS - a series of steps that add VALUE to the INPUT
What is a Process?
CUSTOMER
has a need
PROCESS
CUSTOMER
need is met
INPUT
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
OUTPUT
VALUE
VALUE
VALUE
VALUE
VALUE
VALUE
VALUE
PROCESS - a series of steps
that add VALUE to the INPUT 37
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32. Analyzing a Process PROCESS CUSTOMER CUSTOMER has a need need is met
What things
(equipment, tools, etc.)
are needed to
complete the activities?
Who performs the
activities? How
have their qualifications
been verified?
PROCESS
a series of steps or
activities
CUSTOMER
has a need
CUSTOMER
need is met
INPUT
OUTPUT
What measurements
are used to evaluate
the effectiveness and
efficiency of the process?
What documentation
(procedures, WI’s, records)
is needed to ensure activities
are completed as planned?
Measurements must be based on Objectives for the Process that
Align with the Objectives for the Organization
Analysis must be based on the Risk to achieving an Output result
that Matches the identified Input need 38
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33. How is a Process Managed?
Monitor and Measure the Process
make sure the inputs are right, the transformation
activities consistently work, and the desired results
are achieved, then - improve the process as needed
Activity
Input
Output
Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
Well-managed environment
Desired Results:
Quality Products
Quality Services
Customer Satisfaction 39
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34. How is a Process Measured?
Efficient
No Waste
Effective
Desired Results Achieved
Activity
Input
Output
Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
Well-managed environment
Desired Results:
Quality Products
Quality Services
Customer Satisfaction 40
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35. Critical Elements of all Processes (Suggested by IATF)
Process owner exists
Process is defined
Process is documented
Linkages of process established
Process is monitored
Records maintained 41
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36. Key questions of each COP (Suggested by IATF)
How are customer requirements understood and fulfilled?
How is the process value added?
What are the results of Process Performance and Effectiveness? (Measurements)
What is the evidence of Continual Improvement? 42
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37. Examples of Customer Oriented Processes
INPUTS
Market Data
Customer request
Purchase Order
Cust. Specifications
Product Specs
Drawings/Process Info
Finished Product
Invoice Info
Warranty Request
Performance Data
COPs
1. Marketing
2. Sales
3. Contract Management
4. Product Design
5. Process Design
6. Manufacturing/Assembly
7. Packaging/Shipping
8. Billing
9. Warranty/Service
10. Cust. Feedback Analysis
OUTPUTS
Product Info
Bid/Proposal
Order confirmed
Product Specs
Approved Process
Finished Product
Product Delivered
Invoice Paid
Warranty Accepted
Corr/Prev/Cont. Impr. 43
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38. Customer Oriented Process and Support Processes
Output
Organization 4 3
Support Processes
COP 2 1
Input 44
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39. Support Process and Sub-support Processes
Output
Support 4
Support Process 3
Sub-support Processes 2 1
Input 45
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40. Support Processes
A support process is any planned process whose input, output and transformational activities are established and maintained by the organization in order to comply with requirements or specifications and/or to meet organizational needs in supporting COPs. 46
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41. Support Processes Two truths about support processes:
1. They are in place to support COPs or other support processes
2. They are in place to mitigate risk 47
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42. Turtle Diagram Inputs (What the Customer wants)
With What? (Materials/Equipment)
With Whom? (People, their competence, skills and training)
Inputs (What the Customer wants)
Outputs (What the Customer receives)
Process
With What Key Criteria? (Measurement/Assessment)
How? (Methods/Procedures/Techniques) 48
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43. Process Name ___________________
TURTLE DIAGRAM
With what?
Machines/Equipment:
Materials:
With whom?
People involved with this process:
Links/interfaces with involved parties:
Process Name ___________________
Process Steps/Activities: ____________________________________________________________________________________________________
Outputs? Customer need is fulfilled for:
Output requirements. What output criteria are used to determine that the output meets the requirements?
Inputs? Customer wants:
Input requirements. What are the inputs that determine what the process must produce?
Measure?
With what key criteria? Measurements/Assessments:
How?
Support processes: (Who helps and how?)
Procedures/work instructions/control documents:

44. TURTLE DIAGRAM (Large Scope)
With what?
Machines/Equipment:
Materials:
With whom?
People involved with this process:
Links/interfaces with involved parties:
Stamping presses and tooling
Welding machines
Inspection and test equipment
Mat. handling equipment
Production operators
Process technicians
Material handlers
Quality engineers
Supervisors
Prod.planners
Steel
Subassemblies
Welding supplies
Cleaning supplies
Supplier contact person
Customer contact person
Engineering
Training
Process Name ___________________
Process Steps/Activities: ____________________________________________________________________________________________________
Outputs? Customer need is fulfilled for:
Output requirements. What output criteria are used to determine that the output meets the input requirements?
Inputs? Customer wants:
Input requirements. What are the inputs that determine what the process must produce?
Customer has ordered brakes per P.O. #
Brake Production Process
Customer has received brakes per P.O. #
Stamping
Welding
Testing
Customer specifications
Gov. and Reg. requirements
Production schedule
Inspection and test records
PPM and Ppk records
Delivery performance records
Customer feedback
Plating
Measure?
With what key criteria? Measurements/Assessments:
How?
Support processes: (Who helps and how?)
Procedures/work instructions/control documents:
PPM
Ppk on special characteristics
Equipment availability (uptime-downtime)
Cost of quality
Run-at-rate
Tooling management
Materials management
Logistics
Calibration
Storage
Maintenance
Work instructions
Set-up instructions
Process FMEA
Control plans

45. TURTLE DIAGRAM (Small Scope)
With what?
Machines/Equipment:
Materials:
Computer network - Printers
Phone system
Hand-held computers
With whom?
People involved with this process:
Links/interfaces with involved parties:
Audit Team Leader
Internal Auditors
Technical Experts
Auditees
Guides
Process to be audited
Audit prep materials (Turtles)
Previous Int. and Ext. audit reports
QMS documentation and records
Audit working papers
Management/ Mgt. Rep
Process Owners
Registrar/Ext Auditor
Customer, STA’s
Process Name ___________________
Process Steps/Activities: ____________________________________________________________________________________________________
Outputs? Customer need is fulfilled for:
Output requirements. What output criteria are used to determine that the output meets the input requirements?
Inputs? Customer wants:
Input requirements. What are the inputs that determine what the process must produce?
Mgt. wants audits conducted per annual schedule. Audits contribute to cont. impr. of QMS
Conduct Internal Audit
Audits completed per annual schedule. Audits contributed to cont. improvement of QMS
Plan
Prepare
Conduct
Mgt. memo to Audit Leader
Internal audit procedure
Cust.-specific audit req’s.
Audit reports (Int./ Ext.)
Process owner feedback reports
Management review minutes
Audit performance results
Report
Follow-up
Measure?
With what key criteria? Measurements/Assessments:
How?
Support processes: (Who helps and how?)
Procedures/work instructions/control documents:
Audits prepared and completed on time
Audit reports error-free, submitted on time
Audit results are used for continual improvement
Process owner and auditee feedback positive
No nonconf. discovered by Reg. and/or Cust.
Doc. and Rec. Control
Management
I.T.
Accounting
Training
Audit Proc., Schedule
ISO 19011:2002
ISO/TS 16949:2002
Cust. Spec. Audit Req.

46. Examples of Support Processes
Training
Calibration
Purchasing
Maintenance
Inventory control
Control of documents
Control of records
Control of NC product
Change control
Manufacturing 52
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47. Management Processes
Management processes are defined as those processes necessary to comply with the requirements of the ISO/TS 16949:2002 standard and/or determined by the needs of the organization with respect to the role of Top Management. 53
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48. Examples of Management Processes
Business planning
Management review
Data analysis
QMS planning
Internal communication
Continual improvement
Corrective action
Preventive action
Employee motivation
Internal auditing 54
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