The document discusses the objectives and requirements of the TS 16949 awareness program conducted on January 4, 2012, aimed at preparing for an audit by emphasizing the importance of quality management systems in the automotive sector. It outlines various clauses of the TS 16949 standard which include quality management system, management responsibility, resource management, product realization, and measurement, analysis, and improvement. Additionally, it highlights documentation requirements, the process approach for QMS development, and the importance of effectively managing interrelated processes for continual improvement.

1. 1
TS 16949 Awareness Program
4th
Jan 2012
On
Refresher Before Audit

2. 2
Objectives of the Session
Objectives of the Session
• Preparedness for the Audit
• Understanding Process Approach of ISO
9001:2008 and additional requirements
of ISO/TS 16949:2009.
• Documentation and Actions required for
implementation
• To Correlate existing process with
Manual
• To take necessary Corrective Actions

3. 3
Goals of Technical
Specification
– Development of fundamental quality systems that provide
continuous improvement,
 emphasizing defect prevention and
 the reduction of variation and waste in the supply
chain
– This TS and customer specified requirements defines
fundamental QMS for those subscribing to this document
– To avoid multiple certification and provide common
approach

4. 4
TS Standard
Requirements of ISO 9001:2008 are in Block
Additional requirements of Automotive Sector are
outside of the block .
Word “ Shall ” : indicates a requirement .
Word “ Should ” : indicates a recommendation.
Word “ Note ” : are for guidance in understanding
or clarifying the associated Requirement
Word “ Such as ” : any Suggestion given are for
guidance only

5. 5
Terms & Definitions as per TS
Std.
Organization - Company implementing QMS ( e.g VEPL )
( Term “Organization” replaces the term “Supplier” used in
ISO9001:2002 )
Supplier - Providing product and/or services to organization
(Shubhneel)
(“Supplier”now replaces the term “Subcontractor” or “Vendor”.
Customer - Customer End User ( BAL, SD, ZF etc )
Product - Result of a Process. (Means Service also)
Site - Location at which value added manufacturing
process
occurs
Procedure – Specified way to carry out an activity or a process
( may be documented or not )

6. 6
TS:16949 Clauses -
TS:16949 Clauses -
• 20 clause concept changed to 5
categories
 1 ) – Quality Management System( QMS )
 2 ) - Management Responsibility –
 3 ) – Resource Management –
 4 ) – Product Realization
 5 ) – Measurement , Analysis and Improvement

7. 7
TS 16949 & QS 9000 Clause -
TS 16949 & QS 9000 Clause -
• 4.0 ( Quality Management System )
- 4.5 , 4.16
Control of Documents
Engineering Specification
Control of Records & Record Retention
Quality Manual

8. 8
TS 16949 & QS 9000 Clause
TS 16949 & QS 9000 Clause
• 5.0 ( Management Responsibility )
 Management Commitment
 Quality Policy,Objectives
 Responsibility , Authority &
Communication
 Management Review

9. 9
TS 16949 & QS 9000 Clause
TS 16949 & QS 9000 Clause
• 6.0 ( Resource Management ) - 4.18
 Human resources ( Competence , Awareness,Training )
 Infrastructure- Plant, Facility , Equipment planning,Contingency
Plan
( Building, Hardware-Machine,Equipment ), Utilities,
Software, Checking Aids ,Transportation &
Communication Means )
 Work Environment – Personal safety to achieve product
Quality & Cleanliness .
( Lighting,Temperature,Noise,Humidity, Dust , Smoke ,
Personal Protective Equipment ( PPE ) , Safety
Equipment & House Keeping )

10. 10
TS 16949 & QS 9000 Clause
TS 16949 & QS 9000 Clause
• 7.0 ( Product Realization ) - 4.2, 4.3, 4.4,
4.6,4.7 ,4.8+ 4.12 , 4.9+ 4.19 , 4.10
( Incoming ) ,4.11 , 4.15
 Planning of Product Realization ( APQP )
 Customer Related Process ( Contract Review )
 Design & Development ( APQP & PPAP )
 Purchasing ( Incoming Product Quality ,
Supplier Development & Rating )

11. 11
TS 16949 & QS 9000 Clause
TS 16949 & QS 9000 Clause
• 7.0 ( Product Realization )
 Production & Service Provision ( Process
Control ,Maintenance ,Tooling Management ,PPC
& Dispatch ,Validation of Process ,Identification &
Trace ability ,Customer Supplied Product ,Stores)
 Control of Monitoring & Measuring Devices ( MSA
, Calibration & Lab Management )

12. 12
TS 16949 & QS 9000 Clause
TS 16949 & QS 9000 Clause
• 8.0 ( Measurement , Analysis & Improvement ) –
4.1 ( Customer Satisfaction , Analysis of Data ) ,
4.2 ( Continuous
improvement ),4.13 ,4.14 ,4.17 ,4.20 , 4.10 (final
Inspection )
 SPC
 Monitoring and Measurement ( Internal
Audit ,Customer Satisfaction,Process & Product
Audit ,Lay out )

13. 13
TS 16949 & QS 9000 Clause
TS 16949 & QS 9000 Clause
• 8.0 ( Measurement , Analysis &
Improvement ) –
 Control of Non conforming Product (
Rework & Customer information )
 Analysis of data
 Improvement ( Continual
Improvement , Corrective & Preventive
Action , Customer Complaint ,)

14. 14
Documentation Requirements
Example -
• Business Plan
• Calibration procedures
• Control Plan
• Customer Specific Requirements
• Engineering Drawings & Standard
• Industry Standard where
applicable
• Inspection Instructions
• Job Description requirements , for
education Qualification & training

15. 15
Documentation Requirements
Example
• Job setup sheets
• Material Specifications
• CAD data
• Operating Procedure ( W.I , Test
Procedures )
• Process Flow charts or Description
• Quality Assurance Procedure
• Quality Manual , Policy

16. 16
Process Approach Required-
 To improve customer satisfaction by meeting
customer requirement .
 During -
 Developing of a QMS.
 Implementing the QMS
 Improving the effectiveness of a QMS .

17. 17
Understanding the Process
Approach
• Process – Set of inter related or interacting
activities , which transforms input into output .
 Input & Output Can be -
 Material
 Component
 Equipment
 Energy
 Information
 Resources etc .

18. 18
Understanding the Process
Understanding the Process
Approach
Approach
• Guidance on the Process Approach to QMS
– Outputs from one process can be input of other subsequent processes
PROCESS A PROCESS C
PROCESS B Inputs to
Process C
Outputs from
Process C
Inputs to
Process A
Inputs to
Process B
Outputs from
Process A
Outputs from
Process B
CHAIN OF INTER- RELATED PROCESSES
MEASUREMENT OPPORTUNITIES
MONITORING AND
(Before, during and after the process)

19. 19
Process Approach -
For Process Approach –
organization must identify and
manage numerous interlinked
processes to function effectively.
Identification & Management of
processes with in organization
( interactions between processes )
is the Process Approach.

20. 20
Process Approach
• Process Approach consistent with Plan , Do ,
Check , Act ( PDCA ) improvement cycle.
 Define the Work ( Plan )
 Execute the Work ( Do )
 Measure the Results ( Check )
 Identify the improvement ( Act )

21. 21
Process Approach
Process Approach
Customers Management
Responsibility
Resource
management
Measurement,
analysis and
improvement
Requirements
Satisfaction
Product
Continual Improvement of the Quality
Management System
INPUT OUTPUT
Product
realization
Customers

22. 22
Understanding System Approach to
Understanding System Approach to
Management
Management
5. Top Management Processes
Examples
• Process to define quality policy
and objectives
• Communication Process
• Management Review
6. Resource Management
Processes
Examples
• Determination and provision of
resources
• Human resources
• Infrastructure and definition
• Work environment definition
8. Measurement, Analysis and
Improvement Processes
Examples
• Processes to demonstrate
•Conformity of product
•Conformity of management
system
•Continual improvement
7. Product Realization Processes
Examples
• Planning
• Customer related processes
• Design & Development process
• Purchasing process
• Production & service provision
• Control of monitoring and
measuring devices
4. Quality
Management System
Processes

23. 23
Importance of Process
Approach
 Ongoing Control
 Desired results achieved
more efficiently when
activities and related
resources are managed
as a process .

24. 24
Importance of Process
Approach
 Understanding & Meeting requirement
easily.
 Obtaining Results of Processes
Performance in terms
of Effectiveness & Efficiency of the
process .
 Continual improvement of Process
based on objectives
/ objective Measurement .

25. 25
Effectiveness & Efficiency
EFFECTIVENESS
OF PROCESS =
Ability to achieve
desired results
( Focus of ISO
9001:2002 )
EFFICIENCY OF
PROCESS =
Results achieved
Vs resources used
( Focus of
ISO/TS 16949:2008 )

26. 26
Process Approach ( Turtle Diagram )
Controls –
W.I ,Standard,Spec.,
Procedure,Guidelines,
Operation Sheet ,
Drawing
Name of the Process
Output of the Process-
-Finished product or
-updated or modified
information
Monitoring &
Measurement
-Effectiveness
-Efficiency Parameter
Resources Required
- Infrastructure
- Work Environment
-Competent Manpower
Interfaces Support / Process
- Interrelated Department
Input of the Process
-Material or
-Information
Competency Skill Required

27. 27
Thanking You
Target -TS Surveillance Audit with Zero NC