SHYAM JI TRIVEDI

Need for Revisions to Standards

ISO Protocol requires 5 years
Current 20 element model oriented towards manufacturing
sector.
Need for driving process oriented management
Evolving customer/consumer/end-user needs
Expectation from the standard to help move beyond
certification towards performance improvement.
Compatibility between ISO 9001 and ISO 9004.
Difficulties experienced by small business, especially in terms
of documentation
Proliferation of guideline standards
Confusing supply chain terminology

Year 2000 QMS Standards

Earlier versions of ISO 8402 and ISO 9000 replaced by ISO 9000:2000

Earlier version of ISO 9001, ISO 9002 and ISO 9003 replaced by ISO
9001:2000
Earlier version of ISO 9004 replaced by ISO 9004:2000
Goal of this Technical Specification

The goal of this technical specification is the development
of a quality management system that provides for continual
improvement, emphasizing defect prevention and the
reduction of variation and waste in the supply chain .

The technical specification, coupled with applicable
customer-specific requirement, defines the fundamental
quality management system requirements for those
subscribing to this document.

This technical specification is intended to avoid multiple
certification audits and provide a common approach to a
quality management system for automotive production, and
relevant service part organization.
TS 16949 : 2006



FORMATION OF TASK FORCE IN 1995 BY THE
AUTOMOTIVE MANUFACTURERS OF USA, FRANCE,
GERMANY AND ITLY TO HARMONISE QUALITY SYSTEM
REQUIREMENTS.

ISO/ TS 16949:2002 WAS PREPARED BY IATF
(INTERNATIONAL AUTOMOTIVE TASK FORCE, JAPAN
AUTOMOBILE MANUFACTURES ASSOCIATION (JAMA)
AND REPRESENTATIVES FROM ISO/TC176, QUALITY
MANAGEMENT AND QUALITY ASSURANCE, AND ITS
SUBCOMMITTEES.

RELEASE OF TS 16949 AS A STANDARD IN THE YEAR 1999
ISO/TS 16949:2006 has been released subsequently

EVALUATION OF ISO/TS 16949


VDA 6.1
(Germany)
QS 9000
(USA)
AVSQ94
(ITALY)

EAQF94
(FRANCE)

ISO/TS 16949
IATF
INTERNATIONAL AUTOMATIVE TASK FORCE


INCLUDES

OEMS BMW, DIAMLER CHRYSLER, FIAT, FORD, GENERAL
MOTORS, PEUGEOT, VOLKSWAGEN.
TRADE ASSOCIATIONS
ANFIA- ITALY (Association National Far /industries Automobilist)
AIAG-USA. (Automotive Industry Action Group)
CCFA-FRANCE (Comate des constructers Franois d Automobile)
FIEV- FRANCE (Federation des Industries des Equipments pour
Vehicles)
SMMT LTD. UK (Society of motor manufactures and traders Ltd.)
VDA-GERMANY ( Verb and deer Automobilindustrie)
BENEFITS OF GETTING
ISO/TS 16949 CERTIFICATION


Improved Product and Process quality.
Provide additional confidence for global
sourcing.
Freeing up supplier resources for other
quality activities.
Common quality system approach in the
supply chain.
BENEFITS OF GETTING
ISO/TS 16949


Reduction of variation and increased
efficiency.
Reduction in 2
nd
part system audits
Reduction in multiple 3
rd
party
registrations
Common language to improve
understanding of quality requirements
Process Approach
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.
For an organization to function effectively, it has to
identify and manage numerous linked activities. An activity
using resources, and managed in order to enable the
transformation of inputs into outputs, can be considered as a
process. Often the output from one process directly forms
the input to the next.
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

An advantage of the process approach is the ongoing control
that it provides over the linkage between the individual processes
within the system of processes, as well as over their combination
and interaction.

When used within a quality management system, such an
approach emphasizes the importance of :-

Understanding and meeting requirements,

The need to consider processes in terms of added value

Obtaining results of process performance and
effectiveness,and

Continual improvement of processes based on objective
measurement.
PROCESS APPROACH

The model of a process-based quality management
system shown below, illustrates the process linkages
presented in clause 4 to 8 of this international standard.
This illustration shows that customers play a significant
role in defining requirements as inputs. Monitoring of
customers satisfaction requires the evaluation of
information relating to customer perception as to
whether the organization has met the customer
requirements. The model shown below covers all the
requirements of this international Standard, but does
not show processes at a detailed level.
Continual Improvement of
the Quality Management System
Customers
Requirements
Customers
Satisfaction
Management
Responsibility
Resource
Management

Measurement,
Analysis and
improvement

Product
Realization
Product
Key
Value-adding activities
Information flow
Model of a process-based
quality management system
Input
Output
WHAT IS A PROCESS


PROCESS :
Any activity or group of activities that
takes an input, adds value to it, and provides an
output to an Internal or External Customer.
Processes use an Organizations Resources to
provide Definitive Results.
WHAT IS PROCESS ?


PROCESS :
1. Is a chain of value added activities.
2. Delivering a product or a service to a
customer (Internal or External) of the process


A Process has a start and end defined by two limits

INPUT OUTPUT
Customer who has a need Customer who has a
WHAT IS PROCESS ?



And a chain of activities between these two limits
INPUT
STEP
1
STEP
2
STEP
3
STEP
n
OUTPUT
PROCESS ANALYSIS



1. CUSTOMER ORIENTED PROCESS :
(COP)

Any process that comes into physical contact with
the hardware or software that will be delivered to
a customer, up to the point the product is
Packaged.
CUSTOMER ORIENTED PROCESS
(COP) :


Key Question
How does an organization develop effective
and efficient COP s ?

Answer:
Support Processes

ANALYSIS OF A COP :

O
DEPARTMENT A

ACTIVITY 1
ACTIVITY 2
ACTIVITY 3
ACTIVITY 4

SUPPORT
PROCESSES
I
WHAT IS A PROCESS ?



12 SUPPORT PROCESS (SOP) :

All service Processes and Processes that
support customer Oriented Processes.
A Support process consists of a group of
Logically
related tasks that use the Resources of the
Organization to provide Defined Results in
support of the organization's Objectives.
EXAMPLE
S
???
WHAT IS PROCESS ?




3. MANAGEMENT PROCESS (MP) :

All such processes which establish the policy,
objectives and goals, provide necessary and
adequate resources and actions to achieve the
same
EXAMPLES
???
List of typical business processes in a COMPANY


Market Survey,
Product Launch,
Product & Process Design
Purchasing
Manufacturing
Calibration
Inspection
Dispatch
Plant &Equipment Control
Recruitment & Training
Operation Review, Sales Review, Quality, Review,
Supplier Review.
PROCESS APPROACH



SYSTEMATIC IDENTIFICATION AND MANAGEMENT
OF THE VARIOUS PROCESSES EMPLOYED WITHIN AN
ORGANIZATION,

AND PARTICULARLY

THE INTERACTIONS BETWEEN SUCH PROCESSES, IS
REFERRED TO, AS THE PROCESS APPROACH TO
MANAGEMENT
PROCESS APROACH


All well defined and well-managed processes have
common characteristics:

A well-defined team with a leader is held accountable for how
well the process performs (the process owner)
Well defined boundaries (the process scope)
Well defined interfaces and responsibilities
Well documented procedures, work instructions and training.
Well defined measurement and feedback controls
Customer related measurements and targets
Well known cycle times.
ESTABLISH
QUALITY POLICY
SET QUALITY TARGET
M.S. PLANNING APPOINT M.R.
CONTROL OF MANAGEMENT RESOURCES
REVIEW & UPDATE M/S REPORT MS RESULT
IMPLEMENT MS
Conti..
MANAGEMENT
PROCESS
MARKET SURVEY
ACCEPT ORDER
REPORT
PRODUCTION PLAN
XYZ, R&D, JAPAN
PURCHASING
RECEIVE PRODUCT DRG.
SPECIFICATION, TOOLING
MANUFACTURING INSPECTION PKG/STORE DESPATCH
CUSTOMER ORIENTED
PROCESS
Conti..
E.G. FOR

PROCESS TO
PROCESS
INTERRELATION
CONTROL OF MEASURING & MONITORING DEVICE
EDUCATION / TRAINING
CONTROL OF DOCUMENTS/RECORDS
CUSTOMER SATISFACTION
SURVEY
INTERNAL QUALITY AUDIT
CORRECTIVE ACTION / PREVENTIVE ACTION
NONCONFORMITY/
MARKET CLAIM
PROCESS
SUPPORTING
PROCESS
Compatibility with other management systems

This international standard has been aligned with ISO
14001:1996 in order to enhance the capability of the two
standards for the benefit of the user community
This international standard does not include
requirements specific to other management systems such as
those particular to environmental management,
occupational health and safety management, financial
management or risk management. However, this
international standard enable an organization to align or
integrate its own quality management system with related
management system requirements. It is possible for an
organization to adapt its existing management system(s) in
order to establish a quality management system that
complies with the requirements of this international
standard.
TERMS AND DEFINITIONS USED IN
ISO / TS 16949 : 2002

Control Plan
Documented description of the systems and processes
required for controlling product

Design Responsible Organization
Organization with authority to establish a new, or change
an existing, product specification

NOTE : This responsibility includes testing and verification of
design performance within the customers specified application.





Error Proofing
Product and manufacturing process design and
development to prevent manufacture of nonconforming
products.

Laboratory
Facility for inspection, test or calibration that may include,
but is not limited to, chemical, metallurgical, dimensional,
physical, electrical or reliability testing.

Laboratory Scope
Controlled document containing
Specific tests, evaluations and calibrations that a laboratory is
qualified to perform.
List of equipment which it uses to perform the above, and
List of methods and standards to which it performs the above


Manufacturing
Process of making or fabricating
Production Material
Production of Service Parts
Assemblies, or
Heat treating, Welding, Painting, Plating or other finishing
services

Predictive Maintenance
Activities based on process data aimed at the avoidance of
maintenance problems by prediction of likely failure modes.

Preventive Maintenance
Planned action to eliminate causes of equipment failure and
unscheduled interruptions to production, as an output of
the manufacturing process design.



Premium Freight
Extra costs or charge incurred additional to contracted
delivery
NOTE : This can be caused by method, quantity, unscheduled
or late deliveries, etc.

Remote Location
Location that supports site and at which non-production
processes occur.

Site
Location at which value-added manufacturing processes
occur.
Special Characteristics
Product characteristics or manufacturing process
parameters which can affect safety or compliance with
regulations, fit function, performance or subsequent
processing of product.
Active Part
An active part is one currently being supplied to the
customer for original equipment or service applications.
The part remains active until tolling scrap authorization is
or service applications. The part remains active until
tooling scrap authorization is given by the appropriate
customer activity. For parts with no customer-owned
tooling or situations where multiple parts are made from
the same tool. Written confirmation from Ford Engineering
and the Buyer is required to deactivate a part.
Aftermarket Parts
Replacement parts not produced or released by Ford
Motor Company for service part applications which may
or may not be produced to original equipment
specifications

Capacity Verification
A verification methodology to demonstrate that an
organization can meet the capacity planning volume
requirements as defined in the purchasing request for
Quote (RFQ)
Customer
For the purpose of ISO/TS 16949:2002, References to
Customer in this document shall be interpreted as the
entity, e.g. Ford Motor Company, Which is both purchasing
and receiving product from the organization complying
with ISO/TS 16949:2002
Ergonomics
Ergonomics is the evaluation of the design of a product or
process to assure compatibility with the capabilities of
human beings. Analysis of motion refers to capabilities of
people with respect to tasks (e.g. lifting, twisting, reaching)
to prevent or relieve problems of strain, stress, excessive
fatigue, etc. Factors involved include anatomical
dimensions of the worker, placement to be worked upon,
placement of buttons/Switches, Physical loads imposed on
the worker, and environmental effects such as noise,
vibration, lighting and space.
Initial Process Study
Initial process studies are conducted to obtain early
information on the performance of new or revised processes
relative to internal or customer requirements. In many cases,
Initial Process studies should be conducted at several points in
the evolution of new processes (e.g. at the equipment for
tooling subcontractors plant, and after installation at the
organizations plant). These studies should be based on
variables data evaluated using statistically valid methods.

NOTE : The following terms used in this standards to describe
the supply chain
Supplier Organization
Customer
The terms organization replaces the terms supplier used
in QS- 9000:1998, and refers to the unit to which this
international standard applies. Also the terms supplier now
replace the terms subcontractors

Organization
Facility adding manufacturing value to production materials;
providers of production or service parts, or heat treating,
plating, painting or other finishing services, directly to Ford
Motor Company.

NOTE 1 : For the purpose of registration under ISO/TS
16949:2002 the Organization is the entity normally
referred to by Ford as the supplier supplier . Ford Motor
Company will continue to use that term when negotiating with
the organization.

NOTE 2 : To avoid additional confusion although the terms
supplier is used by ISO/TS 16949:2002 to indicate
subcontractor, Ford Motor Company will continue to use
the term subcontractor in its normal usage.


NOTE 3 : Full service supplier also provide engineering
services. Program specific Engineering Statement of work
defines engineering responsibilities.

NOTE 4 : Sequencing warehouses and other facilities not
adding manufacturing value to the product are not eligible for
stand-alone registration to ISO/TS 16949:2002.

PPM
PPM (parts per million) is a method or stating the
performance of a process in terms of actual nonconforming
material. PPM data can be used to prioritize corrective
actions. Definition of defective units varies with customer
(e.g. All sorted, only those found to be wrong, all in box).
QUALITY MANAGEMENT PRINCIPLES
&
PDCA

Principles of Quality Management

To lead and operate an organization successfully, it is
necessary to direct and control it in a systematic and
transparent manner.
Managing an organization encompasses quality
management amongst other management disciplines.
Eight Quality management principles have been identified
and they from the basis ISO 9001:2000 / TS 16949 : 2002
standard.

Principles 1

Customer-Focused Organization

Organization depend on their customers and therefore
should understand current and future customer needs, meet
customer requirements and strive to exceed customer
expectations

Principles 2

Leadership

leader establish unity of purpose and direction of the
organization. They should create and maintain the internal
environment in which people can become full involved in
achieving the organizations objectives

Principles 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
organizations benefit

Principles 4

Process approach

A desired results in achieved more efficiently when related
resources and activities are managed

Principles 5

Systems approach to management

Identifying understanding and managing a system of
interrelated processes for a given objective improves the
organizations effectiveness and efficiency

Principles 6

Continual Improvement

Continual improvement should be a permanent objective
of the organization

Principles 7

Factual approach to decision making

Effective decisions are based on the analysis of data and
information

Principles 8

Mutually beneficial supplier relationship

An organization and its suppliers are interdependent, and
a mutually beneficial relationship enhance the ability of both
to create value
SUMMARY OF CHANGES
ISO9001:2000 BASED



1. PROCESS APPROACH INTRODUCED:

FOCUS BUSSINESS PROCESSES

ESTABLISH INPUTS TO & OUTPUT FROM

GENERATE DIRECTIONS (SEQUENCE) OF FLOW

ESTABLISH INTERRELATION

MEASURE PROCESS CAPABILITY
FOR EFFECTIVE
& TARGET
DIVISION
MANAGEMENT
MOST
IMPORTANT!!!
SUMMARY OF CHANGES
ISO9001:2000 BASED


2. QUALITY OBJECTIVES

S.M.A.R.T.


TO IMOLEMENT
IMPROVEMENT
INITIATIVES
STRATEGI
C
MEASURABLE
ACHEIVABL
E
RELEVANT
TARGETED
KPI!
SUMMARY OF CHANGES
ISO9001:2000 BASED




3. COMMUNICATION

INTERNAL

WITH CUSTOMER


SYSTEM EFFECTIVENESS
PRODUCT INFORMATION
ORDER MANAGEMENT
Info Tech/EDP
Processes
In QM Scope

SUMMARY OF CHANGES
ISO9001:2000 BASED





4. CUSTOMER SATISFACTION



PROACTIVE
APPROACH FOR
TAKING PREVENTIVE
ACTION
VOC!!
ISO/TS16949 : 2006
ELEMENT LISTINING

ISO/TS 16949:2006




ISO/TS 16949:2000 concepts





Action elements for ISO9000:2000 is based
On 5 key Elements
Element 4 to 8

ISO/TS 16949:2000 concepts





5 key element can be divided into
System based :
Elements
4,5 and 6

Operational
(Product Centered)
Element 7 and 8


ISO/TS 16949 :2002





ISO/TS SPECIFIC REQUIREMENTS

ISO/TS 16949 :2002





4.1.1 General Requirements- Supplemental
The organization shall be responsible for the
conformity to all customer requirements in case of
outsourced processes
Process not to be confused with
manufacturing process????
E.g. Calibration/Maintenance

ISO/TS 16949 :2002





4.2.3.1 Engineering Specifications

Timely review (shall not exceed two working weeks) of all
customer engineering standards and changes.
Maintain record of Implementation date in production
Update all appropriate documents. (E.g PPAP documents
viz Control plan FMEAs etc

E.g PPAP document viz Control Plan, FMEAs etc

ISO/TS 16949 :2002





4.2.4.1 Record Retention
Shall satisfy regulatory and customer requirements.





Homologation

ISO/TS 16949 :2002





5.1.1 process Efficiency
Top management shall review.
Product Realization Process (Element 7.0)
Support Processes???
Assuring Effectiveness and Efficiency.


MIS?KPIs does it reflect only
Efficiency???? Or Effectiveness????
Or Both????
Not to be Confused
With product
Realization/APQP
In 1999 version

ISO/TS 16949 :2002





5.4.1.1 Quality Objectives - Supplemental

Top management shall :
Shall define the goals and the measurable
Shall be referenced in the business
Shall be referenced in the business.


Quality objectives should link to customer
expectations and achievable within a defined time
period

ISO/TS 16949 :2002





5.4.1.1 Quality Objectives - Supplemental


Management with responsibility and authority for corrective
action shall be Promptly informed or products and processes which
do not conform to requirements


Quality responsibility personnel needs to be identified. He shall
have authority to stop production to correct quality problems.

Shift resources especially concerning the production shall be
staffed with personnel in charge of quality.


Who is responsible for quality????

ISO/TS 16949 :2002





5.5.2.1 customer Representative


Management with responsibility and authority for corrective
action shall be Promptly informed or products and processes which
do not conform to requirements


Quality responsibility personnel needs to be identified. He shall
have authority to stop production to correct quality problems.

Shift resources especially concerning the production shall be
staffed with personnel in charge of quality.


Who is responsible for quality????

ISO/TS 16949 :2002





5.5.2.1 customer Representative


Customer Representative shall be identified to represent
the needs of the customer
Needs to include:
Selection of special Characteristics
Setting quality Objectives
Related Training
Corrective action and preventive actions
Product design and development

ISO/TS 16949 :2002





5.6.1.1 QMS Performance


Review performance trends and link to continual improvement
process.
Review shall include all requirements of the quality systems
Part of Management review shall be the monitoring of quality
objectives and evaluation of the cost of poor quality.
Evidence of achievement pertaining to
Objectives specified in the business plan
Customer satisfaction with product supplied

ISO/TS 16949 :2002





5.6.2.1 Review Input - Supplemental


Shall include :
Analysis of actual and potential field failures.
Impact on Quality, safety and environment

FMEAs???

ISO/TS 16949 :2002





6.6.2.1 Product Design Skills


Applicable tools and techniques shall be identified by the
organization
Personnel in product design are competent?? And have
requires skills in the applicable tools and techniques

Will experience be enough??
Or should include
Qualification/Certifications
for the skill

ISO/TS 16949 :2002





6.6.2.2 Training


Establish and maintain documented procedure for.
Identify Training Needs
Achieving competence of all personnel performing
activities affecting product quality
Personnel performing specific assigned task shall be
qualified with particular attention to the satisfaction of
customer requirements.

Applies to all employees having effect on quality
E.g. of customer specific req. is the application of
digitized mathematically based data

ISO/TS 16949 :2002





6.6.2.3 Training on the job


On job training for personnel in new or modified job
affecting quality.

Consequences incurred by customer in case of non
conformities.

Personnel affecting quality needs to be informed of the
consequences.

Include contract or agency personnel.

Process Operators???

ISO/TS 16949 :2002


6.2.2.4Employee motivation and empowerment


Shall have a process for motivation of employee.
To achieve quality objectives
To make continuous improvements
To create an environment to promote innovation
Shall include promotion of Quality and Technological
Awareness on all levels
Shall have a process to measure the extent to which its
personnel
Are aware of the relevance and importance of their activities
Aware of how they contribute to the achievement of the quality
objective

NEW

ISO/TS 16949 :2002


6.3.1 Plant, Facility and Equipment Planning


Use multidisciplinary approach.
Plant layout to optimize material travel and handling.
Synchronous Material Flow
Maximize Value Added Use of Floor Space

Methods to evaluate and monitor the effectiveness of existing operations
and processes shall be developed and implemented.
These requirements should focus on lean manufacturing
principles and the link to effectiveness of the QMS
Red underlined
is new

ISO/TS 16949 :2002


6.3.2 Contingency Plans


To safety customer requirements in the event of
emergency

Emergency Includes utility interruptions, labour
shortages, key equipment failure and field returns.

May involve visit to Dealers/Service
to replace a defective part????

ISO/TS 16949 :2002


6.4.1 Personnel Safety to achieve product Quality


Due care regarding product safety

Means to minimize potential risk to employees shall be
addresses especially in design control and progress control

ISO/TS 16949 :2002


6.4.2 Cleanliness of premises


Maintain its premises in a state of order, cleanliness and
repair

Shall be consistent with the product and manufacturing
process needs.
Dust free???? Temperature and
humidity control?????

ISO/TS 16949 :2002


7.1.1 Cleanliness of premises


Needs to reference customer requirements and from as a
component of the quality plan



ISO/TS 16949 :2002


7.1.2 Acceptance criteria


Accurate criteria shall be defined by the Organization
and approved by the customer.

For attribute data sampling, the acceptance level shall
be zero defects.



ISO/TS 16949 :2002


7.1.3 Confidentiality


Shall ensure the confidentially of customer related
products and projects under developments.

Includes related product information.


ISO/TS 16949 :2002


7.1.4 Change Control


Shall have a process to control and react to change that
impact product realization.
Shall be linked to verification/validation to ensure
compliance with customer requirements.
Shall include changes caused by supplier.
Synchronous Material Flow
Maximize Value Added Use of Floor Space
Shall demonstrate conformity to customer requirements
for designation, documentation and control of special
characteristics.
ISO/TS 16949 :2002


7.2.1.1 Customer-designated special characteristics


Shall demonstrate conformity to customer
requirements for designation, documentation and
control of special characteristics.
ISO/TS 16949 :2002


7.2.2.1 Review of requirements related to the product-Supplemental


Waiving the requirements stated in contract review (e.g.
internet salves where formal review is impractical) shall
require customer authorization.
ISO/TS 16949 :2002


7.2.2.2 Organization manufacturing feasibility


Shall investigate, confirm and document the
manufacturing feasibility of the proposed products in the
contract review process.
Shall include risk analysis.
Statutory/regulatory violations???
Manufacturing environment????
ISO/TS 16949 :2002


7.2.3.1 Customer Communication-Supplemental


Shall communicate necessary information, including
data in a customer specified language and format
ISO/TS 16949 :2002


7.3 Design and Development


This covers both product and manufacturing process design

Focus on error prevention rather than detection
ISO/TS 16949 :2002


7.3.1.1 Multidisciplinary approach


Use of MFT during the product realization stages especially
related to
Development/Finalization and monitoring of special
characteristics,
Development and review of FMEa including actions to
reduce potential risk
Development and review of control plan
Focus on error prevention rather than detection
MFT includes design, manufacturing,engineering,
quality, production and appropriate personnel
ISO/TS 16949 :2002


7.3.2.1 Product Design Input


Design inputs needs to reference targets for product quality,
life, reliability, durability and maintainability, timing and cost

Needs to have a information systems to review the previous
design projects and competitor analysis, supplier feedback,
internal input, field data for current and future projects of
similar nature.

Customer requirements E.g. special characteristics,
identification and traceability and packaging.
ISO/TS 16949 :2002


7.3.2.2 Manufacturing process design input


Process design input requirements to be documents to be
documented, reviewed and include.

Product design output data

Targets for productivity, process capability and cost
Customers requirements
Experience from previous developments
Shall include product characteristics and process parameters
ISO/TS 16949 :2002


7.3.3.2 Manufacturing process Design output


Specifications and drawings.
Manufacturing process flow chart/layout
Process FMEAs
Control plans/job instructions
Process Approval acceptance criteria-
Data for quality, reliability, maintainability and
measurability
Results of mistake-proofing activities
Methods of rapid detection and feedback of product/process
non conformities
ISO/TS 16949 :2002


7.3.4.1 Monitoring


Should be defined at appropriate stages, analyzed and
reported as an input to the management review.
Includes Quality risks, costs, lead-
times, critical paths
ISO/TS 16949 :2002


7.3.6.1 Design and Development Validation- Supplemental


Shall be as per Customer requirements including
programme timing
ISO/TS 16949 :2002


7.3.6.2 Prototype Programme


Prototype programme when required by the customer
Use of same supplies, tooling and processes as will be used
in production
Monitoring of testing activities for timely completion and
conformance to requirements
Services may be outsourced.
ISO/TS 16949 :2002


7.3.6.3 Product approval process


Use product and manufacturing process approval procedure
recognized by the customer
Shall also be applied to suppliers
Product approval should be subsequent to the
verification of the manufacturing process
ISO/TS 16949 :2002


7.4.1.1 Regulatory conformity


All purchased products or material used in product shall
conform to applicable regulatory requirements
Includes consumables
Grease/Oil??? Raw material
ISO/TS 16949 :2002


7.4.1.2 Supplier Quality Management System Development


Quality system development with the goal of compliance to
TS or an existing customer Quality System manual.
Conformity with ISO 9001:2000 is the first step in achieving
this goal.
1. The prioritization of suppliers for development depends upon supplier
performance and importance of the product supplied
2. Third party audit to ISO9001:2000 if not specified by the customer
ISO/TS 16949 :2002


7.4.1.3 Customer Approved Sources


If specified in the contract (including
drawing/specifications.) the organization shall purchase
products, material or services from approved sources
ISO/TS 16949 :2002


7.4.3.1 Incoming product quality


Receipt and evaluation of statistical data
Receiving inspection and /or testing
Second or third party assessments or audits of supplier sites,
when coupled with records of acceptable delivered product
quality
Part evaluation by accredited labs
Another method agreed with the customer
ISO/TS 16949 :2002


7.4.3.2 Supplier Monitoring


Following indicators shall be used
Delivered product quality
Customer disruptions including field returns
Delivery schedule performance (including incidents of
premium freight)
Special status customer notifications related to quality or
delivery issues.
Shall promote supplier monitoring of the performance of their
manufacturing processes
ISO/TS 16949 :2002


7.5.1.1 Control Plan


At system, subsystem, component, material level for the
product supplied
Shall Cover Pre-launch and production Phases
Shall link to design FMEA and manufacturing process
FMEA output
ISO/TS 16949 :2002


7.5.1.1 Control Plan


Shall list the controls used for manufacturing process control
Include for monitoring related to special characteristics.
Include the customer required information
Initiate the specified reaction plan when the process becomes
unstable or not statistically capable.
Shall be reviewed when any change occurs affecting product,
manufacturing process, measurement, logistics, supply sources or
FMEA

Customer approval may be required after review or
updated of the control plan
ISO/TS 16949 :2002


7.5.1.2 Work Instructions


Work instructions for all employees having responsibilities for the
operation of processes that impact product.
Shall be accessible for use at the work station
Shall be linked to Quality plan, the control plan and the product
realization process.

Quality plan and control plan??? Any
differences????
ISO/TS 16949 :2002


7.5.1.3 Verification of job set-ups


Verify whenever a set up is done (initial run, material changeover, job
change, significant time period, etc..)
Job instruction for set up personnel
Use of statistical methods of verification

Last off part comparisons are recommended
ISO/TS 16949 :2002


7.5.1.4 Preventive and Predictive maintenance


Identify key process equipment
Develop an effective planned total preventive maintenance
and shall include
Planned maintenance activities.
Packaging and preservation of equipment, tooling and gauging
Availability to replacement parts for key manufacturing equipment
Documenting, evaluating and improving maintenance objectives
Use predictive maintenance methods (Noise level of brg.
Vibration, contamination level of fluids, etc.,) to improve
effectiveness and efficiency of production equipment.

ISO/TS 16949 :2002


7.5.1.5 Management of Production Tooling


Provide resources for tool and gauge design, fabrication and
verification activities.
Tool design, manufacturing and modifications, if any including
documentation
Planned preventive maintenance and repair facilities
Storage and Recovery
Set up
Tool change programs for perishable tools
Tool identification, defining the status such as production,
repair or disposal
Track & follow up in case of outsourcing

ISO/TS 16949 :2002


7.5.1.6 Production Scheduling



Shall meet customer requirements.

Information system that permits access to production
information at key stages of the process and is order driven

ISO/TS 16949 :2002


7.5.1.7 Feedback of information from service



Communication On service concerns internally to
manufacturing, engineering and design activities shall be
established and maintained
This is to certify that the organization is
aware of nonconformities that occur
external to its organization
ISO/TS 16949 :2002


7.5.1.8 Service agreement with customer



Verify the effectiveness of

Any organization service centers

Special purpose tools

Training of servicing personnel
ISO/TS 16949 :2002


7.5.4.1 Customer- owned production tooling



Customer owned tools, manufacturing test, inspection tooling
and equipment shall be permanently marked.
Note added to 7.5.4 Customer property Includes
customer owned returnable packaging
ISO/TS 16949 :2002


7.6.1 Measurement system analysis



Applies to measurement system referred in control plan.

Appropriate statistical studies E.G. Bias, Linearity, Stability,
Repeatability and reproducibility etc.

The analytical methods and acceptance criteria used shall
conform to customer reference manuals on MSA
ISO/TS 16949 :2002


7.6.2 Calibration/Verification records



Shall cover employee and customer owned equipment
Records of calibration/Verification activity shall
include
Equipment identification including the masters
Revision following engineering changes
Out of specifications readings and an assessment of the impact
Statements of conformity to specification after
calibration/Verification
Notification to customer in case of shipment of suspect
product/material

ISO/TS 16949 :2002


7.6.3.1 Measurement system analysis



The laboratory shall specify and implement
Laboratory procedures
Competency of the laboratory personnel Testing of products
Capability to perform these services correctly and review of
the related
Accreditation to I SO/I EC 17025 may be used to
demonstrate supplier in-house laboratory
conformity but is not mandatory
ISO/TS 16949 :2002


7.6.3.2 External Laboratory


Covers External, commercial and independent laboratory.
Shall have a defined lab.Scope and includes the capability to
perform testing/calibration and other:
Evidence that the external laboratory is acceptable to the
customer
The laboratory shall be accredited to ISO/IEC 17025 or
national equipment
1. Customer assessment or customer approved second party
assessment may be used.
2. In case qualified lab is not available then such services
can be performed by an equipment manufacturer
provided internal lab. Requirements are satisfied

ISO/TS 16949 :2002


8.1.1 Identification of Statistical tools


Identify appropriate statistical tools
Link through Advance quality planning and included
in control plan
ISO/TS 16949 :2002


8.1.2 Knowledge of basic statistical concepts


Understanding of basic statistical concepts E.g.
verification, control, process capability
ISO/TS 16949 :2002


8.2.1.1 Customer satisfaction-supplemental


Customer satisfaction needs to monitored through performance
indicators:
Delivered part quality performance
Customer disruptions including field returns
Delivery schedule performance (including incidents of premium
freight)
Customer notifications related to quality or delivery issues
Monitor the performance of manufacturing processes to
demonstrate compliance with customer requirements for
product quality and efficiency
Supported by Objective information
ISO/TS 16949 :2002


8.2.2.1 Quality Management System audit


Audit for compliance to TS standard.

Audit for any other additional QMS requirements.

What could this
mean???
ISO/TS 16949 :2002


8.2.2.2 Manufacturing process unit


Audit each manufacturing process to determine its
effectiveness.

ISO/TS 16949 :2002


8.2.2.3 Product Unit


Audit at a defined frequency the products at appropriate stages
of production and delivery
Verify the specified requirements/product
dimensions/functionality/packaging and labeling

ISO/TS 16949 :2002


8.2.2.4 Internal audit Plans


Schedule as per annual plan

Cover all quality management related processes, activities and
shifts.
ISO/TS 16949 :2002


8.2.2.5 Internal auditor qualification


Auditors to be qualified to audit the requirement of TS

IATC objective
ISO/TS 16949 :2002


8.2.3.1 Monitoring and measurement of manufacturing processes


Perform process studies on all new manufacturing
processes to verify the process capability
These results shall be documented along with
objectives for manufacturing process capability,
reliability, maintainability and availability as well as
acceptance criteria.
Shall maintain manufacturing process capability
Control plan and process flow diagram are
implemented

ISO/TS 16949 :2002


8.2.3.1 Monitoring and measurement of manufacturing processes


Significant process events (tool change, machine
repair, etc.,) shall be recorded
For characteristics listed in control plan, If it is
unstable or non-capable
100% inspections
Corrective action plan to achieve stability and
capability Customer approval, if required
Maintain records of process change effective dates

ISO/TS 16949 :2002


8.2.4.1 Layout inspection and functional testing


Shall be performed for each product as specified in the
control plans.
Results shall be available for customer review

Layout inspection is the complete
measurement of all product dimensions
shown on the design records
ISO/TS 16949 :2002


8.2.4.2 Appearance


Appropriate lighting for evaluation areas.
Master for color, grain, gloss, metallic, brilliance,
texture, distinctness of image.
Maintenance and control of appearance masters and
evaluation equipment.
Verification by qualified and competent personnel.
ISO/TS 16949 :2002


8.3.1 Control of nonconforming product-Supplemental


Product with unidentified or suspect status shall be
classified as non conforming product
ISO/TS 16949 :2002


8.3.2 Control of reworked project


Instruction for rework, including re-inspection
requirements, shall be accessible to any utilized by
the appropriate personnel.
ISO/TS 16949 :2002


8.3.3 Customer information


Customer shall be informed promptly in the event
that nonconforming product has been shipped
ISO/TS 16949 :2002


8.3.4 Customer waiver


The organization shall obtain a customer concession
or deviation permit prior to further processing
The organization shall maintain a record of the
expiration date or quality authorized
Material shipped on an authorization shall be
properly identified on each shipping container
This applies equally to purchase product. The
organization shall agree with any request from
suppliers before submission to the customer

ISO/TS 16949 :2002


8.4.1 Analysis and use of data


Development of priorities for prompt solution to
customer related problem
Determination of key customer-related trends and
correlation for status review, decision-making and
longer term planning.
An information system for the timely reporting of
product information arising from usage.

Data should be compared with those of competitors
and/or appropriate benchmarks

ISO/TS 16949 :2002


8.5.1.1 Continual improvement of the organization


The organization shall define a process for continual
improvement.

ISO/TS 16949 :2002


8.5.1.2 Manufacturing process improvement


Manufacturing process improvement shall continually
focus upon control and reduction of variation in product
characteristics process parameters
Continual improvement is implemented once
manufacturing process are capable and stable, or
product characteristics are predictable and meet
customer requirements
ISO/TS 16949 :2002


8.5.2.1 Problem Solving


The organization shall have a defined process for
problem solving leading to root cause identification
and elimination.

ISO/TS 16949 :2002


8.5.2.2 Corrective action impact


The organization shall apply to other similar
processes and product the corrective action, and
controls implemented, to eliminate the cause of
nonconformity.

ISO/TS 16949 :2002


8.5.2.4 Rejected product test/analysis


The organizational shall analysis part rejected by the customers
manufacturing plants engineerings plants, engineerings facilities
and dealership.
The organization shall minimize the cycle time of this process.
Records of these analysis shall be kept and made available upon
request.
The organization shall perform analysis and initiate corrective action
to prevent recurrence

Cycle time related to reject product analysis should be
consistent with the determination of roots cause, corrective
action and monitoring the effective of implementation