SESSION – 2

QUALITY CONCEPT
AND PROCESS APPROACH

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 1 of 29
 What is QUALITY after all ?

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 2 of 29
 Dimension of Quality for Manufactured product:

• Fitness for Use :

how well product or service does what it is supposed to
• Serviceability
Serviceability::
ease of getting repairs, speed of repairs
• Aesthetics
how a product looks, feels, sounds, smells,
or tastes
• Cost Effectiveness
• Perfection
• Zero Defect

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 3 of 29
 Dimension of Quality for Service:
• Time and Timeliness
– How long must a customer wait for service, and is it completed on time?

• Completeness
Completeness::
– Is everything customer asked for provided?

• Courtesy
Courtesy::
– How are customers treated by employees?

• Consistency
– Is the same level of service provided to each customer each time?

• Accessibility and convenience

– How easy is it to obtain service?

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 4 of 29
 Definitions ….. Based on ISO 9000 : 2005

Quality:-
Quality:
“Degree to which a set of inherent characteristics fulfills requirements.”

System:-
System:
“Set of Interrelated or interacting elements.”
A system may or may not have sub-systems

Management System
System::-
“System to establish policy and objectives and to achieve those objectives.”

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 5 of 29
 Definitions ….. Based on ISO 9000 : 2005

Quality Management System

System::-
“Management System to direct and control an organization with regard to
quality."

Quality Control
Control::-
“Part of Quality Management, focused on fulfilling quality requirements.”

Quality Assurance
Assurance::-
“Part of Quality Management, focused on providing confidence that the
quality requirements will be fulfilled.”

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 Quality Management Principles:

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 7 of 29
 Continual Improvement

• Continual Improvement of the organization's overall

performance should be a permanent objective of the
organization.

• Defined as ‘RECURRING activity to INCREASE ability

to FULFILL requirements

• It could be MACRO (strategic breakthroughs) to MICRO

(small-step on- going) level improvement

Refer : ISO 9001:2008 Cl. 4.1, 5.3, 5.6.3, 6.1, 8.1, 8.4, 8.5

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 8 of 29
 Factual Approach to Decision Making

• Effective decisions are based on the analysis of

Data and Information.

• Analysis of Data is an integral part of ISO

9001:2008requirements.

Refer : ISO 9001 : 2008 CI. 8.4, 5.6, 8.2.3

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 9 of 29
 Mutually Beneficial Supplier Relationships

• An Organization and its suppliers are independent

and mutually beneficial relationships enhances the
ability of both to create value.

Refer : ISO 9001:2008CI. 7.4

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 Customer Focused Organization

• Organization depends on their customers and

therefore should understand current and future
customer needs, should meet customer requirements
and strive to exceed customer expectations

Refer : ISO 9001:2008CI. 5.1(a),5.2,5.3, 5.4, 5.5.2(c),

5.6.2(b), 6.1(b), 7.2.1(a), 7.2.1(b), 7.2.3, 7.5.4, 8.2.1

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 11 of 29
 Leadership

• Leaders establish unity of purpose and

direction in the organization. They should
create & maintain internal environment in
which people can become fully involved in
achieving organization’s objectives

Refer : ISO 9001:2008CI. 5.1, 5.2, 5.3, 5.4.1, 5.4.2,

5.5.1, 5.5.2, 5.5.3, 5.6

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 12 of 29
 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.

Refer : ISO 9001:2008CI. 5.5.1, 5.5.3, 6.2.2.d

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 13 of 29
 System Approach to Management

• Identifying, understanding and managing interrelated

processes as a system which contributes to
organization’s effectiveness and efficiency in achieving
the goals or objectives

Refer : ISO 9001:2008Cl. 4.1, 5.4, 7.1, 8.2.3

• The output of one process is the input to one or more

subsequent processes.

• It interfaces between processes to ensure that the

overall system is effective

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 14 of 29
 System Approach to management:

• Applying the principle of system approach to management leads to the

following actions:
– defining the system by identifying or developing the processes that affect a
given objective,
– structuring the system to achieve the objective in the most efficient way,
– understanding the interdependencies among the processes of the system,
– continually improving the system through measurement and evaluation, and
– establishing resource constraints prior to action.

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 15 of 29
 Process Approach

• A desired result is achieved more

efficiently when activities and related
resources are managed as a PROCESS.
Input Process

• Systematic identification and

management of the various processes
employed within an organization, &
particularly the interactions between such
processes, is referred to, as the process Output
approach to management
•
Refer : ISO 9001:2008CI. 4.1, 7.1, 8.2.3

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 16 of 29
 Process Approach:

Identify the
Identify the Establish
Identify the Interactions to Ensure Continual
Inputs & Measuring
Processes other Improvements
Outputs Criteria
Processes

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 Benefits of Process approach:

• Integration and alignment of processes to enable achievement of

planned results.

• Ability to focus effort on process effectiveness and efficiency.

• Provision of confidence to customers, and other interested parties, about

the consistent performance of the organization.

• Transparency of operations within the organization.

• Lower costs and shorter cycle times, through the effective use of
resources.

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 Benefits of Process approach:

• Improved, consistent and predictable results.

• Provision of opportunities for focused and prioritized improvement

initiatives.

• Encouragement of the involvement of people and the clarification of their

responsibilities.

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 19 of 29
 Generic Process:

Input Output
Requirements Inter related or interacting Requirements
Specified activities and control Specified
(Include resources) methods (result of process)

Monitoring and Measuring

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 20 of 29
 Quality Management System
Continual Improvement

Management
Responsibility

Measurement,
Resource
Analysis,
Management
Improvement

Inputs Product Outputs

Realization Product

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 21 of 29
 PDCA Cycle

• Plan – Establish Objectives and Processes necessary to

deliver results in accordance with customer requirements
and organization’s policies Plan DO

• Do – Implement the process

• Check – Monitor and Measure the processes and the Act Check
product against defined policies, objectives and
requirements as defined in procedures; and report the
results to designated authorities

• Act : Take actions to improve process performance viz.

effectiveness and efficiency

TÜV SÜD South Asia 2. Quality Concept & Process Approach Slide 22 of 29