Quality System Structures for Industry 4.

name

Curriculum Development
of Master’s Degree Program in
Industrial Engineering for Thailand Sustainable Smart Industry
 Learning Objectives

After completing this class, you should be able to:

• Understand approaches to Quality Management and how to select them

• Understand the differences between ISO 9000 and TQM and how to implement them
• Understand how Industry 4.0 impact Quality Management System and what Quality
4.0 is
 Presentation

Approaches to Quality
 3 Approaches to Quality Management

Consultancy Standardization/ Quality award

approach principle approach approach

Consultants help organizations to • ISO 9001 • Demin Prize

apply principles, methods and • Total Quality • Baldride Award
technical tools proposed by Management (TQM) • European Quality Award
quality experts • Six Sigma
• Kaizen
• Juran
• Etc.
 Approaches to Quality Management

Factors to be considered when choosing approach • Need a set of requirements

to quality management and systematic approach
• Need a certification
ISO 9001

• Need to reduce costs,

waste
• Need quicker
operation
Lean
Customer and • Simple and easy to
stakeholder needs Compliance
understand
• For individual projects
• Problem-solving
TQM
• For high volume
activities
• Need high level of
stability
Socio-cultural, Technology and Organizational size, • More structured tools
economic, engineering type, location Six Sigma
environmental factors
 ISO 9001 and TQM

In this lessen, we will focus on 2 important quality approaches

TQM and ISO 9000 were found to be the most prevalent quality
approaches or strategies (Lee and Palmer, 1999)
Lee, K.S. and Palmer, E. (1999), “An empirical examination of ISO 9000-registered companies in New Zealand”, Total Quality Management, Vol.10 No. 6, pp. 887-99
 ISO 9001

Quality Management System (QMS) is a formalized system that documents processes,

procedures, and responsibilities for achieving quality polices and objectives.

ISO 9001 is the world’s most popular and most commonly used standard for Quality
Management System (QMS)
Guidelines

Why is QMS important? ISO 9000

- Achieve customer satisfaction
- Low cost of poor performance
- Gain repeat business ISO 9001 ISO 9002 ISO 9003
- Increase profitability • • Inspection
Design • Production
- Increase effectiveness • Development • Installation • Testing
• Production
- Higher consistency • Installation
• servicing
 ISO 9001

Facts about ISO 9001

• Generic – cover any organizational size, industry or culture –
a standard for the whole wold
• An organization can only get a certification of ISO 9001
• Identify what but not how requirements must be met
• Allow for flexibility
• Allow management to stay in the driving seat
• Provides the base level of a quality system, not a complete
guarantee of quality
• Not a quality control tool
• Help facilitate international trade
• Registration process takes 12 – 18 months
• Can cost lots of money, time and paperwork
• Prone to failure when an organization focuses on certification
not quality
 ISO Standards

ISO 31000 IATG 16949 ISO 13485

Risk management Automotive Quality ISO 20000
IT service management. Medical Device
Management

ISO/TS 29001:2010
Petroleum, petrochemical and natural gas industries AS 9100D
Aviation, Space, and Defense Organizations

ISO 9000: Quality Management

ISO15378 and PS9000 ISO 14000

ISO 22000 ISO 50001
Pharmaceutical Packaging Environmental management
Food safety management Energy management
Materials
 ISO 9001 Principles
Customer Focus is to meet customer Leaders at all levels establish unity of purpose
requirements and to strive to exceed and direction and create conditions in which
customer expectations. people are engaged in achieving the
organization’s quality objectives.

Competent, empowered and engaged

An organization manages its people at all levels throughout the
relationships with interested parties, organization are essential to enhance its
such as suppliers. capability to create and deliver value.

Decisions based on the analysis and Consistent and predictable results are achieved
evaluation of data and information are more effectively and efficiently when activities
more likely to produce desired results. are understood and managed as interrelated
processes that function as a coherent system.

Successful organizations have an ongoing focus on

improvement.
ISO 9001 Approach Based on PDCA Cycle
 Establishing and Implementing QMS

Control & Review &

Design & Build Deploy
Measure Improve

• Set up steering • Breaking each • Monitoring & • Maintenance of the

committee process down evaluation system
• Evaluate current into • Internal audit • Continual
quality system subprocesses External audit improvement
• Set up documentation • Training all staff (Certification audit) • Surveillance audits
system on documentation
• Implement the
QMS
 Total Quality Management: TQM

What is TQM?
Total Quality Management (TQM) is “a management approach for an organization, centered on quality,
based on the participation of all its members and aiming at long-term success through customer satisfaction
and benefits to all members of the organization and to the society”

Benefits of TQM
Total
T Involvement & input of everyone in the • Enhance competitive position
organization • Improve customer satisfaction
• Reduce waste and &work-over
Quality • Greater organizational transparency
Q Fully meeting customer needs & requirements al the time • Improve employee participation &
satisfaction
Management • Improve productivity, market share,
M ‘The way we act’ & operate policies, procedures including
training and instruction to all employees
and profitability
• Enhance communication
 8 Elements of TQM

Co
tion mm
a
Roof: provide both
unic un
ica
suggestions and mm ti o
achievements for teams Co Recognition n
and individuals
Training
Bricks: to develop effective

Communication
employees and create
Binding Mortar: Link all Teamwork commitment by top
elements of TQM through management
a common communication Leadership
Foundation: To foster
Integrity, Trust and Ethics openness, fairness and
sincerity and allow
Communication involvement by everyone
 6 C’s for Implementing TQM

 There must be a quality improvement

commitment from all employees of the
organization. Commitme
nt
 Organization must follow a
modern quality improvement
 Effective controls must be laid Control Culture culture on a constant basis.
down to monitor and measure
the real performance of the
business.
6 Cs for TQM

 Continuous improvement must take

 Focus on customers' requirements Continuous
Customer place in all policies, procedures,
and satisfaction of their improvemen
Focus and activities laid down by
expectations are very important for t management for the organization.
long-term survival of the business.

Cooperation  Cooperation and experience of employees must

be utilized to improve strategies and enhance
performance.
 Comparing between ISO9000 and TQM

Characteristics ISO 9000 TQM

Customer focus  
Obsession with quality 
Scientific approach to problem solving  
Long term commitment Partial 
Teamwork 
Continual process and product improvement  
Education and training intensive  
Freedom through control 
Unity of purpose  
Employee involvement and empowerment Partial 
 ISO 9000 and TQM: Which One First?

• ISO 9000 & TQM are not interchangeable, but they are compatible with and complement each other
• The implementation of ISO 9000 & TQM together may lead to organisational success and competitive
advantage.
ISO 9000 First TQM First • Some companies might
• Recommend to implement choose TQM first (Ex.
in a traditional environment Toyota)
• ISO 9000 is a foundation for • ISO 9000 is a subset of
TQM TQM
• Implement TQM later to • ISO 9000 maybe redundant
enhance employee in a mature TQM
motivation and operational environment
efficiency, and achieve • For this case, the objective
overall organisational of implementing ISO is to
success and performance obtain certification – for
marketing purpose.

Source: Magd, Hesham, and Adrienne Curry. "ISO 9000 and TQM: are they complementary or contradictory to each other?." The TQM magazine (2003).
Transforming to Smart Manufacturing

Some of technologies that encapsulate the

physical-to-digital-to-physical of Industry 4.0
 Transforming to Smart Manufacturing

Shifts to digital industrial business

models should be grounded in 5
guiding questions

Source: Deloitte analysis

 Quality Management in Industry 4.0

Industrial revolution, quality goals, and quality strategy

Source: Sung Hyun Park, Wan Seon Shin, Young Hyun Park & Youngjo Lee (2017) Building a new culture for quality management in the era of the Fourth Industrial
Revolution, Total Quality Management & Business Excellence, 28:9-10, 934-945,
 Quality Management in Industry 4.0

Source: Sung Hyun Park, Wan Seon Shin, Young Hyun Park & Youngjo Lee (2017) Building a new culture for quality management in the era of the Fourth
Industrial Revolution, Total Quality Management & Business Excellence, 28:9-10, 934-945,
 How Industry 4.0 aligns with TQM

• Improve responsiveness • Smart allocation of resources

• Customized product/customer • High coordination among all level of
• Smart prediction of market demand the organization
• Effective evaluation for results

• Easy identification and

communication tools • Improve communication and
• The ability to hire segmentation of collaboration
•
stakeholders based on priorities
Stronger collaboration with
TQM • Facilitating innovation and
sharing of ideas
providers and partners to
encourage continuous
& I4.0
improvement
• Transparent, interconnected, dynamic
• Rich information and analytics dashboards processes
about production, machines, markets, etc. • Self-learning, early prediction of errors
• Early prediction of failures, thus, anticipating • Less downtime, early maintenance prediction
early reactions
• Early evidence to correct or support decisions.
Source: Sader, Sami SA, István Husti,
and Miklós Daróczi. “Suggested
• Active dynamic interaction with market needs Indicators to Measure the Impact of
• Industry 4.0 on Total Quality
Instant re-configuration of production processes to
Management" Industry 4.0 2.6 (2017)
respond to improvement request
• Motivating for change environment
 Thank You
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Curriculum Development
of Master’s Degree Program in
Industrial Engineering for Thailand Sustainable Smart Industry