The term Industry 4.0 was mentioned for the first time in Germany, in 2011, as a proposal for the development of a new concept of economic policy based on high-tech strategies . These technologies are changing the role of employees and the work they do, allowing interactions between the different elements of the industrial company, throughout the value chain, since suppliers to customers.

1. Quality 4.0
June 2019 - y 12 N. 102
QUALITY 4.0
=
INDUSTRY 4.0 + QM
NUMBER #102
JUNE 2019
Sergio Salimbeni

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Quality 4.0
Junio, 2019
Quality 4.0
Industry 4.0 and the Digital Transformation
The term Industry 4.0 was mentioned for the first time in
Germany, in 2011, as a proposal for the development of a
new concept of economic policy based on high-tech
strategies1
.
These technologies are changing the role of employees
and the work they do, allowing interactions between the
different elements of the industrial company, throughout
the value chain, since suppliers to customers.
The enterprise digitalization is the beginning of the
organizational evolution, is the main result of the
introduction to digital systems.
The use of digital work tools, collaborative tools and virtual
information, will profoundly change the work profile and
the requirements of employees2
.
The "old" Digital Technologies applied to all aspects of
organizations is what is called: Digital Transformation.
Digital transformation is the profound transformation of
business and organizational activities, processes,
competencies and models, to fully leverage the changes
and opportunities of a mix of digital technologies and their
accelerating impact across society, in an strategic and
prioritized way, with present and future shifts in mind3
.
These "digital" changes reach, not only the industry, but
the entire society. Such is the case of Japan, which has its
own particular challenges and, like Industry 4.0, which is
the digital transformation of manufacturing, aims to face
several challenges going well beyond the digitalization of
the economy towards digitalization at all levels of Japanese
society and the (digital) transformation of it; this is called
Society 5.04
However, just as in Industry 4.0 as the fourth industrial
revolution, Society 5.0 is also depicted as an evolution in
1
Roblek, 2016
2
Ludwig, 2018
3
https://www.i-scoop.eu/digital-transformation/
4
https://www.i-scoop.eu/industry-4-0-society-5-0/
five societal stages in the position paper of Keidanren: 1)
the hunting society, 2) the agrarian society, 3) the
industrial society, 4) the information society, and, 5) the
super-smart society.
All of this does not mean having to completely change the
production processes, replace machinery completely, or
completely change the way of working.
It only needs to change the opinion on how production
and quality have been controlled so far. The acquisition
and analysis of data driven by demand can optimize costs
and manufacturing quality.
The basis of the digital transformation is the targeted
collection and evaluation of data. Entire machinery park
does not have to be changed; in many cases, it is enough
to capture the data, which you have previously received in
paper form, directly electronically, to evaluate
immediately the data that are already provided by systems
and sensors in order to be able to correlate.
Industry + digitalization = Industry 4.0
What is behind the 4th Industrial Revolution?
According to the authors Schlechtendahl, Keinert,
Kretschmer, Lechler, & Verl, (2015) the three pillars of
Industry 4.0 are: (1) the digitization of production, (2)
automation and (3) the automatic exchange of data.
The concept of Digital Transformation brought to the
manufacturing industry is the so-called digitalization of
production, that is one of the three pillars of Industry 4.0
But is "digitization" just a "buzzword" or does it reveal real
value creation potential?5
The Federal Ministry of Economics and Technology of
Germany has recently examined the topics "digitization"
and "Industry 4.0" in detail in a study, and comes to the
conclusion that there is considerable value-added
potential in digitization.
The central issue of digitization in the production process
is the sensible and efficient collection and evaluation of
data "along the production line". This starts with the
5
https://qualitaet-vier-null.de/#industrie-4-0 Germany

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Quality 4.0
Junio, 2019
evaluation of the suppliers of raw materials, the
monitoring of the raw materials used, the development of
the product quality in the course of the production up to
the deliveries to the customer.
Industry 4.0 + QM = Quality 4.0
Whether in agroindustries, automotive industry or
services, the objectives of a professional quality
management do not differ.
It is required, but not limited to, the following:
▪ High operational safety
▪ Reduction of failures and malfunctions
▪ Short downtimes and optimal coordination with
production
▪ High customer satisfaction
▪ High customer loyalty
▪ Improvement of product quality
Trends in Industry 4.0 and the opportunities for quality
assurance6
▪ Kundenintegration: customer integration
▪ Inline Messung der Losgröße 1: Inline measurement of lot size 1
▪ Zustandsorientierte Instandhaltung: Condition-based maintenance
▪ Lernende Produktionsprozesse: Learning production processes
▪ Echtzeit-Prozessparametersteuerung: Real-time process control
parameters
▪ Eigenständiger KVP bei CPS: Independent CIP (Continuous
improvement process) at CPS (Cyber-physical systems)
▪ IntelligenteQAssistenzsysteme: Intelligent Q-assistance systems
6
Qualität 4.0 am Beispiel Katapult – Quality Science Lab | K.
Seiffert, P. Drange Seite 4 | 17.10.2016
Quality is changing due to digitalisation and that is where
Quality 4.0 provides a potential value creation
While there are multiple possibilities, three central themes
can be mentioned:
▪ reaction times,
▪ relationships and
▪ predictions.
Source: Bosch Packaging Technology
For example, the immediate electronic registry of quality
indicators allows their immediate evaluation. When the
metrics get worse, they can be observed immediately and
act before something is damaged. By comparing
production indicators and quality indicators, you can
identify relationships and take action to avoid
interruptions.
Quality 4.0, in summary, could be understood as the
quality without interruptions of media, making use of help
systems, establishment and compliance of standards,
evaluation of machines and measurement data, as well as
integration of identification technologies.
source: https://www.marketing.ch/2017/10/04/industrie-4-0-fluch-oder-
segen/

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Quality 4.0
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The challenges of quality management
In any type of industry quality problems have increased
markedly in recent years. As a result of the increased
pressure on companies, which includes a greater number
of software components, more complex value chains and a
greater reduction in time to market, the quality of the
product has suffered more and more. Quality assurance
has thus become a central issue on the agenda of senior
management, but traditional methods of quality
management are no longer effective.
In order to remedy the quality deficits that have arisen, it
is not enough to adapt the standard quality methods, but
also to implement new innovative approaches to quality
management. This is summarized under the term “Quality
4.0”7
.
Why it is worth investing in digital quality assurance?
While production is highly automated due to increasing
digitization, there is not much of that in quality assurance.
Digitization is changing the economy in a sustainable way.
Even though the vision of Industry 4.0 has not yet been
fully implemented, a basic idea has already emerged:
classic solutions are no longer adequate for digitized value-
added processes.
This development also has implications for quality
assurance, which must be adapted to the digitized
environment.
Nowadays, the procedure is still done by hand. The
checklists are barely digitized and, therefore, breaks occur
frequently, lists and lists are searched.
However, digitalization presents new challenges for the
companies that produce. Product cycles are getting
shorter, and variants of multiple and new releases should
be faster. In this context, the term Quality 4.0 describes
concepts that contain test methods for automated
production. The aim is that the quality controls are already
integrated into the production process in progress.
This requires, on the one hand, a complete evaluation of
the data of the machine in real time and, on the other
7
Qualität 4.0: Präventiv, holistisch und zukunftssicher, p.3
hand, interfaces through which the systems involved can
communicate information without media interruptions.
This is guaranteed through integrated IT systems, which,
however, must be protected against external attacks.
Advantages of Quality 4.0
If quality assurance is digitized, complete traceability of
each batch is possible at any time. This makes it easier to
identify the source of the error in the event of a
malfunction and reduce the liability risks. In addition,
possible errors or incorrect settings can be detected
immediately and machines immediately report if
maintenance is required.
Quality 4.0 - Quality management in the digital era
The increase in the variation of the product, which is
created in the increasingly shorter cycles and in the
creation of value throughout the world, increases the risks
and costs in terms of quality.
While technological change imposes new demands on
quality, digital instruments are at the same time the key to
complement the classic quality guarantee and, therefore,
achieve a higher level of quality.
Especially in the following areas, digitization promises a
high added value8
:
▪ Digital methods to guarantee quality from idea to
delivery.
▪ Reduction of spending on quality through
preventive error detection.
▪ Acquisition and analysis of quality data on needs.
8
Quality 4.0" of ROI IMPULS

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Quality 4.0
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▪ Use of sensors to better understand the process
▪ Use of intelligent data to increase the quality of
the product and the process
Approach to quality 4.09
According to the TQU GROUP, the following could be the
steps for the approach to Quality 4.0:
▪ Reproducible processes (Cp, Cpk)
▪ Plant availability of the measuring systems
▪ Measurements in time
▪ Interface management of the measuring systems
(ID)
▪ Translate customer requirements into product
characteristics (inspection planning)
▪ Abstract and divide the production processes
into substeps
▪ Assignment in the inspection plan from substeps
to product features
▪ Translation of Big Data into Smart Data
▪ Assignment of test methods to unsafe processing
steps
Conclusion:
TQM - total quality management - has been studied
and applied for decades, but the new technologies
and work modalities in this 4th industrial revolution
makes Quality Assurance in smart factories, is still
an issue under development.
Bibliography:
Digitalisierung industrieller Arbeit - Entwicklungsperspektiven und Gestaltungsansa¨tze
Hartmut Hirsch-Kreinsen und Michael ten Hompel.
QUALITÄTSMANAGEMENT IM RAHMEN INDUSTRIE 4.0 Impulsveranstaltung Marcel Ferber TQU
GROUP Magirus-Deutz-Straße 18 89077 Ulm kontakt@tqu-group.com
Quality 4.0: It’s time for a QMS Revolution Posted on January 24, 2018 by Peter-Elias Alouche
Smart Quality, 2017, Luis Villaverde, Director Grupo LVF
9
MODERNES QM IN DER INDUSTRIE 4.0 © 2015/TQU GROUP/Seite 18 TQU
Group
Revista de la ASOCIACIÓN ESPAÑOLA PARA LA CALIDAD www.aec.es | N° I 2016
Quality Control in the Context of Industry 4.0 Conference Paper · April 2019 DOI: 10.1007/978-
3-030-14973-4_17
Leseprobe, René Kiem, Qualität 4.0, QM, MES und CAQ in digitalen Geschäftsprozessen der
Industrie 4.0
Qualität 4.0 am Beispiel Katapult Quality Science Lab Prof. Dr.-Ing. Roland Jochem1, 2 , Dipl.-
Phys. Klaus Seiffert1, M.Sc. Patrick Drange2
Ing. Sergio Salimbeni, MBA, PhD.
Professor and researcher @ USAL University
Director - Activus – Business Engineering
info@activus-be.com