Digital Transformation in the Quality

Management System
Margarita A. Menshikova, Yana V. Piunova, Maria N. Makhova
State Educational Institution of Higher Education Moscow Region «University of Technology»
Korolyov, Russia
[email protected]

Abstract—The article deals with the problems of the quality

management system`s transformation in the digital economy. It is
suggested an integration of quality management system in the
general management system by establishing the digital platform
on the enterprise. The enterprise information systems
architecture are analyzed. Criteria for selection of Enterprise
Resource Planning system are formed in modern conditions.
Steps of implementation of the integrated system at the industrial
enterprises are developed. The necessity of risk identification at
all stages of the system implementation is emphasized. The
authors of the article developed assessing criteria for the
effectiveness of the quality management system of business
processes. The expert`s assessment of it was conducted at
industrial enterprises
Keywords—Quality management; quality management system;
digital transformation; digital platform; risks

I. RELEVANCE Fig.1. The main stages of the QMS digitalization

Enterprises need to solve management problems at a Registration and analysis of data. Reducing the cost and
qualitatively new level, in a digital economy. The need for increasing the speed of information storage and processing
rapid response to market conditions and a rapidly changing systems allow us to solve a problem that previously seemed
economic situation requires restructuring of the internal impossible that is to measure and record everything that could
environment, improvement and optimization of management affect the quality of a product. There are the Internet of Things
processes, which could be best achieved through integrated and various types of door sensors for the new data sources.
management automation. Now it is possible to place sensors where it is needed and not
where it is permitted by technology or product design. At the
Digital transformation offers opportunity to transform same time, the big data systems make it possible to analyze
manual quality management operations into digital form. There these huge, complex and rapidly growing data sets from several
are many tasks that require significant human resources in sources.
quality management.
Demonstration of compliance with the requirements
That is collection and analysis data on products, processes (regulatory instruments, specifications, etc.). It is necessary to
and management systems, monitoring and managing processes, confirm the objectivity of the obtained evidence of compliance
decisions-making based on actual data, scaling requirements of with regulatory provisions (e.g., in pharmaceuticals, medicine,
the quality system to evolving processes, risks identification laboratory tests, etc.) in many processes of an organization.
and analysis etc. Blockchain technology allows to have a secure, decentralized
II. THE MAIN STAGES OF THE QMS DIGITALIZATION and totally objective system to indicate compliance with the
requirements. Under such a system, forgery or swapping of
As the main stages of “digitalization” of the quality certificates is excluded.
management system (QMS), we propose to consider the
following (Figure 1): Monitoring and control. Most often, various quality tools
(statistical methods or expert assessments) are used to manage
processes in quality management. With the advent of deep
learning and neural networks, it became possible to use
artificial intelligence for this purpose. A trained neural network
detects trends and changes in processes much more efficiently
and faster than a human or automated systems based on
statistical data processing.

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 Decision-making in ambiguous situations. The quality
management system requires the creation of “rigid” prescribed
algorithms for process execution. Algorithms are set up in
processes maps or operating procedures. If the process is
complex and extensive and the operations execution depends
on changing parameters, then you have to either prescribe all
possible options for the process or rely on the expert decision
of the contractor. Any ambiguous situation can lead to a
malfunction or process termination. Digital transformation
allows solving this problem through the use of predictive
analytics.
The advances in digital technologies significantly expand
the quality management opportunities at enterprises of different
branches through reducing the “human factor”. However, one
should not identify digital transformation with a reduction in
human activity. Digital transformation removes the “routine”
from the many tasks of quality management, which the staff of
any organization has to perform. With the advent of digital
technology, the challenge is to redesign processes and
procedures so that both people and digital devices can
contribute to quality improvement.
Features of QMS implementation at enterprises in
accordance with the new requirements of GOST R ISO 9001-
2015 imply that they need to switch to new quality
management methods that integrate QMS into other types of
management (such as financial, personnel, environmental,
information), because QMS itself is part of the overall
management system of the enterprise [1].
The peculiarity of the scientific approach to the
implementation of the QMS is determined by the fact that all
management decisions must be justified on the basis of an Fig. 2. QMS in the overall enterprise management system
analysis of actual, reliable data on the quality of products and
processes of the QMS [2]. The lack of information on an Under these circumstances, it becomes relevant to build a
ongoing basis about the state of the system, the external digital platform at an enterprise [6, p.68].
environment and the behavior of the QMS under its influence Enterprise Resource Planning (ERP) is an organizational
reduces the effectiveness of decisions made and the strategy for integrating production and operations, human
effectiveness of management. Here the collection and use of resources management, financial management and asset
information about processes on an ongoing basis is very management which is focused on continuous balancing and
important. In this regard, it is necessary to integrate the QMS optimization of enterprise resources through a specialized
management modules into the overall enterprise management integrated application software that provides a common data
system [3]. model and processes for all areas of activity [5].
III. QMS INTEGRATION OF INTO THE OVERALL In fact, the ERP is a set of integrated applications that allow
MANAGEMENT SYSTEM you to create an integrated information environment (IIE) for
the automation of planning, accounting, monitoring and
Figure 2 shows the version of the QMS integration of into
analysis of all core business operations of an enterprise [8].
the overall management system.
The enterprise information system architecture includes
many subsystems, including such as personnel management,
supply management, production management, analytical
reports, operational reports, etc. (Figure 3)

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 The share of software for industrial enterprises is much
smaller. The main requirements that the management of the
enterprise imposes on such software are the possibility of
conducting data analysis and applying the results obtained in
decision-making process [7].
The main problems that arise when choosing software are
speed of operation, cost, simple user interface and the
availability of the necessary functions [3].
There are a lot of selection criteria of ERP system, the main
ones can be grouped into the following groups (Table 2):

TABLE II. SELECTION CRITERIA FOR CHOOSING AN ERP SYSTEM

Group Selection criteria of ERP system

Fig. 3. Information system architecture of industrial enterprise • Conformity with enterprise business
processes
Enterprise • Scaling
IV. ENTERPRISE RESOURCE PLANNING IMPLEMENTATION • Conformity with goals and strategy of
needs
Prior to the ERP implementation it is necessary to analyze enterprise
the advantages and disadvantages of its implementation (Table • Industry-specific solutions
• Data security
1):
Technologies • Software architecture
used • Technical architecture
TABLE I. ADVANTAGES AND DISADVANTAGES OF ERP IMPLEMENTATION AT • Implementation of ERP system
ENTERPRISE
• Composition of modules
Advantages Disadvantages Functionality • Integration
• Control over all important • High cost (the cost of • Visibility
processes of the organization; software and hardware, the • Compliance with regulatory framework
• Synchronization of processes in cost of planning, • Full-cycle support
the form of a consistent and implementation, Support • Availability of support service
interconnected workflow from configuration and testing, • Experience of implementation
division to division; the cost of service); • Software cost
• Reporting standardization (in • Continuous implementation Cost of • Hardware cost
real time); (from 1 to 3 years); ownership • Service cost
• Unification of information • Learning constrains, long- • Modernization and upgrade cost
systems; term user training;
• Expansion of managerial • Additional costs (additional
functions; hardware, software,
• Integration with suppliers / communication channels); The implementation of the ERP system is a long and
customers; • Data transfer; complicated process. Each major manufacturer of the ERP
• Adaptation to the needs of the • Dependence of ERP system develops its own technology and implementation
business; supplier; techniques. Despite the fact that they all differ from each other,
• Centralization of data; the general algorithm of actions is the same.
• Data protection – special
security policy for each user It can be distinguished the following stages of the
group, control of each user;
• Improved interoperability;
implementation of the ERP system (see Table 3):
• Scaling;
TABLE III. STAGES OF ERP SYSTEM IMPLEMENTATION
№ Stage Content
These implementation problems are the most common. In
addition to these, there are always problems specific to each Implementation • Define targets for implementation (what
preparation does the company want to achieve?)
particular company or organization. An effective method to • Estimate the budget (how much does the
avoid or minimize losses from such mistakes is careful 1 implementation cost?)
preparation and planning of each ERP system implementation • Designate a responsible person (who is
project stage. manage the implementation of the
project?)
In connection with the transition to automated enterprise Analysis of • Assess the market and company
management systems in modern conditions, a wide range of enterprise development prospects for several years.
2 activity • Determine the composition and the
software is presented on the market that corresponds to certain possibility of development of business
demands of consumers. The programs for general purpose processes of the organization
automation, which do not take into account the specific • Evaluate the need for automation
features of industries on the software market are more ERP system • Select the ERP system according to the
common. The market is mainly represented by application 3 selection specified criteria (see Table 2)
• Analyze at least 3 variants of systems
suites for small, medium and large trade enterprises. from different manufacturers

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 Choosing of Determine the specialization of the ERP responsibilities
ERP system system provider: between managers in
provider • horizontal specialization: there is a order to allocate time
developed support service, but the to participate in the
approach to implementation is “typical” project
for all customers 3 Allocation of
• vertical specialization: specialization with labor resources
4 customers from a limited number of Inability to Medium Stoppage of No
industries (from one to three), the finance a the project
approach to implementation is industry- project,
specified disruption
• customer-oriented specialization: the of schedule
implementation of an ERP system to meet of
customer needs, difficulties with updating payments
the consistency of system performance
Project Risks arising from Perpetrator
• Project plan is ongoing
management • Control over deadlines, budget deadlines, Under-rate Low Terms and Terms and cost
scope of work work the cost adjustment after
• Assessment of compliance with Contractor overrun completing each stage
5 implementation objectives of the project.
• Interaction of organization’s employees Insufficient Medium Delay in the 1 Using the typical
with representatives of the supplier software execution solutions and coding
(implementation team from the supplier) performanc of business standards for
are coordinated e / processes maximum
Testing • Testing is being done under the old Insufficient and terms performance.
system hand-in-hand in the ERP system scalability and cost 2 Thorough
6 being implemented, which makes it of system overrun elaboration of “As is”
possible to get rid of major errors in the architecture models, Requirements
new system. Specifications and
7 Training • Training is carried out in the off-the-shelf Terms of Reference
ERP system Risks arising from the external environment
Commissioning • 1 option: launching the system
8 Amend Low Terms and No
immediately throughout the organization
legislation cost overrun
• 2 option: phased input (preferred)
The Medium Terms and 1 Getting
irrelevance cost overrun information about
The QMS for sustainable development of an industrial of the changes in releases as
results of early as possible
enterprise should take into account the impact of business risks. the next 2 Timely adressing
In implementing an ERP system, attention should be paid to the phase of of changes in the
risks (Table 4): work market of ERP
systems
TABLE 1 – RISKS OF ERP SYSTEM IMPLEMENTATION AT AN INDUSTRIAL Inability to High Security 1 Security policy
ENTERPRISE comply breach change
with 2 Redistributing
Risk Assessment of Impact Risk management security users roles
potentiality assessment strategy and data
access
Risks arising from Customer restriction
requirement
Impossibilit High Stoppage of 1 Approval of the
s
y to the project, Requirements
coordinate cost Specification prior to The above-mentioned implementation risks are the most
project overrun. the execution of the
goals following steps. common. An effective method of risks avoidance or
2 Approval of minimizing the likelihood of their occurrence is careful
automation. preparation and planning of each stage of an ERP system
Customer’s High Stagnation 1 Monitoring implementation project.
loss of or stoppage progress towards
interest in of the achieving the goals
the project project 2 Prompt delivery V. QMS AUTOMATION
of results to the One way to continuously improve the quality management
project customer
Changes in Medium Temporary Inform the Contractor
system at an enterprise is its automation, which ensures a clear
the stoppage of in advance about informational interaction of all departments to which the QMS
membershi the project, possible changes in applies.
p of the cost the composition of the
project overrun project team To date there is an experience of introducing modern IT
Participants High Terms and 1 Appointment of
technologies into the quality management system, which allow
’ lack of cost managers who have achieving the goal of improving business efficiency while
time overrun the opportunity to reducing risk. Despite this, these technologies to a varying
required by allocate the necessary degree use people, their knowledge and abilities to ensure
project time
2 Redistribution of
normal operation.

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 Automation of the QMS involves the transfer of manual organization has to perform. With the advent of digital
operations quality management into digital form. There are technology, the challenge is to redesign processes and
many tasks in quality management that require significant procedures so that both people and digital devices can
human resources, for example, collecting and analyzing data on contribute to quality improvement.
products, processes and organization systems, monitoring and
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