Design and Comparative Analysis of Quality Management Systems in
Aseptic Process for Smart HACCP in Food and Beverage Industry
JEONGMOOK CHOI
Department of Software,
Sungkyunkwan University,
2066 Seobu-ro, Jangan-gu, Suwon 16419,
REPUBLIC OF KOREA
JONGPIL JEONG
Department of Smart Factory Convergence,
Sungkyunkwan University,
2066 Seobu-ro, Jangan-gu, Suwon 16419,
REPUBLIC OF KOREA
Abstract: - Traditionally, food and drink have been used as a means of survival. In recent years, as technology
has advanced and our quality of life has improved, we have begun to seek out better food - not just for the sake
of the food itself, but to consume wisely, considering not only the ingredients but also the manufacturing
process. Companies that used to simply produce and deliver products now need to provide services such as
quality, promptness, and information, especially when it comes to quality control and safety, and quality
management, which are directly related to the lives and safety of consumers. Many companies are introducing
quality management systems to provide quality that meets the needs of customers and the market. With the
development of information technology, quality inspection methods are becoming more diverse and
sophisticated. However, the risk of defects occurring in the process still exists. In this paper, when a process
fails due to an unknown cause, the analog/digital data of that process is selected and compared with normal
cases. At that time, the analog/digital data of that process is selected and compared with normal and abnormal
cases. Then, multiple regression analysis is used to describe the process of finding the failure point.
Key-Words: - HACCP, Smart HACCP, Aseptic, Food and beverage, Analysis, Simulation
Received: May 14, 2023. Revised: July 28, 2023. Accepted: September 23, 2023. Published: October 12, 2023.
1 Introduction
Providing quality and reliability has become a major
challenge for companies that supply food and
beverages. Given that potential quality defects can
occur in any process that produces a product for
direct human consumption, it is essential to establish
a system of control and management throughout the
process, [1]. This is where Hazard Analysis and
Critical Control Points (HACCP), a food safety
management system, comes in. It aims to prevent
biological, chemical, and physical hazards
specifically related to food and beverage production
processes by using more quantitative indicators and
upper and lower limits for quality inspection targets
than traditional quality control activities, [2].
With the recent development of information
technology, it is possible to perform advanced food
safety management through automation and
improvement activities by incorporating IT
technology into the existing HACCP system. The
system can provide various services depending on
which IT technology it is integrated with, such as
identifying trends in all products and processes
through data collection and analysis activities and
providing users with quality-level predictions, [3].
The beverage production plant in the
background of the study was the first beverage
production line to undergo overall pre-verification
for Smart HACCP certification in Korea after the
establishment of Smart Factory. The aseptic failure
of the washing water used to clean packaging
materials such as containers and caps for beverages
occurred, and some items produced in the PET
bottle line were found to be out of standard.
Therefore, production/quality managers in the
factory conducted additional inspections of the
aseptic process but were unable to identify the
cause.
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Select the line where the aseptic failure
phenomenon occurred and the data of the aseptic
water treatment process, and perform pre-processing
to convert them into time series data. The data
obtained in the above process is divided and
analyzed using time series decomposition
(production instruction information during the
problem period, aseptic water flow statistics, heat
exchanger discharge temperature statistics, etc.
Time series decomposition is divided into trend,
seasonal, and residual data with time series
characteristics. The de-composition model can be
broadly divided into additive and multiplicative
factor decomposition, [4]. Additionally, since the
residuals of the time series decomposition follow a
normal distribution, it is possible to detect
anomalies by determining whether the current data
exceeds a certain sigma of the period data, [5].
Therefore, regression analysis is performed by
collecting time periods with residuals of 30 seconds
or more. Through multiple regression analysis, we
identified a list of tags that affect the sterility failure
point, and identified precursor symptoms for
selected tags, [6].
Describe the current aseptic process and its
function, and identify possible causes. Analog data
such as temperature, pressure, and flow rate of
facilities, digital signals of pumps and valves, and
production instruction data by period from MES
(Manufacturing Execution System) are collected,
and simulations are performed based on the data of
normal and abnormal cases. After preprocessing the
data into a time series, multiple regression analysis
was used to suggest solutions to the problem.
The structure of this paper is as follows. First, in
Section 2, I describe the food and beverage industry,
Smart HACCP, and the sterilization process.
Second, I briefly describe the process and
environment where the problem occurred, compare
the situation pre-symptoms and post-symptoms the
aseptic failure, and my hypothesis. Section 4
describes the analysis based on time series data and
the process of finding the cause. Finally, Section 5
concludes with a discussion of the result,
implications, and future work of this thesis.
2 Related Work
2.1 Food and Beverage Industry
The food and beverage industry is one of the largest
industries in the global economy and is constantly
evolving. It is made up of many different sectors,
including agriculture, processing, distribution, and
retail. It is also driven by a variety of trends,
including changing consumer preferences,
technological innovation, and globalization. It
creates a lot of jobs and contributes a lot to national
economies. It has also been an important activity in
nourishing humanity and spreading culture.
The food and beverage industry is changing
rapidly. Consumers’ dietary habits and overall
lifestyles have changed compared to the past, and
new food products are constantly being developed
to meet their needs. It is expected to continue to
grow in the future. As the population grows,
technology improves, and the middle class expands,
the demand for food and beverages of varying
quality will increase, [7].
2.2 Smart HACCP
Smart HACCP is a food safety management system
that uses IT technologies such as big data and the
Internet of Things (IoT) to collect and analyze data
at all stages of food production, processing,
distribution, and sales. It improves the efficiency
and convenience of food production companies’
existing HACCP operations while automating the
production process to efficiently manage cross-
contamination of pathogenic microorganisms, which
previously relied on manual work, to improve the
competitiveness of the food industry. In addition, by
preventing human error and data falsification in
advance, it can provide consumers with high
confidence in food safety, [8].
2.3 Aseptic Process
In factories that produce food and beverages, quality
control throughout the production process is
essential. Due to the nature of these products, they
are directly consumed by consumers and therefore
have a direct impact on their safety and health.
Therefore, quality control (QC) procedures must be
in place to ensure that not only the raw materials,
but also the packaging materials meet predetermined
quality standards for purity, stability, and other
quality attributes. QC is essential to ensure product
safety and quality and can help reduce consumer
complaints. There are different aspects of QC to
consider depending on the product you are
producing, and it is a continuous improvement
activity, [9].
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Fig. 1: Flowchart of General Fruit Juice Processing.
Describing (QUALITY CONTROL IN
BEVERAGE PRODUCTION: AN OVERVIEW,
January 2019).
As shown in Figure 1, describes the different
critical control points for a flowchart of general fruit
juice processing.
Aseptic processing is a preservation technique
that uses heat or chemicals to kill harmful
microorganisms and sterilize products to prevent
recontamination. The goal is to eliminate or
inactivate microorganisms from both the contents
and the packaging, achieving a commercially sterile
state. Typical techniques include thermal treatment
with hot steam or hot water, chemical treatment
with hydrogen peroxide, and irradiation. Aseptic
processes require strict process control and
monitoring to ensure that sterility is maintained
throughout the entire production process. After
sterilization or aseptic processing, the aim is to
monitor and control critical control points (CCPs) to
prevent recontamination and ensure a proper aseptic
environment for equipment and products. As shown
in Figure 1, control points (CPs) and CCPs are
designated and managed for each process. Although
it is a complex and costly task, it can be a useful
tool for companies that want to produce safe and
high-quality products. It is an important technology
in modern food processing and packaging, mainly
used in the production of beverages (juices, dairy
products, etc.), liquid foods, and products that
require maintaining product integrity and stability,
[10].
3 QMS for SMART HACCP
3.1 System Architecture
Figure 2 shows a simplified flow chart of the
beverage production plant that is the subject of the
paper. First, the water stored in the buffer tank
(T401A) is transferred to the heat exchanger. High-
temperature steam is provided by the boiler. The
water flowing into the water pipes in the heat
exchanger comes into contact with the hot steam
indirectly (by spraying the surface of the water pipes
with hot steam). The water is then heated until the
water temperature reaches the aseptic processing
standard. Water that has been sterilized by heat
treatment is sterile if it meets the criteria. If the
temperature of the water does not reach the
standard, sterility is not guaranteed. The
phenomenon of de-sterilization can assume several
causes. Firstly, insufficient heat treatment of the
steam due to the unintended introduction of
additional water. Secondly, insufficient heat
treatment due to steam at a lower than standard
temperature. And the possibility of an unknown
causative agent entering due to a faulty process
interlock.
The following Figure 3 is the heat exchanger
and boiling process. The water in the heat exchanger
is in direct contact with the hot steam in the boiler
and indirectly by the hot steam in the boiler,
transferring the heat from the steam to the water.
transfer heat from the steam to the water. The water
receives the hot steam and steam causes its
temperature to rise and the steam to cool. If the
temperature of the steam is not low enough to heat
the water, it will not be heated to the required
temperature, and sterilization cannot be guaranteed.
The threshold for the heat exchanger discharge
temperature is 139 ◦C to 141 ◦C. If the discharge
temperature rises above the threshold, additional
water is added, and if the temperature falls below
the threshold, water is stopped. The water buffer
tank should not simply check the amount of water
entering and leaving the discharge temperature but
should be blocked by a pre-modeled process
interlock.
The following Figure 4 is After passing through
the aseptic treatment process, the water is rapidly
cooled to use the aseptically treated water in
subsequent processes. The cooled water used in the
process is reintroduced into the heat exchanger for
sterilization again, which must also be controlled by
a process interlock. If there is an abnormal inflow
outside of the process interlock, this can cause a
drop in the discharge temperature.
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Fig. 2: Aseptic Process for Smart HACCP
Fig. 3: Aseptic Process and the Potential for
Failure(Pre-symptoms).
Fig. 4: Aseptic Process and the Potential for
Failure(Post-symptoms).
(When the water is in Zone.A passes Point.2, if
the temperature is below the threshold, the process
in Zone. B is stopped by a pre-interlock. Therefore,
the case in Figure 4 case is excluded from the above
requirements.)
3.2 Compare Symptoms
The following Figure 5 shows a simulation of the
data when the sterilization process is running
normally. The blue line is the heat exchanger
discharge temperature, and the orange line is the
buffer tank that supplies water. In this normal case,
the discharge temperature and water flow rate do not
change. (However, there is a point where the flow
rate briefly decreases. This is due to a different
process issue that briefly changed the water flow
rate, but is not related to that issue).
Fig. 5: Simulation Result (Normal Case)
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A sterility failure occurs when the temperature
of the sterile water in the heat exchanger is
abnormally low. If the temperature is abnormally
low, the water will not be sterile. I name the pre-
symptoms and post-symptoms, depending on when
they occur. In particular, the causes of the pre-
symptoms, which will be discussed in this paper,
can be deduced as follows. The hot steam from the
engine room boiler. Or, water entering the heat
exchanger from the buffer tank.
Fig. 6: Simulation Result (Abnormal Case)
Figure 6 shows a simulation of the data at the
time of suspected pre-symptoms and post-
symptoms. The sequence of data changes is as
follows.
1st, drop in heat exchanger discharge temperature
(Blue line).
2nd, decrease in water flow rate(Orange line).
3rd, after some time, the water flow rate switches to
a maximum(Orange line).
4th, after another time, a sharp drop in the heat
exchanger discharge temperature(Blue line).
The heat exchanger discharge temperature, which is
a criterion for sterilization, has not reached the
threshold and sterilization has occurred.
Table 1. Boiler operating environment(Normal).
Table 2. Boiler operating environment(Abnormal).
Type
Property
Value
Aseptic Water Inlet
Temperature
132.6
Aseptic Water Inlet
Pressure
3.71095
Aseptic Water Inlet
Mass Flow
20000
Aseptic Water Outlet
Temperature
138.918
Aseptic Water Outlet
Pressure
3.51095
Aseptic Water Outlet
Mass Flow
20000
Steam Inlet
Temperature
173.089
Table 1 shows the boiler operation data when
the aseptic process is performed normally, and
Table 2 shows the boiler operation data when the
aseptic failure occurs. In the normal case, the aseptic
water flow rate is 16190kg/h and the discharge
temperature is about 140 ◦C. The boiler operation
data for the aseptic failure case shows that the
aseptic water flow rate exceeds 20000 kg/h and the
discharge temperature is lower than the baseline at
about 138.9 ◦C. Although the temperature is low, it
should be considered that the flow rate is already
significantly higher than normal. This is because it
would be unreasonable to assume that the aseptic
failure was caused by the temperature of the steam
provided by the boiler.
4 Experiment
4.1 Simulation Environment
The following Table 3 lists the environments in
which you will perform simulations and analyses.
Table 3. Software Tools : Simulator, Language,
DBMS.
Item
Option
Simulator
DWSIM
Language
Python 3.9 (64-bit)
DBMS
SQL Server 2016 Standard
The simulator uses DWSIM. DWSIM is
available on multiple operating systems including
Windows, Linux, and MacOS. In particular, it is an
open-source CAPE-OPEN simulator, which is
widely used for process simulation in
thermodynamics and chemistry, making it
accessible to beginners.
Python is a free-to-use language, simple,
extensible, and portable. It is also a popular
language for data analytics.
According to the specifications in Table 4, the
server operating system of the factory where the
data for this paper is collected is Windows Server
2016, and the DBMS is MS SQL Server 2016,
Standard. For this research, it is not necessary to
distinguish the DBMS specifically, [11].
Type
Property
Value
Unit
Aseptic Water Inlet
Temperature
132.6
C
Aseptic Water Inlet
Pressure
3.71095
kgf/cm2g
Aseptic Water Inlet
Mass Flow
16190
kg/h
Aseptic Water Outlet
Temperature
140.4
C
Aseptic Water Outlet
Pressure
3.51095
kgf/cm2g
Aseptic Water Outlet
Mass Flow
16190
kg/h
Steam Inlet
Temperature
173.089
C
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Table 4. View Basic Information: PC 1.
Item
Option
CPU
Intel(R) Core(TM) i7-10510U CPU 1.80GHz 2.30 GHz
RAM
32.0GB
Disk
1.50TB(SSD 500GB)
OS
Windows 10 Enterprise
Two PCs are used as shown in the specifications
in Table 4 and Table 5. They were used for
programming and simulation respectively. In Table
IV, the two machines have similar specifications
except for the graphics card.
The following Table 6 information about the
servers from which the data was loaded. The
specifications of the server are also listed in this
paper because they were used to extract the data
needed in the preliminary work of the analysis.
Table 5. View Basic Information: PC 2.
Item
Option
CPU
Intel(R) Core(TM) i7-9750H CPU 2.60GHz 2.60GHz
RAM
32.0GB
Disk
1.0TB(SSD)
GPU
NVIDIA GEFORCE GTX 1660 TI
OS
Windows 11 Pro
Table 6. View Basic Information: DB Server.
Item
Option
CPU
Intel(R)Xeon(R) Gold 6152 CPU @3.20GHz 2.10 GHz
RAM
192.0GB
Disk
3.0TB)
GPU
NVIDIA GEFORCE GTX 1660 TI
OS
Windows Server 2016
4.2 Comparative Analysis
In this paper, I used Python but omitted the source
code.
Simulations were performed to determine if the
heat ex-changer discharge temperature, which is the
baseline information that affects aseptic failure,
varies within the baseline.
There are three main types of data for analysis:
log/digital data, facility operating history, and
production history data. Analog data is temperature,
pressure, flow, etc. collected by SCADA. Log data
is temperature, pressure, flow, etc. collected by
SCADA. Digital data includes things like pump and
valve on/off data. Unavailable data includes history,
production history, and equipment alarm data.
Unplanned maintenance history (unplanned and
unexpected equipment anomaly alarms) is a
component of the smart factory system deployed in
the factory. It is a component of the smart factory
system built in the factory, utilizing data from MES
and SCADA. Unlike the conventional method,
which takes a long time to determine the
corresponding tag by simply comparing normal data
with sterilization failure-related data, it is possible to
determine the corresponding tag by simply
comparing sterilization failure data with sterilization
failure-related data. Also, because visual judgment
is unreliable Select tags related to sterilization by
checking for outliers in the residue.
Figure 7 shows the resulting graphs for two
cases of time series decomposition. After
preprocessing, the time series is decomposed into
the normal operating conditions of the aseptic
process and the date of aseptic failure. Decompose
the time series based on the normal operating
conditions of the aseptic process and the date of
aseptic failure, [12].
Fig. 7. Compare Time-series Decomposition Data
Graphs (Compare normal and Abnormal cases).
5 Results
Simply comparing the normal data with the data
related to sterilization failures to determine the
corresponding tags is time-consuming, and visual
judgment is unreliable. Therefore, we screen for
tags related to sterilization failures by checking for
outliers in the residuals (Checking the quantified
data), [13]. We check when the residuals for each
tag are outliers, which can be detected by logic that
determines whether the current data exceeds a
certain sigma of the historical data (Remember that
after time series decomposition, residuals follow a
normal distribution, [14]). The threshold can be set
to 3 sigma or 6 sigma, which we set to 6 sigma in
this paper.
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Fig. 8: Data extracted by checking for outliers in
the residuals(Tag).
Figure 8 is the Tag information selected through
the previous task (Data selected by checking outliers
in the residuals). However, as mentioned earlier,
instantaneous changes in values caused by already-
known causes are not meaningful for sterilization
cause detection. To select only meaningful data, we
separately select only data lasting more than 30
seconds.
Fig. 9: Check for outliers in residuals for more than
30 consecutive seconds
Figure 9 is the result of extracting only
continuous data over 30 seconds. After analyzing
the time series data, we can select a list of tags
related to sterilization failures. When all tags were
analyzed, the following group of tag values Table 7
showed residual outliers around the time of
sterilization failure.
Table 7. List of Abnormal Residuals.
PRS2 D10107
PRS2 D10106
PRS2 D10128
PRS2 D10127
PRS2 D10801
PRS2 D10804
PRS2 D10101
PRS2 D10146
PRS2 D10403
PRS2 D10145
PRS2 D10123
PRS2 D10802
PRS2 D10402
PRS2 D10404
PRS2 D10401
PRS2 D10122
PRS2 D10142
PRS2 D10121
PRS2 D10108
PRS2 D10147
PRS2 D10141
PRS2 D10144
Select meaningful data from the residuals of
time series data and perform a regression analysis to
determine causality and influence. Perform simple
regression analysis to verify the validity of the
regression analysis. Furthermore, derive a list of
tags that influence the sterilization failure Tag
through multiple regression analysis. From this
analysis, we identified the precursor symptoms for
the selected Tags.
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Fig. 10: Results of Regression Analysis.
Figure 10 shows the results of a simple
regression between one independent variable and
one dependent variable.
1st, R Squared (rsquared adj) is the coefficient of
determination, and the closer it is to 1, the higher the
explanatory power of the regression model.
2nd, F value (fvalue) is the ratio of the square mean
of the regression equation to the square mean of the
residuals (A large ratio means that the regression is
significant in explaining the relationship between
the two variables.).
3rd, Probability of significance (P > |t|): higher than
0.05 is not suitable for use as a variable.
4th, coef (coefficient): Coefficient of the regression
equation, independent variable = intercept +
(dependent variable coef * dependent variable)
After checking the R-value and fvalue, the Tags that
are judged to be causally related to TICA403 (heat
exchanger discharge temperature PRS2 D10101) are
shown in the following Table 8.
Table 8. Tag Results Causally Related to
Sterilization Failure.
PRS2
D10402
PRS2
D10403
PRS2 D10802
PRS2
D10123
PRS2
D10122
Table 8 shows the Tag values that were
determined to be causally related to the heat
exchanger discharge temperature deviating from the
baseline, [15].
6 Conclusion
In this paper, we analyzed the phenomenon of
aseptic failure in aseptic processing. It shows how to
solve the problem in practice. Before the analysis, I
defined some hypotheses.
1st, the temperature of the steam heating the
water is lower than the reference. To identify any
abnormalities in the boiler engine and heat
exchanger, separate checks were carried out.
However, they were operating in the normal range,
so the simulation for verification was also
conducted under normal conditions. Since the
simulation was performed under normal conditions,
we did not find a causal relationship between the
temperature of the vapor and sterility.
2nd hypothesis is an unusual influx of water.
The entry of water into the heat exchanger is
specifically named a pre-symptom. The simulation
results confirm that there is a correlation between
the abnormal inflow of water into the heat
exchanger and the discharge temperature.
3rd hypothesis is that the cooling treatment
water is reintroduced into the heat exchanger. This
is because if cold water flows back into the heat
exchanger, the discharge temperature can be
lowered. This is separately named the post-symptom.
However, due to limitations in collecting relevant
data, this hypothesis was not verified.
For further analysis of the cause of de-
sterilization, we need SCADA Tag information,
which is not yet defined. In addition, the design
specifications for each heat exchanger should
identify its type and performance and the cause of
the discharge temperature variation.
It requires a deep understanding of the process,
such as how to control the sterile water temperature.
It is also a good idea to install an additional flow
meter, as you will need to verify that the flow value
is maintained at 20m3/h in case of sterilization
failure. And, additional instrumentation for the
boiler steam or heat exchanger is also required.
A faulty branching logic based on heat
exchanger discharge temperature was identified and
the discharge temperature measurement sensor was
replaced. More data and further analysis will be
conducted to ensure the aseptic reliability and
stability of the process.
Acknowledgement:
This research was supported by the SungKyunKwan
University and the BK21 FOUR(Graduate School
Innovation) funded by the Ministry of
Education(MOE, Korea) and the National Research
Foundation of Korea(NRF). Corresponding authors:
Prof. Jongpil Jeong.
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Contribution of Individual Authors to the
Creation of a Scientific Article (Ghostwriting
Policy)
The implementation of the algorithmic model and
Python coding for causal inference, simulation,
optimisation, and analysis were performed by
Jungmook Choi.
Jongpil Jung is the corresponding author and helped
review the paper.
Sources of Funding for Research Presented in a
Scientific Article or Scientific Article Itself
No funding was received for conducting this study.
Conflict of Interest
The authors have no conflicts of interest to declare
that are relevant to the content of this article.
Creative Commons Attribution License 4.0
(Attribution 4.0 International, CC BY 4.0)
This article is published under the terms of the
Creative Commons Attribution License 4.0
https://creativecommons.org/licenses/by/4.0/deed.en
_US
WSEAS TRANSACTIONS on ENVIRONMENT and DEVELOPMENT
DOI: 10.37394/232015.2023.19.96
Jeongmook Choi, Jongpil Jeong
E-ISSN: 2224-3496
1025
Volume 19, 2023