SYSTEMATIC LITERATURE REVIEW: QUALITY CONTROL AND ASSURANCE

USING STATISTICAL PROCESSING CONTROL (SPC)

ABSTRACT
In order to achieve effective quality control, companies must establish a good
feedback system, which allows employees to report problems without fear of negative
consequences. An environment that supports open communication contributes to faster
identification and resolution of problems, as well as increasing employee engagement. In the
context of intense market competition, quality control is a priority for companies that want to
survive and thrive. The research method used in this study is the Systematic Literature
Review (SLR), which follows the guidelines set by B. Kitchenham to ensure a thorough
evaluation of the existing literature. The research process begins with a clear research
question, followed by identification of data sources, and determination of inclusion and
exclusion criteria to maintain relevance. Quality assessment is carried out to ensure the
methodological rigor of the selected studies, resulting in an in-depth understanding of the
effectiveness of quality control. The results of the study indicate that the use of Statistical
Process Control (SPC) is very effective in overcoming process variation, minimizing defects,
and increasing customer satisfaction. The integration of SPC with other methods such as Six
Sigma and Just-In-Time, as well as the use of modern technologies such as Artificial
Intelligence and the Internet of Things, can improve the efficiency and responsiveness of
companies to quality problems. Therefore, companies need to invest in employee training and
technology to strengthen quality control, so they can remain competitive in the ever-changing
market.
Keywords :Quality Control, Statistical Process Control (SPC), Feedback Systems

INTRODUCTION
The manufacturing industry plays an important role in the economy, serving as one of
the main drivers in providing goods needed by the community. In the process, this industry
does not only focus on the quantity of production, but also on the quality of the goods
produced. Quality is a determining factor in attracting consumer interest, where high-quality
products have better selling value.[1]. Therefore, many companies invest in technology and
human resource training to improve their production processes. With advanced technology,
companies are able to produce goods more efficiently, reduce waste, and increase accuracy in
the production process. In addition, companies also need to implement an effective quality
management system. Quality management includes various methods and techniques to ensure
that each stage of production meets established standards. Regular quality audits and product
testing are an integral part of this process, to detect and correct problems before the product
reaches the consumer. The involvement of all employees in efforts to maintain quality is also
very important, where each individual has the responsibility to ensure that the products
produced are of good quality.
In facing global competition, manufacturing companies must continue to adapt to
changing market trends and consumer needs. Research and product development are key to
creating innovations that can meet consumer expectations. In addition, understanding
consumer behavior and conducting market surveys can provide valuable insights that help
companies design more effective marketing strategies. By utilizing data analytics and
information technology, companies can identify new opportunities and optimize existing
resources. Technological changes also affect the way companies manage their supply chains.
An efficient and integrated supply chain helps companies reduce operational costs and speed
up delivery times.[2]. Using a modern supply chain management system allows companies to
track every step in the production process, from raw material procurement to finished product
distribution. This system integration not only increases efficiency, but also helps companies
maintain good relationships with suppliers and distributors.[3].
Customer satisfaction is a major focus in the manufacturing industry. To achieve this,
companies need to listen to consumer feedback and make continuous improvements.
Implementing a good customer service program can increase consumer loyalty and trust in
the brand. In addition, companies must also be responsive to changing market needs and be
willing to make adjustments in the products or services provided. In this way, companies can
maintain their relevance in an ever-changing market. Sustainability is also an increasingly
important issue in the manufacturing industry. Companies are required to not only produce
goods, but also to do so in an environmentally friendly way. The use of green technology and
sustainable production practices can reduce the negative impact on the environment. In
addition, many consumers now prefer products from companies that are committed to
sustainability, so this can be an added value for the company[4].
Investment in human resources is an equally important aspect. Skilled and motivated
employees can make a significant contribution to productivity and product quality. Therefore,
companies need to provide adequate training and create a work environment that supports
employee development. By providing opportunities for employees to learn and develop,
companies not only improve the skills of the workforce but also create a positive corporate
culture. Amidst the existing challenges, companies must also pay attention to the financial
aspect. Good financial management is crucial to ensure the continuity of the company's
operations. Careful budget planning and cost control can help companies maximize profits
and reduce the risk of bankruptcy. In this case, the use of information technology in financial
management can provide a significant competitive advantage.[5].
Community involvement can also have a positive impact on a company’s reputation.
By participating in social activities and supporting local initiatives, companies can build
better relationships with their local communities. This not only improves the company’s
image, but it can also open up new business opportunities. For example, companies that
actively support education or environmental conservation can attract consumers who care
about these issues.[6]. Finally, crisis resilience is also an important aspect in the
manufacturing industry. Companies must have a solid contingency plan to deal with various
possible disruptions, such as natural disasters, economic crises, or regulatory changes.
Developing flexible and adaptive systems can help companies survive and remain
competitive in unexpected situations. With the right approach, manufacturing companies can
continue to thrive despite the challenges.
Quality control is a crucial element in every production process in the manufacturing
industry. It involves various aspects designed to ensure that the product produced meets the
established quality standards. This process begins with careful planning, where the company
determines the desired product specifications. These specifications form the basis for all
quality control activities carried out.[7]. In addition, the use of proper equipment is also very
important, because inappropriate equipment can cause errors in production that lead to
defective products. Inspection is also an integral part of quality control. This process is not
only carried out at the final stage of production, but must be carried out continuously
throughout the production process. Continuous inspection helps in detecting problems as
early as possible, so that corrective action can be taken before the product reaches the
consumer. Quality control does not only focus on whether the product is acceptable or
rejected, but also includes an in-depth analysis of various factors that can affect quality, such
as raw materials, production processes, and work environment.
One approach that is often used in quality control is Total Quality Management
(TQM). TQM is a management philosophy that emphasizes the importance of involving all
employees in efforts to improve quality. By involving the entire workforce, companies can
create a quality-oriented culture, where each individual feels responsible for the results of
their work. Through training and development, employees can be equipped with the skills
and knowledge needed to recognize and solve quality problems. The application of statistical
methods in quality control has also proven effective[8]. Statistical Process Control (SPC) is a
technique that uses statistical tools to monitor and control the production process. By using
control charts, companies can identify variations in the process and determine whether the
process is within acceptable limits. If undesirable variations are detected, immediate action
can be taken to restore the process to normal conditions. This approach not only improves
product quality but also operational efficiency.[9, p. 3].
In addition, it is important to conduct periodic quality audits. This audit aims to assess
the effectiveness of the quality control system that has been implemented. Through audits,
companies can identify areas that need improvement and develop action plans to improve
quality performance. A systematic audit process also helps ensure that all procedures and
policies are being followed properly by all members of the organization. Customer
involvement in the quality control process is also very important. Customer feedback can
provide valuable insights into product performance in the market. By understanding
consumer expectations and needs, companies can make necessary adjustments to improve
product quality. In addition, companies can also conduct periodic customer satisfaction
surveys to collect data that can be used as a basis for improvement.[10].
Quality control must also consider sustainability aspects. In this modern era, many
companies are starting to implement environmentally friendly practices in their production
processes. Efforts to reduce waste and optimize the use of resources are not only beneficial
for the environment, but can also improve the company's image in the eyes of consumers.
Thus, quality control does not only focus on the end product, but also includes
environmentally friendly processes. The application of information technology in quality
control is also increasing. Software-based quality management systems allow companies to
manage quality data efficiently. Through this system, companies can monitor all aspects of
quality in real-time and perform in-depth analysis. The collected data can be used to identify
trends and patterns that can help in better decision making.[11].
In facing the challenges of globalization, companies must also adapt to international
quality standards. Certification such as ISO 9001 is one way to demonstrate a company's
commitment to quality. By obtaining this certification, companies not only improve their
reputation but also open up opportunities to enter international markets. The process of
obtaining this certification requires significant effort in terms of documentation, audits, and
training, but the benefits are worth the effort. High product quality also contributes to
customer loyalty. Customers tend to return to buy products from companies they trust to have
good quality.[11]. Therefore, investment in quality control should be seen as a long-term
investment that can provide benefits to the company. By maintaining high quality standards,
companies can build strong relationships with customers, which in turn will increase profits
and business sustainability.
In addition, quality control also plays a role in reducing production costs. Defective
products can cause significant losses, both in terms of product returns and repair costs. By
implementing effective quality control, companies can minimize the level of defects and, as a
result, reduce the costs associated with returns and repairs. This will increase the efficiency
and profitability of the company. The involvement of top management is also very important
in quality control. The support and commitment of top management will ensure that all
necessary resources are available to support quality initiatives. In addition, management must
also be an example for employees in terms of commitment to quality. By demonstrating
strong leadership in quality control, management can encourage the entire organization to
focus on improving product and process quality.
In order to achieve the goal of effective quality control, companies need to create a
good feedback system. This system allows employees to report quality issues without fear of
negative consequences. By creating an environment that supports open communication,
companies can more quickly identify and resolve emerging issues. This will also increase
employee engagement and create a sense of ownership of their work. The importance of
quality control cannot be underestimated in the context of increasingly competitive markets.
With so many choices available to consumers, companies that fail to maintain good quality
standards risk losing market share. Therefore, quality control must be a top priority for any
company that wants to survive and thrive in a competitive industry. Efforts made in quality
control will not only improve the products produced but also make a positive contribution to
the company's image and sustainability in the eyes of consumers and the wider community.

RESEARCH METHODS
1. Systematic Literature Review (SLR)
In this study, the review method follows the guidelines set by B. Kitchenham
for conducting a systematic literature review (SLR).[12]. This structured approach
ensures a comprehensive and rigorous evaluation of the existing literature. The review
begins with a clearly defined research question that guides the scope and focus of the
investigation. Next, data sources are identified, including academic journals,
 conference proceedings, and other relevant publications to gather a robust body of
material. Inclusion and exclusion criteria are then established to filter the literature,
ensuring that only relevant studies are considered. This step is critical in maintaining
the relevance and quality of the review. Following this, a quality assessment is
conducted to evaluate the methodological rigor of the selected studies, allowing for
the identification of high-quality literature.
Data extraction involves systematically gathering information from selected
studies, focusing on key findings and methodologies. Finally, data synthesis integrates
the extracted information, allowing for a comprehensive analysis of trends, gaps, and
implications in the existing body of knowledge on the spiral development model. This
systematic approach not only increases the reliability of the findings but also
contributes significantly to the understanding of the application areas and
effectiveness of the model.

Figure 1: Research Methodology

2. Scientific Article and Journal Search Process
Defining research questions is an important step in conducting a systematic
review, as these questions guide the investigation and focus on addressing specific
issues in the literature. In this study, three main research questions have been
formulated to guide the investigation:
1. RQ1 seeks to identify research topics that utilize the spiral development
method.
2. RQ2 aims to explore trends in the application of this method over the last
decade, providing insights into its evolving use.
 3. RQ3 investigates the different areas in which the spiral model is applied,
highlighting its interdisciplinary relevance.
By articulating these questions, this review establishes a framework for
systematic exploration and analysis of the application of the spiral development
model in research and practice.
To collect relevant data for this literature review, multiple data sources were
used. The “Publish or Perish 8” application facilitated the identification of relevant
papers, while additional platforms such as Connected Papers, IEEE Xplore, Elsevier,
ACM Digital Library, Springer, and ResearchGate were used to access indexed
research articles. Inclusion and exclusion criteria were carefully defined to ensure the
relevance and quality of the selected literature. Inclusion criteria stipulated that only
full-text papers published in the last ten years (2014 to 2022) would be considered.
Conversely, exclusion criteria excluded any studies that did not meet these
requirements or that deviated from the established focus.
Finally, a total of 30 relevant journals were identified for review. The data
extraction process involved collecting key information from these papers, including
author names, year of publication, venue of publication, topic, and field of
application. This data synthesis will culminate in a comprehensive analysis that
directly answers the research questions and contributes to a deeper understanding of
the significance of the spiral development model in various domains.
RESULTS AND DISCUSSION
Production quality control is one of the crucial aspects in industry, aiming to ensure
that the products produced meet the established quality standards.
Table 1 : Journal Article Sources
Source Amount
Google Scholar 22
Semantic Scholar 8
Total 30

Table 2: Scopus Indexed Journals

Index Amount
Quartile 4 6
Quartile 3 9
 Quartile 2 10
Quartile 1 5

This literature review underlines that the application of both approaches is not only
relevant, but also very important in the context of modern industry.

Table 3: Results of Systematic Literature Review

Authors Yea Title Methods Domain Industries Journal
r Quartile
Donmezer, 2020 Statistical Statistical Quality Manufacturing, Q4
S.[13] Process Process Management Public
Control (SPC) Control (SPC), Administration,
and Quality Quality Education,
Management Management Non-Profit
Systems as a Systems
Specialty of
Quality
Management
and Case
Turkey
Alım, M., & 2023 Statistical Statistical Quality Manufacturing, Q4
Kesen, S.E. process control Process Control Industry 4.0
[14] (SPC) and Control (SPC),
quality Industry 4.0
management
Xiao, Q., & 2024 Application Statistical Radiation Healthcare Q4
Li, G.[15] and challenges Process Therapy
of statistical Control (SPC),
process control Quality
in radiation Assurance
therapy quality
assurance
Hajej, Z., 2021 An integrated Statistical Supply Chain, Manufacturing Q4
Nyoungue, model of Process Manufacturing
AC, production, Control (SPC),
Abubakar, maintenance, Integrated
AS, & and quality Model,
Mohamed control with Production,
Ali, K.[16] statistical Maintenance
process control
chart of a
supply chain
Raveendran, 2023 Moving Statistical Radiotherapy Healthcare Q4
V., Anjana, towards Process
PT, Bhasi, process-based Control (SPC),
S., Ranjith, radiotherapy Quality
CP, & quality Assurance
Kinhikar, assurance
R.A.[17] using statistical
process control
Cui, L.[18] 2020 A study on Statistical Pharmaceutical Healthcare, Q3
statistical Process Manufacturing
process control Control (SPC),
(SPC) in Pharmaceutica
pharmaceutical l Contract
contract Manufacturing
manufacturing:
potential
determinants of
SPC
implementation
success
Xiao, Q., 2020 Statistical Statistical Radiotherapy Healthcare Q3
Bai, S., Li, process control Process
G., Yang, and process Control (SPC),
K., Bai, L., capability Process
Li, Z., ... & analysis for Capability
Zhong, R. non‐normal Analysis
[19] volumetric
modulated arc
therapy
patient‐specific
quality
assurance
processes
Puyati, W., 2020 Predictive Statistical Quality Healthcare Q3
Khawne, quality Process Assurance
A., Barnes, assurance of a Control (SPC),
M., Zwan, linear ARIMA
B., Greer, accelerator Forecast
P., & based on the Modeling
Fuangrod, machine
T.[20] performance
check
application
using statistical
process control
and ARIMA
forecast
modeling
Gessa, A., 2022 A practical Qualitative Education Higher Q2
Marin, E., application of methodology, Education
& Sancha, statistical action-based
P.[21] process case study, SPC
control to application on
evaluate the academic
 performance programs
rate of
academic
programs:
implications
and
suggestions
ABEJE, A. 2021 Quality Direct Dairy Industry Dairy Q3
[22] improvement observation,
using focus group
statistical discussion, bar
process chart, flow
control tools chart, control
in process chart, Pareto,
control in cause and effect
dairy diagram
industry-the
case of Sebeta
Agro Industry
Bi, HH[23] 2022 Applying SPC charts Education Higher Q2
statistical (X¯−S), Education
process historical
control to teaching
teaching evaluation data,
quality performance
assurance at assessment
higher
education
institutions
Jin, Y., Du, 2022 Application of NIR Pharmaceutical Traditional Q2
W., Liu, X., near infrared spectroscopy, Chinese
& Wu, Y. spectroscopy RTRT, SPC Medicine
[24] and real time tools
release testing (Shewhart,
combined Hotelling T2,
with statistical SPE)
process
control charts
for on-line
quality control
of industrial
concentrating
process of
traditional
Chinese
medicine
“Jinyinhua”
Prata, 2021 Statistical Risk Food Industry Food Q1
ERBDA, quality control quantification,
Chaves, in the food estimated
JBP, industry: a operating
Gomes, risk-based characteristic
SGS, & approach curves, Monte
Passos, Carlo
FJV[25] simulations
Vysakh, R., 2022 Statistical SPC tools, I- Healthcare Radiotherapy Q2
Raman, Process MR charts,
R.G., Niyas, Control in time-weighted
P., & Aflah, Monitoring control charts,
P.[26] Radiotherapy PSQA analysis,
Quality cause-and-
Assurance effect diagrams
Program: An
Institutional
Experience
Eissa, 2024 Assessment of SPC, box plots, Pharmaceutical Pharmaceuticals Q3
ME[27] Some correlation
Inspection matrix,
Properties of statistical
Commonly analysis of raw
Used material testing
Medicinal characteristics
Excipients
Using
Statistical
Process
Control for
Monitoring of
Manufacturer
Quality

Park, S.H., 2022 Analysis of Statistical Healthcare Medical Q1

Choi, J., criteria applied Process Devices
Kim, K.S., to Control (SPC),
Kim, K., Tomotherapy Data Analysis
Ahn, S., & DQA using
Cho, S. statistical
[28] process control
(SPC)
Goecks, 2024 Industry 4.0 Literature Manufacturing Smart Q2
LS, and Smart Reviews, Manufacturing
Habekost, Systems in Interviews,
AF, Manufacturing: Design
Coruzzolo, Guidelines for Science
AM, & the Research
Sellitto, Implementatio
MA[29] n of SPC
Jin, W., 2021 Research and Statistical Manufacturing Tobacco Q3
Qian, J., Application of Process
Zhang, Q., SPC in Process Control (SPC),
Gao, X., & Quality Control Quality
Xu, Y.[30] of Tobacco Control
Industry
Kyung 2022 Feasibility on Statistical Healthcare Medical Q1
Hwan, C. Statistical Process Devices
[31] Process Control (SPC),
Control Data Analysis
Analysis of
Delivery
Quality
Assurance in
Helical
Tomotherapy
Rana, S., 2020 Determination Statistical Healthcare Medical Q2
Eckert, C., of machine- Process Devices
Singh, H., specific Control (SPC),
Zheng, Y., tolerances QA Dosimetry
Chacko, using statistical
M., process control
Storey, analysis
M., &
Chang, J.
[32]
Xu, Z., 2021 Effectiveness Statistical Construction Road Q3
Zhou, Q., of SPC Control Process Construction
Chen, G., Charts in Control (SPC),
Wang, Y., Asphalt Quality
Yang, X., Pavement Control
& Liu, Z. Construction
[33] Quality Control
Sanchez- 2020 Multivariate Multivariate Manufacturing Automotive Q2
Marquez, SPC methods SPC,
R., & for controlling Predictive
Vivas, manufacturing Modeling
J.M.J[34] processes using
predictive
models
Kharub, 2020 Integrating Statistical Pharmaceutical Pharmaceutical Q3
M.[35] HACCP and Process s
SPC for hazard Control (SPC),
control and HACCP, Case
process Study
improvement
in the
pharmaceutical
industry

Cui, T., 2022 Improving Statistical Healthcare Radiation Q2

Peng, J.X., intensity- process control Therapy
Jin, XL, modulated (SPC), I-chart,
Chu, X.G., radiation Exponentially
Zhang, J., therapy quality weighted
Cui, L.Z., assurance by moving
& Xing, adopting averages
X.F.[36] statistical (EWMA)
process control chart,
Electronic
portal imaging
device (EPID)
Gormen, 2022 Statistical Statistical Manufacturing Gear Wheel Q4
M.[37] Process process control Production
Control (SPC) (SPC)
under the
Quality
Approach of
Just In Time
(JIT)
Manufacturing
Philosophy
and an
Application
Masnar, 2024 Utilizing Statistical Education Construction Q3
HM, & Student Process Technology
Namoco Performance Control (SPC),
Jr, CS[38] Data in P charts, MS
Monitoring Excel
New
Curriculum in
Construction
Technology
Using
Statistical
Process
Control (SPC)
Li, J., 2023 Predictive Statistical Healthcare Radiotherapy Q2
Wang, D., quality Process
& Chan, assurance for Control (SPC),
M.[39] linear AutoRegressiv
accelerator e Integrated
target failure Moving
using Average
statistical (ARIMA)
process control modeling,
Retrospective
QA data
analysis
BETSHA 2021 Quality Using Direct Manufacturing Mobile Phone Q4
SENAI, B. Improvement observation, Assembly
[40] SPC Tools in Pareto chart
Mobile Phone analysis,
Assembly Control charts,
Industry in Interviews,
Case of Questionnaires
Transsion
Manufacturing
PLC
Strand, S., 2021 Analysis of Statistical Healthcare Medical Q1
Boczkows patient-specific Process Imaging
ki, A., quality Control (SPC),
Smith, B., assurance for Gamma pass
Snyder, Elekta Unity rate analysis,
J.E., Hyer, adaptive plans Process
D.E., using capability
Yaddanap statistical ratio, IMRT
udi, S., ... process control QA
& St‐ methodology measurements
Aubin, J.
[41]
Galindo- 2022 Smart Systematic Manufacturing Smart Q2
Salcedo, manufacturing review, Manufacturing
M., applications Machine , Inspection &
Pertúz- for inspection learning, QA
Moreno, and quality Automation in
A., assurance statistical
Guzmán- processes quality control,
Castillo, Artificial
S., vision, Neural
Gómez- networks
Charris,
Y., &
Romero-
Conrado,
A.R.[42]

Quality control is an essential element in any organization that wants to maintain and
improve its reputation and customer satisfaction. In this context, Statistical Process Control
(SPC) emerges as one of the most effective methods used to ensure that the products or
services produced meet the established quality standards. SPC utilizes statistical tools to
monitor and control variability in the production process, thereby helping organizations
detect and address quality problems before they become larger defects. By maintaining
variability within acceptable limits, SPC serves as an essential preventive tool in quality
control.
 One important aspect of SPC is the use of control charts, which allow companies to
visualize and analyze data from the production process. Shewhart charts, X-bar charts, and R
charts are some of the common types of control charts used in SPC. Through these charts,
companies can easily detect changes in the process that may indicate a quality problem. The
main advantage of SPC over other quality control methods is its ability to detect deviations
from quality standards that may not be detected through manual inspection or individual
product inspection. This makes SPC a more proactive approach to quality control, where
problems can be identified and addressed earlier in the production process.
In the manufacturing sector, the application of SPC is very widespread and has proven
effective in improving product quality. A study by Dönmezer[13]showed that the application
of SPC in quality management in Turkey has successfully maintained production quality
within the desired range in various sectors, including manufacturing, education, and public
administration. This shows that SPC is not only relevant in the context of traditional
industries, but can also be adapted to a variety of other applications. In the era of Industry
4.0, SPC is increasingly integrated with digital technologies and automation, which allows
companies to increase the effectiveness of quality control by analyzing data in real time. This
integration brings significant changes in the way quality control is carried out, where fast and
accurate data analysis is key to making the right decisions. However, the application of SPC
is not limited to the manufacturing sector. In the healthcare sector, for example, SPC plays a
very important role in ensuring patient safety and quality of care. The use of SPC in
radiotherapy has shown that continuous monitoring using control charts can help identify
problems early and prevent errors that could potentially harm patients[17]. Additionally, a
study by Xiao et al.[15]about the application of SPC in radiation quality assurance shows that
the application of this method in medical process supervision can improve the accuracy and
reliability of health services. Thus, SPC not only serves to improve product quality, but also
has a significant impact on public safety and health.
Although SPC offers many benefits, there are still challenges in its implementation.
One of the main challenges is the need for accurate data and adequate statistical skills. Many
organizations may face difficulties in collecting the necessary data or in analyzing it
effectively. Therefore, it is important for companies to provide adequate training to
employees on the basic concepts of statistics and quality control. Lack of understanding of
statistical methods can hinder the effectiveness of SPC, preventing companies from utilizing
the full potential of this tool. In addition, organizational culture also plays a significant role in
the success of SPC implementation. Companies that support open communication and
constructive feedback are better able to identify quality issues and respond to them quickly.
Creating an environment that supports employee involvement in the quality control process
not only improves morale but also creates a sense of ownership in the results of their work.
By involving all employees in this process, organizations can increase their commitment to
quality and innovation.
The recommendation for organizations looking to implement SPC is to start with a
structured approach. This includes setting clear and specific goals for quality control and
identifying the most critical processes to monitor. Additionally, investing in technology that
supports data collection and analysis is highly recommended. With the right tools,
organizations can collect relevant data and make more effective, data-driven decisions.
Implementing SPC should be viewed as part of a long-term strategy for continuous
improvement, not just a one-time activity. Finally, continuous evaluation and adjustment of
the methods and tools used in SPC will ensure that organizations remain competitive and able
to meet customer expectations in an ever-changing era. With these steps, quality control
using SPC can become a key pillar in a successful business strategy. In an increasingly
complex and interconnected world, the ability to maintain high quality standards is key to an
organization’s success and sustainability. As such, SPC is not only relevant but also crucial to
the future of quality control, whether in the manufacturing, healthcare, or other industries.
Although Statistical Process Control (SPC) offers many benefits in quality control, its
implementation is not always smooth. One of the main challenges faced is the reliance on
accurate and consistent data. The success of SPC is highly dependent on the quality of data
collected from the process being analyzed. Without good data, SPC analysis results can be
misleading and unreliable. This is evident in several studies that show that data inaccuracy is
often a major obstacle in the implementation of SPC, especially in more complex industries
such as pharmaceuticals and radiotherapy.[18][33]. In this context, organizations must ensure
that the data collection systems they use can produce valid and timely information.
Otherwise, companies risk making wrong decisions, which can have a negative impact on the
quality of their products or services.
In addition, SPC implementation requires a high level of statistical skills. Many
companies or organizations are reluctant to adopt SPC due to limited human resources skilled
in the use of this statistical tool. In the healthcare sector, for example, the use of SPC tools
may be limited by the need for special training for medical professionals who usually do not
have a statistical background. This can slow down the adoption of SPC in certain sectors that
require intensive quality control. Lack of understanding of statistical methods can result in
errors in data interpretation, which ultimately reduces the effectiveness of SPC as a quality
control tool. This constraint indicates the need for investment in human resource training and
development. Companies must provide adequate education for employees on basic statistical
concepts and the use of SPC tools. This is not only about providing technical training, but
also about creating an organizational culture that supports continuous learning and quality
improvement. Without the right skills, even if SPC tools are implemented, the expected
results may not be achieved.
Furthermore, another challenge faced is resistance to change. In many organizations,
especially those with established cultures, SPC adoption can be seen as a threat to the status
quo. Employees may feel uncomfortable with changes in work processes or fear negative
impacts on their jobs. Therefore, it is important for management to communicate the benefits
of SPC implementation and involve employees in the change process. Gaining support from
all levels of the organization is key to achieving success in SPC implementation. In addition,
integrating SPC with modern technologies, such as automation systems and data analytics, is
also a challenge. While technology can improve efficiency in data collection and analysis,
companies need to ensure that the systems used are well integrated with each other.
Incompatibility between different systems can result in problems in data collection and
analysis required for SPC implementation. Therefore, it is important for companies to
conduct a thorough evaluation of their technology infrastructure before adopting SPC.
Overall, although SPC offers many advantages in quality control, the challenges faced
in its implementation cannot be ignored. Reliance on accurate data, the need for statistical
skills, resistance to change, and technology integration are some of the factors that can affect
the success of this method. Therefore, companies must take strategic steps to overcome these
challenges, including investment in training, effective communication, and evaluation of
technology infrastructure. In this way, SPC can be implemented more effectively, helping
organizations to maintain high quality standards and improve customer satisfaction.
The application of Statistical Process Control (SPC) is often more effective when
combined with other methods of quality control. One interesting example is the combination
of SPC with other techniques such as Six Sigma and Just-in-Time (JIT). This method not
only allows companies to monitor product quality, but also to improve overall efficiency and
productivity. In this context, research by Görmen[37]shows that the use of SPC in the JIT
manufacturing philosophy has proven effective in reducing process variability and increasing
production efficiency. The JIT approach emphasizes the importance of producing goods only
when needed, which reduces waste and optimizes resource use. By combining JIT and SPC,
companies can monitor processes in real time, detect variability, and make immediate
improvements, thereby increasing competitiveness in an increasingly competitive market.
In an industrial context, the application of SPC in JIT allows companies to adapt
quickly to market demand. When demand increases, companies can easily increase
production without sacrificing quality. Conversely, when demand decreases, companies can
reduce production to avoid unnecessary inventory buildup. In this regard, SPC serves as a
very important tool for monitoring and controlling processes, which in turn supports the JIT
goal of reducing waste and increasing efficiency. The use of control charts in SPC helps
companies to see patterns in process variability and take necessary actions before quality
problems arise. In the pharmaceutical sector, the combination of SPC with Hazard Analysis
Critical Control Point (HACCP) has also proven to be beneficial in identifying and
controlling risks during the production process. Research by Kharub[35]shows that this
combination ensures that the process is not only controlled statistically, but also through a
more holistic approach to risk management. HACCP, which focuses on identifying critical
points in the production process, works together with SPC to provide a comprehensive
picture of product quality and safety. In the pharmaceutical industry, where product safety is
a top priority, this combination is essential to ensure that all risks are identified and managed
properly.
By implementing SPC within the HACCP framework, companies can more
effectively monitor process variability that may affect product safety. For example, by using
control charts to monitor critical parameters, companies can immediately detect deviations
that may indicate potential risks. This way, corrective action can be taken before the product
reaches the consumer, which is crucial in maintaining customer reputation and trust.
Furthermore, integrating SPC with other methods also provides benefits in terms of training
and development of human resources. When companies adopt a more comprehensive
approach to quality control, employees are given broader and more in-depth training on
various methodologies. This not only improves their skills in using statistical tools but also
helps them understand the importance of quality control in a broader context. As a result,
employees become more involved in the continuous improvement process and more aware of
the impact of their work on the quality of the final product.
However, while this combination of methods offers many advantages, there are some
challenges that need to be addressed. One of these is the need to coordinate the various
systems and processes involved in implementing SPC along with other methods. Poor
coordination can lead to confusion and inefficiencies, which can reduce the effectiveness of
quality control. Therefore, management must ensure that good communication and
collaboration between teams are established to ensure that all elements of the quality control
process support each other. In addition, companies must also be prepared to continuously
evaluate and adjust the methods used. In a dynamic business world, needs and challenges can
change quickly. Therefore, it is important to continuously monitor the effectiveness of the
quality control methods used and make adjustments when necessary. The use of modern
technologies, such as data analytics and automation, can be very helpful in this regard,
providing valuable insights that can be used to improve the quality control process.
Furthermore, the technological aspect must also be considered in the implementation
of SPC and other methods. Innovations in information and communication technology allow
for more efficient data collection and analysis. By utilizing the latest technology, companies
can collect data in real time and integrate it into their quality control systems. This not only
increases the speed and accuracy of data analysis, but also allows companies to respond to
quality issues more quickly and effectively. In conclusion, the combination of SPC with other
methods such as Six Sigma and JIT or HACCP offers a more comprehensive approach to
quality control. Through good integration, companies can reduce variability, increase
efficiency, and maintain product safety. Although there are challenges in its implementation,
with the right strategy and technological support, organizations can achieve maximum
benefits from effective quality control. Thus, the implementation of integrated SPC not only
helps companies maintain high quality standards but also provides a sustainable competitive
advantage in the market.
With the development of technology, the approach to quality control, especially
Statistical Process Control (SPC), has also undergone significant evolution. The Industry 4.0
era, characterized by automation, real-time data analysis, and the integration of digital
technology into the production process, opens up new opportunities to improve the
effectiveness of quality control. This transformation not only improves the way companies
monitor and control quality, but also allows them to adapt quickly to changing customer
needs and expectations. One of the important advances in the implementation of SPC is the
use of technologies such as machine learning and artificial intelligence (AI). In a study
conducted by Sanchez-Marquez and Vivas[34], it was found that combining SPC methods
with machine learning techniques shows great potential in improving the accuracy of quality
prediction and defect detection in manufacturing processes. By utilizing advanced algorithms,
companies can analyze historical data and detect patterns that may not be visible with
traditional methods. This allows companies to intervene before quality problems occur,
reducing the cost and time spent on remediation after defects are detected.
The use of sensors and Internet of Things (IoT) devices also contributes to the
development of SPC. Sensors installed on machines and equipment allow for more accurate
and real-time data collection. This data, which includes a variety of operational parameters,
can be used to continuously monitor processes, providing a clearer picture of product
performance and quality. With real-time data, companies can perform more in-depth analysis
and make faster, more informed decisions. It also allows companies to dynamically adjust
production processes based on current conditions, increasing efficiency and reducing waste.
Integrating SPC with software-based quality management systems also speeds up the analysis
process and allows for more efficient quality monitoring. In this context, quality management
software can automate many aspects of quality control, including data collection, processing,
and reporting. Using a cloud-based platform, data can be accessed and analyzed in real time
by various stakeholders, increasing collaboration and transparency in quality control. In the
healthcare sector, software-based applications for SPC not only enable faster and more
accurate monitoring of the quality of patient care, but also facilitate data analysis that can be
used for continuous improvement.[28].
The combination of all these advancements creates an ecosystem where quality
control is no longer reactive, but rather proactive and predictive. With the ability to identify
potential problems before they occur, companies can reduce risk and increase customer
satisfaction. For example, in the automotive industry, where quality standards are extremely
high, the integration of SPC with modern technology allows manufacturers to monitor every
stage of the production process. If data indicates deviations from quality standards, corrective
action can be taken immediately, before the product reaches the consumer. However, despite
the many benefits offered by the evolution of SPC, there are also some challenges that need
to be addressed. First, investing in new technology often involves significant costs, which can
be prohibitive for small or medium-sized companies. In addition, there is a need to train
employees in the use of these new technologies. Untrained employees may have difficulty
understanding and using new tools, which can ultimately reduce the effectiveness of quality
control. Therefore, it is important for companies to plan appropriate training and skills
development to ensure that all employees can take full advantage of new technologies.
Another common challenge is data integration. When companies adopt new systems
and tools, the resulting data is often not well integrated. This can lead to difficulties in
analysis and decision-making. To address this issue, companies need to ensure that the
systems they use can seamlessly connect and exchange information. The use of consistent
data standards and compatible platforms can help mitigate this issue. In addition, companies
must also consider data security when implementing new technologies. With the increasing
amount of data being collected and analyzed in real-time, the risk of data breaches also
increases. Protecting sensitive data must be a priority so that information about processes and
products does not fall into the wrong hands. Implementing security policies and procedures to
protect data is essential to maintaining customer trust and the integrity of the company.
Despite these challenges, the benefits of implementing SPC integrated with modern
technology are far greater. A more efficient and effective quality control process can make a
significant contribution to a company’s competitiveness. In an increasingly competitive
business world, companies that are able to adopt new technologies in quality control will not
only be able to maintain high quality standards, but will also have the ability to innovate and
adapt quickly to market changes. Successful examples of SPC implementation in the context
of Industry 4.0 can be seen in the case of large companies in the manufacturing and
healthcare sectors. Many automotive companies have adopted advanced technology to
monitor and control quality in their production processes. By using SPC integrated with
sensors and automation systems, they can ensure that each component meets stringent quality
standards before being assembled into a vehicle. This not only increases production
efficiency but also reduces the number of defective products reaching the market.
In the healthcare sector, hospitals and medical facilities are beginning to adopt
software-based SPC systems to monitor the quality of patient care. Using real-time data, they
can identify potential problems in care and take preventive action. For example, if data shows
that waiting times for a particular treatment are increasing, management can immediately
evaluate and make adjustments to improve efficiency and quality of service. The successful
implementation of SPC in the context of Industry 4.0 shows that combining traditional
quality control methods with modern technology can create a more robust and responsive
quality control system. By leveraging data collected from various sources and analyzing it
with sophisticated tools, companies can make better and more timely decisions in
maintaining the quality of their products and services.
In conclusion, the evolution of SPC in the Industry 4.0 era opens up significant new
opportunities to improve quality control. By leveraging technologies such as machine
learning, AI, and IoT, companies can monitor and control product quality more accurately
and efficiently. Despite the challenges in implementation, the benefits offered by integrating
modern technologies with traditional quality control methods are enormous. Companies that
are able to adapt to these changes will have a significant competitive advantage in the market.
Therefore, investing in the right technology and training is critical to ensuring the success of
effective and sustainable SPC implementation.
Histograms are an essential tool in data analysis, serving to illustrate variations in a
process in an easy-to-understand manner. These bar charts present a tabulation of data
arranged according to a specific measure, known as a frequency distribution. Each bar in the
histogram represents the frequency or number of occurrences of the data within a specific
range of values, allowing the user to quickly see how the data is spread out. One of the main
characteristics of a histogram is its ability to show patterns in the data. A normal, or bell-
shaped, histogram indicates that the data is mostly distributed around the mean. In a normal
distribution, the frequency of the data decreases as you move away from the mean, so that the
mean, median, and mode are all roughly the same. This shows consistency in the data, which
can be an indication that the process that produced the data is working well and consistently.
[43].
On the other hand, an asymmetrical or skewed histogram can provide important
information about the imbalanced distribution of data. For example, a histogram that is
skewed to the left indicates that much of the data is concentrated at the upper limit, while a
histogram that is skewed to the right indicates that the data is concentrated at the lower limit.
This abnormality can indicate factors that affect the process, such as variability in raw
materials, production methods, or even measurement errors. Thus, histogram analysis can
help professionals identify and understand the source of problems in the production process.
[43]. One of the advantages of histograms is their ability to provide easy-to-understand visual
information. Through graphical displays, a data analyst can quickly understand how the data
is distributed, without having to analyze the numbers in detail. This makes histograms a
popular tool in data presentations, both in academic and industrial settings. This clear and
concise visualization helps in conveying information to a variety of stakeholders, from
managers to field staff.
In practice[43], histograms are also used to compare the distributions of two or more
data sets. By displaying multiple histograms on the same graph, comparative analysis can be
performed to identify differences and similarities between the datasets. This approach is
particularly useful in experimental studies where the researcher wants to determine the effect
of a particular variable on an observed outcome. For example, in a study of the effectiveness
of two teaching methods, a histogram might be used to compare the test scores of students
taught by the two methods. Creating an effective histogram requires attention to several
factors, including choosing the right number of classes or intervals. If too few classes are
selected, important details in the data may be lost, while too many classes can make the
histogram complex and difficult to interpret. Therefore, the determination of the number of
classes must be done carefully, often taking into account the sample size and the variation in
the data. Common approaches are Sturges' rule or the Freedman-Diaconis method, which can
provide guidance in determining the optimal number of classes.
Histograms can also be applied in a variety of fields, including statistics, engineering,
and scientific research. In statistics, histograms are often used to evaluate the distribution of
data before conducting further analysis. In engineering, histograms can aid in quality control
by providing insight into variations in the production process. For example, in the
manufacturing industry, histograms are used to monitor product dimensions and ensure that
they meet set specifications. Histograms are also useful in public health. For example, in
epidemiology, histograms can be used to depict the distribution of disease in a population and
aid in decision-making regarding health interventions. By effectively visualizing data,
histograms enable policymakers to understand disease trends and patterns, thereby
formulating more appropriate strategies for addressing public health issues.[44].
The use of histograms is not limited to quantitative data analysis. In qualitative data
analysis, histograms can also be used to depict the frequency of certain themes or categories
appearing in the data. For example, in a study of customer satisfaction, a histogram can show
how many respondents gave a particular rating to a product or service. This provides a clear
visual representation of how customers perceive the product being offered, as well as areas
for improvement. In the business world, histograms can be a very useful tool in analyzing
sales performance. By visualizing sales data by product category or geographic region,
companies can quickly identify trends and patterns that may not be apparent in tabular form.
This helps managers make better decisions regarding marketing strategy, product
development, and resource allocation. Additionally, modern technology has made it easier
than ever to create and analyze histograms.[45]. With a variety of statistical software and data
analysis tools available, users can easily generate histograms from large datasets. Software
such as Microsoft Excel, R, or Python with the Matplotlib and Seaborn libraries allow for
more in-depth analysis, including the addition of interactive features that enhance
understanding of the data.
Overall, histograms are an invaluable tool in data analysis. Their ability to present
information visually and intuitively makes them a top choice for professionals in a variety of
fields. Through a deep understanding of data distribution, histograms enable users to make
better evaluations, identify problems, and plan necessary corrective actions.[46]. Thus,
histograms not only serve as analysis tools, but also as effective communication tools in
explaining findings to various stakeholders.
Standardization measures are essential in the context of quality control, especially as a
preventive measure to ensure that quality problems that have arisen and have been resolved
do not recur. This approach is oriented towards a prevention strategy, which is more effective
than relying solely on a detection strategy. In an effort to improve quality, there are several
systematic steps that can be followed to analyze and find solutions to existing quality
problems. The first step is to understand the need for quality improvement. At this stage,
management must have a clear and in-depth understanding of the reasons behind the need to
improve quality. Awareness of the importance of quality improvement is the main foundation
that every organization must have. Without a strong understanding of this need, quality
improvement efforts tend to be ineffective and will not produce the expected results.
Therefore, identifying existing quality problems or potential improvement opportunities is a
crucial initial step.[47].
Once the need for quality improvement is understood, the second step is to clearly
state the quality problem. The problems that have been identified previously need to be stated
in a specific and measurable form. A clear and precise formulation of the quality problem is
essential so that all parties involved have the same understanding of the issue that needs to be
addressed. Ambiguous or immeasurable problem statements will only make the improvement
process more difficult at a later stage. The third step involves evaluating the root causes of
the problem that has been stated. This evaluation can be done using various analytical tools,
such as cause-and-effect diagrams and brainstorming techniques. During this process, all
possible causal factors that may contribute to the quality problem should be analyzed in
depth. Using a Pareto diagram, the company can rank these causes based on their impact on
the performance of the product or the overall quality management system. This allows the
company to focus on the most significant and impactful causes.
Once the root cause has been evaluated, the next step is to plan a solution to address
the existing problem. The improvement plan should focus on actions aimed at eliminating the
root cause of the problem. In this stage, all improvement plans need to be recorded in the
form of a detailed action plan list. This will help in ensuring that every step required for
improvement has been well considered and planned. Implementation of the improvement is
the crucial fifth step. The implementation of the solution plan should be carried out according
to the action plan list that has been prepared previously. Here, commitment from the
management and full involvement of the employees is very important. All team members
must actively participate and work together to eliminate the root cause of the quality problem
that has been identified. Without the full support and participation of all parties, the
improvement efforts are likely to fail.
After implementing quality improvement, it is important to evaluate the results of the
improvements that have been made. In this sixth step, the company needs to conduct a study
and analysis based on the data collected during the implementation stage. The goal is to find
out whether the existing problems have disappeared or at least decreased. This result analysis
process can provide additional information that is very valuable for decision making and
planning for future improvements. The seventh step is to standardize the solutions that have
been successfully implemented. Satisfactory results from quality control actions need to be
standardized to prevent the same problems from recurring in the future. This standardization
not only helps maintain the quality that has been achieved, but also creates a foundation for
continuous improvement in other types of problems that may arise in the future. After solving
the first problem, the last step is to solve the next problem that has not been resolved. By
moving on to the next issue, the company can continuously improve and maintain the quality
of products and processes. This continuous approach to quality control will not only improve
organizational performance but also provide significant added value to customers and other
stakeholders. A systematic and structured process in quality control will support the company
in achieving competitive advantage and sustainability in an increasingly competitive market.

CONCLUSION AND RECOMMENDATIONS

Overall, quality control using Statistical Process Control (SPC) has proven to be a
very effective approach in maintaining product and service quality across various industrial
sectors. The use of SPC helps organizations identify and address variations in the production
process, thereby minimizing defects and increasing customer satisfaction. Although SPC
implementation faces challenges, such as the need for accurate data and adequate statistical
skills, the benefits gained from using this method far outweigh the difficulties. The success of
quality control lies not only in the implementation of SPC itself, but also in its ability to be
integrated with other methods such as Six Sigma and Just-In-Time (JIT). This synergy allows
companies to achieve higher efficiency and significant cost reductions. In addition, current
technological advances, including the use of Artificial Intelligence (AI) and the Internet of
Things (IoT), further strengthen the effectiveness of SPC by providing faster and more
accurate data analysis. Thus, companies can be more proactive in quality control, respond to
problems faster, and continuously improve processes. Therefore, SPC is not only relevant but
also crucial in future quality control, whether in the manufacturing, healthcare, or other
industrial sectors.
The recommendation for organizations looking to implement SPC is to start with
adequate training for employees on the basic concepts of statistics and quality control.
Investment in technology that supports data collection and analysis is also highly
recommended, so that the information used in quality control can be more accurate and real-
time. In addition, it is important for management to build an organizational culture that
supports continuous improvement and collaboration between teams. By involving all
employees in the quality control process and providing them with the right tools,
organizations can create an environment that supports innovation and development. Finally,
continuous evaluation and adjustment of the methods and tools used in SPC will ensure that
the organization remains competitive and able to meet customer expectations in this ever-
changing era. With these steps, quality control using SPC can be a key pillar in a successful
business strategy.

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