Aid Hleem, Mohd Jvid*, Rvi Prtp Singh, Rjiv Sumn

a. Department of Mechanical Engineering, Jamia Millia Islamia, New Delhi 110025, India

b. Department of Industrial and Production Engineering, Dr B R Ambedkar National Institute of Technology, Jalandhar, Punjab 144011, India

c. Department of Industrial &Production Engineering, G. B. Pant University of Agriculture and Technology, Pantnagar, Uttarakhand 263153,India

Keywords Quality 4.0 COVID-19 Digital healthcare Traditional Chinese medicine (TCM)Industry 4.0 Quality revolution

ABSTRACT The Quality 4.0 concept is derived from the industrial fourth revolution, i.e., Industry 4.0. Quality 4.0 is the future of quality,where new digital and disruptive technologies are used to maintain quality in organizations. It is also suitable for traditional Chinese medicine (TCM) to maintain quality. This quality revolution aims to improve industrial and service sectors’ quality by incorporating emerging technologies to connect physical systems with the natural world. The proposed digital philosophy can update and enhance the entire TCM treatment methodology to become more effective and attractive in the current competitive structure of the pharmaceutical and clinical industries. Thus, in healthcare, this revolution empowers quality treatment during the COVID-19 pandemic. There is a major requirement in healthcare to maintain the quality of medical tools, equipment, and treatment processes during a pandemic.Digital technologies can widely be used to provide innovative products and services with excellent quality for TCM. In this paper, we discuss the significant role of Quality 4.0 and how it can be used to maintain healthcare quality and fulfill challenges during the pandemic. Additionally, we discuss 10 significant applications of Quality 4.0 in healthcare during the COVID-19 pandemic. These technologies will provide unique benefits to maintain the quality of TCM throughout the treatment process.With Quality 4.0, quality can be maintained using innovative and advanced digital technologies.

1 Introduction

In healthcare, Quality 4.0 enables personalized quality services for excellent clinical outcomes. This technological revolution adopts a new facility for the manufacturing of required medical parts and accessories. The field is centralized and can handle risk with the help of connected network activities during the COVID-19 pandemic. This requires extensive flexibility to satisfy patients’ needs and provide effective, innovative solutions. Quality 4.0 provides improved service design for managing health risk and satisfying various organizational requirements. This optimizes the treatment process to achieve better clinical outcomes during the COVID-19 pandemic. Various technologies are available to support Quality 4.0, such as artificial intelligence, deep learning, blockchain, Big Data,machine learning, sensors, actuators, open-source software, data science, cloud computing, Internet of Things (IoT), virtual reality (VR), augmented reality,mixed reality, and 5G[1,2].

TCM practitioners use various mind and body practices and herbal products to address health problems. Quality 4.0 is the extension of new technological platforms, which can enhance the quality-related activities of TCM. Quality 4.0 transforms the leadership and activities of quality processes, bringing improvements to previous quality methods. For healthcare, personal protective equipment (PPE) can be easily manufactured using advanced manufacturing technology. This equipment will be of higher quality and help to fight against the COVID-19 pandemic. The personalized PPE is more comfortable for the doctors. All compliance processes will be automated and digitized with the proper implementation of Quality 4.0. Thus, the decision-making and product development processes are improved[3,4].

Continuous quality is maintained through Quality 4.0 with the help of IoT and real-time data. The quality-management challenge can be quickly addressed with better safety. This quality revolution provides significant healthcare developments owing to its flexibility[5,6]. The present article introduces Quality 4.0 and its benefits for maintaining the quality of manufacturing, treatment, and services. The significant application areas for employing the proposed Quality 4.0 in TCM are pharmacology, pharmaceutical analysis, clinical research, dentistry,herbal medicines, toxicology, pharmaceutical preparations, and pathology, along with mind and body practices[7,8]. The focus of this study was the implementation of Quality 4.0 philosophies and strategies in the broad domain of traditional Chinese medicine(TCM) practices for achieving an overall improvement in quality perspectives while offering quality services to the customers.

1.1 Major quality revolutions

Quality 1.0 assured the quality checks through measurement and inspection. In Quality 2.0,financial quality is measured according to scrap and rework. Quality 3.0 improves the quality of business and ensures customer satisfaction with the help of highly efficient processes. In Quality 4.0, digital machines automatically control the quality of the entire process. These digital technologies are being embraced to achieve excellence. Thus, new processes can be automated, and a treatment strategy can be developed to maintain optimal quality standards in healthcare. Advanced technologies provide an innovative platform in healthcare and the potential to create better output[5,9,10]. Support provides digital transformation and can fulfill various challenges, such as IoT and connecting every medical device to the internet to provide new and innovative healthcare services. A telemedicine service, which supports personalized and predictive services, is introduced for maintaining the treatment quality during the COVID-19 pandemic.

1.2 Need for the study

Healthcare remains a concern for the masses and requires the collection of quality patient data.Various advanced technologies are now available to collect quality data from various sources to improve the decision-making process. Extensive research is being conducted on the TCM system, which has been developed over thousands of years, and further research is necessary. Incorporating the proposed Quality 4.0 concept will enable effective TCM treatments that ensure the satisfaction and comfort of patients[6,11]. Additionally, it will help to predict failures and suggest strategies for healthcare treatment, particularly during the COVID-19 pandemic.Quality 4.0 provides the connectivity of information,as real-time data are collected for the qualitymanagement system. These tools and practices are leveraged to improve the patients, satisfaction, which has always been the primary goal of TCM-based philosophies.

Technology, such as VR, has significant potential in the workplace to achieve quality objectives. Advanced technologies are now available to automate processes and focus on innovation during the COVID-19 pandemic. Additionally, in Quality 4.0, various tools and techniques are used to automate continuous activities[12,13]. This helps to access various compliance-related activities, providing a better opportunity for improvement. It represents a new opportunity to align the objectives using a variety of technologies.

1.3 Perceived benefits of Quality 4.0 in TCM framework

Quality 4.0 provides flexibility in the entire system,which reduces the risk in the TCM treatment process during the COVID-19 pandemic. Cloud-based technologies are directly applied to the quality system and provide real-time updates. This allows smart decision making with quality risk management. Thus, the risk is easily evaluated to meet high-quality healthcare services throughout the TCM philosophies. Modern technologies are implemented for developing better procedures and work instructions for all information updates. Quality 4.0 provides real-time visibility during the smart decision-making process[14,15]. Significant benefits of Quality 4.0 in TCM systems are envisaged as follows:

· Improve the collaboration among doctors, patients, and the research and development process for TCM

· Developing the quality treatment process of TCM

· Useful for designing and manufacturing higherquality products and providing better services to patients

· Actively monitor all quality-related processes involved in TCM

· Obtain, store, and analyze patient and associated data and then use it for a better management system

· Eliminate unnecessary processes/procedures and standardize the dosage

· Improve the performance of the overall TCM systems through standardization

· Optimize quality processes/as being followed in the existing systems to improve patient outcomes

· Perform real-time process monitoring, with a higher level of research and quality data for validated results (it is necessary to validate the outcomes)

· Improve data-acquisition processes, the support system for improved experimentation

· Improve the system performance by following the best practices of quality management

· Enhance the intelligence of the quality control and assurance systems.

2 Quality 4.0 for improving quality of healthcare

Healthcare professionals wish to improve the quality of healthcare with reduced effort, keeping in view the increasing public demand for safety, quality, and transparency. Additionally, doctors are attempting to improve their sequela in the interest of public health and patients. The Quality 4.0 revolution highlights the necessity of quality improvements in the field of healthcare. For performance improvements, at the end of every quality assessment period, staff and providers should have sufficient information to perform modifications that lead to the development of a new policy[16,17].

Modern healthcare requires an upgraded quantitative assessment system rather than a traditional quality control or assessment system. A system that deals with the activities professionally should maintain efficiency at every stage of processing. Efficiency in the medical field must be maintained for the outputs, as this sector directly deals with human lives.Thus, the results of a medical procedure are the measure of success. The effectiveness of medical procedures is difficult to measure owing to the limited outcome knowledge, lack of evidence-based guidelines, and data accessibility problems. Healthcare often adopts quantitative measures, but this usually focuses on profit and loss reports. Highly detailed information can be obtained as profit/loss reports are more vital to operations, revenue, and cost/procedure etc.[18,19].

Healthcare professionals are dedicated to satisfying the quality measures or standards that are aligned with professional ethics, law, and regulations.Controlled protocols and quality assurances are the means of gauging the standards of care to find nicety in professional practice. A plan that can provide quality assurance must include the following elements:

· Identification of quality issues

· Development of a problem-resolution strategy

· Progression of quality assessment

· Implementation of changes.

2.1 Features of Quality 4.0 for supporting healthcare

The Quality 4.0 philosophy is a unique and promising idea that can be employed to serve the healthcare domain, particularly during the COVID-19 pandemic. The vital components of Quality 4.0 and its services allow healthcare to be improved with regard to the level of care and patient satisfaction.Figure 1 presents the numerous vital components and elements that comprise this quality-based philosophy for healthcare[20,21].

It includes many classes of factors, revealed facts,notions, and concepts derived from the background of quality and its revolutions towards the healthcare domain’s sustenance at several platforms. It further explores the applicability of analytics, connectivity,scalability, and quality culture throughout the healthcare platforms. This usage of Big Data, better and efficient supply chains, wellness hubs, cloud-based facts, etc., makes the fourth quality revolution successful in serving healthcare effectively and competently[22,23].

Figure 1 Quality 4.0 features for supporting healthcare during COVID-19

2.2 Enhancing transparency in healthcare treatment using Quality 4.0

Quality 4.0 enhances the high-volume acquisition of data to provide transparency during treatment.Machine intelligence and Big Data technologies can be used to quickly analyze data for establishing a culture of quality. The quality revolution touches various managerial and operational areas to achieve the required goals. Modern technologies are available to efficiently manufacture innovative products using innovative tools and techniques. The data-acquisition process can be used to maximize the utilization of advanced manufacturing strategies[24,25].This is used to promote high-quality components that satisfy the performance objectives. Quality 4.0 provides an advanced approach for implementing the optimal strategy for treatment and services. The quality revolution provides a better opportunity for quality movement and adopts quality assurance for better future advancement. This creates significant technological advancements in the field of healthcare and can interact with doctors with the patient. In Quality 4.0, all processes are involved digitally and software-controlled[26,27], reducing errors and simplifying the traditional treatment process.

2.3 Quality 4.0 for fulfilling patient-specific needs

Currently, the entire healthcare sector is transforming according to patient-centric needs, as it lacks quality and consistency in the changing healthcare industry. For achieving complete patient satisfaction, healthcare professionals are directly involved in patient-centric outcomes. The medical field is in the early stage of incorporating new technologies to cope with these changes with the help of Quality 4.0. Previous efforts to satisfy the standards involved patient feedback and public surveys[28,29].

Achievements can be monitored as per the required goals. Doctors attempt to provide patientcentric treatments according to individuals’ needs to maintain international hygiene and standards. There is no confusion among doctors to develop a quality system based on patients’ requirements. This can be accomplished only by enhancing patients’ satisfaction for improving the overall reputation of the healthcare practice. Two main factors that can play an essential role in the enhancement of healthcare are improvements in the organization and management of practice[30,31]. For a particular organizational system, quality in practice should satisfy requirements. Such requirements will help the organization in many ways, e.g.,

· Reduce financial losses

· Minimize mistakes in routine practices

· Increase precision in operational procedures

· Improve skill sets, boosting efficiency levels

· Maximize the use of resources

· Enhance performance as per standards.

3 Crucial roles of Quality 4.0 philosophy in healthcare support during COVID-19

Philosophies like Quality 4.0 are reported as a perfect candidate that serves all the features and strategies in improving the healthcare domain. During the pandemic, patients with severe health issues fear catching the coronavirus and are now courageous enough to visit nearby care centers. Such issues are also revealed to be fruitful when implementing the quality aspects in well-established TCM approaches for satisfying societal/national healthcare-related needs. To resolve the aforementioned issues, Quality 4.0 and its smart services offer fruitful outcomes with regard to smart care, better treatments for patients,remote service, learning with working, applications of smart processing, compatible materials, etc. for enhancing patient satisfaction[32,33].

Figure 2 Roles and responsibilities in Quality 4.0 for healthcare during COVID-19

Figure 2 shows the various roles, features, and strategies being offered to apply quality-based services in the broad domain of healthcare. The roles and services, which include information security management, information technology facts, software services, and cloud-based data reflections, enable the Quality 4.0 philosophy strategies for the extensive care and support for patients, particularly during the current coronavirus and in cases of similar pandemics.The benefits of the quality system are not limited to the healthcare field but applicable to various industries. Enhancing quality refers to improvements in overall measures or standards at all levels of the healthcare sector so that a patient can feel safer and more satisfied. The proposed digitalized TCM-based healthcare support services will help physicians to provide patients the highest-quality service with consideration of hygiene, safety, and modern treatment and the healthcare practitioner’s professional skills. Thus, Quality 4.0 technologies provide better procedures and quality improvement throughout the entire TCM structure[34-37]. This can eliminate pain during the treatment of the patient. A healthy condition can be maintained with the proper daily perpetuation and timely visits to the doctor. The doctors can quickly address problems using the latest technology, which can be implemented for patients of all ages.

4 Significant applications Quality 4.0 in healthcare during COVID-19 pandemic

The major role of digital technologies is to enable person-centered care with reduced human interaction. These technologies also overcome the challenges of data storing and sharing, thereby supporting the decision-making process. The demand for digital healthcare services with the support of the TCM framework/treatment is increasing owing to the COVID-19 pandemic. With the introduction of these technologies, the wastage of time during the treatment process is reduced. This can be flexibly automating the medical devices and efficiently resolving the challenges. Services are provided intelligently and monitored for all ongoing processes[38-40]. The patient can coordinate better with doctors, and there is an opportunity for better treatment. Table 1 presents the significant applications of Quality 4.0 in healthcare during the COVID-19 pandemic.

Medical devices can now be tracked through the smart supply chain. This improves the existing services whereby a network of machines exchanges the data. With a centralized information system, an autonomous decision can be made, providing the real-time capability to create new services[67]. This helps to address the critical risk of life with the help of smart inhalers. Thus, Quality 4.0 improves the treatment quality with remote monitoring and an improved medical-device management system for overcoming the challenges posed by the COVID-19 pandemic.

5 Discussion

Quality 4.0 in TCM practices improves patient satisfaction by improving the operational efficiency of healthcare during the COVID-19 pandemic. It provides valuable opportunities for quality-related improvements and the development of high-quality medical-related parts. Digital technologies, when applied in the TCM structure, can improve the quality of healthcare by monitoring all medical

processes and handling various ongoing issues. They allow doctors to do their jobs better and faster.Intelligent materials such as superabsorbent polymers can be printed using advanced manufacturing technology to absorb large amounts of water. Sensors are used to perform different tasks in any environmental changes COVID-19 pandemic.The real production data is managed appropriately for optimizing the process parameters using Quality 4.0. It enhances the flexibility of manufacturing systems and can adapt to various environmental changes. The significant intelligence applications of Quality 4.0 in healthcare during the COVID-19 pandemic include digital quality services, selfmanaged quality care, transparency in quality data,doctor confidence and appraisal, ensuring quality during the design of medical tools and devices,smooth exchange of quality information, quality checks of medical parts, improved communication,digital transformation, and quality information.Quality 4.0 digitalizes the quality-management system of TCM through advanced technologies,enhancing the operational efficiencies, patient safety,and patient satisfaction. It is used to address the requirements of precision medicine. Thus, Quality 4.0 in the TCM framework will help automate all ongoing processes and connect manufacturers,suppliers, and services to achieve higher quality in healthcare.

Table 1 Significant applications of Quality 4.0 in healthcare during COVID-19 pandemic

6 Future scope of Quality 4.0 in TCM domain

In the future, Quality 4.0 will provide reality in all manufacturing and service sectors. The healthcare field will adopt a better solution to improve operational efficiency with the help of patients’ realtime quality data, and its analysis ultimately improves the overall quality structure of TCM approaches. Quality 4.0 can enhance collaboration to fulfill the demand for quality manufacturing and service. This revolution enhances the teaching and learning process of the medical education system.Complex medical devices are used to ensure the safety of the patient. In the future, Quality 4.0 will integrate the programmable system into TCM for automating the treatment process. This approach will give rise to higher-quality medical products that can help to overcome various upcoming challenges.

7 Conclusion

During the COVID-19 pandemic, Quality 4.0 can enhance patient support by digitally managing the various process-related quality issues of TCM. It improves disease detection, drug effectiveness and safety, dosage precision and quality, and the efficacy of mind and body practices through advanced technologies. IoT infrastructure allows data-related issues to be anticipated by implementing a digital strategy. Failure-free treatment can be achieved by managing the quality, enhancing the ability of the healthcare system during the COVID-19 pandemic.The quality-management system is effective for fulfilling the unique requirements of healthcare. It provides smart and agile facilities using innovative information technologies. Processes are easily optimized to perform smart production operations with the help of entire facilities. This helps to manage all the supply-chain processes of required medical parts. The quality digital record provides appropriate visibility and transparency for the testing and analysis of new products and services. Medical devices can be intelligently managed in accordance with the required quality standard during the COVID-19 pandemic. Quality 4.0 allows all processes to be connected through the stored quality record of the patient. It rapidly analyzes quality issues using connected technologies that help to improve quality management during the COVID-19 pandemic. In the future, Quality 4.0 is expected to improve treatment outcomes for patients.

Competing interests

The authors declare no conflict of interest.