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This research paper aims to analyze the scientific and grey literature on Quality 4.0 and zero-defect manufacturing (ZDM) frameworks to develop an integrated quality 4.0 framework (IQ4.0F) for quality improvement (QI) based on Six Sigma and machine learning (ML) techniques towards ZDM. The IQ4.0F aims to contribute to the advancement of defect prediction approaches in diverse manufacturing processes. Furthermore, the work enables a comprehensive analysis of process variables influencing product quality with emphasis on the use of supervised and unsupervised ML techniques in Six Sigma’s DMAIC (Define, Measure, Analyze, Improve and Control) cycle stage of “Analyze.”

The research methodology employed a systematic literature review (SLR) based on PRISMA guidelines to develop the integrated framework, followed by a real industrial case study set in the automotive industry to fulfill the objectives of verifying and validating the proposed IQ4.0F with primary data.

This research work demonstrates the value of a “stepwise framework” to facilitate a shift from conventional quality management systems (QMSs) to QMSs 4.0. It uses the IDEF0 modeling methodology and Six Sigma’s DMAIC cycle to structure the steps to be followed to adopt the Quality 4.0 paradigm for QI. It also proves the worth of integrating Six Sigma and ML techniques into the “Analyze” stage of the DMAIC cycle for improving defect prediction in manufacturing processes and supporting problem-solving activities for quality managers.

This research paper introduces a first-of-its-kind Quality 4.0 framework – the IQ4.0F. Each step of the IQ4.0F was verified and validated in an original industrial case study set in the automotive industry. It is the first Quality 4.0 framework, according to the SLR conducted, to utilize the principal component analysis technique as a substitute for “Screening Design” in the Design of Experiments phase and K-means clustering technique for multivariable analysis, identifying process parameters that significantly impact product quality. The proposed IQ4.0F not only empowers decision-makers with the knowledge to launch a Quality 4.0 initiative but also provides quality managers with a systematic problem-solving methodology for quality improvement.

The main purpose of this paper was to evaluate the validation process of food safety control measures.

The validation of control measures has been analyzed at 50 food companies in Serbia. The sample included companies that produce food of both plant and animal origin and have certified food safety management systems. A total of 156 control measures that combat physical hazards (41.6%), followed by microbial hazards (34.0%) and chemical hazards (24.4%), have been analyzed. To enable quantification of the validation protocols, each control measure was assigned a score.

The validation scores showed that the highest level of validation was observed in large companies, as opposed to small and medium-sized companies (p < 0.05). The type of food safety hazards and the food sector did not reveal any statistical differences in-between the scores. The main approach to validating control measures was referring to the technical documentation of equipment used (52.6%), followed by scientific and legal requirements (30.7%). Less than 20% of the analyzed control measures were validated with operational data collected on-site. No mathematical modeling was observed for the sampled food companies. Future steps should include the development of validation guides for different types of control measures and training modules.

This study can serve as an improvement guide for food safety consultants, food safety auditors, certification bodies, inspection services, food technologists and food managers.

This study is one of the first to provide an insight into how food companies validate their control measures to combat microbial, chemical and physical food safety hazards.

This study intends to improve the quality of venous thromboembolism (VTE) prophylaxis practices including proper VTE risk assessment and the appropriate prophylaxis measures for surgical urology patients.

The authors applied the Six-Sigma define, measure, analyze, improve and control (DMAIC) improvement methodology in a pre–post interventional study that involved all adult patients above 18 years old indicated and scheduled for urology surgical interventions including endoscopic urological surgeries in a urology specialized 60-bed hospital. The pre-intervention sample included all patients meeting the inclusion criteria over a period of six months. Post-intervention sample included all patients meeting the inclusion criteria over a period of six months. The improvement areas included both the VTE risk assessment as well as the VTE prophylaxis prescription.

DMAIC methodology has achieved a substantial sustained improvement in surgical urology VTE prophylaxis practices with an average of 70% on both levels; VTE risk assessment practices and VTE prophylaxis prescribing practices were statistically significant. The post-intervention results also showed a statistically controlled process with no special cause variations. Based on the study results, the Six-Sigma DMAIC methodology can be considered of high value when applied in healthcare clinical practice improvement projects.

The project study includes some pitfalls that can be addressed as follows: 1. The lack of VTE rate incidence tracking. This limitation can be partly refuted when the authors conduct a literature review and explore that the VTE prophylaxis effectiveness had been proven with sufficient evidence to an extent that pushed several scientific societies to develop their own guidelines to support VTE prophylaxis. (Algattas et al., 2018). 2. Another limitation of this study can be that it handled only surgical patients and more specifically surgical urology patients. Of course, VTE prophylaxis is a crucial life-threatening problem not only for the surgical admitted patients but also for all the medical admitted patients either in hospital wards or ICUs. However, the prediction that surgical patients especially surgical urology patients are more prone to VTE development risk as they have -in several cases-two or three main additive risk factors which are age, procedure duration and malignancy in elderly men. (Tikkinen et al., 2014). So, the authors consider the study project to be a prototype that hopefully can be utilized for future study projects that will manage both other surgical specialty patients and medical patients on the national level and can track accurately and effectively report the VTE incidence rates.

Several recommendations can be extracted from the research project that is summarized in the following points: Paying focused attention to continuous healthcare quality improvement initiatives and projects as a main approach for healthcare improvement especially for the public health-related problems. This might be achieved through periodic region-specific or specialty-specific focus groups from which public health problems could be addressed and prioritized to be considered as a part of country healthcare campaigns regarding cost-utility and feasibility studies. The adoption of a system thinking approach in dealing with the improvement strategies; all efforts and resources are to be employed to achieve a common objective. This includes the generation of a national-wide electronic health information system that can aid in healthcare resource allocation and direct the healthcare efforts towards the most important, high-priority public health problems. Electronic national-wide health record is really an effort, and resources consuming activity, but actually, it's worth exerting efforts, and its valuable outcomes may be seen several years later. 3. Development of unified national specialized VTE prophylaxis pathways to standardize the patient-specific VTE prophylaxis plans. Standardization of healthcare pathways enables healthcare professionals to follow an evidence-based practice which will be reflected on the improvement of healthcare quality level, cost-effectiveness enhancement, and timely patient care on all levels especially in high critical areas like ER and ICU. 4. Incorporation of VTE prophylaxis costs in the universal health insurance diagnosis-related group (DRG) insurance packages and service pricing. Universal health insurance is a nationwide strategy that is aiming to cover all Egypt residents by the year 2030. Universal health insurance is being following the DRG reimbursement policy that is thought to control all the healthcare-associated costs so, the VTE prophylaxis costs shall be added as the main cost item to encourage all healthcare facilities to follow an evidence-based VTE prophylaxis pathway taking into consideration the high-risk patient categories who will definitely represent a high-cost burden on the long run if they suffer a VTE event.

DMAIC improvement methodology applications in healthcare are still relatively limited, especially on the clinical level. The study can be considered one of a kind in Egypt dealing with a comprehensive DMAIC methodology application on the clinical level.

This chapter of the book aims to introduce multiobjective linear programming (MLP) as an optimum tool to find the best quality engineering techniques (QET) in the main domains of supply chain management (SCM). The importance of finding the best quality techniques in SCM elements in the shortest possible time and at the least cost allows all organizations to increase the power of experts’ analysis in supply chain network (SCN) data under cost-effective conditions. In other words, this chapter aims to introduce an operations research model by presenting MLP for obtaining the best QET in the main domains of SCM. MLP is one of the most determinative tools in this chapter that can provide a competitive advantage. Under goal and system constraints, the most challenging task for decision-makers (DMs) is to decide which components to fund and at what levels. The definition of a comprehensive target value among the required goals and determining system constraints is the strength of this chapter. Therefore, this chapter can guide the readers to extract the best statistical and non-statistical techniques with the application of an operations research model through MLP in supply chain elements and shows a new innovation of the effective application of operations research approach in this field. The analytic hierarchy process (AHP) is a supplemental tool in this chapter to facilitate the relevant decision-making process.

First is to develop the time truncated median control chart for the Rayleigh distribution (RD) and generalized RD (GRD), respectively. Second is to evaluate the performance of the proposed attribute control chart which depends on the average run length (ARL) and third is to include real life examples for application purpose of the proposed attribute control chart.

(1) Select a random sample of size n from each subgroup from the production process and put them on a test for specified time t, where t = ? × µe. Then, count the numbers of failed items in each subgroup up to time t. (2) Step 2: Using np chart, define D = np, the number of failures, which also a random variable follows the Binomial distribution. It is better to use D = np chart rather than p chart because the authors are using number of failure rather than proportion of failure p. When the process is in control, then the parameters of the binomial distribution are n and p0, respectively. (3) Step 3: The process is said to be in control if LCL = D = UCL; otherwise, the process is said to be out of control. Hence, LCL and UCL for the proposed control chart.

From the findings, it is concluded that the GRD has smaller ARL values than the RD for specified values of parameters, which indicate that GRD performing well for out of control signal as compared to the RD.

This developed control chart is applicable when real life situation coincide with RD and GRD.

Researcher can directly use presented study and save consumers from accepting bad lot and also encourage producers to make good quality products so that society can take benefit from their products.

This article dealt with time truncated attribute median control chart for non-normal distributions, namely, the RD and GRD, respectively. The structure of the proposed control chart is developed based on median lifetime of the RD and GRD, respectively.

This study aims to examine the impact of Lean 4.0 practices on value co-creation in the dairy ecosystem.

Data collection were carried out through a questionary application with 126 professionals linked to the dairy ecosystem, including milk producers, milk cooperatives and milk transporters. The data were analyzed using Cluster Analysis, Mann-Whitney test and Chi-Square test.

A strong relation was found between the use of Lean 4.0 tools and the increase in operational performance, in addition to milk quality. Moreover, it can be noted that the use of digital technologies from Industry 4.0 has a strong relation with dairy production optimization, in other words, it is possible to be more efficient in the dairy process via Lean 4.0 adoption.

The study is limited to analyzing the Brazilian dairy ecosystem. The results presented may not reflect the characteristics of the other countries.

Once the potential empirical impacts of the relation between Lean 4.0 and value co-creation are elucidated, it is possible to direct strategies for decision-making and guide efforts by researchers and professionals to deal with the waste mitigation present in the dairy sector.

Lean 4.0 proves to be a potential solution to improve the operational performance of the dairy production system. Lean 4.0, linked to value co-creation, allows the integration of the production sector with consumers, through smart technologies, so new services and experiences can be provided to the consumer market. Additionally, the consumer experience can be stimulated based on Lean 4.0, once the quality specification is highlighted based on data science and smart management control.

To the best of the authors’ knowledge, this is the first study that analyzes the interrelationship between the Lean 4.0 philosophy and the value co-creation in the dairy ecosystem. In this sense, the study reveals the main contributions of this interrelation to the dairy sector via value co-creation, which demonstrates a new perspective on the complementarity of resources, elimination of process losses and new experiences for the user through digital technologies integrated with the Lean Thinking approach.

With the increasing concern over environmental pollution and global warming, companies are required to act responsibly to mitigate these environmental issues. Their activities should adhere to the standards of environmental sustainability. Thus, this study aimed to investigate the impact of green supply chain management (GSCM) and total quality management (TQM) on environmental sustainability, with environmental management practices (EMP) as the moderating factor.

A quantitative study was adopted using the management data from various manufacturing companies in Jordan. A total of 362 responses were collected, and the proposed hypotheses were tested using a structural equation model.

The study findings revealed that both GSCM and TQM significantly and positively influenced environmental sustainability. The impact of TQM on environmental sustainability was higher than that of GSCM. Moreover, no evidence was found on the moderating role of EMP.

The study’s results highlighted to the decision-makers the main practices to expand the quality implementation across their supply chain to improve environmental sustainability. The study also demonstrated the reasons behind the insignificance of EMPs in strengthening the relationships between GSCM, TQM, and environmental sustainability.

While there are very few studies examining the relationships between GSCM and TQM on environmental sustainability. This study adds to the literature body as one of a few empirical studies that tested the integrated effect of GSCM and TQM practices within the context of the manufacturing industry in a developing country. Moreover, this study takes a holistic approach by tapping into EMP to confirm whether it moderated the relationships between GSCM, TQM, and environmental sustainability.

The paper aims to identify the effect of ignorance of correlatedness among process observations and to implement new sampling schemes; skip and mixed sampling, in order to reduce the effect of autocorrelation on process capability index (PCI) Cpm.

Autocorrelated observations are generated using autoregressive process of order two (AR (2)) using Monte Carlo simulations. The PCI is computed based on these observations assuming the independence. The skip and mixed sampling schemes are then used to form sub-groups among correlated observations. The PCI obtained using sub-groups from skip and mixed sampling schemes are assessed using sample mean and sample standard deviation.

The paper provides empirical insights into how the effect of autocorrelation decreases in the estimated value of PCI Cpm. The use of new sampling schemes, skip and mixed sampling, reduces the effect of autocorrelation on estimates of PCI Cpm.

This paper fulfills an identified need to study how to reduce the effect of autocorrelation on PCI Cpm.

There is increasing interest in the connection between Industry 4.0 (I4.0) and operational excellence approaches; however, studies on the integration between Six Sigma (SS) and I4.0 have been absent from the literature. Integration with I4.0 technologies can maximize the positive effects of SS. The purpose of this study is to understand what types of relationships exist between SS and I4.0 and with I4.0's technologies, as well as the benefits derived from this integration and future directions for this field of study.

A Systematic Literature Review (SLR) was carried out to analyze studies about connections between I4.0 technologies and SS. SLR analyzed 59 articles from 2013 to 2021 extracted from the Web of Science and Scopus databases, including documents from journals and conferences.

The SLR identified relationships between SS and several I4.0 technologies, the most cited and with the greatest possibilities of relationships being Big Data/Big Data Analytics (BDA) and Internet of Things (IoT). Three main types of relationships were identified: (1) support of I4.0 technologies to SS; (2) assistance from the SS to the introduction of I4.0 technologies, and, to a lesser extent; (3) incompatibilities between SS and I4.0 technologies. The benefits are mainly related to availability of large data sets and real-time information, enabling better decision-making in less time.

In addition, the study can help managers to understand the integration relationships, which may encourage companies to adopt SS/Lean Six Sigma (LSS) in conjunction with I4.0 technologies. The results also drew attention to the incompatibilities between SS and I4.0 to anticipate potential barriers to implementation.

The study focuses on three previously unexplored subjects: the connection between SS and I4.0, the existing relationships with different technologies and the benefits resulting from the relationships. In addition, the study compiled and structured different types of relationships for SS and I4.0 and I4.0's technologies, identifying patterns and presenting evidence on how these relationships occur. Finally, exposes current trends and possible research directions.

Effective total quality management (TQM) practices rely on the accurate classification of critical success factors (CSFs). The impact matrix cross-reference multiplication technique for classification (MICMAC) or/and fuzzy MICMAC (FMICMAC) can be used to identify key factors in the complex set. However, TQM includes both “hard” and “soft” factors, limiting application of the traditional MICMAC/FMICMAC method.

Previous literature on TQM was reviewed, CSFs were identified, and factors were sorted into soft and hard categories. The combined fuzzy integration and dual-aspect MICMAC (fuzzy dual-aspect MICMAC approach) was then applied to identify, cluster and prioritize the CSFs of TQM.

A total of 20 factors (10 soft and 10 hard) were identified and isolated to assess the manufacturing- and service-related TQM practices of the Pearl River Delta Region of China. Seven driver factors and one linkage factor emerged as the key CSFs that managers should prioritize.

A major limitation of this study is the dependency of the results on the definitions of linguistic labels. If the linguistic definitions of TQM CSFs do not closely correspond to the expert opinion data, then the analysis results may be inaccurate. Additionally, although expert opinions are utilized in the proposed method for comprehensive assessments, these opinions may influence the final results due to their inherent subjectivity.

A novel fuzzy dual-aspect MICMAC approach was developed to identify and classify CSFs for optimal TQM practices. This approach allows clustering of CSFs so that decision-makers can prioritize factors according to their dependence and driving powers. Practitioners should concentrate on the CSFs with higher driving powers for successful TQM.