Efforts to Optimize Clinical Trial Management by Revising Deviation Reports and Classifying Deviation Cases for Efficient Clinical Trial Quality Improvement at Asahikawa Medical University Hospital.

Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).

FlexiTeam: Flexible Team and Work Organization using Process-Oriented Case-Based Reasoning

During crises such as COVID-19, there is a need to adapt existing work processes and teams to the changing environment in a very flexible and dynamic way in many business and healthcare organizations. In this paper, we conceptualize the advances required for Process-Oriented Case-Based Reasoning to flexibly and dynamically organize human resources in a team and work processes. The novel contributions of this paper include an extended case representation to represent resources, profiles, and key performance indicators (KPIs) of processes, a query definition which covers the "context”, and an overall process to flexibly and dynamically organize work processes and human resources. We evaluate the FlexiTeam process using a cooking recipe casebase and analyze the quality of the retrieval using a quality measure. We also derive the research questions that need to be addressed to fully explore this approach and the specific difficulties involved in solving this problem. © 2022 Copyright for this paper by its authors. Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0). CEUR Workshop Proceedings (CEUR-WS.org)

The Integration of Risk Aspects into Business Process Management: The e-BPRIM Modeling Method

Risk consideration in enterprise engineering is gaining attention since the business environment is becoming more and more competitive, complex, and unpredictable. Risk-aware Business Process Management (R-BPM) is a recently emerged management paradigm, which assists organizations in addressing this concern. R-BPM strives to integrate two traditionally isolated areas: risk management and business process management. This chapter will present recent achievements of our long-term research devoted to this field. It consists in developing an integrated process-risk management methodological framework, named BPRIM, and its related multi-view modeling method, called e-BPRIM, which promotes and supports risk-aware process management with ADOBPRIM, a computer-assisted modeling environment based on ADOXX. A case study related to the management of the COVID-19 pandemic in France shall illustrate the usage of the e-BPRIM method with the ADOBPRIM modeling environment. © Springer International Publishing AG 2018.

Rigidity in crisis: The impact of OHSAS 18001 certification on production repurposing during COVID-19

It is important for firms to repurpose production responsively during a crisis such as the COVID-19 pandemic, to seize the market opportunity and create social value. However, occupational health and safety (OHS) can also be a concern in a crisis, and adherence to OHS management systems can undermine a firm's responsiveness in repurposing decision making. We adopt the "capability-rigidity" lens to construct a connection between OHS management standards (i.e., OHSAS 18001) and firms' adaptation responsiveness. After sampling 734 listed Chinese manufacturing firms, our match-based analysis reveals that firms certified with OHSAS 18001 were less responsive during COVID-19 in terms of production repurposing than those without the certification. Yet, certain experience, namely, prepandemic manufacturing of related products, experience of the severe acute respiratory syndrome (SARS) epidemic, and being geographically located close to firms that produced medical supplies, could attenuate this effect. We discuss the implications of our findings in the context of and adding to the literature on safety management, certified management standards, and organizational adaptation and learning.

Efforts to Optimize Clinical Trial Management by Revising Deviation Reports and Classifying Deviation Cases for Efficient Clinical Trial Quality Improvement at Asahikawa Medical University Hospital

Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).

Efforts to Optimize Clinical Trial Management by Revising Deviation Reports and Classifying Deviation Cases for Efficient Clinical Trial Quality Improvement at Asahikawa Medical University Hospital.

Face-to-face communication during on-site monitoring is important for clinical trial quality assurance. However, with the coronavirus disease early 2020 pandemic, medical institutions placed restrictions on hospital visits to secure their medical systems. Asahikawa Medical University Hospital similarly established restrictions on outpatient and inpatient visits and legal restrictions on outside vendors. Therefore, the frequency of on-site monitoring of clinical trials conducted at our hospital was reduced. Since there was no sign of convergence at the infection units even after 2 years, we investigated the frequency of on-site monitoring and the frequency of clinical trial deviations in the review of the system. In addition, although a clinical trial deviation report form (previous form)was prepared in the fiscal year 2019, there were many free descriptions, and many deviation reports were difficult to understand. Similarly, there were cases where deviations were not recorded on the deviation report form but only on article records (source documents), such as electronic medical records after consultation with the sponsor, and deviations were not recorded in a uniform format. Thus, the hospital experienced difficulty tabulating and classifying the number of deviation occurrences. Based on this experience, this report describes the progress of revising the clinical trial deviation report, clarifying the items to be included in the report, and establishing a system to clarify the process related to clinical trial deviation occurrences.Copyright: © 2023 the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT).

Total quality management in Peruvian goods companies during the COVID-19 pandemic

PurposeThe aim of this research is to empirically assess the nine dimensions of the Total Quality Management (TQM) model, which have been categorized into four blocks: the top management block, the supplier block, the process management block and the customer block. The nine dimensions represent key strategic activities of company performance. A comparative analysis of companies with ISO 9001 certification and those without certification in a developing country during the COVID-19 pandemic is carried out.Design/methodology/approachA survey was administered to the management of 259 Peruvian goods companies (in the mining, repair and manufacturing sectors) during the COVID-19 pandemic. The survey consisted of 35 Likert-scale items, which were grouped into the following nine TQM dimensions: Top management (leadership), quality planning, quality audit and assessment, product design, suppliers' quality management, process control and improvement, education and training, quality circles and focus on customer satisfaction. Then, Cronbach's alpha, the Kolmogorov–Smirnov test, the Mann–Whitney U test and means were computed for each of the dimensions. This analysis made it possible to estimate significant differences between ISO 9001 certified and non-certified goods companies in terms of the dimensions.FindingsThe results showed that, for ISO 9001 certified companies, the averages for all of the dimensions were significantly different from those of non-certified companies, except for the education and training dimension. ISO 9001 certified companies scored higher than non-certified companies in the TQM dimensions. For both certified and non-certified companies, the leadership dimension had the highest average and the quality circles dimension had the lowest average.Originality/valueThis study addresses two main gaps highlighted in the research on quality management: the application of Quality Management Systems (QMS) in developing countries like Peru, and the impact of ISO 9001 on the performance of goods companies during the COVID-19 pandemic.

Process Modeling and Conformance Checking in Healthcare: A COVID-19 Case Study: Case Study

The discipline of process mining has a solid track record of successful applications to the healthcare domain. Within such research space, we conducted a case study related to the Intensive Care Unit (ICU) ward of the Uniklinik Aachen hospital in Germany. The aim of this work is twofold: developing a normative model representing the clinical guidelines for the treatment of COVID-19 patients, and analyzing the adherence of the observed behavior (recorded in the information system of the hospital) to such guidelines. We show that, through conformance checking techniques, it is possible to analyze the care process for COVID-19 patients, highlighting the main deviations from the clinical guidelines. The results provide physicians with useful indications for improving the process and ensuring service quality and patient satisfaction. We share the resulting model as an open-source BPMN file. © 2023, The Author(s).

Collaborative E-Learning Process Discovery in Multi-tenant Cloud

With the appearance of the COVID-19 pandemic, the practice of e-learning in the cloud makes it possible to: avoid the problem of overloading the institutions infrastructure resources, manage a large number of learners and improve collaboration and synchronous learning. In this paper, we propose a new e-leaning process management approach in cloud named CLP-in-Cloud (for Collaborative Learning Process in Cloud). CLP-in-Cloud is composed of two steps: i) design general, configurable and multi-tenant e-Learning Process as a Service (LPaaS) that meets different needs of institutions. ii) to fulfill the user needs, developpe a functional and non-functional awareness LPaaS discovery module. For functional needs, we adopt the algorithm A* and for non-functional needs we adopt a linear programming algorithm. Our developed system allows learners to discover and search their preferred configurable learning process in a multi-tenancy Cloud architecture. In order to help to discover interesting process, we come up with a recommendation module. Experimentations proved that our system is effective in reducing the execution time and in finding appropriate results for the user request.

CONSEQUENCES OF INTEGRATION PROCESSES FOR BUSINESS CONTINUITY MANAGEMENT

The modern business environment in which the world economy operates brings increasing unpredictability, which makes it difficult to plan and implement business continuity management. Recent examples are the emergence and spread of the corona virus and the war in Ukraine. Market-oriented economies are characterized by a reduction in the life cycle of companies and competition in saturated industrial sectors. Integration processes, takeovers and mergers, represent one of the ways of implementing development strategies of organizations and most often take place in waves and in crisis periods due to economic shocks and the influence of internal and external factors on the organization. Mentioned strategy is used by companies in order to acquire the necessary capital and resources in an effort to establish their position on the market more quickly and efficiently and to carry out activities of greater volume and income for the purpose of survival and faster progress. Due to the trends of M&A and the growing inconsistency and uncertainty in business, the aim of this paper is to highlight the consequences that M&A brings when it comes to managing the business continuity of a "newly integrated" organization. The impact on employees, business processes and general functioning and management of business continuity during and especially after integration will be observed. In order to fulfill the objective of the paper, the empirical part of the paper uses the Delphi method, in which the source of data is based on statistical collection and then the interpretation of the answers to the set questionnaire from a number of experts in the field of business continuity management, the banking sector, auditing and several business units that have recently passed M&A activities in order to consolidate attitudes about the consequences that integration processes bring for business continuity management and the organization as a whole. The paper will analyze the consequences of mergers and acquisitions for the management of business continuity, identify its advantages and disadvantages, and present recommendations for future such processes in the concluding remarks.

Robotic Process Automation - The Ineluctable Virtual Workforce in Various Business Sectors: Post Covid-19 Scenario

Covid – 19 is a sudden unexpected jolt on the functioning of every sector's day-to-day work and dragged everybody to find the best alternative for the automation of processes to enable more work from home. Robotic Process Automation (RPA) is one of such promising technologies which would help in the automation of mundane everyday tasks. With this technology, software robots would be deployed to perform the repetitive tasks done by humans in various sectors. This technology is also sometimes termed software robotics. In this paper, we have studied and discussed about the different tools used for developing software robots, traditional methods of completing the task without RPA being used and also how the task is automated after the use of software robots in various fields, viz., banking, e-commerce, educational institutions, human resources, health care and office. We have also discussed the pros and cons of automating the task using robotic process automation. In short, this paper will give an overview of the emerging technology – RPA. © 2023 Seventh Sense Research Group®

The Study on the Effectiveness of Sustainable Customer Relationship Management: Evidence from the Online Shopping Industry

Sustainable development integrates business, environmental, and social objectives into a unified effort to achieve a common goal. Sustainable customer relationship management (CRM) combines company strategy, customer-focused business processes, and computer technologies. From the consumer's perspective, it lowers psychological, energy, time, and other costs;from the company's perspective, it offers a means of engaging with customers to build lasting and reliable relationships. The sustainable CRM program provides advantages to businesses in various industries, particularly online commerce. It alludes to a comprehensive strategy that promotes solid interactions between buyers and sellers of goods and services. Since current customer retention is less costly than new customer attraction in competitive markets, especially online shopping, identifying the factors affecting relationship management with stable customers is essential. This investigation intends to evaluate the effect of the use of management information systems (MIS), as well as insights on employee behavior and knowledge, and customer behavior (satisfaction and loyalty), on the effectiveness of sustainable CRM in online shopping. The model is validated using the PLS–SEM technique, and study sample of 293 employees and managers from private organizations. According to the results, the MIS, employee behavior and knowledge, customer satisfaction, and customer loyalty influence the effectiveness of sustainable CRM in online shopping. Furthermore, employee behavior and knowledge positively moderate the relationship between customer loyalty and the effectiveness of sustainable CRM. However, the moderating role of employee behavior and knowledge on customer satisfaction and the effectiveness of sustainable CRM is not confirmed. Overall, taking these characteristics into account might help organizations to take significant steps toward increasing the efficacy of sustainable CRM.

Implementing caregiver management measures in general hospitals to prevent the COVID-19 pandemic.

AIM: To summarize the whole process management measures for caregivers of inpatients in a non-new coronavirus pneumonia designated hospital in China during the novel coronavirus pneumonia epidemic. The implementation of these measures is mainly to prevent the virus pandemic caused by crowd gathering. DESIGN: A quasi-experimental study. METHODS: Novel coronavirus pneumonia prevention and control measures were implemented in the 'pre-hospital link, hospitalization link and discharge link' for the whole process of the hospitalized patients' caregivers. To evaluate the effects by time point inspection, the results were fed back using information technology for quality improvement. RESULTS: The results of three time point inspections indicated that the management quality of many projects improved continuously (p < 0.05). From January to June of 2021, 20 departments implemented a facial recognition information management system. The ratio of patients/caregivers admitted was 1:0.528~1:0.965; It was found that it is effective to implement the whole process management measures. The facial recognition system plays a key role in the comprehensive management of the caregivers.

Management Tools for Process Mapping and Modeling in Assembly Industry

In a highly globalized world affected by economic policies and a latent COVID-19 pandemic, companies need to organize or reorganize to achieve efficient operations. The correct management of organizations has led their administrators to adopt resourceful management models that guide their activities towards fulfilling their objectives. Thus, management tools have been presented as an effective alternative to control processes and activities. According to a previous study, the main tools that allow process mapping and modeling are Business Process Management (BPM), Business Process Reengineering (BPR), and Event Process Chain (EPC). This article analyzes their characteristics based on compatibility and affinity with four case studies dedicated to the assembly industry using this previous study. In addition, the advantages and disadvantages of the three tools related to the possible adaptability in the four companies are studied. This work uses qualitative qualification matrices, which answer specific questions, determine the potential improvement of organizational management, and create a methodology for mapping and modeling processes. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Using Service Blueprint to Optimize the Process Management of Group Package Tour in Kinmen

The COVID-19 led to a global border blockade, and domestic group package tours have become Taiwan tourism industry's main economic source. This study takes 30 group package tours in Kinmen by non-participatory observation method and in-depth interviews with eight tour guides, and four components based on the service design optimization are categorized as follows: (1) accommodation;(2) restaurant;(3) attractions visit;and (4) shopping. The research data indicates that: (1) Tourism operators should consider both the input of service manpower and the supervision of the quality of service delivery. (2) Tour guides are the most important key in multiple delivery services. Practical implications and future research directions are also proposed for application and management. © 2022, Chinese Society for Quality. All rights reserved.

Proposal and Implementation of a Model for Organizational Redesign and Its Influence on Digital Transformation in the Public Sector

This paper reviewed the literature on the topics of organizational redesign, digital transformation, strategic planning, process management, administrative simplification, continuous improvement, redesign and automation, and also considered the activities developed to implement organizational redesign in the quarantine declared by the Peruvian state as a result of COVID 19, with the purpose of proposing a method for organizational redesign towards digital transformation in public entities, with a strategic and operational approach. For the implementation of the strategic approach, the institutions that functionally depend on the Ministry of Education were involved, considering the current situation in relation to the operational and territorial capacities of each region, to develop the strategic and process design. Likewise, for the implementation of the operational approach, the results of the virtual course on process management for administrative simplification 2 were used, involving several institutions that proposed and implemented improvements towards the digitization of processes, promoting digital transformation. The results of the present work consider the effective time of the administrative procedures and the cost of implementation. The effective time of the procedures was reflected in a reduction of 11% and 52% in the reduction of the cost of the procedures. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

CRISIS MANAGEMENT IN THE COVID-19 PANDEMIC

This paper analyzes what the tasks of crisis management are, how it is implemented, how much trust the nation or the organization's employees have in it, and how the crisis managements of the Republic of Croatia and Europe reacted to this unprecented crisis. Crisis management has a clear goal, which is to protect human capital, protect the organization's stakeholders and ensure key business processes in the short and long term. Although crisis management in Croatia responded well to the health threat of the pandemic in the first months of the pandemic, financial, economic and tourism management did not adequately respond to all challenges, nor did they have concrete plans or knowledge on how to "get the business back on its feet" after such an unexpected disruption It is believed that, in addition to the crisis management that dealt with the health aspect of the pandemic, one should have been established for the previously mentioned issues, however this remained only an idea. EU did not cope well in the first weeks of the pandemic and its response to the pandemic, should not serve as an example to other countries of the world (Janse, Tsanova, 2020).

Exogenous Shocks and Business Process Management

Business process management (BPM) drives corporate success through effective and efficient processes. In recent decades, knowledge has been accumulated regarding the identification, discovery, analysis, design, implementation, and monitoring of business processes. This includes methods and tools for tackling various kinds of process change such as continuous process improvement, process reengineering, process innovation, and process drift. However, exogenous shocks, which lead to unintentional and radical process change, have been neglected in BPM research although they severely affect an organization’s context, strategy, and business processes. This research note conceptualizes the interplay of exogenous shocks and BPM in terms of the effects that such shocks can have on organizations’ overall process performance over time. On this foundation, related challenges and opportunities for BPM via several rounds of idea generation and consolidation within a diverse team of BPM scholars are identified. The paper discusses findings in light of extant literature from BPM and related disciplines, as well as present avenues for future (BPM) research to invigorate the academic discourse on the topic.

Processes Management for Competitiveness of a SME Company in the Hotel Sector to Face of Covid-19

The objective of the research was to design a process management model for competitiveness in an MSE in the Hotel Sector against COVID-19. The methodology used is prospective-descriptive, a questionnaire reliable (Cronbach's Alpha with 0.736) and validated in the opinion of experts was applied to 27 clients (convenience sampling) and collaborators. The company complies with what is necessary, however, they do not exceed the expectations of their clients, due to the absence of good practices in process management. A new process management model was developed, analyzing the hotel internally and externally, the activities of the reservation process were detailed, their characterization and indicator sheet for the process under evaluation. Concluding that the company is strong internally with 2.64 in the EFI matrix and 2.67 in the EFE matrix, which means a favorable environment, therefore 12 strategies were established in the SWOT matrix. The as is diagram was restructured, generating a reservation process that contains digital activities, the implementation costs were estimated with a total of S / 9'204 and the social and environmental impact matrix was prepared in order to achieve greater sustainability and competitiveness in the organization. © 2021 Latin American and Caribbean Consortium of Engineering Institutions. All rights reserved.

Governance for post-COVID-19 carbon reduction: A case study of the transport sector

This chapter argues that carbon reduction goals in the transport sector should be achieved through the management of policy making and implementation processes, based on a transport-sector carbon emissions identity and the DIRECT approach. Based on the above identity, it is argued that carbon emissions from the transport sector can be reduced from the following six connected domains: (1) carbon intensity of energy consumption from transport, (2) energy consumption from transport, (3) transport pressures from life and business activities, (4) high-carbon life and business activities, (5) changing the needs in life and business, and (6) population policy. The DIRECT approach includes six steps: (1) Detect, (2) Inform/Intervene, (3) React, (4) Enlighten/Enforce/Evaluate, (5) Collaborate, and (6) Transfer, which should be applied to manage each of the above six domains. The “6-domain and 6-step” is proposed as an integrated policy framework for reducing carbon emissions from the transport sector in a seamless way.