QRM: a Case for Convergence: a Reminder that Quality Risk Management Must Work With Other Risk Management Systems

This article reflects that Quality Risk Management (QRM) is operating in a different technological environment since the ICH Q9: Quality Risk Management [1] guidance was first published in 2005. This paper explores the array of risk management systems that influence operations in a typical modern high-tech manufacturing facility. These ‘other’ risk management systems, either directly or indirectly, inform both the risk assessments and the control strategies developed by QRM. Convergence is another word for coming together. In order to assure that QRM can fully align and converge within operations, it must also ensure that it can align with these allied risk management systems

The new challenges of the manufacturing industry applying the norm ISO 45001:2018

The present work reflects the impact that the manufacturing industries must solve in the application of the ISO 45001: 2018 Standard on Occupational Health and Safety Management Systems. In such, a globalized market where human and material assets must be preserved for the survival of organizations, management systems based on continuous improvement play an important role in ensuring compliance with applicable legal requirements, risk management and the opportunities, as well as the achievement of the best working conditions. The manufacturing industry has not been alien to this evolution; the nature of the risks present in the different industries, the operations carried out, the machinery, the use of work teams and their processes make this sector a priority and strategic sector that should be at the forefront of new technologies and rules. The implementation of the ISO 45001: 2018 standard in the manufacturing industry is a challenge for the implementation of high-level management systems that guarantee a healthy and safe environment for workers and a strategic and operational decision from the business point of view based on improving the performance of health and safety at work and increasing competitiveness in an increasingly demanding market.Universidad de Málaga. Campus de Excelencia Internacional Andalucía Tech

Integrated Attack Tree in Residual Risk Management Framework

Safety-critical cyber-physical systems (CPSs), such as high-tech cars having cyber capabilities, are highly interconnected. Automotive manufacturers are concerned about cyber attacks on vehicles that can lead to catastrophic consequences. There is a need for a new risk management approach to address and investigate cybersecurity risks. Risk management in the automotive domain is challenging due to technological improvements and advances every year. The current standard for automotive security is ISO/SAE 21434, which discusses a framework that includes threats, associated risks, and risk treatment options such as risk reduction by applying appropriate defences. This paper presents a residual cybersecurity risk management framework aligned with the framework presented in ISO/SAE 21434. A methodology is proposed to develop an integrated attack tree that considers multiple sub-systems within the CPS. Integrating attack trees in this way will help the analyst to take a broad perspective of system security. Our previous approach utilises a flow graph to calculate the residual risk to a system before and after applying defences. This paper is an extension of our initial work. It defines the steps for applying the proposed framework and using adaptive cruise control (ACC) and adaptive light control (ALC) to illustrate the applicability of our work. This work is evaluated by comparing it with the requirements of the risk management framework discussed in the literature. Currently, our methodology satisfies more than 75% of their requirements

The European Respiratory Society and European Society of Thoracic Surgeons clinical guidelines for evaluating fitness for radical treatment (surgery and chemoradiotherapy) in patients with lung cancer

The European Respiratory Society (ERS) and the European Society of Thoracic Surgeons (ESTS) established a joint task force with the purpose to develop clinical evidence-based guidelines on evaluation of fitness for radical therapy in patients with lung cancer. The following topics were discussed, and are summarized in the final report along with graded recommendations: Cardiologic evaluation before lung resection; lung function tests and exercise tests (limitations of ppoFEV1; DLCO: systematic or selective?; split function studies; exercise tests: systematic; low-tech exercise tests; cardiopulmonary (high tech) exercise tests); future trends in preoperative work-up; physiotherapy/rehabilitation and smoking cessation; scoring systems; advanced care management (ICU/HDU); quality of life in patients submitted to radical treatment; combined cancer surgery and lung volume reduction surgery; compromised parenchymal sparing resections and minimally invasive techniques: the balance between oncological radicality and functional reserve; neoadjuvant chemotherapy and complications; definitive chemo and radiotherapy: functional selection criteria and definition of risk; should surgical criteria be re-calibrated for radiotherapy?; the patient at prohibitive surgical risk: alternatives to surgery; who should treat thoracic patients and where these patients should be treated

Identification of optimal international market strategies:comparative case study of Finnish health tech startups

Abstract. Technological advancements and internationalisation has changed the dynamics of economic growth. As countries move towards entrepreneurial growth, the traditional large-scale organizations have become obsolete. Instead small and medium enterprises have contributed to the economy through job creation and increasing of exports. Technological start-ups with their lean structure and high growth have contributed to the economy manifold. In this regard Finland is known to have one of the leading start-up eco-systems globally. Health tech start-ups in Finland have contributed to economic growth through their exports and provided the country with an innovative technological base. They have further provided growth through job creation and foreign market penetration. This research is conducted to study the factors that enable a health tech start-up to internationalise and contribute to economic growth in Finland. Entrepreneurial orientation, market driven management, networking and culture are the internal and external factors associated with international entrepreneurship and studied in this research. Data was collected through semi structured interviews from three health tech start-ups in Finland, that have created an international customer base within the first six years of their operations. Results of the study show that entrepreneurial orientation when treated as a collective of its three constructs, innovativeness, risk taking and pro-activeness is an internal factor that enables a start-up to develop competitive advantage and seek international opportunities. Whereas market driven management was found essential for the start-ups to maintain that competitive advantage in international markets. Networking was found to have a significant impact on retention of international opportunities while culture did not seem to drive the international efforts of health tech start-ups

Unmanned aerial systems: Status and Forthcoming challenges for Safety Risk Management

Urban Air Mobility (UAM) promises a revolution in urban transportation: for the first time ever, cities will be able to use the third dimension for their mobility needs. The traditional aviation industry and high-tech newcomers alike are making huge investments to make this - still unproven - technology a reality. Although Unmanned Aerial Systems (UAS) have now for some time been used in segregated airspace where separation from other air traffic can be assured, potential users have interests to deploy UAS in non-segregated airspaces. Recent technological and operational improvements give reason to believe that UAS safety and performance capabilities are maturing. However, there is still the need for establishing a systematic agreement between UAS safety policies with commonly accepted UAS Safety Risk Management processes. This agreement is needed to show that the risks related to UAS operations in all the different airspace classes can be adequately controlled in a way that would not jeopardize current safety levels and safety mitigations effectiveness. This study aims to investigate the current status of UAS operations and future concepts of operations with specific interest in the management of safety risk. This manuscript aims to summarize some of regulatory aspects currently available linked to safety investigation and reporting of drone operations and consequently draw some potential lines for future research

A sector analysis for RFID technologies: fundamental and technical analysis for financial decision making problems

Automatic identification technologies have been used in a wide range of applications for reducing the amount of time and labor needed to input data and improving data accuracy. As an important automatic identification technology, radio frequency identification (RFID) technologies allow contactless reading and these technologies are particularly successful in manufacturing and other environments where traditional identification technologies such as bar codes can not perform well. By integrating the RFID technology into their business models, companies may save time, lower labor cost, improve products quality and provide better service. RFID is the wireless technology that uses RF communication to identify, track and manage objects and collect and store data. RFID technology enables companies to develop applications that create value by tracking and identifying objects, animals or people. Business applications of RFID technology can be seen in areas such as manufacturing, supply chain management, software integration, security systems, asset tracking and many others. RFID technology was predicted to be one of the “top ten” technologies in 2004 by CNN. Although, the RFID market is less than five years old, it has been applied to many different industries, from retail industry to logistics, or from healthcare to service business industry – and it is still growing. Particularly, RFID has fundamental influences on today's retailing and supply chain management for applications like asset tracking the inventory control and management. RFID technology also finds major application in mobile phones and is widely used in toll collection of highways, for payments in restaurants, vending machines, retail and parking lots. There are a wide range of RFID systems currently being used or being developed. Examples to these systems include but not limited to the following; automatic vehicle and personnel access control for security (Simpson, 2006), airport passenger and baggage tracking (Ferguson, 2006), tracing blood for cutting down errors such as giving patients wrong blood types (Ranger, 2006), payment process systems (Ramachandran, 2006), production control in manufacturing (Liu & Miao, 2006), transfusion medicine (Knels, 2006) real-time inventory control by automated identification of items in warehouses, tracking and management of physical files, tracking of books in the libraries (Shadid, 2005). For some other applications, interested reader is referred to (Finkenzeller, 2003; Smith, 2004). RFID solution providers claim that their technology and solutions bring significant benefits and have valuable advantages in practice. As new RFID solutions being developed and more RFID tags and equipments being used, these solutions will become more cost effective and RFID businesses are expected to grow rapidly. Since RFID is fairly new, it’s difficult to measure resulting sales increases or heightened customer satisfaction quotients. On the other hand, according to IDC estimation (IDC is a subsidiary of International Data Group, a leading technology media, research, and events company and provider of market intelligence, advisory services, and events for the information technology, telecommunications, and consumer technology markets), companies in the retail sector will spend nearly $1.3 billion on RFID in their supply chain operations in 2008, compared to about$91.5 million in 2003 which corresponds to annual growth rate of 70 percent. In a similar look; the Wireless Data Research Group projected that the global market for RFID increased from $1 billion in 2003 to$3 billion in 2007 (Asif & Mandviwalla, 2005). There are two major drivers of this growth. The first one is the adoption of RFID technology by major retailers and government agencies. The second one is the reduction in the price of RFID tags, readers, and IT systems required to deploy RFID. Given the huge potential of RFID technology, there has been a huge emergence of RFID specialty companies and the development of RFID practices within many market-leading companies. Due to huge emergence, it is desirable to make a sector analysis. In this study, we perform a sector analysis for RFID technologies for researchers and analysts. We investigate public RFID companies traded on the stock exchange markets, summarize their financial performance, describe their RF products, services, and applications, and perform fundamental and technical analysis

The Relationship Between Employee Perceptions of the Employment Game and Their Perceptions of Cooperative Knowledge Behavior in High Tech Firms

The relationship between knowledge sharing and organizational performance for high technology start-up companies is not well understood. Using game theory and the concept of competitive advantage through human resource management, I examine employee perceptions of the employment game relating to cooperative knowledge behavior and firm performance as an entry point into researching organizational knowledge utilization. I draw upon classical game theory to develop four measures of perceptions critical to game playing and apply these to organizational situations via a survey instrument. I propose that perceptions of the employment game held by organization members are determinants of cooperative knowledge sharing and subsequently firm performance. I analyze survey data gathered from high-tech workers using both regression and path analysis techniques. The results from this study offer new insights into methods for measuring both the connections between knowledge work and firm performance and the perceptions critical for fostering collaborative knowledge work in high tech firms. Results of the study show a significant relationship between the game theory construct of reciprocity, knowledge building behavior and firm performance. The mediation model was weakly supported but shows potential usefulness for further research in the field of strategic human resource management

Market Structure and Energy Efficiency: The Case of New Commercial Buildings

This is a report on why commercial office buildings aren’t more energy efficient. Several decades of energy efficiency programs have resulted in some gains, but overall increases in the energy efficiency of buildings have fallen far short of the 30 to 50 percent improvement that many efficiency advocates believe is possible. The purpose of this study is to consider the “why” question by empirically examining the dynamics of new commercial building markets. To do so, the authors used multiple research techniques, including qualitative field observation and interview methods that allow for a more in-depth understanding of complicated market processes. Their research focused primarily on new office buildings and centered in four regional markets: Sacramento, San Francisco, Seattle, and Portland. The authors identify key dynamics of commercial office building markets, describe how change and innovation occurs in commercial development, discuss the implications for energy efficiency, and suggest next steps