<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Maria Tereza de Sousa Silva</style></author><author><style face="normal" font="default" size="100%">Edison Nunes da Silva Junior</style></author><author><style face="normal" font="default" size="100%">Jorge Magalhães</style></author><author><style face="normal" font="default" size="100%">Vanessa da Silveira dos Santos Pacheco</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">THE MANAGEMENT OF PROCESS LEAD TIME IN THE RELEASE OF STERILE PHARMACEUTICAL BATCHES: A CASE STUDY OF OPTIMIZATION IN AN OFFICIAL BRAZILIAN PHARMACEUTICAL LABORATORY</style></title><secondary-title><style face="normal" font="default" size="100%">Problems of Management in the 21st Century</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">good manufacturing practices pharmaceutical industry</style></keyword><keyword><style  face="normal" font="default" size="100%">risk management</style></keyword><keyword><style  face="normal" font="default" size="100%">risk management tools</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">June/2021</style></date></pub-dates></dates><urls><web-urls><url><style face="normal" font="default" size="100%">http://oaji.net/articles/2021/450-1624470982.pdf</style></url></web-urls></urls><volume><style face="normal" font="default" size="100%">16</style></volume><pages><style face="normal" font="default" size="100%">Continuous</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">Medicines must comply with quality, safety, and efficacy pillars. Nowadays, organizations seek to incorporate new management models encouraged by quality program following the world trend regarding the technological revolution. The present research aims to improve the sterile pharmaceutical product batches release process, using the Failure Mode Effects Analysis (FMEA) method. This study addresses the gap in literature on quality risk management during batch release. The methodology uses a form adapted to the process in order to systematize the information, improving its comparison and analysis, thus estimating, the identification of potential failure modes and their effects on their performance. Made it possible to assign values for the severity, occurrence, and failure modes detection, to then determine the risk level and the priority of risk level. The results obtained showed the mitigation and elimination of failures in the process, as well as opportunities for improvement and causes of failures identification, improvement in the process performance indicators, greater reliability, and reduction in batch release time.</style></abstract><issue><style face="normal" font="default" size="100%">1</style></issue><work-type><style face="normal" font="default" size="100%">Original article</style></work-type><section><style face="normal" font="default" size="100%">42-51</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Iwona   Gorzeń-Mitka</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">THE EVOLUTION OF RISK MANAGEMENT RESEARCH: CHANGES IN KNOWLEDGE MAPS</style></title><secondary-title><style face="normal" font="default" size="100%">Problems of Management in the 21st Century</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">knowledge maps</style></keyword><keyword><style  face="normal" font="default" size="100%">network analysis</style></keyword><keyword><style  face="normal" font="default" size="100%">risk management</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2017</style></year><pub-dates><date><style  face="normal" font="default" size="100%">December/2017</style></date></pub-dates></dates><urls><web-urls><url><style face="normal" font="default" size="100%">http://oaji.net/articles/2017/450-1515833475.pdf</style></url></web-urls></urls><volume><style face="normal" font="default" size="100%">12</style></volume><pages><style face="normal" font="default" size="100%">Continuous</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">One of the leading trends in modern academic research is risk management. Over the years, the approach to risk management has changed and affected many different areas. This study aims to investigate changes in risk management and trends of risk management in the past 20 years. Risk management related publications from 1990 to 2016 were retrieved from the Web of Science and Scopus databases. VOS viewer software was used to analyse the research trend. Literature growth related to risk management is expanding rapidly. Significantly more publications related to risk management aspects were collected in Scopus, compared to the Web of Science. Since 2005 is to be noted a significantly increasing interest in risk management problems (nearly 5300 publications by year in Scopus database). Risk management problems mainly appearing in publications related to the fields of Medicine and Engineering, Business, Management and Accounting, Economics, Econometrics and Finance, Computer Science and Environmental Science. In Business, Management and Accounting a significant jump in the interest in the issues of risk management was noted in 2011. Recent studies focus on the enterprise risk management, environmental and industry management innovation in strong connection with risk assessment. The enterprise risk management associated with environmental and sustainable perspective may be the newest topics that should be closely followed in risk management research.</style></abstract><issue><style face="normal" font="default" size="100%">2</style></issue><work-type><style face="normal" font="default" size="100%">Original article</style></work-type><section><style face="normal" font="default" size="100%">106-121</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Iwona   Gorzeń-Mitka</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">MANAGEMENT CHALLENGES IN THE CONTEXT OF RISK CULTURE</style></title><secondary-title><style face="normal" font="default" size="100%">Problems of Management in the 21st Century</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">continuous improvement</style></keyword><keyword><style  face="normal" font="default" size="100%">corporate decision-making</style></keyword><keyword><style  face="normal" font="default" size="100%">management process</style></keyword><keyword><style  face="normal" font="default" size="100%">risk culture</style></keyword><keyword><style  face="normal" font="default" size="100%">risk management</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2015</style></year><pub-dates><date><style  face="normal" font="default" size="100%">December/2015</style></date></pub-dates></dates><urls><web-urls><url><style face="normal" font="default" size="100%">http://oaji.net/articles/2015/450-1451415096.pdf</style></url></web-urls></urls><volume><style face="normal" font="default" size="100%">10</style></volume><pages><style face="normal" font="default" size="100%">Continuous</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">In recent years (especially in the context of the financial sector) we can find many debates (public and academic) which emphasise the need to change mindsets in management (Gorzeń-Mitka, 2012). This discussion is a result of the dynamically changing external and internal conditions of the functioning of organizations. At the same time, we observe great progress over the past decade in developing effective tools and techniques for managing (also risk and complexity) within organizations. But management is carried out by people. Their awareness of threats and opportunities determines the effectiveness of the whole management process within the organization. One of the themes of this discussion is to indicate the need for changes in the area of organizational culture by creating the so-called risk culture. </style></abstract><issue><style face="normal" font="default" size="100%">2</style></issue><work-type><style face="normal" font="default" size="100%">Editorial</style></work-type><section><style face="normal" font="default" size="100%">60–61</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Tatiana   Karkoszka</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">OPTIMIZATION OF QUALITY, ENVIRONMENTAL AND OCCUPATIONAL RISK BY THE SYSTEM AND TECHNOLOGICAL SOLUTIONS</style></title><secondary-title><style face="normal" font="default" size="100%">Problems of Management in the 21st Century</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">occupational safety</style></keyword><keyword><style  face="normal" font="default" size="100%">quality</style></keyword><keyword><style  face="normal" font="default" size="100%">risk management</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2013</style></year><pub-dates><date><style  face="normal" font="default" size="100%">April/2013</style></date></pub-dates></dates><urls><web-urls><url><style face="normal" font="default" size="100%">http://oaji.net/articles/2014/450-1392545843.pdf</style></url></web-urls></urls><volume><style face="normal" font="default" size="100%">6</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">The purpose of the research has been preparation of the univocal methodology of integrated risk management and usage of the system and technological solutions as a manner of quality, environmental and occupational risk optimization. The methodology used for the analysis has included a proposition of system, technological and cost aspects of integrated risk management. Particularly the methodology management should be based on the optimization of the risk and realized as the integrated operational control as well as on the monitoring of integrated system risk. Findings of the research, which have been conducted on the basis of the prepared methodology, are as follows: one of the manners of the integrated risk reduction is application of the univocal method of integrated risk estimation, which should be specific for the organization. Results of the integrated analysis should be a starting point for the minimization of the integrated risk by assuring processes continuity both on organizational and technological level. Practical implication, confirmed in the chosen production organization, can be applied in case of any organization, which wants to manage the integrated risk in the complex meaning of clients’ requirements, natural environment protection and safety conditions assurance. </style></abstract><work-type><style face="normal" font="default" size="100%">Original article</style></work-type><section><style face="normal" font="default" size="100%">7-14</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Iwona   Gorzeń-Mitka</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">RISK IDENTIFICATION TOOLS – POLISH MSMES COMPANIES PRACTICES</style></title><secondary-title><style face="normal" font="default" size="100%">Problems of Management in the 21st Century</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">risk identification</style></keyword><keyword><style  face="normal" font="default" size="100%">risk management</style></keyword><keyword><style  face="normal" font="default" size="100%">small and medium enterprises</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2013</style></year><pub-dates><date><style  face="normal" font="default" size="100%">July/2013</style></date></pub-dates></dates><urls><web-urls><url><style face="normal" font="default" size="100%">http://oaji.net/articles/2014/450-1397905044.pdf</style></url></web-urls></urls><volume><style face="normal" font="default" size="100%">7</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">The purpose of this study is to present risk identification tools in Polish micro, small and medium-sized enterprises (MSMEs). Risk identification is a key element of the risk management process in companies. Correctly fitting risk identification tools affect the accuracy of management decisions. The result of research is to identify the leading risk identification tools used by MSMEs. The study was conducted in 2010-2012 using a mixed survey-monographic method and questionnaires. The qualitative data were obtained during the study.</style></abstract><work-type><style face="normal" font="default" size="100%">Original article</style></work-type><section><style face="normal" font="default" size="100%">6-11</style></section></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Iwona   Gorzeń-Mitka</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">RISK MANAGEMENT AS CHALLENGE TO TODAY’S ENTERPRISES</style></title><secondary-title><style face="normal" font="default" size="100%">Problems of Management in the 21st Century</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">management systems</style></keyword><keyword><style  face="normal" font="default" size="100%">risk management</style></keyword><keyword><style  face="normal" font="default" size="100%">system of risk management</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2013</style></year><pub-dates><date><style  face="normal" font="default" size="100%">July/2013</style></date></pub-dates></dates><urls><web-urls><url><style face="normal" font="default" size="100%">http://oaji.net/articles/2014/450-1397904999.pdf</style></url></web-urls></urls><volume><style face="normal" font="default" size="100%">7</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">Risk and its management are becoming increasingly important issues in modern theory and practice of managing organizations. It is propounded that organizations, regardless of the type or size of activity they carry out, take into account the impact of risk in their decisions and processes. Managerial approach to risk is aimed at reducing the extent to which risk impacts the functioning of an organization, allowing it to take optimal decisions. At the same time, changes occurring in the environment increase manifold the risk that organizations are forced to take. Inadequacy of the existing, traditional approaches to risk management, which often do not correspond to the dynamics of the changes in the environment in which today’s organizations function, makes it necessary to look for new, innovative managerial solutions. This has led to the emergence of the paradigm of enterprise risk management (ERM).</style></abstract><work-type><style face="normal" font="default" size="100%">Editorial</style></work-type><section><style face="normal" font="default" size="100%">4-5</style></section></record></records></xml>