New Tools for Microbiological Risk Assessment, Risk Management, and Process Validation Methodology

Over the last years, in response to the increasing complexity and demand of clinical trials, there has been a growing concern with the application of efficient risk management methodologies. The main objective of this work is to assess the current level of implementation of risk management activities by clinical trials sites' teams and identify points of improvement. A cross-sectional study was conducted through an original, non-validated questionnaire created to assess the risk management practices at Portuguese clinical trial sites. The web-based survey was sent by e-mail to the clinical trial sites identified, and it was available for one month. Descriptive statistics were used to summarize the findings. In total, 46 clinical trial sites accepted to participate in this study. The surveys' answers showed that although 57.0% of sites reported the use of a systematic risk management tool, only nine sites (19.6%) described a standard tool or document that captured systematically the analysis of risks at the site level. Most of the sites (87.0%) showed willing to use a risk management tool specifically tailored for their operational needs, with the lack of knowledge about risk management being the main reason against its implementation. This work indicates that the surveyed clinical trial sites generally recognize the importance of risk management methodologies as an opportunity to anticipate difficulties in the trial conduct and optimize the use of sites' resources. However, mainly due to lack of experience with risk management methodologies, sites are not currently implementing these strategies in the management of their trial-related operations. The development of a risk management tool for sites can be useful in this context.

In the marine industry although there has been significant growth towards safety, security and risk assessments or risk-based strategies such as marine insurance and regulations to avoid the risks of damage to properties and the environment or the prospect of premature death caused by accidents etc, the moves toward managing the risks which are linked directly to the business functions and decision making processes have been very slow. Furthermore in the marine industry most perceptions, methodologies and frameworks of dealing with hazards, risks, safety and security issues are for their assessment rather than their management. This trend reveals the fact that in different marine industry sectors such as logistics and shipping there is a lack of coherent risk management framework or methodology from which to understand the risk-based decisions especially for the purpose of design, construction, operation, management and even decommissioning of the marine related applications. On the other hand risk management is not yet viewed holistically in the marine industry in order to, for example, assign a right person, i.e. risk manager, who can act as a coordinator and advisor with responsibilities that are only specific to risk management. As a result this paper, by examining the present physical borders and risk-based activities in the marine industry, aims to propose an appropriate risk management methodology in addition to the emergent role of risk managers which will enable the industry users initially to become familiar with the concept of risk management at its holistic level. In the later stages this eventually can lead to development of risk management capabilities at an exclusive level and its integration into the marine industry functions in future.

Unified Modelling Language (UML) has a graphical notation for 13 different types of diagrams and can be used as a general modelling tool. Well-known examples of diagram types are class diagrams for modelling classes that can be instanced into objects, state machine diagrams for modelling states in systems and activity diagrams for modelling process flows. A literature survey shows that UML has been used to model concepts and methodologies of risk assessment and risk management. One example is the Coras Framework. The international standard CEI IEC 61882 Hazard and operability (HAZOP) studies describes concepts for investigating and detecting possible hazards in systems. In CEI IEC 6882, guide words like ‘More’ and ‘Less’ are applied to system parameters to invoke deviations in the system and assess possible hazards due to the deviation from the design intent. In this paper, we have used UML to model concepts of CEI IEC 61882 Hazards and operability studies. Diagrams of UML were used to show dependencies and relations between parts of the target system and concepts of CEI IEC 61882. Extensions of UML are suggested to better capture and display the concepts of CEI IEC 61882, the results of a HAZOP study and emerging risk. These extensions are referred to as UML for emerging risks (UML-ER).

This book on methodologies for risk assessment and management of transgenic fish is written by 44 authors from 19 countries. It is comprised of 10 chapters giving emphasis on developing countries which have transgenic fish research programmes or aquaculture systems that may use transgenic fish in the future. This book is aimed at helping governments, scientists, potential users of genetically modified organisms (GMOs) and civil society organizations in developing countries involved aquaculture and other countries of the world to strengthen their understanding of the scientific knowledge and methods that are available for conducting environmental risk assessments of GMOs.

On a world-scale basis, fossil fuels are likely to remain the main sources for electricity generation in the twenty-first century, and many industrial processes that are also large CO2 emitters will still be active for many decades. Therefore, carbon capture and storage (CCS) is generally considered a necessary option for reducing CO2 emissions to the atmosphere. This chapter introduces the concept, which consists in the separation of CO2 from energy-related and industrial gas streams, and its transport to a geological storage location where it is permanently and safely stored. The characteristics of the main capture processes: postcombustion, oxycombustion, and precombustion are summarized in terms of energy consumption and costs. Some other possible technological options are briefly described. The methods utilized for CO2 transport are also presented with some cost estimates. The main formation for geological storage—depleted oil and gas fields, deep saline aquifers, and nonexploitable coal seams—are briefly described, with the mechanisms involved in storage operations. Storage capacity evaluations, methodologies for risk assessment and management, are also briefly summarized. The chapter discusses the 14 large-scale integrated CCS projects which are in operation or under construction today, with a rough total storage capacity of 33 million tons a year. This could indicate that provided public awareness, social acceptance, and economic drivers evolve favorably, CCS could play a very significant role in the transition to a future low emission energy use.KeywordsCO2 captureGeological storageImplementation costsRisk assessment

We aimed to develop a user-centered, web-based, decision support tool for breast cancer risk assessment and personalized risk management. Using a novel model choice algorithm, iPrevent® selects one of two validated breast cancer risk estimation models (IBIS or BOADICEA), based on risk factor data entered by the user. Resulting risk estimates are presented in simple language and graphic formats for easy comprehension. iPrevent® then presents risk-adapted, evidence-based, guideline-endorsed management options. Development was an iterative process with regular feedback from multidisciplinary experts and consumers. To verify iPrevent®, risk factor data for 127 cases derived from the Australian Breast Cancer Family Study were entered into iPrevent®, IBIS (v7.02), and BOADICEA (v3.0). Consistency of the model chosen by iPrevent® (i.e., IBIS or BOADICEA) with the programmed iPrevent® model choice algorithm was assessed. Estimated breast cancer risks from iPrevent® were compared with those attained directly from the chosen risk assessment model (IBIS or BOADICEA). Risk management interventions displayed by iPrevent® were assessed for appropriateness. Risk estimation model choice was 100 % consistent with the programmed iPrevent® logic. Discrepant 10-year and residual lifetime risk estimates of >1 % were found for 1 and 4 cases, respectively, none was clinically significant (maximal variation 1.4 %). Risk management interventions suggested by iPrevent® were 100 % appropriate. iPrevent® successfully integrates the IBIS and BOADICEA risk assessment models into a decision support tool that provides evidence-based, risk-adapted risk management advice. This may help to facilitate precision breast cancer prevention discussions between women and their healthcare providers.Electronic supplementary materialThe online version of this article (doi:10.1007/s10549-016-3726-y) contains supplementary material, which is available to authorized users.

Pipeline systems must contend with many hazards, of which ground movements such as landslides and washouts represent one type. Under the broader umbrella term, natural hazards, individual ground movement threats can be subdivided into geotechnical and hydrotechnical hazards. A four-phase natural hazard and risk management system (NHRM) is being developed. Although research and development are ongoing, implementation over the past seven years spans approximately 25,000 km of main-line pipeline in North and South America. It complies with CSA requirements for ‘hazard identification’ as well as current standard-of-care guidelines related to case-law in Canada. It is designed as a simple yet reproducible methodology that can be operated by pipeline companies, particularly their field staff. The first two phases of hazard identification/assessment are described here with reference to a recent study of hydrotechnical hazards along the Trans Mountain Pipe Line Co. Ltd. main line from Hinton, Alberta to Kamloops, British Columbia in the mountains of western Canada. The relative hazard ratings generated by the Phase I and II methodology can be integrated into existing risk management methodologies used in the industry. Alternatively, the risk assessment and risk management methodology of the NHRM system can be used as outlined in this paper.

Floods are one of the most frequent and destructive natural disasters, requiring advanced methodologies for effective risk assessment and management. This study evaluates flood risk in the Upper Tigris Basin using Geographic Information Systems (GIS) integrated with the Analytic Hierarchy Process (AHP) and Fuzzy AHP (FAHP). By analyzing eight critical parameters—precipitation, slope, elevation, lithology, land use, soil type, aspect, and proximity to rivers—risk maps were generated through Multi-Criteria Decision-Making (MCDM) techniques. The AHP method identified precipitation as the most critical factor, contributing 32.5% to overall risk, while FAHP refined the results by addressing uncertainties, enhancing the weights of key parameters like precipitation (32.6%) and slope (15.4%). The FAHP map showed greater differentiation in medium- and low-risk areas, improving its suitability for localized interventions. High-risk zones in northeastern districts, including Lice, Hani, and Hazro, were influenced by high precipitation and steep slopes. Beyond the local context, this study demonstrates the global applicability of integrating GIS with fuzzy logic-based methods for disaster risk assessment. By effectively capturing uncertainties and enhancing precision, these methods provide a replicable framework for other regions facing similar challenges. This research contributes to the scientific understanding of flood dynamics and offers innovative tools for improving disaster preparedness and mitigation strategies worldwide.

Effective information asset management is the basis of information security as well as many other issues. IT risk assessments work well with the proper handling of asset values, and also it is for effectively securing information assets. There is also a wide variety of risk assessment methodologies. This chapter presents information about the overall IT risk management process and methodologies. Best practices are mentioned and occasionally compared based on the requirements of the information technology (IT) sector in practice. This chapter will provide deep knowledge about the IT risk management approach and construction to implementers, risk owners, IT auditors, executive managers, and other IT staff.

Intimate partner violence (IPV) is a crime that is present in all countries, seriously impacts victims, and demands a great deal of time and resources from the criminal justice system. The current study examined the use of the Spousal Assault Risk Assessment Guide, 2nd ed. (SARA; Kropp, Hart, Webster, & Eaves, 1995), a structured professional judgment risk assessment and management tool for IPV, by police officers in Sweden over a follow-up of 18 months. SARA risk assessments had significant predictive validity with respect to risk management recommendations made by police, as well as with recidivism as indexed by subsequent contacts with police. Risk management mediated the association between risk assessment and recidivism: High levels of intervention were associated with decreased recidivism in high risk cases, but with increased recidivism in low risk cases. The findings support the potential utility of police-based risk assessment and management of IPV, and in particular the belief that appropriately structured risk assessment and management decisions can prevent violence.

In modern military operations, nations participate as members of a coalition. In order to realize a rapid command and control cycle, the armed forces of one nation need to establish communication links between their information system and that of other members of the coalition. These interconnections inevitably introduce risks, and these risks need to be managed. However, because each nation uses its own risk management methodology and tools, integrating the results of the risk assessment performed by a partner in the coalition with whom information is exchanged, into one's own risk management process, remains a periodically performed, manual operation. In this paper we will first discuss risk management approaches in a single organization, and show why it is important to adopt a continuous risk management approach. Next we will present a concept for realizing this continuous risk management in a coalition environment.

Agriculture is an economic sector facing large risk, mainly from natural factors and despite of relatively low price responsiveness to supply and demand causes output volatility in general. It is a risky business, and risk assessment and management tools have become increasingly important in recent years. Risk assessment and management is a complex process, since the risk arises from different sources. Typically, literature analyzes financial, business, credit, or currency risk. There is lack of research of human risk, especially in agriculture sector. It is important to identify knowledge, attitudes, behaviors, and priorities among farmers regarding safety, health, and risk management. This research focuses on identifying main human risk factors, identifying vulnerable populations in agriculture, including immigrants, migrants, refugees, young and older persons, women, persons with disabilities, and minority workers. The research explores human risk assessment and management problems in agriculture. Only then is it possible to increase safety and health for agriculture workers and decrease human risk manifestation in agriculture and to make the agriculture sector socially beneficial for its nation.

The purpose of this research was to identify and examine risk assessment tools evaluating at least two risk dimensions to evaluate the risk assessments of patients in mental health areas in a more comprehensive and standard manner. This systematic review was prepared according to the PRISMA guidelines. The databases to be scanned and the keywords to be entered were identified before scanning the literature. The keywords risk assessment, risk management, mental health, psychiatry, risk assessment scales, and risk assessment tools were scanned. The CINAHL, EMBASE, PsycInfo, Medline, APA PsycNET, Science Direct, Pubmed, ProQuest, and Google Scholar databases were searched. All full-text articles published between December 30th, 1970, and January 1st, 2020, were examined. A total of 7385 papers were investigated using the keywords listed above, and 18 studies meeting the inclusion criteria were identified. The tools involved were SPC, FACE, Clinical Risk Management, Threshold Assessment Grid, Risk Assessment for People with Mental Health Problems, Psychogeriatric and Risk Behavior Assessment Scale, Sainsbury Risk Assessment Tool, Risk Assessment Management and Audit Systems, Generic Integrated Risk Assessment for Forensic Environments, FRAME, Brief Risk Assessment, Clinical Assessment of Risks to Self & Others, RIO, The Risk Assessment and Management, Risk Assessment and Management Self-Efficacy Study, Galatean Risk and Safety Tool, Short-Term Assessment of Risk and Treatability, and Psychiatric Risk Assessment Scale.

Public procurement in many countries is one of the most important factors in governance and is a priority target of reform. In many humanitarian situations however, service delivery cannot wait for procurement reform. The needs of many of the Millennium Development Goals are immediate, while procurement reform may take years to institutionalize. Under these circumstances, international organisations such as the United Nations have both implementation and capacity-building roles, often placing them in high-risk situations. This has led to the development of procurement risk assessment and management tools, designed to provide objectivity in country procurement risk monitoring and review, as well as assist capacity building. The procurement risk assessment methodology that follows uses established risk modeling to provide procurement risk ratings in 60 HIV/AIDS, Tuberculosis and Malaria programs in 26 countries, and is successfully promoting procurement strengthening within high-risk country offices.

RAMP (Risk Assessment and Management tool for manual handling – Proactively), a freely accessible MSD risk management tool for manual handling work, was launched 2017 to contribute to the reduction of musculoskeletal disorder (MSD) risks for manual handling work-tasks. The tool is currently developed further, using an iterative participative methodology, to: i) enhance the RAMP tool’s application range, mainly to include hand-intensive work, ii) develop a system version of the tool, and iii) include key performance indicators (KPIs). A needs analysis resulted in 99 identified needs. Regarding i), six needs were assessed as “very important to include” to enhance the application range. A literature study focusing on relevant risk factors and how exposure to them is associated with MSD risks was carried out and first drafts of a model for assessing risks in hand-intensive work are iteratively developed, using feedback from intended users. Regarding ii), 50 needs and suggestions on what to consider when developing a databased system version of the RAMP tool were identified. Prototypes of parts of the system-version are iteratively developed, using intended users’ feedback. Regarding iii), the needs analysis resulted in 16 suggested KPIs, including KPIs based solely on RAMP results and KPIs which can be established combining RAMP results and company data. The project is ongoing. An enhanced RAMP tool, RAMP 2.0, with the abovementioned expansions could support MSD risk assessment and risk management in systematic MSD risks reduction work for a wide range of work tasks.