Search results for "Specific risk"
showing 6 items of 16 documents
Components of software development risk: how to address them? A project manager survey
2000
Software risk management can be defined as an attempt to formalize risk oriented correlates of development success into a readily applicable set of principles and practices. By using a survey instrument we investigate this claim further. The investigation addresses the following questions: 1) What are the components of software development risk? 2) how does risk management mitigate risk components, and 3) what environmental factors if any influence them? Using principal component analysis we identify six software risk components: 1) scheduling and timing risks, 2) functionality risks, 3) subcontracting risks, 4) requirements management, 5) resource usage and performance risks, and 6) person…
A Quality Risk Management Model Approach for Cell Therapy Manufacturing
2010
International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell-based therapies in regenerative medicine. The available risk management guidelines, however, provide little guidance on specific risk analysis approaches and procedures applicable in clinical cell therapy manufacturing. This raises a number of problems. Cell manufacturing is a poorly automated process, prone to operator-introduced variations, and affected by heterogeneity of the processed organs/tissues and lot-dependent variability of reagent (e.g., collagenase) efficiency. In this study, the principal challenges faced in a cell-based product manufacturi…
Can software risk management improve system development: an exploratory study
1997
Software risk management can be defined as an attempt to formalise risk oriented correlates of development success into a readily applicable set of principles and practices. Earlier research suggests that it can reduce the likelihood of a system failure. Using a survey instrument we investigate this claim further. The investigation addresses the following questions: (1) which characteristics of risk management practices; and (2) which other environmental and process factors (such as development methods, manager's experience) relate to improved performance in managing software risks? Our findings support in general the claim that the use of risk management methods improves system development…
The Stroke Riskometer (TM) App: Validation of a data collection tool and stroke risk predictor
2014
Background The greatest potential to reduce the burden of stroke is by primary prevention of first-ever stroke, which constitutes three quarters of all stroke. In addition to population-wide prevention strategies (the ‘mass’ approach), the ‘high risk’ approach aims to identify individuals at risk of stroke and to modify their risk factors, and risk, accordingly. Current methods of assessing and modifying stroke risk are difficult to access and implement by the general population, amongst whom most future strokes will arise. To help reduce the burden of stroke on individuals and the population a new app, the Stroke Riskometer™, has been developed. We aim to explore the validity of the app fo…
Data Analysis of Epidemiological Studies
2010
Epidemiology is used to describe the distribution of diseases in the population and to analyze the causes of these diseases. One important objective is to identify risk factors and to quantify their significance. A risk factor can influence the probability that a specific disease develops. Risk factors include: Environmental influences (for example, exposure to radon) Predisposition (for example, genes), or Behavioral characteristics (for example, hormone intake). Epidemiological research employs various different types of study (1–3), depending on the question asked. The most important are Cohort studies Case-control studies, and Cross-sectional studies In cohort studies, persons exposed t…
Impact of vCJD on blood supply.
2007
Variant Creutzfeldt-Jakob disease (vCJD) is an at present inevitably lethal neurodegenerative disease which can only be diagnosed definitely post mortem. The majority of the approximately 200 victims to date have resided in the UK where most contaminated beef materials entered the food chain. Three cases in the UK demonstrated that vCJD can be transmitted by blood transfusion. Since BSE and vCJD have spread to several countries outside the UK, it appears advisable that specific risk assessments be carried out in different countries and geographic areas. This review explains the approach adopted by Germany in assessing the risk and considering precautionary measures. A fundamental premise is…