Assessing Risk of a Serious Failure Mode Based on Limited Field Data

Nowadays, many consumer products are designed and manufactured so that the probability of failure during the technological life of the product is small. Most product units in the field retire before they fail. Even though the number of failures of such products is small, there is still a need to model and predict field failures for purposes of risk assessment in applications that involve safety. Challenges in modeling and predictions of failures arise because the retirement times are often unknown, few failures have been reported, and there are delays in field failure reporting. Motivated by an application to assess the risk of failure for a particular product, we develop a statistical prediction procedure that considers the impact of product retirements and reporting delays. Based on the developed method, we provide the point predictions for cumulative number of reported failures over a future time period and corresponding prediction intervals to quantify uncertainty. We also conduct sensitivity analysis to assess the effects of different assumptions on failure-time and retirement distributions

Assessing Risk of a Serious Failure Mode Based on Limited Field Data

Many consumer products are designed and manufactured so that the probability of failure during the technological life of the product is small. Most product units in the field retire before they fail. Even though the number of failures of such products is small, there is still a need to model and predict field failures for purposes of risk assessment in applications that involve safety. Challenges in the modeling and prediction of failures arise because the retirement times are often unknown, few failures have been reported, and there are delays in field failure reporting. Motivated by an application to assess the risk of failure for a particular product, we develop a statistical prediction procedure that considers the impact of product retirements and reporting delays. Based on the developed method, we provide the point predictions for the cumulative number of reported failures over a future time period, and corresponding prediction intervals to quantify uncertainty. We also conduct sensitivity analysis to assess the effects of different assumptions on failure-time and retirement distributions

Quality of medicines commonly used in the treatment of soil transmitted helminths and Giardia in Ethiopia: a nationwide survey

Background: The presence of poor quality medicines in the market is a global threat on public health, especially in developing countries. Therefore, we assessed the quality of two commonly used anthelminthic drugs [mebendazole (MEB) and albendazole (ALB)] and one antiprotozoal drug [tinidazole (TNZ)] in Ethiopia. Methods/Principal Findings: A multilevel stratified random sampling, with as strata the different levels of supply chain system in Ethiopia, geographic areas and government/privately owned medicines outlets, was used to collect the drug samples using mystery shoppers. The three drugs (106 samples) were collected from 38 drug outlets (government/privately owned) in 7 major cities in Ethiopia between January and March 2012. All samples underwent visual and physical inspection for labeling and packaging before physico-chemical quality testing and evaluated based on individual monographs in Pharmacopoeias for identification, assay/content, dosage uniformity, dissolution, disintegration and friability. In addition, quality risk was analyzed using failure mode effect analysis (FMEA) and a risk priority number (RPN) was assigned to each quality attribute. A clinically rationalized desirability function was applied in quantification of the overall quality of each medicine. Overall, 45.3% (48/106) of the tested samples were substandard, i.e. not meeting the pharmacopoeial quality specifications claimed by their manufacturers. Assay was the quality attribute most often out-of-specification, with 29.2% (31/106) failure of the total samples. The highest failure was observed for MEB (19/42, 45.2%), followed by TNZ (10/39, 25.6%) and ALB (2/25, 8.0%). The risk analysis showed that assay (RPN = 512) is the most critical quality attribute, followed by dissolution (RPN = 336). Based on Derringer's desirability function, samples were classified into excellent (14/106,13%), good (24/106, 23%), acceptable (38/106, 36%%), low (29/106, 27%) and bad (1/106,1%) quality. Conclusions/Significance: This study evidenced that there is a relatively high prevalence of poor quality MEB, ALB and TNZ in Ethiopia: up to 45% if pharmacopoeial acceptance criteria are used in the traditional, dichotomous approach, and 28% if the new risk-based desirability approach was applied. The study identified assay as the most critical quality attributes. The country of origin was the most significant factor determining poor quality status of the investigated medicines in Ethiopia

A commentary on recent water safety initiatives in the context of water utility risk management.

Over the last decade, suppliers of drinking water have recognised the limitations of relying solely on end-product monitoring to ensure safe water quality and have sought to reinforce their approach by adopting preventative strategies where risks are proactively identified, assessed and managed. This is leading to the development of water safety plans; structured ‘route maps’ for managing risks to water supply, from catchment to consumer taps. This paper reviews the Hazard Analysis and Critical Control Point (HACCP) procedure on which many water safety plans are based and considers its appropriateness in the context of drinking water risk management. We examine water safety plans in a broad context, looking at a variety of monitoring, optimisation and risk management initiatives that can be taken to improve drinking water safety. These are cross-compared using a simple framework that facilitates an integrated approach to water safety. Finally, we look at how risk management practices are being integrated across water companies and how this is likely to affect the future development of water safety p

Transportation of hazardous materials via pipeline. A historical overview

The transportation of hazardous materials via pipelines is often considered a safer alternative to other transportation modalities such as railway, road and ship. However, pipelines often cross industrial and highly populated areas, so that their failure can pose a significant risk to the surrounding environment and the exposed population: the possible release of flammable and/or toxic materials in such areas can generate catastrophic events with very severe consequences. A number of accidents have actually occurred in the past years, and even when no deaths or injured are reported, significant damages to the surrounding environment often occur. This suggests that, given the extremely wide extension of the network worldwide, and the very high amounts of transported materials, a careful analysis is still required. In addition, the construction of pipelines also involves the contribution of expertise from a range of technical areas. As a consequence, the occurrence of accidents and the impact of their consequences, depend on the combination of a large number of parameters. In the present paper, an analysis of data relative to pipelines transporting hazardous materials has been carried out, and the influence of specific issues connected with their type and operation, has been assessed

Software reliability and dependability: a roadmap

Shifting the focus from software reliability to user-centred measures of dependability in complete software-based systems. Influencing design practice to facilitate dependability assessment. Propagating awareness of dependability issues and the use of existing, useful methods. Injecting some rigour in the use of process-related evidence for dependability assessment. Better understanding issues of diversity and variation as drivers of dependability. Bev Littlewood is founder-Director of the Centre for Software Reliability, and Professor of Software Engineering at City University, London. Prof Littlewood has worked for many years on problems associated with the modelling and evaluation of the dependability of software-based systems; he has published many papers in international journals and conference proceedings and has edited several books. Much of this work has been carried out in collaborative projects, including the successful EC-funded projects SHIP, PDCS, PDCS2, DeVa. He has been employed as a consultant t

NICEly does it: economic analysis within evidence-based clinical practice guidelines

There is increasing professional and policy interest in the role of clinical guidelines for promoting effective and efficient health care. The NHS Health Technology Assessment Programme identified an urgent need, when such guidelines are produced, to develop a framework and methods for incorporating the best evidence of effectiveness, taking into account information on cost-effectiveness. This paper describes the development of recent evidence-based guidelines, for use in primary care, which were the result of recent work by the North of England Guidelines Development Group. Their specific aim was to incorporate economic analysis into the guideline process and treatment recommendations. The introduction of economic data raised some methodological issues, specifically: in providing valid and generalisable cost estimates; in the grading of cost ‘evidence’; in finding a presentation helpful to clinicians. The approach used was to help clinicians aggregate the various attributes of treatment to make good treatment recommendations, rather than interpret cost-effectiveness ratios. In none of the guideline areas was there adequate information to estimate a cost per quality-adjusted-life-year. In the light of this research, future areas of work are identified and some recommendations are made for the forthcoming National Institute for Clinical Excellence.evidence-based medicine, economic evaluation, clinical guidelines, NICE

Scientific Standards and the Regulation of Genetically Modified Insects

Experimental releases of genetically modified (GM) insects are reportedly being evaluated in various countries, including Brazil, the Cayman Islands (United Kingdom), France, Guatemala, India, Malaysia, Mexico, Panama, Philippines, Singapore, Thailand, the United States of America, and Vietnam. GM mosquitoes (Aedes aegypti) have already been released for field trials into inhabited areas in the Cayman Islands (2009–?), Malaysia (2010–2011), and Brazil (2011–2012). Here, we assess the regulatory process in the first three countries permitting releases (Malaysia, US, and the Cayman Islands) in terms of pre-release transparency and scientific quality. We find that, despite 14 US government–funded field trials over the last 9 years (on a moth pest of cotton), there has been no scientific publication of experimental data, and in only two instances have permit applications been published. The world's first environmental impact statement (EIS) on GM insects, produced by US authorities in 2008, is found to be scientifically deficient on the basis that (1) most consideration of environmental risk is too generic to be scientifically meaningful; (2) it relies on unpublished data to establish central scientific points; and (3) of the approximately 170 scientific publications cited, the endorsement of the majority of novel transgenic approaches is based on just two laboratory studies in only one of the four species covered by the document. We find that it is not possible to determine from documents publically available prior to the start of releases if obvious hazards of the particular GM mosquitoes released in Malaysia, the Cayman Islands, and Brazil received expert examination. Simple regulatory measures are proposed that would build public confidence and stimulate the independent experimental studies that environmental risk assessments require. Finally, a checklist is provided to assist the general public, journalists, and lawmakers in determining, from documents issued by regulators prior to the start of releases, whether permit approval is likely to have a scientifically high quality basi