Fuzzy quality-team formation for value added auditing: A case study

Value-added (quality) auditing is emerging as one of the most powerful tools for continuous quality improvement, with the introduction of the ISO 9001:2000 and ISO 19011 standards that focus team-based audits, proper auditor skills, process auditing, and effectiveness, etc. Formation of an effective quality audit team (QAT) based on the required auditor skills is therefore the initial stage of the value added auditing. QATs audit organizations at different locations with varying auditing requirements in order to evaluate an organization's own quality system (first party part audits according to IEC9001 Clause 8.2.2). The QAT consists of a lead auditor and one or more auditors that have the required skills in varying levels for the execution of an audit. For a successful audit, the formation of a QAT is vital since each audit team must at least fulfill the minimum requirements and skills needed for a specific audit. In this case study, a fuzzy mathematical-programming model and a solution algorithm based on “simulated annealing” is proposed for the formation of QATs. This is one of the first attempts in the literature to form this kind of teams analytically. Example problems are also solved in the paper to present the application of the proposed approach.     

A developing countries' perspective on population,environment, and development

The subject of this paper is the political behavior of developing states (the South) on issues of population, environment and development. It attempts to understand why the South is so weary of international population policy in the name of the environment. It argues that the South's response is shaped by five inter-related concerns about responsibility, efficiency, efficacy, additionality, and sovereignty. That is, the developing countries, (a) do not want their population growth to be held responsible for global environmental degradation, (b) argue that a more efficient solution to the environmental crisis is consumption control in the North, (c) believe that development remains a necessary condition for efficacious population control, (d) are weary of the population priorities of the North distracting international funds from other developmental goals of the South, and (e) are unprepared to accept any global population norms which challenge their fundamental political, cultural or religious sovereignty. It is maintained that these concerns have historically guided the positions of the South and remain valid and relevant today. Although, over the last two decades of North-South debate on the subject the nuances within these concerns have evolved, the concerns themselves remain valid and were apparent again at the 1994 International Conference on Population and Development. Finally, it is proposed that although a grand North-South bargain around population-environment-development issues remains unlikely, both sides can gain much from trying to understand - even where they do not agree with - the other's concerns. The purpose of this study is not as much to defend the South's position, as to present it and the rationale behind it.     

Letters to the editor

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons—particularly for orphan diseases without sufficient revenue incentive for industry investment—regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model comprising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.     

Adverse events reporting—the tip of an iceberg*

The right not to know personal health-related information has been included in prominent human rights documents and subsequently in national legislation since the middle of the 1990s. Apart from situations where another life is at stake, the right not to know has in these documents been formulated as if it should have precedence over other interests. This article argues against giving the right not to know such a prominent position. It does so by questioning the ethical relevance of the concept for both theoretical and empirical reasons. The main focus of the article is on empirical data from a prospective population screening for Type 1 diabetes. Data indicate that research participants are not as autonomous as is generally assumed by the defenders of the right not to know.     

Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs

The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called “off-label use,” is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children. Federal regulations provide broad rules and guidance for the protection of human subjects in research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are routinely used off-label and widely believed to be beneficial. We attempt to describe these ethical challenges and provide recommendations, including alternative study designs, to resolve them in an ethical framework that takes into account the Belmont Report, the statement of the World Medical Association (WMA), and federal regulations.     

Ethical and Regulatory Challenges in Psychophysiology and Neuroscience-Based Technology for Determining Behavior

In the past three decades, there has been an explosion in research to understand the mechanisms of brain function. Recent advances in psychophysiology and neuroscience, while still limited, have sparked great interest in developing technologies that could peer into the brain and be used to identify or indicate certain behaviors. The polygraph (lie detector) represents an old technology used for discerning clues to the human brain; functional magnetic resonance imaging (fMRI) represents one of the newest efforts. The use of these technologies in intelligence and counterintelligence in the field without validation represents a major concern about its usefulness. Both research on this new technology and subsequent use on public raise ethical challenges. This article will address the overall ethical issues associated with these new technologies. The report identifies the ethical and cultural challenges in conducting research on these new tools, explores the possibility of using current U.S. regulatory requirements regarding drugs and devices as a model for regulating these new technologies, and suggests approaches for the future.     

Scientific evidence and the judicial system

Research involving the vulnerable sick raises difficult challenges for investigators and Institutional Review Boards. Exactly who among the ill counts as vulnerable is a matter of judgement, and involves consideration of susceptibility to harm and capacity to provide free and informed consent. A balanced approach is required when protections are considered, and the benefits as well as the risks of research participation must be carefully weighed. A variety of protections for the vulnerable sick in research are available, including enrolling subjects in a study only with a strong justification, ensuring that consent is free and comprehending, and setting limits on the risk to which they may be asked to endure. Discussion of three contemporary controversies, placebo‐controlled trials in the psychiatric setting, phase I clinical trials and oncology patients, and emergency room research involving patients incapable of giving consent, highlights the little recognized prominence of risk‐benefit issues in the clinical studies in the vulnerable sick.     

Data audit: Its place in auditing

The terms “audit”; and “data audit”; have previously appeared in the science literature (see for example, Glide, 1975, p. 207, 1976, pp. 187–190; Noel, 1979, p. 73). Attempts have been made in that literature to discuss the nature of these terms. However, we are not aware of any discussions that have evaluated the nature of “data auditing”; in terms of the existing auditing literature. In this paper we briefly review the history of traditional auditing; briefly review the various types of auditing and auditors that exist in the United States; consider the generic nature of auditing; consider definitions of data audits that appear in existing science literature; consider the nature of data auditing; and consider where data auditing can be placed within auditing.