Regulatory Agencies and Operational Risk

2016 ◽  
pp. 131-158
Author(s):  
Douglas Robertson
Author(s):  
Jeremiah P. Konell ◽  
Jack Van Schenck ◽  
Joseph P. Bratton ◽  
Steven J. Polasik

Annually or as events occur, operators submit data to various regulatory agencies about the operation, maintenance and extent of their assets. Many of these figures are used by the public, non-profit organizations and private companies to independently conduct assessments about operators, ranging from safety to quality assurance to scope and nature of product deliveries. The Pipeline Hazardous Materials Safety Administration (PHMSA), the National Energy Board (NEB), and other industry organizations have recently put an emphasis on more meaningful metrics by releasing guidelines and leading discussions at industry conferences and workshops. In order to derive more strategic accuracy and pertinence, Explorer Pipeline Company (Explorer) and Det Norske Veritas (U.S.A.), Inc. (DNV GL) have developed a procedural effort to develop meaningful metrics. Several derivative benefits come from this effort such as support for calculating cost-benefit / ROI figures for maintenance projects, justification for compliance-plus activities and, most importantly, a more informed perspective of operational risk. A renewed approach to this effort is to organize the more meaningful factors into three categories: (1) Metrics of job roles and tasks within Explorer’s Asset Integrity staff, (2) Other existing influential metrics (3) Regulatory metrics. Using this approach, Explorer defined well-targeted, unitized metrics, each with a meaningful basis. Explorer anticipates the development of these more meaningful metrics to support the transparency sought by regulators and other stakeholders, benchmark and continually evaluate our Asset Integrity program and possibly support the development of practical metrics for the pipeline industry.


Author(s):  
Margaret Jane Radin

Boilerplate—the fine-print terms and conditions that we become subject to when we click “I agree” online, rent an apartment, or enter an employment contract, for example—pervades all aspects of our modern lives. On a daily basis, most of us accept boilerplate provisions without realizing that should a dispute arise about a purchased good or service, the nonnegotiable boilerplate terms can deprive us of our right to jury trial and relieve providers of responsibility for harm. Boilerplate is the first comprehensive treatment of the problems posed by the increasing use of these terms, demonstrating how their use has degraded traditional notions of consent, agreement, and contract, and sacrificed core rights whose loss threatens the democratic order. This book examines attempts to justify the use of boilerplate provisions by claiming either that recipients freely consent to them or that economic efficiency demands them, and it finds these justifications wanting. It argues that our courts, legislatures, and regulatory agencies have fallen short in their evaluation and oversight of the use of boilerplate clauses. To improve legal evaluation of boilerplate, the book offers a new analytical framework, one that takes into account the nature of the rights affected, the quality of the recipient's consent, and the extent of the use of these terms. It goes on to offer possibilities for new methods of boilerplate evaluation and control, and concludes by discussing positive steps that NGOs, legislators, regulators, courts, and scholars could take to bring about better practices.


2019 ◽  
Vol 12 (1) ◽  
pp. 56-62 ◽  
Author(s):  
A. O. Nedosekin ◽  
A. V. Smirnov ◽  
D. P. Makarenko ◽  
Z. I. Abdoulaeva

The article presents new models and methods for estimating the residual service life of an autonomous energy system, using the functional operational risk criterion (FOR). The purpose of the article is to demonstrate a new method of durability evaluation using the fuzzy logic and soft computing framework. Durability in the article is understood as a complex property directly adjacent to the complex property of system resilience, as understood in the Western practice of assessing and ensuring the reliability of technical systems. Due to the lack of reliable homogeneous statistics on system equipment failures and recoveries, triangular fuzzy estimates of failure and recovery intensities are used as fuzzy functions of time based on incomplete data and expert estimates. The FOR in the model is the possibility for the system availability ratio to be below the standard level. An example of the evaluation of the FOR and the residual service life of a redundant cold supply system of a special facility is considered. The transition from the paradigm of structural reliability to the paradigm of functional reliability based on the continuous degradation of the technological parameters of an autonomous energy system is considered. In this case, the FOR can no longer be evaluated by the criterion of a sudden failure, nor is it possible to build a Markov’s chain on discrete states of the technical system. Assuming this, it is appropriate to predict the defi ning functional parameters of a technical system as fuzzy functions of a general form and to estimate the residual service life of the technical system as a fuzzy random variable. Then the FOR is estimated as the possibility for the residual life of the technical system to be below its warranty period, as determined by the supplier of the equipment.


2018 ◽  
Vol 24 (3) ◽  
pp. 629-640
Author(s):  
P.V. Revenkov ◽  
◽  
A.A. Berdyugin ◽  

Author(s):  
Miriam del Carmen Carrasco-Portugal ◽  
Francisco Javier Flores-Murrieta

Pharmaceutical alternatives are products with the same active moiety, but different salt, ester or pharmaceutical form. Regulatory agencies have different criteria for this kind of drug. The European Medicines Agency (EMA) accepts the generic substitution using these alternatives, whereas the Food and Drug Administration (FDA) only authorizes generic substitution of pharmaceutical equivalents. The objective of this paper is to describe some relevant aspects that should be considered before deciding on making a generic substitution with pharmaceutical alternatives. It is important to note that a pharmaceutical alternative must show no significant difference in the rate and extent of absorption (bioequivalence) in a well-conducted in vivo study when compared with the reference formulation. Current Mexican regulations state that generic substitution is possible using pharmaceutical alternatives when bioequivalence is demonstrated in in vivo studies conducted under the NOM-177-SSA1-2013 criteria. In conclusion, generic substitution with pharmaceutical alternatives is possible if these products demonstrate in vivo bioequivalence when compared with the reference product.


2010 ◽  
Vol 27 (1) ◽  
pp. 74-101 ◽  
Author(s):  
M. Kabir Hassan ◽  
Muhammad Abdul Mannan Chowdhury

This paper seeks to determine whether the existing regulatory standards and supervisory framework are adequate to ensure the viability, strength, and continued expansion of Islamic financial institutions. The reemergence of Islamic banking and the attention given to it by regulators around the globe as to the implications of a recently issued Basel II banking regulation makes this article timely. The Basel II framework, which is based on minimum capital requirements, a supervisory review process, and the effective use of market discipline, aligns capital adequacy with banking risks and provides an incentive for financial institutions to enhance risk management and their system of internal controls. Like conventional banks, Islamic banks operate under different regulatory regimes. The still diverse views held by the regulatory agencies of different countries on Islamic banking and finance operations make it harder to assess the overall performance of international Islamic banks. In light of the increased financial innovation and diversity of instruments offered in Islamic finance, the need to improve the transparency of bank operations is particularly relevant for Islamic banks. While product diversity is important in maintaining their competitiveness, it also requires increased transparency and disclosure to improve the understanding of markets and regulatory agencies. The governance of Islamic banks is made even more complex by the need for these banks to meet a set of ethical and financial standards defined by the Shari`ah and the nature of the financial contracts banks use to mobilize deposits. Effective transparency in this area will greatly enhance their credibility and reinforce their depositors and investors’ level of confidence.


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