Safety Documentation Research Articles

Experiences with a Japanese-American Fusion Fuel Processing Hardware Project

This paper reports that the United States Department of Energy (USDOE) and the Japan Atomic Energy Research Institute (JAERI) have installed a full-sale fuel cleanup system (JFCU) for testing at Los Alamos. The JFCU was designed by JAERI and built by Mitsubishi Heavy Industries (MHI) in Kobe, Japan. Experience gained by Japanese working at Los Alamos facilitated development of a system consistent with Los Alamos operations and standards. US or equivalent Japanese standards were generally used for design resulting in minor problems at electrical interfaces. Frequent written interchanges were essential to project success, as spoken communications can be misunderstood. Differing work styles required detailed pre-planning, separation of responsibilities, and daily scheduling meetings. Safety and operational documentation drafted by JAERI personnel was revised at Los Alamos to assure conformance with USDOE and Los Alamos standards. The project was successful because both Japanese and American participants worked hard to overcome potential problems. These experiences will be valuable in conducting future international fusion projects.

Computer tools for hazard identification, modelling and analysis

Plant safety and reliability analysis is a complex task often with a need for computer support. The phases of the analysis are information collection, qualitative hazard identification, system modelling and analysis, and consequence assessment. Computer software tools have been developed for different analysis tasks. They are very useful in the automation of the routine parts of the analysis. However, knowledge-based techniques are needed in the development of more powerful tools. This paper gives a short review of software tools developed for the documentation and calculation tasks of safety and reliability analysis. The main emphasis is on describing and evaluating the possibilities of knowledge engineering to support human reasoning in hazard identification and system modelling. An example of an advanced software environment, stars, for carrying out multi-level knowledge-based safety and reliability analysis is presented.

Trends in Chemical Process Safety Control Systems

Recent advances in computer technology are changing the equipment and procedures available to the chemical processing industry, particularly in the domain of chemical safety. The capabilities of protective systems and emergency response systems designed to limit the consequences of an accidental chemical release are greatly expanded through the incorporation of computer technology....For the forensic engineer, the investigation of a chemical plant accident requires additional areas of inquiry; a more complex safety protective control system, new safety system hardware failure modes, software errors, documentation and procedural violations, and interfacing with environmental response actions. Key issues involving the nonfunctional erroneous chemical safety response system are becoming major factors in litigation and insurance decisions.

The role of the Food and Drug Administration in ophthalmology.

Since 1976, the Food and Drug Administration (FDA) has been increasingly involved in the regulation of medical devices, much as it has been involved for decades in the regulation of drugs. For the ophthalmic profession and industry, this regulatory role of the FDA that requires documentation of safety and effectiveness has often appeared as both burdensome and detrimental to new developments. The most visible and immediate effect of FDA regulation has been on the development of new devices designed to improve the practice of ophthalmology but which at the same time present major potential risks. Delays in the availability of new devices for general use are understandably perceived as a negative effect of the FDA's involvement. Furthermore, during the course of investigation of a new device, investigators are required by the FDA to establish both its safety and effectiveness. The need to collect and report extensive data to the manufacturer

An Overview of Qualification of Equipment for Seismic and Dynamic Loads

This paper presents the regulatory review process for seismic and dynamic qualification of safety-related electrical and mechanical equipment in nuclear power plant design, and highlights those areas that need careful attention in a qualification program. Qualification requirements as embodied in the General Design Criterion 2, Appendix A to the Code of Federal Regulations (CFR) 10 Part 50, VI(a) (1) and (2) of Appendix A to 10 CFR Part 100, and the Standard Review Plan Section 3.10 are reviewed. In addition, the review procedure of seismic qualification review team (SQRT) is described. In the past years of SORT review of near term operating license (NTOL) plants, some problem areas have been identified regarding applicant's equipment seismic and dynamic qualification programs. In this paper, the problem areas which are of generic nature are discussed. Among the areas covered are: shake-table input wave forms, consideration of hydrodynamic loads, sequential testing procedure, surveillance and maintenance program, fatigue cycling effects, qualification of mechanical equipment, site-specific earthquakes, auditability of qualification documents, update of final safety analysis report and documentation filing system.

Ethmozine suppression of single and repetitive ventricular premature depolarizations during therapy: Documentation of efficacy and long-term safety

This study reports a total of 1677 patient days' experience with the use of Ethmozine to suppress ventricular premature depolarizations. A total of 39 patients were studied on three placebo-controlled protocols. Ethmozine, given at a mean total daily dose of 830 mg ± 318 mg on a dosing schedule of every 8 hours, resulted in a mean plasma Ethmozine level of 0.42 μg/ml ± 0.28 μg/ml. In addition to reducing ventricular premature depolarizations from 11,049 24 hr during placebo to 2231 24 hr during Ethmozine therapy (80% reduction), the drug also resulted in a 95% reduction in paired forms and a 99% reduction in total runs of ventricular tachycardia. Ethmozine is extraordinarily well tolerated with only mild side effects of dizziness, perloral tingling, and euphoria, with no serious toxicity requiring discontinuation of therapy. Ethmozine demonstrates great potential as an effective drug in suppressing ventricular premature depolarizations with minimal side effects or toxicity.

Guidelines for the Documentation of Safety Related Computer Systems

The Guidelines described are under development within PURDUE EUROPE Technical Committee on Safety and Security (TC7).The purpose of the Guidelines is to provide a comprehensive reference work to assist various parties, involved in the procurement and operation of safety related computer systems, to determine the scope and contents of associated documentation.The proposed Guidelines take account of a number of specific influencing factors. The overall structure was determined by consideration of definitively stated principles which reflect the requirements of producers and users of documentation throughout a system’s life history. Attention is paid to selecting the optimum documentation for a project.Although the Guidelines are not yet complete certain parts are well under development. The current status and projected progress are reported.