Wyniki wyszukiwania - BazTech

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Handling of medical devices’ customer complaints on the example of companies based in Poland

Feliczek Patryk, Górna Justyna, Buszczak Aleksandra

Zeszyty Naukowe. Organizacja i Zarządzanie / Politechnika Śląska

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2022

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z. 160

159--172

EN

Purpose: The main purpose of this article was to identify and analyze correction activities and corrective actions, taken by medical devices’ companies, as a result of a customer complaint. Design/methodology/approach: The article presents the results of the study conducted among medical devices’ companies, operating on the Polish market. These companies have implemented and certified quality management system in accordance with the requirements of ISO 13485. In addition, these companies, as part of their activities, carry out various processes related to medical devices, but performing production process was the main criteria for qualifying the company for the study. On this basis, 209 companies, meeting these criteria, have been defined. The study was conducted using a survey questionnaire, available in electronic form. As part of the survey, 90 correctly completed survey questionnaires were received, what means that the response rate of surveys reached the level of 43%. Findings: The most important correction activities, indicated by the surveyed companies, include verification of suspicious products throughout the whole supply chain and replacement of a defective product with a new one. From the corrective actions perspective almost 70% of respondents indicated trainings of production employees. This is strongly related to the identified root causes, by these companies, as operators’ errors (50% of the causes lie with such errors). Almost 50% of respondents declared the update of work instructions as a corrective action, which is also related to the high number of indications for operator trainings. Originality/value: The article presents main activities, that are taken by the medical devices’ companies in Poland to increase the safety and performance of medical devices, if an abnormality occurs. The article may be treated as an benchmark for medical devices companies once reviewing their approach to implementing corrections and corrective actions.

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A model of hydrogen passive autocatalytic recombiner and its validation via CFD simulations

Orszulik M., Fic A., Bury T., Składzień J.

Archives of Thermodynamics

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2013

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Vol. 34, no. 4

257--266

EN

Passive autocatalytic recombiners (PAR) is the only used method for hydrogen removal from the containment buildings in modern nuclear reactors. Numerical models of such devices, based on the CFD approach, are the subject of this paper. The models may be coupled with two types of computer codes: the lumped parameter codes, and the computational fluid dynamics codes. This work deals with 2D numerical model of PAR and its validation. Gaseous hydrogen may be generated in water nuclear reactor systems in a course of a severe accident with core overheating. Therefore, a risk of its uncontrolled combustion appears which may be destructive to the containment structure.

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Validation of the heat and mass transfer models within a pressurized water reactor containment using the International Standard Problem No. 47 data

Bury T., Składzień J., Fic A.

Archives of Thermodynamics

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2012

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Vol. 33, no. 2

23-46

EN

A lumped parameter type code, called HEPCAL, has been worked out in the Institute of Thermal Technology of the Silesian University of Technology for simulations of a pressurized water reactor containment transient response to a loss-of-coolant accident. The HEPCAL code has been already verified and validated against available experimental data, which in fact have been taken from separate effect tests mainly. This work is devoted to validation of the latest version of the HEPCAL code against experimental data from more complex tests. These experiments have been performed on three different test rigs (called TOSQAN,MISTRA and ThAI) and a part of them became the basis of the International Standard Problem No. 47 (ISP-47) dedicated to containment thermal-hydraulics. Selected experiments realized within the framework of the ISP-47 project have been simulated using the HEPCAL-AD code. The obtained results allowed for drawing of some important conclusions concerning heat and mass transfer models (especially steam condensation), two-phase flow model and buoyancy effects.

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Thermodynamic consequences of hydrogen combustion within a containment of pressurized water reactor

Bury T.

Archives of Thermodynamics

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2011

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Vol. 32, no. 4

67-79

EN

Gaseous hydrogen may be generated in a nuclear reactor system as an effect of the core overheating. This creates a risk of its uncontrolled combustion which may have a destructive consequences, as it could be observed during the Fukushima nuclear power plant accident. Favorable conditions for hydrogen production occur during heavy loss-of-coolant accidents. The author used an own computer code, called HEPCAL, of the lumped parameter type to realize a set of simulations of a large scale loss-of-coolant accidents scenarios within containment of second generation pressurized water reactor. Some simulations resulted in high pressure peaks, seemed to be irrational. A more detailed analysis and comparison with Three Mile Island and Fukushima accidents consequences allowed for withdrawing interesting conclusions.