Aplikace FMEA návrhu gynekologického křesla

Abstract

The subject of this thesis is „Use of Product FMEA in Design of the Gynaecological Chair“. Seeing that it is medical equipment and using of its brings measure of risk, the universal standard ČSN EN ISO 14971 require to implement process regulation of liability. The propose of this course work was to make a database of potencial failures and hazards, detection their sources and consequences. It was necessary to make possible causes of failures which are critical and put forward corrective actions, out of acceptable risks, we did not have to consider. In the first part of this work is characteristic of the company - its history and emergence. In second part are explained a basic terms of system management of quality and recent management of quality principles. In the third part we focused on quality planning, continual improvement of quality, which include lot of usefull methods. One of them is the FMEA. Singles methods of quality planning are illustrated in here, more in detail is decomposed the FMEA, its history, meaning and procedure. In next step is characterised a product, whereon the FMEA was aplicated and steps how was proceeded while the FMEA application. It was used FMEA manual 4th edition (QS 9000) as guideline for working-out, which is used by automotive suppliers like DaimlerChrysler, Ford Motor Company and General Motors Corporation. Next we propose corrective measures for most hazardous potencial failure, verified its realisation and review once again to find out how was influence aggregate risk of those failures. In the end we sumed up total contribution for company BORCAD Ltd.