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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

2022

z. 160

159--172

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.