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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.
EN
The current research study aimed to explore the utility of selected problem-solving tools and techniques in root-cause analysis to demonstrate their practical application. An experimental research design adopting a positivist empirical approach with a deductive strategy was followed to assess the effectiveness of a combined (8D & Six Sigma) problem-solving approach in reducing a high defects rate of a mixer shower assembly line. A novel application of the 8D framework in combination with Six Sigma and other analytical tools was found highly effective in reducing the reject rate from 11.84% to 0.11%. Successful identification of the root cause led to the implementation of permanent corrective action ensuring a long-term stable assembly process. The research study provided a problem-solving framework that was found effective in resolving a complex problem and implementing long-term corrective action in an assembly production line. However, this framework can be used in other industries. The research study provides a solution to a high number of leak rejects in a subassembly where “O-seals” are used between mating parts. It also provides analytical tools that were found highly effective during the problem-solving process.
PL
Scharakteryzowano zakres usług świadczonych przez jedno z przedsiębiorstw transportowych mające swoją siedzibę na terenie Szczecina. Przedstawiono profil działalności przedsiębiorstwa. Opisano sposób realizacji składanych reklamacji przez klientów przedsiębiorstwa. Przedstawiono liczbę zgłoszonych reklamacji w czasie działalności przedsiębiorstwa i ich charakter. Przedstawiono strategię przedsiębiorstwa podjętą w celu ograniczenia liczby reklamacji niezadowolonych klientów.
EN
In this paper have been characterized range of services provided by one of the transport companies having their registered office in Szczecin. The paper also presented the profile of the company. There are also described methods of realization the customer's complaints. It showed the number of complaints reported during the company's activities and their character. The following study described the company strategy taken to reduce the number of lodged complaints by claimant.
PL
Zaprezentowano wykorzystanie urządzeń pracujących we współrzędnościowej technice pomiarowej stosowanych w firmie Volkswagen Poznań do analizy reklamacji pochodzących z rynku motoryzacyjnego. Przedstawiono poszczególne funkcje działów związanych z zapewnieniem jakości oraz omówiono ich miejsce w strukturze organizacyjnej zakładu. Pokazano schematy wyszukiwania reklamacji oraz omówiono system punktów referencyjnych i narzędzia Cubing i Meisterbock. Całość opisu zilustrowano konkretnymi przykładami, jakie zaistniały w trakcie wytwarzania pojazdów, popartymi szczegółową analizą wymiarową przeprowadzoną z wykorzystaniem współrzędnościowej techniki pomiarowej.
EN
Presented is practical application of the coordinate measuring machines in Volkswagen Poznań Company for estimation of the automotive market customers complaints. Described are exemplary situations occuring in the vehicle production process supported by detailed dimensional analysis based on the coordinate measurement technique.
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