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Complaints root cause analysis as a part of the medical devices quality improvement process

Ziarkiewicz Aleksandra, Górna Justyna

Zeszyty Naukowe. Organizacja i Zarządzanie / Politechnika Śląska

2020

z. 145

675--683

Purpose: The purpose of the paper is to present the essence of the complaint handling process as an element of the process of improving the quality of manufactured medical devices, ensuring their safety of use and meeting the declared by the manufacturer efficiency of the medical devices. Detailed analysis of complaints received from the customers in order to identify the root cause of the reported problems allows initiating the appropriate actions by the company. The remedial actions are designed to eliminate defects reported by customers, while the corrective actions are carried out to eliminate the causes of the reported defects. All these actions taken by the company in course of the complaint handling process are the important element influencing not only the effectiveness of the complaint handling process but also improvement of the product, elimination of defects, and thus the safe use of the device by the user. Design/methodology/approach: The analysis of the main causes of the reported failures and actions taken was conducted through a survey questionnaire forwarded to 24 medical device manufacturers in Poland. Findings: The results of this survey allowed to identify the categories of root causes, which are the most frequent reasons for complaints concerning medical devices and to identify the most frequent corrections and corrective actions based on the example of selected companies manufacturing medical devices in Poland. Originality/value: The results of the survey regarding the main causes of the reported failures and actions taken during the complaint handling process may provide guidance for the manufacturers during the evaluation of the reported failures.