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

• Autorzy: Ziarkiewicz Aleksandra , Górna Justyna

Identyfikatory

DOI

10.29119/1641-3466.2020.145.50

• Języki publikacji: EN

Abstrakty

EN

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.

Słowa kluczowe

EN

complaint; medical devices; root cause; remedial actions; corrective actions

PL

skarga; wyroby medyczne; pierwotna przyczyna; działania naprawcze

• Wydawca: Wydawnictwo Politechniki Śląskiej
• Czasopismo: Zeszyty Naukowe. Organizacja i Zarządzanie / Politechnika Śląska
• Rocznik: 2020
• Tom: z. 145
• Strony: 675--683
• Opis fizyczny: Bibliogr. 11 poz.

Twórcy

autor

Ziarkiewicz Aleksandra

• Uniwersytet Ekonomiczny, Poznań

autor

Górna Justyna

• Uniwersytet Ekonomiczny, Poznań

Bibliografia

• 1. Czerwińska K., Pacana A. (2012). Zastosowanie narzędzi zarządzania jakością do analizy przyczyn wadliwości wyrobu. Zeszyty Naukowe Politechniki Śląskiej, Seria: Organizacja i Zarządzanie, 117, 424- 429.
• 2. Gołaś, H., Mazur, A. (2010). Zasady, metody i techniki wykorzystywane w zarządzaniu jakością. Politechnika Poznańska.
• 3. Guidelines on complaint handling (2017). Western Australia: Ombudsman.
• 4. Krajnc, M. (2012). With 8D method to excellent quality. Journal of Universal Excellence, 3, 119-122.
• 5. Medical device complaint handling: Understanding the basics, https://www.orielstat.com/ blog/medical-device-complaint-handling-understanding-basics/, 20.02.2018,
• 6. Medical Devices: Managing the Mismatch: An outcome of the Priority Medical Devices project (2018). World Health Organization.
• 7. Menon, M., Kamath, K., Shabaraya, A.R. (2016). Conducting root cause analysis and its implementation: A perspective. Manipal Journal of Pharmaceutical Sciences, 2, 2, 22-24.
• 8. Olszewska, B., Szewczyk, P. (2012). Skuteczne i efektywne zarządzanie reklamacjami na przykładzie wybranego przedsiębiorstwa. Zeszyty Naukowe Politechniki Śląskiej, 63a, 276.
• 9. Regulation (EU) 2017/745 of European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
• 10. PN EN ISO 9000:2015 Systemy zarządzania jakością – Podstawy i terminologia.
• 11. PN EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.

Uwagi

Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2020).