[Failure mode and effects analysis to improve quality in clinical trials].

Autor:	Mañes-Sevilla M; Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, España. Electronic address: Mireya.manes@salud.madrid.org., Marzal-Alfaro MB; Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, España., Romero Jiménez R; Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, España., Herranz-Alonso A; Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, España., Sanchez Fresneda MN; Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, España., Benedi Gonzalez J; Departamento de Farmacología, Universidad Complutense de Madrid, Madrid, España., Sanjurjo-Sáez M; Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, España.
Jazyk:	Spanish; Castilian
Zdroj:	Journal of healthcare quality research [J Healthc Qual Res] 2018 Jan - Feb; Vol. 33 (1), pp. 33-47. Date of Electronic Publication: 2018 Feb 15.
DOI:	10.1016/j.cali.2017.12.001
Abstrakt:	Introduction: The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures. Methods: A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed. Results: Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area. Discussion: The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD. (Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu