Risk management applying fmeca in pharmaceutical packaging production: implementation of iso 15378-2017 : case study

Abstract

The quality of primary pharmaceutical packaging materials is crucial to ensure product safety and regulatory compliance. This study aims to apply the FMECA (Failure Mode, Effects and Criticality Analysis) method to manage risks and improve the production process of pharmaceutical packaging at CENTRA MED, a company in Algeria specialised in the manufacturing of primary packaging for the pharmaceutical and medical industries. The study is part of a project to achieve certification to the ISO 15378:2017 standard. In this case, we adopted a qualitative method based on a research-action approach. We collaborated with internal stakeholders within the company to support them in designing and implementing appropriate tools. Data were collected through observation, document analysis, and interviews. As a result, based on collected data, a FMECA matrix was developed to identify and assess production risks. This enabled the implementation of corrective and preventive actions, evaluation of their effectiveness, and improved control over risks. The approach helped eliminate unacceptable risks, reduce undesirable ones, and strengthen the management of acceptable risks.In the end, the results confirmed the effectiveness of FMECA in optimizing processes and meeting quality requirements. The originality of our study lies in the fact that it fills a gap in the literature, addressing the lack of previous research on the application of FMECA in the implementation of the ISO 15378 standard. Its added value lies in the fact that it led to CENTRA MED achieving ISO 15378:2017 certification.