5PSQ-035 Using failure mode and effects analysis to improve production of non-sterile preparations

<h3>Background and Importance</h3> The production of non-sterile preparations (NSP) is a critical task that requires high levels of accuracy and safety. A risk management tool is essential to ensure quality and minimise the risks associated with this process. Publications on this topic in the scientific literature are limited. <h3>Aim and Objectives</h3> To identify potential risks in the NSP production process using a Failure Mode and Effects Analysis (FMEA) and to measure whether these risks decrease with the implementation of improvement actions. <h3>Material and Methods</h3> A team of the personnel involved in the NSP development process, a pharmacist from the quality area and the Head of Pharmacy Department perfomed the analysis using the FMEA methodology. In 2021 all possible failure modes were identified by brainstorming. After analysis and implementation of corrective and preventive measures, in 2024 the FMEA model was re-evaluated and potential risks were reassessed. The risk priority number (RPN) was calculated according to Severity x Frequency x Detectability, assigning values from 1 to 10 to each index. The variation in risks following the improvement actions implemented was quantified. <h3>Results</h3> The process was divided into 11 different phases. A total of 26 failure modes were defined, accumulating 1,929 RPN points in 2021 (range: 8–240). RPN scores &gt; 100 were obtained for seven of the failure modes, which were considered critical. There was only one failure mode with RPN &gt; 200 (inadequate raw material selection). The phase with the most failure modes with RPN &gt; 100 was the elaboration of the preparation, four in total. After prioritisation, an improvement plan was proposed, in which the following actions were highlighted: implementation of specific software (CPFarma), establishing double checking by a qualified pharmacist and a plan for the training of new residents in the Pharmacy Department. After reevaluation of the FMEA in 2024, the 26 failure modes accumulated 594 RPN points (range: 6–180). There was only one failure mode with RPN &gt; 100 (incorrect measurement of raw materials). <h3>Conclusion and Relevance</h3> The FMEA methodology is a useful instrument in the detection of potential risks in the production of NSP and in the implementation of improvement actions that have an impact on process quality and patient safety. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest