FMECA (Failure Modes, Effects and Criticality Analysis) in manufacturing pediatric individualized parenteral nutrition (IPN) bags process: 4 years review of corrective actions.

Introduction
Individualized Parenteral Nutrition bags (IPN) are manufactured by hospital pharmacy (HP). This activity consists of different processes, from prescription to administration. In 2017, an analysis by the FMECA method (Failure Modes, Effects and Criticality Analysis) on the entire circuit, identified and prioritized encountered risks.
In 2019, the implementation of the action plan led the HP to acquire the BP’Prep-Pean^® prescription software interfaced with the production automate.
The aim of this work is to assess the impact of the corrective actions deployed, recalculate the criticality indices (CI), and identify new failures.

Methods
In 2017, FMECA identified the main failures modes (FM) as well as their causes for the 8 processes: prescription, transmission to the pharmacy, pharmaceutical analysis, manufacturing sheet and labelling, preparation and production, release and control, transport, storage. The rating grid allowed to define, for each FM, their frequency, severity, and detectability, which was necessary to calculate the CI. In 2021, during 3 meetings organized with a multidisciplinary working group, each FM was reassessed to recalculate a new CI. New FM have been identified and rated.

Results
In 2017 the 8 processes had 58 FM (CI from 2 to 100) with a total CI of 1552. In 2021, after the reassessment, 10 FM were eliminated: 2 for the prescription process; 2 for transmission to the pharmacy; 1 for pharmaceutical analysis; 3 for the manufacturing and labeling sheet and 2 for the preparation and production process. Nevertheless, the computerization of the prescription generated 5 new FM. Three at the prescription step, whose 1 with a high CI (108) explained by the acquisition of Logipren^®, a prescription software in neonatal units, requiring a step of transcription from Logipren^® to Péan and 2 steps for the preparation process and production. The overall CI decreased by 46.8% with a cumulative CI of 825, (including 139 for new FM), against 1552 in 2017 (-727).

Discussion-conclusion
Several actions have been implemented over the past 4 years especially for the storage, transport, and preparation parts, as well as on the computerization of the prescription. This analysis highlights the positive impact of the action plan on reducing CI and securing the production process.
The acquisition of an interface between Logipren^® and BP’Prep^® software, scheduled for autumn of 2021, should reduce the CI for the prescription stage, which one is predominant in cumulative CI.

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