Risk management in parenteral nutrition: risk mapping associated with the preparation process

Context
Parenteral nutrition (PN) is counted as a high risk activity both through the category of patients for whom it is intended but also through its prescription, method of production and conditions of administration. As part of our ISO 9001: 2015 quality certification intent and to control the preparation process, we undertook a mapping of the risks associated with the production of adult and pediatric PN bags in the Pharmaceutical Compounding Unit.

Methods
To carry out this mapping, we used the FMECA method (Failure Modes, Effects and Criticality Analysis), which consists in identifying potential failures, to assess the risks associated rating them according to a criticality scale and weighting them according to the attendance or not of a means of control. The criticality obtained makes it possible to distinguish 3 levels of risk: acceptable, tolerable under control and unacceptable. For the latter, a cause analysis is performed with the "5M" method and corrective and / or preventive actions are thus identified. Finally, for each action, a level of effort is assigned to assess its implementation difficulty and an action plan is built.

Results
In total, 162 defaults were identified: 73% belonged to the operational process, 20% to the support processes and 7% are part of the management process. 92 defaults have at least one means of control: 53 have a good / very good level of control, 31 are intermediate and 9 are insufficient. Thus, 51 have acceptable criticality, 79 are under control and 32 have unacceptable criticality. Of these, 2 have a good means of control and 13 have not seen their critical level decrease despite the presence of a means of control. 80% of these defaults concern the operational process. The presence of control means has lowered the unacceptable criticality of 6%.

Discussion-conclusion
Thirty two defaults with unacceptable criticality make us question the achievement and effectiveness of the actuals measures. This risk mapping made it possible to build an inventory of the risks and existing measures to reduce them. This work will be continued by analyzing the potential causes of default and then by identifying, ranking, implementing and monitoring improvement actions.

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