Risk assessment and securing the supply circuit of production unit of parental nutrition at hospital Robert Debré (AP-HP).
Each year, our production unit of parenteral nutrition produces about 24.000 personalized mixes used for hospitalized and home-based patients. New premises of production have been designed to be able to produce until 40.000 preparations yearly. This activity needs soluts and medical devices (MD) exclusively reserved to this production, supply disruptions may stop it.
The objective of this study is to achieve a systematic criticality analysis (product by product) which associates preventive actions with the references that are more risked. This study will feed into the criticality analysis on all the supply chain.
All references used for the preparation of parenteral nutrition have been listed. The risk for each product has been evaluated using several criteria encoded :
- Captive use (0 to 3 points)
- Delivery time depending on circuit or suppliers (0 to 2 points)
- Proportion in the production cost for one preparation (0 to 2 points)
- Storage volume : unit, cardboard box or pallet (0 to 2 points)
The addition of these criteria will give the criticality score, on a scale of 0 to 9 points.
The MD of automaton, because of their captive use and delivery time (one month minimum) have the maximal score of 7/9. The amino acids get maximal score of 7/9 too because of the process and stability studies depending on the reference. The empty pocket obtains a score of 5/7, their cost representing a significant part of the price of parenteral nutrition.
The riskier references and measures required in case of a failure of supply chain have been identified. Furthermore, the interest of improving our order management and their anticipation has been brought to light. Quantity ordered is not always adapted to the unit’s needs and brings an important acquisition cost and storage or a risk of stock shortage.
This preliminary work of risk mapping the activity fits into an objective of compliance of the unit to the ISO standard 9001.