Optimisez la gestion du changement avec vos fournisseurs...
La gestion du changement peut s'avérer complexe notamment pour les fournisseurs informatiques dont les "release notes" sont quelquefois très succinctes.
Une mise en demeure récente de la FDA à l'encontre d'un fabricant de dispositifs médicaux vient rappeler l'importance de ce processus vis à vis des fournisseurs:
Une mise en demeure récente de la FDA à l'encontre d'un fabricant de dispositifs médicaux vient rappeler l'importance de ce processus vis à vis des fournisseurs:
8. Failure to establish and maintain purchasing data that assure that you are aware of any changes in the products made by your suppliers that may affect the quality of the finished device, as required by 21 CFR 820.50(b). For example:
- For at least two suppliers, a signed Supplier Quality Plan was not signed prior to them being added to the Approved Supplier List.
- We also observed that your firm’s SOP required that a signed Form FM-105-3 be completed for all of your suppliers. This form indicated that the supplier would notify Spine Frontier of any changes made to their products. During the inspection, firm representatives indicated this firm was no longer being used, yet it was still referenced in your current SOP.
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