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We recently had an employee who was trained on the purchasing process not follow the purchasing process. Our purchasing process requires that an employee fill out a request form with a detailed description or attached quote of what they want to purchase. The form also calls for the verification that the supplier they wish to purchase the goods from is on the approved supplier list. Once the form is completed the form is given to management for their review and sign off.
In this case the employee did not follow any of the steps in the process he simply just purchased the good. Lucky enough for us the supplier that he purchased the goods from was actually an approved supplier.
My question is what type of paperwork needs to be completed on this for ISO 13485? Does this just require an email to the employee reminding them of the process or does their need to be a CAPA completed for this?
Thanks
In this case the employee did not follow any of the steps in the process he simply just purchased the good. Lucky enough for us the supplier that he purchased the goods from was actually an approved supplier.
My question is what type of paperwork needs to be completed on this for ISO 13485? Does this just require an email to the employee reminding them of the process or does their need to be a CAPA completed for this?
Thanks
