When should a note-to-file be used in a QMS vs Deviation Report

Ajit Basrur

Staff member
Hi everyone,

When should a note-to-file be used in a QMS? When should a deviation report be filed?

As a tool, Quality Risk Management (QRM) has always been part of the analysis process linked to the handling of events and deviations. See the attached guidance document from World Health Organization (WHO) that proposes a possible strategy to differentiate non-significant events which actually do not affect the product’s quality or violate any norm or defined procedure, from actual deviations which could impact on the product´s quality.

I am not sure if your "note-to-file" document is an official document. Take a look at the attachment and see if it fits your QMS needs.