The Complaints Module allows you to document all the complaints received for your product(s). You can triage the complaints and take appropriate action.
To document a complaint, start by creating a new complaint record. Then when you are ready, route the complaint record for approval.
To edit to an approved complaint record, you must first re-open it. Once you make changes, the complaint record must be rerouted for approval again.
A nonconformance (NC) occurs when specifications or requirements that were defined by the company's procedures are not met.
The Nonconformance (NC) Module helps companies capture and manage all NC incidents that occur, may have occurred, or may occur (possible future NC for which action seems warranted) in a service, product, process, from a supplier, or in the QMS itself.
When you become aware of an NC, create a new NC record and when you are ready, it can be routed for approval.
Creating and Submitting an NC Record
Editing a Closed NC Record
If an NC is closed, it can be reopened and edited. If the NC has an open CAPA associated with it, the CAPA must first be closed (or cancelled) before the NC can be reopened.
Canceling an NC Record
If needed, an NC record can be cancelled.