Looking for feedback on Nonconformity Process Flowmap

#1
Hello folks,
Lorenzo here, first post but I've been reading the forum for a while getting always valuable info.
I'd like to have comments/suggestions regarding an high-level process flow created to define inputs and outputs to/from a nonconformity management process, with main purpose to ensure a strong documented organizational knowledge.

Background: need to create a QMS from scratch for a manufacturing branch to be established in Baja California (1st branch ever) of an Italian company, targeting solely the US market. The Italian HQ has a large undocumented operational knowledge (personnel averagely employed continuously for 15+ years, high processes maturity) that has to be transferred to the new branch.

Criteria: ISO 9001:2015 requirements applied to a consumer electronic company. Willing to implement automotive best practices (in a reasonable manner, without overloading the management system) to create a modern and robust QMS.

Attached picture is showing the actual flow as a baseline: any feedback is welcomed!
Thanks.

Lorenzo

Nonconformity-Management-Flow.jpg
 
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Welcome Lorenzo!

That is certainly the most detailed map for nonconformity management that I have ever seen. It seems to be very comprehensive and thorough. :applause:

I don't see any inaccuracies, but I worry that some auditor will try to hold you to this as though it is a defined process. Do you think that would be possible?
 

John Broomfield

Leader
Super Moderator
#3
I would separate Controlling Nonconforming Products from Removing the Root Causes of Nonconformity each with their own process objectives.

And, most important, it is better to flowchart the actual processes instead of clauses in the standard.
 

Bev D

Heretical Statistician
Leader
Super Moderator
#5
I agree with eliminating the clauses - they aren’t useful to the organization.
I also agree that corrective action and NCs should be separate. Not all NCs require corrective action…and this flowchart strongly implies that corrective action is required for all NCs.

What seems to be missing for me is how NCs are actually handled. How are they identified and segregated?, analyzed? (Are they real or not), Hwo do you investigate for containment or recall from the field? how are they dispositioned? (Rework, scrap, use as is, Return to supplier, etc). Who does these things? How do you decide if the NC requires corrective action or simple correction?
 
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