Should Potential Customer Complaint Outcome Define Registrar NC Rating?

M

MrPhish

#1
I didn't see any existing thread this issue fits in, so here goes: On a recent surveillance audit, the Registrar was reviewing my listing of customer complaints that were actively being managed via my internal process (i.e. CAR had been created, root cause identified, actions being taken, and managed). The subject of a specific complaint caught his eye. Let's say for example, the complaint had to do with an issue that could have but did not cause any death or injuries to personnel. The Registrar wanted to write this up as a automatic MAJOR nonconformance because of the severe potential of the event (even though the worse case never happened). Now remember, the complaint was actively being worked through the QMS ... the Registrar did NOT uncover the issue for the first time. Can anyone explain to me WHY this should be a MAJOR nonconformance solely based on a potential outcome that never happened, for an already identified issue? What am I missing? BTW: the Registrar did confirm the MAJOR NC was being issued because of the potential "gravity" of the complaint.
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Based on what you describe, it seems that the auditor might not be reacting appropriately.

The severity and criticality of the problem should be taken into account by your organization on how to respond to it. Actually ISO 9001:2015, par. 10.2.1 states:
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
As long as you can demonstrate that you have reacted with the urgency and seriousness of the risk at hand, the CB auditor should not write up anything, because you would have demonstrated that your system is working.

Now, on the other hand, if the auditor believes that your organization was not taking the issue seriously, expeditiously enough, etc..he could have written up a NC against the requirement I mentioned above.

That's my take on your scenario.
 
M

MrPhish

#3
Thanks for the "sanity check". My records on this issue were documented nine ways to Sunday ... and then some. Had e-mails from all Top Leadership and Contracts folks to show full involvement. Had a matrix of all identified CAs and the current status of all CAs and their projected due dates and/or completion dates. IMHO, all was compliant with clause 10.2.1.

In the end, I gave him some additional info/data and he dropped the issue (i.e. no MAJOR NC).
 
M

MrPhish

#5
No minor NC either. He dropped the whole issue ... but it took me a while to show him he was wrong. Purpose for this thread was to obtain a "sanity check" from the experts here at the Cove to make sure my thought process wasn't flawed.
 

Randy

Super Moderator
#6
I wouldn't raise one and I've refused to allow one in the past when the organization had identified a "problem", and was working it through their corrective action system...Which helps to provide evidence that the process works...DUH!

Legalities aside...Even if someone had been killed, as long as the organization/client was following their corrective action process, and as long as the CA process meets requirements, and there is evidence to show that the org/client was striving to correct whatever, then at the most you say "Good Job" and move on to something else, like worrying if the tape measures are calibrated.

Over reaching auditor for sure, but looks like everything came out OK
 

Big Jim

Super Moderator
#7
You had a very sick auditor. He needs educating. You should still consider having a conversation with your registrar. He was out of place and don't forget that you get what you tolerate.
 
M

MrPhish

#8
Randy: you've hit on a secondary concern I had about this instance. If the Registrar is going to write me an new NC for an existing active CA I am currently processing, then why not just ask for my active CA list and write up an NC for every open CA on the list ... then move on tho the rest of the audit ... like making sure the 12 inch ruler is calibrated too ... LOL.

Big Jim: That is exactly why I continued to question his Major NC finding and got him to rescind it ... didn't want to set a precedent for the future.
 

Randy

Super Moderator
#9
CB's are supposed to check status of complaints at all audits and nonconformities identified during previous audits. The Duh factor says to look at the corrective action process evey audit but it's not an absolute (except for the CB I audit for, and review of CA's is supposed to be at every audit and you can see that in all of my plans & reports going back to 2002)
 
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