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New Nonconformance Findings During Corrective Actions

F

Falken

#1
#1
Hi

During a supplier audit with an ISO 9001 certified company we found a minor deviation. After de audit, when discussing their corrective action new non conformities were found.

I see that I have two possibilities to handle this.

1. Keep the remark from the audit as opened until this new issue is closed
2. Keep this information to next audit (this may take 1-2 year or so)

Have anyone had this kind of experience earlier?

Best regards
Fredrik
 
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Paul Simpson

Paul Simpson

Trusted Information Resource
#2
#2
:2cents:
  1. If the "new" nonconformities relate to the original then I would just go back and say they haven't closed the NC
  2. If the "new" nonconformities relate to information supplied when they were trying to address the original nonconformity then I would raise another NC (or more) referring to the evidence supplied
  3. If you have "found" new nonconformities by going over old records (that you had before) then you need to decide if it can wait to the next visit. Otherwise either raise another NC saying it is too important to leave or just let them know informally that you have found another problem (that could have been found before) and that you want (informally again) details of what they plan to do about it.

Hope this helps!
 
F

Falken

#3
#3
Thanks

Both the first and the “new” finding is based on supplier evaluation and supplier development.

The first finding was regarding lacks in the quality system regarding what is the basis for when supplier audit/evaluation is to be done.

In the answer/corrective action they show documentation for initiating a supplier audit. The problem is that they don’t follow this routine. Therefore I think the best thing might be to keep the remark end extend regarding the new information.

Best regards
Fredrik
 
Jim Wynne

Jim Wynne

Staff member
Admin
#4
#4
Falken said:
Thanks

Both the first and the “new” finding is based on supplier evaluation and supplier development.

The first finding was regarding lacks in the quality system regarding what is the basis for when supplier audit/evaluation is to be done.

In the answer/corrective action they show documentation for initiating a supplier audit. The problem is that they don’t follow this routine. Therefore I think the best thing might be to keep the remark end extend regarding the new information.

Best regards
Fredrik
Click to expand...
It sounds as if you've found further evidence of the original problem, and not a new problem, per se. In any event, the source of the discovery shouldn't have any bearing on the course of action. Problems should be corrected, and you shouldn't worry about how or when they're discovered.
 
M

mdemirer

Starting to get Involved
#5
#5
All findings must be corrected by QA responsible, so you should not pretend to see disconformities acceptable and dismiss them. I think your supplier thinks that thier actions are good enough and proper to close your findings. For my opinion you have to declare all disconformities and ask for another action plan asap. This will bring them to their senses immediately, then they will be more careful to fulfill their quality obligations for their customer.
If you do not give any reaction, this will bring complaints in the near future.

Good luck Fredrick...

Bye,
MD.
 
W

Weiner Dog

Med Device Consultant
#6
#6
How are these non-conformances related? Does the supplier have a manpower or training issue?

If these additional non-conformances are major, they are not to be undertaken during the next supplier audit because these non-conformances could cause unforeseen quality/product/service problems.
 
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