An uncontrolled record is it a non-conformance?

qualprod

Trusted Information Resource
#1
Hello to all
I want to hear your opinion in this issue.
If I refer in a procedure, a document (no name, nor registered into the qms, however it is an evidence and complies its purpose, which is traceability.
Does this case deserve a nc under 9001: 2015?

If the nc exist, under which clause will fall?

Do all the documents referred into a qms procedure, must be registered/controlled in the QMS, Regarding to records? (Qms numbering)

Thanks
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
We establish records to keep important information to the extent it remains important for our customer/management system.

Records may logically be controlled as documents if they include instructions, acceptance limits or parameters, or if important information is added or removed, or if the change is extensive enough to confuse people when an out-of-date version is used.

There is no need to "register" a controlled document or record form - that is, a list is not required for ISO 9001; it seems sensible to reference the record/form in the procedure to which it applies, to help personnel perform accurately.
 

qualprod

Trusted Information Resource
#4
Golf
I mean controlled, when I have include in my control of records and documents a form.
It is supposed it is the official control, compared to an external control.
But going back to the original question, cold this be an nc?
Thanks
 
S

suffelde

#5
What's the risk of having two or more different revisions of the document (subsequent record) being available for those who have to use it? Are there any potential product/process integrity issues should more than one revision level be used? If one can answer the above issues (plus being in compliance with internal documented process on how your QMS documents change revision levels) as having little or no impact on product/process integrity, then within the context of your QMS, one doesn't need to have the document/record controlled. Good luck.
 

Golfman25

Trusted Information Resource
#6
Golf
I mean controlled, when I have include in my control of records and documents a form.
It is supposed it is the official control, compared to an external control.
But going back to the original question, cold this be an nc?
Thanks
Whether it is an NC or not would be fact specific. Something to the effect of how is it controlled vs. how should it be controlled?
 

Al Rosen

Staff member
Super Moderator
#7
Hello to all
I want to hear your opinion in this issue.
If I refer in a procedure, a document (no name, nor registered into the qms, however it is an evidence and complies its purpose, which is traceability.
Does this case deserve a nc under 9001: 2015?

If the nc exist, under which clause will fall?

Do all the documents referred into a qms procedure, must be registered/controlled in the QMS, Regarding to records? (Qms numbering)

Thanks
if it is evidence that shows compliance, then it's necessary for the effectiveness of the QMS and requires control. Look at 7.5.1 b & 7.5.3.1.
 
#8
Is the original question because of a nonconformance written, or is it a theory question? If it is a real nonconformance written by an auditor, we could be of more help if you posted the exact wording of the nonconformance. That is if it would be appropriate and proper to post it.
 

qualprod

Trusted Information Resource
#9
Thanks Big Jim.
What I post is the case I have, and want hear your opinion, regarding if such evidence(record) should be included into the list if documents/records or could be outside of the Qms (no control)
Thanks
Thanks
 
#10
Several actual questions, for the most part which can be answered very simply: Yes, whatever the relevant clause which created the record and yes.
 
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