ISO 9001/IATF 16949 Audit Finding Question - Document Retention

#1
My company is working toward IATF 16949 certification. We have a consultant assisting with the implementation. The consultant performed an internal audit of the full system.
Brief System description:
(1)When we revise or create a new procedure/work instruction, we approve the document in document control which makes it available for use. As soon as the document is released we train to the controlled document. We received a finding for not training before placing it in document control.
(2) We retain our documents electronically and have an "active" 1 year minimum retention period and an "Inactive" 30 year minimum retention period. The inactive retention meets our customers longest minimum retention period. We do not have a maximum retention period as we support OEM's End of Life products that could be as old as 40 years.

Finding below covers two issues.
ISO 9001:2015, cl. 7.5.3.2. “the organization shall address…a) distribution, access…d) retention and disposition…” Control of Documented Information
MINOR: The process for control of documented information does not meet the intent of the requirements.
Findings: (1)The organization requires training when documents are issued or revised but there is evidence that documents are effective immediately upon approval.
(2)The records retention requirements are stated in minimum time frames rather than maximum.
Are these valid nonconformances?
 
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jmech

Trusted Information Resource
#2
I don't think so. The auditor is trying to apply their understanding of "the intent of the requirements", rather than verify that you have met the written requirements.
1. Where is the standard's requirement to perform training before placing it in document control? This may be a good idea in many cases, but does not appear to be a requirement in the standard.
2. Your system seems to clearly address retention. It is not clear if it addresses disposition at all, but it should (and likely already does) in some way (i.e. "Documents will not be disposed until after the minimum retention period has elapsed and QA Manager verifies that the document is no longer needed. There is no maximum retention period."). Stating maximum retention time frames is not an ISO 9001 requirement.
 

leftoverture

Involved In Discussions
#3
Well, only my opinion (but I have been in the quality field for 42 years). I think your consultant is being quite picky, especially about the training requirement. Unless there is something in your system that says you will train to a new revision before releasing (which the auditor seems to indicate there is), I don't see anything in 7.5.3.2 that would specifically require you to do so. In terms of record retention, there is nothing stating you have to have a maximum retention time, but you do need to have something about disposal. IATF 16949 does say that approvals, tooling records, product & process design records, POs, contracts, and amendments shall be maintained for the life of the project + one year, which I suppose someone could interpret as a maximum, but I certainly interpret that as a minimum.
 
#5
I don't think so. The auditor is trying to apply their understanding of "the intent of the requirements", rather than verify that you have met the written requirements.
1. Where is the standard's requirement to perform training before placing it in document control? This may be a good idea in many cases, but does not appear to be a requirement in the standard.
2. Your system seems to clearly address retention. It is not clear if it addresses disposition at all, but it should (and likely already does) in some way (i.e. "Documents will not be disposed until after the minimum retention period has elapsed and QA Manager verifies that the document is no longer needed. There is no maximum retention period."). Stating maximum retention time frames is not an ISO 9001 requirement.
(1) This was my understanding of the standard as well.
(2) We don't account for disposal yet but will add it as the standard identifies. Thank you very much for your input.
 
#6
Well, only my opinion (but I have been in the quality field for 42 years). I think your consultant is being quite picky, especially about the training requirement. Unless there is something in your system that says you will train to a new revision before releasing (which the auditor seems to indicate there is), I don't see anything in 7.5.3.2 that would specifically require you to do so. In terms of record retention, there is nothing stating you have to have a maximum retention time, but you do need to have something about disposal. IATF 16949 does say that approvals, tooling records, product & process design records, POs, contracts, and amendments shall be maintained for the life of the project + one year, which I suppose someone could interpret as a maximum, but I certainly interpret that as a minimum.
We do not have a requirement to train before releasing a document. The consultant/auditor is telling us we must have this. He wrote it up against Documented Information rather than Training. We will include the disposal requirement as the standard states as this is missing from our process. Thank you for your help.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#8
I'm AS9100 not 16949 but I release my document then train to it shortly thereafter. Then I know I am training to the final released version. Have done it this way for 30 years and haven't had a NC written for it yet, nor would I expect to, as I don't see a shall requiring such.

Nor have I ever seen or heard of a shall requiring a maximum doc retention time.
 
#9
I'm AS9100 not 16949 but I release my document then train to it shortly thereafter. Then I know I am training to the final released version. Have done it this way for 30 years and haven't had a NC written for it yet, nor would I expect to, as I don't see a shall requiring such.

Nor have I ever seen or heard of a shall requiring a maximum doc retention time.
Thank you for your input.
 
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