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Exclusion of IATF 16949 Clauses - 8.5.5.1 & 8.5.5.2 & Justification

SATHYABALARAMAN

Involved In Discussions
#1
As per 4.3.1, permitted exclusion is product design & development requirement in 8.3.

But companies like job order / machining: Service is not in their scope, so how to exclude or address the requirements of these clauses - 8.5.5.1 & 8.5.5.2...
 

somashekar

Staff member
Super Moderator
#2
Re: Exclusion & Justification

Simply they are non-application... Write the details of and justification for your non-application.
 
T

TamTom

#3
Re: Exclusion & Justification

Simply they are non-application... Write the details of and justification for your non-application.
Hello,

will it really work this way?
In another thread I read "ignore" it.
I don't think this will work this way.
What is meant with "management of product-safety related products and manufacturing processes". I can't find a link to "Special characteristics", but I produce according to a customer drawing and design, if the customer but a special characteristic on it, it should have some influence, maybe also on the product safety. I don't know. One auditor will accept my exclusion another one not. Does my customer release my Control Plan, by approve my PPAP documentation? Or do I need to get a special agreement with all my customer how to handle this? (My first impression was the new standard was written in a more clearer language, but especially in the new section, you see the learning curve is missing :bonk:)

And Somashekar, where would write this down?
For my Medical device stuff, I have listed all exclusions in the Scope of my manual.
Could this an appropriate way.

Or should I create a document, describing a process that I don't want to use?

Regards,

TamTom
 

Peters

Quite Involved in Discussions
#4
Re: Exclusion & Justification

You can put this clause into "potential applicability". I mean "we are ready for service activities if required by the customer or law".
 

LUV-d-4UM

Quite Involved in Discussions
#5
8.5.5.1 Feedback of Information From Service: Expanded scope including
materials handling and logistics. Service concerns in this section refers to
nonconforming products and materials in the customer location or field and
includes field failure test analysis. IATF suggests that the intent of the notes is to
make the organization aware of the nonconformities that occur outside the
organization.

8.5.5.2 Service Agreement with Customer: Service centers need to comply with
all applicable requirements when there is a service center agreement.

IMHO: these 2 clauses should be excluded when defining the scope. Document the justification.
 
#6
In one of notes to 8.5.5.1 you have reference to 10.2.6, so forget about "excluding" this section. "Service" does not apply only to organization-managed service stations. It includes also OEM-dealership. You can even not be obliged to give warranty for your product, but search iSO 9001 & IATF 16949 for word "field". Without process of getting information related to servicing of your parts you can not meet e.g. 6.1.2.1 ("field repairs"), 8.3.3.1 ("field data"), etc.
 
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T

TamTom

#7
In one of notes to 8.5.5.1 you have reference to 10.2.6, so forget about "excluding" this section. "Service" does not apply only to organization-managed service stations. It includes also OEM-dealership. You can even not be obliged to give warranty for your product, but search iSO 9001 & IATF 16949 for word "field". Without process of getting information related to servicing of your parts you can not meet e.g. 6.1.2.1 ("field repairs"), 8.3.3.1 ("field data"), etc.


didn't get the message here? Can I exclude or not? (think of my language limitations please)

TamTom
 
#8
Englisch ist auch für mich Fremdsprache. :D

8.5.5.1
Your parts are assembled into car by OEM. Maybe in future, there will be a car failure, which requires exchange of your used part assembled into car to your new part. This exchange will be performed by e.g. OEM service station.
Your organization must have process to get information related to nature of this and other failures and share this information internally.
This requirement is related to 10.2.6. Using process of getting information from service, your organization can analyse field failures, e.g. your parts exchanged by OEM service stations.
 

LUV-d-4UM

Quite Involved in Discussions
#9
didn't get the message here? Can I exclude or not? (think of my language limitations please)

TamTom
IMHO:I think the standard explicitly state that you are only allowed to exclude Product Design with the documentation of justification. If you caome across a clause and you want it to be excluded for some valid reasons, you can always say that "at the present time (activity/clause) is not covered by the scope but should there be changes we will evaluate the risk and perform (describe the activity/clause).
 
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