Questions concerning QMS and/or company specific nonconformance

#1
Good afternoon.

To start, I am unsure if this topic would specifically be here, but I thought this might be a good starting point and if it is not, I can direct my questions elsewhere.

My company is an automotive manufacturing company. Primarily dealing with stabilizers, tie rods, and control arms.

I am one of 4 Quality Engineers and my responsibility falls primarily with PCRs, APQP/ANPQP, etc. With that, I deal with internal trouble calls that need approval, etc.

As a company, we have restructured and our new Quality Manager has been diving more into our usage of terms like NCR/DMR/Safe Launch/200% inspection, etc.

My question is this:

If we fall under the ISO 9001 QMS system for Minor and Major Nonconformance, should we also be calling out internal defects 'Nonconformance Records'?
We are wanting to specify our system, but I was hoping for some feedback regarding that. We currently use the term 'Safe Launch' for things outside of New Launch programs but we also use the term '200% inspection' while creating our containment and corrective action plans for 8Ds, etc.

For example, if machining passes a non-threaded ballstud to assembly and assembly catches the lot or suspected parts and we do internal investigations without a formal complaint involved- we would normally just red tag those parts and call it a NCR and have our Quality Team sort for the NG parts and return all Good components to production.

Should these systems be more inline with CAPA style of wording? I understand they are a nonconformance to specific customer requirements and tolerances, but I am just curious if we are using these systems as intended or if it is completely up to internal quality teams to set the terms of how they deal with defects and what they call that system.

Thank you in advance for any and all feedback. I appreciate it.
 
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#2
Good afternoon.

To start, I am unsure if this topic would specifically be here, but I thought this might be a good starting point and if it is not, I can direct my questions elsewhere.

My company is an automotive manufacturing company. Primarily dealing with stabilizers, tie rods, and control arms.

I am one of 4 Quality Engineers and my responsibility falls primarily with PCRs, APQP/ANPQP, etc. With that, I deal with internal trouble calls that need approval, etc.

As a company, we have restructured and our new Quality Manager has been diving more into our usage of terms like NCR/DMR/Safe Launch/200% inspection, etc.

My question is this:

If we fall under the ISO 9001 QMS system for Minor and Major Nonconformance, should we also be calling out internal defects 'Nonconformance Records'?
We are wanting to specify our system, but I was hoping for some feedback regarding that. We currently use the term 'Safe Launch' for things outside of New Launch programs but we also use the term '200% inspection' while creating our containment and corrective action plans for 8Ds, etc.

For example, if machining passes a non-threaded ballstud to assembly and assembly catches the lot or suspected parts and we do internal investigations without a formal complaint involved- we would normally just red tag those parts and call it a NCR and have our Quality Team sort for the NG parts and return all Good components to production.

Should these systems be more inline with CAPA style of wording? I understand they are a nonconformance to specific customer requirements and tolerances, but I am just curious if we are using these systems as intended or if it is completely up to internal quality teams to set the terms of how they deal with defects and what they call that system.

Thank you in advance for any and all feedback. I appreciate it.
There is no ISO 9001 QMS system for Minor and Major non conformance, so I’m not sure what you mean, however:
If your manufacturing process creates a nonthreaded ball stud, your people should follow the process to control non-conforming outputs (product) in accordance with 8.7.

That includes disposition like scrap, rework etc. CAPA is usually employed when you see a repeat of smallish quantities or one big spill (internally)
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#3
Good afternoon.

To start, I am unsure if this topic would specifically be here, but I thought this might be a good starting point and if it is not, I can direct my questions elsewhere.

My company is an automotive manufacturing company. Primarily dealing with stabilizers, tie rods, and control arms.

I am one of 4 Quality Engineers and my responsibility falls primarily with PCRs, APQP/ANPQP, etc. With that, I deal with internal trouble calls that need approval, etc.

As a company, we have restructured and our new Quality Manager has been diving more into our usage of terms like NCR/DMR/Safe Launch/200% inspection, etc.

My question is this:

If we fall under the ISO 9001 QMS system for Minor and Major Nonconformance, should we also be calling out internal defects 'Nonconformance Records'?
We are wanting to specify our system, but I was hoping for some feedback regarding that. We currently use the term 'Safe Launch' for things outside of New Launch programs but we also use the term '200% inspection' while creating our containment and corrective action plans for 8Ds, etc.

For example, if machining passes a non-threaded ballstud to assembly and assembly catches the lot or suspected parts and we do internal investigations without a formal complaint involved- we would normally just red tag those parts and call it a NCR and have our Quality Team sort for the NG parts and return all Good components to production.

Should these systems be more inline with CAPA style of wording? I understand they are a nonconformance to specific customer requirements and tolerances, but I am just curious if we are using these systems as intended or if it is completely up to internal quality teams to set the terms of how they deal with defects and what they call that system.

Thank you in advance for any and all feedback. I appreciate it.
Welcome to The Cove!

I am not clear on why you are asking about ISO 9001 when you are an automotive manufacturing company. You are only responsible to ISO 9001:2015?

If you are only responsible to ISO 9001:2015, the standard does not dictate that you differentiate among NCR levels, but certainly the business you sell to invites you to have a more nuanced approach than is/is not.

That said, what you call your records is up to you. Just define it in procedure (because automotive likes procedures though ISO 9001:2015 no longer requires a documented procedure for everything) and keep the practices consistently conforming. The process users will need to be familiar with the process and effectively follow it.

How you differentiate types/levels of nonconformities would potentially (I would say logically) reflect impact on end product/effect on customer. Example: Minor if the issue has no effect on product/service going to the customer, and Major if the nonconformity involves bad stuff going to the customer. It might also be worthwhile to "elevate" a nonconformance that repeats.

This nuanced approach is not easy to manage. I attached an Excel tool in the thread Looking For Excel Template for Tracking & Trending Rejections.

I hope this helps.
 
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