ISO 9001 clause that covers Production Line Re-Validation

[Qualitygoalieman]

I'm new to the Cove, so please bear with me.

One of my suppliers has moved their production line to a different location and I was wondering under which if any ISO 9001/2008 clause do they have to re-certified or re-validate the prodcution line? It's an automotive supplier but they are only required to be ISO and NOT TS certified. Thanks.

Chris

[Stijloor]

Chris,

Welcome to The Cove Forums!

A few questions for my clarification.

Is your supplier PPAP responsible? Are you ISO/TS 16949:2009 Certified?

The AIAG PPAP Manual 4th Edition, Paragraph 3.1 requires that the organization must notify their customer of any planned changes to the design, process, or site.

Examples are provided in table 3.1 on page 13.

Hope this helps.

[Qualitygoalieman]

The supplier is NOT required to do PPAP and we are ISO and NOT TS certified.

We have asked them to conduct a process readiness review, review and approval of the work instructions, and walk the new production line but wasn't sure if there was a requirement to hold them too.

[Stijloor]

In Reply to Parent Post by Qualitygoalieman

The supplier is NOT required to do PPAP and we are ISO and NOT TS certified.

We have asked them to conduct a process readiness review, review and approval of the work instructions, and walk the new production line but wasn't sure if there was a requirement to hold them too.

OK. No, not unless they are PPAP responsible. Or, your organization requires it just to make sure.

Caution: See ISO 9001 clause 7.4.1 (2nd Par) Verify that this move does not negatively impact your supplier's ability to supply products in accordance with your requirements.

[Mikishots]

In Reply to Parent Post by Qualitygoalieman

I'm new to the Cove, so please bear with me.

One of my suppliers has moved their production line to a different location and I was wondering under which if any ISO 9001/2008 clause do they have to re-certified or re-validate the prodcution line? It's an automotive supplier but they are only required to be ISO and NOT TS certified. Thanks.

Chris

AS9100C clearly identifies this requirement under clause 7.5.1.1 (usually referred to as first article inspection) Unfortunately, this is not detailed under ISO9001-2008 (one of the improvements that the ISO group can make for the next revision).

You would need to refer to Clause 8.2.4, which requires the organization to monitor and measure the characteristics of the parts coming off that line to make sure that the product requirements are still being met. The resulting records are to show proof that the part is still what the customer requires, and that you have a record of who signed-off saying that everything was good to go for a production run.

To ask if it's "required" is really a moot point, in my opinion - it would be a massive and unnecessary risk to NOT revalidate that moved line prior to resuming production. I couldn't imagine any organization that would entertain an idea like that (but maybe I'm just naive).

[Sidney Vianna]

In Reply to Parent Post by Qualitygoalieman

It's an automotive supplier but they are only required to be ISO and NOT TS certified.

Welcome to The Cove. If the supplier is certified to ISO 9001 by a (properly) accredited certification body and they have relocated their production line, according to ISO 17021, their CB must have contractually enforceable requirements that the supplier should have notified them (the CB). Upon being notified of the relocation, the CB should have triggered a "special" audit to ensure the new location is performing work still in accordance with the requirements of the standard and re-issue a new certificate covering the new location.

If the supplier failed to notify their CB and that has created problems for you, you can engage with the supplier CB and ask for an immediate action.

[thebestroe]

This is kind of relative to the thread. MY shop is ISO 9001:2010 ceritfied and we are currently validating our cut processes on 2 new Hi def plasma tables we purchased. I was wondering this: Since we are an ISO shop registered as 9001:2010, can we reference the deviation and angle chart from ISO 9013:2002 (e) to validate our theraml cut processes? Is there an issue directly referencing ISO 9013:2002 in our work instructions?

[Randy]

In Reply to Parent Post by thebestroe

This is kind of relative to the thread. MY shop is ISO 9001:2010 ceritfied and we are currently validating our cut processes on 2 new Hi def plasma tables we purchased. I was wondering this: Since we are an ISO shop registered as 9001:2010, can we reference the deviation and angle chart from ISO 9013:2002 (e) to validate our theraml cut processes? Is there an issue directly referencing ISO 9013:2002 in our work instructions?

You are not ISO 9001:2010 certified, you may be IAS BCP 9001:2010 certified, but there is no ISO 9001:2010