TS 16949 Clause 5.6.2.1 - Review of Potential Field Failures

Hey guys, I am looking to close a minor that I received during our audit. Our auditor hit us up for not discussing potential field failures of our products. We are a laser cutting job shop that does mainly ISO work, but we do have some small GM work (Cutting one hole in a stamped part for example). We do not control any of the design, so We do not have any idea most of the time what the content that we are putting in does. Many parts, we do not even know what they are for. How am I supposed to discuss field failures when I do not even know what the part is for? Even if I know what the content I am cutting is for, how can I determine field failures. Say I am cutting a hole in a fender for a turn signal light...If the hole is too big, the light will fall out. If the hole is too small, the light can not be installed. Beyond this, I have no idea. Please enlighten me.

Phantasm said:

Please enlighten me.

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You are fine. It is your auditor that needs enlightenment.

Appeal the NC. I don't have the TS document with me now, but I am sure there must be an "as applicable" or an "as appropriate" somewhere.

Phantasm said:

Please enlighten me.

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The auditor is correct. Even though you are not product design responsible, you are for process design. So, during process FMEA, you assess if a process failure could potentially cause a field failure. Your example of a light falling out is a (potential) field failure. Both actual and potential field failures must be escalated to Top Management for Management Review. All that is required is that you have considered it during Process FMEA.

Hope this helps.

I still beg to differ. Any "machine shop", build to print type supplier who has no idea of where and how the component will be used at, would be doing just speculative engineering, as they can not realistically assess how the component might fail, since they have no knowledge of expected life cycle, stresses, dynamic loads, shock loads, etc. their part(s) will be subjected to.

The TS standard talks about potential failure modes to be reviewed during the management review. Failure modes are, obviously, product related.

We have the same situation. My suggestion is to cover all the agenda items in the Management Review for TS16949 and just say No field failures to report and no action items to follow-up. Full stop.

I did not see any "as appropriate" word in 5.6.2.1. Perhaps the link to this clause might have.

I am a bit confused. I thought PFMEA is process related (process that makes the product).

auditor's observation is right. it calls for reviewing the process FMEA to include the potential field failures as you may not be design responsible.

Sidney Vianna said:

I still beg to differ. Any "machine shop", build to print type supplier who has no idea of where and how the component will be used at, would be doing just speculative engineering, as they can not realistically assess how the component might fail, since they have no knowledge of expected life cycle, stresses, dynamic loads, shock loads, etc. their part(s) will be subjected to.

The TS standard talks about potential failure modes to be reviewed during the management review. Failure modes are, obviously, product related.

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I agree. Implicit in most of the TS requirements is they apply to the degree that is reasonably applicable to your situation. Whether the standard states "as applicable" or not, it can only apply where it applies. You can't be expected to imagine what effects the part might have beyond your knowledge of how the customer intends to use it. That is why the design responsible customer is supposed to provide a Design FMEA, which of course, they don't bother doing.

But, you have to address it in Mgt Review, and detail in your FMEA what risks you were able to identify which could affect the assembly line or he end user. So you will have some features. If you can envision certain field failures, then list those as well.

Don't overthink it, but don't underthink it either.

We include this statement in our MR meeting minutes: *No End User Field Failures, Product Recalls or Warranty Issues were reported*. 3 different auditors have all had positive comments...