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Material Verification and Validation
When required or not?
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annie
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13 December, 2018 - 1:35 AM
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A recent registrars audit resulted in us raising an internal corrective action because we did not have a process for periodically sending out samples of parts (or coupons) for material chemical/mechanical analysis.  We dropped it when Rev C was introduced. Under rev D, none of our customers have identified raw material as a critical characteristic.  We are satisfied with our material supplier and verify all raw material certs they supply to us for accuracy against the specified material standard.  We adopt a similar approach for component parts that are provided to us, when we have determined for ourselves that material certs need to be verified.

OK, now to my question(s)…………Why would the auditor tell us that if we do not have a program for VALIDATION  (documented of course! 🙂 of the material content for our raw material or component purchases (by an independent 3rd party test facility), then the next time he audits us, it will be a nonconformity finding?

Have I misunderstood the AS9100D requirement?  I can see that where a customer has determined raw or component material content as a critical characteristic and therefore high risk to them, that it is reasonable to perform additional checks, such as independent laboratory testing. What if there is no such requirement form the customer?

 

Hope this all makes sense

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Christopher Paris
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17 December, 2018 - 9:39 PM
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Under AS9100 Rev D, as you suspected, the requirement for validation is OPTIONAL. It is not mandatory, and is decided by your customer and/or your own internal needs. If you have decided it’s not required, then I suggest documenting this somewhere in your QMS. If you have a quality manual, you could add language there; otherwise, you could enter a corrective action or even a risk register entry (assuming you have a risk register or something like it) that shows you thought about the risks of not validating incoming materials. You could even discuss it as a risk during management review, and then include that discussion in the minutes of the meeting. In short, show something that reveals management discussed this internally and decided it was not a risk.

If you really want to get crazy, write to a couple of customers and ask them if they have identified raw materials as a risk that requires third party validation. They are likely to say “no” and then you have even more documentation. The risk is that they will say “yes” because they don’t understand the question, and then you’re screwed.

The auditor is likely stuck on old AS9100 language, or just auditing to what his (or her) prior employer did, and not the actual standard.

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annie
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18 December, 2018 - 11:36 AM
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Thank you Christopher.  I must admit, I enjoyed reading your response to confirm I was right!  What I almost liked better was the idea of getting crazy with the customers, but I don’t quite have the courage to risk it.  Laugh

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annie
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18 December, 2018 - 11:58 AM
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if you could clarify a little further please……

A Customer requires our finished product to be supplied with a whole bunch of stuff – dimensional reports, evidence of qualification for certain special processes, product functional test reports, and supplier material certs for some of the components that are assembled into the finished product.

Without actually stating the “raw material” composition for these components is “Critical”, should I assume it is?  Or , if it is Critical, shouldn’t the customer actually designate it as such on their drawing or specification?

They do not request it for every single item in the finished product just a limited number of components, and that mere fact indicates to me material is important to them.

The reason I ask for your insight, is because some of my colleagues often try to get smart with words, and in this instance, will go all out to remind me that since the customer does not state “Critical” then we don’t have to lift our butts to do anything extra.

[I see their view, why do more than you have to or do more than is actually being requested?…………more stuff takes time and additional resources etc = more cost and less on the bottom line]

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Christopher Paris
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20 December, 2018 - 3:49 PM
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If the customer requires material certs, and you just forward the material certs given to you by your supplier, then you’re finished. You’ve complied with the customer, and you’ve met AS9100.

The customer will specifically ask for “third party validation” of material certs if they want it. They won’t just drop the word “critical” in there, they will be more verbose. They may even use terms like “independent lab testing,” etc. You won’t be confused when they ask for it. It’s also really, really rare.

More common is when YOU as a company decide to do it. This can be driven by two factors: (1) you suspect the quality of the supplier isn’t up to snuff, no matter what their certs say, so you decide to double check, or (2) you just think the particular material is so risky (perhaps very expensive, or very hard to get) you want to be sure, so you double check. Even though this might be more common, many companies don’t do it.

I’ll keep going. The AS9100 standard does not even say anything about third-party testing. Rev. D now says in those cases you “shall implement a process to validate the accuracy of test reports.” That could be wholly internal (checking the math) or it could be sending it out to a lab. So that means the auditor has even LESS of a leg to stand on.

Apologies to any one-legged auditors who may be reading this.

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annie
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20 December, 2018 - 3:52 PM
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Thank you for your clarification.  In this instance, it is clear now where I move forward.  You are inspiring!

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Christopher Paris
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22 December, 2018 - 12:52 PM
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Aren’t I, though?

🙂

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