AS9100 Major for repeat.

[Bev D]

Thanks John.

So if I’m interpreting this correctly "When external provider test reports are utilized to verify externally provided products, the organization shall implement a process to evaluate the data in the test reports to confirm that the product meets requirements”, means that receiving can simply look at the actual test results - both dimensional and material - on the certificate and compare them to the specifications as ordered. (This would be verification).

And IF the Customer or the organization has determined that one or more of the characteristics are critical, THEN the organization needs to confirm through independent testing that the supplier’s certification is correct (When a customer or organization has identified raw material as a significant operational risk (e.g., critical items), the organization shall implement a process to validate the accuracy of test reports" and they need to verify that the results meet the specification. (This would be validation)

Please correct me if I have mis-interpreted this*…

Now we need the OP to clearly explain their specific situation.

*I had this exact situation when I was working for an aircraft engine manufacturer. There was a paint used on a small but high volume part that was intended as an ‘error-proofing’ visual. The paint would be burned off during initial uses and so the paint could not be contaminated with certain chemicals. The aircraft manufacturer had a very strict specification and had historically certified a few suppliers to manufacture and test/certify the paint, providing a material certification. Historically, any company purchasing and using the paint could accept the supplier’s certification with a simple ‘verification’ that the paint met spec. Eventually however, the few certified paint manufacturer’s stopped certification as it was prohibitively expensive. This left the companies that purchased the paint to validate the certificate results with independent testing at a ‘certified’ lab. Plus we had to verify that the results met the specification.

 

[Sidney Vianna]

Please note this issue has been covered a number of times already. For example,

AS9100D 8.4.2 NC for verification of raw material chemistry to SAE / ASTM specification

AS9100D, raw material standards are a requirement for manufacturing?

The key issue at hand is the need to understand the difference between a TEST REPORT and a (real) MATERIAL CERTIFICATE.

 

[StebanGtz]

Thank you for all your answers. I see we need to verify the material composition (Supplier CofC) vs the Specification (% of iron, carbon, etc.)
To comply with this requirement, we created a spreadsheet with all the raw materials and their respective specifications where we can find the composition and a quality inspector will compare the information.

But I wanted to know how we can address the NC 10.2.1 for the repeat NC vs our Corrective Action Process?
As I said, this is our first Major NC and we don't know how we can response to that.

Thank you again for your help.

 

[Sidney Vianna]

To comply with this requirement, we created a spreadsheet with all the raw materials and their respective specifications where we can find the composition and a quality inspector will compare the information.

The OBVIOUS question that any auditor worth it’s bitcoin would ask is: who controls this spreadsheet? What happens if a material specification gets revised?

 

[Golfman25]

Thank you for all your answers. I see we need to verify the material composition (Supplier CofC) vs the Specification (% of iron, carbon, etc.)
To comply with this requirement, we created a spreadsheet with all the raw materials and their respective specifications where we can find the composition and a quality inspector will compare the information.

But I wanted to know how we can address the NC 10.2.1 for the repeat NC vs our Corrective Action Process?
As I said, this is our first Major NC and we don't know how we can response to that.

Thank you again for your help.

It seems clear there was a misunderstanding of the requirement. I would push back on the "major" nature of the finding. They obviously approved your prior corrective action. If the CA didn't include evidence that the spec and cert where checked element via. element, I would say some of it is on them.

If it did include such evidence, then the question becomes why didn't you continue to check that way? That could be a major -- failure of the CA process that you'll need to rectify. Good luck.

 

[Bev D]

Having a spreadsheet is a recipe for disaster as Sydney pointed out. There should never be two independent sources of information. Write that down on a sticky note and attach it to your computer monitor.

As for answering the major: you need to state several things:
- what did you tell the receiving people to do? Did you tell them to verify all material and dimensional results against the specification? If not, why not? Did you not understand the requirement? If not why not?
- What did they do? Did you verify that they were doing what you told them to do? If not, why not? If they weren’t doing what you told them to do, why were they not following the instruction? You cannot tell them and forget it…
What does the requirement actually say? Do you understand it now? How will you verify that it is effective and that it ‘stuck’?

And most importantly how will you prevent something similar from happening again? How will you fix the system?

 

[Sidney Vianna]

Attempting to “comply” with a misunderstood requirement will always lead to unmanageable solutions. That’s why on another thread I suggested contacting the 9100 SDR/IDR for clarification. If the intent of the standard were for organizations to verify conformity of the material against the standard for chemical, mechanical and metallurgical properties in ALL CASES, they would also demand incoming parts to be fully inspected at receiving.

Pay attention to the words TEST REPORTS. These don’t have the same level of confidence as original material certificates. The aerospace business has been exposed to counterfeit material and equipment. This requirement is obviously aimed at ensuring material integrity.

 

[ChrisM]

Addressing the REPEAT nnconformance:
I fear that the answer is that whoever was tasked with addressing the nonconformance initially did not understand or appreciate what the nonconformance was actually stating, and the corrective action implemented did not address the issue raised by the auditor. Therefore at the next audit, the issue was still unresolved.
Now having had a repeat "offence", the company has decided to further investigate why the action it took first time round was not adequate, has determined with the help of external consultants (eg responders to this thread on Elsmar Cove) what the real nonconformance is, and has now taken steps to address it.
Do not forget that you need to follow up on these actions to make sure that they are effective; you cannot wait until the next external audit to see if the CB auditor is satisfied with them, and therefore deem the actions as effective. you must check yourselves - if you do implement the spreadsheet solution, you could conduct random audits to make sure that those completing it understand what they are doing, that the figures entered in it are correctly copied from Mill certs or whatever, that someone is monitoring the limits in the spreadsheet to make sure that they are correct especially if any of the relevant standards are updated or changed.

 

[Golfman25]

Addressing the REPEAT nnconformance:
I fear that the answer is that whoever was tasked with addressing the nonconformance initially did not understand or appreciate what the nonconformance was actually stating, and the corrective action implemented did not address the issue raised by the auditor. Therefore at the next audit, the issue was still unresolved.
Now having had a repeat "offence", the company has decided to further investigate why the action it took first time round was not adequate, has determined with the help of external consultants (eg responders to this thread on Elsmar Cove) what the real nonconformance is, and has now taken steps to address it.
Do not forget that you need to follow up on these actions to make sure that they are effective; you cannot wait until the next external audit to see if the CB auditor is satisfied with them, and therefore deem the actions as effective. you must check yourselves - if you do implement the spreadsheet solution, you could conduct random audits to make sure that those completing it understand what they are doing, that the figures entered in it are correctly copied from Mill certs or whatever, that someone is monitoring the limits in the spreadsheet to make sure that they are correct especially if any of the relevant standards are updated or changed.

sure, but how much of that falls on the auditor and the CB? I mean they issued the NC and reviewed the CA. If it was deficient, shouldn't it be called out then? I have frequently had auditors issues NCs which made zero sense. Badly framed NCs are very difficult to resolve.

 

[Big Jim]

sure, but how much of that falls on the auditor and the CB? I mean they issued the NC and reviewed the CA. If it was deficient, shouldn't it be called out then? I have frequently had auditors issues NCs which made zero sense. Badly framed NCs are very difficult to resolve.

Not only poorly written and administered, but trying to get an explanation out of the auditor that makes sense. I don't remember how many times asking "what are you after", just got a word salad answer. Something to the effect of I can't tell you too much on how to respond to the NCR because I can't do that for you.