AS9100 Section 8.4.2 - External provider test reports

[lorenambrose]

Regarding the requirement below, how could I address this?:

Section 8.4.2
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. 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.

We provide product X:
1) We completely outsourced the D&D. We have NO hardware or software engineers on staff.
2) Our product X is completely manufactured by an external PMA manufacturer (not the D&D org). Our organization does not manufacture and has no PMA certification. All product X is received with an 8130-3 Airworthiness Certificate from the PMA manufacturer.
3) We do not buy any materials for production.
4) The finished product X is received by an EXTERNAL logistics provider that provides receiving, inventory, order aggregation, packaging, and shipping functions.
5) we literally never physically handle product X ourselves.

I am a bit stuck on this.

 

[Randall Beck]

We are design exempt in our processing functions so we only follow outlined specifications and test accordingly in house to verify, so I certainly am looking forward to any input from more experienced others. Just to ask a couple specific questions about the worst case scenario to help others understand your issue better, if your product X failed in the field or did not meet the requirements of safety, color, form, fit or function you advertise or claim it can/does, how would you know if you never see it first? Do you at least perform periodic audits of your supplier or just completely rely on the 8130-3 Airworthiness Certificate from the PMA manufacturer?

 

[lorenambrose]

We do manage the supply chain properly and we do have some of the product X in our lab for system testing. As a PMA article, form, fit, and function are very closely managed between us and the manufacturer. Design changes all go through is but we do not actually do any of the development work in-house.

I should mention that we do test the design and verify that it meets our system requirements. DO-160 is part of that.

 

[Sidney Vianna]

how could I address this?:

You outsource pretty much everything, so you obviously have to flow down all the proper requirements to the involved parties, such as the (PMA) supplier to comply with all of the applicable requirements, including the verification of test reports and raw material certs.

As a side note, I wish the IAQG would heed to one of my suggestions and follow the IATF model that only manufacturing plants could be certified.

As in this case, companies doing "brokerage services", having products directly shipped or directly delivered to customers should not be eligible for AS9100 certification, IMO. The chain of accountability can get lost very easily.

 

[lorenambrose]

We do rely heavily on outsourcing and in some ways act as a giant program management office. All requirements are flowed down and activities are verified via, auditing, performance indicators, etc.

 

[darkopsghost]

You still have Trace and Retention requirements.

We are an AS9110 FAA/EASA Repair Station with a Permissible Design Exclusion, but before we split, our company was also AS9100, AS9102, and NADCAP certified.

When you receive a product in, it should be as simple as how the Trace is reviewed, by whom, and how those Trace documents are stored and the retention time of those records. This would be true if you had Design & Development, were Manufacturing, or just kitting parts.

One thing I might add... the FAA, DCMA, and your Prime or other Customers will want to see how you select and control Special Processors. I keep it simple by using Prime Approved sources whenever I can and I record all of them in a log with their capabilities. if they are not Special Processors, just identify that they are COTS. Things like Commercial Off The Shelf (COTS) and Time & Temperature Sensitive items (TATS) which have a Shelf Life still have the same Trace requirements and TATS will require some sort of control log and all will require identification to insure proper usage and what to do with expired product.

Military will require separate holding areas from Civilian and all will require some sort of Red Tag system to identify Product Non-Cons. We also buy from the OEM when we need an article so we don't have to worry about Counterfeit Parts and how we handle them if ever discovered.

 

[Big Jim]

Can you get certified to AS9102?

 

[darkopsghost]

Can you get certified to AS9102?

I know 9102 is invoked by 9100 and 9110, whether there is an actual certification for it, I will have to leave that to someone more knowledgeable than myself.

Working with the Military, they can't force you to do something outside of your normal day to day so it is acceptable to just be "compliant".

The Primes on the other hand can force you to become ISO/AS, NADCAP certified through a P.O. Clause or a Supplier Statement of Work (SSOW). By doing some negotiation, you can work to a Letter of Deviation but that only works for so long while you are getting set up, audited, and become certified. It boils down to Swim or Get Off The Ship and you loose any chance of getting new or run-on contracts. They have you by the Registrar if you would.

I do know there is training available and they sell that training as if it was something a company could achieve, I just can't remember for sure it it was a ride-on or that we actually had a separate cert. I'm thinking we might of had an actual cert. Been too long and all of that could have changed too.

DarkOps

 

[Big Jim]

I know 9102 is invoked by 9100 and 9110, whether there is an actual certification for it, I will have to leave that to someone more knowledgeable than myself.

Working with the Military, they can't force you to do something outside of your normal day to day so it is acceptable to just be "compliant".

The Primes on the other hand can force you to become ISO/AS, NADCAP certified through a P.O. Clause or a Supplier Statement of Work (SSOW). By doing some negotiation, you can work to a Letter of Deviation but that only works for so long while you are getting set up, audited, and become certified. It boils down to Swim or Get Off The Ship and you loose any chance of getting new or run-on contracts. They have you by the Registrar if you would.

I do know there is training available and they sell that training as if it was something a company could achieve, I just can't remember for sure it it was a ride-on or that we actually had a separate cert. I'm thinking we might of had an actual cert. Been too long and all of that could have changed too.

DarkOps

For the record, there is no certification available for AS9102, Also AS9102 is not invoked by AS9100 or AS9110. AS9100 requires production verification of a representative sample of the first production run. The note (which is not auditable) following that statement says this activity is often referred to as first article inspection. This clause is only two short paragraphs.

AS9102 is much more involved comprising of some 20 or so pages. It specifies the forms to use and provides instruction on how to fill them out. It can be required by customers, but it certainly isn't mandated by either AS9100 or AS9110.

 

[darkopsghost]

What I should have said is that it is invoked by the Customer, but the use of the proper forms and proper usage of those forms are invoke by AS9102 itself.

and a 9102 does not have to be 20 or so pages. I have completed plenty that are only 3 pages...Part Number Accountability, Product Accountability, and Characteristic Accountability. There does have to be Objective Evidence unless that's what you are referencing. Most of our contracts are Repair so there is no FAI requirement ever nor do we have to worry about FPQ any longer either.