AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations

Big Jim

Admin
As one of our founding fathers said not all men are angels and as a result our government system had many checks and balances built into them.

If a company wants to cheat they will find a way and it may take a while for it to become known. Examples include Enron and Kolbe Metals. eventually their downfalls were horrendous. Their downfalls pulled others down with them who were were actually innocent bystanders.

What are some of the other ways to check them out? Providing samples to evaluate. A site visit with or without a customer audit. If that isn't practical then hire an independent auditor to go in and evaluate them. Check out their reputation from others that may be using them. Run A D & B report to get a good clue on their financial dealings. More closely monitor what you receive from them for a while until you feel comfortable with their product and with them. Have an outside company run NDT on what you are buying at least for a while. Have chemical analysis performed on critical raw material. I'm sure there are many more ways. Pick what seems appropriate for the circumstances. Be very wary when or if you start to think they are hiding things from you.

There are horror stories galore about companies that may seem great at first glance but are really rotten to the core.

On NADCAP keep in mind that all they are doing is assuring that they performed according to the checklists and that NADCAP doesn't actually confront that the product turns out right.

I call on a plating shop that can't get their act together to get registered to AS9100 but they can consistently provide much better product than their AS9100 & NADCAP competitors. Guess who gets the contract. A NADCAP Accreditation doesn't mean diddly if the final product is trash.
 

CanadianQA

Involved In Discussions
What are some of the other ways to check them out? Providing samples to evaluate. A site visit with or without a customer audit. If that isn't practical then hire an independent auditor to go in and evaluate them. Check out their reputation from others that may be using them. Run A D & B report to get a good clue on their financial dealings. More closely monitor what you receive from them for a while until you feel comfortable with their product and with them. Have an outside company run NDT on what you are buying at least for a while. Have chemical analysis performed on critical raw material. I'm sure there are many more ways. Pick what seems appropriate for the circumstances. Be very wary when or if you start to think they are hiding things from you.

Thanks for these suggestions Big Jim. Very helpful.

I call on a plating shop that can't get their act together to get registered to AS9100 but they can consistently provide much better product than their AS9100 & NADCAP competitors. Guess who gets the contract. A NADCAP Accreditation doesn't mean diddly if the final product is trash.
I may be stating the obvious here, but I'm guessing you meant the non-accredited shop got the contract? I wish that more companies had this mentality. As far as I know though, you can't even tender a bid with Government, one of the primes or their 1st tier suppliers without holding that AS91XX or NADCAP certificate.
 

outdoorsNW

Quite Involved in Discussions
I have seen some bad ideas come out of customers requiring AS9100 certification. We are As9100 certified. In one case a customer asked us to do a first article on something designed and produced by a non AS9100 company. We are an electronics company. While we are qualified to evaluate the control box, the pumps and other items we are completely unqualified to evaluate. But to our customer, we were qualified and the manufacturer is not qualified. We turned the job down because a lot of it was outside our area of expertise. This was a ground support item for an aircraft that I don't think was even a core item for the project. I suspect the item was to support testing and qualification of something else.
 

Big Jim

Admin
Thanks for these suggestions Big Jim. Very helpful.

I may be stating the obvious here, but I'm guessing you meant the non-accredited shop got the contract? I wish that more companies had this mentality. As far as I know though, you can't even tender a bid with Government, one of the primes or their 1st tier suppliers without holding that AS91XX or NADCAP certificate.

The prime came to them.

What is sad here is that the prime would like to give them more business but won't until they get their act together on AS9100 certification.
 

sherniece

Manufacturing Quality
Section 8.4.1 of AS9100 includes the NOTE: "the organization can use quality data from objective and reliable external sources, (e.g., information from accredited quality management system ... Use of such data would be only one element of an organization’s external provider control process and the organization remains responsible for verifying that externally provided processes, products, and services meet specified requirements" [emphasis added]. That means evidence of AS9100 or NADCAP certification should not be your only qualification.

Section 8.4.2 lists different examples of control over vendors, and your decision should be balanced against risk. Whatever review you say you do in your procedure, be sure a record exists. You stated your QMS allows your President to approve an exception (Vendor not currently certified) but it would be wise to enact additional controls on the exception supplier(s) and the product/service provided, to address risk in line with section 8.4.2. My company wrote a separate Supplier QMS Exception procedure to document in detail how that exception scenario is handled.
Hello John - this is good information, and I would like to know if could share the Supplier QMS Exception Procedure. Also, I am looking for Vendor Management SOP with spreadsheet/template. We have some gaps in our vendor Management Program. Any suggestions/tools that will aid in creatin g a Robust Vendor Management Program for GxP - for our contract Manufacturers.
 

John Predmore

Trusted Information Resource
could you share the Supplier QMS Exception Procedure.

I am not at liberty to share our procedure. One form of control over a non-ISO-compliant supplier might be Certificate of Analysis where you specify in-process measurements and machine settings and environmental conditions be recorded at predetermined points during a production run, and reported with the shipment. Another option is send your quality rep on-site for source inspection, to review quality records before shipment. A third option is to hire a manufacturer's rep and have him on-site from the start of your product run at the supplier, in order to verify lot traceability identification, monitor process startups and machine conditions during the run.

As far as Vendor Management tools, we are a small firm. We use spreadsheet lists for most of our quality tracking.
 

donalexinder24

Registered
hi

However, in one or both of these instances, it could be a viable alternative. I'd previously thought of a protocol for exceptions, so I'm delighted to see that suggestion as well.
 
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