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Re: Who to Include on an Approved Supplier List
Hi Ironcountry, Aren't you too hard on yourself?
Take a look at this article: www.devicelink.com/mddi/archive/05/03/025.html and see the quote:
(Sorry - please put the two dots and five slashes there at the spaces. I am so newbie at this site that they say "To prevent forum spamming, to be able to post links or images your post count must be 5 or greater. You currently have 3 posts. Please remove links from your message, then you will be able to submit your post.")
(quote) It is critical to remember that the certifiers are not authorized to evaluate the quality of the risk analysis. They are not to second-guess a manufacturer’s determination of risk levels—they are only to ensure that the required tasks have been performed. (end quote)
Of course there is FDA which may be a little harder than Notified Bodies here in EU, but isn't that an American article?
Start from what are your company's expectations for the components/ingredients you are putting to your product. If it doesn't matter who the manufacturer behind the supplier is, say so and you are all right. Of course unless it matters - but then (and only then) you must be in control of that and you definitely need to decline "the fine print" which allows the multisourcing and check that you get from the original source you want. All depends on what is your specification, which depends on your risk analysis/FMEA, doesn't it.
We are buying a lot of computers and computer components. I hope you don't mind if I take examples from this world since I do not know much about screws. As examples let's first take hard drives. The guys, who buy these things tell me, that they select (or avoid) certain brands (i.e. the manufacturer matters) and that they also have knowledge which vendor (shop/wholesale) they buy from, in order to get a reliable delivery schedule and warranty handling (i.e. it matters too). Some things like cables are bulk (brand does not matter), as long as the vendor is reliable.
As long as you don't get troubles due to some components, or if they are not identified as high risk items in the risk analysis of YOUR EXPERTS, neither you nor an external inspector should have anything to say against low control - provided the documentation exists to prove that this process has been performed.
So YOU (or actually your experts) draw the line. Only thing for you to really be concerned about is that experts are almost always poor in documenting their knowledge.
Hi Ironcountry, Aren't you too hard on yourself?
Take a look at this article: www.devicelink.com/mddi/archive/05/03/025.html and see the quote:
(Sorry - please put the two dots and five slashes there at the spaces. I am so newbie at this site that they say "To prevent forum spamming, to be able to post links or images your post count must be 5 or greater. You currently have 3 posts. Please remove links from your message, then you will be able to submit your post.")
(quote) It is critical to remember that the certifiers are not authorized to evaluate the quality of the risk analysis. They are not to second-guess a manufacturer’s determination of risk levels—they are only to ensure that the required tasks have been performed. (end quote)
Of course there is FDA which may be a little harder than Notified Bodies here in EU, but isn't that an American article?
Start from what are your company's expectations for the components/ingredients you are putting to your product. If it doesn't matter who the manufacturer behind the supplier is, say so and you are all right. Of course unless it matters - but then (and only then) you must be in control of that and you definitely need to decline "the fine print" which allows the multisourcing and check that you get from the original source you want. All depends on what is your specification, which depends on your risk analysis/FMEA, doesn't it.
We are buying a lot of computers and computer components. I hope you don't mind if I take examples from this world since I do not know much about screws. As examples let's first take hard drives. The guys, who buy these things tell me, that they select (or avoid) certain brands (i.e. the manufacturer matters) and that they also have knowledge which vendor (shop/wholesale) they buy from, in order to get a reliable delivery schedule and warranty handling (i.e. it matters too). Some things like cables are bulk (brand does not matter), as long as the vendor is reliable.
As long as you don't get troubles due to some components, or if they are not identified as high risk items in the risk analysis of YOUR EXPERTS, neither you nor an external inspector should have anything to say against low control - provided the documentation exists to prove that this process has been performed.
So YOU (or actually your experts) draw the line. Only thing for you to really be concerned about is that experts are almost always poor in documenting their knowledge.
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