Advisory Notices for a Component Supplier

[cubix rube]

I'm a fairly recent member here at these forums, and have been very impressed with the knowledge, and willingness to share such knowledge with others, all in the spirit of helping somebody out, with no compensation other than "thank you very much". What a blessing...

I'm working for a component supplier that provides laminated, die cut components to OEM's for use in their medical devices. I've only been on board for a few months, so I'm not quite sure how it came to be that we're seeking certification to 13485 (we're already certified to 9001, which seems appropriate to me, for what we do), but we are, and it's my job as quality manager, and MR, to develop the QMS. I've got 20+ years experience in automotive, and have gotten 3 different companies certified to ISO 9001, and ISO 14000, so I understand the process of developing a QMS/EMS very well, but everything specific to medical is new to me, and not being the manufacturer of an actual medical device seems to be making it a bit less clear as to how certain requirements apply to us.

Anyway, it appears that the last thing I have to deal with is advisory notices. The standard requires a procedure. I've looked in these forums for exapmles, and have found that most of those who have replied to such inquiries have attached their advisory notice procedure to their "recall" procedure. I'm puzzled by this, as I've not found a requirement in the procedure for a recall procedure (am I missing something?). Secondly, I can imagine many scenarios where an advisory notice might be issued without any consideration for a recall, so why would it be made only to be an element of a recall procedure?

We do not design a single product that we make. Our customers design their devices, and source us for their die cut components. They provide design, as well as specify materials, etc. We only ship their products to their mfg. facilities, to be used by their team members. They, generally, know far more about the components we make than we do, so I struggle to imagine when we would need to advise tham about anything.

Can the procedure be as simple as stating that "whenever supplemental information comes to light regarding a product that we have already shipped to a customer, an advisory notice will be sent, to all locations to which product has been shipped."??

Obviously, there's more detail to be filled in, but conceptually, wouldn't this pretty much fit the bill?

 

[Stijloor]

I'm a fairly recent member here at these forums, and have been very impressed with the knowledge, and willingness to share such knowledge with others, all in the spirit of helping somebody out, with no compensation other than "thank you very much". What a blessing...

I'm working for a component supplier that provides laminated, die cut components to OEM's for use in their medical devices. I've only been on board for a few months, so I'm not quite sure how it came to be that we're seeking certification to 13485 (we're already certified to 9001, which seems appropriate to me, for what we do), but we are, and it's my job as quality manager, and MR, to develop the QMS. I've got 20+ years experience in automotive, and have gotten 3 different companies certified to ISO 9001, and ISO 14000, so I understand the process of developing a QMS/EMS very well, but everything specific to medical is new to me, and not being the manufacturer of an actual medical device seems to be making it a bit less clear as to how certain requirements apply to us.

Anyway, it appears that the last thing I have to deal with is advisory notices. The standard requires a procedure. I've looked in these forums for exapmles, and have found that most of those who have replied to such inquiries have attached their advisory notice procedure to their "recall" procedure. I'm puzzled by this, as I've not found a requirement in the procedure for a recall procedure (am I missing something?). Secondly, I can imagine many scenarios where an advisory notice might be issued without any consideration for a recall, so why would it be made only to be an element of a recall procedure?

We do not design a single product that we make. Our customers design their devices, and source us for their die cut components. They provide design, as well as specify materials, etc. We only ship their products to their mfg. facilities, to be used by their team members. They, generally, know far more about the components we make than we do, so I struggle to imagine when we would need to advise tham about anything.

Can the procedure be as simple as stating that "whenever supplemental information comes to light regarding a product that we have already shipped to a customer, an advisory notice will be sent, to all locations to which product has been shipped."??

Obviously, there's more detail to be filled in, but conceptually, wouldn't this pretty much fit the bill?

Can someone help?

Thank you!!

Stijloor.

 

[somashekar]

I'm a fairly recent member here at these forums, and have been very impressed with the knowledge, and willingness to share such knowledge with others, all in the spirit of helping somebody out, with no compensation other than "thank you very much". What a blessing...

I'm working for a component supplier that provides laminated, die cut components to OEM's for use in their medical devices. I've only been on board for a few months, so I'm not quite sure how it came to be that we're seeking certification to 13485 (we're already certified to 9001, which seems appropriate to me, for what we do), but we are, and it's my job as quality manager, and MR, to develop the QMS. I've got 20+ years experience in automotive, and have gotten 3 different companies certified to ISO 9001, and ISO 14000, so I understand the process of developing a QMS/EMS very well, but everything specific to medical is new to me, and not being the manufacturer of an actual medical device seems to be making it a bit less clear as to how certain requirements apply to us.

Anyway, it appears that the last thing I have to deal with is advisory notices. The standard requires a procedure. I've looked in these forums for exapmles, and have found that most of those who have replied to such inquiries have attached their advisory notice procedure to their "recall" procedure. I'm puzzled by this, as I've not found a requirement in the procedure for a recall procedure (am I missing something?). Secondly, I can imagine many scenarios where an advisory notice might be issued without any consideration for a recall, so why would it be made only to be an element of a recall procedure?

We do not design a single product that we make. Our customers design their devices, and source us for their die cut components. They provide design, as well as specify materials, etc. We only ship their products to their mfg. facilities, to be used by their team members. They, generally, know far more about the components we make than we do, so I struggle to imagine when we would need to advise tham about anything.

Can the procedure be as simple as stating that "whenever supplemental information comes to light regarding a product that we have already shipped to a customer, an advisory notice will be sent, to all locations to which product has been shipped."??

Obviously, there's more detail to be filled in, but conceptually, wouldn't this pretty much fit the bill?

If you do not make and place your medical device in the market, then this aspect does seem to be a little strange. However under improvements you are required to have a procedure about this advisory notice. Moreover it is also stated that these procedures shall be capable of being implemented at any time.
The core thought here is about how you will establish a channel of communication where in information is shared with user about further ways of safe and effective use of the product OR is made available based on the manufacturers knowledge and other enhancements that are constantly made on products. Your line of thought must work I guess

 

[yodon]

Can the procedure be as simple as stating that "whenever supplemental information comes to light regarding a product that we have already shipped to a customer, an advisory notice will be sent, to all locations to which product has been shipped."??

We're an R&D services company and we faced the same dilemma. That's pretty much what we ended up doing and it was accepted by our registrar. I don't know about your business, but if it's possible that this additional information might affect other customers, you should also contact them.

 

[Roland Cooke]

13485 was clearly written with finished device manufacturers in mind, rather than subcontractors / outsources / service providers etc.

So I think the full-on advisory notice process is a bit of a misnomer for such companies.

But I do look to see that such a company has a formal process for notifying its finished device customers of (serious) deficiencies it discovers - regardless of the source - especially if that deficiency could in turn lead to the customer having to recall its finished device from the market (or somesuch action).