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Same product - new vendors; how to avoid changing part numbers

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Michelle Wilkinson Program Manager, Supplies & Accessories| Spacelabs Healthcare Snoqualmie, Wa, United States
I work for a company that makes medical devices. We are in the process of changing suppliers. The size, shape, and material of one of the components is the same, although it will be coming from a different supplier. Another material is new and will need to have biocompatibility testing done. We had planned on rev'ing the part number when we change to the supplier that has the same material and then changing the part number when we have to use the new material. However, I was told by my Regulatory group yesterday that when I change the part number, I'll need to place a new registration for each Country of Origin we sell this product to. I've been told this can take as little as 3 months (very unlikely) to 2 years (again, unlikely). Companies change part numbers and vendors all the time. It can't be this difficult. Does anyone have any suggestions on how I can work through this?
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Keith Novak Tukwila, Wa, United States
It will depend on how your product is defined in your configuration management system.

Part number rolls are actually very expensive industry-wide. Lots of people have to touch paperwork. A lower tier part number change requires all higher assemblies to change as well.

If the parts are identical with respect to form, fit and function, then you may be able to make the parts 2-way interchangeable. Your higher level product structure then says you can use A or B without rolling the next-higher assembly.

Vendor parts can also be managed via a Specification Control Drawing which defines all the requirements for the parts (often part families). Your new vendor will have their own internal part number which is qualified against the Spec. You then use your own internal part number in the Spec., and any vendor part qualified to the spec part number is valid for use. In that case your next-higher assembly calls out the spec part # and not the vendor part number.

As a former enterprise rep. for configuration control, there are many ways this can be handled and much of it depends on how it's defined in your product structure, so I would try and work with your own CM people to identify viable solutions. They often exist, but may incur other costs IF your system is set up to use them.
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1 reply by Michelle Wilkinson
Jul 10, 2020 3:17 PM
Michelle Wilkinson
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Thank you so much!!
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Kiron Bondale Retired | Mentor| Retired Welland, Ontario, Canada
Michelle -

I'd suggest finding out from the regulatory folks what control objective they are trying to satisfy and see if there's a different way in which that can be addressed. The healthcare sector does have more regulatory "bureaucracy" than many others, but you'll want to ensure it is not bureaucracy for its own sake, but rather to manage well identified risks.

Kiron
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1 reply by Michelle Wilkinson
Jul 10, 2020 3:18 PM
Michelle Wilkinson
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Thank you!! I appreciate your response.
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Michelle Wilkinson Program Manager, Supplies & Accessories| Spacelabs Healthcare Snoqualmie, Wa, United States
Jul 10, 2020 12:27 PM
Replying to Keith Novak
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It will depend on how your product is defined in your configuration management system.

Part number rolls are actually very expensive industry-wide. Lots of people have to touch paperwork. A lower tier part number change requires all higher assemblies to change as well.

If the parts are identical with respect to form, fit and function, then you may be able to make the parts 2-way interchangeable. Your higher level product structure then says you can use A or B without rolling the next-higher assembly.

Vendor parts can also be managed via a Specification Control Drawing which defines all the requirements for the parts (often part families). Your new vendor will have their own internal part number which is qualified against the Spec. You then use your own internal part number in the Spec., and any vendor part qualified to the spec part number is valid for use. In that case your next-higher assembly calls out the spec part # and not the vendor part number.

As a former enterprise rep. for configuration control, there are many ways this can be handled and much of it depends on how it's defined in your product structure, so I would try and work with your own CM people to identify viable solutions. They often exist, but may incur other costs IF your system is set up to use them.
Thank you so much!!
avatar
Michelle Wilkinson Program Manager, Supplies & Accessories| Spacelabs Healthcare Snoqualmie, Wa, United States
Jul 10, 2020 1:06 PM
Replying to Kiron Bondale
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Michelle -

I'd suggest finding out from the regulatory folks what control objective they are trying to satisfy and see if there's a different way in which that can be addressed. The healthcare sector does have more regulatory "bureaucracy" than many others, but you'll want to ensure it is not bureaucracy for its own sake, but rather to manage well identified risks.

Kiron
Thank you!! I appreciate your response.
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Tarun Nair Adoor, Kerala, India
Generally it is managed with one part number with multiple sub supplier number. If you change the part number, it may lead to type approval process from regulatory bodies, this may be the reason that you are told of long duration due to part number change.
Please check with other projects in your org, about how multiple suppliers for same part is managed. Is there a way to not changing the part number. Also to have a discussion on understanding the reason for long duration when the parts are identical. You might get a better solution with more information exchange with relevant stakeholders.

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