John Walters
Registered
A medical device company (A) decides to utilize contract manufacturing to produce their medical device.
The services that the contract manufacturer (B) will perform include: Purchasing components (some with specific suppliers or subspecifications specified by A and some not), Incoming Parts Inspection, Assembly, In Process and Final Acceptance Testing, Distribution, and Production Process Monitoring and Control.
Company A will purchase the medical device from contract manufacturer B, and so will need an in-house Purchasing process within their QMS, but this will only handle internal business needs, Product Design, and the purchasing of finished systems from contract manufacturer B.
The manufacturing tasks seem to clearly include outsourced service/processes for Incoming Parts Inspection, Assembly, In Process and Final Acceptance Testing, Distribution, and Production Process Monitoring and Control.
The manufacturing tasks seem to also include an outsourced service/process for the Purchasing of components required for the manufacturing of the medical device, but it is not clear to me how or why this is different from similar issues in an otherwise typical n-tier supply chain that didn't outsource manufacturing.
Questions:
1) Wouldn't outsourcing of manufacturing typically include outsourcing of purchasing for the parts needed for manufacturing? (I understand that you could supply the parts directly or hire a separate company to purchase and supply the manufacturer, but I am thinking of a more typical case.)
2) How is this outsourcing of purchasing process for contract manufacturing different from the purchasing process (conducted by various suppliers) of sub-components in the normal n-tier supply chain of individual parts (regardless of who manufactures the final medical device or the individual parts at any level)?
I ask, as I am not sure how to define/limit the scope of activities in a QMS for the purchasing activities at the contract manufacturer. It seems like we need to define the outsourcing of purchasing process to the contract manufacturer (because the purchasing of production parts needs to be controlled by some form of purchasing process), but if this is the case, it also seems like we would do the same all the way down our supply chain for every part (which seems ludicrous / inappropriate). I am not understanding the rationale/principle for justifying that one of these is not an outsourced process (or when to stop saying it is), while one of them is.
I know that 13485 expects QMS process effort to be identified and implemented proportional to Risk (Product Safety, Product Quality, Product Compliance, Process Compliance), but it does not otherwise provide guidance on when the Outsourcing of purchasing process is needed vs simple ordinary supply chain purchasing.
3) Does the subsequent provision of the product make the difference (product will next be distributed/released to customer/market vs component just supplied to next level in normal supply chain)?
4) Does the level of the product make the difference (final medical device, vs components)?
5) Does the level of part specification make the difference (outsource purchasing as far down as you identify part specifications)?
6) Does the level of supplier specification make the difference (outsource as far down as you identify part suppliers)?
7) Any combination of the above or some completely different distinction?
Thanks in advance for any wisdom!
The services that the contract manufacturer (B) will perform include: Purchasing components (some with specific suppliers or subspecifications specified by A and some not), Incoming Parts Inspection, Assembly, In Process and Final Acceptance Testing, Distribution, and Production Process Monitoring and Control.
Company A will purchase the medical device from contract manufacturer B, and so will need an in-house Purchasing process within their QMS, but this will only handle internal business needs, Product Design, and the purchasing of finished systems from contract manufacturer B.
The manufacturing tasks seem to clearly include outsourced service/processes for Incoming Parts Inspection, Assembly, In Process and Final Acceptance Testing, Distribution, and Production Process Monitoring and Control.
The manufacturing tasks seem to also include an outsourced service/process for the Purchasing of components required for the manufacturing of the medical device, but it is not clear to me how or why this is different from similar issues in an otherwise typical n-tier supply chain that didn't outsource manufacturing.
Questions:
1) Wouldn't outsourcing of manufacturing typically include outsourcing of purchasing for the parts needed for manufacturing? (I understand that you could supply the parts directly or hire a separate company to purchase and supply the manufacturer, but I am thinking of a more typical case.)
2) How is this outsourcing of purchasing process for contract manufacturing different from the purchasing process (conducted by various suppliers) of sub-components in the normal n-tier supply chain of individual parts (regardless of who manufactures the final medical device or the individual parts at any level)?
I ask, as I am not sure how to define/limit the scope of activities in a QMS for the purchasing activities at the contract manufacturer. It seems like we need to define the outsourcing of purchasing process to the contract manufacturer (because the purchasing of production parts needs to be controlled by some form of purchasing process), but if this is the case, it also seems like we would do the same all the way down our supply chain for every part (which seems ludicrous / inappropriate). I am not understanding the rationale/principle for justifying that one of these is not an outsourced process (or when to stop saying it is), while one of them is.
I know that 13485 expects QMS process effort to be identified and implemented proportional to Risk (Product Safety, Product Quality, Product Compliance, Process Compliance), but it does not otherwise provide guidance on when the Outsourcing of purchasing process is needed vs simple ordinary supply chain purchasing.
3) Does the subsequent provision of the product make the difference (product will next be distributed/released to customer/market vs component just supplied to next level in normal supply chain)?
4) Does the level of the product make the difference (final medical device, vs components)?
5) Does the level of part specification make the difference (outsource purchasing as far down as you identify part specifications)?
6) Does the level of supplier specification make the difference (outsource as far down as you identify part suppliers)?
7) Any combination of the above or some completely different distinction?
Thanks in advance for any wisdom!