Control over an Overseas Supplier

[jennaleeb]

Hi everyone! Hope I am not overposting to the point of annoying...

We are a small start-up company that makes Class I non-sterile devices. Our manufacturing, packaging, storage, shipping, etc is all done by a company overseas (who are ISO 13485 certified). We have visited their site several times during the course of supplier evaluation and setting up this partnership, however it is not really feasible to plan ongoing visits for audits, inspections etc. In addition, they have storage and shipping abilities so they will also ship product directly to our customers.

How would we integrate this in our quality system? If we are not doing incoming inspections of all product they manufacture, is it sufficient to ask that they provide an inspection report to us? If we make a requirements checklist and ask that they use it and sign off on everything....

THANK YOU FOR ALL YOUR WISDOM! I am quite "green" on this topic.

 

[Claes Gefvenberg]

I usually stay away from questions about 13485, as I know little about it.

Anyone?

/Claes

 

[somashekar]

How would we integrate this in our quality system? If we are not doing incoming inspections of all product they manufacture, is it sufficient to ask that they provide an inspection report to us? If we make a requirements checklist and ask that they use it and sign off on everything....

You are just opening a big task about what is typically called "Control over outsourced process"

We have visited their site several times during the course of supplier evaluation and setting up this partnership,

When you did this what were the agreed types of information sharing, quality assurance and product release activities discussed.

however it is not really feasible to plan ongoing visits for audits, inspections etc

Yes, and doing such is not the only way to control processes. It will burn your profits in the business if you go about visiting and auditing.

How would we integrate this in our quality system?

By documenting in your QMS what the controls are that you plan to exercise on this activity, and establishing such records with you that gives confidence that your overseas company is doing the inspection and product release activities just the way you want it to be done, also being competent and well mapped within the overseas company QMS.
Consider how you want the device history records to be maintained by the manufacturer and when it needs to be sent to you for your traceability requirements.

 

[jennaleeb]

Hmmm ok. So if an auditor were to ask us, "how do we ensure compliant product is produced by our subcontractors" we can say that we have evaluated their competency, and they are responsible for all non-conformances ? Should I expect our subcontractor to send their 1st inspection/batch reports to us every time?

 

[somashekar]

Hmmm ok. So if an auditor were to ask us, "how do we ensure compliant product is produced by our subcontractors" we can say that we have evaluated their competency, and they are responsible for all non-conformances ? Should I expect our subcontractor to send their 1st inspection/batch reports to us every time?

Forget the auditor.
Ask yourself, "how do I ensure compliant product is produced by our subcontractor"
You must be asking this question at the time of supplier evaluation and setting up the partnership.
Remember that you are the manufacturer to the world and your name is on the device label.
So now, what do you expect your subcontractor to be doing

 

[treesei]

Hmmm ok. So if an auditor were to ask us, "how do we ensure compliant product is produced by our subcontractors" we can say that we have evaluated their competency, and they are responsible for all non-conformances ?

Suppose there were an auditor, this answer would be unacceptable.

Should I expect our subcontractor to send their 1st inspection/batch reports to us every time?

It is more a question of what YOU expect. Many details can be specified in the Quality Agreement which should be co-prepared by you and the CM.

 

[jennaleeb]

So the truthful answer is that we as a company are new to this game, and are trying our best to figure out what industry standards are, as well as put together a satisfactory quality control system. Our subcontracted manufacturers have more expertise than us when it comes to medical device manufacturing, and have provided us with the inspection protocols, testing, etc that they are doing.

In the 1 year we have been working with them to develop the product we have always received compliant product, and any deficiencies have been ironed out very quickly. So, in essence, we trust them as manufacturers to produce product. But I am unsure how to proceed (we have not brought our product to market yet) in setting up an efficient way to monitor product quality.

 

[somashekar]

So the truthful answer is that we as a company are new to this game, and are trying our best to figure out what industry standards are, as well as put together a satisfactory quality control system. Our subcontracted manufacturers have more expertise than us when it comes to medical device manufacturing, and have provided us with the inspection protocols, testing, etc that they are doing.

In the 1 year we have been working with them to develop the product we have always received compliant product, and any deficiencies have been ironed out very quickly. So, in essence, we trust them as manufacturers to produce product. But I am unsure how to proceed (we have not brought our product to market yet) in setting up an efficient way to monitor product quality.

You must quickly engage a medical device quality / regulatory expert or engage a competent medical device quality / regulatory consultant.
You must be able to leverage a lot of learning from your CM, but first must be in a position to determine what you exactly want, as very soon your product will hit the market, and if you are not prepared, your will being to get the hit from the market and regulators.

 

[LUV-d-4UM]

If the auditor ask us how we control our overseas supplier, we give the auditor evidence that there is a supplier score card that we issue to our supplier and also the supplier response to nonconformance via a Supplier Corrective Action process. Hope this helps.

 

[Sidney Vianna]

In the 1 year we have been working with them to develop the product we have always received compliant product,

One of the "typical" unmitigated risks that many organizations fail to realize is the transition from small volume, clinical-trials, prototyping to volume manufacturing and distribution. When you assessed this supplier, did you look at their ability to ramp up production in a controlled manner?