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What to expect when a Critical Supplier moves? - Page 2

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critical suppliers, fda (food and drug administration), iso 13485 - medical device qms, validation plan, suppliers (general topics), validation of machines equipment processes design etc., letter to file (fda term), 510(k)
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  Post Number #9  
Old 9th November 2010, 07:47 AM
Phil Fields

 
 
Total Posts: 376
Re: What to expect when a Critical Supplier moves?

Quote:
In Reply to Parent Post by JJLit View Post

I was just informed from one of our suppliers that they will be moving their operations into a facility that is owned by their parent company. This supplier provides a critical cobalt-chrome porous coating for several of our medical devices. This process was part of our 510(k) submission for this device. We are both FDA and ISO 13485 certified.

My question is what should I expect this supplier to provide as evidence of validation once the move takes place? Obviously we will be doing a vendor audit but I don't know what to request of them. I am sure they will put together a validation plan as part of their move and that should evaluate all risks that are associated. Are there some guidelines that I should follow?
JJlit,
This an interesting question. You have received good feedback from others.

I would like to ask back to you:
What do you expect from the supplier
What would satisfy you and your management that the supplier move will have no adverse effects on your product or production

Phil

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  Post Number #10  
Old 9th November 2010, 03:43 PM
DrM2u's Avatar
DrM2u

 
 
Total Posts: 777
Re: What to expect when a critical supplier moves?

Quote:
In Reply to Parent Post by drewsky View Post

I have a similar situation where the supplier of a component is going to manufacture that component in one of its other locations. How would this be treated in a "letter to file"? How would it be categorized in the FDA flowcharts? It is not a new supplier or ownership change. We are conducting all of the above OQ, PQ, audit, etc but it doesn't seem to fit anywhere in the FDA flowcharts. Any input would be appreciated.

Thanks
Drewsky
Look up the requirements for product and process validation, and risk assessment.
  Post Number #11  
Old 9th November 2010, 07:24 PM
drewsky1

 
 
Total Posts: 122
Re: What to expect when a Critical Supplier moves?

Thanks for this information. We have covered most if not all of what you have mentioned. From a Regulatory standpoint, even though it is not a new vendor, as the intent of the vendor location change is to consolidate their manufacturer facilities, there is not a FDA Guidance flow sheet that emcompasses this that I could include in my letter to file. Any guidance here?
  Post Number #12  
Old 12th November 2010, 09:46 PM
Michael Malis's Avatar
Michael Malis

 
 
Total Posts: 310
Re: What to expect when a Critical Supplier moves?

Quote:
In Reply to Parent Post by drewsky View Post

Thanks for this information. We have covered most if not all of what you have mentioned. From a Regulatory standpoint, even though it is not a new vendor, as the intent of the vendor location change is to consolidate their manufacturer facilities, there is not a FDA Guidance flow sheet that emcompasses this that I could include in my letter to file. Any guidance here?
Is this a supplier for finished goods or just a component part?

If you move your finished goods production to a new location, you need:
1. Validate new product line.
2. Register a product in this (new) location.
but
if this a component part, you only need to approve new vendor and update your internal records (subject to Quality approval of this part)
  Post Number #13  
Old 13th November 2010, 01:11 AM
arios's Avatar
arios

 
 
Total Posts: 637
Re: What to expect when a Critical Supplier moves?

You have received great feedback.

My two cents are for you to consider this situation a candidate for a formal Preventive Action (CAPA). The potential problem description could be described as:

"Key supplier is relocating which could have a potential impact on process, regulatory and logistics"

Then as your preventive action you could address your plans for validation, and so on.

Furthermore contact your Notified Boby as the change may need notification to them. Also have the plans included as an input for your managemnent review under changes with potential impact in the QMS.

You could also consider ordering a built up of raw materials prior to the move as a contingency for potential delay in shipments or identify alternate sources if possible.

Hope this helps.
  Post Number #14  
Old 13th November 2010, 03:55 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,371
Re: What to expect when a Critical Supplier moves?

Quote:
In Reply to Parent Post by drewsky View Post

Thanks for this information. We have covered most if not all of what you have mentioned. From a Regulatory standpoint, even though it is not a new vendor, as the intent of the vendor location change is to consolidate their manufacturer facilities, there is not a FDA Guidance flow sheet that emcompasses this that I could include in my letter to file. Any guidance here?
Supplier move is one of the several other criteria that needs to be captured in a Change notification agreement which is good to establish for critical suppliers more so in Medical device business. What to do in a facility location change is said in other posts in detail. You can plan and take the necessary actions when prior notification is sent by supplier per such an agreement.
  Post Number #15  
Old 13th November 2010, 12:48 PM
drewsky1

 
 
Total Posts: 122
Re: What to expect when a Critical Supplier moves?

Thanks for your input.
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