JJLit

Starting to get Involved
#1
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?
 
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DrM2u

#2
Well, assuming that they will move equipment, you should first expect an Installation validation (IQ). Whether they will run the process on the same equipment or not, any move can cause changes in the process variables and/or controls, therefore an Operational validation should be expected also (OQ). Last but not least you should validate that the new location and/or process is capable of making product that meets your requirements, therefore a Process validation (PQ) should be expected.

One last thing, plan ahead for temporary inventory levels that will allow for a smooth transition without any major impact on your production and/or customer.

In a nut shell, I would treat this just as if I were to re-source a product and deal with a whole new supplier who also might or might not implement process-related new equipment. Hope this helps and also hope that the supplier gave you enough notice.
 
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JJLit

Starting to get Involved
#3
Thanks for the info. That is what I will request. Fortunately, they did give us 12-18 months notice of their move. I have experienced time frames that were much shorter and those cause quite a headache.
 

Michael Malis

Quite Involved in Discussions
#4
Thanks for the info. That is what I will request. Fortunately, they did give us 12-18 months notice of their move. I have experienced time frames that were much shorter and those cause quite a headache.
You also need to schedule another supplier audit to make sure that in addition to Validation that Quality System still in place and nothing else was changed...
 
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DrM2u

#5
You also need to schedule another supplier audit to make sure that in addition to Validation that Quality System still in place and nothing else was changed...
The need for a supplier audit is dictated by the organization's process/system that addresses clause 7.4.1 regarding supplier selection, evaluation and re-evaluation; it is not an automate requirement. In line with Michael's suggestion, it is not a bad idea to treat the new facility as a 'new' supplier. You would be amazed by how different two sister plants can be.
 

Ajit Basrur

Staff member
Admin
#6
Thanks for the info. That is what I will request. Fortunately, they did give us 12-18 months notice of their move. I have experienced time frames that were much shorter and those cause quite a headache.
JJLit,

Since you do not have an alternate supplier, you have no choice but to audit their changed location. On a Preventative action, I would suggest that you develop alternate suppliers so that your production is not hampered by such instances.

Btw, in this age of mergers and acquistions and unhealthy economy scenario, having multiple approved suppliers is necessary :)
 
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drewsky1

#7
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:)
 
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tbsiva

#8
Before moving the facility, ensure that sufficient stocks are produced and moved to warehouse area. Because, in most cases we take the stocks in production or semifinished stage in to account and when it comes to final inspection, there is a risk that even whole lot can get rejected.

Perform site audit to validate the manufacturing process/Logistics flow inside plant/Floor plan layout. Remember to check whether NC parts storage area/rework area are alloted properly. Produce atleast 300 nos, conduct process capability. BAsed on the process capability results & New site evaluation results, You can certify the new manufacturing site
 
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Phil Fields

#9
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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DrM2u

#10
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.
 

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