Supplier Sample Run Rejection

[theGrod]

We have received a sample run of some product from a supplier. It was rejected. I don't think this should be addressed through our Nonconforming Product procedure or our Corrective Action procedure because we are still trying to see if they have the capability to produce the item. We don't have a work instruction for this in Design Control or Process Control. Any suggestions?

 

[PaulJSmith]

Re: Supplier Sample Run

I'm not in the medical device field, so I can't speak to that aspect regarding the standards. However, you have clearly identified a gap in your own internal process. That can be easily corrected. You can use this situation as a great example to drive that change.

 

[Ronen E]

We have received a sample run of some product from a supplier. It was rejected. I don't think this should be addressed through our Nonconforming Product procedure or our Corrective Action procedure because we are still trying to see if they have the capability to produce the item. We don't have a work instruction for this in Design Control or Process Control. Any suggestions?

I would document it as part of supplier evaluation.

 

[somashekar]

Looks like this is an output of your design and development or changes in design ...
You are talking about its validation.
Are you now looking at making some more modifications based on the analysis ?
Then it is a part of design and development changes ....
Are you looking at an other supplier to make it .... ?
Clearly a supplier evaluation and selection exercise.