How to handle an Advisory Notice from a Supplier?

[san777das]

Hello All

I am a Quality Engineer working for a Med device company.
One of our supplier has sent us an "Advisory Notice" which states that a certain chemical included a COA with a wrong a value. They have attached updated COA along with this notice.

My question is that how should I handle this notice? Do I need to SCAR them or create an internal CAPA to document this?
Or should this be simply attaching the updated COA along with the wrong one in our database?

Thanks

 

[Sidney Vianna]

My question is that how should I handle this notice? Do I need to SCAR them or create an internal CAPA to document this?
Or should this be simply attaching the updated COA along with the wrong one in our database?

To me the obvious line of action is to have the condition reviewed by engineering to determine if the chemical analysis has any impact on regulatory compliance or quality performance.

 

[Chrisx]

Did the chemical meet specification? Are there tolerances on the C of A?

 

[dubrizo]

Do you still have any stock on hand or any product built up and within your control? I would immediately quarantine if what they provided was non-conforming to spec. Make sure containment is in place and parallel path engineering analysis. This may also trigger post market analysis depending on some of the discovery and/or your internal processes.

SCAR and/or CAPA would depend on your process. I would imagine the vendor has or should have already kicked off something formal on their end to capture the escape to customer.

 

[san777das]

The chemical still meets the required spec. It is not affecting our products in any manner. The parameter that has the wrong value is not used by us. Hence, it does not affect us in any quality way. So just wanted to know if this needs to be documented in some way within our QMS system?

 

[Ronen E]

Hello All

I am a Quality Engineer working for a Med device company.
One of our supplier has sent us an "Advisory Notice" which states that a certain chemical included a COA with a wrong a value. They have attached updated COA along with this notice.

My question is that how should I handle this notice? Do I need to SCAR them or create an internal CAPA to document this?
Or should this be simply attaching the updated COA along with the wrong one in our database?

Thanks

First of all you should analyse and determine the significance of the error in your application / use.

I wouldn't initiate a corrective action unless it has a major significance or is a recurring issue (has something similar happened before?).

You should also analyse and document any possible consequences downstream in your own manufacturing processes, and further (if any). Then decide what sort of action is necessary. What does your QMS say about handling deviations? Is it actually a deviation for you?