Product label supplier, critical or non-critical vendor

P

pavanamg

Starting to get Involved
Hi Everyone,

Do you consider the product label supplier critical or not?

If the supplier is not ISO certified, how do you approve vendors who are critical?

Thanks
 
shimonv

shimonv

Trusted Information Resource
You should follow the definitions in your supplier selection and evaluation procedure.
Usually, label suppliers are not consider critical suppliers. Usually, again, it's a small printing workshop. The qualification can be stated in a memo based on past experience or feedback from other clients. Also, for V&V purposes, you should prepare label verification protocol and report.


Good luck,
Shimon
 
ChrisM

ChrisM

Quite Involved in Discussions
I very much doubt that you would have a label supplier that is critical, even if they had to have specific approvals. However, as you have thought to ask this question, does your business have a contingency plan in place should your label supplier be unable to supply? Potential second source identified even if you have not started a formal approval process?
 
L

LUFAN

Involved In Discussions
ChrisM said:
I very much doubt that you would have a label supplier that is critical
Click to expand...

I'd be careful to make such a blanket statement. Critical supplier is not a defined ISO term therefore the use of it is subjective. If your label supplier provides input or content on your labeling and that influences the safety and/or performance the device, that is critical, in my eyes.
 
ChrisM

ChrisM

Quite Involved in Discussions
^
That's why I started off with "I very much doubt".... of course, there is a possibility that the label supplier is critical but in the few medical device companies where I have worked, our label suppliers were never classified as "critical"
 
L

LUFAN

Involved In Discussions
ChrisM said:
^
That's why I started off with "I very much doubt".... of course, there is a possibility that the label supplier is critical but in the few medical device companies where I have worked, our label suppliers were never classified as "critical"
Click to expand...

Neither have I, but I would not represent my own personal experience as an assumption for someone else without knowing for certain, especially given the fact that a "critical supplier" could mean literally anything to that person. @shimonv correctly highlighted those definitions are self defined and suppliers need to be evaluated in accordance with such.
ChrisM said:
I very much doubt that you would have a label supplier that is critical
Click to expand...
 
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