Product label supplier, critical or non-critical vendor

[pavanamg]

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]

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]

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?

 

[LUFAN]

I very much doubt that you would have a label supplier that is critical

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]

^
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"

 

[LUFAN]

^
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"

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.

I very much doubt that you would have a label supplier that is critical

 

[pavanamg]

Thank you so much for help.