Customers ask me all the time – “Michelle, I keep hearing this term – supplier criticality. What does that even mean?”
Supplier criticality is an indication of how much potential regulatory scrutiny and/or negative impact a third-party vendor could have on your business IF that vendor fails to meet expectations.
For example, if a component provided by a supplier has the potential to cause significant harm or damage or any other adverse event, then THAT supplier is considered critical.
Likewise, if a supplier is the sole source for a key component of your device, and that supplier shuts down or goes out of business unexpectedly, meaning you can no longer produce your device, THAT supplier is also considered critical.
To make things even more interesting, a given product or service provided by a third-party supplier may have different risks (or different levels of criticality) based on how it is used.
And, a supplier may present different risks for each product or service they provide.
Defining the criticality of your suppliers is a serious business and it can get complicated very quickly – check out the flowchart image attached to this post. That is how the EU notified bodies define supplier criticality.
And establishing the criticality of your suppliers is just one component of the purchasing controls required by the FDA.
Keep the ibuprofen handy, stay calm and QMS on. 😁
Want to learn about other hot regulatory topics? Check out my YouTube channel: https://www.youtube.com/channel/UCUqIDQVrq5A9k8ZBnSeonUw
Or visit my website: https://leanraqa.com/services/regulatory-strategy/