What is perceived as a risk from production control?

Following questions can be asked when analyzing risks from production control:

• Are all checkpoints correctly identified and set?
• If you use any measuring equipment for the control, is that equipment properly maintained and calibrated (if applicable)?
• What is the sample size for control, whether the sample quantity is correctly defined with respect to the batch size?

It is not important what your prediction is that something will happen, but how much such a risk can have negative consequences for the user of the medical device (harm). Usually, if the prediction is very small, it just means that you keep that risk under very good control. The point is that the risk is there, that you have to recognize it and that you have to take all possible measures to reduce it to a minimum.

For more information regarding the risk in medical devices please see the following article:

• How to use ISO 14971 to manage risks for medical devices https://advisera.com/13485academy/blog/2017/09/21/how-to-use-iso-14971-to-manage-risks-for-medical-devices/