What is the difference between document change control and design change control?

Your document control process should only be used for control of quality system procedures, while your design change control process should be used for controlling changes that affect a specific device or manufacturing process.

When you make changes to the design of your device, the manufacturing process, or even the supplier, you need a more rigorous process for controlling these design changes. For this process we use our Change Control Procedure (SYS-006), then we enter the change notice in our CN Log (LST-009), we document the approval of the change on a Change Notice (CN) or FRM-006, and then we update our DMR/TF Index (FRM-040).

The details of the design change control process are more complex because design changes also affect other documentation. For example, you may need to update your approved supplier list, you may need to change your work instruction for final inspection, you may need to update your risk management file, you might even need to submit an updated Technical File to your Notified Body for review and approval prior to CE Marking the revised design of your device.

You might also want to consider the need for the following activities when you make a design change:
1 - updates to your risk management documents
2 - updates to your post-market surveillance plan
3 - conducting an internal or supplier audit to verify the effectiveness of the changes

We noticed that many of our clients are incorrectly using the DCN process instead of the CN process to control design changes. Therefore, we are updating our procedure for Change Control (SYS-006) to explain how to properly complete FRM-012, and we are hosting a new training webinar on January 20, 2022, @ 11 am EST to help you learn how to properly manage design changes. If you want to register for this training webinar, please visit our website: https://medicaldeviceacademy.com/desi...

If you want to purchase our change control procedure (SYS-006), please use the following link: https://medicaldeviceacademy.com/chan...

If you would like to discuss your company's specific situation regarding change control, please schedule a call with me: https://calendly.com/13485cert/30min