Realization processes input into overall risk

[Igor Guba]

By referring to safety test results and we are proving that the Design of the device is safe enough. Then we need to duplicate this design into lots of serial devices by conducting product realization processes (manufacturing + distribution). It means that the final product put into market may be different from the original design and the Devise Under Test.
I need somehow consider the possible effect of the production and distribution processes on the safety of the finished product. At first I was thinking about adding production "step" into each chain of events potentially leading to harm. Say, we have an electrical device and a user is protected by electro insulation on the wires. One day Mr. X at the production area misplaced the marking labels for wires. And another day Mr. Y used the wrong wire (with insufficient insulation) during the device assembly process. As a result - user gets a potentially dangerous equipment.
Then I realized that since our whole production process is covered by ISO 13485 Quality Management System I do not need to consider every possible production quality fault.
So now my idea is to add a section "Realization processes associated risks" into Risk Management Review and state that all production and distribution processes are under control of the certified QMS so the overall production risk is negligible.
What do you think?

 

[yodon]

since our whole production process is covered by ISO 13485 Quality Management System I do not need to consider every possible production quality fault

How do you see that being 'covered' by ISO 13485 will eliminate faults?

What I see as typical is that the manufacturing process for the device undergoes a Process FMEA. This identifies where faults might occur and allows you to add controls to minimize the likelihood that they occur. It also helps you define what your in-process and final acceptance tests are.

In essence, you can't just ride your certification to safety, you need to be actively ensuring it.

 

[Tidge]

I think you only need to consider those production faults that could lead to risk for patients and users. If you do not, you will be in for unpleasant times ahead.

If you do go ahead and consider production faults as contributing to patient/user risk, and identify "ISO 13485 certification" as your risk control... be prepared to have some evidence of the effectiveness of that risk control for the specific failure modes identified.