Risk Management Process, How far do I need to go?

[Niber]

It's about interfaces to customer risk analysis. Make sure two things:

• that you know which product characteristics are related to safety or customer important function and
• Inform customer if you detect a possible impact of your process on the final customer.

Example: you may use fluids in your process that customer designers have never taught of and might interfere with whatever the device is supposed to do.

 

[cjwillenborg]

First Time Poster
I work at a manufacturing facility that makes medical devices - we are a contact facility, meaning we do not design the product. As far as risk management goes, i cant really say much about anything else other then our production processes/human errors -- would it be necessary for me to go beyond -- such as an effect to end user?

Hi Melissa. Did you ever come up with anything? I am in this exact situation now, would love an example if you have it completed.

 

[Melissa]

Hi Melissa. Did you ever come up with anything? I am in this exact situation now, would love an example if you have it completed.

Unfortunately I am still working on it. I would love to collaborate!!

 

[Melissa]

Hi Melissa. Did you ever come up with anything? I am in this exact situation now, would love an example if you have it completed.

you are a contract mfg as well?