wrensch

Involved In Discussions
#1
Hey everyone,

I lead the Quality and Regulatory department for a medical device company and am interested in understanding what department or organizational umbrella environmental related product compliance (RoHS, REACH, Prop 65 etc) responsibilities generally fall under in other companies. Because they are regulations the assumption is usually that my department owns them. If I find that is usual and customary I will embrace it but if I find its not it will help me push back and spare my very limited resource. Thanks in advance for any feedback!
 

JoshuaFroud

Involved In Discussions
#2
Hi Wrensch,

Where I currently work, we make capital equipment, the environmental product compliance is handled by R&D and Sourcing, in that R&D designs the equipment compliant and sourcing purchases only approved items from approved suppliers.
This could also be an artefact of company size (<50 employees) and there only being me on Quality and Regulatory as a full time position.
 

John Broomfield

Fully retired...
#3
Design.

Ask the owners of your organization’s product and service design processes how they address these requirements.

First build a relationship with the process owners by respectfully studying and understanding their processes as they are.

They may appreciate your help in staying up to date on these regulations.
 

wrensch

Involved In Discussions
#4
Hi Wrensch,

Where I currently work, we make capital equipment, the environmental product compliance is handled by R&D and Sourcing, in that R&D designs the equipment compliant and sourcing purchases only approved items from approved suppliers.
This could also be an artefact of company size (<50 employees) and there only being me on Quality and Regulatory as a full time position.
Thank you Joshua!
 

wrensch

Involved In Discussions
#5
Design.

Ask the owners of your organization’s product and service design processes how they address these requirements.

First build a relationship with the process owners by respectfully studying and understanding their processes as they are.

They may appreciate your help in staying up to date on these regulations.
Thanks John. I don't mind staying up to date on regulations and interpreting applicability to our products. The problem that I encounter is that when these types of regulations come up and I determine that they do apply to us the owners of the product and service design processes think that the QA/RA department should lead the project for compliance.
 
Top