C
Hi, I have been lurking for a few years and have to say the information within this forum has been a great resource.
I made a mistake and in my initial QM. I exempted my company from Risk Management. Being a contract manufacture I thought that risk assessment and management was solely the responsibility if the customer.
Well my auditor was happy enough to point out that the standard says "SHALL" and I must perform risk management.
Well where do I start? and how do I implement it? All the information and resources I can find refer to design risk management and long term safety etc...
We are a small shop and I want to make this as simple as possible.
I suppose I could create a checklist, list all a products process and possible failure points.
What I mean is from a manufacturing side would risk be defined as any process or operation failure that could cause the product to not meet customer specifications?
If so, am I not already doing that thru monitoring and measurement of process & products?
And if I were to assign a risk level would they not all be "sever" since any missed operation would cause the product to not meet requirements?
I'm am just really struggling with how to effectively implement this requirement. If any one could point me in the right direction it would be greatly appreciated.
-Chris
I made a mistake and in my initial QM. I exempted my company from Risk Management. Being a contract manufacture I thought that risk assessment and management was solely the responsibility if the customer.
Well my auditor was happy enough to point out that the standard says "SHALL" and I must perform risk management.
Well where do I start? and how do I implement it? All the information and resources I can find refer to design risk management and long term safety etc...
We are a small shop and I want to make this as simple as possible.
I suppose I could create a checklist, list all a products process and possible failure points.
What I mean is from a manufacturing side would risk be defined as any process or operation failure that could cause the product to not meet customer specifications?
If so, am I not already doing that thru monitoring and measurement of process & products?
And if I were to assign a risk level would they not all be "sever" since any missed operation would cause the product to not meet requirements?
I'm am just really struggling with how to effectively implement this requirement. If any one could point me in the right direction it would be greatly appreciated.
-Chris