M
Hello-
A little background on us, we are a medical device job shop. We are registered to 13488 and are transitioning to 13485.
We are currently addressing risk assessment, as it applies to us, so we are looking at the risk to business, since we do not always know the use of the components that we work on.
That said we have decided to focus on assessing risk once a project becomes a transition/production process. In our flow we have R&D =>Transition=>Production.
I was wondering if anyone is facing the same struggle that we are and how have you addressed this?
Any help and/or examples would be greatly appreciated.
Thanks in advance.
Mark Benton
A little background on us, we are a medical device job shop. We are registered to 13488 and are transitioning to 13485.
We are currently addressing risk assessment, as it applies to us, so we are looking at the risk to business, since we do not always know the use of the components that we work on.
That said we have decided to focus on assessing risk once a project becomes a transition/production process. In our flow we have R&D =>Transition=>Production.
I was wondering if anyone is facing the same struggle that we are and how have you addressed this?
Any help and/or examples would be greatly appreciated.
Thanks in advance.
Mark Benton