O
orangeisenergy
Hello Covers,
I am tasked with updating our D&D process to better reflect all the different ways that we can do D&D activities. We currently have a "one size fits all" process, which is too robust for most of our activities. We manufacture IVDD tests. Some of these are for clinical, but most are veterinary or environmental. But we do all our activities to the ISO standard (for clinical). Many of our new tests are variations of our current tests, but according to our current process, they have to follow all the steps of our D&D process. I would like to edit our process to allow for a less paperwork intensive D&D process for a variation on a current product (i.e. use the groundwork of the base product, and carry out product specific testing and validation - but the design groundwork is already there from the similar product), but can't figure out how to get this across properly, or if it is appropriate. Have any of you done or seen a D&D process in this manner?
Also with our ISO 13485 certified QMS, could we do things differently for our products not covered under our ISO certification scope (i.e. veterinary & environmental products)-i.e. simplify process for this division of products - as long as it is clearly defined in our QMS?
I appreciate the feedback!
I am tasked with updating our D&D process to better reflect all the different ways that we can do D&D activities. We currently have a "one size fits all" process, which is too robust for most of our activities. We manufacture IVDD tests. Some of these are for clinical, but most are veterinary or environmental. But we do all our activities to the ISO standard (for clinical). Many of our new tests are variations of our current tests, but according to our current process, they have to follow all the steps of our D&D process. I would like to edit our process to allow for a less paperwork intensive D&D process for a variation on a current product (i.e. use the groundwork of the base product, and carry out product specific testing and validation - but the design groundwork is already there from the similar product), but can't figure out how to get this across properly, or if it is appropriate. Have any of you done or seen a D&D process in this manner?
Also with our ISO 13485 certified QMS, could we do things differently for our products not covered under our ISO certification scope (i.e. veterinary & environmental products)-i.e. simplify process for this division of products - as long as it is clearly defined in our QMS?
I appreciate the feedback!