Q
QA-RA Jones
All:
I recently started a position with a manufacturing company of medical devices. They have process sheets/routers/work instructions in place for every job that runs through the shop. When I arrived in this position there were several of these routers sitting in a box that were missing signatures for applicable steps (even though they say that the step was definitely completed), dates for the work completed, changes in quantities throughout that were not explained or associated to NCMRs, etc. At this point, some of these routers are 1-4 yrs old and have never been closed out due to these documentation gaps.
How can I move to close these out? Can I create a Letter to File to close the routers without the applicable information?
Any thoughts on this would be appreciated! Thank you!
I recently started a position with a manufacturing company of medical devices. They have process sheets/routers/work instructions in place for every job that runs through the shop. When I arrived in this position there were several of these routers sitting in a box that were missing signatures for applicable steps (even though they say that the step was definitely completed), dates for the work completed, changes in quantities throughout that were not explained or associated to NCMRs, etc. At this point, some of these routers are 1-4 yrs old and have never been closed out due to these documentation gaps.
How can I move to close these out? Can I create a Letter to File to close the routers without the applicable information?
Any thoughts on this would be appreciated! Thank you!