Hello everyone. I first off want to say this is a great forum with a wealth of information.
I just recently transferred to a Quality Engineer position from R&D. I've been asked to take over some shelf life studies that have been idle for quite sometime now. Currently, I'm assigned to complete 6 shelf life studies.
We have an issue of an overall system to keep track of the various shelf life studies. Currently there isn't a system. It is pretty much whoever is responsible for the aging study, they handle all communication with the Outside Testing Laboratory. Now we have ran into issues for various reasons: Turnover within the company, lack of system, lack of priorities, etc.
I'm curious to find out what are the systems out there everyone is using for their shelf life studies. Below are some of the issues we are having:
The team was talking in regards to using tools like Microsoft outlook to create a specific email address to send all communications to and also using it for reminders. But again, there isn't a system in place.
Any help or suggestions would be greatly appreciated! Thank you in advance!
I just recently transferred to a Quality Engineer position from R&D. I've been asked to take over some shelf life studies that have been idle for quite sometime now. Currently, I'm assigned to complete 6 shelf life studies.
We have an issue of an overall system to keep track of the various shelf life studies. Currently there isn't a system. It is pretty much whoever is responsible for the aging study, they handle all communication with the Outside Testing Laboratory. Now we have ran into issues for various reasons: Turnover within the company, lack of system, lack of priorities, etc.
I'm curious to find out what are the systems out there everyone is using for their shelf life studies. Below are some of the issues we are having:
- Can't find documentation - Sterilization reports, gross leak tests, seal strength tests, etc
- No designated area for storage of samples and no system to keep track of samples
- Lack of priority - There is no set time to complete studies so motivation to complete ASAP isn't there
The team was talking in regards to using tools like Microsoft outlook to create a specific email address to send all communications to and also using it for reminders. But again, there isn't a system in place.
Any help or suggestions would be greatly appreciated! Thank you in advance!
