1. I keep reading, "you're probably already doing it since the standard has always implicitly required it. It just makes it more explicit now." If that's the case, then what exactly needs to be changed?
2. I don't know if this will be worded properly, but we've already "approached" our processes, meaning we've already implemented all of our processes, so is the standard now requiring to retrospectively do a risk-analysis on those processes? We do not have documented risk-analysis on our processes, but I believe we already have many risk-mitigation tools in place (i.e. control plans, first piece, in-process, and final inspection sheets, work routers, PMs, change orders, contract review, etc.). I just don't know if all of this is enough to fulfill the heightened risk requirements.
3. Some of our processes are risk-mitigation activities themselves, such as change orders, contract review, inspection, etc. Do we then have to do a risk-analysis on the risk mitigation activities? On that note, risk management is a process in itself, so do we then have to do a risk-analysis on the risk management process?
4. Which leads me to the question: am I getting too detailed with my QMS process? Should they be more high level, such as Production and Purchasing?
5. Am I overthinking everything?
6. What major changes have you implemented at your company to follow the new 2016 standard?
Thank you all.
2. I don't know if this will be worded properly, but we've already "approached" our processes, meaning we've already implemented all of our processes, so is the standard now requiring to retrospectively do a risk-analysis on those processes? We do not have documented risk-analysis on our processes, but I believe we already have many risk-mitigation tools in place (i.e. control plans, first piece, in-process, and final inspection sheets, work routers, PMs, change orders, contract review, etc.). I just don't know if all of this is enough to fulfill the heightened risk requirements.
3. Some of our processes are risk-mitigation activities themselves, such as change orders, contract review, inspection, etc. Do we then have to do a risk-analysis on the risk mitigation activities? On that note, risk management is a process in itself, so do we then have to do a risk-analysis on the risk management process?
4. Which leads me to the question: am I getting too detailed with my QMS process? Should they be more high level, such as Production and Purchasing?
5. Am I overthinking everything?
6. What major changes have you implemented at your company to follow the new 2016 standard?
Thank you all.