Well, folks, last week my facility hit a milestone (so to speak)...Surveillance Audit #10. We have been registered to ISO 9001 (originally, 9002 thought) since May 19, 1998.
Over time, our system has evolved in a continual improvement manner (at least I like to think it has....especially since I took it over...yes, this is Roxane's chance to toot her own horn). And last week, with SA#10, we hit a secondary milestone....0 findings. Can I get a whoop!whoop!
Truth be told, there were 2 teeny, weeny, itsy bitsy (yellow polka dot?!?!) issues at the end of Day 1, but with a quick wave my magic wand, they were addressed, documentation and records provided and they were no longer an issue.
We did walk away with 4 Opportunities for Improvement, as well, and for once I'm glad to say that these are OFI's with some weight behind them!
Our Auditors indicated that when a system reaches the age/maturity such as ours, they stop focusing on documentation and records, and look more towards the effectiveness of the process. Okay, personnally, who are they to tell us if our processes are effective or not?? But still, they make a valid point...over the course of the past few years, our findings (from Internal and External audits) have been less with systematic issues and more on the detailed stuff. While this evolution has been happening, our OFI's are increasing in value...they've become more meaninful, real Opportunities for Improvement.
An additional item noted to us by our Registrar - unsure if this is unique to them or if all will be doing this - but they will be looking to ensure that any items they issue (be it an NCR or an OFI) are entered into the organization's Internal NCR system. This was said with a strong *wink*wink*nudge*nudge* from the Auditors, as if they were giving me the key to the city with this information. As we were already in our Internal NCR system, I filtered for EA (External Audit) and promptly demonstrated how that has been part of our system since the very beginning. Next topic, please.
It was great fun when it came time to discuss system changes since the last audit. The Auditors love our Quality Planning checklist, citing that they seldom see such a tool used for issues beyond ISO 9001:2000 concerns. We use ours for everything from new software to new technology to new products to new processes. But I managed to say that nothing new had really changed to system in the past nine months or so.
For the next audit, though, I gave them a heads up to bring a pen with lots of ink. We're going to have some changes coming out the wazoo. And I was able to demonstrate how we are controlling the implementations, the plans for implementation, and our current status.
So, for those of you who have experience with a mature Business Management System (note...Business....not just Quality!), how do you find the evolution it progressing? Do you still experience systematic issues? Or have you moved on to the nit-pick details?
What are your next steps? The Continual Improvement cycle is just that...a never-ending circle of Plan-Do-Check-Act. Do you find yourself struggling to find new areas to focus on? Or is CI so ingrained into your BMS that you can barely keep up with Improvements and Innovations?
Over time, our system has evolved in a continual improvement manner (at least I like to think it has....especially since I took it over...yes, this is Roxane's chance to toot her own horn). And last week, with SA#10, we hit a secondary milestone....0 findings. Can I get a whoop!whoop!
Truth be told, there were 2 teeny, weeny, itsy bitsy (yellow polka dot?!?!) issues at the end of Day 1, but with a quick wave my magic wand, they were addressed, documentation and records provided and they were no longer an issue.
We did walk away with 4 Opportunities for Improvement, as well, and for once I'm glad to say that these are OFI's with some weight behind them!
Our Auditors indicated that when a system reaches the age/maturity such as ours, they stop focusing on documentation and records, and look more towards the effectiveness of the process. Okay, personnally, who are they to tell us if our processes are effective or not?? But still, they make a valid point...over the course of the past few years, our findings (from Internal and External audits) have been less with systematic issues and more on the detailed stuff. While this evolution has been happening, our OFI's are increasing in value...they've become more meaninful, real Opportunities for Improvement.
An additional item noted to us by our Registrar - unsure if this is unique to them or if all will be doing this - but they will be looking to ensure that any items they issue (be it an NCR or an OFI) are entered into the organization's Internal NCR system. This was said with a strong *wink*wink*nudge*nudge* from the Auditors, as if they were giving me the key to the city with this information. As we were already in our Internal NCR system, I filtered for EA (External Audit) and promptly demonstrated how that has been part of our system since the very beginning. Next topic, please.
It was great fun when it came time to discuss system changes since the last audit. The Auditors love our Quality Planning checklist, citing that they seldom see such a tool used for issues beyond ISO 9001:2000 concerns. We use ours for everything from new software to new technology to new products to new processes. But I managed to say that nothing new had really changed to system in the past nine months or so.
For the next audit, though, I gave them a heads up to bring a pen with lots of ink. We're going to have some changes coming out the wazoo. And I was able to demonstrate how we are controlling the implementations, the plans for implementation, and our current status.
So, for those of you who have experience with a mature Business Management System (note...Business....not just Quality!), how do you find the evolution it progressing? Do you still experience systematic issues? Or have you moved on to the nit-pick details?
What are your next steps? The Continual Improvement cycle is just that...a never-ending circle of Plan-Do-Check-Act. Do you find yourself struggling to find new areas to focus on? Or is CI so ingrained into your BMS that you can barely keep up with Improvements and Innovations?