How is your BMS (Business Management System) evolving?

RoxaneB

Change Agent and Data Storyteller
Super Moderator
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! :rolleyes:

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. :magic:

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! :applause:

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. :D 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?
 
Whoop....

Sounds like a job well done there, Rox.:agree1:
RCBeyette said:
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?
Oh yes, we still have systematic issues, but not to the extent we used to.:lol: Nit-picking is on the rise...

As a matter of fact I just finished my yearly summarys of our audits and of the system as a whole. More or less everything is moving in the right direction, so I'm happy.

/Claes
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
Claes Gefvenberg said:
Sounds like a job well done there, Rox.:agree1: Oh yes, we still have systematic issues, but not to the extent we used to.:lol: Nit-picking is on the rise...

As a matter of fact I just finished my yearly summarys of our audits and of the system as a whole. More or less everything is moving in the right direction, so I'm happy.

Claes, if I may ask, what kind of systematic issues are you still finding? Are there any trends in the audit results? I track the process that a finding/OFI is issued against, as well as the clause/subclause. I will also look at any findings issued against documentation to see if there is a particular Document Author that needs a visit from me. *insert Darth Vader music here*

Over the past couple of years, the findings have not only been less systematic, they've branched off into those little dark nooks and crannies of our BMS that were seldom investigated in the past. Places like H&S and Engineering - but as these areas piggy-back the BMS very closely, the nit-pick details are quickly resolved.

The Registrars also indicated that they want to see NCRs closed in a more timely manner. They said that only 20%-30% should be above our allowable triggers.

  • NCs (minors) Pending > 45 days
  • CARs/PARs Pending > 90 days (i.e., with actions pending...Pending Verification or Ready to Close are NA to trigger)
  • OFIs Pending Analysis > 14 days
  • OFIs Approved and Open > 60 days

The issue here is that our current NCR system allows for more than product-based issues and Internal/External Audit findings. Everything from department-noticed trends...it's a pretty full system and actively used (which is good). But sometimes actions are not controllable us. We may be waiting for information from a vendor or waiting for shut-down or stuff like that. Most of why our numbers are higher than the 30% (2004 results were 46% over the trigger points) because of vendors or shut-downs.
 
RCBeyette said:
Claes, if I may ask, what kind of systematic issues are you still finding? Are there any trends in the audit results?
Well, one of the things I see on a regular basis is training issues including introduction of new staff. Corners are sometimes cut, but as I said, these things are not of the magnitude they used to be. The audits are more and more becoming the improvement tool they should be.

/Claes
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
Claes Gefvenberg said:
Well, one of the things I see on a regular basis is training issues including introduction of new staff. Corners are sometimes cut, but as I said, these things are not of the magnitude they used to be. The audits are more and more becoming the improvement tool they should be.

Training used to be a big deal here, too....or concern, rather. For the most part, though, it is now under control. We had an issue with it during the audit (i.e., missing evidence that the individual was actually trained and the computer database was not updated for the sake of updating), but were able to provide evidence of why the evidence was not available (i.e., archived computer records).
 
M

M Greenaway

Word of advice - don tlet your external auditor set your process performance objectives, to suggest that 20 to 30% of NCR's should be above a 'trigger level' is nonsense !!
 
L

little__cee

Congrats

RCBeyette said:
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.
First of all, congratulations. :applause:

Second, could you please share the Quality Planning checklist?
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
little__cee said:
First of all, congratulations. :applause:

Second, could you please share the Quality Planning checklist?

Thanks! :eek: I'm in the middle of training right now, but I'll email it to you by week's end. :)

M Greenaway said:
Word of advice - don tlet your external auditor set your process performance objectives, to suggest that 20 to 30% of NCR's should be above a 'trigger level' is nonsense !!

Yeah, that's what I was thinking, too, but that wasn't the place to start the argument....err...debate. :)
 

Govind

Super Moderator
Leader
Super Moderator
Design for Scalability

RCBeyette said:
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?

RCB,
There is always room for improvement in any organization’s BMS however mature they are. At this point, I would also focus on reviewing the existing BMS and adding improvements to make it Scalable upwards and downwards.

Ask yourself questions like, if the Organization ramps up multiple times the current volume, recruit twice the employee strength, expand horizontally into other product families; will the system cater?

and the exact reverse: Downsizing scenario, will the system sustain?

By (re) designing a system scalable in either directions, you can maintain the effectiveness and integrity of the system without spreading thin.

Wes and I had a productive discussion in ASQ Board some time ago in the very same topic. Hope I did not distract the flow of this thread.

Regards,
Govind.
 
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