Using Unreleased Documents & Process Maps for Internal Audit purposes

#1
This may be a no brainer for seasoned ISO 9001 pros, but since I have less than two years under my belt and I have no access to the previous QMS Manager, I'm on my own. Our company has one file that contains all 20 Process Maps for our QMS. As I was about to start a round of Internal Audits, I asked all Process Owners to update their maps (many were out of date and inaccurate). This document has been in a workflow over a month and all owners have not reviewed (I have tried to expedite). I continued with the audits and told Internal Auditors to use the map from the unreleased document--this allowed them to audit against any changes pro-active owners made to their maps. In a meeting this week in preparation for our Management Review Meeting, I mentioned what I did--used unreleased process map. I had one owner pitch a fit so I explained my reasoning for using the unreleased document. The explanation was not accepted.

I realize there are several issues here, but I would like an opinion on unreleased document. Was it wrong to use the Process Maps that were changed by owners--even though the complete document was not released? Our review/approval software can generate a list showing when people signoff, so I have evidence the pro-active owners reviewed and approved their map. Of course another owner could change a map that isn't theirs, but I would hope a level of professionalism could be assumed.
 
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Jim Wynne

Staff member
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#2
First, don't conflate the process with the document that describes it. The map is not the territory. That said, I don't think that what you did is much of a problem. In fact, when processes are changed, I think it's a good idea to run them in "beta" fashion before finalizing the documentation. In this scenario, the changed process would be audited to ensure that it's running in accordance with the new requirements, and that the new requirements are what's needed or expected.
 
#3
First, don't conflate the process with the document that describes it. The map is not the territory. That said, I don't think that what you did is much of a problem. In fact, when processes are changed, I think it's a good idea to run them in "beta" fashion before finalizing the documentation. In this scenario, the changed process would be audited to ensure that it's running in accordance with the new requirements, and that the new requirements are what's needed or expected.
Thank you Jim. I appreciate your perspective and insight.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
I think it's a good idea to run them in "beta" fashion before finalizing the documentation..
In complete agreement with Jim. Just like some organizations run products in low volume mode, before transitioning from prototyping stage into (large) volume production, it is totally appropriate to run a process in a trial mode, to ascertain if there are any unexpected risks not visualized by the process owner(s). But, each process owner should have informed you if the processes have been running in accordance with the draft process maps or not, as they might have good reason on why the "revised processes" are not in effect yet. If that were the case, the internal audits should not be performed against a process map that has not been put in operation.

You might also want to consider to split the process maps into separate documents; that way, one process owner that procrastinates does not hold up the whole document.
 

John C. Abnet

Teacher, sensei, kennari
#6
Good day @Buckeye001 ;
You have received some good council from @Jim Wynne and @Sidney Vianna .

Please allow me to add that is important to ensure that management systems first and foremost serve the organization. It may be presumptuous of me, but based on the information in your original post it sounds as if you may have been handed a cumbersome system that was created more for the auditor than for your organization and teams. This is not to imply that establishing and maintaining an effective management system does not require cooperation and effort, however, those working within the framework of the management system (ESPECIALLY leadership ...including process owners) should see the benefits of the management system and their efforts therein. It sounds as if the process owners you speak of may not necessarily see the benefit of their efforts and may indeed see any efforts towards maintaining the management system as OTHER work and not congruent with their daily roles and tasks. If a monster has been created then there will be considerable push back from those being asked to feed that monster.

Hope this helps.
Be well.
 

Kronos147

Trusted Information Resource
#7
If an organization was diligent enough to vet new docs with a special or internal audit, I would consider that a positive. It's basically a risk assessment at that point too.

You may want to review the document policy to make sure these unapproved docs meet your internal document requirements. If not, you may need to modify your policy.
 
#8
Question. Did the team issue audit findings against the unreleased documents?
The Team DID NOT issue audit Findings against the unreleased document. Having told the Internal Auditors prior to the audits that this document was not released, I think they saw I was giving a "pass." I have been working with all the Process Owners to get the Process Maps completed prior to the end of Internal Audits. And, since I am signing off on all the audits, I have been verifying the maps are completed before I sign off on the reports. But your comment gives me an idea for "next time"- I could issuing a Finding for POs that are not expeditious with document review/revision approval.
 
#9
Good day @Buckeye001 ;
You have received some good council from @Jim Wynne and @Sidney Vianna .

Please allow me to add that is important to ensure that management systems first and foremost serve the organization. It may be presumptuous of me, but based on the information in your original post it sounds as if you may have been handed a cumbersome system that was created more for the auditor than for your organization and teams. This is not to imply that establishing and maintaining an effective management system does not require cooperation and effort, however, those working within the framework of the management system (ESPECIALLY leadership ...including process owners) should see the benefits of the management system and their efforts therein. It sounds as if the process owners you speak of may not necessarily see the benefit of their efforts and may indeed see any efforts towards maintaining the management system as OTHER work and not congruent with their daily roles and tasks. If a monster has been created then there will be considerable push back from those being asked to feed that monster.

Hope this helps.
Be well.
Thank you for the feedback. You've hit the nail (or monster) on the head. Not all the POs see the benefit of ISO 9001 and use the daily responsibilities to forgo completing tasks related to the QMS. I am trying to build sufficient knowledge and credibility to garner true support from executive management- some of which are POs.
 
#10
If an organization was diligent enough to vet new docs with a special or internal audit, I would consider that a positive. It's basically a risk assessment at that point too.

You may want to review the document policy to make sure these unapproved docs meet your internal document requirements. If not, you may need to modify your policy.
Thank you for the advice. Our internal procedures do not specifically state what documents can or "shall be" used. This is a good point and I need to revise the procedure to identify any exceptions (that do not affect the intent of the QMS) that can be used.
 
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