Fully Electronic Quality Management System - Any Special Considerations to take Note?

[assyrian47]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

Thanks for taking interest in my issue.

The ultimate goal is to get the QMS into a digital format. This includes all documentation, procedures, processes work instructions and related documentation using the Microsoft SharePoint Server Application. This provides the controls that are needed for the manual and associated documents.

Initially we have to have it all in paper. That is the document that will be used for the accreditation process. Within this document we will present our process and workflow to make the manual digital.

I noted that ISO has finally accepted the Adobe pdf format for documentation. This will also enhance my plan to digitize. There are a few smaller issues that have to be addressed, i.e. printing forms for usage in day to day processes until the become fully digital.

 

[JaneB]

This is putting the QMS documents online, not the QMS itself

Thanks for taking interest in my issue.

The ultimate goal is to get the QMS into a digital format. This includes all documentation, procedures, processes work instructions and related documentation using the Microsoft SharePoint Server Application. This provides the controls that are needed for the manual and associated documents.

Initially we have to have it all in paper. That is the document that will be used for the accreditation process. Within this document we will present our process and workflow to make the manual digital.

I noted that ISO has finally accepted the Adobe pdf format for documentation. This will also enhance my plan to digitize. There are a few smaller issues that have to be addressed, i.e. printing forms for usage in day to day processes until the become fully digital.

Interesting. What I hear is that despite the title, you are not really putting the system itself online, you are actually just putting the documentation of your system online.

I don't mean to split hairs here, but a quality management system is more than its documentation. The doco is a part of it, and an important part of the system, but definitely not the system itself.

But congratulations, online doco for a QMS can work very well, & save time that can be put into improvements.

 

[w_grunfeld]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

I see no problem with watermark except I'd add not only that printed copies are uncontrolled but also that the 'master' is the electronic version located at :<full path on the intranet/shared folder on server>
So if someone shows an auditor an outdated printed version the worse is a write-up against that peson rather than a systemic problem

 

[Helmut Jilling]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

I see no problem with watermark except I'd add not only that printed copies are uncontrolled but also that the 'master' is the electronic version located at :<full path on the intranet/shared folder on server>
So if someone shows an auditor an outdated printed version the worse is a write-up against that peson rather than a systemic problem

That is a good point. The key control is not that it is an electronic copy, but THE correct, controlled elctronic copy in the correct, controlled location. A footer helps identify whether people are cheating the system.

"Paper copies are uncontrolled" sounds safe, but remember there will be some need for some paper copies. You can't just uncontrol these. There must be a valid method to manage those. But, I think you are on the right track.

 

[kreco]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

I see no problem with watermark except I'd add not only that printed copies are uncontrolled but also that the 'master' is the electronic version located at :<full path on the intranet/shared folder on server>
So if someone shows an auditor an outdated printed version the worse is a write-up against that peson rather than a systemic problem

Our standard blurb on all of our printed work instructions states "Printed copies are for reference only. The revision must be verified PRIOR TO USE". I used this for many years at a company that was AS 9100, ISO 9001, TS 16949 & ISO 14000 and not one auditor had issues with it.

We had our Quality Manual, Level II docs, Level III docs, forms, CAPA system, process control information, engineering drawings & specs, quality test reports, audit results/reports, RMAs, accounting credits, PO Reqs, online training tutorials and numerous other things online. It really was well received from both auditors and customers.

We did try to emphasize during training that paper copies should be used sparingly (like during training) and that they *should* be discarded after use, but if they wanted to retain copies it was their responsibility to verify the rev prior to use. And we always tried to tell them to reference the online version during audits.

The fact of the matter is that operators etc will need to print some of the instructions since not all of the tasks can easily be conducted in front of a computer terminal.

 

[Helmut Jilling]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

Our standard blurb on all of our printed work instructions states "Printed copies are for reference only. The revision must be verified PRIOR TO USE". I used this for many years at a company that was AS 9100, ISO 9001, TS 16949 & ISO 14000 and not one auditor had issues with it.

We had our Quality Manual, Level II docs, Level III docs, forms, CAPA system, process control information, engineering drawings & specs, quality test reports, audit results/reports, RMAs, accounting credits, PO Reqs, online training tutorials and numerous other things online. It really was well received from both auditors and customers.

We did try to emphasize during training that paper copies should be used sparingly (like during training) and that they *should* be discarded after use, but if they wanted to retain copies it was their responsibility to verify the rev prior to use. And we always tried to tell them to reference the online version during audits.

The fact of the matter is that operators etc will need to print some of the instructions since not all of the tasks can easily be conducted in front of a computer terminal.

The only concern I would have as an auditor is I doubt people are really "verifying before use." Not likely this is happening, so it would liekly lead to some issues eventually.

2 things may help:

1. Encourage people to refer to the electronic version whenever possible. That solves a lot of the issues, by eliminating most paper.

2. Some docs probably should be controlled, like the operator instructions you mentioned.

 

[w_grunfeld]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

The only concern I would have as an auditor is I doubt people are really "verifying before use." Not likely this is happening, so it would liekly lead to some issues eventually.

2 things may help:

1. Encourage people to refer to the electronic version whenever possible. That solves a lot of the issues, by eliminating most paper.

2. Some docs probably should be controlled, like the operator instructions you mentioned.

Marc,
Your last comment seems to imply that after all you don't trust electronic control as discussed in the previous messages as being "real control". How else should I understand your comment that "some" documents should be controlled?[nevertheless] No control is fool-proof or idiot proof, if that operator instruction is blue-stamped , blue signed and dated by some archaic DCC (Document Control Center) you can still not be sure it wasn't revised one hour after the "certified" print was issued. Why is that more "controlled" than a print that says "verify before use"? That verification can be done with two or three clicks at any computer terminal within the organization. If you don't trust users doing that, how do you trust an operator will tighten a screw to x.y lbs-inch, just because the blue-print says so? There is no end to mistrust and to what operators may or may not do....
I think an auditor's job is to verify that a system is in place and used as written, not that every single person in the organization doesn't ever err or take a short cut....

 

[Helmut Jilling]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

Marc,
Your last comment seems to imply that after all you don't trust electronic control as discussed in the previous messages as being "real control". How else should I understand your comment that "some" documents should be controlled?[nevertheless] No control is fool-proof or idiot proof, if that operator instruction is blue-stamped , blue signed and dated by some archaic DCC (Document Control Center) you can still not be sure it wasn't revised one hour after the "certified" print was issued. Why is that more "controlled" than a print that says "verify before use"? That verification can be done with two or three clicks at any computer terminal within the organization. If you don't trust users doing that, how do you trust an operator will tighten a screw to x.y lbs-inch, just because the blue-print says so? There is no end to mistrust and to what operators may or may not do....
I think an auditor's job is to verify that a system is in place and used as written, not that every single person in the organization doesn't ever err or take a short cut....

I agree. It isn't more controlled, and I do not recommend the "blue stamp method." Perhaps you misunderstood my comment.

I like electronic control and recommend it highly. But not for every type of document. It won't work for some document types, because 100-200 people in a company simply will not "verify before use" everytime. It is just practical common sense. And, it might be a terrible waste of time if everyone did spend a lot of time verifying things. It is more effective if just a few people control that.

I control almost everything. And, I do it with little effort.

I think most secondary documents, could be accessed electronically. That simplifies a lot of doc control right there. If you don't use it often, look it up electronically. Don't file a paper copy. That way you know you are using the latest version without any effort.

Primary instructions, and things used often, should be controlled more formally, so people know it is up to date and don't waste time looking things up, or making unauthorized copies.

If you can make a 100% electronic system work for you, that would be great. I just see too many examples where it does not quite work, and they end up taking it apart after a year or so.

 

[LR Mitchell]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

We have attempted to go paperless with some success. It seems there is alot of resistance to accessing information on the computer. Not everyone has become computer literate and are terrified to go near one. I control documents at our manufacturing facility and have watermarks or footers that print "Considered UNCONTROLLED unless attached to a Control Binder or verified per (our) LAN system." which shows on printed copies. We discourage printing of any of the controlled documents unless absolutely necessary. We still have about 40 control binders on the shop floor and are slowing placing computers at all workstations for paperless access. So far, we have managed to pass our continuous assessments without any nonconformances. :

 

[Helmut Jilling]

Re: Fully Electronic Quality Management System - Any Special Considerations to take N

We have attempted to go paperless with some success. It seems there is alot of resistance to accessing information on the computer. Not everyone has become computer literate and are terrified to go near one. I control documents at our manufacturing facility and have watermarks or footers that print "Considered UNCONTROLLED unless attached to a Control Binder or verified per (our) LAN system." which shows on printed copies. We discourage printing of any of the controlled documents unless absolutely necessary. We still have about 40 control binders on the shop floor and are slowing placing computers at all workstations for paperless access. So far, we have managed to pass our continuous assessments without any nonconformances. :

Congratulations on your success. Personally, I would go slow on the shop floor part, but it sounds like you are doing well.