Completely Revising Documentation - Start Over as Initial Release?

OLD ISO QMS documentation is gone as if they didn't exist

We are working into ISO2k certification, and I understand that we need to update our QMS documentations in compliance to what ISO2k says. We have existing domentations before but what our QA Analyst did was create new documentations and make them all as INITIAL issue. Will not this be an issue during the audit? Making those documents rev. status "as initial issue" might give an impression that we don't have previous documentations. IMO, we need at least to put in the revision history that we change/update the "OLDIES " documentation per new ISO reqmt?

gheghe said:

We are working into ISO2k certification, and I understand that we need to update our QMS documentations in compliance to what ISO2k says. We have existing domentations before but what our QA Analyst did was create new documentations and make them all as INITIAL issue. Will not this be an issue during the audit? Making those documents rev. status "as initial issue" might give an impression that we don't have previous documentations. IMO, we need at least to put in the revision history that we change/update the "OLDIES " documentation per new ISO reqmt?

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It's not quite the way I would have proceeded (I would have made a big point of educating everyone in the organization on WHY), but I don't see anything wrong from a Standards point of view of creating entirely new documentation for everything. It's definitely one way of clearing out any "murky" phrasing from previous issues and may have a lot to do with creating a new document numbering system, format, etc. to go along with the general "makeover" initiated by the consultant.

My first suggestion would be to get an explanation from the Consultant about the motivation.

(I suspect it may have a lot to do with being able to use his preset templates to give everything a similar look and feel.)

Wes Bucey said:

It's not quite the way I would have proceeded (I would have made a big point of educating everyone in the organization on WHY), but I don't see anything wrong from a Standards point of view of creating entirely new documentation for everything.

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Not my route of choice either.... In one way it may in fact become an audit issue. This sounds more like replacing the old system than upgrading it, and auditing a new system would be a bit different from an upgrade audit of an existing one. What would happen if the new system is not ready to fly, and the old one is gone?

Wes Bucey said:

My first suggestion would be to get an explanation from the Consultant about the motivation.

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Absolutley... Same here.

/Claes

We took the chance when updating to 9K2k to review andf update EVRYTHING (Manual, Procedures, Work Instructions & Forms). We redesigned their layout, presentation and access (intranet). Everything started as a new revision.
We now have a new system that has been designed and upgraded by the users into a user friendly system. We are still tweaking some components but it is light years ahead of our old system and in no way linked to the old documents so a new revision status is warranted. All of the old stuff has been electronically archived.
The history of the change can be tracked to a 'Management Review' meeting where it was approved.

Greg B

Greg B said:

We took the chance when updating to 9K2k to review andf update EVRYTHING (Manual, Procedures, Work Instructions & Forms). We redesigned their layout, presentation and access (intranet). Everything started as a new revision.
We now have a new system that has been designed and upgraded by the users into a user friendly system. We are still tweaking some components but it is light years ahead of our old system and in no way linked to the old documents so a new revision status is warranted. All of the old stuff has been electronically archived.
The history of the change can be tracked to a 'Management Review' meeting where it was approved. Greg B

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Right, Greg. The difference, I'll bet, was that your organization told folks within the organization what you were doing. The situation here sounds like Consultant and his organization contact made a unilateral decision with NO EDUCATION to the involved folks - pretty much a big "OOPS" in my book.

Greg B said:

All of the old stuff has been electronically archived.
The history of the change can be tracked to a 'Management Review' meeting where it was approved.

Click to expand...

Right! No problem there.

/Claes

We actually took a similar route when switching from QS to TS - we took the change as an opportunity to look over all our procedures, discard those we didn't need any longer, write some new ones, revise some "keepers." We wrote into our Doc/Data control procedure a quick line or two explaining that with the advent of TS we assigned an "A" revision level to every procedure. Ultimately any revisions are traceable back to the last "QS" revision, so we have traceability and we addressed it in the doc procedure for clarity. We did it more for psychological reaons than anything else, because we were trying to get people to think of this as a new way of looking at things - moving away from procedures in many areas, toward a new way of auditing, etc. So we wanted to sort of force everyone into looking at even "old" procedures as something new, with fresh eyes.

Zat make sense?

SteelWoman said:

We did it more for psychological reaons than anything else, because we were trying to get people to think of this as a new way of looking at things - moving away from procedures in many areas, toward a new way of auditing, etc. So we wanted to sort of force everyone into looking at even "old" procedures as something new, with fresh eyes. Zat make sense?

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Absolutely! I never had a quarrel with the fact of starting over from scratch - my only objection was for not communicating the "WHY" to the troops. If the powers that be had taken care of just that one little detail, gheghe would never have written his post.

The moral of the story is
gheghe's organization fell down on the job of educating the employees.

Wes Bucey said:

It's not quite the way I would have proceeded (I would have made a big point of educating everyone in the organization on WHY), but I don't see anything wrong from a Standards point of view of creating entirely new documentation for everything. It's definitely one way of clearing out any "murky" phrasing from previous issues and may have a lot to do with creating a new document numbering system, format, etc. to go along with the general "makeover" initiated by the consultant.

My first suggestion would be to get an explanation from the Consultant about the motivation.

(I suspect it may have a lot to do with being able to use his preset templates to give everything a similar look and feel.)

Click to expand...

Maybe I am missing something, but where does it say that they used a Consultant (I see QA Analyst) and are we assuming that they did not edeucate/inform the rest of the orginization as to what and why they were doing this? I did gheghe made a comment about adding an explination to the rev history of what they were doing.

SteelWoman said:

We actually took a similar route when switching from QS to TS - we took the change as an opportunity to look over all our procedures, discard those we didn't need any longer, write some new ones, revise some "keepers." We wrote into our Doc/Data control procedure a quick line or two explaining that with the advent of TS we assigned an "A" revision level to every procedure. Ultimately any revisions are traceable back to the last "QS" revision, so we have traceability and we addressed it in the doc procedure for clarity.

Zat make sense?

Click to expand...

This is what exactly I'm telling the ISO coordinator, that at least we have some traceability to look back to the last QMS we had before. The ISO coordinator is requiring us to indicate in the document the history of changes but when it comes to the documents he created, all are Initial Issues.

Wes Bucey said:

Absolutely! I never had a quarrel with the fact of starting over from scratch - my only objection was for not communicating the "WHY" to the troops. If the powers that be had taken care of just that one little detail, gheghe would never have written his post.

The moral of the story is
gheghe's organization fell down on the job of educating the employees.

Click to expand...

I perfectly agree with you Bucey, we're always surprise in here. This ISO coordinator just told us what to do without even explaining why we have to do it, and then the next day he'll change his mind. That's the reason why even little things I post it in here, because this ISO coordinator of ours get me confuse every day. Just an example, in document control procedure, he indicated there that "all documents must have the originators name", if you take a look at our document template /format there's no alloted space for orignator, there's only the approving bodys. When I asked him this is exactly what his answer was " the approving body and originator are the same, I'm the originator and I'm the one who will approved it, even if the document is created by Purchasing dept, I am the originator and that will not be changed".So,if you will take a look at our QMS document, there's one name appear there, and he's also the one approve it(no other parties approved it), I guess Im the only one reacting on the contents of the documents he said created.(ooopps i don't think he created it, they bought this canned system)

Anyway, thanks pals for the input and ideas.