Faux Document Control System - Tear it down or transition?

normzone

Trusted Information Resource
#1
All -

As always, thanks for your inputs.

I'm always reluctant to air my employer's dirty laundry on the internet, but I've a quandary, and figure I may as well come to you folks for advice.

In my new position, with a company with it's first 9001 certificate, I find that my predecessor established a document control system as follows:

1) Engineering controls drawings
2) The QA manager controls all SOPs
3) Everybody else controls their own documentation - each department has a Technical Document Control (TDC) person responsible for anything that doesn't fall under 1) and 2) above.

Unfortunately this document control system was established without informing the players of their responsibilities. Nobody is aware that they are TDC. Each department creates their own uncontrolled documents.

I have begun to remedy this - all the SOPs are being revised, renumbered and transferred to Document Control under Engineering auspices.

But do I leave some of the TDC nonsense stand for the (new) external auditor to discover in January 2014, or do I strip all that language out of the SOPs and let the chips fall where they may?:cfingers:

All advice appreciated...
normzone
 
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John Broomfield

Staff member
Super Moderator
#2
All -

As always, thanks for your inputs.

I'm always reluctant to air my employer's dirty laundry on the internet, but I've a quandary, and figure I may as well come to you folks for advice.

In my new position, with a company with it's first 9001 certificate, I find that my predecessor established a document control system as follows:

1) Engineering controls drawings
2) The QA manager controls all SOPs
3) Everybody else controls their own documentation - each department has a Technical Document Control (TDC) person responsible for anything that doesn't fall under 1) and 2) above.

Unfortunately this document control system was established without informing the players of their responsibilities. Nobody is aware that they are TDC. Each department creates their own uncontrolled documents.

I have begun to remedy this - all the SOPs are being revised, renumbered and transferred to Document Control under Engineering auspices.

But do I leave some of the TDC nonsense stand for the (new) external auditor to discover in January 2014, or do I strip all that language out of the SOPs and let the chips fall where they may?:cfingers:

All advice appreciated...
normzone
normzone,

Resist the temptation to centralize control or to dictate design of the document control process.

First, agree the process objective with the owners of each "sub-process", perhaps along the following lines:

"Valid documented information available to authorized persons as and when required to effectively operate the management system's processes."

Then engage the users of "controlled" documents in a review of how effectively the various schemes fulfill the agreed upon objective. Document the nature and evidence of any failures to fulfill requirements (nonconformities). Agree these nonconformity statements with the users

Then engage the sub-process owners in the redesign of their scheme so each scheme meets the requirements of the users. Document the schemes in the updated document control procedure, review it, approve it and issue it for ongoing use and improvement.

In doing this you may also specify a computerized document management system such as Documentum and for this you would seek management/IT approval while using your in-house schemes.

By engaging the process owners and users (stakeholders) you should end up with more buy-in than if you had redesigned it yourself.

This work should be covered by your corrective action request.

Good luck,

John
 
P

PaulJSmith

#3
But do I leave some of the TDC nonsense stand for the (new) external auditor to discover in January 2014, or do I strip all that language out of the SOPs and let the chips fall where they may?:cfingers:
Not sure why you would want to do that. If you are aware of any problems in your system, you should make every attempt to identify and correct them. There's no need to leave "easter eggs" for your auditor. They'll find plenty of stuff all on their own.

Keep it your goal to make any needed corrections, and there should be no "chips" to fall. As long as you are doing what you should be doing, any competent auditor will recognize that.

Good luck.
 
M

mguilbert

#4
As far as the "TDC nonsense", have they not been notified prior or are they just throwing the previous person under the bus because they do not want the responsibility. Either way you should write an internal Non-conformance and fix this. The issuance of an internal non-conformance will let the external auditor know that the problem has been identified and is being corrected. If I were a CB auditor and I was told by an employee that they knew about the problem prior to the audit, I would issue a Corrective Action for the Corrective Action system not working properly. That is to say a problem was identified with the system but no corrective action was issued.:2cents:

BTW: It is my understanding if an internal non-conformance is issue then an external auditor can not issue one if they notice it.
 
Last edited by a moderator:

normzone

Trusted Information Resource
#5
Okay, running stream of thought here...

Interesting that I've been counseled to avoid centralizing Document Control, that's how I've always experienced it. But [John Broomfield] makes a good case for redefining and shoring up the system my predecessor documented, although the persons responsible for maintaining that system were never defined or trained. And his tactics for how to do it make sense.

The current system strikes me as so uncontrolled that I couldn't rationalize keeping it, but perhaps I need to wrap my head around that. I think I need a smoke...

Thanks -
normzone
 

normzone

Trusted Information Resource
#6
Damn, typed a lot of edited response and lost it...

My first action upon arrival was an internal audit. Several CARs and PARs resulted.

The corrective action system was dysfunctional at best - I've reclaimed it and turned the procedure from a rant into a rational document.

I've been told that my predecessor was not a person who inspired others to work with him. The SOP documents are worded such that all processes hinge around the QA manager if so desired, or they can be handed off to persons undefined and unidentified. I'm cleaning up as I go.

I guess I'll follow the counsel given regarding shoring up the system - I just didn't have the heart to engage in such elaborate redecorating, and was hoping instead to subtly demolish and rebuild.:nope:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Hi Normzone,

Your story reminds me of how often we say here "Congratulations for your certification! Now the real work begins..."

It isn't enviable to walk into a messy system, but you're in good company and you are among friends here.

I want to add that in a past employer there were of course a centrally managed set of procedures etc., but departments were allowed to maintain their own set of lower level documents internally so long as they conformed to all the standards' requirements. Of course internal audits often found issues so NCs would get written, but they did appreciate being allowed to have their own documents and I appreciated their attentively listening when I explained the responsibilities. This method passed many audits for various standards.

I hope this helps!
 

normzone

Trusted Information Resource
#8
Jennifer -

Thanks for the encouragement - It's a new thing for me to wrap my head around, having half a dozen document control horses that I'll need to ride separately, instead of one wagon pulled by a team.
 
W

Wilderness Woody

#9
Okay, running stream of thought here...

Interesting that I've been counseled to avoid centralizing Document Control, that's how I've always experienced it. But [John Broomfield] makes a good case for redefining and shoring up the system my predecessor documented, although the persons responsible for maintaining that system were never defined or trained. And his tactics for how to do it make sense.

The current system strikes me as so uncontrolled that I couldn't rationalize keeping it, but perhaps I need to wrap my head around that. I think I need a smoke...

Thanks -
normzone
It looks like you found a root cause to pull on... now to get a functional core group of process owners to work with you!

A common platform or format for controlled documents can be important for access and consistency, but decentralized responsibility to process owners and their users gives them the buy-in that they should have.

Hey, if the "Graphic Arts" department wants their documentation done in calligraphy, by all means let them and then have them scan their results as a PDF for all to access :lol:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#10
Jennifer -

Thanks for the encouragement - It's a new thing for me to wrap my head around, having half a dozen document control horses that I'll need to ride separately, instead of one wagon pulled by a team.
The group I mentioned was definitely in the minority. My clients since then don't try to pull it off. If the documents can be centrally controlled, it's generally better to do that, especially in a young system.

But I wanted to let you know there are choices that are eventually available to you. What it comes down to is this: are the documents legible? Are changes done by/approved by authorized people? Are the documents people are using up-to-date? How are old versions maintained to make sure the obsolete versions are not confused and used by mistake? Who is in charge of that, and what direction (documented procedure) is available to make sure the next person can get it all done in case Person #1 wins the Powerball?

The control is what matters.
 
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