First, my complements and gratitude to all - I have learned quite a bit from reading in the forums and I appreciate having the opportunity to learn from others experiences.
Secondly, I am a newby, both to the forums and to Quality Systems in general. I have a few clues (thanks to you) but little else.
I am working with document control software based on Lotus Notes Applications (databases). The software comes configured 'out-of-the-box' so that users (document initiators or drafters) can specify who is to review and approve the document. Multiple reviwers can be specified and the workflow default is draft->document controller->initial approver->reviewer(s)->final approver->document contoller->completed. So far, so good.
Here's my issue: Who should be able to /have rights to edit the documents? As the software is configured, the default is that anyone can edit the document anywhere along the workflow routing. In other words, a document can start out with a specific intent and objective but get derailed at any point along the way. Since there are provisions to reject or "send back" documents to the previous phase (requiring comments), it would seem to me that the document should be protected from editing except by the author. Any ideas?

The WHO, WHY, WHEN, WHERE and HOW with regards to document change/control should be found in your document control procedure. Have a look!

Regards.

First, my complements and gratitude to all - I have learned quite a bit from reading in the forums and I appreciate having the opportunity to learn from others experiences.
Secondly, I am a newby, both to the forums and to Quality Systems in general. I have a few clues (thanks to you) but little else.
I am working with document control software based on Lotus Notes Applications (databases). The software comes configured 'out-of-the-box' so that users (document initiators or drafters) can specify who is to review and approve the document. Multiple reviwers can be specified and the workflow default is draft->document controller->initial approver->reviewer(s)->final approver->document contoller->completed. So far, so good.
Here's my issue: Who should be able to /have rights to edit the documents? As the software is configured, the default is that anyone can edit the document anywhere along the workflow routing. In other words, a document can start out with a specific intent and objective but get derailed at any point along the way. Since there are provisions to reject or "send back" documents to the previous phase (requiring comments), it would seem to me that the document should be protected from editing except by the author. Any ideas?In m experience, regardless if the document is paper, videotape, or electronic foo foo dust, the original author writes/rewrites the document and reviewers have rights to "redline" a document for return back to original author. The original author may "argue" over the suggestions and the string of reviewers/approvers ultimately settle on a consensus final document for approval.

The critical issue of allowing other than the original author to make a fixed version of the document always hinges on the audit trail to show who exactly is responsible for a change and whether that change is unilateral or goes through a chain of review/approval by others before release.

Congrats on making your first post, METerry. :applause:

My organization uses IBS (formally called QSI) software for our document control and is run off of a Lotus Notes platform. Are you using the same software?

If so, edit rights for our documents have been set up as follows:

Document Author - primary person responsible for document
Document Manager - used as a secondary (i.e., back-up) author, but has same access rights as Document author
Document Approver(s) - typically a department manager

FYI - In the software, the Document Author may not be an Approver...the software will prompt you to select either a different Approver or Author. However, a Document Manager, may be an Approver.

Administrator - I am the super user for the software and play with and approve and kill off any document I feel like...I mean, which should be modified or addressed in case of an emergency...phew...close call.


These people play with documents within the Document Control database. Anyone who is not an Author/Manager/Approver/Administrator does not have the Document Control database on their desktop. Should they find it, no worries, but they will be unable to modify any documents so the precautions are in place so that non-designated personnel can not monkey around in the system.

All people with a computer have access to the Released Documents database. If, while reading/reviewing a document, a person believes that a change is necessary, the software allows the individual to create a Document Change Request (DCR). When submitted, the DCR goes to the Author and Manager and waits for their approval/rejection. Notice of the approval/rejection is automatically sent back to the requester when the Author/Manager has made his/her decision.

While in the submission phase of document control, if an Approver does not like the content of the document, it is part of our process for them to state the reason for rejection as well as to highlight any proposed changes within the document itself.

We do not have any problems with documents being derailed, mainly because our Authors/Managers are the process owners and know the details of what they are writing. Out of curiousity, who is writing your documents, METerry? The only time that I can really recall a "derailment" with a document is when an Approver includes either our Environment or Health & Safety Manager. They may reject a document because the process owner has missed or has incorrect legal information within the document and Env/H&S will attempt to correct the document and process before providing final approval.

In m experience, regardless if the document is paper, videotape, or electronic foo foo dust, the original author writes/rewrites the document and reviewers have rights to "redline" a document for return back to original author. The original author may "argue" over the suggestions and the string of reviewers/approvers ultimately settle on a consensus final document for approval.

The critical issue of allowing other than the original author to make a fixed version of the document always hinges on the audit trail to show who exactly is responsible for a change and whether that change is unilateral or goes through a chain of review/approval by ohers before release.

Agreed!:yes:

Andy

In our company only the Quality and Compliance Department, ie 4 out of over 1,000 employees can store controlled documents. As I say "it is your document, send the document to me and I will see if it complies with our own and industry, regulatory and ISO standards." Once we have agreed or is amended to ensure compliance then I will ensure that it is version-controlled and stored as the master copy. It works!

We do as Wes outlines. Anybody can ask for a revision or edit, but in the end the "approver" is the one that decides which, if any, of the suggested revisions are used.

It sounds like the culture is to make the changes online - which is fine - reduces paper, etc. If that's the case, then changing a culture to adopt a (new) process is always a challenge. Most document tools allow you to redline or somehow otherwise indicate a change (or, at worst, offer a difference between documents). You can use such features (e.g., change tracking in Word) to ensure the author has final say in changes. As an author, I would not want to sign something that has been taken out of my hands and potentially modified.

Like Roxane, we use the QSI software. If that is what you have, there is a database, Information Catalog, in which to set-up various approvers, editors, managers, etc. for the databases. There is where you define the controls.

UNLIKE Roxane, I do kill off documents:notme:

Many thanks Harry. You are correct and we are reviewing what we say we do to see how close it is to what we actually do. Fortunately or unfortunately, depending on your perspective, the software allows us a lot of flexibility in regards to work flow and there a at least a couple of descrepancies between the Doc Control Procedure and the software handling of change requests, etc.

Wes,
Thank you for your clarifying perspective. Where I started on this was how document control would be handled if we were using paper and then configuring a system to leave a proper audit trail. Having the possibility that a document could be altered without a clear trail of who did what and when and why it was done resulted in the original post. I suppose the real issue is administration but I can't think of a good reason to allow for changes (even typographical) that are outside the audit trail.

Roxanne,
Thanks. We are using another Lotus Notes based system, the origin of which I'd just as soon keep to myself. We started looking for a Notes based system after a client/ customer suggested we use theirs. It turned out theirs was created by a couple of very good Notes people in Belgium and was extensively modified for one reason or another. My contact with the vendor indicated that they basically couldn't offer tech support so we went looking and ended up with the current system.
We have a couple of issues with the Notes based system: 1.) a lack of familiarity and knowledge of Notes and 2.) a lack offamiliarity with ISO and ISO type quality management. We tend to get confused by one, the other, or both. But we are making progress - we have been registered.