Hi,

Hope someone can help me out with this. As a company, we recently implemented a QMS with the intention of achieving ISO 9001:2000 registration, which duly happened at the end of November. As the appointed management representative (in addition to all my other duties!), one of my tasks is ensuring that the quality & procedures manuals are kept up to date.

This is where I have hit a little problem. As a result of some of our internal audits, some minor changes had to be made to some of the documented procedures. No problem with this, and the relevant sections of the manual were changed & reissued, with the next issue number (in this case issue 2). Where I am totally confused is what I need to do with the document register and table of amendment within the manual. I know that these have to be updated to indicate the new issue number of the modified procedures, but as a result of this do these documents themselves have to be reissued?

I know that this is probably a stupid question, but this is all new to me, and I hope that I have explained my problem clearly enough. Thank you in anticipation of your assistance.

Regards,

Mark

Welcome to the Cove Mark. There is no such thing as a stupid question so keep on asking.

I am concluding that these procedures are kept in a manual which is controlled by a revision date and recirculated each time a change is made. I assume your procedure for control of documents states this is how your procedures will be controlled.

If your procedures can be removed from the manual and used as stand alone documents, you need to control the individual document. Each document should have its own revision level. Your manual register should reflect the revision level of each document. Hopefully, when you change a procedure, all you have to do is re-issue that procedure (with a new revision date) and a new register page (showing the current revision date of the procedure).

Just a comment. It sounds like you are maintaining an amendments section of the procedure manual. You may find it easier to track revisions on the procedure itself and eliminate the amendment page. Another thought is, you could maintain your documents electronically and eliminate the manual entirely.

Dave

Hi,

Hope someone can help me out with this. As a company, we recently implemented a QMS with the intention of achieving ISO 9001:2000 registration, which duly happened at the end of November. As the appointed management representative (in addition to all my other duties!), one of my tasks is ensuring that the quality & procedures manuals are kept up to date.

This is where I have hit a little problem. As a result of some of our internal audits, some minor changes had to be made to some of the documented procedures. No problem with this, and the relevant sections of the manual were changed & reissued, with the next issue number (in this case issue 2). Where I am totally confused is what I need to do with the document register and table of amendment within the manual. I know that these have to be updated to indicate the new issue number of the modified procedures, but as a result of this do these documents themselves have to be reissued?

I know that this is probably a stupid question, but this is all new to me, and I hope that I have explained my problem clearly enough. Thank you in anticipation of your assistance.

Regards,

Mark

Short answer is it depends what your document control procedure says! Here are a couple of options:


If your procedure says the amendment record is a controlled document then it needs to be identified at each revision to show that it has been changed - e.g. by upissuing it from 1 to 2
If it is a record then it needs to be identified each time a new record is created (i.e. a new amendment is recorded), perhaps by a date of update and the superseded record stored (in accordance with your records procedure)
If it is a form then there will be field to be entered each time the form is completed and, once completed the form will become a record.


Hope that helps!

Short answer is it depends what your document control procedure says! Here are a couple of options:


If your procedure says the amendment record is a controlled document then it needs to be identified at each revision to show that it has been changed - e.g. by upissuing it from 1 to 2
If it is a record then it needs to be identified each time a new record is created (i.e. a new amendment is recorded), perhaps by a date of update and the superseded record stored (in accordance with your records procedure)
If it is a form then there will be field to be entered each time the form is completed and, once completed the form will become a record.


Hope that helps!
Hello,

First of all I must inform you that this is my first message on Elsmar Cove Forums, and I am by no means a very reliable source as we are in the process of setting up all of our documented procedures.
Our registrar is scheduled for a document review in April 2008.
So our documentation system has not been verified and approved yet.
Maybe someone can tell us if what we are doing is ok.

We are a small machine shop (27 employess) manufacturing parts for aerospace OEMs. We are in a similar situation, i.e. we have documented procedures that need to be updated as a results of internal audits.
The way we have organised it is like this.

We make the changes/amendments directly in the body of the documents and record the changes in the change log table and submit the document for review. All the changes are incorporated in the document, we only issue new revision when the document is reviewed and modified for adequacy.

The clause we have in our document control procedure says something to the effect of:
-All revisions, changes and amendments must be reviewed and approved for adequacy.
-When changes and amendments are required prior to re-issuing a new revision of the document, these changes shall be made directly in the body of the document and then listed, recorded and explained in the change log section (table). The prefered method is to identify the changes using the is/was method, for example.

Revised 5.3

Was
5.3 do X

Is
5.3 do Y

I think this meets the requirements of section 4.2.3 however I am not sure about the fact that changes are made directly in the body of the spec and then explained in the change log, i.e. do you need to re-issue a new revision when changing the content of the document. AS9100 does not appear to say so and our document control procedure neither.

Our revision history is done by keeping the older revision of the file.
Our changes/amendment history is done by recording the is/was in the change log table within the controlled document.
Our system consists of electronic word processing files.

Thank you. /jf

Hello,

First of all I must inform you that this is my first message on Elsmar Cove Forums. And I am by no means a very reliable source as we are in the process of setting up all of our documented procedures.
Our registrar is scheduled for a document review in Arpil 2008.
So our documentation system has not been verified and approved yet.
Maybe someone can tell us if what we are doing is ok.

We are a small machine shop (27 employess) manufacturing parts for aerospace OEMs. We are in a similar situation, i.e. we havedocumented procedures that need to be updated as a results of internal audits.
The way we have organised it is like this.

We make the changes directly in the body of the documents and record the changes in the change log table and submit to document for review.

The clause we have in our document control procedure says something to the effect of:
-All revisions, changes and amendments must be reviewed and approved for adequacy.
When changes and amendments are required prior to re-issuing a new revision of the document, these changes shall be made directly in the body of the document and then listed, recorded and explained in the change log section (table). The prefered method is to identify the changes using the is/was method, for example.
Revised 5.3
Was
5.3 do X
Is
5.3 do Y

Welcome to the Cove - and please relax! Everyone gets to have 'first post nerves'!

I'm not sure from the last few lines in your post what the "5.3 do X" represents.

In most cases the simplest approach is the best. I advocate (with success) the use of a "document change note" which looks after a lot of the recording of the reasons for changes, approvals etc. instead of burdening documents with that detail. Then, a simple revision numbering system 00, 01, 02, 03 etc or A, B, C etc is all that is really needed.

For a small shop, it appears you have a more complex system that really required. Also, it reads more like some else wrote it, not what I'd expect for a small shop, too.

BTW - weekends are slow here - I was munching on my breakfast while stopping by here!

Let me know if you want to take a look at the DCN.....

Hello Andy,

Yes you are correct on all points.

Yes I would like to take a look at a "document change note", i have never seen one.

We did write our own procedure but have read others and have tried to reproduce the formal "style" which may not have been a great idea.

An example of our change log follows
(sorry the table does not keep the proper format)

Change log
-----------------------------------------------
ID Date Reason for change or comments
1 2007/10/29 Revised 5.3
Was
5.3 do X
Is
5.3 do Y


Thanks again. / jfg

Glad to be of help. I'm still not sure what the log entry refers to! It looks like a drwg dimension change, not a QMS document change, however, the point is not the content of the chnage, but the mechanism. The DCn and associated procedure are posted elsewhere on the Cove.

I'll try to look them up (later on this weekend) and link them here or you can search in the attachments area of the site.

Welcome jfg,

I do not see anything wrong with your description of change.

I have seen a simple method that works well. On the cover page of each document, a table is placed that shows this change information. When a new change is made, that is added to the table. There might be a limit--that is, after five the earliest one could be dropped off. Dropping it off is only possible if you keep an archived copy of the old document, away from access of the new revision, and plainly marked "superseded" or some such.

As an auditor I have seen your method (5.3 do Y) and prefer it to the more generic "revised inspection techniques in 5.3". However, it's only fair to point out that the generic description has passed muster with our registrars.

So, I would apply the method that best suits the need. If it's a critical clause and the change can be described in a short paragraph or less, be specific. That should help make sure people can get things done properly. That's the main goal, after all.

Welcome jfg,

I do not see anything wrong with your description of change.

I have seen a simple method that works well. On the cover page of each document, a table is placed that shows this change information. When a new change is made, that is added to the table. There might be a limit--that is, after five the earliest one could be dropped off. Dropping it off is only possible if you keep an archived copy of the old document, away from access of the new revision, and plainly marked "superseded" or some such.

As an auditor I have seen your method (5.3 do Y) and prefer it to the more generic "revised inspection techniques in 5.3". However, it's only fair to point out that the generic description has passed muster with our registrars.

So, I would apply the method that best suits the need. If it's a critical clause and the change can be described in a short paragraph or less, be specific. That should help make sure people can get things done properly. That's the main goal, after all.
Hello Jennifer and thank you for the welcome message.

This method is simple and always keeps the latest approved (by the required authorities) changes incorporated in the body of the document with changes loged in the change log table on the front page.

I have had comments though from co workers that everytime we change the body of the procedure we need to issue a new revision. I told them that I could not see anywhere in AS9100 a requirement stating that a new revision should be issued everytime a change is made to the content in the body of the document. But I may be mising something.

Have a great week. /jf

J-F:
You're correct, AS9100 won't tell you how to do something like revision control, just that you have a procedure for revision control.
I'd tend to agree with your co-workers. If you make a change to the body of a document, it becomes a different version, so you should re-issue it. There's nothing to stop you rolling up changes - using the DCN I talked about earlier - and put them into one change, but, in effect, changes = revisions.

One thing with document control; K.I.S.S.........:lol:

Well thank you again Andy.

I like the way you put it: changes = revision

I will modify the procedure to state that the changes shall appear only in the change log table and are to be incorporated in the body of the document only at the next revision of the document.

Our change log is a table on the front page and is prior to and part of the MS word document, is that OK or does the document change notice you are talking about have to be a separate electronic document ?

Thanks for the advices and have a great week end. /jf

I would put the change notice on the document itself, where people are more likely to notice it.

And your coworkers are correct in that each time you do this, it becomes a new revision.

jfg:

A simple note in the revision history is fine, as is noting the change in the margin next to the affected text. The primary concern is being able to identify what has been changed between revision #1 and #2....

There's a number of ways to be compliant here - make sure that whatever system you use is appropriate to your organziation and isn't too complicated.

Hope this helps,

Mark