To ensure that document changes are identified...

G

global citizen

#1
Is Document revision history being implied as a requirement here? I am planning to create a spreadsheet to show the revision history for our documents. However, I am reading that some say it is not required. But how do you identify the changes if you don’t have a record of it? How do you have a record of document revision history if you ‘forget’ the previous revisions?

I was thinking of doing what some say showing the changes in bold or italic text but if we are going to remove some portions of a document as a revision, then there is nothing to bold or italicize. Therefore, a log would be needed. Also, down the road, in tracking Improvements, wouldn’t document history be relevant to show on how much you have changed the system and are improving?

Any inputs? Thanks!

:read:
 
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SteelMaiden

Super Moderator
Super Moderator
#2
what will work best for you? Some folks save copies of each version for reference, some folks have selected some key documents that they want to save a copy of each version. Some have a listing of the changes right with the documents (last page or whatever) some just summarize the changes in a data base.

So, you have to work with what you have. You create the system that will best work for you and your employees. Again, don't make this so difficult that nobody would ever be able to step in and do your job if they needed to. Make sure the system makes sense, and people understand at least the basic concepts.

I will tell you what I am doing now, (although we will soon be moving to another system). This does not mean it is the only way to handle revs, nor does it mean it is the best. It just works for us and works well.
Revs are denoted within the body of the document by placing a | (pipe symbol) at the point of revision. The actual changes are summarized in our document control database. If something was removed, we insert a quote of the removed text. If added, we say Added "xyz" in whatever section. We do have some specific documents that we save a copy of each version for in a folder called obsolete documents, for reference only.
 
C

ccochran

#3
GlobalCitizen,

Steelmaiden's advice is right on the mark, as usual. Here are some additional thoughts. There are 3 main purposes for identifying changes to documents:

1) Letting document approvers know what has changed, so they know what they're being asked to approve.
2) Letting document users know what has changed, so they don't have to search through the document and guess what's new.
3) Creating a history of what was done in the past, just in case we get into a bind and need to know this.

Purposes 1 and 2 will be closely tied to whatever format your deliver your documents in. I have always used a cover sheet of some sort, even with electronic documents, and this creates a quick and easy place to identify changes. I've also seen change histories at the end of documents. The technique of weaving the changes into the body of the document (with bold text, cross-outs, whatever), while brilliant in theory, doesn't really work that well. Firstly, it requires that people search through the document and see what changed, which is exactly what you're trying to avoid. Secondly, people often screw up the 'track changes' faeture and the document becomes a mess. Thirdly, it adds a level of complexity to the document that's not really necessary.

Personally I would recommend that you put a "Changes in the current revision" section on the cover sheet of each document, or a "Change History" at the end of each one. There are, of course, many other ways to meet this requirement, but these are the 2 ways that seem to work with the least hassles and most effectiveness.

Happy doc controlling,
Craig
 
V

Valeri

#4
What we use: red/bold/italic for changes and strikethrough text for anything to be removed. We have a change history in each page identifying the rev.#, section revised, change made and date.
 
H

halfhog

#5
Hope this is the best place for this.
I am at odds with a superior on the best way to handle the creation and format of work instructions. Through trial and error we have found that what works best for the shop as far as work instrcution go is to have them short, detailed enough to follow and be successfull but without all of the following as part of the instruction itself; "The document has to be in our standard format…it has to have a header, rev level, rev history, etc…those are all requirements." The revision page on the front follwoed by the Scope, Purpose etc.. is not pertainent information to them. They need steps to follow period. I belive that a short title at the top and putting the rev level on the last page at the bottom(footer) would be sufficient and maintaining a spreadsheet of changes NOT attached to the actual work instructions is the way to go and still satisfy requirements. any feedback is greatly appreciated

Note: we are ISO9001:2000 / AS9100 certified and are having our first recertification audit tomorrow through ffiday.
 

Stijloor

Staff member
Super Moderator
#6
Hope this is the best place for this.
I am at odds with a superior on the best way to handle the creation and format of work instructions. Through trial and error we have found that what works best for the shop as far as work instruction go is to have them short, detailed enough to follow and be successful but without all of the following as part of the instruction itself; "The document has to be in our standard format…it has to have a header, rev level, rev history, etc…those are all requirements." The revision page on the front followed by the Scope, Purpose etc.. is not pertinent information to them. They need steps to follow period. I believe that a short title at the top and putting the rev level on the last page at the bottom (footer) would be sufficient and maintaining a spreadsheet of changes NOT attached to the actual work instructions is the way to go and still satisfy requirements. any feedback is greatly appreciated

Note: we are ISO9001:2000 / AS9100 certified and are having our first recertification audit tomorrow through ffiday.
You can use any format you want.

If the information helps the employee to be:
  • Safe
  • Effective and
  • Efficient
then the work instruction has met its intent.

Stijloor.
 
C

ccochran

#7
Halfhog,

I agree with you. Keep work instructions as lean and concise as possible. Certainly don't add sections like purpose, scope, definitions, etc, unless they are absolutely necessary. One of the biggest documentation mistakes I see is the tendency for companies to think that all documents must all look the same with the exact same format. I would strive to keep work instructions to a single piece of paper (real or virtual) and as graphic as possible. A cover sheet could be forsaken in favor of a slightly more detailed header or footer. The approach you described sounds perfect. Now you just have to educate your superior. For whatever it's worth, I've attached an old article of mine entitled "Lean Management System," which addresses some of the paradigms you're facing.

Good luck,
Craig
 

Attachments

howste

Thaumaturge
Super Moderator
#8
Hope this is the best place for this.
I am at odds with a superior on the best way to handle the creation and format of work instructions. Through trial and error we have found that what works best for the shop as far as work instrcution go is to have them short, detailed enough to follow and be successfull but without all of the following as part of the instruction itself; "The document has to be in our standard format…it has to have a header, rev level, rev history, etc…those are all requirements." The revision page on the front follwoed by the Scope, Purpose etc.. is not pertainent information to them. They need steps to follow period. I belive that a short title at the top and putting the rev level on the last page at the bottom(footer) would be sufficient and maintaining a spreadsheet of changes NOT attached to the actual work instructions is the way to go and still satisfy requirements. any feedback is greatly appreciated

Note: we are ISO9001:2000 / AS9100 certified and are having our first recertification audit tomorrow through ffiday.
Sounds great! I don't like people to have to wade through pages of stuff to get to the information they're looking for. Give it to them in a format that allows them to find the information they need as quickly as possible so they can get back to doing the real work.
 
Z

zancky

#9
Hi, all good comments,
May I add one point of view about "Is Document revision history being implied as a requirement"?.
Some customers require to keep data for 10 years, but data are nothing if You don't have a copy of all procedures and related documents You used to generate them. So for some documents like drawings, measuring protocols , customers specifications in force etc, You need to keep on all the versions, no way.
 

howste

Thaumaturge
Super Moderator
#10
Hi, all good comments,
May I add one point of view about "Is Document revision history being implied as a requirement"?.
Some customers require to keep data for 10 years, but data are nothing if You don't have a copy of all procedures and related documents You used to generate them. So for some documents like drawings, measuring protocols , customers specifications in force etc, You need to keep on all the versions, no way.
It sounds like you have a medical device or pharmaceutical background? In ISO 13485, there is an explicit requirement to maintain at least one copy of controlled documents for at least as long as the affected records. If you are already doing this, then you don't necessarily need a change log. However, a change log (summary) is a lot easier to use to quickly identify what the changes were. What do the system users need? That's the question...
 
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