Document Revision Numbering and Related Requirements

K

KCIPOH

#1
Hello Cove members,

Let say i have a document A with its own format and contents inside:

1. Do i need to give a new revision number if i change anything for the format
(no contents changed)?

2. Do i need to give a new revision number if i change the content (format
remains the same)?

3. Or is it i should revise the revision number of document A whenever there
is changes for either the format itself or contents?

Please advice, thank you :confused:
 
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howste

Thaumaturge
Super Moderator
#2
Re: Document Revision

Hello Cove members,

Let say i have a document A with its own format and contents inside:

1. Do i need to give a new revision number if i change anything for the format
(no contents changed)?

2. Do i need to give a new revision number if i change the content (format
remains the same)?

3. Or is it i should revise the revision number of document A whenever there
is changes for either the format itself or contents?

Please advice, thank you :confused:
Here are my quick thoughts:

1) I believe that if only the format has changed, but not the content, then you get to decide if you want to change the revision level or not (in keeping with your document control process).

2) If the content changes, you would almost always need to change the revision. You should always change the revision level for content that changes requirements. However, it may be acceptable to keep the same revision for minor changes like correcting spelling errors. Make sure that your document control process allows for it if you don't change the revision level.

3) See above.
 

Randy

Super Moderator
#3
Re: Document Revision

Forget format...not required

Just fret over content, if it changes then so should the revision identification (you don't have to use numbering either)
 

somashekar

Staff member
Super Moderator
#4
Re: Document Revision

Hello Cove members,

Let say i have a document A with its own format and contents inside:

1. Do i need to give a new revision number if i change anything for the format
(no contents changed)?

2. Do i need to give a new revision number if i change the content (format
remains the same)?

3. Or is it i should revise the revision number of document A whenever there
is changes for either the format itself or contents?

Please advice, thank you :confused:
Look at it as the picture and the picture frame
As long as you are clear about all that comes into the picture, and get that into your change control process, the QMS does not really bother about what picture frame you use ....
 

v9991

Trusted Information Resource
#5
Re: Document Revision

Content part of the above question and answers are quite clear;

BUT i would like to get clarity wrt following pionts..
What is the significance of format in the process of defining a document?

for eg.,
1) Can we consider the "land scape / portraint" presentation to be part of format?
or
Can I use/implement a format in either of the presentation modes of landscape or portrait?

2) does format indicate sequence of contents? i.e., if i rearrange sequence of contents presented in the document can i consider that contents are not changed; ....just being reformatted!!!

3) then how do we interpret the regulations which require the submissions to be made in specific format (including contents of course); (i say this because, the acceptance checklist for receiving a submission has a question to verify the specific format/proforma which are to be submitted in specific forms!!!)
 
Last edited:
K

KCIPOH

#6
Hello Howste, Randy, Somashekar,

Thank you for your clear explanation and verification as it has been a great help for me.

v9991 has pointed out some interesting points related to this issue as well, can guide along?

Appreciate and Thank You :yes:
 
G

Geoff Withnell

#7
Re: Document Revision

Content part of the above question and answers are quite clear;

BUT i would like to get clarity wrt following pionts..
What is the significance of format in the process of defining a document?

for eg.,
1) Can we consider the "land scape / portraint" presentation to be part of format?
or
Can I use/implement a format in either of the presentation modes of landscape or portrait?

2) does format indicate sequence of contents? i.e., if i rearrange sequence of contents presented in the document can i consider that contents are not changed; ....just being reformatted!!!

3) then how do we interpret the regulations which require the submissions to be made in specific format (including contents of course); (i say this because, the acceptance checklist for receiving a submission has a question to verify the specific format/proforma which are to be submitted in specific forms!!!)
Here is my take on the issue. If you change a dosument, and you want ONLY the new version used - change the rev. level. Purge the system of the old rev. If you change a document, and don't care if the old version is used, don't change the rev. level. Sometimes format is important, and will drive a rev. level change. Sometimes it's a "don't care state" kind of issue. The revision level exists to tell the user if they have the correct "latest and greatest" document. If both the before and after are correct and usable, there is no issue.

Geoff Withnell
 

v9991

Trusted Information Resource
#8
Re: Document Revision

Here is my take on the issue. If you change a dosument, and you want ONLY the new version used - change the rev. level. Purge the system of the old rev. If you change a document, and don't care if the old version is used, don't change the rev. level. Sometimes format is important, and will drive a rev. level change. Sometimes it's a "don't care state" kind of issue. The revision level exists to tell the user if they have the correct "latest and greatest" document. If both the before and after are correct and usable, there is no issue.

Geoff Withnell
I agree;

As per my observation(more so in my domain of Pharma)...following are few reasons for getting into mode of thumb rules. (viz., format change does not matter...other extreme of anything changed would require a revision etc.,)

  • when we bring the concepts/theme into implementation, most of times, we tend to write (well almost) everything in black&white!!! (SOPs are supposed to be crisp & (over emphasized)precise(no room for interpretation) right!!!)
  • & anything which leaves a room for interpretation is not complete/precise!!!( it always happen that anything to be interpreted will be taken the way it is not intended to be taken!!!)
  • + we get into forming some thumb rules which results into situation wherein the real concepts/themes get undermined; And this may be also because of having to convey the concept(SOP) across all relevant-people and over continuous period of time.
 
L

Lektrik

#9
So if I add a block to the form to record the "Date:",... by what yall have said the format changed but the form doesn't need to change revs?
2nd question: A Repair Request Form which is a Template (top of the form has blocks for P/N, S/N, WO#, etc) where, in the body of the form, the repair steps are different for different parts, so we'd like to "prepopulate" the contents rather than having the tech handwrite the steps. Does each one need to be a different document number?
 

Jim Wynne

Staff member
Admin
#10
So if I add a block to the form to record the "Date:",... by what yall have said the format changed but the form doesn't need to change revs?
A form is different from a procedure or work instruction, but the thinking should be similar. If the content changes, a new revision should generally be issued. Addition of a field to a form is a content change, not a formatting change. A formatting change might involve moving an existing field from one place to another on the form.

2nd question: A Repair Request Form which is a Template (top of the form has blocks for P/N, S/N, WO#, etc) where, in the body of the form, the repair steps are different for different parts, so we'd like to "prepopulate" the contents rather than having the tech handwrite the steps. Does each one need to be a different document number?
Rather than thinking about it strictly in terms of numbering, you should think about it as each of the varieties needing to be individually controlled. If you were to use the same identifier for each of the iterations, how would you control changes to an individual document?
 
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