6 replies to this topic

[Doubleu]

I know this question has been commented on before but after extensive searching, I can not seem to find the thread.

 

I have inherited an OAP manual that has not documented its changes well. Is there a standard practice for documenting changes to text? It does have an amendment register which is well documented. 

 

Additions - highlighted and do you have to use a different colour for every year?

Deletions - Strikethrough?

Changes to text/wording - Underlined?

 

 

[Brothbro]

Is this a written manual that you're looking to log changes in? Or digital document? Personally I favor a well documented "history of changes" section at the end of each document that records what aspects were changed, when, and by whom. I have never used strikethroughs or highlighting within the document to show these changes, and it has never been an issue with auditors. Too many strikethroughs/underlines/highlights in a document make it annoying on the eyes to read in my opinion.

 

If anything I would only opt to highlight the most recent change in the document, provided it's an important procedural change that you want readers to take notice of. I wouldn't highlight or strikethrough corrected typos, because that seems confusing. So to answer your question, the only "standard" with changelogs I've heard of in our industry (I have FDA and SQF experience) is that you need to have a way to keep track of your revision history (what was changed, and how can you ensure the most up-to-date version is available to staff). 

[Doubleu]

Thank you for your comments, totally agree. Currently, every addition is in red text, all deletions are strikethrough and changes are highlighted in yellow. It is nearly impossible to read.

[EagleEye]

Hi Doubleu,

 

One can imagine how annoying it would be. How would we go through a well comprehensive reading with all that lines and contrasting colors which actually not adding any value to the text but only cause distraction all the way.

 

I agree with "Brothbro" as that is the standard method in use to record changes.

[G M]

I know this question has been commented on before but after extensive searching, I can not seem to find the thread.

 

I have inherited an OAP manual that has not documented its changes well. Is there a standard practice for documenting changes to text? It does have an amendment register which is well documented. 

 

Additions - highlighted and do you have to use a different colour for every year?

Deletions - Strikethrough?

Changes to text/wording - Underlined?

 

For a document that is meant to be read by users and auditors, I wouldn't do any of that.  Like Brothbro most documents simply have a small section at the end recording a description of what was changed, for what purpose, by who and when.  

 

Old versions are retained in an archive if someone wants to look at them side by side and see exactly what changed.  Digital storage space is cheap, and I see no reason to ever get rid of any program document if they are secure and versioned.

[Miss Frankie]

I have a section in my SQF binder that has a list of all updates/revisions for each FSC.

example:

2.5  mm/dd/yyyy Updated frequency of mock recall

 

2.6 mm/dd/yyyy updated due to personel changes

 

2.9 mm/dd/yyyy added additional supporting documents

 

9.3 mm/dd/yyyy updated element numbers to match edition 9.0

[Charles.C]

Another approach used in some Manuals is to sequentially number all the pages in the Manual just like a book.

 

The Manual has a Preface Page which chronologically records  (Columns for Page Number/reason for change/date/signature) any changes on specific Page Numbers. The only snag IMEX is where (the usual) replacement of a section by a new section overflows onto a further page but this can be allowed for.

The advantage is a substantial reduction in "Changes" documentation.