Change Log in (controlled) Forms? (ISO 9001:2015)

#1
Hi All,

Quick intro: I'm Lisa, from the Netherlands, currently started a QA/QC position in a very small company that has no procedures in place...or at least not documented.

I've been reading along on this site for a little while now, finding it very useful.
I have a question (ISO 9001:2015) I hope someone here can help me with. I did try searching on the forum, but can't find the answer to my question (or maybe I'm not using the correct search words as English is not my mother tongue) .

I've created a Document Control Procedure and am now also creating a Document (Change) request Form.

My question: This Form should be a controlled document. But do you then with revisions of this Form also require to keep a change Log (for the changes per Rev.)?

With my procedures, manual etc, I have a change log at the end of the document. But I don't want a Change Log/Revisions History in the Form itself (and have never seen one elsewhere).
How do you guys/girls track Changes in Forms...or is this not required??

Thanks all! Hope my English is good enough to make clear what I'm asking :)
 
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JimS

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#2
Hi Lisa,

It's not necessary to have the change log on any documents. It can seem like a convenience on things like procedures but it just gets in the way on forms. Do you serialize and catalog your change requests? If not, you probably should. Then all you need to do is reference the DCR number somewhere, probably the document footer. We eliminated all revision tables on documents, instead putting a code in the footer that contains the DCR number that released it, along with a date code for the MMYY when it was released. If you need information on what changed and why, you can go look up the DCR. No need to clog up the document with stuff that isn't related to the document's purpose.
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#3
For procedures and manuals, I keep a revision record at the end of the document.

For forms, I archive all of the old versions in a drive that only my boss, the IT guy, and I can get to.

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#4
We make the form an appendix to the procedure, so if the procedure version number changes, then the form version does too. The revision history is at the end of the procedure. When the procedure is issued for use we create a controlled version of both the procedure (including the form) and the form as a separate file.

If the form needs to be changed then the procedure is re-issued with an update in the revision history and new version number. This means that form changes are subjected to the same review and approval as the procedures themselves. Both procedure and form(s) have the document number and version number in the footer but forms have _F1 etc at the end of the filename.
 
#5
I think that is reasonable to keep the old versions (obsolete) recorded because it maintain the historic of all your documents.
For the new ones you can just use a new version.
 
#6
Thank you all for your helpful responses!
I have not ad any DCR yet as I'm only just starting up the entire QMS for our company :)
But I will catalogue and serialize them, so that's a great tip to reference the DCR in the footer.

Keeping old versions of forms in a seperate "obsolete" folder is a good one too.

Thanks again!
 

lanley liao

Involved In Discussions
#7
Hi, Lisa, In fact, You need to maintain a documented procedures of documents and records for your company. and then performing them accoriding to their requirements such as you will catalogue and serialize them, etc. Record what you specified, to make sure both contents performed and written are consistent.
 
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