Advice on moving QMS Documents and Maintaining Revision History

S

slq777

#1
Hi

New poster - so apologies if in wrong forum. I have been tasked with moving our existing QMS documentation into a new purpose built QM database. The database will allow for us to track revision histories within each document record. My question is what would you do with the existing revision histories which are currently kept at the bottom of each document?

We are keen to avoid duplication but also keep inspectors happy that we know what has happened to our documents in the past.

Thank you, Sarah
 
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qusys

Trusted Information Resource
#2
Hi

New poster - so apologies if in wrong forum. I have been tasked with moving our existing QMS documentation into a new purpose built QM database. The database will allow for us to track revision histories within each document record. My question is what would you do with the existing revision histories which are currently kept at the bottom of each document?

We are keen to avoid duplication but also keep inspectors happy that we know what has happened to our documents in the past.

Thank you, Sarah
Hi Sarah,
welcome on the forum. This site is very precious for sharing help and ideas for quality issues.
I am giving you my response for your question, waiting for additional responses of other .
Im my opinion the traceability is ensured after the breakthrough with the new db.
From what you wrote, I have understood that the revision is now assured in automatic way. However, I would suggest to also update manually the history at the bottom of a document when there is a revision. I think there is no duplication, the important is ensured that the modification is done at the same time .
Hope this helps:bigwave:
 
S

slq777

#3
Hi Qusys

Thanks for your reply, sorry if my question wasn't clear - ideally I wasnt to be able to remove the revision history table from the Word document and only keep it in the electronic document record in the DB in future starting with the current version of each document. Do you think it will be a problem if the electronic document record does not show the whole revision history of a document (prior to installing the DB), we would of course keep a copy of the pre-DB documents for audit purposes.

Thanks
 

qusys

Trusted Information Resource
#4
Hi Qusys

Thanks for your reply, sorry if my question wasn't clear - ideally I wasnt to be able to remove the revision history table from the Word document and only keep it in the electronic document record in the DB in future starting with the current version of each document. Do you think it will be a problem if the electronic document record does not show the whole revision history of a document (prior to installing the DB), we would of course keep a copy of the pre-DB documents for audit purposes.

Thanks
I do not think it is a problem. However, could you also update the history of revision in the table when you make some changes?
 
L

Lucasmf

#5
Hi,

I know many companies who do not track revision history on the documents itself and rely on the change record in the QM database. In your case I would record that decision in your quality plan or SOP for you new DB implementation. Something as simple as "Revision histories prior to DD/MM/YYYY are maintained on the cover page of each document. After implementation of QM DB, revision histories reside in the QM database and will no longer be included in the document itself. Revision history tables will be removed from each document next time a revision occur. Refer to the archive version for any reference to prior revision histories."

This is very common when companies goes from a paper to an electronic doc control system.
 

Mikishots

Trusted Information Resource
#6
Hi Qusys

Thanks for your reply, sorry if my question wasn't clear - ideally I wasnt to be able to remove the revision history table from the Word document and only keep it in the electronic document record in the DB in future starting with the current version of each document. Do you think it will be a problem if the electronic document record does not show the whole revision history of a document (prior to installing the DB), we would of course keep a copy of the pre-DB documents for audit purposes.

Thanks
I'd be curious as to what one would do if that document was printed? Yes, I understand it would be uncontrolled, but if the revision info was stripped from the document itself, it would have no identification in it to tell you what version it is. You'd have to do a direct comparison to what is currently showing in the DB.
 

Helmut Jilling

Auditor / Consultant
#7
Hi,

I know many companies who do not track revision history on the documents itself and rely on the change record in the QM database. In your case I would record that decision in your quality plan or SOP for you new DB implementation. Something as simple as "Revision histories prior to DD/MM/YYYY are maintained on the cover page of each document. After implementation of QM DB, revision histories reside in the QM database and will no longer be included in the document itself. Revision history tables will be removed from each document next time a revision occur. Refer to the archive version for any reference to prior revision histories."

This is very common when companies goes from a paper to an electronic doc control system.
It is not required for the revision history to be in the document itself, though it is a common approach. However, the document must be able to show some form of revision control, especially if it is printed.
 
K

kgott

#8
Hi

New poster - so apologies if in wrong forum. I have been tasked with moving our existing QMS documentation into a new purpose built QM database. The database will allow for us to track revision histories within each document record. My question is what would you do with the existing revision histories which are currently kept at the bottom of each document?

We are keen to avoid duplication but also keep inspectors happy that we know what has happened to our documents in the past.

Thank you, Sarah
As I understand things, you can restart your numbering system from scratch again but use a different means of doing it and do in a way that avoids confusion with the existing identification system. As said earlier, describe all that has been done in the QM.

Sometimes, when moving to a new way of doing things it's also a good opportunity to implement change.
 
B

buzzjaw

#9
I think the key here is that you must be able to trace the documents history. As long as you can do this the actual system used for doing it is immaterial. Nothing says the history has to be easy to trace or in the document itself. The fact that there is a transition from one system of management to another is no problem except that your management system must appropriately reflect this change.
 
S

slq777

#10
Thank you all for your comments so far, not being a QA specialist this has all been very useful.

Just to clarify we do have the version number in the document itself and an "uncontrolled if printed" label so if users do print things out they will know which version they are using. One hard copy of all documents would be maintained for emergency back up and we would print out a copy of the electronic document record which displayed the revision history and approver to accompany this. The numbering of our documents will have to change as we move to the new DB so we can make the most of the automated numbering functionality.

Reading through your answers has helped me come up with the following plan:


  • Numbering for SOPs will remain the same so they will be put into the system as are, to be updated with a new document template the next time they are revised.
  • Numbering for our guidance and forms will have to change so will use the transfer to the DB to put them into new templates (assume therefore I will have to move them on a version even if informative content hasn't changed?)
  • When recording revision history in DB for those documents whose template is updated we will include a reference to revision history being removed from document and that previous revision history will be found in archived document.
 
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