Setting deadlines (ex. 45 days) for Document Registration & Review Cycle

#1
Mabuhay! I'm Ian. I have been a regular visitor in this forum and it has been very helpful to me as my company's EMR.
I want to improve our Document Control Procedure and would like to confirm the following after reading everything I could find here related to the topic.

(1) We have set a 45-day deadline for our documented information registration and review cycle.
- once the process owner intends to make a new document or review an existing one, they are
required to fill-out the Document Registration and Review Form and the 45-day countdown begins
> I believe this is our consultant's idea of conforming 7.5.2 and 7.5.3 (ISO14001:2015) but I could not
really see it in the standard and it's very restrictive. Am I right?
> It was also intended to control editable copies of the procedures so that process owners are required to
complete the document within the 45-day cycle or else they need to return all the files back to the Document
Controller. For me, this seems to be another source of unnecessary nonconformities.

(2) We already have a footer in place in our documents that indicates that unless it is marked "Controlled" then
it is uncontrolled. Yet, we are always on the lookout for copies of uncontrolled documents that may be left
lying around. As I understood it, we just have to make sure our personnel are aware how to identify controlled
copies from uncontrolled ones to ensure that they always use the correct one.

I have downloaded several examples of Document Control Procedure from here and I am amaze how simple it is and yet
addresses the requirements of the standard.
 
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Watchcat

Trusted Information Resource
#2
Document control systems vary a lot from company to company. Your last point under (1) states that they need to return all files back to the Document Controller. However, neither of your previous two points indicate that any files were ever removed from the Document Controller. What kinds of files would someone who is planning to make a new document or review an existing one remove from your Document Controller?

PS As a practical matter, the only way to "ensure" that personnel use the correct document is to make it physically impossible for them to get their hands on an incorrect document. Nothing you put in a footer is likely to achieve that end.
 
#3
"...However, neither of your previous two points indicate that any files were ever removed from the Document Controller. What kinds of files would someone who is planning to make a new document or review an existing one remove from your Document Controller?"

Thanks for the inputs.

For new documents (maintained), we just have to register it after we have the final draft and it gets routed for checking and approval. This document should be approved within our set 45-day document registration cycle.

For documents (maintained) to be revised, we need to pull-out from the document controller editable of copies of the controlled documents. Then the revised document should be approved within our set 45-day document registration cycle.

For both cases, this would be a nonconformity against our procedure if the 45-day cycle lapses without the document being approved. Since we made this a requirement which I am thinking now that it is not actually necessary. Our intention was to "control" the editable files which may not actually be necessary since what we should focus more should be the control of our signed and approved documents.

I observe that we may have been having unnecessary nonconformities related to requirements we have set ourselves but not necessarily required by the standard.
 

Watchcat

Trusted Information Resource
#4
I have always maintained that any document that has to be approved before it can go into effect is not actually a document until it has been approved. By this I mean that such documents are not company documents until they have been approved. Ergo, from the company's perspective, they do not exist and they cannot fall within the scope of a company SOP. Not sure if that helps or confuses, but it's always worked for me.

To be less obtuse, I can't think of any rationale for a 45-day deadline under either circumstance (create new or revise old), so I would agree that's just creating an opportunity for a pointless nonconformity.
 
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