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Document Change Request forms (or no forms)?

#1
I would like to know what your opinions are regarding the implementation of a specific Document Change Request form as part of the SOP for control of documents as opposed to leaving it out.
I have worked with both in the past and I find that having a separate DCR form and therefore also a DCR log can sometimes equate to unnecessary work if for example the software used to manage the QMS already tracks these changes and requires review and approval, etc. The standard does not explicitly state the way in which we must comply with the requirement.
Perhaps this may vary according to the size/scale of the company/QMS and so on?

Looking forward to input!
 
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William55401

Involved In Discussions
#2
If your software tracks the required attributes, then why have a separate form and log to maintain? Waste, especially in a QMS, causes frustration with the users (read as customers). Before committing to this plan, double check what the standard requires, determine if your org needs anything more, confirm if your s/w captures this info, if needed, configure doc mgmt s/w to capture any incremental info (yes,, validate changes to QMS s/w), and implement.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
I'm with William55401. :agree:

I have seen clients accomplish the minimum (much depends on what your Interested Parties need or require) by using the Voting Button feature in MS Outlook. The body of the email can describe the change while attaching the relevant document(s), and the sender can set up the voting to include ability to reply with comments. The approvals/rejections and comments are recorded with date and time stamps that the sender can, in the end save as a file for records of change.

One key benefit of the software approach is people's ability to log in to their Outlook email from wherever and conduct this business while not in the office.
 
#4
William55401 and Jen Kirley, thanks very much for your input, I'm also of the opinion that a simple but effective and compliant approach is best!
 
#5
@Jen Kirley how we can assess the impact of the change in other documents without DCR forms? and also plan training? Because I'm migrating the current paper-based QMS to a s/w eQMS and I am trying to figure out how I can do these tasks without DCR Form?
 

Tidge

Trusted Information Resource
#6
@Jen Kirley how we can assess the impact of the change in other documents without DCR forms? and also plan training? Because I'm migrating the current paper-based QMS to a s/w eQMS and I am trying to figure out how I can do these tasks without DCR Form?
I think the implementation will depend on the maturity level of the organization. In a mature organization: there won't be ad hoc treatment of documents; the impact to other documents will be routine enough that 'suprises' won't pop up. In a less mature organization, you will have no choice but to implement guardrails and ad hoc checks for document changes.

In the case of the less mature organization, I suggest that the 'guardrails' be moved early in the change process, i.e. before the 'change approval' phase. I have witnessed change requests that have dozens of 'approvers' when really where their input was needed was in the 'planning' phase of a change. This is a mess and leads to lots of delay and rework (in the change process!) for all sorts of human reasons that can be imagined.

Similarly, if there are necessary implementation activities: A mature organization will have the same implementation activities for specific types of changes, and so there should be no need to evaluate individual changes only to 'approve' routine implementation activities (such as scrap, rework, training) that would be a natural consequence of the change. Again, it is the immature organization which has to add 'change approvers' to agree with proposed implementation plans... typically because everything is ad hoc or there is no trust in the system.

A well-constructed plan which is executed properly does not require dozens of people to evaluate if the plan was executed correctly and if it supports a proposed change.
 
#7
@Tidge Thank you for your clear and complete answer :)
I would say that we are an immature company because we are building our QMS from scratch.
And we are using software that tracks changes and requires review and approval for every change. And there is a feature in the Document Management module that allows users to request a major or a minor version change. So, in this case, we can track changes in a document but we cannot see what other documents need to be changed. so, I was wondering if it is necessary to keep the DCR form just to inform about changes in other documents and see if training is required. And it seems like yes, it is needed...
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
@Tidge So, in this case, we can track changes in a document but we cannot see what other documents need to be changed. so, I was wondering if it is necessary to keep the DCR form just to inform about changes in other documents and see if training is required. And it seems like yes, it is needed...
I think this is the main benefit of having a Reference Documents section in a controlled document. It helps us remember relationships between documents, and to look in there to see if a related update is needed. I always advocate for a systematic avoidance of repeating requirements in various documents, because updating all of them can become a nightmare. Having done that, the Reference section can lead us to affected documents. I am not aware of a software package that will automatically trigger reviews of these affected documents. It has generally fallen upon the document owner(s) to do the due diligence to ensure consistently accurate controls get maintained.
 

Tidge

Trusted Information Resource
#9
... the Reference section can lead us to affected documents. I am not aware of a software package that will automatically trigger reviews of these affected documents. It has generally fallen upon the document owner(s) to do the due diligence to ensure consistently accurate controls get maintained.
I have worked with a company that did exactly this (in more than one way) for QMS documents; which existed in a hierarchy:
  • The documents themselves would list their 'parents' and 'children'
  • The doc control software was configured to show those relationships
  • The database of (released) QMS documents allows for text searches; this can be used to find instances where a QMS doc is called out
 
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