Change Control Form vs. Document Change Notification

#1
Hi everyone,

Can somebody explain to me the difference between a change control form and a document change notification?

I worked at a fairly large medical device company where change requests were completed using a "document change notification (DCN)" form. The sign-offs by the required approvers are at the end of the form. There is only one section for signatures.

In my new role at a smaller company, I noticed that the form is called "Change Control Form" where the change requester (somebody who initiates a new document or plans to revise a document) first gets approval from their department, and at the discretion of RAQA, the change request is approved or pushed to a Change Control Board (CCB) for further assessment. I am not fully understanding the purpose of sending a request for further assessment by a CCB when the department has given the go-ahead to change the document. The final revised document is then circulated to a designated group of SMEs for review. Can the CCB step be skipped? As it is, the form requires signatures at multiple sections.

Perhaps a smaller company works in a different way from a larger company. If anyone has a sample change control or document change notification form, could you please share with me?

Please let me know if you have advice. :thanx:
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Hi Snoopy,

To me Change Control involves more than controlling a (single) document change. Indeed changing documentation is usually a big part of any controlled change in a medical device environment, but I would look at it as a subset of the activity/process.

I think that it matters little how the form is called, though, and as noted above different orgs have different terminologies. What matters is what the process consists of.

You didn’t provide a lot of details about the process in the previous, bigger company you worked for, so it’s difficult to do a side-by-side comparison and rationalise the differences. based on my experience, I’ll venture a guess that in most bigger companies there are well-established processes and roles, and less regard to efficiency. In smaller companies, on the other hand, resources are often more scarce and systems are less elaborate so individual roles are empowered to make decisions on their own. Your current company seems to also be aware of the need for checks and balances, which is good.

The process where a change is first reviewed and screened inside the relevant department makes sense - it’s simple and efficient, almost trivial. Then the QA review provides external oversight and the QMS perspective - also makes sense. The CCB seems to be an option for more complicated / problematic cases, where the QA manager feels they can’t / wouldn’t want to decide alone, and ask for wider consultation. To me it makes sense too - some changes involve a lot of different aspects and require input from multiple disciplines. Any given department may not be aware of some consequences of the change; they may think that it’s the perfect solution, while from another aspect it might be a disaster.

It seems that the QA manager has the discretion over handing over to the CCB, which supports efficiency - not all changes will go that extended route (probably most won’t). However it’s good to have that option available.

Regarding multiple / recurring signatures, it’s hard to tell without seeing the actual forms. It’s possible that there’s some redundancy there. However, I don’t consider signatures on the change form and on the revised documents as superfluous, even where the same roles sign both. They have different purposes - the first set approves the change as a whole (macro level) and the second is about the details that change in each and every revised documents (micro level). It might look like a duplicate for simple changes that involve a single document update, but in more complex changes it is important for good control, clarity, traceability etc.

Have you reviewed Elsmar’s Post Attachment Files? I believe that there’s a good chance you’ll find more than one sample there.

Cheers,
Ronen.
 
Last edited:

Wes Bucey

Quite Involved in Discussions
#4
Over the years, I've written a lot about Document Management, Change Control and, especially, the term "Configuration Management." Here's something from 10 or 11 years ago that is as valid today as it was then:

"The basis of Configuration Management is to do the following, more or less simultaneously:

  1. go through a formal process of revision and approval when you change any aspect of the part or document
  2. make a determination about the compatibility of the changed part or document with all the other Associated Documents (a specific term)
  3. determine if any of the Associated Documents must be revised to be compatible in form, fit, or function with the original changed document
  4. notify all parties who may be concerned about the change and get acknowledgment that change is implemented and obsolete documents or processes are withdrawn
  5. monitor the process to ensure all the changes work together
That may seem overly complicated. Let's explore a very simple change and see how the steps above would fit in.

One of my favorite examples I frequently use (to carry a premise of saving on assembly cost) is switching from Phillips Head fasteners to Torx drive or square drive fasteners for more efficient assembly. (Form and Fit of thread profile and length are the same, fastener Function remains - service personnel may need notice to add Torx driver to kit, but can replace with current stock of Phillips head)

On the surface, this is a simple change, but consider:

  1. organization needs to make a formal document change on the part, checking and approving the change.
  2. We check the compatibility with the mating parts, but we also have to
  3. change work instruction, assembly tools, inventory (use up old inventory first?), purchasing (same or different supplier? same or different price?), repair instructions sent to field personnel, pricing on the final product, advertising, etc.
  4. notify all parties - quality inspectors, assembly workers, quality inspectors at customer, suppliers, inventory clerks, repair stations, decide whether repair stations can continue to repair with Phillips head in inventory or must implement new Torx, decide whether recall is necessary to change out old parts,
  5. continue to monitor how all parties adapt to and implement change and decide whether further modification of any of the steps is necessary
All of us go through these steps consciously or unconsciously. The key is to do the steps purposefully and consistently and to record the steps as they are completed to assure optimum efficiency. (It would be foolish to scrap or sell off all the old Phillips head fasteners and order in all new Torx ones, only to discover no one had thought to order new Torx drivers.)"

From my point of view, Document Control IS a process and like all processes, an organization should first perform a FMEA (Failure Mode & Effects Analysis) - in everyday terms - "What can go wrong? What are the ramifications if it does go wrong? How can we prevent it going wrong? What do we have to do to cure it if it still goes wrong?"

With the FMEA results in hand, it should be relatively easy to establish one or two statistical checks on the document flow to assure crucial failures are spotted BEFORE they cause damage to the organization. The organization must continually evaluate the effectiveness of its controls and determine whether changes in the controls are necessary.

I absolutely agree the biggest problem I've seen recurring time after time over the past 50 years is ineffective "busy work" in passing the document flow through choke points where one or two reviewers are overwhelmed checking for errors that NEVER occur while ignoring whether the documents themselves are accessible, readable, and usable by the individuals who are tasked with activities dependent on those documents. For example, I've seen documents distributed to English as a second language workers that would challenge me (a PhD from a major US University) to understand and implement because the language used is so technical and poorly written.
 
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