Change Request Documents - What's Typical These Days?

[Watchcat]

In another forum (not the Cove) someone recently bemoaned a 5-page change request to support changing a single paragraph in a product catalog.

Been a long time since I reviewed a change request. Like all things regulated, seems they were trending longer. Just wondered what is typical these days. I know, there is no such thing as "typical" in medical devices, but still interested to hear what individual Covers see within their little corners of the world. Is 5 pages really long? Not unusual? How many pages would make you go yikes?

Also, I dunno, but it seems weird that there would be a request to change a paragraph in a product catalog and nowhere else. Seems like other documents should have been affected? But then I'm mostly premarket, so not a lot a whole lot of experience with product catalogs, either.

 

[indubioush]

I guess I'm wondering what was in those five pages. Was that just the change request form filled out, or was that including the redlined catalog? If it was just the form, and there was only one document that changed, then yes, that is long.

 

[Watchcat]

I would love to see those five pages too, along with the proposed change.

Initially I was thinking of a 1- or 2-page form plus some attachments to justify the change. I see many forms that have a text field that will sometimes suffice, but often just has two words, "See attached." For a change request, I think of a text field (or two) to describe the change and/or justification.

Based on how the situation was described, the change request form itself is 5 pages long. And apparently this is all the fault of the regulators; not whoever it was that designed a 5-page change request form. I poked a little and learned that other documents will also be changed, so apparently one form per document, not one form per change.

This got me to thinking about "change control." I'm most familiar with it in reference to a change in design, labelling, process. And sometimes used less to control change than to justify not submitting a 510(k). In the latter scenario, the attachments can be numerous and lengthy.

There is no "change control" in the QSR, right? Just "design," "document," "purchasing," etc controls? Nor in ISO 13485? So it is one of those widely used terms, like "technical file," that many within regulated industry think came from the regulators (like 5-page change request forms, LOL) but did not?

Could a revision to an entry in a product catalog be any other kind of change in addition to a change to a document?

 

[blackholequasar]

Currently we're using a DCO process where we fill out the change order on a form - no more than 2 pages, even with revisions going as far as the 20s, and that becomes the document of reference for all changes. I can't imagine anything longer unless it was an extremely comprehensive change? But dang that seems so excessive. (though we are currently ISO 9001 certified, working towards 13485 although we are not CURRENTLY producing any medical devices... CEO thinks it'll get us more business, my ulcer isn't sure about that at all)

We're transitioning over to paperless QCBD now, so I'm hoping that we'll have a much more cohesive change order plan... but now I'm thinking about change control, too!

 

[Ed Panek]

If it's a clerical error we have a very simple process. Changes to a catalog involving description may have t o undergo a label design review though since it could impact claims.

 

[yodon]

5 pages does seem (quite) excessive. And it's unclear why a product catalog would be an item that would fall under design change controls (820.30(i)) (unless as @Ed Panek points out, they're making claims in it)

The regulation lays out the requirements for change controls; however, we also include assessments from other standards / regulations. For each change to a controlled item, we assess impact on / to Form/Fit/Function, Applicable Regulatory Requirements, Intended Use, Risk Analysis, Usability, Constituent Components, Units in the Field, Realization

We also document How / What to Verify and/or Validate

Each of those is just a few lines at most so maybe a page (if printed).

 

[Tidge]

I can easily imagine a "change request form" being 5 (paper) pages. My imagination requires that the form include all sorts of information, this is not an exhaustive list:

• The objects identified to change
• the nature of the change (including if necessary, scoping descriptions)
• the validation strategy for the change
• An assessment by all potentially impacted departments 9positively and non-impacted)
• A regulatory assessment
• Planning elements

I don't think it is fair to draw a straight line between a long change request form and a "regulators", as different organizations can combine some things that other orgs do not, and some orgs can put a LOT of guardrails around a change request (and change control) process.

 

[Watchcat]

some orgs can put a LOT of guardrails around a change request (and change control) process.

Some may just be exercising an abundance of caution, but I have often found that a large volume of documentation means the company isn't confident in the process. Not confident in document retention, everyone keeps their own copies. Not confident in what information needs to be included in a change request, include everything you can think of. And then there is "the lady doeth protest too much," where people write and write and write because they are not confident in the change itself, and are trying to convince themselves as much as anybody.

Also, I haven't been involved with document control since risk management came into vogue. Seems like there should be overlap? Is it possible that some of the information I used to see with a change request form can now be found with risk management documentation instead?

(For the 1,000th time...some day I really *must* read ISO 14971.)

 

[Tidge]

Absolutely this:

Some may just be exercising an abundance of caution, but I have often found that a large volume of documentation means the company isn't confident in the process.

The lack of confidence (which can be measured by count of ad hoc implemented "guardrails") in established processes is an indication that an organization is not particularly mature (in the CMM sense).

Another crude method that can help to gauge organization maturity (with respect to change requests) is the number of different types of change requests, and the method of assessing what "type" of change request is appropriate. Some mature organizations will have narrowly defined, specific change request processes for particular business areas... but most mature organizations should be able to make do with a single, straight-forward process implemented by trained individuals. An outcome of a single well-defined process is that there ought to be limited questions about wether or not the change request was well-formed... either during initial review or a post hoc review of records.

 

[Jen Kirley]

Five pages seems excessive, but:

1) We are talking medical device here, correct? What sort of device? A finished medical device? What class?
2) It is entirely possible that an organization's QMS has extensive requirements for document change, regardless of what the change is.
3) A product catalog is describing a device to a user/buyer. Regulations and approval by an organization's Regulatory Agency may therefore become involved, along with all he documentation normally required for that.

I find it very difficult to offer anything of substance without seeing the thread and without knowing what this change is about.