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Challenges in Change Control and Automation

Automation - 17 June 2015

I enjoy exchanging ideas with Mr. Graeff and Mr. Prince on quality operations, best practices, and quality management in general.

First of all, I enjoy our conversations because they have both seen many different quality processes in a variety of scenarios. They always come up with creative ways of approaching challenges I had not thought of.

Secondly, but most importantly, I love having in-depth discussions with these ‘experienced experts’. I really enjoy, in particular, the exchanges where I get them to share their knowledge, experience, ‘war stories’ and of course their opinion. The way I am ‘wired’ the more information they share the more curious I become and the more questions I ask!

Here is one of our discussions on Change Control:

Me (PG): Brian, is it just me or Change Control is not an easy process to automate? Or maybe it is a process most organizations struggle with – automated or not.

Brian Graeff (BG): Philippe, I think it’s the latter.

PG: Why is that?

BG: Uhm… [Followed by a long sigh… whisper…]

First: Trying to create a “unified” Change Control process to handle all types of changes– changes to SOPs, MBR, specs, test methods, protocols processes, equipment, and labeling– is a very tedious task.

Second: Forcing all document revisions through a Change Control system is not always necessary. Documents are revised in response to a change. They are not the change themselves. A good document control process incorporates Change Control elements that are usually sufficient for document control purposes.

Third: Not understanding the background and purpose for the Change Control and the associate reporting requirements for different markets is problematic. The purpose of Change Control is to prevent unintended consequences to the safety, purity, efficacy and quality of products. This includes:

Managing changes to information contained and commitments made in the regulatory dossier

Managing changes that may impact the safety, purity, efficacy and quality of a product

Managing changes that may impact the validated state of the product

Managing changes that may impact the validated state of the facility, equipment and process used in the manufacture of the product

Four: Organizations are reluctant to delegate responsibility and authority for Change Control. Rather than giving a group the responsibility, they tend to involve too many departments and overly complicate internal review and approval processes. In addition, they often require that Regulatory Affairs, in addition to the Quality, review all changes regardless of the category of the change.

Five: Trying to force documentation of a particular change into a template to help inexperienced people evaluate a change is not efficient. Each change is unique and requires review and approval by both SME’s and Quality.

PG: Thanks, Brian. All good points. I get it. So I guess it makes sense that a process built to control changes is so difficult to introduce in the first place!

PG: OK Benoit, you’re up. Assuming you figured out all of the above, why is it such a challenge to automate this process?

Benoit Prince (BP): Uhm… I don’t have time for this.

PG: OK… Tomorrow then?

BP: Alright, let’s get this over with…

Overall, I think the Change Control process is a challenge to automate because it is difficult for people to imagine an automated Change Control process being as flexible as the manual process, i.e. back and forth of the paper form, ad hoc meetings, discussions on outstanding items, etc. And we all know people love flexibility and options.

More specifically some of the challenges identified during our requirement elicitation workshops are:

Agreeing on types of changes that can be submitted

Adding implementation tasks once the Change Control is approved

Documenting the changes on the initial ‘target implementation date’

Adding approvers during the approval process

Handling emergency changes or documenting changes that have already taken place

Avoiding the temptation to turn the process into a project management tool

Ensuring there are clear designations on routes of approvals

PRE and POST approval related actions

The possibility of adding additional steps once the process is ready to close

Employees losing a “feeling” of control vs. their current manual change control process

PG: So how exactly does a company overcome these challenges?

BP: By focusing on what is key to the clients: compliance fundamentals, and making sure we do not focus too much energy on handling exceptions or tricky cases (there is always a way to document those, and they will always demand more time, automated or not).

PG: OK, you guys you’re off the hook. So I guess I get to keep my job for a little while after all, which is good news because I love this job.

If anyone needs help with Change Control and automation, we’ve seen a lot– so just give us a call!— at which point we’ll probably realize we haven’t seen it all. And that’s fine, because we’re always up for a challenge!

Philippe Gaudreau
Founder & CEO, SOLABS

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