It strucked me a few days ago.
I had never thought about it this way.
I needed to take a step back to see the horrible reality. CHANGE CONTROL… if CHANGE could be controlled!
I needed a frank conversation with a colleague to see it all.
Sooo clearly.
The main problem with the process change control in a regulated industry is that CHANGE :
– is inevitable (except of course from a vending machine);
– is almost occurring on a continuous basis;
– is the result of human creativity and initiative;
– is always carried for everyone around the person who initiated the change;
– is frequently accompanied by a ton (metric or imperial) of documents
and is NOT documented most of the time….

But we pretend we can CONTROL change by documenting it profusely.
I am again reminded to the Cynefin model of Dave Snowden.

Oh, I admit… I am not a certified Cynefin expert. I merely look at it and find so many applications that I am bound to write about it.
Oh, I will gladly take any comments from you, dear readers, that would correct my interpretations and help me learn more.
Oh, I might even be totally wrong about the model and my conclusions …
The model helps me explain so many situations and helps me see the futility of some of our efforts to manage our reality by adding layers upon layers of complicated (not complex) documents.

So yes… change control is an oxymoron!

Oxymoron : a figure of speech in which apparently contradictory terms appear in conjunction.

Change happens.
Documenting the change does not control it. You merely accept it. Or not.
Oh yes, it does look that way but think again…
Do you really look into every possible implication of this change?
Do you assess systematically the risk associated with it?
Do you talk with all the employees targeted or related by the change?
Do you, gulp, even understand the change?

Yes. Do you understand de change or why you document so much around it?
It might not be representative of all organizations but a few years ago a participant in my training session on validation and change control came to see me after the session to thank me. I was grateful for the compliment of course but she kept talking…
“you do not understand how good it was. How important is was for me! I used to work in the change control team in PharmXX. I worked for two years in that department and I approved change controls everyday. I never understood the work. Now I see.”
I almost fainted!
Oxymoron alert : change control!
Oxymoron alert : change control!

The process in some organizations is so vague, so ambiguous that some employees responsible for the process do not even understand!
The name itself is a contradiction.
And an emotional challenge!

Who wants changes imposed by others?
Who wants to be controlled?

I have yet to encounter a company where the change control process is a welcome addition to the plethora of documented process in place.

Et pourtant….

Oxymoron alert : change control!

I therefore propose a change !
Let’s change the name of the process !
From Change control to change assessment
OR change planning
Or even better : change optimization.

Change is complex. Always.
Even when a simple part is changed, the ramification of this change is not always foreseeable.

Trying to control it is sometimes like holding water in your bare hands. You might close your fist, try to squish it tight, water will win and leak out.
BUT…. understanding how water behaves might help you in the future.

The Cynefin model (yes again!) states that complex situations are always understood after the fact. Complicated situations are dealt with good practices… best practices are used only for simple situations.
Where do most of the changes occur in your organization?
Think back on past situations where problems occurred after a change. Were there simple situations ? No.
Were they complicated situations where lots of parts had to come together? Maybe. You might have to re-write a few procedures as a corrective action and modify the Change Control SOP.
Or maybe, those were complex situations where not only the processes involved lots of parts but also lots of different systems and, OH NO ! several human beings.
UNCONTROLLABLE human beings.

Yes, we do need procedures to structure the work, the process.
Yes, we need to document changes.
But we also need to admit that we do not control changes.
This fallacy has put us in a comfortable situation where we THINK we are in control and sometimes has blinded us to the real situation going on in our organization.
Coupling the Cynefin model to risk analysis and CHANGE OPTIMIZATION might help us go to the next step.


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