Listening to people distill what change management is over the years will be no different than this post. It will be reductive and miss some major points. You have to live change management. Change management is nuanced, fraught with risk, and most importantly requires the change owner to truly 'own' the system. Not just in name but in character and responsibility, they should be the R, A, C, and I about everything to do with their system. Reductive, I told you. But the people that most corporations put into change owners are typically on of the RACI letters that some manager or supervisor says "Just give it to [so and so], they really know that system". Another level of reductivism. Owners have a keyhole view of their system. Look at how and what owners are responsible for, pieces of a program, typically around a piece of software or a piece of a quality system for an area. You may be the system or process owner (yet another issue in granularity and change) for deviations in your department. You may own a larger software system because you are an IT person. But in the end do you know what you are doing? Be honest. And if you do truly know, what did you have to do and how long did it take for you to become conversationally the proud custodian of that system. Even though, it is still a narrow view of a critical piece of the site. And even further, your site may integrate or influence other sites. If you truly think about it, this is where it gets scarier.
If you live in the world where you are always going to be a startup, guess what, you may have dodged a bullet, there is nothing for you to really be scared of. But if you plan to be acquired. If you plan to be integrated in a short time. If your mission critical goal requires that there is tight control of the 'secret sauce' that is your tech, IP or whatever, then maybe there might be nuggets to think about (I didn't say if those nuggets would be gold or shit.)
Every program needs a change manager. Every company needs a change architect. I will fight you on this. There may be multiple tracks for change but I assure you there is not enough oversight.
Unfortunately I am going to stick another sword into what the industry and quite frankly humanity has a problem with, how we communicate. More on that later. Likely lots more on that later because we are all guilty. EVERY ONE OF US.
The corporate global types of the world have such a reductive big Pharma view of the world that they don't understand that the level of churn that happened over the past several decades has resulted in our collective industry brains scrambled about change management.
In the late 90's and 2000's the industry went mad with mergers and acquisitions. Flush with cash, the growth was artificial. The integrations were shit. Only until someone said, "STAHHHHHP" in the respective company was there a step back where a corporate system pushed down a corporate standard/guidance. IT TOOK WAY TO LONG TO FIGURE THAT OUT. Millions/Billions were spent only for standards when finally applied, seeing the real value of the company acquired. We looked at financial value, and value of IP but were so reductive as to the amount of change that would be needed to assimilate to the absorbing companies values. Let alone look at the company to be absorbed and question if the acquiring company should take on the acquired companies values.
Unfortunately companies do not do the most basic thing we do when people enter into a relationship, evaluate what makes them better for being in the relationship; I digress.
When I mean every program, I do indeed mean every program. Yeah it sounds like a drag, but that is how we get to meaningful quality.
What do I mean by program? Every quality system is just that, a system. They perform one part of the overall program function. CAPA, Internal Audit, Supplier Quality Management are in general, a program when you cobble them together. They are a machine that runs one portion of the business. Quality Operations, is another program. Quality Control, yet another program.
So if you are a director or manager, you should have people assigned that are the change managers for the area. They do not need to be management themselves but to be able to manage specifics about the system and overall program at a detailed level.
Each of these programs as you put them together have interconnections. This is where you have organizational change management, a step higher than change management, which is, in my opinion a stage higher than just change control.
The interconnections are the next level to deal with, this is where the Change Architect comes in. The Architect needs the keys to the kingdom. They need the vision, the roadmaps and the reality of what is going to be able to happen. Some would say that this is the CEO or general manager, that is rubbish. HOW CAN THEY.
[sidebar] Think about every title you have ever had. Did your job description cover what you were actually doing? Did it capture 20%? MAYBE? Depending on the chaos, depending on the growth, those functional people are absolutely dysfunctional. They have no bandwidth to do the role. They need enablers. People that DO. Take people off the playing field and give them a unit focus as much as practical. For the change architect, the sell is this: dear corporate overlords, you continue to ask more and more of us faster and faster and are upset that you cannot get a weekly report on updates to what you asked in terms of implementation this Monday. How about you pay a person low six figures to just move parts and pieces into place. That you value them enough that when they tell you where it is stuck, you believe them and resource it accordingly. [Sidebar over]
Here is my pitch.
Let's take it back to training. Then let's look at systems and how robust they can be.
Scale is a problem. The FDA I would imagine understands that.
Being in the quality unit ends up being adversarial as there is this propensity to pick sides, but there should not be sides. The only way that the industry is going to grow is to lean into the trust paradigm. That being that there is no way that there are enough inspectors to look at everything in the industry. Jesus they have 1/6th of the economy. We need to be the good actors. We have to be critical of what we do and create a system that has enough data resolution with sensitivity to pick up how we are operating. My point of change management being not utilized enough is that we, as an industry, need to create the trails to diagnose what happened so we can determine what went wrong. All while trying to change the systems meaningfully to improve the environment and the system.
As I have vacillated through my career as being part of big Pharma, consulting, start up and CDMO quality person I have a perspective that I think may be helpful.
The organism that is management in its evolutions and distractions does not have enough self awareness to manage itself in the current minimalistic paradigm which is cGMP. This isn't taking on a total quality management schema. What I am proposing is that change management is a proper tool that needs wider usage that is empowered. We empower our operators, but we don't empower the people because quite frankly we don't communicate the vision.
For example, when looking at a simple piece of equipment, I gather that the simplicity of an equipment use and cleaning log at scale tend to get convoluted from their simple purpose. The purpose being that at any point in time, what happened to the equipment? Let's take that even a step further back. How often in an environment is the following paradigm executed; "each time I touch a piece of equipment, I need to have a permission piece of paper to interact with the quality system that is the equipment use and cleaning log so I can use the equipment? However, the level of detail needed to interact is NEVER built into the system. The process of signing on, because of people, takes the lazy route. Checkboxes make it quicker, but it has no substance. We have used change management to dumb down our systems. As an industry, we need to elevate our operators through training. Training an experience in the cGMPs should, in my opinion, be amended to the following. "Have the training and experience to understand the intent of their role and how it impacts the quality of the products they directly/indirectly produce." See what I did there? This both helped to define the deliverables while helping to screen out the bad ones. If the training does not relate back to the intent of what they are doing and how it supports the quality of the product, then it sucks as a training. See you have a reductive horizon. You. Are. Welcome.
I hate saying that but it's true.
Operations wants to do one thing, make product. Right. Yeah. Makes sense. But because of the overhead of a quality system we have yet to see the collective value of execution in a quality mindset. I mean, some people absolutely get it, but ask yourself as a quality professional, how many people in your peer and colleague group get the religion of cGMP. The real meaning of it. Be honest.
The paper gets in the way. Being honest again, it is supposed to be in the way. But how many people get that? They need to know WHY it is in the way.
We have valued the operator's time and therefore paper burden and training to minimize errors, but we do not consider that part of the errors that we are introducing through being reductive in our systems is devaluing compliance itself. We need to value operators and that they can fully understand the intent of what they do. How it impacts their families and friends.
We in pharmaceutical management are using different value statements. Quality has one mission, Operations, has another. And in the end Quality gets marginalized. What I am proposing here is that we take some of the medical device mindset from ISO and take it into Pharma. Give it teeth. Both the program managers will have the intimacy of the programs, with the architect setting the vision, and the operators seeing the point of it all.