Whenever someone asks me “what is organizational change management?”, I have to pause as all my thoughts clamor to be expressed. After over a decade and a half of practicing the discipline as an organizational change management consultant, I’m still excited to talk about it in any way anyone will allow me to. Since most of my years of practice have been within the life sciences industry–working particularly with pharmaceutical and biotech manufacturers–I’ve found that tying it to some of the subtle differences that those industries have and comparing them to non-regulated industries brings a bit more illumination.

There are two that I’ll focus on here:

1. How the term change management can be confused with organizational change management and how to clarify.
2. How change management can be used as a bridge, if you will, for quality organizations to build stronger connections across the departments with which they work.

Semantics – Change Control vs. Change Management vs. Organizational Change Management

Pharmaceutical companies, being in a regulated industry with a high degree of oversight by health authorities, are obligated to show control over their manufacturing processes. This control is intended to ensure the safety, purity, and identity of the products they make and thereby protect patients. Unlike consumer products companies, pharma companies can’t immediately switch out an ingredient (or active pharmaceutical ingredient in their case) for another. Processes that touch directly upon the product are highly controlled and should not change without a careful consideration of all impacts.

For example, a bicycle manufacturer can quickly switch out one part for another from a different vendor and maybe outsource some of the manufacturing to keep production running and customers happy. Pharma companies cannot change ingredients or process steps without a long string of time-intensive steps and approvals from various organizations and agencies. A change to any process that touches on a product require what is referred to as change control.

If that term sounds familiar, it’s because it’s a discipline also used by project management and IT. A change control process is intended to ensure that changes are assessed and implemented in a structured and controlled way so as to avoid conflicts with other suggested or implemented changes. If the conflicts are great enough, it could require the time, resources, and funding to back out those changes and go back to the status quo. In this context, change control is part of a broader discipline of change management which includes procedures for efficient handling of changes.

If you mention the word “change management” in a life sciences environment, minds will immediately go to this practice of change control. It’s not uncommon for this to happen, especially at pharma companies that are building their process maturity in change control. Some years ago I was introduced at a client as being an expert in change management. The client was delighted and began asking me questions about change control systems and processes. When we clarified that my expertise was organizational change management, or the people side of change, she was a bit dismayed but nevertheless intrigued.

I’ve found that one of the most important things to do when starting an organizational change management project at a pharma company is to explain the difference between organizational change management and their concept of change management/change control to more clearly outline the emphasis of each. Contrasted to change control, organizational change management is a cousin once removed. Those changes that are being examined also need a look at the other factors needed to make implementation a success.

You’ve likely heard of the People-Technology-Process triangle. It’s the People side of that triangle that organizational change management is focused on, and in a greater context. The People part of that triangle should include considering people both as interconnected members of a structure within an organization and also as individuals. If the change will require people to behave differently or perform their processes differently or use technology differently, the more you will want to include an organizational change management approach to ensure people will actually adopt those changes. The more that the success of your project relies on people doing things differently, the more organizational change management becomes a critical factor for success.

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The Quality Unit as User Advocate

Some of my favorite memories of change management projects were those where I worked with the quality unit at a pharma company. These departments are frequently viewed with fear and respect. Respect for what their aims are — ensuring a safe and pure product is released — and fear of the power they can wield — shutting down a process, rejecting a lot to be released (with the corresponding loss in revenue and potential loss in customer satisfaction for missed orders), and requesting a mountain of “paperwork” to get back on target.

For quality units that want to evolve from being viewed as policing the organization to having a role of “to serve and protect”, an organizational change management approach can be quite useful. Motivating, rather than ordering, people to behave differently may have more success. I had the pleasure of leading an organizational change management portion of a project for a pharma company that decided to take this new type of approach. Rather than wielding the hammer of “use the system or lose your job,” which, in practical terms was actually true, the quality unit wanted to take up the baton of User Advocate through the use of an organizational change management approach. We leveraged the Clarkston OCM methodology to take a clear-eyed examination of the stakeholders who would be impacted and to what degree, assessed and addressed their learning and communication needs, leveraged the strengths of the sponsors to visibly endorse the effort, and spun up an existing rewards system to enhance alignment. This approach succeeded in moving the individuals through the changes in a smoother and quicker manner while also making them fans of the newly implemented system and the quality unit that was behind it.

For those organizations that are considering or in the midst of rolling out a quality culture or quality mindset, this is one way to underscore and support that effort. Using a strong organizational change management approach to address the people side of the change shows a consideration for the end users rather than steamrolling over them with new processes.

When You’re an Organizational Change Management Consultant, The More Things Change, The More They Stay the Same

While it’s ironic to hear that “the only constant is change,” it’s also true that “the more things change, the more they stay the same” with respect to people being people. Transformational change is still racing ahead, particularly in the COVID-19 environment of today. But the affected people still need to learn and understand why they are being asked to change or execute differently, and ultimately obtain the necessary skills with user-friendly learning events in order to adapt to the changes coming their way. Using a flexible methodology that can scale to the situation at hand will always be foundational to success at both the individual change level and organization change level. Ultimately, it will ensure that business objectives are met.