Process improvement projects start in many ways — top-down, bottom-up and sideways — but they succeed only one way, with proper governance. Someone needs to be in charge: someone to be respected by those participating in the process, and empowered by those who need to fund it or enforce the results. It is governance that is too often the downfall of the best improvement plans.

Governance is critical to any process change or improvement, any technology introduction, mergers and acquisitions, and all other organizational change. Governance is a combination of people, empowerment, legitimacy, procedure, politics, communication and financing that ensures change gets done. Because change, by definition, is so disruptive to any group focused on its daily work, proper governance can be the difference between that change being a positive force, and being a never-ending torment.

A team instead of a leader
How is governance of a change management project usually handled? The most common approach is to appoint a “team”. We have previously excoriated teams in this column, for too often being formed because of a lack of imagination in ways to get work done. Teams have many uses in change management: ensuring all affected constituencies are involved, subdividing tasks and responsibilities, serving as a communications exchange. But they can’t govern.

A team can have a leader, but by itself it cannot lead. Indeed, teams are often appointed because the organization or executive is afraid of choosing a leader. By stepping on no one’s toes, you only step to the right or left, and never forward.

Teams are too readily victims of our overcrowded calendars. The team meeting is one of dozens every month and they all begin to blur. More importantly, teams usually consist of individual contributors without any power in their own department, much less the power to handle an interdepartmental project.

In over his head
Another common way to fail at governance is to appoint a low-level manager as the leader of the change –a junior member of the management team, or worse, a “business analyst”. What message does this send to the rest of the organization? That this project is not important enough for a more visible, empowered leader. Often we see someone purposefully put in over his head. Usually when executives say the person will “grow into it”, what they mean is “not in my lifetime,” and use the tactic to ensure delay or inaction. Even if this choice is sincere, rarely can someone in fact “grow into it” without active mentoring. This method of governance ultimately lacks the legitimacy, in the political sense of the word, to marshal action, follow through, and success.

The third party
One of the more dangerous mistakes of governance in change management is choosing a “disinterested third party” as the project manager. Too often these folks are not only disinterested, but uninformed. Typically such managers are pulled from information services (IS) groups, or perhaps an organizational development group (i.e., generic trainers), or corporate process group. The rationale is often stated as, “we’re the project management experts,” or “we’re the process change experts”, which may be true, but such skills are not universally applicable or necessarily sufficient.

IS departments do implement large scale projects, but so do a lot of other groups in your company. Would you make them your clinical study manager tomorrow? Then why make them your clinical trial process improvement manager? If there are no other strong managers to look to for project governance within clinical research, then maybe generic managers can help, or maybe you should be developing more process management skill within the clinical disciplines.

No one has the time
When confronted with these suboptimal alternatives for project governance, most executives will say that no one who would be really appropriate for the job has the time. If the process improvement, or technology adoption, or acquisition is worth doing, then someone of sufficient skill and power needs to be assigned the time. Do you not have time to breathe? Do you not have time to achieve your goal for First Patient In, or Database Lock? Do you not have time to meet your regulatory filing dates? Of course you do. We make time for what is important to us.

The cost of poor governance
What’s so bad about poor project governance? Maybe you feel you have very strong political, personal, or financial reasons to make one or more of the compromises outlined above. The cost of poor governance is high. It directly and quickly leads to:

– A lack of focus: a weakly governed project will inevitably drift, as different forces jump in to fill the vacuum of power, even in all sincerity and goodwill;

– A lack of pace: the fatal start-and-stop of a major change process, which undermines staff motivation, stretches the timeline painfully, and is very costly;

– A lack of decisiveness: no governance, no government — critical decisions stall;

– A lack of learning: people will move in and out of the project, without much buy-in, and therefore have little to gain from learning how to “do it right next time”;

– A lack of gravitas: the absence of the credibility of a true leader — the embodiment of the project itself –someone who can look in the eye of the naysayers, the obstructionists, the skeptics, and the newcomers, and say “I was there; this is what we did.”Not just a champion

So how do we properly run a process change project? It is not just about picking a strong leader. You will need to decide carefully how important this project is and how much political weight it deserves. The leader must be backed by upper management, and be able to discuss frankly with management the obstacles she is finding to achieve success. The leader must indeed have a team — one made of people who have the time and knowledge to devote to the project and who are willing to be led. The leader must have the money she needs to get the work done, to see it through, especially from one budget year to the next. And he must have a process of governance to use, with an effective range of communication options, clear decision milestones, contingency plans, and a framework of purpose.

Governance can make or break your initiative. If it’s not clear who’s in charge here, then no one is. Stop and find yourself a leader. Give her the respect and the funding she needs, and follow her to the future.