Who's in Charge Here?


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-04-01-2003

If it?s not clear who?s in charge, then no one is?and process improvement can be undermined.

Process improvement projects start in many waystop-down, bottom-up, sidewaysbut they succeed only one way: with proper governance. Someone needs to be in charge: someone respected by those participating in the process and empowered by those who need to fund it or enforce the results.

Governance is too often the downfall of the best improvement plans. It is critical to any process change or improvement, any technology introduction, merger or acquisition, and all other organizational change. Governance is a combination of people, empowerment, legitimacy, procedure, politics, communication, and financing that ensures that change takes place. Because change, by definition, is disruptive to any group focused on its daily work, proper governance can make the difference between change as a positive force and change as a never-ending torment.

Governance folliesA team instead of a leader. The most common approach to a change management project is to appoint a team. We have previously excoriated teams in this column; they are too often formed because of a lack of imagination in ways to get work done. Teams have many uses in change managementensuring that all affected constituencies are involved, subdividing tasks and responsibilities, serving as a communications exchange. But they cant 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 ones toes, you step only to the right or left, 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 changea junior member of the management team, or worse, a business analyst. Consider the message this sends to the rest of the organization: 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. They use the tactic to ensure delay or inaction. Even if the choice is sincere, rarely can someone grow into a position 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 governance mistakes 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 (that is, generic trainers) or corporate process group. The rationale is often stated as, were the project management experts, or were the process change experts. That 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. If you wouldnt make them your clinical study managers tomorrow, then why make them your clinical trial process improvement managers today? Only when clinical research offers no other strong managers for project governance should you go to generic managers. Even then, your time may be better spent 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
Whats 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 governmentand 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 leaderthe embodiment of the project itselfsomeone 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
Properly running a process change project is not just about picking a strong leader. You 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 in the way of achieving success. The leader must indeed have a teamone made up 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 needed to get the work done, to see it through, especially from one budget year to the next. And that person 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 its not clear whos 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.

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