From The Anonymous Plant Manager The words from the outside compliance consultant hit me right between the eyes. So that was the official diagnosis for the incredible frustration and stress my team and I felt in trying to reach a consent decree commitment date at this manufacturing site. It should have been apparent for at least the last 10 months that this was a commitment no one else too high up in the organization really supported, despite the presence of the FDA decree. I asked, So, what can I do about it? The consultant replied, What do you want to do? I told the consultant that I wanted this situation to change and improve. I wanted other directors to demonstrate support and accountability for reaching milestones and commitment dates that had been promised the FDA. I told the consultant that I wanted to get the voices of my team members heard so we could reduce work pressure and make life easier for everyone. I dont know if I can promise you all of that, but heres what I can promise, the consultant replied. Youve got to change your strategy and approach if youre going to get what you want and especially if youre going to stop being marginalized in this environment. I was eager to learn how to work through this difficult and frustrating situation. The consultant shared with me that from his observation post, we had no real or effective sponsor for our work. I hate to break it to you, but the managing director doesnt care about this part of the quality system as much as you do. His expectations are far, far lower than yours. In fact, he sees your efforts as slowing down the manufacturing process and preventing product from getting shipped. Before I could say anything, the consultant said, I know, I know, its hard to believe, but thats the situation and other directors are just taking his cue. Im going to tell you that youll need to get a new sponsor without alienating or creating any more friction with the current director. In fact, this little shift in sponsorship may be a win-win solution considering the workload and stress this person is experiencing. So, how do I go about persuading someone else to sponsor this consent decree project? Before we talk who, lets discuss how youre going to approach this someone else and what information youll be presenting and why. Look, in the process of accepting change, people go through predictable and normal responses. I dont care who you are or what topic youre talking about, this is the process you have to work other people through. What do you think the first step is? Well, Ive got to let someone know about the current situation. Correct. This step of the change process is called Awareness. We see thing through eyes that are accustomed to business as usual. It doesnt really matter if theres a consent decree or not, or if theres a huge market for the new product youve developed or whether senior executives have given speeches on this topic. People have two questions at this stage of the game: Why do I (or we) have to change and whats in it for me? I thought we did all of this at the beginning of the project. I thought we had consensus during the project kickoff. Why arent we just getting on with it? You had an agreement 10 months ago, but something has changed in the environment and you havent changed your thinking or strategy in response to this change. Many leaders, including you, mistakenly believe that people should automatically know whats going on and change or improve because they have to. The consultant continued, So, the Awareness thats required today is different than when you started the project 10 months ago. What information would you present to a potential new sponsor about the need for change with your consent decree project? So, what information would you present to a potential new sponsor about the need for change with the consent decree project? I replied, Well, I would bring this individual up-to-speed on whats been happening - or not happening - in the last 10 months. I would go back to the business case for why we as a manufacturing site have to do this. I would provide documented examples of failures within this quality system that have impacted our ability to meet both GMP compliance and delivery requirements. I would also ask this individual for their perspective and then their advice. Very good, the consultant replied. You have been paying attention to some of the topics weve been reviewing in the change management classes. How do you think your potential new sponsor is going to react? Probably in the same fashion as everyone else “ negatively. There seems to be a built-in, automatic reflex in this organization to immediately deny that anything is wrong. I know the company has been besieged with lawsuits over the past eight years, but sticking your head in the sand isnt going to make the situation better. This second phase of change “ the Denial phase “ is tricky, the consultant said. Most responses to even the prospect of change are negative. Change is viewed as a threat to stability, but its really a fear of the unknown. People in denial usually say some pretty interesting things. What do you think your new sponsor might say? Certainly, I hope this individual would be different, but they might initially say, ˜Im too busy right now. They might minimize the potential impact of not taking action by saying, ˜its not a compliance or consent decree risk. They might even want to wait until someone else takes action to reduce any perceived political risk. The consultant replied, Im glad youre starting to anticipate typical responses of people in denial. Of course, if you select your person correctly, the amount of time you and he or she spend in this phase will be minimal. What do you think happens next? I remember all of the discussions about ˜resistance to change. Resistance occurs when people begin to let reality sink in. People in the Resistance phase show anger, complain, and sometimes sabotage. They provide excuses, act burned out, and wont let go of old habits or ˜comfort zones. The consultant said, Youve met some major resistance to the changes proposed by your consent decree project. How might your potential new sponsor facilitate the transfer of this project? And, how do you both do it in a way that saves face for the managing director? If I select an individual that the managing director respects, then I think we have a chance. But its going to take a person with a strong personality and armed with a lot of data to work this individual through denial and resistance. Do you think your new sponsor will understand these first three phases of the change process? I replied, I can think of two people who might be willing to provide me with advice as well as consider taking on project sponsorship. Ill need to work them through any denial or unwillingness they have to face up to these critical issues. I need to help them understand that weve had unrealistic expectations about the type of change weve asked of ourselves and the amount of resources needed to accomplish it. I need to frame the issue as less of the managing directors treatment of the project or myself and the team and focus instead on how we can find a win-win solution. The consultant replied, It sounds like youre starting to move through your own denial and resistance to confront this situation and make a change for the better. The consultant replied, It sounds like youre starting to move through your own denial and resistance to confront this situation and make a change for the better. Yeah, Im starting to see that if my team and I are going to stop being marginalized, then we need to approach the issue from a different point of view. And that means I have to start the process. Good, now that youve seen the light, lets talk about the final two stages of the change process. The Exploration Phase is where your new sponsor or sponsors will be willing to take on some risk in proposing a change in project sponsorship. You have to also be willing to entertain new ideas and possibilities, including the possibility that the hoped for change might not happen. Are you ready for this? asked the consultant. Yes, I am. But Im starting to realize as a result of our discussion that I first need to have a conversation with my supervisor, the managing director, about my perceptions of being marginalized. I guess Ive been dreading this dialogue because of his reputation for responding emotionally to negative situations. How might you start off the discussion? Id use the same approach that I just mentioned a second ago with the two individuals I thought might make better sponsors for this consent decree project. And they still could become sponsors, could they not? asked the consultant. Well, youre right. But thats a solution that might come about as a result of having an honest, heart-to-heart conversation with my boss. Once I work this person through the denial and resistance phases, this is something that could pop out of our exploring possible solutions together. I know the managing director will be looking for solutions, so I need to have a number of practical options available for him to consider. One of these could be a change in sponsorship. My friend, intoned the consultant, youve just worked through the last phase of change, the Commitment Phase. This is where people take ownership and responsibility for new and improved ways of doing things. People with commitment feel in personal control and they take ownership. They feel comfortable and hopeful about the future. They reflect on what theyve learned or just been through. Congratulations, but you did a great job of talking yourself through the process of change. Youre back on the road to implementing this consent decree project and meeting the upcoming commitment date. I want to thank you for helping me think through this situation. Do you have any other words of wisdom for me? Of course, thats what I get paid for, chuckled the compliance consultant. If youre going to be a change-meister, then you are in the business of helping people (1) see why they have to change, (2) let go of old ways and habits, (3) align with new requirements or direction, (4) adapt to new values and behaviors, (5) commit to what needs to be done to make it work, (6) get involved with creating success, (7) develop resiliency by learning new skills, and (8) view continuous improvement as just a part of their jobs. As the story goes within this pharmaceutical plant, our compliance project manager was successful in getting required support, a project completed by the commitment date, and a better opportunity within the organization.