Why Most Compliance Remediation Projects Struggle on Forever

Are you a heavyweight project manager?  I’m not asking if you’re a heavy project manager.  Let me explain what a heavyweight project manager is and why it’s important.

If you are leading a compliance upgrade project, most of the people whom you rely upon to make the project successful probably don’t report to you.  You don’t write their performance reviews.  You didn’t hire them.  You can’t fire them.  You are not a heavyweight project manager.

We’ve talked about how you can influence the behavior of your team. It turns out that there many ways that you can improve the performance of your team.  But now I’d like to pull back and look at the structure of project management as a profession.

I’ll use an example from a completely different industry to illustrate how differences in the structure of your project team can make or break your project – and you.  In the 1980’s General Motors was trying to catch up with the new product development cycle that the Japanese car companies had been achieving for years.

Toyota and Honda had been churning out new models in less than 36 months.  GM’s goal was to design the car and start production in 60 months. 

Because GM knew that they couldn’t continue to lose the new model cycle-time race, they picked their best manager to lead the project.  They allocated plenty of resources to insure that they would not fail. 

It didn’t work.

GM’s project management process was the traditional stepwise approach.  Upper management decided that a new model was necessary and determined the general outline of the new car.  Marketing defined the detailed specifications.  Then the package was thrown over the wall to the designers. 

When the car’s styling was set, the package was again thrown over the wall to the Engineering department.  Engineering did its job in a vacuum, just like the other departments, then turned over its work to the next department, Manufacturing.

The net result with this sequential approach was that any changes that occurred during the project required that every previous department agree to the change and be prepared to revise the work they had already done.

For instance, by the time Manufacturing found out what they had to make, the design was essentially set.  Any changes to improve manufacturing costs or to reduce the chances of errors during assembly were very difficult to justify because of the amount of work that would have to be redone in order to implement them.

In addition to the ossified project management process that GM used, their personnel organization was equally dysfunctional.   Few of the project personnel actually reported to the project manager.  They were drawn from the functional departments and retained their allegiance to those departments. 

The path to promotion for team members was through their functional department.  Success depended on whether they made their department look good, not their contribution to the project.

The functional department managers chose who was assigned to the project and would even change who was assigned to the project if it suited the needs of the functional department.  The needs of the project were secondary.

In contrast, the status and authority that the Japanese companies assigned to their project managers towered over the Americans.  The terminology says it all, Shusa; loosely translated as heavyweight.  Project team member were transferred from their functional departments to the project as long as they were needed on the project.  Moreover, the Shusa had primary input on their careers.

The employees of the Japanese projects formed tightly knit teams around the Shusa.  They were supported by their respective functional department managers.  But their allegiance was to the project. 

Needless to say, GM’s project was delayed.  The first project manager quit in disgust.  The Japanese companies, meanwhile, continued to hone their management practices and decrease their project cycle times.

Why bring up auto company experience from thirty years ago when I’m mainly speaking to an audience of health product producers today.  The reason is that FDA compliance upgrade projects today are usually structured like GM’s new model project of the 1980s.  The remediation project is given to someone in Quality, who is told that the functional departments will supply all the help that is needed.  There is usually a big project kick-off meeting where top management tells everyone how important the project is and how everyone needs to support the project manager. 

In fact, in this case and also in the case of the GM project manager, manager is not the proper term.  Coordinator would be more apropos.  The project coordinator has all the responsibility and none of the authority needed to complete a successful project.  The result is that within a short time the team members start reverting to their normal roles within their functional departments.

Interestingly, many companies that are in the process of remediating compliance deficiencies rationalize their situation by claiming that they are too busy rolling out new products.

Does your company claim to be an innovation machine?  Really?  Here’s how to test that hypothesis.  Are your project managers heavyweights? If so, then your company is designed for innovation.  Are your project managers more like project coordinators?  Then your company is designed to be stationary.  If so, then you might want to think about moving.