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“In each of our engagements, Shelley took the lead to work with me individually to design our objectives, approach, and measures of success. Working with Shelley, I was able to achieve clarity of the goal and methodology for achieving the goal prior to engaging within the stakeholder communities.

Shelley is well prepared, drives to common understanding and alignment, and engages in the subject content and dialog to achieve group consensus on core root cause issues and possible solutions.”

JuneAn Lanigan
Director (former) Cisco Systems


Should the Process Office Lead a BPI Project? The Good and the Bad

Screen Shot 2014-11-08 at 9.44.54 AMA pharmaceutical company had been operating for over 15 years, so it was not a start up, but it was still privately owned.  It had grown to a middle market company with 1500 employees in the US and globally and had five successful products in the market place. 

Regulation demanded that clinical trials meet specific criteria.  The company had a small Process Improvement Department.  One of the projects they were working on was the Study Quality Metric Development Process, which allows for monitoring of critical components of a clinical study from the time the company starts collecting data on patients to database lock (the end of the project).

The Process Improvement Department knew how important this process was to the company.  Currently the process took too long and was often not finished by the time the first patient was enrolled.  The SQM Requirements frequently changed.  And, it was unclear who was in charge of this process.

When the Process Improvement Department decided to tackle this process, they knew improving it would result in faster cycle times and better quality results, not just for one drug but for many drugs.  So they began to look at how it worked today and see what improvements they could recommend.

The Good News 

1. They modeled a real SQM Development As Is processes
A BPM specialist from the Process Office and a Project Lead began by looking at one instance of the SQM Development process.  They modeled it, gathered baseline data, noted issues and improvement ideas that arose with the As Is modeling. 

2. They analyzed the current state and displayed it visually.
They determined problem areas, showed quantitative data to further clarify the As Is processes, and displayed these on a Visual Analysis Diagram. The model generated a lot of good discussion.  The example below is a portion of the Visual Analysis Diagram for the Study Quality Metric Development Process.

Screen Shot 2014-11-08 at 9.55.01 AM

3.  They discussed the current situation with the head of the Process Office and got her input.
They also talked about it with a few other managers and subject matter experts and gathered more ideas.

4.  They recommended Quick Wins and longer term improvements. 
They discovered where rework was slowing down the process and found out why.  The estimated the time of the rework and extrapolated the employee cost.  They determined what roles and responsibilities were unclear, often duplicative, and slowing approvals. 

The Bad News

1. There was no Process Owner or Executive Sponsor for this process. 
The Head of the Process Office operated as a spokesperson for management and the process, but did not have authority over any of the SQM Development processes.

 2. No charter was written. 
With no Process Owner and no Executive Sponsor, there was no one to set the goals (improvement targets) for the SQM Development Process,

When the Executive Sponsor and the Process Owner help formulate the charter, they take on ownership—not only for SQM Development in their own product area, but for the process across the enterprise.  They put their stamp on what needs to be done.  They sign up to advocate for the process effort, to drive implementation, and foster its execution across divisions.

3. There was no ongoing team of subject matter experts to help with the BPI effort.
Without a charter, Process Owner, and Executive Sponsor, no team was identified and assigned.  The Process Office worked with subject matter experts (SME’s), but more on an individual input basis.  An ongoing team of SME’s is critical for change management, building a company solution in response to the improvement targets, and having the synergy for implementing the improvements.  

 4. Implementation got stalled.
The head of the Process office moved on to another job at the company.  Another priority came up for the Process Improvement staff.  The implementation ideas got postponed.  As I say, “The air went out of the balloon.”  If the project had a Process Owner and Executive Sponsor it would have gone forward (although changes in leadership in these roles is also a risk.)

There is nothing wrong with having the Process Office support a BPI project and take roles the BPM Team Facilitator, or possibly the Project Lead.  But it is critical to identify the right Executive Sponsor and Process Owner and begin with a charter to focus the effort.

Want to learn more?  Take the virtual Starting and Organizing a BPM Project class February 17 and 18, 2015 and learn how to build committed executive support from the beginning and focus the project on a few key outcomes.  

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