Here's an article I wrote a few years back showing how to plan a computer systems validation project. The methodology works for any project and it's the way I've been successfully planning projects for twenty years.
Project management techniques are universal. The proven, time-honored disciplines that make up project management can be effectively utilized and applied by virtually any manager, leader, or team member—regardless of industry, profession, or job title. The same skills I have used to develop and bring medical devices to market I have used to remodel my home and, most recently, validate pharmaceutical systems.
As Vice President of Project Management at QPharma, I train my project managers in a system I have developed over the years called ProgressixSM. The word is derived from three concepts central to my teaching:
- Progressive elaboration. The concept that a project needs to be elaborated progressively as we move from Idea*, to Purpose*, to Objective*, to Work Breakdown Structure*, to Responsibility Matrix*, to Schedule*, to Budget*, to Risk Analysis* to full Project Plan*. The project continues to be elaborated through execution and into closeout. (I first learned this order of project elaboration 9 years ago through a class I took from Cadence Management Corporation and have used it successfully since.)
- Six honest serving men. I use a poem from Rudyard Kipling to illustrate the key things that need to be known about a project to ensure a good, manageable plan.
I keep six honest serving men
(They taught me all I knew)
Their names are WHAT and WHY and WHEN
And HOW and WHERE and WHO
- Progress. Using the Tuckman Model, progress is made when the team moves from an awareness phase (which Tuckman refers to as FORMING*) through a conflict / control phase (STORMING*), a cooperation phase (NORMING*), and, finally, a productivity phase (PERFORMING*). This concept is evident with any group and is particularly useful in project teams.
So how do I go about this progressive elaboration? Let me use the example of a computer system validation we recently planned for a client. I became involved in a project that was already underway, because it was in trouble and the client had seen the success I had at projects in other departments.
The project was a corrective action tracking system. I was present at a very contentious meeting where two sides, the Clinical and the Information Services departments, were pointing fingers about how the project should progress. The meeting was very acrimonious, with little likelihood of any work being accomplished in the future.
Someone suggested I intervene, so I asked a simple question: “Who is the project manager?” Two hands rose, and I nodded, expecting them to glare at one another. But they had a different problem. One said she was the project manager from the programming group, and the other claimed to be the project manager from the users’ group. They added that they loved working together. I announced, however, that there can be only one project manager, and they needed to decide who it would be. The programmer was decided upon.
I requested that all the project participants, including the users and heads of the clinical and IS* departments, be present the following week at an all-day project kick-off session, which I would facilitate. They all agreed and, when the meeting time was decided, I sent out an agenda as shown below:
AGENDA
Time
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Item
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Led by..
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9:00 – 9:05
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Check in at room, Introductions
|
Bruce
|
9:05 – 9:15
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Icebreaker exercise
|
Bruce
|
9:15 – 9:30
|
Project Background
|
IS & clinical heads
|
9:30 – 10:00
|
Project Objective
|
Bruce
|
10:00 – 10:30
|
List of Deliverables
|
Bruce
|
10:30 – 10:45
|
Break
|
|
10:45 – 12:00
|
Work Breakdown Structure
|
Bruce
|
12:00 – 1:00
|
Working Lunch
|
|
12:00 – 2:00
|
Responsibility Matrix
|
Bruce
|
2:00 – 2:15
|
Break
|
|
2:15– 4:30
|
Schedule
|
Bruce
|
I arrived early, and posted my responsibility matrix and schedule charts on all the walls. People were slow to arrive (is this an IT thing or is it just me?), but they were all present just before 9:30. I scanned the room and, sure enough, Clinical was on one side, IT on the other.
I started with introductions and then we went into a quick icebreaker exercise, which melted rather than broke the ice in that room. The one I chose was participant bingo, where I had a 5 x 5 matrix filled out with things like: “Drives a red car; Has more than three children; Loves the show Survivor,” etc. People tried to achieve Bingo by taking it around and getting people to sign their names in the appropriate box.
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Next, I entered the six serving men scenario by answering the first question: WHY? Both department heads were able to speak their piece. Why are we doing this project? Why is it important to the company? Why is it important to the various departments and participants?
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During this project background session, the location of the project, WHERE, was easily answered as only the US offices, nowhere else in the worldwide offices of this company
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Then I took over. The room was clearly in a FORMING mode,