The Enterey Blog

4 Rules to Facility Start-up. Check Out Rule #1

Posted by Tita Tavares on Fri, Apr 17, 2015 @ 09:56 AM

A blog reweind:
Rule #1: Don’t lose the forest for the trees

Manufacturing facility start-up is a fact of life in the lifecycle of any biotech, pharmaceutical, or medical device company.  Whether it be a parent company that does manufacturing in house or a CMO, at some point in time during the lifecycle of a life sciences company a manufacturing facility will need to be built/acquired in order to manufacture the product.  When it comes to growing life sciences companies that have focused on small scale R&D type manufacturing, large scale facility start-up can seem like a daunting task.  To be sure, facility start-ups are large scale, complex projects that require careful coordination between multiple stakeholders both internal and external to life sciences companies.  However, the task can be much more manageable and much less daunting if you keep in mind these four simple rules.    

1)      Don’t lose the forest for the trees  

2)      Keep your air in balance  

3)      Remember Humpty Dumpty  

4)      The law of “The Jungle”  

Now you’re probably thinking, “What in the world do these 4 rules have to do with facility start-up?”  Over the next four weeks we’ll explore what each of these rules means and how they can set you up for a successful facility start-up.  We will start with the rule that is probably easiest to interpret:    

Don’t lose the forest for the trees”This oft used colloquialism is especially apropos of a start-up.  Due to the inherent complexity of start-ups there is a tendency to want to detail every activity and put it in a project plan so that nothing “slips through the cracks.”  While it is certainly beneficial to have a detailed project plan it is important to keep in mind that it must have an APPROPRIATE level of detail – that is, be detailed, but not too detailed.  Let’s explain further.  

It easy to understand why having too little detail allows for things to be missed since a lack of detail inherently implies that something is missing.  But how can too much detail be negative?  Often times an overly detailed schedule leads to too much schedule management (which is a non-value added activity) and detracts from project execution which is value add.  But even in the case where there are sufficient resources to manage a schedule, “over detail” leads to a false sense of security that everything is in the schedule and therefore nothing has been missed when something important truly is missing.

Take a look at the following 2 pictures as an example of this principle:

Facility Start-Up Pixel      Facility Start-up Mona Lisa

Suppose you were told that the picture on the left was an art masterpiece and you were asked to identify it.  You are unable to, because there is too much missing; there is not enough detail.

Now take a look at the picture on the right.  At first glance you may still feel like there still isn’t enough detail in order to identify it, but try stepping back from your computer screen.  The farther back you go the clearer the picture becomes until it is easily recognizable as Leonardo da Vinci’s Mona Lisa.  The picture on the right has an appropriate level of detail for you to recognize it for what it is and your facility start-up project plan should do the same.

You don’t want your project plan to be so simple that no one on the project team recognizes it as a project plan but you also don’t want to require so much detail that you are unable to take a step back and see the forest for the trees.

For more fun examples of “appropriate detail” go to:

Published by Carlo Odicino | VP, Operations


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Next blog:
4 Rules to Facility Start-up. Keep Your Air in Balance Rule #2

Tags: Facility Start-up, Start-up Biotech, Lifecycle of Pharmaceautical Company, Lifecycle of Biotech, Lifecycle of Medical Device, Manufacturing Facility, Small Scale R&D type Manufacturing, Appropriate Detail, Project Plan, Project Execution