The Enterey Blog

We’ve all been involved in projects that seem to go on forever and ever or seem to take on additional resources. As project management specialists, we’ve come up with a list of five key components necessary for project management.

The five, explained below, are:

1. Scope definition at the start of the project

2. Set milestones and goals

3. Define your team and resources/Ensure you have the expertise to identify problems

4. Maintain good communication throughout the project

5. Track progress and review results

Scope definition at the start of the project: In this first, important step, we establish exactly what the project’s goal is, what’s in the scope and what is outside of the scope of the project. Experience has shown us that it is just as important to define what the project WILL accomplish as what it WILL NOT in order to control the direction of the project. Part of defining the scope is to also to define the timeline and deadline for the project’s completion.

Set milestones and goals: Once we define the scope, we can then define the different tasks that go along with it. The purpose of identifying milestones is to set intermediate measuring points to rate the project. By grouping milestones together, we can then establish more specific timelines.

On some projects, a milestone will serve as a marker to make a decision or to reassess a previous decision. For instance, while going through the review of a bidding process for a facility or in processing equipment, you will need to review different bid packages. In this case, a milestone will represent a decision point during the evaluation process to select a contract. Your overall goals will incorporate a number of milestones and you’ll need to create a schedule that ties all of these components together.
 

Define your team and resources: Depending on the project, you will need to identify the disciplines that your project requires. If it is technical, you will need people with certain problem-solving or trouble-shooting expertise. If there are trades involved, you might need somebody from electrical or quality. Whatever the project requires, you’ll need to identify all the stakeholders as well as what role each would play. You’ll also need to establish who would be reviewing/managing the work that gets done to make sure it is completed satisfactorily.

Also, when putting your team together, you’ll need to take into consideration the time commitment involved and ensure that each person involved is able to dedicate the time to work on it.

Maintain good communication throughout the project: Good communication is key to the success of any project. Each team player needs to be aware of the overall schedule, of the work they need to complete or what they will have to review. They will also need to be aware of what is going on with the rest of the project as it moves along.

In addition to making sure that those involved know their responsibilities, they also may need to know the milestones that have been set. Throughout the project, maintain a central repository of information, whether it is on a shared drive, online, or at a physical location. This will be where the team can get the latest information or whatever else they may need. Make sure that everybody has proper access to it.
 

Track progress and review results: Initially, you’ll need to establish how often your team or key players will need to meet: Will it be daily or weekly? Then you’ll need to track the progress that has been made in between each meeting for each of the tasks. Is everything on schedule? What tasks have been completed?

It’s helpful to identify any obstacles you may run into ahead of time so that you can account for them. Do you need any additional resources or departments to complete a task?

When additional resources have been requested, track whether they have been provided. When reviewing the results, you will need to identify when each tasks was completed, acknowledge that it was completed, and share this information with the stakeholders so that a task is not revisited and time is not wasted. By following through on the Five Critical Areas of Project Management, you can ensure that you meet your deadlines on time, on target and on budget.

Now we’d like to hear from you. What areas of project management have been problematic for your team? Where has your project hit a snag or lost or gained time? With these tips, do you think you can be more effective in your project management?

Similar to our cars, manufacturing facilities require periodic maintenance.  Most facilities are shutdown every 6-18 months to perform preventative maintenance or repair tasks on facility and utility systems.  What’s the worst that can happen if these are skipped?  There’s probably no significant damage to systems if caught in relatively short time.  But despite the low risk, there is a possibility of failure of equipment and systems when operating outside of the manufacturers’ recommended maintenance intervals.  These repairs can cost a significant amount of money, cause facility downtime, and most importantly potential contamination or loss of product. Most importantly, it will also require a resource draining assessment of the impact to manufacturing processes and products.  

Knowing this, the U.S. Food and Drug Administration requires that facilities and equipment be maintained and kept in good repair in 21 Code of Federal Regulations (CFR) Part 110.  One manufacturer, a pharmaceutical manufacturing facility in North Carolina, who ignored this warning learned the hard way when in November of 2007, they underwent an inspection by the FDA.  The inspector found environmental monitoring excursions in the purified water loop dating back to February and March of 2007 – eight months earlier. 

While the company noted that a modification to the purified water loop would correct the problem, the necessary parts had not been ordered or installed.  In fact, the company waited until June 2008, during the plant’s semi-annual plant maintenance shutdown, to install it.  In the meantime, production was compromised by this and other issues which they failed to address or rectify.

As a result of this and other significant violations, the FDA issued a warning letter and advised the company to take prompt action to correct all deviations. Failure to do so would result in regulatory action including seizure and/or injunction.

Had this company taken the necessary steps to schedule the maintenance and modification of their purified water loop during their annual or semi-annual plant maintenance shutdowns, they could have identified issues causing the environmental excursions, then successfully taken corrective action.  Their inspection would have gone smoother and they could have avoided receiving the dreaded “483 - FDA Warning Letter” and the prospect of fines, penalties and expensive repairs.

Most importantly, they would not have compromised their manufacturing facility with potential contaminants which could lead to risks for patients, loss of contracts, the destruction of inventory, and a public relations nightmare.

By scheduling periodic facility maintenance shutdowns, complete preventative maintenance designed to improve equipment life can be performed along with any modifications and system updates.  With the appropriate time afforded for a shutdown, operations can be expected to run at the greatest efficiency, eliminating or minimizing the need for unplanned facility downtime.

To ensure the longevity of your operations, schedule your facility maintenance shutdowns. You’ll sleep better knowing that all systems are on track.

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Next week’s blog:
A Look at What Happens Behind the Scenes of a Plant Maintenance Shutdown

We’ve reached our final rule for facility start-ups:

The law of “The Jungle”
 

This rule is a play on two literary references that are applicable to a Life Sciences facility start-up.  The first is a reference to the book The Jungle by Upton Sinclair.   This book, published in 1905, exposed unsanitary conditions in the Chicago meat packing industry and served as a catalyst for the Pure Food and Drug Act passed in 1906.  This act is a pre-cursor to today’s current good manufacturing practices (cGMPs) that govern Life Sciences companies.  These cGMPs are non-negotiable and must be followed regardless of impact to the schedule of the start-up.  I know for most this goes without saying, but it is worth driving home the point.  Yes cGMPs are guidelines, and yes most companies go above and beyond cGMPs but in the thick of some of the financial pressures that occur during a highly visible capital projects like a facility start-up these sometimes can and do get forgotten. 

I realize in rule #3 we stressed not placing invisible boundaries to problem solving, cGMPs are very real boundaries and should always be followed.

The second literary reference is to the last line of Rudyard Kipling’s poem The Law of the Jungle which is as follows

“…For the strength of the Pack is the Wolf, and the strength of the Wolf is the Pack.”

This one line summarizes the type of teamwork that is required through a successful start-up.  There is no one individual or functional area that is more important than another.  All groups / individuals play their part and need to work together to both solve problems and drive towards success.   There will be problems, there will be delays but a start-up team will always succeed if they focus on the appropriate level of detail, are balanced in their approach, don’t create artificial boundaries, all while adhering to cGMPs and working as a TRUE team.

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Next week’s blog:
Laboratory Information Management System (LIMS) toward Streamlined Biotechnology and Pharmaceutical Operations

Rule #3: A deeper look into facility start-up.

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“Remember Humpty Dumpty”

Now I’m sure you’re wondering what this rule has to do with facility start-ups, but before we go down that path let’s start with a simple exercise: draw Humpty Dumpty.  Go ahead, get out a sheet of paper and draw Humpty Dumpty.  It doesn’t need to be a masterpiece, just draw what you think of when you hear Humpty Dumpty…I’ll wait.   How many of you drew something that resembles an egg?  Before we go further, go ahead and read the typical version of the nursery rhyme “Humpty Dumpty”

Humpty Dumpty sat on a wall,
Humpty Dumpty had a great fall.
All the king's horses and all the king's men
Couldn't put Humpty together again

After reading the rhyme, I’ll ask a simple question, where does it say that Humpty Dumpty is an egg?  Obviously it doesn’t but we’ve been trained to think of Humpty Dumpty as an egg because someone drew him/her/it (I’ll use him for ease) that way many moons ago.  If you didn’t draw him as an egg; bravo!  I know I would have drawn him as an egg.  The point I’m trying to make is that it is important not to set artificial boundaries, particularly when trying to solve a problem.

During facility start-up the only thing you can count on is that things will change.  Issues will arise that are unexpected and that will require creative solutions.  When trying to come up with a solution just remember; Humpty Dumpty does not have to be an egg.  In other words, question everything and don’t set artificial boundaries for yourself.  Life sciences is already a regulated industry and you certainly don’t need to add more “artificial” regulations.

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Published by Carlo Odicino | Former Director, Client Services

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:

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:
http://www.moillusions.com/2010/11/our-brain-is-truly-wonderful.html

Published by Carlo Odicino | Director, Client Services

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

Is Social Media
that Important to Pharma Companies?

As a follow up to our May 5, 2011 post, Pharma, Social Media and the FDA's Delay, here's an interesting development that just might help push pharma companies to stay on top of the FDA to issue further guidelines on the industry's interaction in the social media world.

By August 15th, Facebook will require pharmaceutical companies to enable and allow public comments on their posts. This could be a huge risk and may be a big problem for pharma marketers, posing whether or not the benefits of Facebook are worth the effort.

Basically, it will take a lot of monitoring to make sure the conversations and dialogues on their company pages remain in a positive light for the manufacturers. Will this solution be cost prohibiting or will it be minor when weighed against the benefits and attraction Facebook interaction creates?

Is this decision made by Facebook a good one or not? This type of action may be what the social media mogul needed to keep their brand and product consistent all the way through. Facebook is created to be a virtul forum for real conversations to take place. It allows people to interact in the comforts of their own environments. Taking away the ability to engage in a virtual dialogue would be like telling someone, "Let's talk but do not say anything. I am the only one allowed to talk here but please listen." That isn't much of a conversation anyone would want to engage in, virtual or not!

Though Facebook's policies may be a hurdle for pharma companies and their marketing teams--if they play it right--they should be able to leap easily over the challenges and continue to use the virtual platform as a vehicle to set a casual tone in relating to their customers and patients. The informal approach could lead to patients feeling like they really matter to these seemingly HUMONGEOUS companies and at that, patient loyalty would be well worth the effort.

From stacyrobin on twitter: New realities for pharma? RT @kbkcomm: Hmmm...@Facebook says: pharmas must enable comments by August 15 http://ht.ly/52X6q (http://twitter.com/stacyrobin/statuses/73827493462806529

To get a better understanding of Facebook’s policies towards the pharma industry, read Intouch Solution’s Blog for their view and comments.

Published by: Tita Tavares, Enterey | Director, Brand Development

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Next week’s blog:
Facility Start Up in Biotech

Resource link:
http://bit.ly/gd70PZ
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