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    Pharma Beat

    The Changing Approach to Design: Five Ways to Achieve Warp Speed

    Revisiting facility design and construction based on today’s biopharmaceutical industry needs.

    The Changing Approach to Design: Five Ways to Achieve Warp Speed
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    Jarrod Wrampe, Contributing Editor10.14.20
    The current administration has dubbed the expedited path to COVID-19 vaccine, coordinated through the Department of Health and Human Services, as “Operation Warp Speed,” presumably in a reference to the Star Trek series.

    That’s fitting, because as any die-hard Star Trek fan knows, if the industry is to hit Warp Speed it’s going to rely on architecture and engineering design—along construction. And it will require maximum effort. It’s not for nothing that every time Captain Kirk demanded “more power” from the Enterprise, the hard-working team in engineering were “giving it all [it’s] got.”

    Getting to Warp Speed cannot simply be a matter of doing the same things faster. There will need to be a re-thinking of the process by which facilities are designed, engineered, built and ultimately put to work.

    This new way of thinking has recently been brought into stark relief with my company’s buildout of a multiple production suite coronavirus vaccine manufacturing facility. Effectively the project was begun April 1, with a goal to have a vaccine ready by the end of the year.

    Despite (or perhaps because of) that extremely aggressive timeline, we all knew from Day One that the project will be bigger than any one of the companies involved. This is a project that can positively affect the welfare of billions of people. It’s a sobering responsibility, and it demands real innovation to move forward successfully.

    The essence of Warp Speed: Staying one step ahead
    We’ll provide practical advice in a moment, but at its essence, getting to Warp Speed means taking a completely different approach design, engineering, construction and client leadership than any of us may be accustomed to. You’ll need to be in communication daily with stakeholders, and everyone concerned must stay in lockstep as changes are implemented. It’s more than a “just in time” approach, it is more than an “ahead of the curve” play. The entire team must always stay one step ahead of where you even think you need to be.

    The pandemic has all but eliminated the luxury of time. It’s no longer logical to wait for absolutely every conceivable piece of information to be in your hands before you take a single step forward. All the various project components—design, engineering, construction, and vendor coordination, as well as all of the owner concerns—have to move forward as a cohesive a unit.

    Why? One example is that it allows you to move more easily through possible supply chain problems. For example, in the earliest days of the coronavirus, very few steel mills were operating. Once we found a mill that was able to accommodate the order we needed to place (no easy task), we had to complete our structural steel design package to allow for the flexibility of ongoing design changes (because design was still happening). And this had to happen quickly enough to get into the steel mill’s queue and have our steel delivered on time.

    That led to some departures from traditional practices. Typically, a design engineer, when calculating load, will also make recommendations on a range of shapes for steel to carry that load. That type of recommendation might save some steel tonnage costs, but unless the savings are appreciable, it is more timely to minimize the different shapes used to accommodate unknown design changes. That type of decision will likely give you greater flexibility in the construction phase down the road.

    Practical advice from the engineering deck
    So, what are some of the most important things to keep in mind when approaching facility construction at Warp Speed? Here are five key concepts to start from:

    1. Identify key decision makers early in design, ownership and construction. Generally speaking, there should be an owner counterpart for each discipline, to act as a point of contact and decision making authority to keep the project moving forward.

    This step is essential for budgetary and other concerns on the owner’s side. For example, a budgetary concern may drive a decision to put some aspect of the project on hold, and someone needs to be in charge to question that “hold” decision and approve or remove the roadblock, all within a single day.

    These types of decisions and their motivators must be shared with the entire group of stakeholders. This in turn ensures that alternative plans can be made that will not slow down the project.

    2. Lock down the basis of design early. It’s essential to closely define your true goal and not be distracted from it. Most projects are susceptible to “scope creep,” with new ideas routinely introduced once the project is underway.

    Today’s times require a tighter focus on scope than ever before. There must always be someone responsible to see the project from a higher level, to understand the consequences of even the smallest decisions.

    Experience shows that the design manager and the project director (who oversees construction and design) work well in tandem, to satisfy this role. Together they must be able to see the big picture, and how what seems like a small decision or small adjustment can really throw off the schedule and the budget.

    A great example: Our current project uses modular wall systems. The plans were locked down, complete submittals were approved, and fabrication was underway. Then a change was suggested to one of the door configurations. When we spoke with the wall system builders, the unfortunate consensus was that if a decision could not be finalized in three days it would actually throw off wall construction by six weeks.

    By having decision makers stay more tightly integrated across the project, it’s easier to address those potential disruptions to eventual project completion immediately. It may be that a particular design change could be addressed at some later point in the process where it might be less disruptive.

    3. Code, safety and regulatory issues can slow or stop “Warp Speed.”  Some aspects of the project cannot be put off under any circumstances. Critical factors for late changes that must be addressed immediately would be anything having to do with code compliance, safety or regulatory compliance.

    Those were the three questions we asked for every requested change—does it affect safety, code or regulatory? If the answer was yes, these decisions were made quickly. Budget in these cases was often less of a consideration—especially if spending would satisfy the code, safety or regulatory issue and keep the project running on time.

    4. Daily communication is the new normal. Despite much more frequent communication, your design, engineering and architecture team will actually doing a little bit less on paper than they might have traditionally. Instead, they’ll be coordinating more closely—even daily—with the trade partners and people actually doing the installing. Consequently, construction can begin much sooner than in a traditional delivery method.

    In this way of working, every day is actually a step forward. Understandably, this may be a dramatic change for some who might be used to weekly project management calls. By staying in daily contact, however, all trades can speak with their engineering lead to coordinate and manage activities practically as they happen, and to prevent things from piling up.

    Keep the goal in sight, and be decisive. You cannot afford to go backwards to rethink or rework anything. That’s made much easier if every stakeholder – from design, engineering and construction, to the trades, to ownership—is in daily communication with their counterparts.

    Making better use of communications technology is an important extension of this new normal. Working to minimize unnecessary face-to-face interaction means some daily communications that might previously have been done in person will now more likely be done via video conference.

    On our project, for example, we instituted 360-degree cameras to provide immersive views of the facilities without necessitating on-site visits by larger groups. Images taken by those cameras can be directly correlated to a floor plan, which allows for very specific inspection to be carried out on elements of the construction.

    5. Fast, good, and cheap is a three-legged stool. This is critically important to remember. Each one of these outcomes is dependent on the other two, and they all affect the project. So, if you want things fast, that is possible. If you want things good, that too is possible. If you want things fast and good, that is likewise possible—but it will not come cheap.

    Speaking of cost, remember that time and schedule have value to everyone involved. Getting things done more quickly is not a matter of doing the same thing you always do, only faster. We were mindful that going faster also has a cost—not just in terms of fees, but in terms of the quality of life for everyone on the project.

    If you just maintain a sped-up version of the status quo, you’ll find everyone working longer hours, with an increased financial impact. Working faster while maintaining quality will simply cost more. It’s important to consider those tangible and intangible costs when making decisions. Is it something that can be put off, or is it so important that it must be addressed—even if it costs more and may throw off other schedules?

    Fast and good overcomes fast and cheap every time. And good and cheap are practically impossible. Warp Speed is demanding and also absolutely essential; no team member on board the starship Enterprise ever slowed down to question how much it would cost to get there when the order was given.


    Conclusion
    The tried-and-true approach to facility design and construction needs to be revisited because of the Warp Speed response being demanded of the biopharmaceutical industry today.

    Leaps through the galaxies don’t come without some corresponding leaps of faith and trust in your team. Established practices for managing large architectural, engineering and construction projects are simply out-of-date and cannot keep pace with the accelerated timeline required to arrive at new vaccines.

    Stay focused across every component of the project, stay in daily communication with every partner, stakeholder and counterparts, and expect there to be a cost factor associated with good safe decisions. The result will be safe, state-of-the-art facilities that will be built more quickly.

    These are challenging and disruptive times, yes—but change is vitally important, if we are to move to the starship power level implied by the name of the COVID vaccine mission. It will be up to the engineers (and their design and construction partners) to “give it all it’s got.”

    The new approaches being undertaken in response to Operation Warp Speed are causing the engineering and construction sector of the pharmaceutical industry to boldly go where no one has gone before.


    Jarrod Wrampe
    Contributing Editor
    Jarrod Wrampe is core team leader, associate, and project manager for CRB. He can be reached at jarrod.wrampe@crbusa.com
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