The conventional approach to design and construction of biopharmaceutical facilities involves the use of separate and distinct design and construction teams. The design team focuses on design deliverables, while the construction team focuses on the construction of the facility. Neither team, however, is driven by the ultimate deliverable, which is the completion of an operational facility that manufactures new medicines for patients in need.
To address this shortcoming, CRB established the ONEsolution approach to change how projects are delivered. With the ONEsolution vision, an integrated team consisting of owners, designers, engineers, subcontractors, and construction professionals are engaged with the project from the outset and focuses on the end goal of opening an operational facility. Everyone on the team is thinking about how the facility will operate and what needs to happen for it to be operational from the start of the project, thus aligning a team of hundreds of people for end-to-end delivery.
CRB’s ONEsolution program is a process that is a genuinely integrated approach that can provide support for any stage of a project, from operations improvement to predesign and preconstruction through procurement and construction. The members of our integrated teams of planners, architects, designers, engineers and constructors work with one another on a daily basis. They are cohesive units with strong collaborative foundations that know how to support clients from the conception of the idea for a facility to startup of operations.
ONEsolution integrates in-house planning, design, and construction into a structured, measurable, and efficient approach to achieve your project objectives. As single, accountable, and collaborative entities, multi-disciplinary teams partner with clients to execute architecture, engineering, procurement, construction, safety, quality, regulatory inspection, commissioning, and management of each project. From concept to completion, our integrated, multidisciplinary process allows for innovation and efficiency in achieving success.
An integrated design and construction provides clients with a single source of responsibility, communication, and streamlined coordination. From the start of a project, planning, design, and construction professionals are aligned with the client’s vision and driven to collectively pursue and achieve the project goals. With everyone on the team embracing an environment of trust, collaboration, shared incentives and common purpose, there is much greater project buy-in than is possible when a project is controlled by a single project manager that sets the schedule and assigns responsibilities.
Frontloading of projects with larger teams from the outset also reduces the need for the handoff of information, thus minimizing risks. Those handoffs that must occur are much more reliable and meet the conditions that satisfy those involved with respect to content, quality, and on-time delivery. When teams get the information they need when they need it and at the quality they are expecting, greater trust is established, leading to further team integration.
A high-performing team with members that trust one another and are focused on the end delivery of an operational facility enables leaner operations. Through our commitment to lean design and construction principles, we can eliminate waste and identify innovative, cost-effective solutions to maximize the value of your project and reduce project timelines. Resources are maximized, schedules are optimized, and redundancies are eliminated, allowing projects to move forward with streamlined consistency.
We challenge these high-performing teams to target 0 RFIs when there is high trust and accountability and reliability of information exchange, and many such integrated projects have reduced project delivery time by more than one-third compared with industry norms.
There is also a financial benefit. Rather than budgeting to the client’s design, the integrated team gains a deep understanding of the facility requirements and then provides a design that meets the client’s budget and needs, minimizing financial risk with an early cost projection and predictable results.
The key to a successful design-build approach is integrating teams that are focused on the ultimate deliverable of an operating biopharmaceutical facility.
Key roles on these integrated teams begin at the leadership level with directors, managers, and key build strategy experts from clients, key team members, and trade partners and continue to build throughout the development of the project.
These integrated teams thus provide seamless collaboration between the client and design, construction, and C&Q professionals. By removing the traditional trade boundaries and layers of responsibility, sound judgments can be made that transform the client’s vision into reality. There are no handoffs, priorities lost in translation, or finger pointing, removing inefficiencies and the stress of decision making.
Projects that will be completed using this fast-track design and construction approach begin with an integration workshop. Depending on the size of the project, these workshops may last a few hours to a couple of weeks. They provide an opportunity for team members to meet and get to know one another. They also provide the mechanism for building the project strategy, which is codified as a project charter around which the team can rally.
Underlying all of the activity at these integration workshops is the recognition that safety comes first and quality must always be expected. These concepts are pillars that do not move. The team focuses on the elements of a project that can be adjusted — cost and schedule.
Generally, five or six key areas are identified, starting with the purpose of the project, which for biopharmaceutical facilities means getting needed medicines to patients. The team works with the client to establish the essential elements required to meet the minimum needs of the project with regard to safety, basal level of facility functionality, regulatory compliance and operability.
In essence, the charter includes all of the information that is needed to make decisions and provides an order of priority for those decisions whether schedule or cost is the primary driver. It is essential that these issues are established at the initial integration workshop so that it is possible to have solid decision-making capability throughout the entire project without concern that priorities will change.
Even so, the charter is a living document that evolves during the life of the project. The target schedule and cost are generally fixed elements in the form of a commitment to have an operational facility by a certain date for a certain cost. Within those elements, however, there is flexibility to adjust the scope — specifically how those targets will be achieved.
The charter, which describes the key elements of the job, must be made available to everyone on the team. It is used during the onboarding process when additional team members join the project following the initial integration meetings. Having access to this information help these new partners understand why and how decisions are being made and ensures that everyone is on the same page.
In some cases, it is not possible to align all aspects of the project as initially envisioned. Part of being a highly functional team is having the ability to identify when problems occur and address them early on so they will not impact the overall mission. The living nature of the charter helps facilitate this process.
For ONEsolution to be effective, clients need to be seeking a new, innovative project experience and accept that change is needed to achieve maximum project results –– one that delivers an operational facility at their target cost and schedule. They need to have the flexibility to assemble integrated delivery teams committed to their project goals rather than the traditional procurement of a design, then construction, then commissioning and qualification.
Sometimes, this approach is not right for every project. Because it involves establishing an integrated team from the outset that executes planning, design, engineering, and construction work in parallel and is aligned with the project charter, it may not be suitable for projects with owners that have a procurement-driven organization or mindset that expect design completion before bidding out construction activities.
ONEsolution is ideal for projects that desire cost and schedule certainty, because, with this approach, the entire team is engaged early on and are all working toward the same goal.
Often, emerging biopharmaceutical companies that are trying to be first to market with a novel drug product are attracted to the ONEsolution approach, as most of their projects require schedule and cost certainty. Often, these firms typically have smaller, more intimate project teams that can make decisions more quickly than is possible in large, mature organizations with many stakeholders.
ONEsolution execution is also well suited for projects from big pharmaceutical companies that have a nimble mindset and recognize the value offered by an integrated design, engineering, and construction approach.
The trust that is created within the collaborative teams that complete these integrated projects has a significant impact on team members working on them. It creates a positive work environment within which people have fun and spend time working to improve, rather than pointing fingers. As a direct result, the overall experience for everyone involved from project team members to client partners to contractors is better overall.
Clients have reported a sense of calm on these projects despite the accelerated timelines. They are amazed that we can set a target completion date 18 months in the future and finish a project on time — or in many cases early. CRB employees always look forward to the opportunity to work on the next ONEsolution project, because it is a genuinely enjoyable experience.
Mike Barrett is a project delivery champion in CRB’s Raleigh, NC office and his experience spans design and construction of biotech and pharma facilities. He is recognized for expertise using Lean design and construction techniques, tools, and behaviors to build successful high-performing teams. His collaborative, focused teams have deep levels of trust working towards the common project purpose of operational facilities.