Seven Tenets For 'Just In Time' Delivery of New Facility

Designing and constructing a technically complex yet efficient, fully integrated fill-finish facility is no small task. The time-frame can be long, the costs can be high, and the stakes with numerous stakeholders involved, can be even higher. 

Given the complex nature of any proposed fill-finish facility, the following seven tenets can be easily applied to construction project for coordinated delivery in a time-constrained manner.

1. A Team with a Can-Do Mentality

In a team selection process, quality, their ability to meet regulations, and price are only cursory parameters for the evaluation and selection of design and construction partner.

The company should seek designers and a contractor who would be collaborative and innovative in a way they can work and how they can work together. In order to create solutions in a fast-paced project, it is critical to have a team approach rather than a number of individual groups working in separate silos. 

For solutions to be explored and options available, all team members had to be working toward a common goal, not at odds with one another. Included in this team approach must be regular defined interaction and updates with both local government and other regulations to keep them aware of and to advance project goals and schedule deadlines.

2. Clear Project Goals and a Strategic Vision

You should have a vision at the start of the project and understand new facility’s function of producing sterile solutions and how products produced in the facility would save lives. The notion that the faster the building is completed, the more lives could be saved is a powerful one. This single act identifies that it isn’t just about building a building, but coming together as a group to provide a solution to improve the quality of patients’ lives. 

The top management’s continued involvement in creating a project vision is critical to buy-in by the local community. While moving ahead, any clearly identified milestones along the path should be shared with key managers to keep them aware and help guide the process, chart progress, and maintain budget control. If any of these items begin to deviate from the desired course, a recovery plan needs to be put in place to realign the goal.

3. Clear Decision-Making Process

In a project of this size, there will be many disciplines and people required to execute all the necessary tasks; it is important to make sure that no one person becomes a bottleneck in the process. Sometimes there may be competing goals, be it from a budget, schedule, or function point of view.

The project structure must be organized with tiered levels of decision-makers, corresponding to the various discipline groups ranging from process equipment to quality to construction and design with strong alignment and interactions with legal, corporate relations, and government affairs. Ultimately, the company’s core team should have the ability to sanction changes and resolve project-defining issues.

4. Clear Roles and Responsibilities

Given the scope and schedule of the project and once the basis of design is defined, it is imperative that a “divide and conquer” approach is adopted. The design disciplines should operate in work groups to develop each of the scopes, and then meet on a regular basis as a large group to collaborate and review interdisciplinary coordination. 

Each group should have a clear development schedule with milestones that are tied into the integrated construction strategy.

5. Balance Cost vs. Function for all Design Solutions

Although the phrase ‘least cost scope’ will be repeatedly used, it is also imperative to align the budget allocation with the functional requirement. Not all items are created equal and having a hierarchy of equipment, spaces, finishes, and materials to work with not only results in a judicious use of resources, but also adds to the richness and variety of the environment. 

Designing appropriately is as critical as maintaining budget.

6. Phased Sequencing and Schedule Execution

A key strategy is to have the contractor engaged early in the process as a single point of contact that understands the project goals and drivers. 

The design team collaboratively designs the schedule with the contractor to benefit these goals. This results in a distinct approach to engage the construction process, harnessing the abilities of the team to hasten the overall schedule and meet the vision by allowing a fast acceleration of the workforce.

7. Flexibility in Solutions

Satisfying a fast-track schedule requires flexibility with the design solution, budget application, and schedule impact. The team must work to balance all these items, while still addressing the least cost scope directive. 

Function is a key driver in all decisions, along with availability of resources, be it material or labor.

(Abstract from the source: “Just in Time. An Approach for a cGMP Fill-Finish Facility” by Andrew Cunningham, Principal, Flad Architects │ Pharmaceutical Engineering – March / April 2010)