When pharmaceutical, biotechnology, and medical device companies are expanding their facilities today for tomorrow’s needs, whether in the United States or abroad, it is an exciting time and one that comes with many challenges. Whether your company’s capital improvements planning includes expansion of an existing manufacturing facility or scaling production of an innovative discovery, one of the thoughts likely on your mind is how to extend your internal resources to manage this capital expansion and what processes must be put in place to ensure accountability and transparency for costs and schedule. Time to market is critical. You may have found that there is a substantial learning curve needed to deliver this unique project on time and on budget, and your internal resource pool may already be fully committed to other initiatives. Below is a brief guide to the next steps a project owner can take to bring the project vision to reality.

Envisioning the Project Organization Structure

Contractors and suppliers will need to be managed from the start of facility design through production facility startup. An important first step in this is deciding how the project team will be organized and extended to ensure successful project delivery, including assessing the company’s internal resources and experience to successfully deliver this unique project. Below are some of the options a project owner has for the delivery of capital improvement initiatives.

Managing the Project Internally

Managing the capital project internally may be an option.  Internal resources need to include project management, design, validation, construction management, and general contracting personnel with proven experience and the bandwidth realistically required to deliver the capital project plan.

Depending on the size of the capital improvement initiative being considered, temporary changes may need to be made in the company’s internal organization to ensure project success, including setting up or improving an existing Project Management Office (PMO). A well-organized PMO can focus on successful project delivery by deploying proven processes like project scope charters, progress monitoring tools, cost management, communication plans, and resource tracking.

Design firms and construction management entities who are contracted for the delivery of the project may be asked to report the project’s status through the PMO if an internal PMO is used as the point of contact for the project.

Hiring an Owner’s Consultant

An Owner’s Consultant (also known as a Design-Build Consultant, Owner’s Advisor, or Owner’s Agent), that has a record of accomplishment of successful delivery of similar type projects and is contracted directly with the owner, provides several benefits. The consultant’s expertise is a source of reliable project management information for complex and critical project elements, such as the selection of a project delivery method (CMAR, Design-Bid-Build, or other models), selection criteria for contractors and other consultants, management of change orders and identification of problems, as well as independent cost, schedule, and compliance reviews for the project.

A design-build consultant is experienced in preventing critical components of the project from being missed, identifying project issues to the owner in a timely fashion, and explaining complex or contentious components of the project to staff and leadership, all of which allow the owner to remain impartial and ahead of issues.

Contracting with a Design-Build Firm

Hiring a company that will be fully responsible for delivering the project in a turnkey fashion, from design completion to facility validation, including meeting budget and schedule targets and ensuring GMP compliance, is another option. A design-build firm can work alongside the project owners from the very beginning of the project to identify cost, scope, and schedule objectives, and directly manage the design and construction of the project so that you, as the owner, do not have to reconfigure your organization for the delivery of a one-time capital project. To mitigate the risk of defective design, materials, or construction, changes in work, and defensive engineering that can occur with the Design-Build project delivery method, hiring a separate Owner’s Consultant that reports to and that solely represents the interests of the owner is often advised.

Ensuring the Project Delivery Team has the Competencies Needed

Whether provided by an owner’s internal management team or by contractors, the project owner will need to ensure that their team has certain competencies and experience to deliver a significant capital improvement project, as well as the bandwidth to provide those competencies.

Project management, risk analysis, and schedule compliance competencies

Project management and scheduling expertise equal with the project’s size and complexity often makes the difference between project success and failure. To ensure success, project managers and schedulers collaborating on these complex projects must be proficient in the following competencies:

Selecting and implementing an adequate project management software platform

Project management information systems (PMIS), as well as other software systems, may need to change to accommodate the scale of the new initiative. If internal team members do not have the time or relevant experience to efficiently track the progress of a significant capital improvement project, the owner’s consultant can aid with the selection and implementation of software platforms based on prior successful deployments.

Establishing project metrics and progress information

Knowing the right Key Performance Indicators (KPIs) to track allows an owner to understand the ongoing status of the project. Having staff at hand whose role it is to both collect and interpret project progress information and create meaningful and actionable metrics helps an owner address project needs on time.

Processes modifications

To successfully manage a project, one which significantly deviates from the owner’s day-to-day business, on time and on budget, existing processes such as workflows, communication protocols, and team collaboration may need enhancements or project-specific modifications.

Risk analysis competencies

Expertise on how project risks that have the potential to impact the project’s budget and/or schedule will be handled is beneficial, including which risks will be quantified and then either accepted, avoided, mitigated, or transferred.

Claims avoidance strategies

Successful owner avoidance of construction claims starts before contracts are signed and continues throughout the life of a project. Expertise in this field such as selection of delay analysis methodologies to be written into contracts, use of best practices in cost and schedule information collection, and how to communicate with contractors in ways that will avoid later disagreements on entitlement can lead to more successful owner outcomes for delay claims.

Cost and budget tracking competencies

Processes and systems for how costs and budgets will be tracked and reported on are already in place within the owner’s organization, but these may need to be expanded or modified to fit the scope of the initiative.

Change order management

Inevitably projects will have change events and change notices as the project develops. Setting up methods for and tracking these against the budget is critical for understanding the cost and schedule projections for the project.

Cost KPIs establishment and tracking

Being able to understand, at a glance, the status of project costs and budgets is a benefit as the owner considers the best use of appropriated funds or looks forward to other associated scope.

Value engineering

When substitutions are acceptable or alternatives should be considered on a project, having a structured and industry-validated method of tracking these value-engineered items allows an owner to promote the alternatives without affecting project delivery or compliance with regulatory requirements.

Construction management competencies

A construction manager with the skill to oversee designers, specialty consultants, trade subcontractors, and suppliers, is essential to the successful completion of a capital improvements pharmaceutical or biotechnological project. There are many companies in the construction industry that have successfully managed these types of projects from conception to validation. A construction management entity that acts on behalf of the owner brings experience and expertise that can be leveraged from day one, including recommendations for decisions on the use of Building Information Modeling (BIM) and 4D scheduling /Virtual Design & Construction (VDC) to avoid installation problems, choices between stick-build or modular construction, and paths of travel. Selecting a company that has a record of success will increase the chances that your project will be delivered to meet the owner’s definition of success.

GMP compliance

Augmenting the current compliance and validation teams with added resources to support the scale of this new initiative is necessary. The FDA expects that pharmaceutical companies will improve their manufacturing standards as what is considered ‘current’ evolves, and what was considered GMP in the past may not be cGMP today. Project teams that have the competency to select proven state-of-the-art equipment and technology which will ensure product quality and purity can ensure that the best of current practice is used to the owner’s benefit. Experience in supporting project teams with the complexities of cleanroom construction, and commissioning, validating, and qualifying a capacity expansion is a specialized skill set that will ensure facility readiness for product launch.

Next Steps

Equipped with the above knowledge, what are some of the next steps a project owner can take on the path to successful project delivery?

Clarify project goals (time-to-market speed, net present value maximization, or other goals), envision what a successful project delivery looks like, and work back to what needs to be done today to ensure that the company can achieve these stated goals.

Build a project team, whether it is securing the commitment of internal resources or external consultants who will provide expert services for the duration of the contract.

What PMA Does

PMA helps pharmaceutical and biotechnology companies deliver compliance-driven projects on time and on budget by establishing proven project processes and tools on day one and supporting projects throughout their entire lifecycle. In this competitive landscape, flexibility and speed to market are just a few of the challenges we can help owners like you overcome. Please review some of our recent projects and solutions provided for the pharmaceutical industry. As an owner, when looking to confidently expand your pharmaceutical and/or biotechnological operations, let our practiced experts help you along the way.