How lean principles can reduce the pain of pharma project delivery

"Just get it done.”

If you have been involved in a facility renovation or expansion project in any capacity, I bet these words sound familiar.

Maybe you’ve said them yourself, as a project owner who’s tired of seeing a new facility’s most important features fall under the ax of a limited budget. Or maybe you have heard these words as an order from above. If you’re a project engineer, they signal that no one’s listening when you point out the gap between expectations and professional standards; if you’re a trade partner, they’re a warning to keep your ideas to yourself and follow orders.

Historically, those words have served an important function, especially in the conservative and highly regulated pharma industry where project owners are locked in a pressure cooker of competing challenges. On one hand, owners need to proceed cautiously to protect patients whose lives may depend on the project’s outcome; on the other hand, they are expected to lower costs, integrate new technologies, and beat their competitors to market — all while facing a gridlocked pharmaceutical supply chain.

Under these circumstances, 'just getting it done’ is a win, right?

But at what cost? If the experience involves constant firefighting, frequent changes, high turnover, and a mountain of RFIs — well, that’s a painful process with no clear winner.

CRB recently surveyed nearly 500 companies for this year’s Horizons: Life Sciences report and discovered that 96% of respondents plan to expand their GMP operations within the next five years. That means a lot of design and construction work is on its way. And if we stick to tradition, then a lot of pain is on its way, too.

There is an alternative: lean design and construction, supported by a lean corporate culture. This could mean the difference between ’just getting it done’ and getting it done rapidly, smoothly and even painlessly — all while maximizing value by eliminating many of the sacrifices typically expected to keep a project on track.

Committing to lean

The word ‘lean’ is often bolted onto other, more concrete terms: lean tools, for example, or lean processes.

This creates the impression that tools and processes are all it takes to 'do lean.’ But even the most sophisticated tools won’t deliver on their promise unless they’re supported by a shift in a company’s internal business philosophy — a commitment, in other words, to ‘be lean’ at an organizational level.

That means rethinking the way work gets done and clarifying the relationship between that work and the value it delivers. The keyword here is value: that is, what the customer expects to get back for the time, money, and effort (both mental and emotional) that they invest.

On a lean project, everyone understands this value, and team members work together to develop conditions of satisfaction (CoS) that support it. Together, these critical elements — clearly defined value statements, and a CoS document — become compass points that steer a team away from wasted effort and toward a shared understanding of success.

This shift in focus creates a cascading impact:

•  Cost and schedule become inputs rather than goalposts
• Tools and processes become enablers of value rather than checkboxes
• People become vital resources capable of driving mutual success, rather than gears in a machine built to cross that finish line at any cost

For these shifts to happen in a meaningful and sustainable way, organizations should strive for an internal foundation that’s based on the five core principles of a lean corporate culture.

The principles behind a lean culture

Respect people
This principle is all about empowering those who are doing the real, hands-on work of project delivery. All members of the delivery team are recognized for their unique expertise and are invited to put that expertise to work within a collaborative, blame-free environment.

Focus on customer value
Lean organizations begin a project by seeking to understand the value that customers need from their investment, and then working together to deliver that value within constraints like time and budget.

Returning to CRB’s Horizons: Life Sciences survey, we get a clearer idea of potential customer values from the owner’s perspective:

•  We expect this project to help us lower the cost of goods (CoGs) for patients. Many survey respondents are seeking opportunities to impact CoGs by lowering their raw material costs (52%), potentially by bringing manufacturing in-house. Others are embracing automation to reduce labor costs and, by extension, CoGs (47%). These values could necessitate a facility with the flexibility to integrate emerging capabilities and technologies over time.
•  We expect this project to help us find and retain a skilled workforce. Of the survey respondents who work in cell therapy manufacturing, for example, 57% say that attracting top talent is a problematic area. This may impact capital decisions related to a new facility’s location, architectural features, and other important elements. 
•  We expect this project to help us reach a new level of digital plant maturity. Nearly all (87%) of our survey respondents expect to deepen their digital maturity in the near future, with some aiming for a fully adaptive and self-optimizing ‘plant of the future’ within the next two years. This may require a project team to invite information technology and data experts to the design table, which will help drive decisions that align with this vision of the future.

Optimize the whole, not just parts
This principle strives to end the practice of devoting isolated support to specific problem areas and instead move organizations toward a more integrated, big-picture approach to full-system optimization. For this principle to operate successfully, teams must abandon operational silos and embrace the idea of cross-functional collaboration.

Create a reliable and sustainable flow
'Flow’ is the key word here: in a lean culture, team members are constantly scanning for ways to resolve a bottleneck or eliminate stage gates to facilitate continuity and ease at every stage in the delivery life cycle. This is the opposite of simply checking boxes. Instead, this principle is about returning to the customer’s value and the CoS document and making commitments that serve those goals, rather than obsequiously following a templated requirement.

Commit to continuous improvement
Standard designs and practices are a useful starting point for project delivery teams, particularly in a highly regulated arena like the the pharma industry. But the distance between what’s standard and what’s uniquely improved is where you’ll find real and lasting value.

Lean teams navigate that distance by innovating, experimenting, and questioning established assumptions. They start with a standard concept and continuously strive for something better —something that drives more value for the customer.

How do you know if your lean culture is working?

Crossing the distance from a 'just do it’ mentality to a lean culture takes time. But as with any large-scale project, organizations can track their progress by noting and celebrating incremental success along the way.

As your own lean journey matures, here are a few signs of positive change to look for:

●  Less churn around redundant tasks: In a lean culture, the right experts — including trade partners — are involved in early decision-making. This eliminates many of the unpleasant surprises and breakdowns in communication that typically impede downstream progress.

At CRB, this shift has had a measurable impact. For example, on one large expansion project for a biopharma CDMO, our lean culture cut the number of RFIs from several hundred (typical on a project of that scope) to just 70, which helped us accelerate from kickoff to full validation in just 18 months.

You don’t need to be working on a large-scale capital project to measure the impacts of less wasted effort, though. Other, smaller-scale metrics can be equally informative. Maybe there are fewer meetings on your calendar. Maybe you’re spending less time answering questions. Or maybe you’re simply more confident in the decisions you make every day because you have the information, the people, and the environment you need to make them confidently.

●  Greater job satisfaction: Before experimenting with lean principles, conduct an employee satisfaction survey and use that as a benchmark to track changes over time. You’ll likely see a positive shift as employees experience life with more scheduling stability, safer conditions, and higher morale.

A lean culture isn’t a magic bullet, but it is part of an urgently needed solution to a chronic cycle of cost overruns, worker exhaustion, adversarial conditions, and lower value. We can do better — and we must.

●  Fewer cost and scheduling overruns: Teams working within a lean culture are statistically more likely to complete projects ahead of schedule and under budget, according to a study from the Lean Construction Institute. 

From ‘just get it done’ to ‘join the discussion’

As pharma companies strive to accelerate the delivery of lifesaving therapeutics to the patients who depend on them, they need solutions that will cut waste, shrink timelines, and improve business outcomes — without creating unnecessary pain along the way. Those solutions are especially crucial as supply chain disruptions become the norm and uncertainty in the regulatory and commercial environments continues to challenge capital project decision-makers.

Among these countless risks and barriers, lean design and construction have emerged as a flexible, resilient alternative to the status quo. By taking small steps toward a lean transformation today, you could see a massive change in project outcomes tomorrow — for you, for your capital project delivery team, and, most of all, for patients and their families.