Most industry insiders recognize that there are two types of objectives associated with renovating legacy manufacturing facilities: opportunity-based and risk-based.
- Those that are opportunity-based seek to create a business advantage through improvements in capacity, quality or efficiency. These are the fun projects; however, they sometimes don’t come to fruition because they fall victim to the tyranny of the urgent.
- Objectives that attempt to mitigate risk are motivated by loss aversion. These are often the high profile remediation efforts that jump to the fast track after an accident, loss, or regulatory observation.
In my experience with facility designs executed by DME, most renovations are not purely opportunistic or risk-driven. Rather, they typically have a combination of opportunity and risk-based objectives, which need to be consistently understood and prioritized by the project team.
Without a shared understanding of desired outcomes, priorities can be confused; owner stakeholders often send mixed signals; and suppliers end up disappointing their clients.
As part of DME Facility Focus, an industry-wide survey of the life sciences industry conducted by DME in partnership with INTERPHEX, we asked industry insiders to rank the most frequent capital project objectives they encounter when renovating manufacturing space.
- Increase process throughput
- Retrofit for new product or process
- Increase facility flexibility
- Improve product quality
- Achieve regulatory compliance
- Improve reliability
Facility renovations are disruptive, so it makes sense to take care of as many issues as possible during construction. Note that the execution of opportunity-based objectives is usually not mutually exclusive with the execution of risk-based objectives. From our experience, it is frequently more efficient to execute projects with multiple compatible objectives under the common overhead of a single project. To do so takes careful planning, and perhaps the willingness to invest in some front-end feasibility analysis and engineering studies to refine the scope.
Perspective vs. Perception
When asked to rank the frequency of risk-based capital project objectives in cGMP facility renovations, our responders answered differently based on their affiliation vs. job function. The data showed a significant divergence when parsed by the respondent’s affiliation.
When the same data is parsed by the respondent’s job function, we saw a different frequency distribution.
Some of the results make sense. It’s entirely plausible that participants from an API chemical manufacturing operation (small molecule), which often involve processes with flammables and combustibles, would more frequently encounter projects where safety improvements were paramount. Alternatively, those from an R&D background, where the central mission is to develop new products and processes, are less likely to encounter capital projects addressing obsolescence issues. These deviations most likely reflect real differences in the types of projects people are exposed to in the context of their jobs.
Other deviations are more difficult to explain. Why would those working in engineering roles be less likely to encounter projects where safety improvement is a major objective? Why would consultants be more likely to engage in projects where GMP compliance is the primary objective over those engaged in GMP manufacturing? In these cases, the divergence in response is more likely due to a difference in perception.
Manufacturers see safety improvements as a key objective (it’s their safety we are assuring after all), while those who are supporting manufacturing in engineering roles are more likely to see safety as due diligence. Likewise, those who work for manufacturers are more likely to overlook project objectives related to GMP compliance because they aren’t used to thinking about facility design in that context (in their day-to-day experience they think of GMP requirements in terms of its demands on operations), while those who design GMP facilities for a living are always thinking about the impact of GMP compliance on facility design, process segregation and product protection (hence the perception that achieving GMP compliance is the foremost objective for these kinds of projects). Both examples illustrate the relationship between perspective and perception.
Our personal perspectives—the context of our job responsibilities and relationships—influence the way we perceive and prioritize project objectives.
Project Managers Can Leverage Diversity While Aligning Priorities
On the positive side, a diverse project team can ensure that the various needs of the organization are considered from the get go. Diversity also helps to identify unintended consequences, prior to implementation. On the other hand, stakeholder diversity can make it more difficult to establish a shared understanding of objectives, and to maintain those priorities throughout the life of the project. This is where the Project Manager can shine.
Project managers should be the strongest champions of project objectives. It is the PM’s job to ensure that every aspect of the effort – from design to delivery – serves the desired outcome. Project Managers are responsible for casting the vision and aligning the team’s efforts, so that everyone stays on mission. This starts by clearly articulating all objectives and priorities, including schedule and budget. Project objectives should be clearly stated in the project plan, presentations to management, requests for proposal from suppliers, and most importantly at the kick off meeting with the project stakeholders. These objectives should be revisited periodically throughout the project, particularly during periods when key design decisions are made. When difficult decisions need to be made that balance competing priorities, project managers need to remind the team of their shared vision and get everyone pulling in the same direction. The objectives articulated in the project charter become the project manager’s compass to determine the right path forward. Keeping the project team in sync with these priorities will go a long way toward assuring the ultimate success of the effort.
The DME Facility Focus survey has provided insight into the minds of industry insiders – those who have their share of war stories from experience with cGMP projects in legacy facilities. We’d like to continue the dialog, so I’m planning future posts to reveal insights every few months, culminating in a fresh and informative Facility Focus program at INTERPHEX 2017. For more information about DME Facility Focus, check out www.dmeforlife.com/about-us/facility-focus.