Especially because checklist commissioning appears to be a cheaper alternative to enhanced commissioning, it can be a real temptation for owners. Whether you are building a laboratory, pharmaceutical manufacturing plant, research greenhouse or other life science facility, how can you best determine what level of commissioning to deploy? It comes down to balancing needs for immediate cost savings with longer-term savings in efficiencies and the type of project in development.
Nine times out of 10, enhanced commissioning will end up being the better option for life sciences owners who want to maintain their budgets, reduce risk, get to market quickly, and avoid the rework that can lead to significant change orders and delays. This is especially important for more complex, highly regulated facilities.
Additional elements to consider include:
- Regulatory requirements: If you are building a manufacturing facility for products that will have a human application, your regulatory requirements will be much more intense than they would be if you were building a simple research and development office. Conducting a risk assessment can help you to understand the impact of potential product errors
- In-house resources: If an organization has extensive in-house resources, they may be able to supplement checklist commissioning. But if your team is lean or has multiple competing priorities, you may not have enough support to do the job correctly yourself.
- Facility complexity: The complexity of your facility should be another consideration. The more involved the build, the more you will gain from working with a firm experienced in enhanced commissioning.
- Operational readiness: For many owners, it will save time, money, and frustration to work with a firm that can deliver consistent oversight throughout the project, from inception to operational readiness. With end-to-end supervision from commissioning agents, owners can achieve seamless, comprehensive oversight that minimizes handovers, risk, and rework.
The best time to engage with a commissioning firm is before you have started construction. If brought in early, a good commissioning firm can help to guide the design process to lay a firm foundation for the commissioning and validation work that will come later. By working strategically and collaboratively, commissioning firms can act in an advisory capacity to understand and match the owner’s user requirement specifications (URS) so as to avoid miscommunications or gaps in alignment. More experienced firms can also recommend new ways to accomplish tasks that are typically difficult to implement because they have “been there, done that.”
To vet a potential commissioning partner, ensure they have the following elements in place:
- A licensed professional engineer (PE) in charge of the commissioning department
- Strong knowledge of and experience with good manufacturing practices (GMP) facilities
- A process that integrates enhanced commissioning activities with IQ/OQ services
- A team that is well-versed in the Food and Drug Administration’s regulatory environments
- Experienced operational readiness experts can expedite processes for organizations that do not
have in-house resources. This gives owners one less contract to manage and helps mitigate communication gaps