The Value of Conducting Operational Readiness in Parallel with Commissioning for Life Sciences Capital Projects

The Value of Conducting Operational Readiness in Parallel with Commissioning for Life Sciences Capital Projects

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Risk Assessments | Maintenance & Calibration Programs | Spare Parts & Inventory

Developing maintenance plans and spare parts inventories. Uploading accurate asset data into the CMMS and verifying workflows, alerts, and links work correctly. When developing new life sciences capital projects, who on your team has the time and expertise to efficiently tackle these tasks on top of a likely large list of competing priorities?

Operational readiness tasks are cumbersome and can be quite complicated, even for those who do it regularly. They require careful attention to detail. Once complete, it makes a world of difference in your day-to-day operations and has a huge ROI when commissioning and operational readiness are done right the first time.

Commissioning and Operational Readiness Warehouse Image

Traditional guidance and program sequencing would suggest that operational readiness follows commissioning in a standard life sciences or biotech capital project. However, implementing commissioning and operational readiness in parallel, and integrating the work early in the project life cycle (in the design and construction stages) is the best way to streamline projects. This is where having the right partner can help preserve your project budget and schedule, not to mention your team’s bandwidth. Additionally, working these services in parallel with a proven approach will help owners deliver a best-in-class experience with the startup and maintenance of a new project – without stalls or setbacks.

Commissioning and Operational Readiness Project Life Cycle

To ensure that your capital project is operational on day one, it is imperative to have a calibration and maintenance program in place that accounts for risks, spare parts, inventory, and regular reviews. The ultimate goal is to get to Transfer of Care, Custody and Control (TCCC) to the owner efficiently.

Activities on the construction timeline often take up most of the spotlight, while more administrative tasks, like those associated with operational readiness, fade into the background. But these activities must be accomplished in order to efficiently complete commissioning, qualification, and validation (CQV) packages, a critical step in the life cycle of any capital project.


Risk assessment


Maintenance and calibration


Spare parts inventory management

3 Areas of Focus for Operational Readiness

Because the FDA has decreed that pharmaceutical and biotech companies must be in control of their assets, it is critical that organizations have a robust and sustainable operational readiness plan in place to help them manage their facilities and the equipment that runs them.

A leading practice for highly successful capital projects is to undertake commissioning and operational readiness tasks simultaneously so that project owners have everything they need to begin and continue to run operations without a hitch. The primary areas of focus, from an operational readiness perspective, include:

1. Risk Assessment

The first item to think about is assessing risks that might be associated with operational readiness. You must think through all scenarios that could potentially affect equipment reliability. Consider how the facility will be used. What could go wrong? Where are there potential failure points?

The more proactively you think about challenges or pitfalls, the more prepared you will feel to handle them should they arise during the operational readiness phase or once the facility is turned over and operational.

2. Maintenance and Calibration

The next step is to move into the development of preventive maintenance (PM) and calibration programs for the facility. Collecting information on all the parts for each piece of equipment in their facilities, uploading it into the CMMS, and testing functionality is an extensive undertaking. Operational readiness teams can do this with ease.

Creating ultimate efficiencies is one of the benefits of working with a consulting firm that offers both commissioning and operational readiness. Integrating these activities into the work already being done to analyze your risk and develop your commissioning and operational readiness plans creates a smooth transition. Your commissioning expert should gather all manuals and asset data and pass them along to the operational readiness team. The operational readiness team will be able to easily develop the PM and calibration specifications and upload them into the CMMS, ensuring all is properly linked.

The technical aspect of linking assets in the CMMS with correct maintenance and calibration tasks, while verifying accuracy, can be complex and time-consuming for those who do not often do it.

When this information is uploaded into the software, it allows the organization to conduct ongoing maintenance of the facility and its assets in a clear and simplified manner. Alerts and automatically generated work orders assist in maintaining proper compliance. All of this depends, however, on configuring the system to a T in the beginning.

Operational readiness teams are well-versed in these processes and can complete them in a well-structured, systematic way that saves clients time and resources.

Operational readiness is an integral component to commissioning systems and facilities. Collaboration between commissioning and operational readiness services can streamline verification activities and mitigate roadblocks and setbacks to qualification processes. As an example, GMP facilities can require particular commissioning tasks that have pre-requisites pertaining to operational readiness deliverables, such as calibration and critical component verification. With one partner capable of managing commissioning and operational readiness activities, project owners benefit from collaborating with a unified team – meaning leveraging the distinct advantage of their holistic understanding of the process, smoother communications, and a more efficient path to turnover.

Developing a Maintenance Strategy

A thoughtful approach to facility maintenance can save your team time and budget year-round.

Case in point: scheduling all monthly maintenance at the same time every month can create resource constraints and downtime risks. The best maintenance strategies spread out tasks throughout the year – scheduling the right maintenance at the right time.

A best practice is to base the timing of specific maintenance on workloads, environmental conditions, and operational restrictions. For example, you may want to schedule filter changes at the beginning of spring (just before pollen counts increase), include rooftop maintenance tasks during cooler weather, and schedule work on boilers in the summer when they are not in use.

An effective maintenance strategy will base timing of tasks on workloads, environmental conditions, and operational restrictions.

Your operational readiness team should look at everything holistically to avoid these potential (and easily missed) pitfalls.

3. Spare Parts Inventory Management

Another key factor is to assess and verify that spare parts needed for your maintenance program are on hand or can be ordered and delivered at the right time.

Setting up a minimum and maximum threshold for your spare parts inventory will enable the system to automatically order spare parts as needed. This helps minimize spare parts storage and implements just-in-time ordering.

Much like an old basement without a sump pump, people often do not think about spare parts until they become an issue. But they are a critical component of operational readiness and can make or break a maintenance program, especially with today’s ongoing supply chain constraints. Identifying spare parts needs early in a project’s life cycle ensures inventory is available for both anticipated and unexpected maintenance.

Typically, organizations setting up a spare parts inventory go with the manufacturer’s recommendations, which often assumes you are running equipment around the clock. There is no need to replace parts that are still in good working order. Executing a comprehensive operational readiness assessment will allow you to right-size your spare parts inventory program and develop PM aligned with your type of use and specific maintenance needs.

Did You Know?

A survey of more than 300 life sciences capital project owners revealed the top five most challenging aspects of operational readiness for a new facility. The top three are:

  1. Predictive/Preventive/Corrective maintenance
  2. Calibration programs
  3. Maintenance program SOPs

Discover the rest, as well as the most challenging aspects of commissioning, in our full report by accessing The 2023 State of Life Sciences Capital Project Development.

Leading Practices of Project Owners

Preventative and predictive maintenance programs are not set-it-and-forget-it initiatives. Once the facility is complete and turned over to project owners, most life sciences companies schedule their commissioning team to come back within 10 months for seasonal testing, before standard equipment warranties run out. This is especially valuable for systems that are used more heavily in seasons opposite of when your initial testing was done. For instance, if your startup was in winter, you will want to verify optimal performance of systems in summer as well (with varying environmental conditions such as temperature, humidity/dewpoint, etc.).

Another leading practice after startup is for in-house operations teams to review PM programs periodically and make data-driven adjustments over time. Some of the more common updates include PM intervals, calibration specifications, or spare part quantities, lead times, and costs.

By reviewing your maintenance programs regularly, you can ensure that major issues will not slip through the cracks. Systematic assessments can keep minor gaps from becoming massive chasms that are hard to recover from.

Be Ready to Start on Day One with a Team of Commissioning & Operational Readiness Experts Behind You

The best way to ensure your capital project is fully operational on day one is to partner with an experienced firm that understands the why and how to integrate commissioning and operational readiness early in the project life cycle (in parallel). It is also critical for your partner to understand the nuances of your industry and respect the unique specifications of your project – proven processes and experience matter.

To learn more about how 35 North can help you seamlessly conduct commissioning and operational readiness in parallel, contact us today. Our team of experts look forward to learning more about your project and helping you maximize efficiency and quickly bring your vision to life.

Chad Merewether, P.E., headshot

Chad Merewether, P.E., leads the 35 North commissioning team and provides strategic engineering programs and CQV solutions for project initiatives. He specializes in commissioning plan development, CMMS development, and implementation.

Zachary Taylor is a commissioning engineer at 35 North. He specializes in streamlining the execution of commissioning and operational readiness services for large-scale projects, CMMS development and implementation, and owner’s rep commissioning for global life sciences companies and startups alike.