Change Orders, Delays, and Extended Timelines: The Hidden Cost of Checklist Commissioning

Change Orders, Delays, and Extended Timelines: The Hidden Cost of Checklist Commissioning

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When life sciences owners begin looking for a commissioning firm to work with on their projects, cost is often a high-priority concern. And it can be tempting to partner with organizations that offer competitive pricing for what appears, on the surface, to be sufficient commissioning oversight. We refer to this approach as “checklist commissioning.” It is appealing because it seems to cost less, can be accomplished with fewer resources, and completed more quickly than more robust solutions.

Yet, when you really dig into it, most owners come to realize that this cut-corners approach often actually adds cost and precious time to their project as change orders roll in when issues are discovered late in the project lifecycle, causing significant delays. Projects are rarely executed exactly to plan; the key to success is to identify and address any errors or potential problems as early and quickly as possible. Ultimately, it’s about securing the right level of service for the project – one that does not waste budget on things you don’t need or underestimate project requirements, leaving owners to deal with the consequences of an over-budget, late-to-market nightmare.

With “enhanced commissioning,” the level of verification is comprehensive enough to not only meet project needs around budget, quality, and efficiency in the commissioning phase but also to help position the organization to breeze through a one-time validation and qualification effort (therefore getting to market faster).

With “enhanced commissioning,” the level of verification is comprehensive enough to not only meet project needs around budget, quality, and efficiency in the commissioning phase, but also to help position the organization to breeze through a one-time validation and qualification effort.

When errors are not uncovered until the validation stage, project impacts are more severe (with more paperwork, additional quality assurance processes, and delays). Especially in light of today’s supply chain issues, if owners or project managers must order additional materials or parts to remedy a problem, it can derail already-tight schedules. With enhanced commissioning, these issues would be caught early via pre-approved test plans, while installation and automation teams were still on site and can make corrections quickly.

When commissioning teams work in tandem with operational readiness teams from the same firm, it allows for a smooth transition in which calibration and maintenance plans (including spare parts and inventory) can be loaded efficiently into the organization’s computerized maintenance management system (CMMS). This helps to reduce the risk of errors and helps to proactively satisfy validation requirements.

For life sciences project owners, the key is to determine which level of service will ultimately deliver the cost, timeline, and quality they need to safely build and operate their complex facilities.

Checklist Commissioning vs. Enhanced Commissioning

So what’s the core difference between the two approaches?

Checklist commissioning only takes a high-level look at equipment without verifying whether it satisfies the sequence of operations set by engineers. Purveyors of checklist commissioning fail to perform functional testing to find the root cause of underlying problems. This approach, essentially, is one step above construction quality control. It’s a mechanical completion checklist.

Enhanced commissioning, on the other hand, uses thorough testing protocols to verify how the actual setup compares to the agreed-upon vision set at the start of the project. This detailed oversight can help catch issues that may not be obvious at first glance — things like wrong parts, malfunctioning technology, installation errors, broken switches, or problems with automation programming. Commissioning agents get into the nuts and bolts of the operation to ensure life sciences organizations are ready to hit the ground running safely when the facility is turned over to the owners.

Checklist Commissioning Enhanced Commissioning
  • Completes basic operational checks to determine if equipment meets specifications
  • Looks “under the hood” to ensure installation meets user requirements for operational use and routine maintenance
  • Only focuses on equipment installation at a high level and does not inspect for hidden damage or gaps in the sequence of operations
  • Uses the engineer’s sequence of operations to implement integrated systems testing protocols, verifying all equipment works as it should
  • Collaboration with construction is not achieved and teams often work in siloes, potentially leading to miscommunication or gaps in alignment
  • Works collaboratively with construction teams to prevent duplication of efforts for documentation of testing and punch list development
  • Collaboration with operational readiness teams is not achieved; this misalignment can lead to rework and missteps in the validation stage
  • Works collaboratively with operational readiness team to document critical data and more efficiently set up maintenance or calibration programs

Determining the Level of Commissioning Service Needed

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:

  1. A licensed professional engineer (PE) in charge of the commissioning department
  2. Strong knowledge of and experience with good manufacturing practices (GMP) facilities
  3. A team that is well-versed in the Food and Drug Administration’s regulatory environments
  4. 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

An Example of Checklist Commissioning Gone Wrong

A research greenhouse went through checklist commissioning. And everything appeared to be in fine working order.

The incubators were about to be qualified, but the temperature reading in the control room did not match the reading on the incubators. This was something the checklist commissioners failed to review.

In turns out, the wrong temperatures probes were installed. So new ones had to be ordered, causing further delays, change orders, and rework, which negatively impacted the budget.

Avoid Headaches from Unwelcome Surprises with Enhanced Commissioning

Partnering with an enhanced commissioning firm can help life sciences owners save time and money, while avoiding headaches from unwelcome surprises along the way. Timing is everything. When it comes to project success, the earlier you can identify errors the better. To ensure you are getting the appropriate level of service for your specific needs, partner with an experienced life sciences commissioning firm at the start (so problems can be identified early and addressed quickly). This will allow you to execute your project seamlessly, without missing a beat due to errors or issues that do not get caught until the last minute. When speed to market, cost containment, quality, and safety are your top priorities, enhanced commissioning is your best bet.

 

If you would like to discuss in more detail how to determine the right level of service for your next project, contact us. We’d be happy to share thoughts on your specific project and provide details of what is working well for similar types of facilities.

Ashton Hyman, Commissioning Engineer headshot

Ashton Hyman, commissioning engineer II at 35 North, works with clients to ensure life sciences facilities, utilities, equipment, and systems are fit for intended use. He is experienced in providing efficient, effective solutions and customized plans for complex projects.

Chad Merewether, PE, commissioning manager, 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.

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