While most advanced manufacturing clients require some level of risk analysis and mitigation, traditional quantitative risk analysis alone is not enough to ensure project success.  

Manufacturing and research projects need to incorporate high-quality qualitative analysis to deliver projects on-time and on-budget, while minimizing risk to operations, quality, and regulatory compliance.   

The Status Quo  

Advanced manufacturing projects require absolute precision. From product, compliance, and operational design to disaster-proofing facilities, every element of designing, building, commissioning and qualifying advanced manufacturing facilities requires careful analysis of cost and schedule as well as detailed risk mitigation strategies.  

Traditional quantitative risk assessments have often been driven by factors like market demand vs. product supply (i.e. capacity), funding availability, project timelines, and operational readiness. As clients strive to bring pharmaceutical products to patients quickly, their projects require shorter timelines with a higher degree of certainty for early project milestones.   

Project teams ideally seek to identify all critical product and operational milestones, fully integrating them with key project milestones from the EPCMQV service providers.   

However, these milestones are often in conflict, as respective schedules developed at the onset of projects typically fail to consider common uncertainties or fluctuations in advanced manufacturing timelines.  

When teams rely on this type of generalized data, deterministic schedules and quantitative risk assessments alone become often less accurate. An average risk assessment may only be 15% accurate, creating highly variable project scenarios, ineffective risk strategies, and less confidence in project success.  

The Importance of Qualitative Risk Analysis 

In contrast, qualitative risk analysis or cost and schedule risk assessment (CSRA) offers a holistic view of projects, anchored first in logically driven project timelines, and secondly, in individual planning and analysis of critical or near-critical tasks with the highest probable impact on project pathways and key milestones.  

Effective CSRA begins with integrating all client and EPCMQV project schedules into a true end-to-end master schedule. A fully integrated, logically driven schedule affords more transparency, eliminates arbitrary or unnecessary activities, and identifies critical pathways, resulting in a more realistic project schedule and roadmap for project delivery.  

CSRA also evaluates uncertainties and variabilities inherent in advanced manufacturing projects. It considers the likelihood of different outcomes, such as best-case and worst-case scenarios using statistical methods, and then elevates risks that have a high probable impact on costs and timelines. Drawing on all this information, a project team can more properly assess individual risks and refine management strategies around them.  

An Experienced Approach to Qualitative Analysis 

Not all CSRA methods for advanced manufacturing projects are created equal. Effective CSRA methods use AACE and PMI risk management frameworks, ensuring a structured and standardized approach.  

These methods allow teams to apply industry benchmarks and lessons from other projects onto global pharmaceutical and high-tech capital projects, leveraging best-in-class risk modeling techniques. 

At Cumming Group, we have extensive experience managing CSRA on critical and complex projects, not only in advanced manufacturing, but also in other sectors, including semiconductors and critical infrastructure as well as data center projects. Our interdisciplinary Project Controls specialists— as well as our EPCMQV expertise— ensure seamless and collaborative project delivery. As a fully independent consultancy, clients trust our careful stewardship of their resources and investments.  

Cumming Group has supported billion-dollar projects in North America, Europe, and Asia, integrating lessons learned across industries to benefit capital projects. Our diversified industry expertise allows us to anticipate and mitigate risks proactively, reducing cost overruns, schedule delays as well as operational, compliance, and product risks. The result of this approach is strengthened client decision-making and successful long-term outcomes on complex projects.