Written by Paige Kane, PhD, CPIP
If you work in Life Sciences, you know that it is a complex, high-stakes operation. I’ve been through my fair share of startups, and as many of you know, what CAI calls “getting to Day One” is hard—and continually improving operations is even harder. That’s why CAI approaches performance as a continuum that starts with Operational Readiness (OR) and matures into Operational Excellence (OE). OR helps you identify risks and gaps in a holistic manner so you can startup safely, compliantly, on time and on budget. OE is about consistent and sustainable operations, right first time and continually improving—every day, across people, processes, data — never losing focus on quality.
OR lays the foundation
Operational Readiness (OR) is the CAI structured method to be ready and in control from “Day One”—with the right people, systems, and processes in place. The OR journey follows five phases as described below.
Our OR methodology includes a workshop where we ‘plant the flag’ so all know and are aligned with the target condition. The workshop produces a practical roadmap, identifies risks and talent requirements (and gaps if any) needed to initially deliver high quality, on schedule and on budget.
As teams progress, OR emphasizes disciplined execution—in commissioning, qualification and validation (CQV), people readiness, governance, and KPI visibility,—to hit targets and enable right first time PPQ and startup. Crucially, transitions its leaders and routines into the OE team at startup, preserving momentum and lessons learned.
The OR→OE continuum
Everything has a lifecycle, from our facilities to our equipment to the medicinal products we manufacture. The diagram below provides a pictorial representation of the OR and OE continuum.
OR and OE aren’t separate programs; they are a staged progression. This continuum depicts how your project effort gradually shifts into operations without dropping the ball: the metrics, cadences, and accountabilities established during OR become the operating system for OE.
OE turns readiness into results
Where OR sets the stage to operate, Operational Excellence makes you more efficient, reliable, and resilient over time, all with a keen focus on quality. Our OE framework focuses on a combination of everyday improvements in our flow of work and targeted projects that compound into big, lasting gains—and it explicitly builds on routines stood up during OR. The Six Pillars of Operational Excellence are described below.
CAI’s Six Pillars of Operational Excellence
- ORGANIZATIONAL LEADERSHIP
Drives focus and alignment through clear priorities, empowerment and metrics. Inspires a culture of accountability and improvement; leadership models, invests, and reinforces OE at every level.
- PRODUCT & PROCESS EXCELLENCE (Manufacturing & Business Processes)
Uses OE tools and methods to deliver consistent, high-quality outcomes through disciplined processes, visual management and measurable improvements. Embeds a “make it better” mindset into daily operations.
- PERFORMANCE EXCELLENCE & AGILITY (People-Centered Processes)
Strengthens a skilled, agile and engaged workforce via ongoing training, frontline leadership and empowerment so teams adapt, take initiative, and drive improvements.
- FACILITY & EQUIPMENT OPTIMIZATION (Physical Assets & Controls)
Maximizes reliability by optimizing assets, reducing downtime and ensuring process continuity—through lifecycle management and proactive planning. Reliability. Efficiency. Sustainability.
- DIGITAL & DATA MATURITY
Advances data-driven operations with automation, integrated digital systems and real-time insights to reduce variability and enable smarter decisions.
- QUALITY OPERATIONS & INNOVATION
Harnesses data, technology, and quality expertise so compliance and innovation converge—delivering smarter, faster, future-ready outcomes.
Together, these pillars operationalize the continuum: leadership sets direction, processes and people execute, assets stay reliable, data informs action, and quality accelerates speed-to-value.
How to put the OR/OE Continuum to work for you:
If you’re in startup: schedule an OR workshop, don’t wait for mechanical completion—earlier alignment returns more value! Case Study: Biotech Plant Scale Up Support Summary.
If you’re in operations but plateauing:
- Conduct a maturity audit against the six pillars, build a 90-day CI backlog, and restart daily/weekly tier boards to re-establish momentum. Identify CI Champions and provide training and support.
- Choose a focus on where you would like to improve. See a few examples of case studies.
The bottom line: OR gets you organized and in control from Day One; OE keeps you advancing and strengthening a culture of continuous improvement. Based on my experience, I look at OR/OE as a journey, not two projects. It has been proven to convert startup energy into a durable performance advantage. If you would like to learn more, please reach out! Paige.Kane@caiready.com
Paige Kane, PhD, CPIP, is a seasoned leader with over 30 years of experience across the biotech and pharmaceutical industry, including roles at MSD, Pfizer, Wyeth, Genetics Institute, and Monsanto. Her expertise spans the full product lifecycle—from R&D and clinical development to commercialization, facility startup, technology transfer, and GMP manufacturing — making her a trusted advisor in Operational Readiness and Operational Excellence.
Paige is known for developing strategies that drive performance, innovation, and compliance. A recognized thought leader, she has contributed to key industry guidance such as the BPOG Technology Roadmap and ISPE’s GAMP® and Pharma 4.0™ publications. With a PhD in Pharmaceutical and Regulatory Science from TU Dublin, she is passionate about improving global access to medicines and building high-performing, collaborative teams that embed a culture of continuous improvement. www.linkedin.com/in/paigekanephd