At Validate 2024 in Berlin, Pierre Winnepenninckx delivered a compelling talk titled “Repairing a C&Q Program with Digitization,” offering deep insights into how companies can enhance their Commissioning and Qualification (C&Q) processes by embracing digital tools. Pierre’s experience of over 23 years in the C&Q space has led him through multiple roles and challenges in pharmaceutical projects worldwide, shaping his lean thinking approach to addressing the complexities in pharmaceutical manufacturing.
In this blog post, we’ll explore some of the most valuable takeaways from Pierre’s talk, particularly focusing on how digitization can repair and revolutionize C&Q programs. If your organization is considering modernizing its C&Q workflow, these insights are invaluable.
1. Understanding the Challenges in C&Q Projects
Pierre emphasized the fundamental challenges present in C&Q projects, particularly the clash between OpEx (Operational Excellence) and CapEx (Capital Expenditure) mindsets. While OpEx focuses on continuous improvement and optimizing current operations, CapEx deals with the lifecycle of a project—from initiation to completion. These differing approaches often result in a disjointed workflow where project delivery and quality control processes compete for priority.
In a traditional C&Q project, change controls between operations and quality are often overly complex, leading to bottlenecks. Pierre pointed out that embracing digitization, particularly with tools like Kneat, simplifies change control management and allows for real-time adjustments, speeding up project completion without compromising quality.
2. Digitization Brings Data Integrity by Design
One of the most significant advantages of using digital platforms like Kneat is the inherent data integrity by design. Pierre shared that with Kneat, companies can expect a significant reduction in execution time, enabling them to meet project deadlines faster, especially in highly regulated environments. This is crucial in ensuring the integrity of the data used throughout the C&Q lifecycle.
By digitizing processes, regulatory authorities gain the transparency they need to assess compliance more easily. As Pierre mentioned, “Every opportunity someone sees as a benefit, others see as a risk.” However, with digitization, the risks of non-compliance, manual errors, and data manipulation are significantly mitigated, giving teams the confidence to move projects forward efficiently.
3. Navigating the VUCA World with Agility
The world of C&Q projects is often described as VUCA—Volatile, Uncertain, Complex, and Ambiguous. Pierre highlighted that every project brings its own set of unknowns and challenges. Whether it’s a change in vendor supply chains or evolving regulatory demands, the ability to adapt quickly is paramount.
Digitization provides the agility required in such a fast-paced environment. Tools like Kneat allow teams to visualize project timelines, track real-time updates, and maintain flexibility to address changes without derailing the entire project. This capability is a game changer in projects where meeting strict timelines and adhering to compliance are critical for success.
4. Why ‘Lean Thinking’ is Key
Pierre identifies himself as a “lean thinker” and explained how lean principles apply directly to the C&Q process. The core idea is to eliminate waste, improve the flow of value, and continuously improve the process. Digitization facilitates lean thinking by creating a streamlined workflow where every step is optimized for efficiency.
In a digital C&Q program, tasks such as change approvals, document reviews, and process verifications are no longer manual, allowing team members to focus on value-added activities rather than administrative burdens. Additionally, digital platforms allow for immediate access to relevant data, providing transparency and ensuring everyone is working with the same information.
Lean thinking also applies to how C&Q projects are deployed. Pierre advised that instead of attempting to digitize all processes at once, companies should start small, learn quickly, and then scale up. The concept of a Minimum Viable Product (MVP) is central here—begin with the essential elements that create immediate value and build upon that as the organization becomes more familiar with the technology.
5. Clarifying Project Scope to Drive Efficiency
Pierre underscored the importance of having a clearly defined project scope in C&Q initiatives. One of the biggest contributors to inefficiency is constantly shifting project scope. A Master System List is essential for driving the project forward. Without it, the project timeline can suffer, as resources and priorities become misaligned.
Digitization makes it easier to lock in the project scope early, reducing the chances of scope creep. Tools like Kneat enable project teams to document, manage, and track all system lists, change requests, and deliverables in one centralized system. This reduces ambiguity and ensures everyone is aligned on what needs to be done.
6. Bridging the Gap Between Engineering and Quality Assurance
Another key point Pierre touched on was the relationship between engineering and quality assurance (QA) teams in C&Q projects. Traditionally, these departments operate in silos, leading to communication breakdowns and delays in project execution. By adopting a digital C&Q platform, teams can work in tandem, ensuring that engineering handovers to QA are seamless.
Pierre highlighted that the digitization of C&Q processes reduces the chance of discrepancies between engineering deliverables and QA requirements. By having both teams work from the same platform, issues can be identified early and addressed before they affect the overall project timeline. Additionally, QA teams can leverage vendor documentation through Kneat, further accelerating the approval process.
7. Training and Adoption—A Critical Factor for Success
Training is vital when deploying any new technology. Pierre emphasized the importance of instructor-led training for key users, followed by on-the-job learning to embed the new processes. While online training can provide foundational knowledge, hands-on experience allows users to troubleshoot, make mistakes, and build confidence in using the system.
Pierre’s company, No Deviation, has trained over 1,000 people in Kneat, and their experience shows that the best way to ensure successful adoption is through continuous learning and support. As part of their deployment strategy, No Deviation forms a “Kneat Catalyst” team—people well-versed in both C&Q and Kneat who can act as mentors and troubleshooters for the broader team.
8. Governance is Key to Effective Digitization
A well-defined governance structure is crucial for managing a successful digital C&Q program. Governance ensures that decisions are made efficiently, responsibilities are clear, and everyone understands the processes. Pierre stressed that governance is not something that can be left until the last minute—it must be established from the beginning to guide the entire project.
At No Deviation, they’ve implemented governance structures that address user access, workspace management, and system discipline, providing clarity and ensuring that the digital tools are used consistently across teams. This approach minimizes the potential for confusion and helps teams stay aligned with project goals.
9. Continuous Improvement—The Key to Longevity
Digitization in C&Q is not a one-off exercise—it requires continuous improvement. Pierre spoke about the importance of failing fast and learning from mistakes to drive better results over time. With digital tools, you can iterate quickly, applying lessons learned to improve processes and templates for future projects.
For instance, Kneat allows companies to revise templates and workflows in real-time, ensuring that improvements are implemented without delay. By embracing a continuous improvement mindset, organizations can stay ahead of challenges and maintain a competitive edge in their operations.
Conclusion
Pierre Winnepenninckx’s talk at Validate 2024 provided a comprehensive look into how digitization can repair and enhance a C&Q program. From ensuring data integrity and bringing agility to projects to fostering lean thinking and continuous improvement, the benefits of adopting digital tools like Kneat are clear.
If your organization is facing challenges in managing its C&Q projects, now is the time to explore how digitization can transform your processes. At No Deviation, we specialize in helping pharmaceutical companies modernize their C&Q workflows using cutting-edge tools and lean methodologies.
Ready to take the next step? Contact us at hello@nodeviation.com or visit our website at www.nodeviation.com to learn more about how we can help streamline your C&Q processes with digitization.
Watch the full presentation on YouTube: https://youtu.be/hOJEBQPng8o
