Deviations: streamlining their management for strategic gain
Paradigm shift — In the life sciences industry, deviation management is a crucial activity that must be mastered to comply with good practices. A deviation, or an unplanned event that diverges from an established standard in a GxP environment, requires thorough resolution and documentation. Yet, an overemphasis on immediate fixes can overlook the opportunity for significant quality improvements and operational excellence. Recognising this gap, ALTEN has developed a functional service model designed to transform deviation management from a quality issue into a proactive operational asset.
Traditional deviation management often traps companies into focusing on quick fixes for immediate quality issues, leading to a host of challenges. This approach tends to divert resources away from strategic objectives aimed at long-term improvement and compliance, making it difficult for companies to maintain a consistent focus on quality and operational excellence. Additionally, the fluctuating number and the unpredictable nature of deviations can overburden in-house resources, leading to peaks that create backlogs and bottlenecks that hinder effective management. Furthermore, this variability could expose a knowledge gap in handling specific deviations or in the overall process of managing deviations. This complicates the identification of the root causes and implementation of effective corrective actions. This reactive stance also impacts a company’s readiness for regulatory inspections, as a lack of continuous improvement and proactive quality culture can leave gaps in compliance and operational integrity.
The impact of ALTEN’s deviation management functional service: a measurable success
— In this context, ALTEN introduced a functional service model that redefines the essence of deviation management. The model quickly proved effective through a pilot project, where a team of five deviation coordinators demonstrated its strengths early on. Within a couple of months, the team started to deliver deviations ready to be closed, and by the third month, operated autonomously. This early success was driven by strategically capitalising on knowledge, boosting the model’s capacity and sustainability. This approach enabled clients to focus on core activities, offering adaptability and access to an extensive expert network. Following the pilot’s success, the model gained recognition by several life sciences clients and expanded rapidly. Since then, over 200 consultants have collaborated on various projects and contributed to the closure of more than 4500 deviations. This growth led to the establishment of a Belgian center of excellence, now a global hub for sharing best practices and expertise.
The ALTEN’s model: a critical breakthrough
— Historically, the Belgian consultancy industry has relied on the time-material model for technical support, placing consultants under client supervision to meet specific needs. While effective to a point, this model often led to inefficiencies, focusing more on filling roles than on enhancing performance and knowledge management. ALTEN’s technical direction identified an opportunity to rethink this approach, resulting in the creation of the deviation management functional service model.
This model marks a significant leap from the status quo by emphasising performance and outcome-driven results. This model shifts consultant management and performance monitoring to ALTEN, enhancing expertise and efficiency while decreasing reliance on individual client process knowledge through structured knowledge management. It offers high flexibility in resource allocation and includes efficient turnover management for consistent support. Additionally, ALTEN now oversees consultant training to ensure a standardised understanding of deviation management across the team.
— In summary, ALTEN reshaped deviation management, turning challenges into strategic assets for better quality. With our expansion into Corrective Action & Preventive Action (CAPA) and Change Controls since 2023, we’ve significantly extended our reach. Our strategy goes beyond creating a generic expertise hub; we leverage ALTEN’s extensive global network to establish specialised hubs that enable profound synergies within the same client across different countries. This initiative will optimise interconnectivity and efficiency, transforming how multinational clients manage deviations worldwide.
