LIFE SCIENCES
How quality experts turned deviations into continuous improvement
In the complex manufacturing of vaccines, identifying the root causes of deviations is essential to demonstrate control over manufacturing processes and ensure product quality, with the ultimate goal of always safeguarding patient safety. ALTEN supports a world-leading vaccine developer, managing their end-to-end deviation process. Our consultants provide the technical rigor required to investigate, solve, and prevent recurrences in high-compliance environments.
The challenge
The client required a flexible, high‑calibre team capable of integrating seamlessly into both the Manufacturing Units. This need was driven by the challenge of managing a high volume of deviations without disrupting production throughput in a fast‑moving manufacturing environment. At the same time, deviation handling demanded complex root cause analysis, going beyond superficial corrective actions to identify the true underlying causes within highly technical vaccine processes. These activities also had to meet stringent technical and regulatory expectations, ensuring that corrective and preventive actions were fully GxP‑compliant while remaining practical and executable within tight operational timelines, and efficient enough to prevent recurrence.
The solution
ALTEN acts as the bridge between technical operations and quality assurance:
- Deviation Management: Leading investigations to identify root causes, evaluating potential SQIPP impacts, and implementing effective corrective and preventive actions to maintain compliance and product quality.
- Technical Expertise: Applying in-depth knowledge of manufacturing and quality processes to accurately identify root causes, challenge assumptions, and implement game-changing corrective actions. Our expertise also enables independent deviation assessment and validation, improving investigation quality and maximising Right-First-Time (RFT) rate
- Fully Integrated Service Model: Deploying multidisciplinary teams combining technical experts, quality specialists, and dedicated management resources. Fully integrated into the client’s organisation, ways of working, and decision-making processes, these teams provide seamless support, improve responsiveness, and ensure consistent delivery across the entire deviation management lifecycle while minimising the On-Time-Delivery (OTD)
Results & benefits
Our team has optimised the client’s deviation management, leading to:
- Proactive Problem Solving: Applying proven investigation methodologies, such as 5 Whys, Fishbone diagrams, and Human Error Analysis, to accurately identify root causes and support the implementation of robust CAPAs that help prevent recurrence. This expertise is backed by more than 200 consultants specialised in deviation management, covering over 10 areas of expertise.
- Operational Stability: Maintaining seamless support for Manufacturing Units, Technical Services, and QC by deploying an adaptive team capable of scaling quickly to absorb workload peaks, manage fluctuating demand, and accelerate backlog resorption without impacting operational performance. This approach contributed to a 50% reduction in QA workload within three months, a 20% increase in productivity, and a 40% reduction in operating costs.
- Audit-ready Documentation: Delivering accurate and high-quality technical documentation in strict adherence to client procedures
- CAPA Excellence: Leveraging a dedicated team of more than 30 CAPA specialists to drive effective remediation and sustainable compliance. Over the past six years, ALTEN has supported the closure of more than 4,000 CAPAs, while achieving six times fewer CAPA extensions over the last three years and maintaining over 95% on-time delivery.
- Right-first-time quality: Achieving 85% right-first-time performance from the initial deviation investigation, improving efficiency and accelerating deviation closure while strengthening compliance.
- Risk reduction: Enhancing quality oversight and investigation effectiveness, resulting in a 50% reduction in operational and compliance risks.
Key project takeaways
Reflecting on this engagement, several takeaways stand out as critical to effective deviation management in complex manufacturing environments. Deviation must be treated as a technical discipline in its own right, requiring not only quality expertise but also a deep, hands‑on understanding of the manufacturing processes behind each deviation. Equally important is a data‑driven approach to continuous improvement: leveraging digital tools such as Power Apps and e‑tracking systems like COMET and Trackwise enables real‑time KPI monitoring and more informed, timely decision‑making. Ultimately, success is driven by multidisciplinary synergy, with ALTEN’s consultants able to collaborate seamlessly across Manufacturing Units, QC, and Quality Systems, an approach that clearly differentiates ALTEN as a trusted partner.
