Transforming quality assurance: a grassroots approach to operational excellence and patient safety
In the high-pressure environment of clinical pharmacy, Quality Assurance (QA) is often viewed as a regulatory hurdle rather than an operational engine. This presentation challenges that perception by demonstrating how "grassroots" clinical pharmacy professionals can drive significant impact through proactive In-Process Quality Assurance (IPQA) and lean process optimization. Project Overview: Drawing on 18 years of pharmaceutical experience, including a leadership role at Zydus Group UK, I spearheaded an initiative to bridge the gap between strict GMP compliance and operational reality. The project focused on three pillars: streamlining technical documentation, accelerating risk resolution through root cause analysis (KT), and fostering cross-departmental collaboration. Key Findings and Learning: Delegates will learn how a systematic revision of over 20 technical SOPs led to a 25% reduction in operational deviations by focusing on clarity and requirement-alignment. Furthermore, the session will detail how proactive CAPA management and Situation Forecasting accelerated risk resolution by 35%. These grassroots changes directly improved efficiency, resulting in a 15% increase in on-time batch releases and the identification of £25,000 in annual cost-saving opportunities. Conclusion and Impact: The "real-world" impact of this work is two-fold: it ensures that life-saving medications reach patients faster while maintaining 100% adherence to MHRA/EMA protocols. This session provides a practical roadmap for pharmacy professionals to transition from reactive compliance to proactive leadership, using lean methodologies to deliver results that align both commercial and quality objectives.
- Streamlining technical documentation
- Accelerating risk resolution through root cause analysis
- Fostering cross-departmental collaboration
- ALCOA

