Root Cause Analysis (RCA) is essential for identifying and addressing the underlying causes of problems to prevent recurrence. Below are 7 powerful tools that every quality professional should master: ❶ Ishikawa Fishbone Diagram: Organize potential causes into categories for better visualization. ❷ Pareto Chart: Prioritize causes by focusing on the vital few rather than the…
In the pharmaceutical industry, quality is more than a goal—it’s a responsibility. At the heart of this responsibility lies the Quality Management System (QMS). A well-designed QMS ensures that every product is safe, effective, and compliant with regulatory standards. Key QMS tools driving success in pharma include: Risk Management Quality Risk Management is a systematic…
Quality excellence is the commitment to consistently meet standards by continuously improving processes, reducing errors, and delivering high-quality products to ensure patient safety, regulatory compliance, and operational efficiency. However, achieving quality excellence doesn’t always require major overhauls; small, strategic adjustments can make a powerful impact. Here are some actionable tips to boost quality performance today!…
Errors are not a reflection of individual incompetence but a result of complex interactions between human factors, system design, & environmental influences. We must abandon the naïve belief that BETTER TRAINING will MAGICALLY ERASE ERRORS and instead embrace a holistic approach. The CAPA framework focuses on both PREVENTION and REACTION to errors: PREVENTION: BUILDING A…
