ROOT CAUSE ANALYSIS, WHERE QUALITY GROWS UP A strong Root Cause Analysis converts confusion into cause–and–effect clarity: 1) It separates symptoms from sources2) It turns firefighting into learning3) It transforms compliance into confidence HUMAN ERROR ≠ ROOT CAUSE Human actions are effects of system design & not the source of failure. Ask deeper questions:1) Was…
To most organizations, CAPA metrics are about compliance i.e., meeting timelines, closing investigations, passing audits. To regulators, they are a window into your quality culture i.e., how we think, learn & respond to risk. ILLUSION OF 100% ON-TIME SUCCESS Many companies proudly report: 1) 98% CAPAs closed on time2) 100% effectiveness checks completed3) Zero overdue…
The difference between ISO standards and EU GMP Annex 1 regarding airflow velocity measurement points is a common source of confusion in qualifying HEPA filter velocity is measured in both cleanrooms and laminar airflow (LAF) especially in Grade A areas. Air velocity is crucial to maintain cleanliness and prevent contamination at clean room but for…
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…
