AssurX Blog
Straight talk for regulated industries.
Root Cause Analysis Tools: Which Should You Use?
Root cause analysis is a common weak spot in manufacturing, causing numerous quality issues, product safety problems, and enforcement actions. For example, recent headlines over baby f [...]
FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls
Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufacturers. It applies equally to animal food manufacturers. Recently, the FDA released updates for animal f [...]
How Hybrid Audits Can Help MDR Compliance in the European Union
The shortage of notified bodies (NB) in the European Union is a key challenge for device manufacturers struggling with Medical Device Regulation (MDR) compliance. As a result, the EU’s [...]
8 Essential CAPA KPIs to Measure
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS) and critical to the Plan-Do-Check-Act process approach. Like any quality process, tra [...]
Finding the Root Cause: Where Manufacturers Go Wrong
Finding the root cause of a manufacturing quality issue prevents unsafe or poor quality products from reaching consumers. Unfortunately, many investigations don't get to the true root [...]
5 Strategies to Improve Quality Incident Management and Root Cause Analysis
Imagine you’re doing a pre-shipment inspection on multiple pallets containing product canisters. As a result of the inspection, you observe wrinkled labels throughout the lot. While th [...]
