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6 Common Reasons External Quality Audits Fail
In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, an [...]
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, an [...]
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 foo [...]
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 M [...]
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 P [...]
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 [...]
