Managing deviations and investigations efficiently is critical to ensuring product quality, compliance with regulations, and continuous improvement. An effective quality management system (QMS) must include procedures to identify, document, segregate, evaluate, and disposition production and post-production issues. You need to report and document the deviation as soon as it is identified. This includes…
“In many organization, politics are allowed to influence the CAPAs simply because there are too many people involved in the approval process—approval to actually open a CAPA, or approval to finish one. Very often there are too many people, or the wrong people, in the approval process. I’ve seen real problems get swept under…
Root Cause Analysis (RCA) is a problem-solving methodology that steps you through the RCA process. Each RCA process phase has a range of root cause analysis tools that you can use. The RCA process starts at the problem event then moves through evidence collection, investigation, analysis, developing corrective actions to address the problem or…
