Errors, Accidents, Suspected Adverse Events, Biological Product Deviations, Variances, and Complaints
{"Image DocumentName": "Errors, Accidents, Suspected Adverse Events, Biological Product Deviations, Variances, and Complaints", "Image ImageDescription": "Ability to detect issues, correct both isolated and systematic problems, and report to the appropriate organizations. Detect. Investigate. Document. Track. Report. Correct. Evaluate. The requirements for errors, accidents, suspected adverse events, biological product deviations, variances, and complaints have several steps, but they are simply intended to provide the program or bank the ability to detect issues and then correct them, while reporting to the appropriate organizations. Detect: Be able to determine when products or units do not meet product specifications and process controls. Investigate: Find the cause by collaborating with all facilities, registries, etc. Document: Written reports, complaint files, review by Director. Tracking: Categorizing issues allows identification of systematic problems. Report: Notify all facilities, governmental authorities, registries, etc. when appropriate and required. Corrective Action: Do not forget to include both short and long-term action and evaluate the action. Commonly Cited! Evaluation: Review all of the information. Detailed information regarding this requirement is provided in the recording of the FACT product deviations webinar, which is available on the FACT website.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}