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This document provides guidance on the investigation of Sterilisation Dose Audit (SDA) positive results and failures.  It contains best practices shared bypanel members and example tools that can aid the targeted investigation and evaluation of root cause. The guidance is intended to promote a proactive approach to SDA positive results, enabling manufacturers to identify emerging trends, address underlying causes, and reduce the risk of future SDA failures. This guidance supplements, but does not replace, the requirements of ISO 11137, ISO 11737 and applicable company quality management system requirements.

This guidance is intended for product manufacturers that encounter positive SDA results or failures during routine testing and provides a structured approach to identifying the root cause of surviving microorganisms and determining appropriate methods for their eradication.