Your Input is Requested: AQCG Survey on OOS Investigations

The ECA Analytical Quality Control Group (AQCG) is currently revising and updating its guidance on Out-of-Specification (OOS) results. The goal is to better reflect current industry practices and to provide clear, practical recommendations that are aligned with today’s regulatory expectations.

To support this important activity, AQCG has launched a member survey focusing on how OOS investigations are defined, structured, and performed across the industry. The questionnaire addresses key aspects such as internal SOPs, investigation phases, testing and retesting strategies, hypothesis testing, decision-making processes, and the handling of confirmed or inconclusive OOS results.

All responses will be evaluated in an aggregated and fully anonymized manner. None of the questions are mandatory, and participants may skip any questions they prefer not to answer. At the end of the survey, respondents are also invited to propose additional topics or questions that AQCG should consider in future guidance documents.

Take part in the survey here.

Thank you for your valuable time and support.