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Dear Colleague,

The ECA Analytical Quality Control Group (AQCG) is currently in the process of revising and updating its existing guidance related to Out-of-Specification (OOS) results. The objective of this activity is to better reflect current industry practices and to develop clear, practical guidance aligned with current regulatory expectations.

To finalize the revised document, we rely on your valuable input. This questionnaire is intended to gather insights into how OOS investigations are defined, structured, and executed within your organization, including applicable SOPs, investigation phases, testing strategies, and decision-making processes.

All responses will be evaluated in an aggregated manner and published in an anonymized form. The results will serve as an important foundation for the further development of the AQCG OOS guidance. Your participation is highly appreciated and will directly contribute to a more robust and practical OOS framework.

None of the questions in this questionnaire are mandatory. You may skip any question you do not wish to answer. At the end of the questionnaire, you are invited to add any additional comments or topics you would like AQCG to address in future guidance documents.

Thank you very much for your time and support!
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Which formal recommendations are included in your internal OOS SOP?
(Select all that apply)
Do you clearly define what constitutes an OOS test result?
Do you make a distinction between OOS, OOT (atypical, aberrant), and invalid results?
To which areas does your OOS SOP apply?
(Select all that apply)
Do you apply a replication strategy and define the mean as the reportable result?
If you define the mean as the reportable result, which statements apply?
(Select all that apply)
Do you describe timelines for each investigation phase (e.g., Phase I, IA, IB, Phase II and Phase III within X days)?
At which stage(s) do you perform a second-person review?
(Select all that apply)
How often do you discover obvious errors (i.e. directly identifiable, e.g. spilling of sample solution, overfilling, power failures) as the root cause of the OOS?
Do you use a step-by-step checklist during Phase I?
Do you always perform hypothesis testing?
During what phase do you perform hypothesis testing?
Do you retain all test samples and step solutions for OOS investigations?
Do you have a structured approach to hypothesis testing (e.g. by use of fishbone analysis or other tools)?
Do you prepare a protocol for hypothesis testing with expected outcome of the testing (acceptance criteria)?
How often do you perform re-analysis (i.e. repeated analysis of existing sample solutions) during Phase I?
During what phase do you perform retesting (i.e. a complete repeated preparation of the original sample)?
(Select all that apply)
How often do you perform retesting (i.e. a complete repeated preparation of the original sample)?
How often do you perform Phase IIA (Review in manufacturing)?
When do you perform Phase IIA (review in manufacturing)?
How often do you have an inconclusive OOS (i.e. neither laboratory error, nor clear product failure could be identified)?
Do you describe retesting procedure (e.g. sample size, outlier test and evaluation) in your analytical procedure SOP?
How often do you identify a root cause for the OOS?
Do you have CAPA requirements when root causes are identified?
How often do you have a confirmed OOS?
Additional Comments
Please add any additional questions or topics you would like AQCG to address in future guidance documents.
Thank you for taking the time to complete the survey.

Your ECA Analytical Quality Control Group Team
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