TABLE A-I

The Table of Issues and Mitigation Plans Identified during the Risk Assessment

Operations That May Have Impact
Issue	Severity	Mitigation plan
Equipment is not properly calibrated	Critical	Large scale: Introduce non-intrusive sensors (e.g., vibration) that could lead to the anomalous function. Small scale: Working with experimented operators that should not be a problem
No good data quality is available to allow application of AI models afterwards	Critical	When large time series are used as input data for AI, it is necessary to get frequent CQA measurements close to the real process in order to have better models. Otherwise, if only one CQA measure is sampled at the end of the process, all the time series must be collapsed, losing the expected data quality.
Instrumentation not properly calibrated	High	Use common sense to establish the proper actions to keep the instrumentation calibrated.
There are manual operations (cleaning, setup, sampling) affecting critical operations during the process	High	Add recommendations supplied by AI recommender systems Automate all those manual actions considered as medium or high risk. Assign a risk to each manual action Take measures of manual actions (operator, duration, process, task, etc.) Emphasize trainings for complex and critical tasks