Activity

  • Scott replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices 8 years, 2 months ago

    In agreement with this post. AQL levels for most companies are the guideline for identifying what the sample size should be depending on the risk. However, further analysis such as power level, significance level, confidence intervals, etc can be applied to potentially explain why that sample level isn’t necessary for that level of risk. Usually this can be frowned upon, going against what the AQL levels are, however it is up to Quality if they are willing to accept less samples if the risk isn’t as severe.