Fundamentals of Statistics for Quality Control and Quality Assurance (2 days)

  Content Day 1
09.00 - 09.30 Introduction
09.30 - 10.30 Distribution of Analytical Data
  • Error types, data categories 
  • Data distributions, normal distribution
  • Sample and population, parameter of location and dispersion, method/process capability
  • Log-normal distribution
10.30 - 11.00 Break
11.00 - 11.30 Uncertainty of Statistical Parameters
  • Confidence intervals, statistical assurance level
  • Compensation of standard deviation uncertainty, significant figures and round
11.30 - 12.15 Normal or not normal?
  • Graphical presentations of (normally distributed) data (histograms, Box-and-Whisker plot, normal plot)
  • Outlier tests (according to Grubbs, Dean-Dixon, Hampel, for bioassays)
12.15 - 13.30 Break
13.30 - 15.00 Workshop: Variability
  • Statistical simulations (scatter of single results, means, standard deviations, method suitability: OOS risk)
15.00 - 16.00 Error Propagation and Precision Levels
  • Additivity of variances
  • Measurement uncertainty
16.00 - 16.30 Break
16.30 - 17.30 Workshop: Error Propagation & Analysis of Variances
  • Example error propagation, 1-factor-ANOVA with Excel, assignment of ANOVA-variances
17.30 End
  Content Day 2
09.00 - 10.00 Comparison of Data - Significance and Equivalence Tests
  • Analytical applications
  • Principles of statistical tests, significance tests (mean, nominal value, paired t-test, variance analysis)
  • Issues with significance tests, comparison of standard deviations (Fisher's F test)
  • Equivalence tests (mean, nominal value, paired) 
10.00 - 10.30 Break
10.30 - 11.00 Comparison of Data - Point Estimates
  • Simple comparison of means and precisions
  • Variability and differences between means
  • Probability of acceptance for the comparison approaches
11.00 - 11.45 Workshop: Comparison of Data
  • Statistical simulations
  • Comparison of comparisons: results for simple comparison, significance, and equivalence tests
11.45 - 12.30 Linear Regression
  • Analytical applications
  • Correlation analysis (coefficient of correlation and determination)
  • Unweighted linear regression, evaluation (residuals, sensitivities, intercept)
  • Requirements to calibration models
12.30 - 13.45 Break
13.45 - 15.00 Workshop: Linear Regression
  • Extrapolation and intercept, graphical evaluation of response functions
15.00 - 15.30 Break
15.30 - 16.30 Workshop: Statistics Quiz
  • Multiple-choice questions for statistical fundamentals
16.30 Final Discussion

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