TRAINING COURSE TITLE:
To whom it is addressed:
The training course is addressed to Quality Managers, Technical Managers, Internal Auditors of QMS according to ISO/IEC 17025 as well as to Scientific and Technical Staff of Testing and Calibration Laboratories.
Trainer:
Miltiadis Volotopoulos, Chemical Engineer, MSc Quality Management, Member of the Chartered Quality Institute of UK, Management Systems Development Consultant of PROSPERITY Ltd. with experience since 1995 in more than 60 laboratory accreditations and delivery of more than 200 training courses.
FIRST DAY
11.00 – 11.45 Introduction,
Basic statistics – Standard deviation, Relative standard deviation.
Common Probability distributions.
11.45 – 12.00 Break
12.00 – 12.45 Basic statistics – Precision & Accuracy.
12.45 – 13.00 Break
13.00 – 13.45 Testing methods Validation and verification.
Accuracy, precision, linearity of instrument measurements.
Repeatability and reproducibility – Coefficient of Variation (%CV).
Precision of quantitative measurements.
Exercise 1: Precision of quantitative measurements.
13.45 – 14.00 Break
14.00 – 14.45 Evaluation of the precision of quantitative measurements,
Exercise 2: Calculation of the Horwitz Ratio,
Accuracy and Limit of Detection (LOD) of qualitative measurements,
Evaluation of the Limit of Detection (LOD) and the Limit of Quantification (LOQ).
Exercise 3: Determination of the limit of detection and the limit of quantification.
14.45 – 15.00 Break
15.00 - 15.45 Testing methods Validation and verification.
Evaluation of the Specificity, selectivity, sensitivity and robustness for method verification and validation.
Exercise 4: Determination of testing method Robustness.
Verification of medical examination methods.
15.45 – 16.00 Break
16.00 – 16.45 Evaluation of the Accuracy - Comparison between in-house method and standard method.
Exercise 5: Comparison between in-house method and standard method.
Evaluation of the significance of distributions and differences.
Exercise 6: Evaluation of Bias. Check for the existence of systematic error.
Comparison with reference materials. Spiking and recovery - Acceptance criteria.
SECOND DAY
11.00 – 11.45 Verification of microbiological testing methods (repeatability, reproducibility, limit of detection in quantitative and
qualitative testing).
Exercise 7: Evaluation of the reproducibility in microbiological testing.
11.45 – 12.00 Break
12.00 – 12.45 Interlaboratory comparisons and Proficiency Testing (PT).
Evaluation of the results – Z-score.
Exercise 8: How to check for outliers.
Exercise 9: Evaluation of the results from participation in PT.
12.45 – 13.00 Break
13.00 – 13.45 Internal quality control.
Preparation of X and R control charts.
Interpretation and evaluation of the results.
13.45 – 14.00 Break
14.00 – 14.45 R control charts according to ISO 5725-6.
Exercise 10: Preparation of an R control chart according to ISO 5725-6.
Quality control in microbiological testing.
14.45 – 15.00 Break
15.00 – 15.45 Equipment calibration. Traceability of measurements.
Acceptance of calibration certificates and results provided by external metrology laboratories.
Exercise 11: Acceptance of calibrated equipment, based on calibration results.
15.45 – 16.00 Break
16.00 - 16.45 Calibration and verification of balances and thermometers,
Calibration and Internal verification of common laboratory equipment (volumetric equipment, ovens, water baths,
refrigerators, freezers and incubators),
Preparation and acceptance of calibration curves of analytical instruments,
Confidence limits of the calibration curves.