Sample Size Selection: Is That Number Right?
Yuval Shapiro is the founder of QWV – Quality with
Value, QA/RA Services. An expert for products and companies primarily related to medical devices that meet the real needs of their clientele.
Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries. More than 20 years of experience
in QA; including MD&D RA & QA;QMS (21CFR - Part820, ISO13485,
TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in
R&D Projects; Risk Analysis as per ISO14791& ISO31000; EMC
& Safety Certifications.
Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially,
when regulatory authorities require to provide a justified rationale for
- What is Sample Size and why is it important?
- Power Analysis
- Estimation, Accuracy, Precision
- Hypothesis testing, type of errors
- Effect size
- The alternative hypothesis (one-tailed vs. 2-tailed)
- Problem with overpower
- Replicates when sampling
- Sample size calculations
- Sampling plans as per ISO 2859-1 (Mil-std 105E)
Course Level - Intermediate
Who Should Attend
- Quality Engineers
- Quality Managers
- R&D Engineers
- Transfer to Production
- Quality Control
Why Should You Attend
- Identifying the statistical rationale is the first step for selecting the correct sample size
- Once understood the principles of the rationale, the selection becomes easy, and the provision of justifications is straight-forward
- The trainee shall know the statistical rationale behind selecting a sample sizes for the Design (verification and validation) phase and for the production
- Practical examples will be provided as well