Validation Sample Sizes and Selection: An Example

Steve Prevette

Deming Disciple
Staff member
Super Moderator
#11
Well, okay. Here is a good tutorial (from Virginia Tech) on t distributions, and refers to more basic information on hypothesis testing.

http://simon.cs.vt.edu/SoSci/converted/T-Dist/

Without understanding the underlying theories (and limitations) of hypothesis testing, it is a little hard to jump to issues of what sample size is needed. Even after gathering the proper sample size, you need to know how to process the data.

In this case, the "delta" is the average difference from before to after shots made (also, the same as the "after" average minus the "before" average). The issue with when to choose the t-distribution and the normal (z-distribution) is also very important, or at least shall we say if you like Guiness Stout you should find the t-distribution to be important . . .
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
B Sample Sizes for In-Vivo Design Validation Testing Other Medical Device and Orthopedic Related Topics 1
A Sample Sizes for Process Validation - Medical device manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 6
J Validation Sample Size for Tray Seal Qualification and Validation (including 21 CFR Part 11) 3
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 39
T Sample Size for Design Validation Design and Development of Products and Processes 4
R Sample size for clinical validation/investigation EU Medical Device Regulations 4
R Process Validation sample size selection Statistical Analysis Tools, Techniques and SPC 0
R Determining Sample Size for Medical Device Component Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
P Cleaning and Disinfection Validation Sample Size of 3? Other Medical Device Related Standards 2
N ETO Sterilisation Validation - EO Residual Minimum Sample Requirement ISO 13485:2016 - Medical Device Quality Management Systems 2
G Sampling Plan - Sample Size Justification for a Bottling Cleaning Process Validation Qualification and Validation (including 21 CFR Part 11) 2
P Sterile Medical Packaging and Shelf Life Validation Sample size ISO 13485:2016 - Medical Device Quality Management Systems 10
G Sample Size for Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
E Determining Sample Size for Design Verification and Design Validation Other Medical Device and Orthopedic Related Topics 20
L Sample size for validation run with product users 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Sample Size in Design Verification & Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
Q Determining Sample Size for FDA Verification and Validation Activities Inspection, Prints (Drawings), Testing, Sampling and Related Topics 41
S Which sample to use for PV (Production Validation) or DV (Design Verification) tests Manufacturing and Related Processes 4
Q Differences between Sample Sixes for Design Verification vs. Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Determining the Appropriate Sample Size for Process Validation/Qualification Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 2
C Spreadsheet Validation and Release Qualification and Validation (including 21 CFR Part 11) 2
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
M Sterile packing validation tests to be performed and protocol Other Medical Device and Orthopedic Related Topics 1
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
C ISO 19227 Validation Cost Other Medical Device Related Standards 2
A CNC Mill and Lathe - Validation Manufacturing and Related Processes 2
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
W LTPD, AQL, Ppk and Cpk validation sampling plan table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
F AS9100 - Validation, FAIR's, ITAR and Sub-Contracting AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
B Sterilization Validation Plan Other Medical Device Related Standards 3
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
T Laboratory Verification after validation ISO 17025 related Discussions 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2

Similar threads

Top Bottom