Design Verification Testing and Statistics

J

JasonR

Registered
#1
#1
When it comes to design verification testing of a medical devices, a justification of sample size is required. If I need to verify outer diameter for example, typically I would use a minimum sample size of 15 and claim a 95% confidence level with a 90% reliability/conformance level of variable data (assuming normal dist.). But what if we are measuring 100% of the samples in production to verify that the diameter is with in a specification of 2.0mm +/- 10%. When production gives me the samples for testing I already know they are in specification. So do I still have to do design verification testing using relaibility statistics? Doesn't seem to make sense. What type of analysis of the data set do I say I'm going to perform in my protocol? The testing of the diameter is still required according to the regulations.
 
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T

Tidge

Trusted Information Resource
#2
#2
In the case of a measurement like you describe, you are doing a variable study as opposed to an attribute study.
 
S

Semoi

Involved In Discussions
#3
#3
If you verify each product, you don't have to validate the production process. However, it might be useful to perform a gauge R&R study and to validate the measurement device -- as always everything depends on your risk assessment (FMEA). Performing the gauge RR study you are able to estimate how reliable you are able to measure the diameter.
 
Y

yodon

Leader
Super Moderator
#4
#4
As @Semoi indicates, it sounds like you're conflating design verification with process validation.

Your design verification is (can be) that the drawings show the right dimensions. Your process validations will determine if you're actually holding to the tolerances indicated.
 
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