I’m 99% sure that I know this answer, but I could be wrong.
A colleague at my company says you ALWAYS must do a Gauge R&R in a validation. The FDA says use statistical tools, but they don’t prescribe a specific tool right? All validations are different!
I need to update my manager as to if this is true. Any input is helpful. Thanks, Steve
[quote=mattossa]I’m 99% sure that I know this answer, but I could be wrong.
A colleague at my company says you ALWAYS must do a Gauge R&R in a validation. The FDA says use statistical tools, but they don’t prescribe a specific tool right? All validations are different!
I need to update my manager as to if this is true. Any input is helpful. Thanks, Steve[/quote]
It is no where mentioned that you have to do certain tests. But, it is beneficial to do as many tests as you can (or applicable to your data). It is beneficial for your process understanding (FDA has no benefits, it’s all for your good not theirs). R&R gives you broad perspective of your process, increases your process understanding and knowledge space. I would prefer R&R for all Analytical methods.
You use RR to verify whether there is variation on measurement system or a product.
You can use the following:
Acceptance sampling plan
Analysis of mean (ANOM)
Analysis of variance (ANOVA)
Capability study
Challenge test
Component swapping study
Control chart
DOE
Dual response approach
FMEA
FTA
And more…
I hope I can help you with this.
[quote=mattossa]I’m 99% sure that I know this answer, but I could be wrong.
A colleague at my company says you ALWAYS must do a Gauge R&R in a validation. The FDA says use statistical tools, but they don’t prescribe a specific tool right? All validations are different!
I need to update my manager as to if this is true. Any input is helpful. Thanks, Steve[/quote]