Mandatory Gauge R&R for Process Validation?

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

I believe you are correct; I have not seen anywhere in the regulations or guidance documents the agency specifically require a Gage R&R study.

[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.

Please correct me if I am wrong.

Hello Mattossa,

You use RR to verify whether there is variation on measurement system or a product.

You can use the following:

  1. Acceptance sampling plan
  2. Analysis of mean (ANOM)
  3. Analysis of variance (ANOVA)
  4. Capability study
  5. Challenge test
  6. Component swapping study
  7. Control chart
  8. DOE
  9. Dual response approach
  10. FMEA
  11. 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]

Thanks all for your input!