Acceptance Criteria Gage R&R - Simple vs Complex Techniques

[v9991]

usual its defined as...
< 10% acceptable gage
10-30 marginal
> 30 unacceptable;
since this is coming from engineering/automative industry, My assumption is that this is for simple direct measurements, such as dimensions check using screw gauge, verniers, or temperature, pressure check using appropriate gagues?

The question is,
does the same acceptance criteria apply for complex analysis (involving multiple steps); viz., analytical methods in pharmaceutical world involves each analysis for
standard :- weight - dilution - response of UV -
test :- weight - dilution - response of UV - comparison with Std response.

I was trying to discuss same on separate thread.....
https://elsmar.com/elsmarqualityforum/threads/62417&page=2

thank you

 

[somashekar]

Are the results an attribute in the complex techniques .....

 

[v9991]

we are dealing with continuous measurments.

 

[somashekar]

I guess these are always run with positive control and negative control test in order to validate the results. So such process R&R is always tested.

 

[v9991]

Yes, as indicated, we do run standard (+ve) control;
and my query was that, for R&R, can we (do we need to) consider the often used criteria of <10 :: 10-30 :: >30 criteria for evaluation of gage?

one logic to consider is the simple/direct VERSUS complex technique used in measurements.?

kindly add or correc to the thoughts.

 

[somashekar]

Not necessarily...
Where is this requirement to do a R&R coming up for your complex techniques coming from.

 

[v9991]

thank you Somashekar,
so, when you say "

not necessarily...

" can i take it as endorsement for the alternative approach... viz., we standardize the performance value for the given method(technique) and product;

Where is this requirement to do a R&R coming up for your complex techniques coming from.

a) this is attempt to screen/standardize the method before use the data from same for process capability measures.

b) this is not exactly a requirement,(external expectation!!!); this is more of an attempt to characterize the method better (normally we follow the ICH Q2 standards; and wrt R&R, it stops with determining repeatability - ruggedness and comparing with acceptance criteria!)

thank you.

 

[somashekar]

Your process capability measures are performed to assess suitability of the technique used.
Repeated process capability over time will show you how rugged your process is, which in itself is a R&R.

 

[v9991]

Your process capability measures are performed to assess suitability of the technique used.
Repeated process capability over time will show you how rugged your process is, which in itself is a R&R.

Somashekar,

thank you for response; i understand the intetn however, would like to understand following point....R&R is performed as pre-requisite before using/relying on results (or method) for calculating process capability.