FDA Guidance on Inspection Error Handling
I've encountered an issue with error handling for inspection of medical devices. The tool being used reads out to .0001", but operator influence makes it less accurate to only .0004". Given that the inspection equipment's readout is more precise than the operator is capable of, how should the error be handled? Are rounding schemes or truncation permissible? Will the data handling differ by the specific tolerance of a product (i.e. .001" tolerance vs .006" tolerance)?
Submitted August 07, 2017 at 10:19AM by Its_Old_Greg
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