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Interpreting Test Method Validation Results

When doing a test method validation, how do you know what the acceptable results are? Is it percent R&R? Other?

Last Updated On May 15, 2008

The acceptable results are relative to your test method and your specifications. For variable data the results would be gauge R&R percentages per testing equipment. For attribute data this could be based on confidence limits set by your company’s risk policy.

Percent R&R are common statistical references with the following ranges:

  • 0-10% of tolerance – typically acceptable.
  • 10-30% of tolerance – can be acceptable with rationale or justification.
  • >30% of tolerance – typically unacceptable.

Other acceptance criteria should be based on your company’s risk policy and the relationship to specifications, if not already defined in a standard test method.