Question 1
A pharmaceutical company is validating a new titration process. A Gage R&R study was performed on the measurement system used to determine chemical concentration. The results show a %Contribution from Part-to-Part variation of 65%, Repeatability of 30%, and Reproducibility of 5%. The Number of Distinct Categories is 4. What is the most appropriate next step for the quality team?
Answer and explanation
Correct answer: C
The key issue is the high %Contribution from Repeatability (30%), which indicates that the measurement device itself is inconsistent when measuring the same part multiple times. This is equipment variation. Reproducibility (operator variation) is low at 5%. The total Gage R&R variation (%Contribution of 35%) is unacceptable. Since the Number of Distinct Categories is 4 (less than the recommended 5), the system cannot distinguish adequately between parts. The largest component of this unacceptable variation is Repeatability, pointing directly to the measurement equipment.