CVM Data Analysis & Reporting 5

Question 1

Which standard provides sampling plans for inspection by variables rather than attributes?

Accepted Answer

ANSI/ASQ Z1.9

Answer

ANSI/ASQ Z1.9 covers variables sampling, while Z1.4 covers attributes.

Question 2

What does the Acceptable Quality Limit (AQL) represent in a sampling plan?

Accepted Answer

The worst tolerable process average percent defective considered acceptable for routine acceptance

Answer

AQL is the quality level that is the worst tolerable process average for continuing sampling acceptance.

Question 3

In hypothesis testing applied to lot acceptance, what does a Type I error (alpha) represent?

Accepted Answer

Rejecting a good lot (producer's risk)

Answer

A Type I error rejects a true null hypothesis, i.e., rejecting an acceptable lot, known as producer's risk.

Question 4

Per ICH Q2, what is the minimum design for assessing repeatability of an analytical procedure?

Accepted Answer

At least 6 determinations at 100% or 9 determinations covering the specified range

Answer

ICH Q2 specifies a minimum of 9 determinations across the range (3 levels × 3) or 6 at 100%.

Question 5

Per AIAG MSA guidance, how is a measurement system with a %GRR between 10% and 30% generally classified?

Accepted Answer

May be acceptable depending on application importance and cost

Answer

AIAG considers 10–30% GRR conditionally acceptable based on application criticality and cost.

CVM - Certified Validation Manager Practice Test