Data Analysis & Reporting Flashcards

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

Answer: ANSI/ASQ Z1.9

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

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

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

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

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

Answer: Rejecting a good lot (producer's risk)

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

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

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

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

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

Answer: May be acceptable depending on application importance and cost

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

Which statistical approach is preferred to demonstrate that results from a receiving lab are comparable to the sending lab during analytical method transfer?

Answer: Two one-sided tests (TOST) for equivalence

TOST demonstrates equivalence within predefined margins, which a non-significant t-test cannot prove.

Per ICH Q1E, what significance level is used when testing whether stability data from multiple batches can be pooled?

Answer: 0.25

ICH Q1E recommends a 0.25 significance level for batch poolability tests to compensate for low power.