CAPA Effectiveness Verification 2

Question 1

What distinguishes effectiveness verification from implementation verification in a CAPA?

Accepted Answer

Implementation verification confirms actions were completed; effectiveness verification confirms the problem was solved

Answer

Implementation verification confirms the planned actions were executed, while effectiveness verification confirms those actions actually eliminated the root cause and prevented recurrence.

Question 2

A medical device company completed a CAPA for sterility failures. Which metric best demonstrates effectiveness?

Accepted Answer

Zero sterility failures in 500 subsequent lots tested

Answer

Zero recurrence of the original failure mode in subsequent production is the most direct evidence that the corrective action eliminated the root cause.

Question 3

When should effectiveness criteria be defined in the CAPA process?

Accepted Answer

During the initial CAPA planning phase, before implementation

Answer

Effectiveness criteria must be defined upfront during planning so they are objective and not influenced by results observed after implementation.

Question 4

A CAPA was opened for excessive customer complaints about product labeling errors. What is the most appropriate effectiveness check timeframe?

Accepted Answer

Following 3-6 months of production with zero labeling nonconformances

Answer

A sufficient observation period with zero recurrence of the original defect type provides statistically meaningful evidence of effectiveness.

Question 5

Which regulatory standard explicitly requires verification of CAPA effectiveness for medical device manufacturers?

Accepted Answer

21 CFR Part 820.100

Answer

21 CFR Part 820.100 (FDA Quality System Regulation) requires manufacturers to verify or validate corrective and preventive actions to ensure they do not adversely affect the finished device and are effective.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA Effectiveness Verification 2