CAPA CAPA Process & Documentation 2

Question 1

Which document typically serves as the formal input to initiate a CAPA in a regulated environment?

Accepted Answer

Nonconformance report or deviation

Answer

A nonconformance report or deviation is the most common formal trigger that initiates a CAPA by documenting an identified problem.

Question 2

In CAPA documentation, what does the term 'effectiveness check' refer to?

Accepted Answer

Verification that implemented actions eliminated the root cause

Answer

An effectiveness check confirms that the corrective or preventive actions taken have successfully eliminated the root cause and prevented recurrence.

Question 3

When documenting a CAPA, the 'scope' field should describe:

Accepted Answer

The extent and boundaries of the problem being addressed

Answer

The scope defines the extent and boundaries of the identified problem, clarifying what is and is not included in the CAPA investigation.

Question 4

Which of the following best describes a 'containment action' in CAPA documentation?

Accepted Answer

An immediate step to limit the impact of a nonconformance

Answer

A containment action is an immediate, short-term measure taken to limit the spread or impact of a nonconformance while the root cause investigation proceeds.

Question 5

Under 21 CFR Part 820, what must a manufacturer document regarding CAPA procedures?

Accepted Answer

Procedures for analyzing quality data to identify CAPAs

Answer

21 CFR Part 820.100 requires documented procedures for analyzing quality data to identify existing and potential causes of nonconforming product or quality problems.

(CAPA) Corrective and Preventive Action Certified Practice Test

(CAPA) Corrective and Preventive Action Certified Practice Test

CAPA CAPA Process & Documentation 2