CRAP Quality Management Systems 3

Question 1

Under 21 CFR Part 820, which type of change to a device's design requires formal design control procedures?

Accepted Answer

Changes that could affect the device's safety or effectiveness

Answer

Design changes that could affect safety or effectiveness must go through formal design control procedures including review, verification, validation, and approval.

Question 2

Which of the following is a key output of the quality planning process in a QMS?

Accepted Answer

Quality objectives and processes needed to meet requirements

Answer

Quality planning produces defined quality objectives, processes, resources, and controls needed to fulfill requirements and achieve desired outcomes.

Question 3

An FDA Form 483 observation during a QMS inspection indicates:

Accepted Answer

Inspectional observations of conditions that may constitute regulatory violations

Answer

FDA Form 483 lists inspectional observations of conditions that appear objectionable and may constitute violations of FDA regulations, but it is not a final agency determination.

Question 4

In a QMS, document control procedures must ensure that:

Accepted Answer

Obsolete documents are removed from points of use and only current versions are available

Answer

Document control requires that obsolete documents be promptly removed or otherwise prevented from use to ensure only current, approved versions are utilized.

Question 5

Which metric is most useful for evaluating the effectiveness of a CAPA system?

Accepted Answer

Recurrence rate of nonconformities after CAPA closure

Answer

The recurrence rate of nonconformities measures whether CAPAs have actually eliminated root causes, making it the most direct indicator of CAPA system effectiveness.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Quality Management Systems 3