CCA CCA Quality & Compliance 3

Question 1

When assessing compliance risk for a change initiative, a change agent should FIRST:

Accepted Answer

Identify applicable regulations and standards that govern the change

Answer

Identifying applicable regulations and standards is the foundational step before any risk assessment or planning can occur.

Question 2

A CAPA (Corrective and Preventive Action) plan differs from a simple corrective action in that it also:

Accepted Answer

Addresses prevention of recurrence in addition to fixing the current issue

Answer

CAPA combines corrective action (fixing the current problem) with preventive action (stopping it from recurring).

Question 3

In ISO 9001:2015, which clause specifically addresses 'Management Review' of the quality management system?

Accepted Answer

Clause 9.3

Answer

ISO 9001:2015 Clause 9.3 covers management review, requiring top management to periodically evaluate the QMS.

Question 4

A change agent discovers that a quality procedure was updated but employees are still following the old version. This is BEST described as:

Accepted Answer

A document control failure

Answer

Document control ensures current versions are accessible and obsolete versions are withdrawn; failure here causes version misalignment.

Question 5

The 'Plan-Do-Check-Act' (PDCA) cycle is most useful in quality management because it:

Accepted Answer

Creates a structured iterative approach to implementing and verifying improvements

Answer

PDCA provides a repeatable, iterative framework that tests changes and verifies results before full implementation.

(CCA) Certified Change Agent Practice Test