CCA CCA Quality & Compliance 4

Question 1

A change to an IT system affects personal data processing. Under US privacy frameworks, a change agent should ensure:

Accepted Answer

A privacy impact assessment is completed before implementation

Answer

A privacy impact assessment (PIA) evaluates data protection risks before changes affecting personal data are implemented.

Question 2

In a quality audit, 'objective evidence' refers to:

Accepted Answer

Data or information that can be verified, based on facts obtained through observation or measurement

Answer

Objective evidence is verifiable, factual data obtained through direct observation, measurement, or records — not opinions.

Question 3

Which of the following BEST describes the purpose of a 'traceability matrix' in a regulated change initiative?

Accepted Answer

Linking requirements to their corresponding test cases and implementation evidence

Answer

A traceability matrix links each requirement to evidence of its fulfillment, demonstrating compliance coverage.

Question 4

A change agent is leading a process change in a healthcare setting. Which standard specifically governs quality management systems for medical devices?

Accepted Answer

ISO 13485

Answer

ISO 13485 is the international standard specifically for quality management systems in medical device design, production, and service.

Question 5

When a regulatory change requires process modifications, the change agent's role in compliance is BEST described as:

Accepted Answer

Facilitating cross-functional alignment to ensure the organization adapts to and meets the new requirement

Answer

Change agents facilitate coordination across functions to ensure timely, effective adaptation to new regulatory requirements.

(CCA) Certified Change Agent Practice Test

(CCA) Certified Change Agent Practice Test

CCA CCA Quality & Compliance 4