Practice Test Geeks(CCA) Certified Change Agent Practice Test
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CCA Quality & Compliance Flashcards

7 cards from real CCA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 CCA Quality & Compliance flashcards as text

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

    Answer: A privacy impact assessment is completed before implementation

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

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

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

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

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

    Answer: Linking requirements to their corresponding test cases and implementation evidence

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

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

    Answer: ISO 13485

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

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

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

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

  6. Which quality tool is BEST suited for prioritizing which defects or issues to address first?

    Answer: Pareto chart

    A Pareto chart applies the 80/20 rule to visualize which defects account for the majority of problems, guiding prioritization.

  7. In change management, 'change freeze' periods are typically implemented to:

    Answer: Protect system stability during critical business periods such as fiscal year-end

    Change freezes protect critical business periods from disruption by temporarily halting non-emergency changes.