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CMC Quality & Compliance Flashcards

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

Read the first 7 CMC Quality & Compliance flashcards as text

  1. Which compliance framework is specifically designed to protect the privacy of personal health information in the United States?

    Answer: HIPAA

    HIPAA (Health Insurance Portability and Accountability Act) sets US federal standards for protecting sensitive patient health information from disclosure without consent.

  2. A CMC is helping a client build a risk-based compliance program. The primary advantage of a risk-based approach over a rules-based approach is:

    Answer: It focuses resources on the highest-risk areas rather than applying uniform controls to everything

    A risk-based compliance program prioritizes resources and controls based on risk severity, making compliance efforts more efficient and effective.

  3. What is the purpose of a corrective action plan (CAP) following a compliance audit finding?

    Answer: To document the steps, owners, and timelines to remediate identified deficiencies

    A corrective action plan outlines specific remediation steps, assigns responsibility, and sets deadlines to address and close audit findings.

  4. In the context of consulting ethics, 'conflict of interest' most accurately describes a situation where:

    Answer: A consultant's personal interests could improperly influence professional judgment

    A conflict of interest arises when a consultant's personal, financial, or relational interests have the potential to compromise their professional objectivity.

  5. Quality function deployment (QFD) is a tool used in quality management primarily to:

    Answer: Translate customer requirements into specific technical characteristics of a product or service

    QFD is a structured method that translates customer needs (Voice of the Customer) into engineering and production requirements using the 'House of Quality' matrix.

  6. When a CMC recommends that a client adopt ISO 9001 certification, which of the following is NOT a direct benefit of certification?

    Answer: Guaranteed profitability

    ISO 9001 certification improves quality systems and customer confidence but does not guarantee business profitability.

  7. A CMC conducting a gap analysis compares the client's current state to a desired future state. The PRIMARY output of a gap analysis is:

    Answer: A prioritized list of actions needed to move from current to desired state

    A gap analysis identifies the differences between current performance and the target state, producing prioritized actions to close those gaps.