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Regulatory Compliance & Quality Assurance Flashcards

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

Read the first 7 Regulatory Compliance & Quality Assurance flashcards as text

  1. What is the primary purpose of a corrective and preventive action (CAPA) program?

    Answer: To eliminate the root causes of nonconformities and prevent recurrence

    CAPA targets root causes so problems are fixed and kept from recurring, not just patched.

  2. Which document type defines step-by-step instructions to ensure a task is performed consistently?

    Answer: Standard operating procedure (SOP)

    SOPs standardize how recurring tasks are performed to ensure consistent, compliant results.

  3. In quality management, the difference between quality assurance and quality control is best described as:

    Answer: QA is process-focused and preventive; QC is product-focused and detective

    QA builds quality into processes while QC tests outputs to find defects.

  4. Under OSHA's recordkeeping rules, which situation generally must be recorded as a work-related injury?

    Answer: An injury requiring medical treatment beyond first aid

    Work-related injuries requiring medical treatment beyond first aid, days away, or restricted work are recordable.

  5. What does a 'nonconformity' mean in an ISO 9001 context?

    Answer: Failure to fulfill a requirement

    ISO 9001 defines nonconformity as the non-fulfillment of a requirement.

  6. Why must controlled documents carry a revision number and effective date?

    Answer: So users can confirm they are using the current approved version

    Version control prevents use of obsolete documents.

  7. Which best describes a 'regulatory gap analysis'?

    Answer: Comparing current practices against applicable requirements to identify shortfalls

    A gap analysis finds where existing practices fall short of regulatory requirements.

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