Practice Test Geeks(CAPA) Corrective and Preventive Action Certified Practice Test
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CAPA Change Control & Management Flashcards

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

Read the first 6 CAPA Change Control & Management flashcards as text

  1. What is the primary purpose of change control within a CAPA system?

    Answer: To ensure changes are documented, reviewed, and approved before implementation

    Change control ensures that any modification to a process, product, or system is formally evaluated and authorized before it is enacted.

  2. Which document typically initiates the formal change control process within a CAPA?

    Answer: Change Request (CR)

    A Change Request formally describes the proposed change, its rationale, and its potential impact, triggering the review and approval workflow.

  3. In the context of CAPA, what does 'impact assessment' during change control evaluate?

    Answer: The potential effect of the change on product quality, safety, and regulatory compliance

    Impact assessment identifies all systems, processes, and documents that may be affected so that risks to quality and compliance are understood before approval.

  4. When must a CAPA-driven change be verified before full implementation in a regulated US environment?

    Answer: After a risk-based review confirms the change does not introduce new hazards

    21 CFR Part 820 and FDA expectations require that changes be verified or validated as appropriate before implementation to ensure they achieve the desired outcome without introducing new risk.

  5. Which of the following best describes 'uncontrolled change' in a CAPA context?

    Answer: A modification implemented without formal approval, documentation, or assessment

    Uncontrolled change bypasses the formal change control process, creating regulatory risk and potential product quality issues.

  6. How should obsolete procedures affected by a CAPA-driven change be handled under change control?

    Answer: They should be formally retired, archived, and replaced with updated versions

    Proper document control requires that superseded procedures are formally retired and archived so only current, approved versions are in use.

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