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Quality Management Systems Flashcards

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

Read the first 7 Quality Management Systems flashcards as text

  1. What is the primary purpose of an internal audit within a QMS?

    Answer: To assess whether the QMS conforms to planned arrangements and is effectively implemented

    Internal audits provide an objective assessment of QMS conformance and effectiveness, enabling organizations to identify areas for improvement before external audits.

  2. Under FDA's QSR, which record documents the production history of a specific device unit or batch?

    Answer: Device History Record (DHR)

    The DHR, per 21 CFR 820.184, documents the production history of each manufactured unit or batch, including dates, quantities, and acceptance activity records.

  3. A supplier qualification program in a QMS typically requires which of the following as a minimum?

    Answer: Evaluation of supplier capability to meet specified requirements

    Supplier qualification requires evaluating whether suppliers can consistently meet quality, regulatory, and technical requirements before they are approved for use.

  4. Under ICH Q10, which lifecycle phase does the Pharmaceutical Quality System (PQS) cover?

    Answer: Development, technology transfer, manufacturing, and discontinuation

    ICH Q10 applies across all phases of the pharmaceutical product lifecycle including development, technology transfer, commercial manufacturing, and product discontinuation.

  5. When a nonconforming product is identified during manufacturing, which action must be taken first according to QMS principles?

    Answer: Identify, document, and segregate the nonconforming product

    Nonconforming products must first be identified, documented, and segregated to prevent unintended use or distribution, as required by 21 CFR 820.90.

  6. Which element of a QMS ensures that measuring and monitoring equipment provides accurate data?

    Answer: Calibration and measurement system controls

    Calibration programs ensure that inspection, measuring, and test equipment is calibrated at defined intervals to maintain measurement accuracy and data integrity.

  7. The concept of 'risk-based thinking' in ISO 9001:2015 requires organizations to:

    Answer: Identify and address risks and opportunities that could affect QMS outcomes

    Risk-based thinking requires proactive identification and management of risks and opportunities to prevent undesired outcomes and achieve improvement.