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Regulatory Compliance & Legal Framework Flashcards

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

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  1. In a medical device company, what is the purpose of a Design History File (DHF)?

    Answer: To contain the documentation that describes the design history of a finished device

    Per 21 CFR Part 820.30, the DHF is a compilation of records describing the design history of a finished device, covering requirements, reviews, verification, validation, and design transfers.

  2. A Lean leader working in aerospace needs to ensure process changes comply with AS9100. Which of the following best describes AS9100?

    Answer: A quality management system standard specific to the aviation, space, and defense industry

    AS9100 is an internationally recognized quality management standard tailored for the aviation, space, and defense sector, built upon ISO 9001 with additional aerospace-specific requirements.

  3. When a Lean project eliminates a step that was part of a validated process in a pharmaceutical plant, what action is required before resuming production?

    Answer: Re-validate the modified process before releasing product

    FDA cGMP regulations require that any change to a validated pharmaceutical process be assessed and, if significant, re-validated before product manufactured under the new process can be released.

  4. Under Title III of the Emergency Planning and Community Right-to-Know Act (EPCRA), facilities must report releases of hazardous substances above threshold quantities to:

    Answer: The Local Emergency Planning Committee (LEPC), State Emergency Response Commission (SERC), and National Response Center

    EPCRA Section 304 requires facilities to immediately notify the LEPC, SERC, and the National Response Center of any release of an extremely hazardous substance above the reportable quantity.

  5. Which concept in Lean is most closely aligned with FDA's requirement for 'process capability' in drug manufacturing?

    Answer: Statistical Process Control (SPC)

    SPC uses statistical methods to monitor and control processes, directly supporting FDA's expectation that drug manufacturing processes demonstrate capability and are in a state of control.

  6. In labor law, what does the National Labor Relations Act (NLRA) protect employees from in relation to Lean process improvement activities?

    Answer: Retaliation for engaging in concerted activity, including raising concerns about working conditions

    The NLRA protects employees who engage in concerted activity—such as collectively raising concerns about working conditions, including those affected by Lean changes—from retaliation.

  7. A Lean leader notices that outsourcing a non-core process may involve sharing customer data with a third party. Which U.S. regulation is most relevant to protecting consumer financial data in this scenario?

    Answer: Gramm-Leach-Bliley Act (GLBA)

    The GLBA requires financial institutions to safeguard nonpublic personal financial information and to ensure third-party vendors handling such data maintain appropriate protections.