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Risk Assessment & Management Flashcards

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

Read the first 7 Risk Assessment & Management flashcards as text

  1. A packaging engineer uses a Failure Mode and Effects Analysis (FMEA). What does the Risk Priority Number (RPN) represent?

    Answer: Product of severity, occurrence, and detectability scores

    RPN is calculated by multiplying Severity × Occurrence × Detectability, producing a number used to prioritize failure modes.

  2. Which regulatory body in the U.S. primarily governs packaging risk for food contact materials?

    Answer: FDA

    The FDA regulates food contact substances, including packaging materials, under 21 CFR to ensure they do not pose health risks.

  3. A company ships lithium batteries in packaging that fails UN38.3 testing. What is the primary risk consequence?

    Answer: Thermal runaway and fire during transport

    Lithium batteries that fail UN38.3 testing are at risk of thermal runaway, which can cause fires or explosions during transport.

  4. During a packaging risk review, a product's fragility factor is determined to be 40G. Which packaging design strategy is most appropriate?

    Answer: Cushioning system designed to limit transmitted acceleration to below 40G

    Fragility factor (Gc) defines the maximum acceleration a product can withstand, so cushioning must be designed to keep transmitted G-forces below that threshold.

  5. What does a quantitative risk assessment provide that a qualitative assessment does not?

    Answer: Numerical probability and impact values for risks

    Quantitative risk assessment assigns numerical values to probability and consequences, enabling prioritization and cost-benefit analysis beyond what qualitative ratings provide.

  6. A packaging line experiences recurring seal failures on pouches. In a risk management context, what is the most effective first step?

    Answer: Conduct root cause analysis to identify the failure mechanism

    Root cause analysis identifies the underlying mechanism of failure, enabling targeted corrective actions rather than symptomatic fixes.

  7. Which distribution environment hazard is typically assessed using ASTM D4169 simulation protocols?

    Answer: Vibration, shock, compression, and climate stresses during transit

    ASTM D4169 provides standardized test sequences simulating distribution hazards including vibration, drop, compression, and temperature/humidity exposure.