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
What is the primary goal of a Hazard Analysis and Critical Control Points (HACCP) system as it applies to food packaging?
Answer: Identify and control biological, chemical, and physical hazards that could harm consumers
HACCP systematically identifies food safety hazards and establishes critical control points to prevent, eliminate, or reduce those hazards to acceptable levels.
A risk matrix plots probability on one axis and consequence severity on the other. Which quadrant represents the highest priority for immediate action?
Answer: High probability, high severity
Risks that are both highly likely and highly severe represent the greatest threat and demand immediate mitigation efforts.
During distribution risk assessment, what does 'assurance level' in ASTM D4169 define?
Answer: The degree of rigor and test intensity applied to the distribution cycle simulation
Assurance level in ASTM D4169 (I, II, or III) defines the intensity of testing, with Level I representing the most rigorous simulation for high-value or fragile products.
A pharmaceutical packaging manager discovers that a cold chain shipment exceeded the permitted temperature range. What risk management document should be initiated first?
Answer: A deviation or non-conformance report
A deviation or non-conformance report formally documents the out-of-specification condition and triggers investigation, risk evaluation, and disposition decisions.
What is 'risk transfer' in packaging risk management?
Answer: Shifting financial or operational risk to a third party, such as through insurance or supplier contracts
Risk transfer involves contractually or financially passing risk to another party, such as requiring a supplier to carry liability insurance for packaging defects.
Which factor most directly determines whether a packaging closure system poses a child-resistant packaging risk under PPPA regulations?
Answer: Whether the package passes the child-panel and senior-panel testing protocols
The Poison Prevention Packaging Act (PPPA) requires that child-resistant closures be tested with child and senior panels to verify they meet efficacy thresholds.
In a risk management plan, what is the function of a 'risk register'?
Answer: A living document that records identified risks, their assessments, and mitigation status
A risk register is a central document that catalogs all identified risks along with their probability, impact, owner, mitigation actions, and current status for ongoing monitoring.