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
In packaging risk management, what is the purpose of a containment action versus a corrective action?
Answer: Containment is a short-term fix to prevent defective product from reaching customers; corrective action eliminates the root cause
Containment actions are immediate measures to isolate or quarantine suspect product, while corrective actions address and eliminate the underlying root cause.
A packaging supplier changes a raw material formulation without notifying the customer. From a risk management standpoint, this is an example of what?
Answer: An unauthorized change that violates change control protocols
Unauthorized changes by suppliers bypass established change control processes and can introduce undetected risks to product quality and safety.
What is the significance of the 'detectability' score in FMEA?
Answer: Lower detectability scores indicate the failure is harder to detect, increasing risk priority
In FMEA, a high detectability score (e.g., 10) means the failure is nearly impossible to detect before reaching the customer, increasing the RPN and overall risk.
Which of the following best describes a 'residual risk' in packaging?
Answer: The risk remaining after all mitigation controls have been applied
Residual risk is the level of risk that remains after implementing risk controls; it must be evaluated to determine if it is acceptable.
A packaging team is evaluating a new biodegradable material for a sensitive pharmaceutical product. What risk factor should be prioritized in the assessment?
Answer: Moisture vapor transmission rate and its effect on product stability
Moisture vapor transmission rate (MVTR) is critical for pharmaceutical packaging because high moisture ingress can degrade drug efficacy and safety.
In the context of supply chain risk, what is 'single-sourcing' and why is it a concern?
Answer: Relying on one supplier for a critical packaging material, creating vulnerability to supply disruption
Single-sourcing means relying on one supplier for a critical input, which creates supply chain vulnerability if that supplier faces disruptions, price increases, or quality failures.
Which packaging test method is used to evaluate a package's ability to maintain integrity under compressive loads during warehousing?
Answer: ASTM D642 — Compressive Resistance of Shipping Containers
ASTM D642 measures the compressive resistance of containers, directly relevant to assessing stacking performance and warehouse storage risk.