Risk Assessment & Management Flashcards

In FMEA, the Risk Priority Number (RPN) is calculated by multiplying which three factors?

Answer: Severity, Occurrence, Detection

RPN = Severity × Occurrence × Detection, where each factor is rated on a scale (typically 1–10).

A Lean team identifies a high-severity failure mode with a very low occurrence rating. Which action is most appropriate?

Answer: Apply poka-yoke to prevent its occurrence entirely

Even low-occurrence, high-severity risks warrant mistake-proofing because the consequences of a single failure can be catastrophic.

Which Lean tool is most directly used to prevent a known risk from occurring in a process?

Answer: Poka-yoke (error-proofing)

Poka-yoke devices physically or digitally prevent errors from occurring or immediately detect them, directly mitigating identified risks.

What is the primary difference between a Process FMEA (PFMEA) and a Design FMEA (DFMEA)?

Answer: PFMEA focuses on manufacturing process failures; DFMEA focuses on product design failures

PFMEA analyzes risks within the manufacturing or assembly process, while DFMEA analyzes risks inherent in the product design itself.

During a Lean transformation, a control plan is best described as:

Answer: A document specifying what to monitor, how, and how often to sustain process controls

A control plan details the monitoring methods, frequency, and responsible parties needed to sustain process improvements and prevent recurrence of risks.

Which risk response strategy involves shifting the negative impact of a risk to a third party?

Answer: Risk transfer

Risk transfer moves the financial or operational burden of a risk to another party, such as through insurance or outsourcing.

In the context of Lean risk management, which condition most increases supply chain risk?

Answer: Single-source suppliers with no approved alternates

Relying on a single supplier with no approved alternative creates a critical vulnerability if that supplier experiences a disruption.