CLL Risk Assessment & Management 2 — Questions and Answers
Question 1: In FMEA, the Risk Priority Number (RPN) is calculated by multiplying which three factors?
- Severity, Occurrence, Detection (Correct answer)
- Probability, Impact, Urgency
- Frequency, Consequence, Mitigation
- Likelihood, Severity, Control
Correct answer: Severity, Occurrence, Detection
RPN = Severity × Occurrence × Detection, where each factor is rated on a scale (typically 1–10).
Question 2: A Lean team identifies a high-severity failure mode with a very low occurrence rating. Which action is most appropriate?
- Ignore it because it rarely happens
- Apply poka-yoke to prevent its occurrence entirely (Correct answer)
- Only monitor it without intervention
- Remove it from the FMEA since it is low risk
Correct 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.
Question 3: Which Lean tool is most directly used to prevent a known risk from occurring in a process?
- Value stream mapping
- Poka-yoke (error-proofing) (Correct answer)
- Heijunka board
- Kanban pull system
Correct answer: Poka-yoke (error-proofing)
Poka-yoke devices physically or digitally prevent errors from occurring or immediately detect them, directly mitigating identified risks.
Question 4: What is the primary difference between a Process FMEA (PFMEA) and a Design FMEA (DFMEA)?
- PFMEA focuses on manufacturing process failures; DFMEA focuses on product design failures (Correct answer)
- PFMEA is qualitative; DFMEA is quantitative
- DFMEA uses RPN scoring; PFMEA does not
- PFMEA is done by engineers; DFMEA is done by operators
Correct 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.
Question 5: During a Lean transformation, a control plan is best described as:
- A financial budget for risk activities
- A document specifying what to monitor, how, and how often to sustain process controls (Correct answer)
- A project schedule for kaizen events
- A list of approved suppliers for key inputs
Correct 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.
Question 6: Which risk response strategy involves shifting the negative impact of a risk to a third party?
- Risk avoidance
- Risk acceptance
- Risk transfer (Correct answer)
- Risk mitigation
Correct answer: Risk transfer
Risk transfer moves the financial or operational burden of a risk to another party, such as through insurance or outsourcing.
Question 7: In the context of Lean risk management, which condition most increases supply chain risk?
- High inventory buffers at every stage
- Single-source suppliers with no approved alternates (Correct answer)
- Pull-based replenishment systems
- Standardized supplier scorecards
Correct 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.
CLL Risk Assessment & Management 2
In FMEA, the Risk Priority Number (RPN) is calculated by multiplying which three factors?