CLC Risk Assessment & Mitigation 3

Question 1

A laboratory's biosafety officer wants to evaluate the risk of needle-stick injuries from phlebotomy staff. Which tool is MOST appropriate for this prospective risk assessment?

Accepted Answer

Failure Mode and Effects Analysis (FMEA)

Answer

FMEA is a prospective method designed to identify potential failure modes and prevent harm before incidents occur.

Question 2

According to ISO 15189, a laboratory's risk management activities should be:

Accepted Answer

Integrated into the quality management system and applied continuously

Answer

ISO 15189 requires risk management to be ongoing and embedded within the overall quality management system, not limited to specific phases or events.

Question 3

A laboratory introduces a new automated analyzer. Which risk-related activity should occur BEFORE go-live?

Accepted Answer

Prospective hazard identification and risk assessment of the new workflow

Answer

A prospective hazard identification and risk assessment of the new analyzer workflow should be completed before implementation to identify and mitigate risks in advance.

Question 4

The Risk Priority Number (RPN) in an FMEA is calculated as:

Accepted Answer

Severity × Occurrence × Detectability

Answer

RPN = Severity × Occurrence × Detectability; a higher RPN indicates a higher-priority risk for mitigation.

Question 5

A laboratory implements color-coded tube racks to prevent sample mix-ups. This intervention is an example of a:

Accepted Answer

Engineering control / mistake-proofing (poka-yoke)

Answer

Color-coded racks are an engineering/mistake-proofing control that makes errors immediately visible without relying on staff memory or procedure adherence.

(CLC) Certified Laboratory Consultant Practice Test

(CLC) Certified Laboratory Consultant Practice Test

CLC Risk Assessment & Mitigation 3