White Paper II


Outline of How to Conduct a Hazard Analysis

This first Hazard Analysis of the Design Phase is conducted while Design Inputs are being developed. Additional Hazard Analyses will be conducted during the Design Phase. These later Hazard Analyses will be conducted in a similar manner to the outline here. Details are in the Hazard Analysis SOP.

• Conducted while design Inputs are being finalized

• Purposively conducted while little is known about system details

• Conducted using conceptual system and subsystem block diagram (black boxes)

• Brainstorm possible hazards to users (patient, technician, service)

• Don’t consider probability during brainstorming

• Consider block interfaces and system interfaces

• Estimate severity of identified hazard (scale of 1 to 5)

• Estimate probability of hazard occurring (scale of 1 to 5)

• A risk index to prioritize hazards will be created by multiplying severity by probability.

• Decide which risk indexes are acceptable without further attention (say 1 to 4), which should be addressed and fixed if possible (say 5 to 10), and which must be fixed (say 10 to 25)

• Brainstorm solutions to hazards (risk reduction)

• Incorporate solutions into product requirements

• Incorporate solutions into product design

• Test solutions later in the Design phase