|
Step
|
Example
|
| Identify each Part or Process Step |
Preparation for an MRI-magnetic resonance imaging-in a hospital |
| Identify Potential Failure Modes - All of the
manners in which the part or process could fail. |
Cracked, loosened, deformed, leaking, oxidized, overlooked, etc.
For example, MRIs produce intense magnetic fields. One patient
was killed by a flying fire extinguisher pulled off the wall by
the MRI.
|
| Identify any Potential Effect(s) of Failure - Consequences
on other systems, parts, or people. |
Noise, unstable, inoperative, impaired, injury, death, etc.
The consequence of a fire extinguisher getting pulled off of the
wall is that it could hit someone.
|
| Rank Severity of the Effect (1-10) |
1 = none or no effect, 10 = "hazardous without warning"
For example: a tire blow out may be rated a 2 while a a fire extinguisher
to the skull would be rated a 10.
|
| Evaluate Potential Cause(s) / Mechanism(s) of Failure |
List every potential cause and/or failure mechanism such as Incorrect
material, improper maintenance, fatigue, wear, etc. |
| Rank the Possibility of Occurrence (1-10) |
1 would be remote while a 10 would be high |
| List Your Current Design Controls. |
List prevention and detection activities to assure design adequacy
and prevent or reduce occurrence. |
| Rank Your Ability to Detect a Failure Using these Controls
(1-10) |
1 is almost certain to 10 absolute uncertainty. |
| Calculate the risk-priority number (RPN) for each part or step.
|
RPN = severity * occurrence * detection. |
| Design Recommended Improvement Action(s) |
Design additional actions to reduce severity, occurrence and detection
ratings. Severity of 9 or 10 requires special attention. |
| Assign Responsibility & Target Completion Date for implementing
designed improvements. |
|
| Monitor Actions Taken and effects on RPN. |
|