FMEA has an important relationship with risk management. This article provides an example of this relationship.
The suggested sequence is to first read the article “Relationship between FMEA and Risk Management” to learn about the interactions between FMEA and Risk Management at a high level.
An excerpt from a fictitious Design FMEA on a bicycle brake pad will be used to show the DFMEA portion of the relationship between FMEA and Risk Management.
The scenario for the example DFMEA is: Cost of rubber has skyrocketed. The bicycle product development team has changed brake pad material from rubber to a new synthetic compound, and DFMEA is indicated.
Below is a single-line excerpt from a fictitious example of bicycle brake pad DFMEA.
Risk Management example
An excerpt from a fictitious Risk Management process on a bicycle brake pad will be used to show the Risk Management portion of the relationship between FMEA and Risk Management.
Below is a single-line excerpt from a fictitious example of Risk Management process for bicycle brake pad.
Note, this example of risk management is not an actual risk management procedure. Actual risk management procedures are company specific, and based in selected risk management standards.
Risk Matrix example
As part of the Risk Management process, a Risk Matrix can be generated with Hazard Probability on one side and Hazard Severity on the other side.
Below is a fictitious example Risk Matrix for bicycle brake pad, based on the single-line excerpt above.
What can we learn from this example
The following are potential learnings from this example:
1. What input can DFMEA provide to the Risk Management process?
a. DFMEA Failure Modes and Effects can help identify important hazards.
b. DFMEA risk prioritization can provide input to hazard priority.
c. DFMEA Severity can be input to Risk Management “Severity of Harm.”
d. DFMEA risk assessment Occurrence can be partial input to hazard probability estimation
e. DFMEA Recommended Actions can be input to Risk Management actions to mitigate risk.
2. What are some differences between DFMEA and Risk Management?
a. DFMEA Failure Modes and Effects are not necessarily the same as Risk Management Hazards.
b. Risk Management “Probability of Occurrence of Harm” is not the same as DFMEA Occurrence.
c. DFMEA Severity can have different scale than Risk Management “Severity of Harm.”
3. What input can Risk Management process provide to DFMEA?
a. Hazards from Risk Management process can help ensure no important Failure Modes and Effects are missed in the DFMEA.
b. Risk Management actions to mitigate risk can close the loop to corresponding DFMEA Actions Taken.
The next series of articles will explore the important subject of FMEA facilitation.
Mark Condell OD MS says
I am challenged with getting my Biomedical Engineers to understand that dFMEA is not the same as SO 14971 Risk Assessment.
Your FMEA example is excellent.
Regretfully, your Risk Assessment does not identify the Harm with a Severity of “5”. If one is going to assess the occurrence of a Harm – the Harm must be identified, whether it be “Death”, “Fatal Bodily Injury”, “Bone Fracture”, etc…
Your table is missing a column that lists the potential Harms – in medical terminology (preferably MedDRA terminology).
Carl Carlson says
I hear you loud and clear about the challenge of getting medical device engineers to understand the difference between DFMEA and Risk Assessment. Hopefully both Part 1 and Part 2 of this series is helpful in bringing about the understanding.
Glad you like the FMEA example.
Regarding the Risk Management example, the paragraph below the example says “Note, this example of risk management is not an actual risk management procedure. Actual risk management procedures are company specific and based in selected risk management standards.”
Having said that, looking at the Risk Management example by itself, I agree there is value in adding a column describing the potential harm. The Effect column in the DFMEA example is a candidate and can certainly be brought over, as it describes the potential effect of the failure mode “pad cracks.” In my article, I considered the DFMEA and Risk Management examples together, or I probably would have done this.
For your info, I avoid using the phrase “occurrence of harm” in risk management, and instead use the phrase “probability of occurrence of harm,” to be consistent with 14971. The reason is “occurrence” by itself can be confused with FMEA occurrence, which has a completely different definition.
Other than the added column, any other comments about the Risk Management example?