Use with caution
As a member of the committee that developed the medical device risk management standard ISO 14971 and an adjunct faculty member at Virginia Tech’s Health Products Risk Management Graduate Program, I find I often need to caution those using failure mode and effects analysis (FMEA) to remember it was designed as a reliability tool.
FMEA is not risk analysis, but it is a good tool to use after the product is designed to determine whether all of the hazards in the fault condition are identified as required in ISO 14971. Pharmaceutical guidance ICH Q9, which was derived from ISO 14971, also uses FMEA to aid in risk management.
It is important to identify the definition of risk as it is used in a variety of contexts. In ISO 14971 and ICH Q9, direction is provided for product safety, but it is not intended to address business, compliance or other types of risk. ISO 31000 provides definitions and direction for those types, as well as others.
Because FMEA identifies the hazard and its effect, it operates on a different level than risk analysis, which analyzes the severity of harm and the probability of the harm’s occurrence. This provides a different result than FMEA. ISO 14971 also requires identifying all of the normal condition hazards, which FMEA does not. Normal condition hazards are usually identified in the usability engineering activities.
Regulators require the identification of safety requirements using risk analysis early in the design process, during design input. Because FMEA requires some design to be complete, it is not typical to have inputs from this tool at the design input stage. As inputs are revised later, the inputs from FMEA can be applied.
If an effective risk analysis is performed at the beginning of product design, many of the risks can be identified and input into the design stage, reducing the impact of costly late-stage design changes. While FMEA is a valuable tool when used properly, it can reduce the effectiveness of risk management when used improperly.
"Fail-Safe FMEA" (January 2012) provides good information on the use of FMEA, but the warnings I have provided may guide the reader toward using the tool for effective product risk management.
"Lead On" (January 2012) is truly insightful and reinforces the type of cultural change we are trying to instill at our company: a greater concern for our customer and a clear understanding of our customer-supplier interfaces.
By creating empathy with suppliers and understanding their needs and expectations, we will open the door to improved customer service while helping suppliers perform at optimal capacity and at the same time creating a mutual, trust-based relationship.