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Process FMEA (PFMEA)
Identifying Potential Process and Assembly Failures
Process Failure Mode and Effects Analysis (FMEA) is an analysis technique
normally used to analyze manufacturing and assembly processes at the system,
subsystem or component levels. It is commonly used in the automotive industry
and other industries that focus heavily on manufacturing products, especially
when human safety is involved. This type of FMEA focuses primarily on potential
failure modes of the process that are caused by manufacturing or assembly
process deficiencies. Special attention is given to any process step that may
result in a safety hazard for either the machine operator involved in the
manufacturing or assembly of an item or the end user of the item.
The example below came from the SAE J1739 FMEA handbook and shows an
example of performing risk analysis on the steps involved in applying wax to the
inside of a car door.
normally used to analyze manufacturing and assembly processes at the system,
subsystem or component levels. It is commonly used in the automotive industry
and other industries that focus heavily on manufacturing products, especially
when human safety is involved. This type of FMEA focuses primarily on potential
failure modes of the process that are caused by manufacturing or assembly
process deficiencies. Special attention is given to any process step that may
result in a safety hazard for either the machine operator involved in the
manufacturing or assembly of an item or the end user of the item.
The example below came from the SAE J1739 FMEA handbook and shows an
example of performing risk analysis on the steps involved in applying wax to the
inside of a car door.
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What is FMEA?
How FMEA is Done
Types of FMEA
Benefits of FMEA
FMEA Books
FMEA Software
FMEA Examples
Other Resources
FMEA RPN
In addition to automotive, Process FMEA is becoming more widely used in the
medical and health care industry, and it is now being used in many service
industries. Often here, the goal is to identify and prioritize processes that are
high risk and then conduct a process FMEA on them. For each process the
team would identify potential failure modes where the failure modes would
represent different ways that a process or sub-process step could fail to provide
the anticipated result.
In health care, this could be an analysis of the process steps in place to ensure
patient safety. For example, maybe the analysis team would look at the process
involved leading up to a surgical procedure, or some of the process steps
involved in post operation recovery procedures.
Once failure modes have been identified for the high-risk processes, then the
team would identify possible effects for each failure mode. For the most critical
effects a detailed analysis would be performed to determine the root cause, and
then recommendations would be made to redesign the process to either
eliminate the failure mode or minimize the risk, if it did indeed occur.
This page is meant to merely introduce you to the concept of Process FMEA.
For detailed Process Failure Mode and Effects Analysis examples and a more
in-depth discussion on this topic, please take advantage of some of the
resources on our FMEA Examples page.
medical and health care industry, and it is now being used in many service
industries. Often here, the goal is to identify and prioritize processes that are
high risk and then conduct a process FMEA on them. For each process the
team would identify potential failure modes where the failure modes would
represent different ways that a process or sub-process step could fail to provide
the anticipated result.
In health care, this could be an analysis of the process steps in place to ensure
patient safety. For example, maybe the analysis team would look at the process
involved leading up to a surgical procedure, or some of the process steps
involved in post operation recovery procedures.
Once failure modes have been identified for the high-risk processes, then the
team would identify possible effects for each failure mode. For the most critical
effects a detailed analysis would be performed to determine the root cause, and
then recommendations would be made to redesign the process to either
eliminate the failure mode or minimize the risk, if it did indeed occur.
This page is meant to merely introduce you to the concept of Process FMEA.
For detailed Process Failure Mode and Effects Analysis examples and a more
in-depth discussion on this topic, please take advantage of some of the
resources on our FMEA Examples page.
In the above example, each step involved in the process of applying wax to the
inside of the car door is evaluated and ranked according to the risk that it
poses. Here, we see that the third step is deemed to be the highest risk area,
where if this is not done correctly then we may have too light or too heavy a
coat of wax on the inside of the car door. Below is an example of how the
process FMEA might look for step 3, above, where the operator is manually
applying wax with a spray wand.
inside of the car door is evaluated and ranked according to the risk that it
poses. Here, we see that the third step is deemed to be the highest risk area,
where if this is not done correctly then we may have too light or too heavy a
coat of wax on the inside of the car door. Below is an example of how the
process FMEA might look for step 3, above, where the operator is manually
applying wax with a spray wand.
