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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.
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 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
templates 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 FMEA might look for step 3, above, where the
operator is manually applying wax with a spray wand.
process fmeca
fmea fmeca
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