FMEA Process

Process Failure Mode and Effects Analysis must be done in a step-wise
fashion since each step builds on the previous one. Here’s an overview of
the 10 steps to a Process FMEA.
STEP 1: Review the process
 Use a process flowchart to identify each process component.

 List each process component in the FMEA table.
 If it starts feeling like the scope is too big, it probably is. This is a
good time to break the Process Failure Mode and Effects Analysis
into more manageable chunks.
STEP 2: Brainstorm potential failure modes
 Review existing documentation and data for clues about all of the
ways each component can failure.
 The list should be exhaustive – it can be paired down and items can
be combined after this initial list is generated.
 There will likely be several potential failures for each component.
STEP 3: List potential effects of each failure
 The effect is the impact the failure has on the end product or on
subsequent steps in the process.
 There will likely be more than one effect for each failure.
STEP 4: Assign Severity rankings
 Based on the severity of the consequences of failure.
STEP 5: Assign Occurrence rankings
 Rate the severity of each effect using customized ranking scales as a

guide.
STEP 6: Assign Detection rankings
 What are the chances the failure will be detected prior to it occuring.
STEP 7: Calculate the RPN
 Severity X Occurrence X Detection
STEP 8: Develop the action plan

 Decide which failures will be worked on based on the Risk Priority
Numbers. Focus on the highest RPNs.
 Define who will do what by when.
STEP 9: Take action
 Implement the improvements identified by your Process Failure Mode

and Effects Analysis team.
STEP 10: Calculate the resulting RPN
 Re-evaluate each of the potential failures once improvements have

been made and determine the impact of the improvements.
10 Steps of FMEA
10 Steps of FMEA
In Chapter 8 of The Basics of FMEA by Robin E. McDermott, et. al. discusses the
ten steps for an FMEA. I find it to be an excellent summary for describing and
conducting a failure mode and effect analysis.
Therefore based on the work of McDermott and others, plus my own experience
here are the ten steps with my descriptions.
Step 1 Review the process or product

With the team, clearly define the subject of the FMEA study. What is and is not
included. Discuss the basic features, assembly, materials, construction, and desired
functions.
Step 2 Brainstorm potential failure modes

What could go wrong?
This can be a lot of fun. Use a variety of brainstorm techniques to get as broad a set
of ideas as possible. A good technique is to individually create ideas the collate
them using affinity grouping. Mix up the process with live brainstorming,
anchoring, and focused concerns (i.e. high temperature, user abuse, etc).
For most products, you may want to focus on one function or feature at a time.
Step 3 List potential effects of each failure mode

What could happen if the failure occurs?
Consider the possible failures and imagine what could then happen to the
surrounding environment and people.
For example, if a staircase handrail fails to provide support, it may result in the
effect of a staircase falling injury. Or, it may result in the closing of the staircase
for repair. Or, it may require a maintenance action to re-anchor the handrail.
Step 4 Assign a severity ranking for each effect

For each effect (consequence) provide a ranking score. Common scales include 3,
5, or 10 points. I often start with 10 point scale and adjust depending on the team
and nature of the study.
Common practice is to assign 9 or 10 for those effects that cause injury or death, or
major damage to its surroundings.
Document the scale actually used so others can interpret the study results properly.
Step 5 Assign an occurrence ranking for each

failure mode
How often will the failure mode occur?
The worksheet includes a column of causes, which may help the team judge the
relative frequency of occurrence of failure modes. Keep in mind that a failure
mode may have many potential causes.
Step 6 Assign a detection ranking for each failure

mode and/or effect
Detection is a bit different in ranking then severity or occurrence. A high score
means the effect occurs without warning. It is not detectable.
Detection can include one or both of the following methods for alerting of potential
failure.
1. During product development and manufacturing can we find the defect that
would lead to a failure? Can we find the problem before it is shipped?
2. During normal use does the product provide some means to detect an
upcoming failure?
I use the example of car brakes to illustrate. During design and manufacture, we
can test the brake assembly for braking force. If insufficient, we can redesign or
adjust the brake assembly before installation in a vehicle.
One failure mechanisms that leads to brake failure is the wearing away of the brake
pad. Therefore, the insertion of a piece of metal that creates a warning sound
before the brake pads have worn too far, alerts the vehicle operator to replace the
brake pads before brake failure occurs.
Step 7 Calculate the risk priority number for each

effect
Just a bit of math. Multiple the severity, occurrence, and detection scores together
to find the RPN value.
Items that high dire consequences (high severity), occur often and provide no
warning result in the highest RPN numbers relative to other potential failures.
Step 8 Prioritize the failure modes for action

I recommend a three-step process here.
1. Address the severity 9 and 10 rankings as they are related to safety.

2. Review the prioritized ranks for groups of failure modes that one ‘fix’
(redesign, evaluation, or process improvement) may address. The RPNs of
the individual lines may not be the topped ranked value, yet collectively the
action may provide significant risk reduction.
3. Address the highest remaining RPNs as the represent the remaining risk to
the product working as expected.
No team that I know of addresses every potential failure. It is a balance of safety,

functionality, customer expectation, and resources.
Step 9 Take action to eliminate or reduce the
high-risk failure modes
Assign action items. These may include gathering information, conducting
experiments, considering design or process improvements, adding or removing
functions, etc.
The idea is to do something with the study. The prioritized list provides a guidance
document that the entire team can use to focus on the highest risk areas first.
Step 10 Calculate the resulting RPN as the failure

modes are reduced or eliminated
Document the changes to the product. Ideally, the results of completed actions will
reduce the risk.
Be sure to consider new information and function and recalculate. FMEA is a

process and as the program evolves and grows so should the FMEA. It’s a tool,
that helps the team address risks. Used as such it provides value.
While the basic steps for conducting an FMEA are the same regardless of
the focus of the FMEA, some of the tactics are different if it is a DFMEA or
PFMEA. This table highlights the key differences between the two.
Criteria DFMEAs PFMEAs
To uncover potential
To uncover potential process
failures associated with the
failures that can:
product that could cause:
 Impact product quality.
 Product
 Reduce process
Primary malfunctions.
reliability.
Objectives  Shortened product
 Cause customer
life.
dissatisfaction.
 Safety hazards
 Create safety or
while using the
environmental hazards.
product.
The basis of A blueprint, detailed A process flowchart or detailed

the review product schematic or traveler.
Criteria DFMEAs PFMEAs
prototype.
How Identifying and assessing

potential potential risks with process
Identifying and assessing
failures of operating parameters and
potential risks of the design
intended meeting product specifications.
requirements.
functions are
evaluated
The An evaluation of the ability of

evaluation An evaluation of the ability process controls (mistake-
criteria for of design controls (related proofing, fail-safes, gages) to
Detection to the product or process) prevent a failure mode (or cause)
ratings to prevent or detect from occurring or detect the
usually mechanisms of failure. effect of a failure if a failure has
focuses on: occurred.

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Process Failure Mode and Effects Analysis must be done in a step-wise

STEP 1: Review the process

 Use a process flowchart to identify each process component.

STEP 2: Brainstorm potential failure modes

STEP 3: List potential effects of each failure

STEP 4: Assign Severity rankings

 Based on the severity of the consequences of failure.

STEP 5: Assign Occurrence rankings

 Rate the severity of each effect using customized ranking scales as a

STEP 6: Assign Detection rankings

 What are the chances the failure will be detected prior to it occuring.

STEP 7: Calculate the RPN

 Severity X Occurrence X Detection

STEP 8: Develop the action plan

STEP 9: Take action

 Implement the improvements identified by your Process Failure Mode

STEP 10: Calculate the resulting RPN

 Re-evaluate each of the potential failures once improvements have

Step 1 Review the process or product

Step 2 Brainstorm potential failure modes

Step 3 List potential effects of each failure mode

Step 4 Assign a severity ranking for each effect

Step 5 Assign an occurrence ranking for each

Step 6 Assign a detection ranking for each failure

Step 7 Calculate the risk priority number for each

Step 8 Prioritize the failure modes for action

1. Address the severity 9 and 10 rankings as they are related to safety.

No team that I know of addresses every potential failure. It is a balance of safety,

Step 10 Calculate the resulting RPN as the failure

Be sure to consider new information and function and recalculate. FMEA is a

Criteria DFMEAs PFMEAs

The basis of A blueprint, detailed A process flowchart or detailed

How Identifying and assessing

The An evaluation of the ability of

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