Process FMEA

Process FMEAs uncover process problems related to the manufacture of

the product

It is helpful when conducting a process FMEA to think in terms of the five
elements of a process: people, materials, equipment, methods, and
environment.

With these five elements in mind, ask: How can process failure affect the
product, processing efficiency, or safety?
Process FMEA
FMEA Breakdown
 Review the Process or Product

 Brainstorm Potential Failure Modes

 List Potential Effects for Each Failure Mode

 Assigning Severity Ranking For each failure mode

 Assign an Occurrence Ranking for each Failure Mode

 Assign a Detection Ranking for each Failure Mode and/or Effect

 Calculate the Risk Priority Number for each Failure Mode

 Prioritize the Failure Modes for Action

 Take Action to Eliminate or Reduce the High-Risk failure Modes

 Calculate the Resulting RPN as the Failure Modes Are Reduced

FMEA Worksheet
 The FMEA process should be documented using an FMEA worksheet

 The worksheet must capture all of the important information about the FMEA and serves as an excellent communication tool.

 FMEA Worksheet design may vary from organization to organization

 The worksheet is easiest to work with when enlarged to 11 × 17 inches in size or when put on to a large poster or projected from a
computer for use during the team meeting.

 A numbering system to track and access FMEA previously conducted projects is helpful. The numbering system should enable cross-
referencing to similar FMEAs as well as other improvement activities dealing with the same product or process.

 Copies of all FMEAs should be kept in a central location so they are easily accessible during audits or internal process and product
reviews
Review the process or product
 The team should review a blueprint (or engineering drawing) of the product if they are considering a product FMEA or a detailed flowchart of the operation if they are
conducting a process FMEA.

 If a blueprint or flowchart is not available, the team will need to create one prior to starting the FMEA process.

 With the blueprint or flowchart in hand, the team members should familiarize themselves with the product or process.

 For a product FMEA, they should physically see the product or a prototype of it.

 For a process FMEA, the team should physically walk through the process exactly as the process flows.

 It is helpful to have an “expert” on the product or process available to answer any questions the team might have.
Brainstorming potential failure modes
 Once everyone on the team has an understanding of the process (or product), team members can begin
thinking about potential failure modes that could affect the manufacturing process or the product quality.

 A brainstorming session will get all of those ideas out on the table.

 Team members should come to the brainstorming meeting with a list of their ideas.

 In addition to the ideas members bring to the meeting, others will be generated as a result of the synergy
of the group process.

 Because of the complexity of most manufactured products and manufacturing processes, it is best to
conduct a series of brainstorming sessions, each focused on a different element of the product or process.

 Once the brainstorming is complete, the ideas should be organized by grouping them into like categories

 Grouping the failures will make the FMEA process easier to work through.

 If possible combine some of the interrelated failure modes

List potential effects of each failure mode
With the failure modes listed on the FMEA Worksheet,
the FMEA team reviews each failure mode and identifies
the potential effects of the failure should it occur.

For some of the failure modes, there may be only one

effect, while for other modes there may be several effects.

This step must be thorough because this information will

feed into the assignment of risk rankings for each of the
failures.
Assigning Rankings

 Rankings are based on a 10-point scale with 1 being the lowest ranking and 10 the highest.

 It is important to establish clear and concise descriptions for the points on each of the scales, so that all
team members have the same understanding of the rankings

 The scales should be established before the team begins the ranking process.

 The more descriptive the team is when defining the ranking scale, the easier it should be to reach consensus
during the ranking process.

 Ranking scales should be common for all FMEAs

Assign a severity ranking
The severity ranking is an estimation of how serious the effects would be if
a given failure did occur.

It is necessary to estimate the severity based on the knowledge and

expertise of the team members

It is important to note that because each failure may have several different
effects, and each effect can have a different level of severity.

The effect should be rated and not the failure

Each effect should be given its own severity ranking, even if there are
several effects for a single failure mode
Design FMEA Severity Evaluation Criteria
Process FMEA Severity Evaluation Criteria
Assign an Occurrence Ranking
 The best method for determining the occurrence ranking is to use actual data from
the process

 The above process can be done easily using failure logs or process capability data

 When actual failure data are not available, the team must estimate how often a
failure mode may occur

 The team can make a better estimate of how likely a failure mode is to occur and
at what frequency by knowing the potential cause of failure.

 Once the potential causes have been identified for all of the failure modes, an
occurrence ranking can be assigned even if failure data do not exist.
Design FMEA Occurrence Evaluation Criteria
Process FMEA Occurance Evaluation Criteria
Assign a Detection Ranking
The detection ranking looks at how likely we are to detect a failure or the effect
of a failure.
This step is initiated by identifying current controls that may detect a failure or
effect of a failure
If there are no current controls, the likelihood of detection will be low, and the
item would receive a high ranking, such as a 9 or 10.
Current controls should be listed for all of the failure modes, or the effects of the
failures, and then the detection rankings assigned.
Design FMEA Detection Evaluation Criteria
Process FMEA Detection Evaluation Criteria
Calculate Risk Priority Number(RPN)
 The risk priority number (RPN) is simply calculated by multiplying the severity ranking times the occurrence ranking times the detection
ranking for each item.

 𝑅𝑖𝑠𝑘 𝑃𝑟𝑖𝑜𝑟𝑖𝑡𝑦 𝑁𝑢𝑚𝑏𝑒𝑟 = 𝑆𝑒𝑣𝑒𝑟𝑖𝑡𝑦 × 𝑂𝑐𝑐𝑢𝑟𝑎𝑛𝑐𝑒 × 𝐷𝑒𝑡𝑒𝑐𝑡𝑖𝑜𝑛

 The total risk priority number should be calculated by adding all of the risk priority numbers

 This number calculated in the above step has no meaning because each FMEA has a different number of failure modes and effects

 However, it can serve as a gauge to compare the revised total RPN once the recommended actions have been instituted
Pareto Diagram
Prioritize The Failure Modes for Action
 The failure modes can now be prioritized by ranking them in order, from the highest risk priority number to the lowest.

 When you arrange the failure modes you will see that the failure modes are arranged using pareto principle (80/20) rule.

 In the case of the RPN, a literal translation would mean that 80 percent of the total RPN for the FMEA comes from just 20 percent of the
potential failures and effects

 It is convenient to plot a pareto diagram

 The team must now decide which items to work on

 It helps to set a cutoff RPN, where any failure modes with an RPN above that point are attended to

 Failure modes which are below the cutoff RPN are left off for the time being
Take Action to Eliminate or Reduce the
High-Risk Failure Modes

 Using an organized problem-solving process, identify and implement actions to eliminate or reduce the
high-risk failure modes.
 Ideally, the failure modes should be eliminated completely.
 When a failure mode has been eliminated completely, the new risk priority number approaches zero
because the occurrence ranking becomes one
 While elimination of failure modes altogether is ideal, it may not be achievable in all cases
 When this happens, it helps to refer back to the severity, occurrence, and detection rankings that the team
assigned to each item.
 Think of ways to reduce the rankings on one, two, or all three of the scales.
 Increase detectability of the failure promotes product or process improvement.
 Reducing the severity is important, especially in situations that can lead to injuries.
Steps taken to reduce RPN
Calculate the resulting RPN
 Once action has been taken to improve the product or process, new rankings for severity, occurrence, and detection should be determined,
and a resulting RPN calculated.

 For the failure modes where action was taken, there should be a significant reduction in the RPN

 The resulting RPNs can be organized on a Pareto diagram and compared with the original RPNs

 You should expect at least a 50 percent or greater reduction in the total RPN after an FMEA

 It is up to the FMEA team and the company to decide on how far the team should go with improvements

 There will always be the potential for failure modes to occur. The question the company must ask is how much relative risk the team is
willing to take. That answer will depend on the industry and the seriousness of failure
FMEA application
 The FMEA process is widely applicable in a variety of settings beyond the product design and manufacturing processes.

 FMEAs provide a structure and a common language that can be used by teams in manufacturing and service, profit and not-for-profit,
private, public, or governmental organizations.

 FMEAs can be used to improve the safety of the process of manufacturing a product as well as to improve the safety performance of the
product itself.

 With some modifications to the ranking scales for severity, occurrence, and detection, FMEAs can be helpful in determining financial
strategies and assessing credit or investment risks.

 The effects of software are all around us. Practically everything that we do is governed by software

 Problems created by software bugs or incorrect programs can range from nuisances to potentially fatal disasters.
 As with a product or design FMEA, a software design quality FMEA can identify problems before they occur, so they can be eliminated or
reduced.