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Process FMEA and DMAIC

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DMAIC - is a data driven incremental process improvement methodology in the Six Sigma philosophy. It is acronym which stands for


D - Define

M - Measure

A - Analyze

I - Improve

C - Control




Failure Mode and Effects Analysis (FMEA) - is a risk assessment tool that helps in identifying 'what all can go wrong' with a process/product/service. In addition to identifying the failures that have already occurred, it also helps in identifying the failures that have not occurred so far but have a potential to occur. This provides chances for mistake proofing and preventive actions to be implemented.


FMEA is a team activity and is performed at each step of a process. It gives a severity rating basis the impact of the failure, occurrence rating basis the frequency and a detection rating basis the ability to detect the failure. The three ratings together provide the Risk Priority Number (RPN) at each step. Higher the RPN, greater is the risk. A review of the high RPNs provide us improvement opportunities.



RPN = Severity x Occurrence x Detection


An application-oriented question on the topic along with responses can be seen below. The best answer was provided by Sandra on 14th May  2019.


Applause for all the respondents-  Christopher Marince, Scott Hunter, Steve Cropp, Paul Kurowski, Charles Fieselman, Kevin Naya, Sandra Thomas, Amlan Dutt, Venkatesh Alla, Ransingh Satyajit Ray, Sujata Dhawase, Sreyash Sangam, Sushant Dhir, Vastupal Vashisth.




Q. 159  In how many ways can a Process FMEA relate with a Lean Six Sigma DMAIC project? 


Note for website visitors - Two questions are asked every week on this platform. One on Tuesday and the other on Friday.


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In how many ways can a Process FMEA relate with a Lean Six Sigma DMAIC project


Within FMEA, Failure modes can relate to the define the stage of generating a project idea and defining project charter problem statement

Within FMEA, the operation, step, process function (from pfd) can relate to the define stage of creating a high level map

The requirements column informs of the process/customer requirement

Potential Failure mode effect helps define the impact to the customer or producer


Cause segregates the reasons for the failure

Within FMEA, the severity, occurrence, and detection rankings (and raw values) can support the measure effort

Values can help differentiate which measure is more relevant to address


RPN can relate to the analyze stage to prioritize and down select the project

RPN values can help differentiate which measure is more relevant to address (SO, S, or O, or D)

RPN sets the initial "as is state" of the process to improve from and which causes to mitigate


Mitigation tasks and assigned personnel and committed due dates relate to improving the target RPNs

Implementation of the change will show if a change (improvement) is realized

Reassessment of change (S<O<D) and the RPN will validate if the change was actually an improvement


Once improvement validated, the living document of FMEA would continue to access if the change is stable

Any change in S, O, or D negative would be reflected in new RPN

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I can think of at least four ways that a Process FMEA can be used in a DMAIC project.  The first is as a source of a project itself.  When working through a PFMEA, a team might identify a process step that needs to be improved.  The required improvement may require the use of the DMAIC tool set to accomplish it.


The second is straightforward in that PFMEA is a standard tool used in the Analyze phase to identify likely cause and effect relationships that need to be tested for validity.  The third way is I could see a PFMEA used in the measurement phase to ensure a capable measurement system.  The key point here is to remember that measurement is a process in itself, subject to the same improvement tools used to improve a larger process.


Finally, I have seen PFMEA used in the improve phase as a tool to help bring structure to a team's brainstorming activities.  It can also help to prioritize improvement actions based on impact and likelihood of success.

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Since a process FMEA is identifying risk associated with process application, the PFMEA can be a source of DMAIC projects.  Those projects can cover all aspects of the projected process performance.  The DMAIC approach can be used to increase throughput, increase capability, move the process mean, etc..  Since some KCs and CIs can be controlled through process application we can use DMAIC to make any adjustments needed to achieve the necessary process performance.  Process and tool maintenance plans, safety issues, costs associated with process execution and inventory of parts and assets can also be impacted by DMAIC.

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I am not sure process FMEA is the right question as applied to a Lean Six Sigma DMAIC project. If it was reworded as FMEA as applied... then I would say three FMEAs:

- perform a design FMEA to address what can go wrong with the potential solution.

- perform a process FMEA to address what can go wrong with the process steps.

- perform an application FMEA to address how the customer or user of the product or process can use it incorrectly.

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PFMEA assesses the severity of the most serious effect for a given failure (S), the likelihood of occurrence (O), and the detectability of the failure (D).  The resultant Risk Priority Number (RPN) = S x O x D.  Action is then taken to reduce the RPN to achieve an acceptable risk.  With Six Sigma DMAIC, PFMEA provides a method that could be included in the Analyze phase as appropriate, and it includes actions in the Improve phase (to reduce higher RPNs).

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PFMEA can be applied when:
new technology/process introduced
current process with modifications
current process exposed to new location 


hence it can be applied in following ways:

Define: Project risk analysis including Resources, Timelines, Serviceability

Measure: Measurement error quantification, MSA validation and Statutory risks
Analyze: Resolve contradictions to reflect before/current conditions, prior to a pilot
Improve: Improve function to the extreme to reflect after conditions, after the pilot
Control: Corrective/productive functions in control plan to ensure/restore control



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PFMEA : It provides the project team with frame work to identify potential failure modes in the process and their effects on the process customers. PFMEA can be used in a Lean Six Sigma DMAIC project  in the following phases:

Define: We can have a initial understanding of the potential failures that may have caused the deterioration in the bottom line of the project and come up with an expected timeline for project completion. (Given that the goal and scope supports guesswork) 

Analyze: It pretty direct, it helps in understanding the root causes of the problem.

Control: Including PFMEA in control plan will help the line operators to mitigate the already occurred or potential failures.

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The Process FMEA is used to not only minimise the the risk associated with a process but also define them whenever possible. It helps in identifying the known or potential failure modes and provide follow-up and  corrective action before the first production run.The Process FMEA is related to Lean Six Sigma DMAIC in the following ways to reduce variation in the process and generation of waste.

1. Reduces product development time and costs.

2. Help reduces the redundancies in the process.

3. Help identify the significant characteristics 

4. It helps in identifying the sequence of tasks that come into play in a process.

5. Identifying errors and facilitate.

6. Helps in defining the corrective action.

7. Helps in knowing the magnitude of failures and their effect.



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What is FMEA ?

It is a systematic analysis and team (Cross functional team) activities to recognize and evaluate the potential failures modes and potential mechanism of failure in the product/processes/services based on empirical knowhow and their potential failure effects, and identifying proactive actions that could eliminate or reduce the causes of the occurrence of the potential failure and further document the same.

FMEA focuses on HOW and WHEN

a process, product or service will fail,

NOT IF it will fail !!!!!!!



FMEA is a systematic tool used to prevent the defects/errors from processes before it arises meaning eliminate or reduce the Generation (Occurrence) of problem, incase we can't prevent it then we will try to add detection mechanism so that defect/problem/issue can't pass from Generation point to the next process.

FMEA is to _

•Recognize and evaluate the potential failure of a product/process and its effects

•Identify methods to eliminate or reduce the chance of a failure occurring

•Document the process & rationale for changes (It's a live document)



> It is a used to analyze the manufacturing / service processes

> This focuses on Identification , Prevention & detection of process failure modes caused by process deficiencies.


PFMEA's use/relation in Lean Six Sigma DMAIC project_


> PFMEA in Analysis phase -

1. PFMEA is a useful document when we do 3G (Gemba walk)  - "Gemba, Gembutsu, Genjitsu"

2. After brainstorming & C & E Diagram , we do deep dive in order to understand more facts about the identified probable root cause & finally reach to real root cause after Why-Why (3Way5Why) analysis - During this process "PFMEA" is also useful to verify the "answers of every Why-why question" during 3Way5Why


> PFMEA in Improve Phase _  While creating the improvement action plan on confirmed Root causes we need to conduct below actions:

1. If the issue / defect occurred is a new event not considered in existing PFMEA then we create action in 3 ways _ what improvement action can be taken to eliminate occurrence of this event from process step? Which mechanism can detect this event? & how best we can build a system/process so that this defect should not come in any similar process? ... And finally add these control & detection mechanism in PFMEA

1. If the issue/defect is a reoccurred event then - we focused on our documented " Defect detection & Occurrence elimination/reduction(control)" mechanism & try to find of more root causes , it's effects and accordingly need to identify the new actions for "elimination/reduction (control) & detection" mechanism improvement. ...And finally add these control & detection mechanism in PFMEA


> PFMEA in Control Phase_ Once the improvement actions from Improve phase are positively successful & give us desired result then :

1. Modify the PFMEA aligning with the successful actions from Improve phase

2. Handover the modified PFMEA to process owner

3. PFMEA is a live document to sustain & standardize the improvements


Sometime if problem/issue demands then we also use PFMEA document in measure phase to identify the right sources for "Generation point & Detection mechanism".

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Process FMEA and DMAIC are complementary to each other as both of them serve the purpose to meet the end goal of process improvement. Even though the FMEA was initiated by industries much before the advent of DMAIC methodology came into picture, however currently these are widely used in most of the DMAIC elements, particularly Measure, Analyze, Improve and Control.

Primarily, Process FMEA is used to identify the critical X's by calculating the Risk Priority Number against each X's. This helps the six sigma professionals to identify and focus on those critical few factors, which are contributing majorly in the process.

Process FMEA helps us to look where the root cause is existing. This is done by creating a detailed process map and than carrying out the Failure mode and effective analysis using brainstorming.

Therefore, in Measure, Analyze and Improve phase, FMEA is majorly the result of brainstorming because there is no availability of quantitative data as such, however it is helpful in achieving the purpose of M,A & I phase. Similarly in the control phase, FMEA is essential for continuous and ongoing improvement in the processes. FMEA helps to develop the Standard Operating Procedure (SOP) which will help to control and manage the process on continuous basis.


Lets understand this with an example. Suppose we are doing a DMAIC project on spot welding defect variation in one of our factory. Once we have defined the problem and brought all stakeholders in agreement, next is the Measure phase. In the measure phase as we know, we need to set the baseline performance and carry out the measurement system analysis, FMEA helps to assist in those activities. There are variety of metrics which can be used to baseline these Y's. FMEA can be helpful in identifying those critical X's which have high contribution towards Y, based on Y = f (X) + C. Lets say, in our example, by carrying out the FMEA,  key X's which come out are current, voltage and welding pressure.


Now, Analyze phase is used to identify the root cause of the problem. FMEA can again be helpful to identify the root cause by calculating the Risk Priority Number (RPN) of each X's and understanding which of the X's has more impact or contribution to the Y. i.e., spot welding defect. Lets say the RPN number of welding current is the root cause of the problem. Since we already identify the CTQ or little Y's in the define phase and X's in the Measure phase, Analyse phase is used to identify the root cause using the FMEA.


On similar lines, Improve and Analyze phase can also be used for continuous improvement and monitoring of those critical X's which have an impact on the Welding current or Y. 


Thus, the overall approach of the FMEA does not change with respect to the DMAIC phase, though the focus of its use does.


In totality, DMAIC is a standard Six sigma methodology which gets benefited by incorporating the FMEA as a complementary and supportive tool to facilitate the same.




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Proces FMEA and LSS DMAIC project, both require Conplete understanding of ptocess first using, IPO/ Rich picture duagram or PFDs


both require measurement of what can go wrong in the process. What are the process parameters which can go wrong and how they are measured.


both involves R&R analysis of measurement shstem to identify if the problem is reqlly a problem.


both involves Why why analysis, in Process FMEA it is called Cause and effect Analysis


both involves RPN number calculation to prioritize the Causes/ process parameters and choosin. Process parameters and critical process parameters basis the severity.


both involves CAPA action with measurables, RACI and target date of implementation followed by Effective measurement 

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FMEA stands for Failure Mode and Effects Analysis and is related with Lean Six Sigma DMAIC project in various phases. We can say that it is a risk assessment tool which helps us to prioritizes the failure modes of any product or any process on the basis of RPN score which stands for Risk Priority Number and can be calculated by giving scoring based on Severity, Occurrence and Detection. Severity can not be reduces once decided and the project team has two option to reduce occurrence or increase detection. After action taken we can again calculate RPN number and can determine new risk on the basis of score and further we can do work for improvement so we can use FMEA as continuous improvement and can use for comparison of results before and after  the action.


Six sigma helps us to eliminate the product defect, process failure which can be internal as well as external. FMEA helps us to identify the process failure that is going to impact a customer, product . 


Like Six Sigma, FMEA helps us to access every step and its impact on customer and project team can easily identify by calculating RPN number that Occurrence have the biggest impact. 


in other words we can say that, the ability of FMEA  to measure  the impact on the customer or outcome by any failure is inline with the improvement method which is driven by Voice of Customer and is the focus area of any Six Sigma DMAIC Project. 


FMEA can be interrelated in different phases during any DMAIC Project. During Measure Phase FMEA can be used to identify what can go wrong with the process and can do prioritization to focus of a DMAIC Project and helps the team in right direction to collect the data for its process. Oonce FMEA is created , the team can focus to mitigate the failure areas


During Analyse Phase, FMEA tells us where to look for the root causes as it tell us failure points in the process although FMEA is not a tool which is used to identify root causes but it tells us the focus area to find out root causes of failure. 


During Improve Phase , FMEA helps us to examine process improvement . this helps to identify corrective , preventive action whcih can be used to eliminate the failure. 


During our Measure, Analyse, Improve phase of the project , FMEA is formed with the result of brainstorming because we dont have any quantitative data, so now after taking c/m in improve phase, FMEA can be updated in Control Phase on the base of real data and we can compare results of before and after c/m and this result will be helpful to us for continuous improvement.  

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The chosen best answer is that of Sandra as she has outlined how FMEA can be used in each phase of a DMAIC project.


In addition, read answers from Steve C, Kev N to complete a rounded view of how FMEA can be used in all phases of DMAIC.


Charlie's answer highlights the different FMEAs that can be used in a project and Sujata's answer clearly outlines what FMEA is and why it should be done.

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