The document discusses Failure Mode and Effects Analysis (FMEA) as part of the Six Sigma methodology. It explains that FMEA is implemented during the "Analyze" phase of the DMAIC cycle to help identify process tasks and product features that are prone to failure. The document then outlines the steps for conducting an FMEA, including compiling a failure list, determining failure impacts and rates, establishing detection probabilities, and developing action plans to address high-risk failures. It stresses that FMEA is a priority tool to improve business processes by enabling teams to proactively identify and eliminate likely defects before they impact customers.

1. SIX SIGMA
TOPIC
FMEA (FAILURE MODE AND EFFECTS ANALYSIS)
SUBMITTED TO- SUBMITTED BY-
Er. Vikram Singh Aishwar
Sharma(201810101110137)
Sumit Rajpal (201810101110139)
Himanshu Mishra(201810101110141)
Utkarsh Mishra(201810101110176)

2. INTRODUCTION
• Six Sigma is all about eliminating errors and defects that details
the customer’s experience. And, this is where FMEA comes into
the picture, helping predict possible failures that will impact
customer experience.
• Majorly, FMEA is implemented during the ‘Analyze’ phase of
the SIX SIGMA DMAIC CYCLE.
• It helps project teams to identify product features and process
tasks that are prone to failure. With data analysis and reports,
FMEA provides project teams with enhanced product quality and
reduces errors by modifying the existing processes.

3. SIX SIGMA DMAIC CYCLE
DMAIC Stands for:-
• DEFINE
• MEASURE
• ANALYZE
• IMPROVE
• CONTROL

4. DEFINE
• As the first stage in DMAIC, Define is arguably the most important. The first action it calls for, much like Six Sigma,
is articulate the problem you face in a clear way. This can be anything, for example, you may experience slow
production times, depleted costs, or decrease in quality. It all depends on you and your business. The purpose of
Define is to help you come up with a focused problem statement as well as a measure of success or failure to
support that statement.
State YourProblem
• Stating your problem may seem simple enough, but it involves a lot of additional effort on your part. A deep understanding of your business
and its goals are essential here, as you will need to be able to describe them accurately and in detail, along with any potential resources you
have to assist you. This is also an ideal time to identify future resources you may need, as acquiring them up front can help avoid similar
problems in the future.
• You will also need to consider the overall project scope – including the duration of the project, affected areas/areas that require attention, as
well as costs to you – and a high-level timeline to determine how to proceed. A charter document is the best way to capture all of this
information – write down everything that you know at the moment, collect and collate all of your current knowledge.

5. DEFINE
Produce a Charter Document
• A charter document of this nature should include the project scope (with a statement, overall metric, and project
metric), potential opportunities (including savings, profits, improvements, baseline performance, and goal
performance), project status (historically, currently, and as predicted, with analyses for product returns and root
causes), and finally any actions and/or open issues. This information is essential to the Define stage, which relies
on clear, accurate qualitative data to function. Using the knowledge you have compiled, you will be able to define
the following issues:
• Your Problem – Starting with the issue at hand puts everything else into perspective. Look at what the problem is,
what it does, what it affects. Consider where it may stem from and how it can be resolved.
• Consider your customers – The customer is the backbone of your business. You rely on them for profit, just as they
rely on your for excellent products and services. Consider how the problem affects them. For example, if a
problem causes your product to become defective, it will affect customer satisfaction.
• Critical Process Outputs – Critical process outputs such as Voice of the Customer (VOC) and critical to quality
(CTQs) are also important. Once this is completed, any anomalous or missing data you can seek to clarify. You can
also focus on setting objectives to be met by the conclusion of the project, as well as putting together a project
team dedicated to overseeing and implementing the proposed changes yielded by the DMAIC process.

6. MEASURE
• The capability and stability of the project Y is established by the top Belt. This
individual will also conclude the ability to measure the Y. When the project is obviously
outlined with a clearly quantifiable Y, the process is scrutinized to define the Key
Process Steps, as well as the Key Inputs for every process.
• Once the Key Input list is produced, the Belt will determine the possible influence on
CTQs that every input has in connection to the faults that are being produced within
the process. Each Key Inputs is then prioritized to create a “short list” that can be
scrutinized more precisely.
• The “short list” will be used by the Belt to narrow down the possible methods that
could result in an error or how the input might become flawed. FMEA is the most
effective system for this process. Any input failures can quickly be defined and
preventive action strategies established.
• Having correct metrics is an important part of the Measure phase. Therefore, it is vital
that metrics be validated as reliable during the Measure phase, so that the progress of
the project can be accurately monitored. Tracking project metrics is best done by
using Business Process Charting methodologies.

7. ANALYZE
• In this phase, the group will use analysis to isolate the reasons for
errors that need to be corrected.
• the Analyzephase will provide insight on how to remove the space between the currentlevel of
performance and theanticipated level. Thisencompasses realizingwhy deficiencies are producedby
ascertaining the crucial variables which are apt to generate process variation.
• A frequent misconception individuals have about the Six Sigma
methodology is that the DMAIC process requires too much time to
realize improvements. The reality is that “quick hits” are often
discovered very early in the project.
• In most cases these improvements are established prior the Analyze
phase. Major developments may not happen until the data related to
the process is scrutinized. This is when the revolutions occur. The
Analysis methods used in Six Sigma are designed to expose more
problematic resolutions.

8. IMPROVE
• Although this phase can be the most challenging, it is also one of the
most enjoyable.
• The Analyze phase provides the causes of problems. Now in the
Improve phase the group can determine innovative new
improvement solutions. In most instances basic process testing and
simulation provide the group large achievements in this stage.
• The group also ascertains the results of required improvements not
being completed, as well is the outcome if improvements take an
extended amount of time.

9. CONTROL
• Thefour stages prior to this one will determine how successful we arein the Control phase.
• we utilized the correct change management strategies, such as
identifying the key stakeholders; if we did then a successful
control should be within our grasp.
• The purpose of the Control phase is to establish tools that will
ensure the key variables stay within the accepted variances over
the long run. At this point, the group will create a formula for
handing off the process which would include response
procedures and educational information to guarantee the
performance and long-term project savings.
• The group would complete the phase by establishing the next
phases for supplementary Six Sigma process improvement
prospects.

10. STEPS FOR IMPLEMENTATION OF FMEA
• Projectteams applyFMEA in a series of steps:
• Compile afailurelist foreachandevery step.
• Measure failureimpacts.
• Determinefailurerates.
• Establishprobabilityof discovering errors.

11. APPLICATIONS FOR FAILURE MODE AND EFFECTS ANALYSIS
• FEMA can be applied either on processes on a product, thus making
the technique a flexible one in Six Sigma methodologies. Common
uses of FMEA in the environment include:
• Designing new processes
• Reworking on existing processes
• Building new environment for existing processes
• Proactively following up on problem-solving
• Determining preliminary processes
• Defining and Designing the system and product functionality

12. FMEAS MODULES
FMEA MSRs
This unique FMEA focuses on the potential failure cause that might occur when a customer is operating on a product. Here, the study is done
on the effect of failure caused on a system and regulatory compliance
System FMEA
This FMEA is used to analyze a compilation of subsystems. It focuses on integrations, interactions and interfaces.
 Machinery FMEA
This FMEA is used to assess and increase the reliability of machinery. The module leads to incorporate prevention measures, automated fail-
safe shutdown techniques and reduce both planned and unplanned downtimes.
Software FMEA
This FMEA module studies the programming logic that goes into generating reports or control associate processes.
Service FMEA
This FMEA is concerned and conducted with transactions. Since the transaction is considered a process, the FMEA technique is utilized heavily
in this field.

13. WHEN TO APPLY FMEA?
• FMEA is a necessary methodology for situations related to services, products and processes. Thesituations can be newor being adapted or redesigned for multiple
purposes. It is worth undertakingFMEA periodically throughthelife of the process, product or service to ensure it is effective.
• FMEA should be used:
• When a module is being designed or redesigned following a quality function development.
• When an existing module is being applied ina new eco-system.
• Before the development of control plans for a newor modified process.
• When planningimprovement goals for an existing module.
• When assessing a failure in an existing module.
• To periodically assess a module.

14. HOW TO CREATE AN FMEA
1. Review the process: Map the entire process, capturing every activity.
2. Identify failure modules: Brainstorm all the potential failures/errors for each process.
3. List the cause of failure: For every failed module, list its cause on the output of the process step.
4. Assign severity score: Rank each failure module to show how severe it was on a scale of 1 to 10.
5. Assign each module an occurrence score: Rank each failure module as to how often it will occur on a scale of 1 to
10.
6. Assign each item a detection score: Rank each failure mode as to how easy the errors can be detected by the
oncoming customer in the process on a scale of 1 to 10.
7. Calculate RPN score: For each failure mode, give RPN score. This will allow you to focus on the highest risk score
module first.
8. Develop an action plan: For each high scoring RPN, note who is doing what when close to eliminating the failure
modes.
9. Recalculate new RPNs: Once the action has been completed, recalculate the new RPN numbers. Repeat this
process if further action is needed. (in case the RPN score is too high).

15. HOW TO COMPLETE A FAILURE MODES AND EFFECT ANALYSIS(FMEA)
Every product or process is subject to different types or modes of failure and the potential failures all have
consequences or effects.
The FMEA is used to:
• Identify the potential failures and the associated relative risks designed into a product or process.
• Prioritize action plans to reduce those potential failures with the highest relative risk.
• Track and evaluate the results of the action plans.

17. THE STEPS TO COMPLETE A FMEA ( FAILURE MODES AND EFFECTS
ANALYSIS)

19. Consider the Potential Failure Modes for each component and its corresponding function.
A potential failure mode represents any way the component or process step could fail to perform its intended function
or functions.

20. Determine the Potential Failure Effects associated with each failure mode. The effect is related directly to the ability
Of that specific component to perform its intended function.
1. The effect should be stated in terms meaningful to product or system performance.
2. If the effects are defined in general terms, it will be difficult to identify (and reduce) true potential risks.

21. For each failure mode, determine all the Potential Root Causes. Use tools classified as root cause analysis tool, as well as the best knowledge and
experience of the team.

22. For each cause, identify Current Process Controls. These are tests, procedures, or mechanisms that you now have in place to keep failures from
reaching the customer.

23. Assign a Severity ranking to each effect that has been identified.
• The severity ranking is an estimate of how serious an effect would be should it occur.
• To determine the severity, consider the impact the effect would have on the customer, on downstream operations, or on the employees operating the process.
The severity ranking is based on a relative scale ranging from 1 to 10.
• A “10” means the effect has a dangerously high severity leading to a hazard without warning.

24. For each cause, identify Current Process Controls. These are tests, procedures, or mechanisms that you now have in place to keep failures from
reaching the customer.

26. Assign the Occurrence Ranking
• The Occurrence ranking is based on the likelihood, or frequency, that the cause (or mechanism of failure) will occur.
• Once the cause is known, capture data on the frequency of causes. Sources of data may be scrap and rework reports, customer complaints,
and equipment maintenance records.

28. Assign the Detection Rankings
• To assign detection rankings, identify the process or product related controls in place for each failure mode and then
assign a detection ranking to each control. Detection rankings evaluate the current process controls in place.
• A control can relate to the failure mode itself, the cause (or mechanism) of failure, or the effects of a failure mode.
To make evaluating controls even more complex, controls can either prevent a failure mode or cause from occurring or
detect a failure mode, cause of failure, or effect of failure after it has occurred.

30. RISK PRIORITY NUMBER(RPN)
• The RPN is the Risk Priority Number. The RPN gives us a relative risk ranking. The higher the RPN, the higher the potential risk.
• The RPN is calculated by multiplying the three rankings together. Multiply the Severity ranking times the Occurrence ranking times the Detection ranking
• Calculate the RPN for each failure mode and effect
Prioritize the Risks by Sorting the RPN from Highest Score to Lowest Score. This will help the team determine the most critical inputs and the causes for their failure.

31. DEVELOP ACTION PLAN
• Taking action means reducing the RPN. The RPN can be reduced by lowering any of the three rankings (severity,
occurrence, or detection) individually or in combination with one another

32. Who is Responsible:
• This is a very important step in Taking Action!
• Be sure to include person(s) responsible and the deadline

33. Take Action:
• The Action Plan outlines what steps are needed to implement the solution, who will do them, and when they will be completed.
• Most Action Plans identified during a PFMEA will be of the simple “who, what, & when” category.
• Responsibilities and target completion dates for specific actions to be taken are identified.

34. • Recalculate the Resulting RPN :
• This step in a PFMEA confirms the action plan had the desired results by calculating the resulting RPN.
• To recalculate the RPN, reassess the severity, occurrence, and detection rankings for the failure modes after the action plan has
been completed.

35. SUMMARY
FEMA is a priority list that needs to be taken into account to improve a business process. Implementing the FMEA methodology helps project
teams identify the most likely source of failures. Seasoned Six Sigma project teams know that detection, severity and occurrence of defects,
impacts heavily on customer experience. Thus, with FMEA, the potential defects can be identified easily and can be weeded out before they
come to fruition.

36. Thank you