The Failure Mode and Effects Analysis (FMEA)

What is an FMEA?

Also called: potential failure modes and effects analysis; failure modes, effects, and criticality analysis (FMECA)

• "Failure modes" means the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that affect the customer and can be potential or actual.
• "Effects analysis" refers to studying the consequences of those failures.

When to Use FMEA?

• When a process, product, or service is being designed or redesigned, after deployment.
• When an existing process, product, or service is being applied in a new way.
• Before developing control plans for a new or modified process.
• When improvement goals are planned for an existing process, product, or service.
• When analyzing failures of an existing process, product, or service.
• Periodically throughout the life of the process, product, or service.

Process

• Assemble a cross-functional team of people with diverse knowledge about the process, product or service, and customer needs.
• Identify the scope of the FMEA. 
• "Is it for the concept, system, design, process, or service?"
• "What are the boundaries?"
• "How detailed should we be?"
• Use flowcharts to identify the scope and to make sure everybody understands it in detail.
• Fill in the identifying information at the top of your FMEA form. 
• The remaining steps ask for information that will go into the columns of the form.
• Identify the functions of your scope. Ask:
• "What is the purpose of this system, design, process, or service?"
• "What do our customers expect it to do?" 
• Name it with a verb followed by a noun. Usually, one will break the scope into separate subsystems, items, parts, assemblies, or process steps and identify the function of each.
• For each function, identify all the ways failure could happen. 
• These are potential failure modes. If necessary, go back and rewrite the function with more detail to be sure the failure modes show a loss of that function.
• For each failure mode, identify all the consequences on the system, related systems, process, related processes, product, service, customer, or regulations. 
• These are potential effects of failure. Ask,
• "What does the customer experience because of this failure?" 
• "What happens when this failure occurs?"
• Determine how serious each effect is. 
• This is the severity rating or S. Severity is usually rated on a scale from 1 to 10, where 1 is insignificant and 10 is catastrophic. 
• If a failure mode has more than one effect, write on the FMEA table only the highest severity rating for that failure mode.
• For each failure mode, determine all the potential root causes. 
• Use tools classified as cause analysis tools, as well as the best knowledge and experience of the team. 
• List all possible causes for each failure mode on the FMEA form.
• For each cause, determine the occurrence rating, or O. 
• This rating estimates the probability of failure occurring for that reason during the lifetime of your scope. 
• Occurrence is usually rated on a scale from 1 to 10, where 1 is extremely unlikely and 10 is inevitable. 
• On the FMEA table, list the occurrence rating for each cause.
• 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.
• These controls might prevent the cause from happening, reduce the likelihood that it will happen, or detect failure after the cause has already happened but before the customer is affected.
• For each control, determine the detection rating, or D. 
• This rating estimates how well the controls can detect either the cause or its failure mode after they have happened but before the customer is affected. 
• Detection is usually rated on a scale from 1 to 10, where 1 means the control is absolutely certain to detect the problem and 10 means the control is certain not to detect the problem (or no control exists). 
• On the FMEA table, list the detection rating for each cause.
• Optional for most industries: Ask
• "Is this failure mode associated with a critical characteristic?" (Critical characteristics are measurements or indicators that reflect safety or compliance with government regulations and need special controls.) 
• If so, a column labeled "Classification" receives a Y or N to show whether special controls are needed. Usually, critical characteristics have a severity of 9 or 10 and occurrence and detection ratings above 3.
• Calculate the risk priority number, or RPN, which equals S × O × D. 
• Also calculate Criticality by multiplying severity by occurrence, S × O. 
• These numbers provide guidance for ranking potential failures in the order they should be addressed.
• Identify recommended actions. 
• These actions may be design or process changes to lower severity or occurrence. 
• They may be additional controls to improve detection. 
• Note who is responsible for the actions and target completion dates.
• As actions are completed, note the results and the date on the FMEA form. 
• Note new S, O, or D ratings and new RPNs.

Notes

• This is a general procedure. 
• Specific details may vary with the standards of your organization or industry. 
• Before undertaking an FMEA process, learn more about standards and specific methods in your organization and industry through other references and training.

References

•  What is FMEA? Failure Mode & Effects Analysis | ASQ

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The 5 Whys Method

The 5 Whys technique is a simple and effective tool for solving problems. Its primary goal is to find the exact reason that causes a given problem by asking a sequence of "Why" questions.

Step by Step

• Form a team. 
• Try to assemble a team of people from different departments. Each representative has to be familiar with the process that is going to be investigated.
• Be aware that this is not an individual task, and it needs to be executed by the team.
• Define the problem.
• Discuss the problem with the team and make a clear problem statement. 
• It will help you define the scope of the issue you are going to investigate.
• Ask Why.
• Empower one person to facilitate the whole process. This team leader will ask questions and try to keep the team focused. 
• The answers should be based on facts and real data, rather than on emotional opinions.
• The facilitator should ask "Why" as many times as needed until the team can identify the root cause of the initial problem.
• Take Action.
• After the team detects the root cause(s), it is time to take corrective actions. All members should be involved in a discussion to find and apply the best solution that will protect your process from recurring problems.
• When the decision is made, one of the team members should be responsible for applying the right actions and observing the whole process.
• After a certain period of time, the team needs to meet again and check if their actions actually had a positive impact. If not, the process should be repeated.
• In the end, the case should be documented and sent across the organization. 

Hints

• Don’t ask too many Whys. If you keep going, you may end up receiving tons of unreasonable suggestions and complaints, which is not the purpose. Focus on finding the root cause.
• Sometimes there could be more than one root cause. 
• In these cases, the 5 Whys analysis will look more like a matrix with different branches. 
• This may even help you detect and eliminate organizational issues that have permanent negative effects on overall performance.

Covered Scenarios

• Root cause analysis.

References

• 5 Whys: The Ultimate Root Cause Analysis Tool

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The Problem-Reframing Method

"As Peter Drucker pointed out, there’s nothing more dangerous than the right answer to the wrong question. There is a way to do better. The key is reframing, a crucial, underutilized skill that you can master with the help of the book "What's Your Problem?..." - Amazon.com

Frame the Problem

• What is the problem we are trying to solve?
• Don’t accept the problem statement at face value. Ask: 
• Is the statement true? 
• Are there self-imposed limitations? 
• Is a solution "baked into" the problem framing? 
• Is the problem clear? 
• With whom is the problem located? 
• Are there strong emotions? 
• Are there false trade-offs?

Look Outside the Frame

• What are we missing?
• Avoid delving into the details of the issue you face. Zoom out. Ask: 
• What's missing from the current problem statement? 
• Are there elements we're not considering? 
• Is there anything outside the frame that we're not currently paying attention to? 
• Look beyond your own expertise, and hidden influences, and consider causal events prior to the situation.

Rethink the Goal

• Is there a better objective to pursue?
• As we focus on the problem and how to solve it, it “prevents us from questioning a more important thing: the goal we’re trying to reach.”

Examine Bright Spots

• Where is the problem not?
• "Look for situations or places where the problem is not as bad, or where it may even be entirely absent. Paying attention to such positive exceptions can give you a new perspective on the problem, and may even point you directly to a viable solution."

Look in the Mirror

• What is my/our role in creating this problem?
• "Even if you don’t contribute to the problem, ask whether you can react differently to it.”

Take Their Perspective

• What is their problem? 
• "Discovering how others see the world—and in particular, how they see it differently from you—is perhaps the most fundamental form of reframing there is."
• Try to disregard your own preferences. Focus only on how they might feel and think.

Move Forward

• How can I validate my/our framing of the problem through real-world testing?
• After you have reframed the problem, test it out to see if you are, in fact, targeting the right problem. You may have a number of reframed problems at the end of this process. In that case, narrow them down by looking for surprising, simple, r significant-if-true framings.

The Seven Practices for Effective Reframing

1. Establish legitimacy – It is difficult to use reframing if you are the only person in the room who understands the method. Show them this article, or relate the slow elevator problem and solution.
2. Bring outsiders into the discussion – This is the single most helpful reframe practice. Search for people who understand but are not entirely in your world, and who can speak freely. Don’t expect solutions, but instead, input.
3. Get people’s definitions in writing – People commonly leave a meeting believing they all agree with something just to find out months later that they actually had different views. Writing it down can help define differences and look contrarily at the problem
4. Ask what’s missing – When facing a problem description, we tend to go deep into the details of what has been stated, perhaps overlooking what has been missed.
5. Consider multiple categories – Transforming people’s perception of the problem can bring powerful changes. One method is inviting people to specify which category of the problem they are facing. Is it a motivation problem? A quality problem? An attitude problem? Then try to suggest more categories.
6. Analyze positive exceptions – You can look for new insights and try to find instances when the problem did not occur: “What was different about that situation?“
7. Question the objective – You can reframe a problem by clarifying and challenging the objectives of all involved parties. The slow elevator problem shows us an objective change from making the elevator faster to improving the waiting time experience.

References

• What's Your Problem?: To Solve Your Toughest Problems, Change the Problems You Solve (book)
• Using the Problem Reframing Method to Build Innovative Solutions
• Many Businesses Do Not Struggle With Problem-Solving, But In Understanding The Actual Problem
• The Reframing Canvas (pdf)

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How to Solve Difficult Problems (25 Lenses)

"To find better solutions, you need to first ask better questions. The questions you ask determine which solutions you'll see and which will remain hidden. The Invisible Solutions book by Stephen M. Shapiro contains the formulas to reframe any problem in multiple ways, using 25 lenses to help you gain different perspectives." - Amazon.com

Reduce Abstraction

Use Reduce Abstraction Lenses when questions are overly broad.

• 1 - Leverage: 
• What is the one factor that will have the greatest impact? 
• What gives us the greatest leverage in solving this challenge?
• 2 - Deconstruct: 
• What are the parts or components of this? 
• What are the steps of the process? 
• What are the different segments?
• 3. Reduce: 
• How might lowering our goals and expectations give us a better result or create new opportunities for growth? 
• How can simplification increase usability and accessibility?
• 4. Eliminate: 
• How can this be eliminated? 
• Instead of adding features, what features can you remove?
• 5. Hyponym: 
• Is there a more specific instance of a word that can replace the one originally chosen?

Increase Abstraction

When questions are overly specific, use the Increase Abstraction lenses.

• 6. Analogy: 
• What is this like? 
• Who else has solved a problem like this?
• 7. Result: 
• What does this make possible? 
• What is the desired outcome?
• 8. Concern Reframe: 
• How can we take a progress-blocking statement and convert it into a question that starts with "How can we...?"
• 9. Stretch: 
• Are our challenge criteria stretched enough?
• Are we shooting for a high enough goal?
• 10. Hypernym: 
• How can we replace a word in the challenge statement with a less specific instance of the one originally chosen?

Change Perspective

Zero-In and the Change Perspective lenses should always be considered.

• 11. Resequence: 
• How can we delay a decision until later in the process when we have more or better information? 
• How can we make a decision earlier in the process, before we have all the necessary information? 
• How can we perform multiple tasks in parallel?
• 12. Reassign: 
• Who else could perform this task? 
• How can we generalize the question so that it does not imply anyone in particular? 
• How else might this task be accomplished (e.g. via automation)?
• 13. Access: 
• How can we change ownership words to "access" words, such as rent, subscribe, lease, or use?
• 14. Emotion: 
• How can we shift from corrective words such as "improve," "fix," or "reduce," to a more aspirational goal? 
• How can we reframe the challenge in a way that stimulates solvers from an emotional perspective?
• 15. Substitute: 
• How can we swap out one or more words in the problem statement for different terms?

Switch Elements

The Switch Elements lenses are useful when there are multiple parameters associated with a problem

• 16. Flip: 
• How can we turn the problem upside down by improving a different factor?
• 17. Conflicts: 
• How can we design the challenge to allow for and embrace conflicting attributes?
• 18. Performance Paradox: 
• What can we focus on other than the outcome?
• 19. Pain vs Gain: 
• What is the pain we need to solve? 
• What might be lost if we don’t solve this problem?
• 20. Bad Idea: 
• How can we turn a bad idea into a good one? 
• What will give you what you don’t want—and then do the opposite?

Zero-In

Zero-In and the Change Perspective lenses should always be considered.

• 21. Real Problem: 
• Do we really know the underlying problem we want to solve? 
• Are we solving the root cause of the problem?
• 22. Real Business: 
• What business are we really in? 
• Who are our real competitors? 
• What new technology can make us irrelevant?
• 23. Insights: 
• What data would help reframe the question or provide insights into better solutions?
• 24. Variations: 
• If your question implies that all customers/situations are treated the same, ask, "How can we address exceptions or rare cases in different ways?"
• 25. Observation: 
• Instead of asking our customers what they want, how can we observe them?

References

• Invisible Solutions Book (site)
• Invisible Solutions: 25 Lenses that Reframe and Help Solve Difficult Business Problems (Book)
• Invisible Solutions Supporting Resources (pdf)  

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