October 25, 2016
Failure Mode & Effect Analysis (FMEA)
Siemens AG 2016 All rights reserved.
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Content
This session will provide a basic
understanding of the Process FMEA
quality tool.
After a brief description of the tool we
will use the tool on an example
• FMEA overview
4
• Steps in performing FMEA
7
• Do’s and Don’ts
9
• Example – practice the FMEA
11
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2016-05-17
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“If you don’t have time to do it right
you must have time to do it over.”
Anonymous
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Failure Modes & Effects Analysis (FMEA) overview
FMEA is a step-by-step approach for identifying all possible failures in a design, a manufacturing or
assembly process, or a product or service.
“Failure modes” = 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” = studying the consequences of those failures.
Failures are prioritized according to:
• how serious their consequences are,
• how frequently they occur,
• how easily they can be detected.
The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highestpriority ones.
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FMEA – an example from the service industry
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When to use FMEA
• When a process, product or service is being designed or redesigned, after quality function
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
FMEA is used during design to prevent failures.
Later it’s used for control, before and during ongoing operation of the process.
Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life
of the product or service..
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Steps in performing FMEA
1. Assemble a cross-functional team of people with diverse knowledge about
the process, product or service and customer needs. Functions often included
are: design, manufacturing, quality, testing, reliability, maintenance,
purchasing (and suppliers), sales, marketing (and customers) and customer
service.
2. Identify the scope of the FMEA. Is it for concept, system, design, process or
service? What are the boundaries? How detailed should we be?
3. Review the design/process; identify list of Process Steps (INPUT to meeting)
4. Brainstorm potential failure modes
5. For each failure mode, identify all potential effects of failure
6. Assign severity rating (S)
7. For each failure effect, identify all potential causes
8. Assign occurrence rating (O)
9. For each failure cause, identify all controls that could detect the cause
10. Assign detection rating (D)
11. Calculate Risk Priority Number (RPN) = S x O x D
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Steps in performing FMEA
12. Develop action plan * : tasks to improve the current controls or reduce O. To
reduce S a redesign of product or service may be required.
13. Take action: this is the step where many FMEAs fall apart due to lack of
management support, conflicting priorities, lack of resources and lack of team
leadership. The actions have to be implemented and results should be
validated.
14. Recalculate the RPN: bring the team back and recalculate RPN. Use
objective evidence.
15. Periodically review and update
* Once the initial RPN scores are tabulated, the team may decide on a cutoff
score (if not standardized in the organization). Not too low (spend
time/resources on too many risks) nor too high (not address important risks).
Suggest cutoff = 250
The whole meeting should last no more than 4 hours.
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Do’s
•
•
•
•
•
•
Provide FMEA training to involved team
Always use the approach
Ask for SME if required
Talk to your customer about how they intend to use the product/service
Brainstorm all possible failure modes if they can happen occasionally
When two risks have the same overall score, the risk with the higher Severity
rating is escalated
• Complete the action and reassess the risk as a team
• Update the FMEA with new learned risks.
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Don’ts
• Don’t fight over ratings of small difference. Analyze the impact thoroughly if the
team is divided by two or three rating points (e.g. 4 and 7)
• Don’t get hung up on a number game; the objective is t create a reduced-risk
product and/or service
• Don’t perform FMEA to comply with procedures or standards. FMEA is a
business risk management tool. It has to be used with commitment to make it
work.
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Example – practice the FMEA
Case study: self-checkout product
What to do:
• Fill in the FMEA template
• Don’t overthink it; the purpose is to learn the tool
• Complete a few lines; pretend you implemented
the recommended actions and recalculate RPN
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Contact
Stefano Paoli
Cell: (506) 292-6482
E-mail: [email protected]
siemens.ca/answers
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