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FAILURE MODE AND EFFECTS ANALYSIS (FMEA), XXX, Fadhila Abidah …
FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
Definition:
Step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service
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 quality function deployment (QFD)
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
General procedure of FMEA
Assemble a cross-functional team of people with diverse knowledge about the process, product or service, and customer needs
e.g. Design, manufacturing, quality, sales, marketing, and cust service
Identify the scope of the FMEA: for concept, system, design, process, service? Use flowcharts so every team member understands
Fill in the identifying information at the top of FMEA form
Identify the functions of the scope. Name it with a verb followed by a noun
For each function, identify all the ways failure could happen. These are potential failure modes
For each failure mode, identify all the consequences. These are potential effects of failure
Determine how serious each effect is. This is the severity rating, or S. Scale from 1-10. If a failure mode has more than one effect, write only the highest severity rating for that failure mode
For each failure mode, determine all the potential root causes. List all possible causes for each failure mode on the FMEA form
For each cause, determine the occurrence rating, or O: probability of failure occurring. Scale from 1-10, 1 is extremely unlikely and 10 is inevitable
For each cause, identify current process 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. Scale 1-10, 1 the control is absolutely certain to detect the problem & 10 means the control is certain not to detect the problem (or no control exists)
Calculate the risk priority number, or RPN = S × O × D. Also calculate Criticality = S × O. Provide guidance for ranking potential failures in the order they should be addressed
Identify recommended actions. Note who is responsible for the actions and target completion dates
As actions are completed, note results and the date on the FMEA form. Also, note new S, O, or D ratings and new RPNs
FMEA Limitatitons
Issues beyond team members’ knowledge aren’t likely to be detected or resolved
If the team forgets to list failure modes, they’ll be ignored
FMEA prioritizes failure modes according to their risk. This won’t eliminate the failure modes and may well require other actions outside of the FMEA
The team walks a fine-line between taking on too large of a scope and taking on one that’s too small
Organizations may be susceptible to not recognizing that FMEA is not a static model. For successful risk management, the FMEA should be regularly updated
XXX
Fadhila Abidah
09111840000092
Manajemen Risiko dan Tata Kelola (B)