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(FMEA)
FMEA is a quality audit procedure which aims to anticipate failures in a products functional design. Failure may be the result of a design, manufacturing process, or use or the malfunctions of a product or service.
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FMEA
The aim of FMEA is to anticipate in advance: What might fail What effect this failure would have on the overall function, & What might cause the failure
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FMEA
Concept FMEA
Design FMEA
Process FMEA
Design FMEAs should cover: all new components carried over components in a new environment any modified components Mandatory on all control and load carrying parts
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Failure - a component or system not meeting or not functioning to the design intent Design intent - may be stated in terms of MTBF, load or deflection, coat thickness, finish quality, etc. Failure need not be readily detectable by a customer
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FMEA Process
Identify a failure mode Determine the possible effects or consequences of the failure Assess the potential severity of the effect Identify the cause of failure (to take action!) Estimate the probability of occurrence Assess the likelihood of detecting the failure
Failure Mode
Failure mode - the manner in which a component or a system, where the failure occurs (doesnt meet design intent) Potential failure modes Complete failure Partial failure Intermittent failure Failure over time Over-performance failure
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Failure Mode
Examples: Consider failure modes of a penlights function that is defined as Provide light at 3 0.5 candela.
No light Dim light Erratic blinking light Gradual dimming light Too bright
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Sketch free-body diagrams (if applicable), showing applied/reaction loads. Indicate location of failure under this condition. List conceivable potential causes of failure for each failure mode
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For each failure mode, identify the potential downstream consequences of each failure mode (the Effects) Procedure for Potential Consequences
Beginning with a failure mode (FM-1) list all its potential consequences Separate the consequences that can result when FM-1 occurs: Effects of FM-1 Write additional failure modes for remaining, depending on circumstances
Team brainstorms failure modes and effects Example: Analyzing penlight bulb
Premature burnout user could trip, fall, be injured While used in eye examination, bulb might explode, resulting in injury
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Failure Severity
To analyze risk, one must first quantify the Severity of the Effects Assume that all Effects will result if the Failure Mode occurs Most serious Effect takes precedence when evaluating risk potential Design and process changes can reduce severity ratings
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After the Effects and Severity are addressed, the Causes of Failure Modes must be identified In Design FMEA (DFMEA), design deficiencies that result in a Failure Mode are Causes of failure
Assumes manufacturing and assembly specifications are met
Process FMEA (PFMEA) has similar investigation Causes are rated in terms of Occurrence
Likelihood that a given Cause will occur AND 16 result in the Failure Mode
Estimate the probability of occurrence on a scale of 1 -10 (consider any failsafe controls intended to prevent cause of failure) Consider the following two probabilities:
probability the potential cause of failure will occur probability that once the cause of failure occurs, it will result in the indicated failure mode
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< 1 in 1,500,000
Current Controls
Detection
Detection values are associated with Current Controls Detection is a measure of Type 2 Controls to detect Causes of Failure, or ability of Type 3 Controls to detect subsequent Failure Modes High values indicate a Lack of Detection Value of 1 does not imply 100% detection
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Absolute Uncertainty
Very Remote Remote
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9 8
Very Low
Low Moderate High Very High Almost Certain
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6 5 4 3 2 1
Reducing Risk
The fundamental purpose of the FMEA is to recommend and take actions that reduce risk Adding validation or verification can reduce Detection scoring Design revision may result in lower Severity and Occurrence ratings Revised ratings should be documented with originals in Design History File
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Criticality
No physical meaning to RPN Used to bucket problems Dont spend a lot of time worrying about what a measure of 42 means Rank order according to RPN Note that two failure modes may have the same RPN for far different reasons: S=10, O=1, D=2: RPN = 20 S=1, O=5, D=4: RPN = 20
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Actions
Actions taken are the important part of FMEA Change design to reduce
Severity (redundancy?) Occurrence (change in design, or processes) Detection (improve ability to identify the problem before it becomes critical)
Assign responsibility for action Follow up and assess result with new RPN
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FMEA
Problems Based on qualitative assessment Unwieldy Hard to trace through levels Not always followed up
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FMEA Levels
CFMEA 1 (Concept)
Failures in the concept (inability to achieve performance) Detection
DFMEA 2 (Design)
Failures in current design (performance) Detection
Ability to find the failures (i.e., use of historical data, early models, etc.)
PFMEA 3 (Process)
Failures in production process Detection
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FMEA
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FMEA
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END
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