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Validation
Design FMEA
Packaging Standards
DFMA
Design Verification
Measurement Systems
Evaluation
Preliminary Process
Capability Study
Design Reviews
Prototype Build
Characteristics Matrix
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Engineering Drawings
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for detecting and preventing the failure mode (DET). Thus, RPN = SEV x PF x
DET. The SEV, PF, and DET are also documented in the FMEA Table.
The FMEA Table is a living document, constantly changing from the time of its
first release when the product or process is still being designed until its archiving
after the product or process has been obsoleted.
Critical times or events that require an update to the FMEA Table include the
following:
1) when a new product or process is being designed or introduced;
2) when a critical change in the operating conditions of the product or process
occurs;
3) when the product or process itself undergoes a change;
4) when a new regulation that affects the product or process is instituted;
5) when customer complaints about the product or process are received; and
6) when an error in the FMEA Table is discovered or new information that affects
its contents come to light.
.
Table 1. Example of a Simplified FMEA Table
FMEA Methodology?
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A primary tool used for SPC is the control chart, a graphical representation of
certain descriptive statistics for specific quantitative measurements of the
manufacturing process. These descriptive statistics are displayed in the control
chart in comparison to their "in-control" sampling distributions. The comparison
detects any unusual variation in the manufacturing process, which could indicate
a problem with the process. Several different descriptive statistics can be used
in control charts and there are several different types of control charts that can
test for different causes, such as how quickly major vs. minor shifts in process
means are detected. Control charts are also used with product measurements to
analyze process capability and for continuous process improvement efforts.
Typical charts and analyses used to monitor and improve manufacturing process
consistency and capability (produced with Minitab statistical software).
Benefits:
Capabilities:
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3. For variable data measurement systems, analysis of the results from the
study using statistics (Minitab is commonly used to carry out gauge R&R
calculations) is carried out and shows how much variation comes from
differences in the operators, techniques, or the parts themselves. The
gauge R&R makes up part of the study variation, and is made up from
variation due to measuring equipment (repeatability) and variation due to
operators (reproducibility). Typically, the variation due to gauge R&R
should account for less than 30% of the study variation for a variable
study, and should demonstrate adequate discrimination with the number of
distinct categories (NDC) typically greater than 5.
4. Attribute studies are carried out out in a different way, and again it is
common to use statistical software to analyse the results. The attribute
study is looking for agreement between operators and commonly against
a known standard. Typically, agreement should be greater than 95% for
an acceptable attribute based measurement system.
5. Measurement Systems Analysis is a huge subject and the Automotive
Industry Action Group (AIAG) has devoted an inordinate amount of time to
the production of a Measurement Systems Analysis manual for guidelines
on techniques to be used in the validation of measurement systems for
use in production processes.
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SPC Charts
SPC charts are essentially a sophisticated form of Time Series plot that enable
the stability of the process, and the type of variation involved, to be understood.
Dimension
Time
Changes in process variation
A change in process
variation: The plot shows a
clear increase in the amount
of variation in the process.
Again, this is a very marked
change, but SPC charts can
detect much smaller changes
in variation which wouldnt
normally be obvious
Dimension
Time
Dimension
Time
Control Limits:
These are limits that are calculated using a statistical measure of variation, either
the standard deviation () or the range (R). They represent the limits of the
process, such that all process data should fall within these bounds.
Control Limits
The Tests:
A process is out of control if:
o Any point is outside the control lines
o There is a run of 7 points above or below the mean line
o There is a run of 7 points going in the same direction
Time
As each result occurs it is plotted on the SPC chart and assessed using the tests
above to detect any change in the process. This gives real time information to the
operator of the process who may make adjustments based on data rather than
opinion or gut feel.
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FMEA Methodology
Fundamental to a Process FMEA is the production of a process map that charts
the constituent discrete steps or parts of the relevant process.
In the case of a Design FMEA the Bill of Material is used (BOM)
For each discrete step identified above, an analysis is made of all conceivable
failure modes.
For each failure mode the Root Cause(s) are then identified.
This is undertaken in close association with the Process or Design Owner
(Brainstorming and the 5Ys techniques are usually applied.)
For each Root Cause an assessment is then made of the risks involved in terms
of:
a. Its Occurrence
b. Its Severity
c. Its Detection
d. Its Extent (environmental only)
Each risk element is then ranked using the relevant tables to a ranking number
between 1 and 10.
(1 meaning Virtually Zero Risk, 10 meaning Extreme High Risk)
Each of these Rankings are then multiplied together to give an overall risk rating.
This composite rating is called the Risk Priority Number or RPN.
The RPNs can then be prioritised (highest first) so as to ascertain the most
significant areas for corrective action.
By closely reviewing the individual RPN factors strong guidance is naturally given
as to the actions necessary to reduce the overall RPN.
The conclusions from this exercise (there may be more than one corrective
action possible) are then assessed as to outcome on the overall RPN from which
an actionable corrective action can be taken.
The process can then be repeated for the next highest RPN and so on.
Equally once a FMEA has been produced, investigations of any individual failure
mode or root cause can be individually assessed and the effect of any specific
corrective action evaluated.
SEVERITY
Rankin
g
Description
10
Highly
Hazardous
Hazardous
Very High
High
Moderate
Low
Very Low
Minor
Very Minor
None
Criteria
Failure without Warning
Product is hazardous for production personnel,
Failure affects safe product operation or noncompliance with government regulations
Failure with Warning
Product is hazardous for production personnel,
Failure affects safe product operation or noncompliance with government regulations
Major production disruption,
High rework or scrap potential,
Loss of primary function
Minor disruption to production
Probable sort and scrap procedure.
Primary function is impaired
Minor disruption to production,
A portion of the product may have to be scrapped
(no sorting)
Products primary function continues,
Secondary function is impaired
Minor disruption to production,
High rework potential,
Products primary function continues,
Secondary function is impaired
Minor disruption to production,
Sort and rework potential
Product is non-conformant,
some Customer dissatisfaction expected
Minor disruption to production,
A portion of the product may be reworked
Product is non-conformant,
some Customer dissatisfaction may occur
Minor disruption to production,
A portion of the product may be reworked
Product is non-conformant,
Customer dissatisfaction is unlikely
No Effect
RPN process = S x O x D
OCCURANCE
Rankin
g
Description
10
Very High:
Failure is
almost
inevitable
9
8
7
High:
Frequent
Failures
Moderate:
Mild level of
failure
2
1
10% Probability
(100,000 PPM)
5% Probability
(50,000 PPM)
2% Probability
(20,000 PPM)
0.2% Probability
(2,000 PPM)
0.04% Probability
(400 PPM)
4
3
20% Probability
(200,000 PPM)
1% Probability
(10,000 PPM)
6
5
Failure Rate
Low:
Isolated
Failures
Very Low:
Infrequent
Failures
Remote:
Failure is
unlikely
0.0067% Probability
(67 PPM)
0.0007% Probability
(7 PPM)
> 0.0007% Probability
(> 7 PPM)
RPN process = S x O x D
DETECTION
Rankin
g
Description
Criteria
10
NonDetectable
Very Remote
Remote
Very Low
Low
Moderate
Moderately
High
High
Very High
Highly
Detectable
RPN process = S x O x D
SEVERITY
Rankin
g
Description
Criteria
Failure without Warning
Product is unsafe for customer use,
or violates government regulations
Failure with Warning
Product is unsafe for customer use,
or violates government regulations
10
Highly
Hazardous
Hazardous
Very High
High
Moderate
Low
Very Low
Minor
Very Minor
None
No Effect
RPN design = S x O x D
OCCURANCE
Rankin
g
Description
10
Very High:
Failure is a
Continuous
Problem
9
8
7
Failure Rate
20% Probability
(200,000 PPM)
10% Probability
(100,000 PPM)
5% Probability
(50,000 PPM)
High:
Frequent
Failures
2% Probability
(20,000 PPM)
1% Probability
(10,000 PPM)
6
5
Moderate:
Sporadic
failures
0.2% Probability
(2,000 PPM)
0.04% Probability
(400 PPM)
4
3
2
1
Low:
Relatively few
Failures
Remote:
Failure is
unlikely
0.0067% Probability
(67 PPM)
0.0007% Probability
(7 PPM)
> 0.0007% Probability
(> 7 PPM)
RPN design = S x O x D
DETECTION
Rankin
g
10
Description
Criteria
NonDetectable
Very Remote
Remote
Very Low
Low
Moderate
Moderately
High
High
Very High
Highly
Detectable
RPN design = S x O x D
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