Process
Monitors and Controls
Process Variability and
Capability
Every process varies. If
you try to bake ten cookies using the same mold, mix, and procedure,
none of them will come out of the oven identical. To a certain extent
they will all look similar, but no two of them will be exactly the same.
This inherent tendency of your cookies not to look identical is known as
your
process variability, while the ability of your baking
prowess to make your cookies stay within predictable limits of
similarity is your
process capability.
Using the same process to
bake cookies over and over again will result in many batches of cookies
that look similar, but once in a while you'll get a batch that's quite
different. One time you may get a batch of darker cookies, and another
time you may get a batch of sweeter cookies. When this happens, the
cookies are outside the normal variability of the rest of your cookies,
so they are called
'outliers.'
Something special outside of
your defined process happened that resulted in such outliers, e.g., you
probably set your oven too high or you inadvertently added more sugar.
Your process is said to have gone
out-of-control because
of
special
or
assignable causes.
Special causes
are unpredictable and should be avoided. In processes that are more
complex than baking, the occurrence of out-of-control incidents can be
very costly.
In semiconductor
manufacturing for instance, a single misprocessing incident due to an
assignable cause can mean losses in the hundreds of thousands of
dollars. This is why in this industry, it is everybody's responsibility
to keep the process in control.
This can only be done if
there's a means of observing the process for any abnormalities and to
correct the situation before the process goes out of control. Observing
how the process takes place and behaves is known as
process
monitoring, while responding to changes to keep the process
within its normal variability is known as
process control.
Process Monitoring
Thanks to the
invention of statistics, nobody has to stare at a process all the time
to know how it is behaving. It is just necessary to look at how a
process looks like at specific
intervals
and a fair assessment of how the process generally behaves may be
achieved. In fact, it is not even necessary to scrutinize all aspects of
the process at these intervals. One simply needs to check the
process aspects that matter most.
Process
monitoring consists of observing and
measuring
the critical parameters affecting a process at pre-defined, regular
intervals and recording the observations and results. The critical
parameters monitored are chosen in such a way that they collectively
represent the state of the entire process. Since monitoring costs
money, it is necessary to limit the number of parameters monitored to
the minimum required to ensure that the process is meeting the company's
quality standards.
One
way of reducing the parameters that need to be monitored is to look for
correlations between parameters. If the behavior of one parameter
can be reliably predicted from the behavior of another parameter, then
only one parameter has to be monitored. The process owner should
eliminate all redundancies in process monitoring.
<Proceed to Page 2 - Process Monitoring/Process
Control>
See Also:
SPC;
Quality Systems;
Document Control;
The ISO9000 Standard;
Metrology and Calibration
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