BME OM Finals 4
BME OM Finals 4
BME OM Finals 4
Quality Control
Introduction
This topic covers quality control. The purpose of quality control is to assure that
processes are performing in an acceptable manner. Companies accomplish this by
monitoring process output using statistical techniques. Quality control is a process that
measures output relative to a standard and stakes corrective action when output does
not meet standards. If the results are not acceptable, no further action is required;
unacceptable results call for corrective action.
Every process generates output that exhibits random variability. This is natural and
cannot be corrected. However, if there are nonrandom variations in process output,
that can be corrected. Quality control tools are used to decide when corrective action is
needed.
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Acceptance sampling- quality assurance that relies primarily on inspection of lots
(batches) of previously produced items.
Statistical process control- quality control efforts that occur during production
The best companies emphasize designing quality into the process, thereby greatly
reducing the need for inspection or control efforts.
INSPECTION
Inspection - is an appraisal activity that compares goods or services to a standard.
Inspection is vital but often unappreciated aspect of quality control. In lean
organizations, inspection is less of an issue than it is for other organizations because
lean organizations place extra emphasis on quality in the design of both products and
processes. Inspection can occur at 3 points: before production, during production, and
after production.
The logic of checking conformance before production is to make sure that inputs are
acceptable.
The logic of checking conformance during production is to make sure that the
conversion of inputs into outputs is proceeding in an acceptable manner.
The logic of checking conformance of output is to make a final verification of
conformance before passing goods on to customers.
Inspection before and after production often involves acceptance sampling procedures;
monitoring during the production process is referred to as process control.
Process Variability
All process generate output that exhibits some degree of variability. The issue is
whether the output variation is within acceptable range. The issue is addressed by
answering two basic questions about process variation:
1. Are the variations random? If nonrandom variations are present, the process is
considered to be unstable. Corrective action will need to be taken to improve the
process by eliminating the causes of non-randomness to achieve a stable
process.
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2. Given a stable process, is the inherent variability of process output within a
range that conforms to performance criteria? This involves assessment of a
process’s capability to meet standards. If a process is not capable, that situation
will need to be addressed.
Sampling and corrective action are only a part of the control process. Effective control
requires the following steps:
Define. The first step is to define in sufficient detail what is to be controlled. It is not
enough, for example, to simply refer to painted surface. Different characteristics may
require different approaches for control purposes.
Measure. Only those characteristics that can be counted or measured are candidates
for control. Thus, it is important to consider how measurement will be accomplished.
Compare. There must be a standard of comparison that can be used to evaluate the
measurements. This will relate to the level of quality being sought.
Evaluate. Management must establish a definition of out of control. Even a process
that is functioning as it should will not yield output that conforms exactly to a standard,
simply because of the natural variations inherent in all process, manual or mechanical, a
certain amount of variation is inevitable. The main task of quality control is to
distinguish random from non-random variability, because nonrandom variability means
that a process is out of control.
Correct. When a process is judged to be out of control, corrective action must be
taken. This involves uncovering the cause of nonrandom variability and correcting it.
Monitor results. To ensure that corrective action is effective, the output of a process
must be monitored for a sufficient period of time to verify that the problem has been
eliminated.
In sum, control is achieved by checking a portion of the goods or service, comparing
the results to a predetermined standard, evaluating departures from the standard,
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taking corrective action when necessary, and following up to endure that problems have
been corrected.
Control limits - The dividing lines between what will be designed as random deviations
from the mean of the distribution and what will be designated as non-random deviation
from the mean of the distribution.
Control charts have two limits that separate random variation and non-random
variation. The larger value is the upper control limit (UCL) and the smaller value is the
lower control limit (LCL).
Type I error - where the error is concluding that non randomness is present when only
randomness is present. It is also referred to as an alpha risk, where alpha is the some
of the probabilities in the two tails.
Type II error - Concluding that a process is in control when it is really out of control,
concluding non random variations are not present when they are.
There are 4 commonly use control chart. Two are used for variables and two are used
for attributes. Attribute data or counted, variables data are measured.
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Control charts for attributes
Control charts for attributes are used when the process characteristic is counted rather
than measured. There are two types of attribute control chart, one for the fraction of
defective items in sample (p-chart) and one for the number of defects per unit (c-
chart).
p-chart. A p-chart is used to monitor the proportion of defective items generated by a
process. The theoretical basis for a p-chart is the binomial distribution, although for
large sample sizes, the normal distribution provides a good approximation to it. A p-
chart is constructed and used in much the same way as mean chart.
c-chart- When the goal is to control the number of occurrences per unit, a c-chart is
used. The underlying sampling distribution is the Poisson distribution. Use of the
Poisson distribution assumes that defects occur over some continuous region and that
the probability of more than one defect at any particular point is negligible.
Using control charts adds to the cost and time needed to obtain output. Ideally a
process is so good that the desired level of quality could be achieved without the use of
any control charts. The best organizations strive to reach this level, but many are not
yet there, so they employ control charts at various points in their process.
Run Tests
Control charts test for points that are too extreme to be considered random. However,
even if all points are within the control limits, the data may still not reflect a random
process.
PROCESS CAPABILITY
Control limits are statistical limits that reflect the extent to which sample statistics
such as means and ranges can vary due to randomness alone.
Capability Analysis
Capability analysis is performed on a process that is in control for the purpose of
determining if the range of variation is within design specifications that would make the
output acceptable for its intended use. If it is within the specifications, the process is
said to be “capable” if it is not, the manager must decide how to correct the situation.
In other words, the process could be in control and still generate unacceptable output.
We cannot automatically assume that a process that is in control will provide desired
output. Instead, we must specifically check whether a process is capable of meeting
specifications and not simply set up a control chart to monitor it.
A process should be both in control and within specifications before production begins.
Obviously, process variability is a key factor in process capability. It is measured in
terms of the process standard deviation.
Bill Smith "The Father of Six Sigma". He introduced this quality improvement
methodology to Motorola. Six sigma is a set of the techniques and tools for process
improvement. It was developed by Motorola in 1986.
OPERATION STRATEGY
Quality is a major consideration for virtually all customers, so achieving and maintaining
quality standard is a strategic importance to all business organizations. Quality
assurance and product and service design are two vital links in the process.
Organization should continually seek to increase the capability of the processes they
use, so that they can move from a position of using inspection or extensive use of
control charts to achieve desired levels of quality to one where quality is built into
products and processes, so that little or no effort is needed to assure quality. Processes
that exhibit evidence of nonrandomness, or processes that are deemed to not be
capable, should be viewed as opportunities for continuous process improvement.
TOPIC TERMINOLOGIES
Quality Control – A process that evaluates output relative to a standard and takes
corrective action when output doesn’t meet standards.
Inspection – Appraisal of goods or services
Quality of conformance – a product or services to conforms to specifications.
Statistical process control (SPC)– Statistical evaluation of the output of a process.
Random Variation – Natural variation in the output of a process, created by countless
minor factors.
Assignable variation – In process output, a variation whose cause can be identified. A
nonrandom variation.
Sampling distribution – A theoretical distribution of sample statistics.
Cental limit theorem – The distribution of sample averages tends to be normal
regardless of the shape of the process distribution.
Control chart – A visual tool for monitoring forecast errors.
Control limits – The dividing lines between random and nonrandom variations from the
mean of the distribution.
Type I error – concluding a process is not in control when actually is.
Type II error – concluding a process is in control when it is not.
Variables – Generate data that are measured
Attribute – Generate data that are counted.
Mean control chart – control chart used to monitor the central tendency of a process.
Range control chart – Control chart used to monitor process dispersion.
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p-chart – control chart for attributes, used to monitor the proportion of defective items
in a process.
c-chart - control chart for attributes, used to monitor the number of defects per unit.
Run test – A test for pattern in a sequence.
Run – sequence of observations with a certain characteristics.
Specifications – A range of acceptable values established by engineering design or
customer requirements.
Process variability – Natural or inherent variability in a process.
Process capability – The inherent variability of process output relative to the variation
allowed by the design specification.
Process index – Used to assess the ability of a process to meet specifications.
Announcement/pointers
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