Back To Original Page: Quality System Requirements 9001 9000
Back To Original Page: Quality System Requirements 9001 9000
QS-9000 is the name for the Quality System Requirements used to increase
customer confidence in the quality of its suppliers.
The idea of QS-9000 is quite similar to ISO-9000, International Quality System
Standard, but QS-9000 applies particularly to the automotive industry for Chrysler
Corporation, Ford Motor Company, General Motors Corporation, and truck
manufacturers. QS-9000 is made up of three sections: an ISO-9000 based
requirement, a sector-specific requirement, and a customer-specific requirement.
These requirements guarantee a supplier procures a good quality product.
Furthermore, by developing QS-9000, we will be able to improve our product,
customer satisfaction, and supplier relations as well.
Standards for ISO-9001 and QS-9000
____________________________________________________________________
ISO
QS
Quality System Requirements
9001 9000
-------------------------------------------------------------------Management Responsibility
X
X
Quality System
X
X
Contract Review
X
X
Design Control
X
X
Document and Data Control
X
X
Purchasing
X
X
Control of Customer-Supplied Product
X
X
Product Identification and Tractability
X
X
Process Control
X
X
Inspection and Testing
X
X
Control of Inspection, Measuring, and Test Equipment
X
X
Inspection and Test Status
X
X
Control of Non-Conforming Product
X
X
Corrective and Preventive Action
X
X
Handling, Storage, Packaging, Preservation and Delivery
X
X
Control of Quality Audits
X
X
Training
X
X
Servicing
X
X
Statistical Techniques
X
X
-------------------------------------------------------------------Production Parts Approval Process
X
Continuous Improvement
X
Manufacturing Capability
X
-------------------------------------------------------------------Customer-Specific Requirement
X
____________________________________________________________________
Quality
Quality means a totality of characteristics of an entity that bear on its ability to satisfy
stated and implied needs. In some references, Quality is referred to as "fitness for
use", "fitness for purpose", "customer satisfaction", or "conformance to the
requirements."
To achieve satisfactory quality we must concern all stages of the product or service
cycle. In the first stage quality is due to a definition of needs. In the second stage it is
due to product design and conformance. In the last stage quality is due to product
support throughout its lifetime.
There are two major aspects of quality: quality of design and quality of
conformance. Quality of design involves the variations of a product or services in
grades or levels of quality. This includes the types of materials used in construction,
tolerance in manufacturing, reliability, etc. Quality of conformance concerns how
well the product conforms to the specifications and tolerances required by the design.
Quality of conformance is influenced by the choices of manufacturing processes,
training and supervision of the workforce, the type of quality-assurance system used,
and the motivation of the workforce to achieve quality.
Back to Original Page
SMED, often called "Quick Changeover", is an process that can help us to reduce
downtime due to set-ups and changeovers. Quick Changeover means we reduce time
to set up a machine or process. We use SMED as a guideline to eliminate our waste
changeover time in our production process, especially while changing a machine from
one product to another.
There are six major steps that we should be concerned with :
1. Ensure that everything needed for setup is already organized and on hand to
save time finding something in the process setup.
2. It is good to move your arms but not your legs to avoid spending too much time
during adjustment or set-ups.
3. Do not remove bolts completely to save time during removing bolts and setting
up the process.
4. Regard bolts as enemies; do what ever you can to get rid of them to save time
by using some equipment that is better than bolts when changing the process.
5. Do not allow any deviation from die and jig standards to save time by using the
same standards. For example, use the same size of nut and bolts for each die
and jig.
6. Adjustment is waste to make the jig or figure simple to setup and avoid wasting
time to adjust the positions.
Back to Original Page
SPC can be broken into two components: process control and acceptance sampling.
In process control, SPC involves these seven tools: Histogram, Check Sheet, Parato
Chart, Cause and Effect Diagram, Defect Concentration Diagram, Scatter Diagram,
and Control Chart These tools often called "The Seven QC tools." Most of the tools
help us to identify a problem in the process. Acceptance sampling is used to reduce
variation in the process by using statistical sampling techniques to select the proper
sampling size and to interpret whether our whole product should be accepted or
rejected.
Back to Original Page
Sampling
Sampling is the process of obtaining samples from a large group of data (or
called population). There are numerous data, so it is difficult or impossible to
examine the whole group. Examining all data will expend a lot of time, so doing only
a small part of entire data, a sample, is more appropriate. Additionally, sampling
theory is a study of the relationship between the whole data and the samples. It is
useful to understand whether there are differences between two samples.
All possible samples of size n can be drawn from a given population. For each
sample, we can calculate a statistic; for example, the mean and the standard
deviation of the data will vary from sample to sample. So a sampling distribution is
useful to explain the data characteristics.
There are three types of sampling processes:
1. Single sampling is composed of selecting a specifically random sample
of n items from each group of items presented, and then condemning each
group depends up on the results. For example, chose n items from each group
for inspection. We will accept the group if the number of defects is less than or
equal to d, a specific value. Otherwise, we will reject them.
2. Double sampling is composed of selecting two specifically random samples
of n1 and n2 from data. By a technique of this type, the results of selecting a first
sample (n1) are accepting the group, rejecting, or talking another sample
of n2 items. The decision making depends on the associated results.
3. Multiple sampling is a technique of sampling that is similar to the double
sampling, but there are more than two sampling items used in decision making.
Scatter Diagram
A scatter diagram is a graphical diagram to show the relationship between two data
variables. It is used to display the change of one variable when another changes. From
a scatter diagram, we can find a mathematical equation that relates to the variables. To
create a scatter diagram, these steps are followed:
Collect data. This is the most essential step.
Build a data sheet to show the information from the data.
Define the variable axis of the graph.
1. The horizontal axis (X axis) displays the variable's measurement values;
most are cause variables.
2. The vertical axis (Y axis) shows the measurement values of another
variable; most are effect variables.
Plot data on the graph.
Construct a mathematical equation.
From a scatter diagram, curves are tentatively devised for linear and non-linear
curves. With this, we can call two relationships between variables to linear and nonlinear relationships.
Back to Original Page
Self Inspection
Self inspection is a technique of inspection in which workers check their own work.
Self inspection provides the most immediate feedback. With this technique, the
worker may accept products that ought to be rejected. Furthermore, the worker may
not notice all the errors.
On the other hand, if the errors in decision and careless mistakes are eliminated, self
inspection would be the efficient technique. However, it could be improved by
developing tools or using devices that could automatically detect defects or mistakes.
Providing new knowledge of quality processes to workers is an efficient method to
improve the self inspection technique.
Generally, the results from inspections are reported in terms of the total percentage of
defects. With this method, inspectors will check the final products. They may find
some mistakes or product errors, but they will not know the actual error source. As
mentioned, self inspection is a method to solve this problem.
Back to Original Page
Sensory Inspection
Inspections involve distinguishing acceptable from unacceptable goods and
comparing them with a standard. Sensory inspection is a kind of inspection, conducted
by the human senses, such as inspections of paint saturation or judgments of plating
adequacy. They are different from physical inspection, which involves the use of
devices, like calipers, micrometers or gauges, to measure.
For inspection of this kind, it is difficult to set criteria because it depends on the
physical condition of human workers, the period of work, and the skills acquired from
experience. Naturally, different people have different senses and even the same person
may make different judgments at different times. It is laborious to judge an object
with a complex form or a not-well-defined shape.
7QC Tools
Seven QC tools are fundamental instruments to improve the quality of the product.
They are used to analyze the production process, identify the major problems, control
fluctuations of product quality, and provide solutions to avoid future defects.
Statistical literacy is necessary to effectively use the seven QC tools. These tools use
statistical techniques and knowledge to accumulate data and analyze them.
Seven QC tools are utilized to organize the collected data in a way that is easy to
understand and analyze. Moreover, from using the seven QC tools, any specific
problems in a process are identified.
7QC tools always include :
Check Sheet is used to easily collect data. Decision-making and actions are
taken from the data.
Pareto Chart is used to define problems, to set their priority, to illustrate the
problems detected, and determine their frequency in the process.
Cause-and-Effect Diagram (Fishbone Diagram) is used to figure out any
possible causes of a problem. After the major causes are known, we can solve
the problem accurately.
Histogram shows a bar chart of accumulated data and provides the easiest way
to evaluate the distribution of data.
Scatter Diagram is a graphical tool that plots many data points and shows a
pattern of correlation between two variables.
Flow Chart shows the process step by step and can sometimes identify an
unnecessary procedure.
Control Chart provides control limits which are generally three standard
deviations above and below average, whether or not our process is in control.
Back to Original Page