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Laboratory quality management system

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I. Contents of laboratory quality management system


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Wayne, Pennsylvania, USAAugust 2013The Clinical and Laboratory Standards


Institute (CLSI) has launched its Laboratory Quality Management System (LQMS)
Certificate Program. The LQMS Certificate Program is an online, self-paced distance
learning course that imparts the knowledge and skills necessary for successful
implementation and sustainment of a quality management system (QMS).
A QMS directs and controls an organization with regard to quality. It uses a systematic and
process-oriented approach that is essential to meet quality goals and objectives. The LQMS
Certificate Program, which was developed by content experts, provides comprehensive
coverage of a QMS within a clinical laboratory practice.
The LQMS Certificate Program is a stress-free, cost-effective method to earn P.A.C.E.
continuing education (CE) credits. It is a simple way to stay current with your QMS
knowledge without traveling or attending meetings. Social media networks for program
graduates allow you to interact with leaders in the field and leverage your knowledge for
new career opportunities and advancements.
The CLSI LQMS Certificate Program is a wonderful resource for laboratories interested in
increasing their understanding of QMS, notes Lou Ann Barnett, PhD, MT(ASCP), PMP,

CCRP, Laboratory Quality Program Manager at Sutter Health Sacramento Sierra Region
Laboratories, Sacramento, California, USA. It is well organized, providing expert
information on the 12 quality system essentials (QSEs) described in many of the CLSI
guidelines related to quality. The course is both instructional and practical; it also contains
case studies that help the user understand how to apply the QSE requirements within a
laboratory project. I highly recommend this very useful learning program.
The program consists of 12 modules and each module represents one of the 12 QSEs.
Introductory and summary modules are also included for a total of 14 modules. Each online
module can be completed in one to two hours and includes a lesson, additional transcript
information, case study activities, and a quiz. To earn the LQMS certificate of completion
and 13 P.A.C.E. CE credits, participants must successfully complete all modules and pass a
comprehensive, multiple-choice examination by.
It is strongly recommended that participants purchase the LQMS Certificate Program along
with the new version of CLSIs The Key to Quality because the program references The
Key to Quality in many of its modules. Additionally, CLSI document QMS01-A4 (formerly
GP26-A4)Quality Management System: A Model for Laboratory Services; Approved
GuidelineFourth Edition is an essential document for any organizations QMS collection
and is referenced in the LQMS Certificate Program. The CLSI Shop offers bundle options
for these products at a discounted rate and member discounts also apply.

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III. Quality management tools

1. Check sheet
The check sheet is a form (document) used to collect data
in real time at the location where the data is generated.
The data it captures can be quantitative or qualitative.
When the information is quantitative, the check sheet is
sometimes called a tally sheet.
The defining characteristic of a check sheet is that data
are recorded by making marks ("checks") on it. A typical
check sheet is divided into regions, and marks made in
different regions have different significance. Data are

read by observing the location and number of marks on


the sheet.
Check sheets typically employ a heading that answers the
Five Ws:

Who filled out the check sheet


What was collected (what each check represents,
an identifying batch or lot number)
Where the collection took place (facility, room,
apparatus)
When the collection took place (hour, shift, day of
the week)
Why the data were collected

2. Control chart
Control charts, also known as Shewhart charts
(after Walter A. Shewhart) or process-behavior
charts, in statistical process control are tools used
to determine if a manufacturing or business
process is in a state of statistical control.
If analysis of the control chart indicates that the
process is currently under control (i.e., is stable,
with variation only coming from sources common
to the process), then no corrections or changes to
process control parameters are needed or desired.
In addition, data from the process can be used to
predict the future performance of the process. If
the chart indicates that the monitored process is
not in control, analysis of the chart can help
determine the sources of variation, as this will
result in degraded process performance.[1] A
process that is stable but operating outside of
desired (specification) limits (e.g., scrap rates
may be in statistical control but above desired
limits) needs to be improved through a deliberate

effort to understand the causes of current


performance and fundamentally improve the
process.
The control chart is one of the seven basic tools of
quality control.[3] Typically control charts are
used for time-series data, though they can be used
for data that have logical comparability (i.e. you
want to compare samples that were taken all at
the same time, or the performance of different
individuals), however the type of chart used to do
this requires consideration.

3. Pareto chart
A Pareto chart, named after Vilfredo Pareto, is a type
of chart that contains both bars and a line graph, where
individual values are represented in descending order
by bars, and the cumulative total is represented by the
line.
The left vertical axis is the frequency of occurrence,
but it can alternatively represent cost or another
important unit of measure. The right vertical axis is
the cumulative percentage of the total number of
occurrences, total cost, or total of the particular unit of
measure. Because the reasons are in decreasing order,
the cumulative function is a concave function. To take
the example above, in order to lower the amount of
late arrivals by 78%, it is sufficient to solve the first
three issues.
The purpose of the Pareto chart is to highlight the
most important among a (typically large) set of
factors. In quality control, it often represents the most
common sources of defects, the highest occurring type
of defect, or the most frequent reasons for customer
complaints, and so on. Wilkinson (2006) devised an

algorithm for producing statistically based acceptance


limits (similar to confidence intervals) for each bar in
the Pareto chart.

4. Scatter plot Method


A scatter plot, scatterplot, or scattergraph is a type of
mathematical diagram using Cartesian coordinates to
display values for two variables for a set of data.
The data is displayed as a collection of points, each
having the value of one variable determining the position
on the horizontal axis and the value of the other variable
determining the position on the vertical axis.[2] This kind
of plot is also called a scatter chart, scattergram, scatter
diagram,[3] or scatter graph.
A scatter plot is used when a variable exists that is under
the control of the experimenter. If a parameter exists that
is systematically incremented and/or decremented by the
other, it is called the control parameter or independent
variable and is customarily plotted along the horizontal
axis. The measured or dependent variable is customarily
plotted along the vertical axis. If no dependent variable
exists, either type of variable can be plotted on either axis
and a scatter plot will illustrate only the degree of
correlation (not causation) between two variables.
A scatter plot can suggest various kinds of correlations
between variables with a certain confidence interval. For
example, weight and height, weight would be on x axis
and height would be on the y axis. Correlations may be
positive (rising), negative (falling), or null (uncorrelated).
If the pattern of dots slopes from lower left to upper right,
it suggests a positive correlation between the variables
being studied. If the pattern of dots slopes from upper left
to lower right, it suggests a negative correlation. A line of

best fit (alternatively called 'trendline') can be drawn in


order to study the correlation between the variables. An
equation for the correlation between the variables can be
determined by established best-fit procedures. For a linear
correlation, the best-fit procedure is known as linear
regression and is guaranteed to generate a correct solution
in a finite time. No universal best-fit procedure is
guaranteed to generate a correct solution for arbitrary
relationships. A scatter plot is also very useful when we
wish to see how two comparable data sets agree with each
other. In this case, an identity line, i.e., a y=x line, or an
1:1 line, is often drawn as a reference. The more the two
data sets agree, the more the scatters tend to concentrate in
the vicinity of the identity line; if the two data sets are
numerically identical, the scatters fall on the identity line
exactly.

5.Ishikawa diagram
Ishikawa diagrams (also called fishbone diagrams,
herringbone diagrams, cause-and-effect diagrams, or
Fishikawa) are causal diagrams created by Kaoru
Ishikawa (1968) that show the causes of a specific event.
[1][2] Common uses of the Ishikawa diagram are product
design and quality defect prevention, to identify potential
factors causing an overall effect. Each cause or reason for
imperfection is a source of variation. Causes are usually
grouped into major categories to identify these sources of
variation. The categories typically include
People: Anyone involved with the process
Methods: How the process is performed and the
specific requirements for doing it, such as policies,
procedures, rules, regulations and laws
Machines: Any equipment, computers, tools, etc.
required to accomplish the job
Materials: Raw materials, parts, pens, paper, etc.

used to produce the final product


Measurements: Data generated from the process
that are used to evaluate its quality
Environment: The conditions, such as location,
time, temperature, and culture in which the process
operates

6. Histogram method
A histogram is a graphical representation of the
distribution of data. It is an estimate of the probability
distribution of a continuous variable (quantitative
variable) and was first introduced by Karl Pearson.[1] To
construct a histogram, the first step is to "bin" the range of
values -- that is, divide the entire range of values into a
series of small intervals -- and then count how many
values fall into each interval. A rectangle is drawn with
height proportional to the count and width equal to the bin
size, so that rectangles abut each other. A histogram may
also be normalized displaying relative frequencies. It then
shows the proportion of cases that fall into each of several
categories, with the sum of the heights equaling 1. The
bins are usually specified as consecutive, non-overlapping
intervals of a variable. The bins (intervals) must be
adjacent, and usually equal size.[2] The rectangles of a
histogram are drawn so that they touch each other to
indicate that the original variable is continuous.[3]

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