The document discusses the FDA quality management system and how MasterControl software can help companies achieve and maintain FDA compliance. It provides an overview of MasterControl's quality management system suite and how it allows companies to build customized quality management systems, ensure alignment with business operations, and facilitate adherence to FDA quality standards, cGMP, and ISO standards. The document also lists and briefly describes several quality management tools, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms.

1. Fda qualitymanagement system
In this file, you can ref useful information about fda quality management system such as fda
quality management systemforms, tools for fda quality management system, fda quality
management systemstrategies … If you need more assistant for fda quality management system,
please leave your comment at the end of file.
Other useful material for fda quality management system:
• qualitymanagement123.com/23-free-ebooks-for-quality-management
• qualitymanagement123.com/185-free-quality-management-forms
• qualitymanagement123.com/free-98-ISO-9001-templates-and-forms
• qualitymanagement123.com/top-84-quality-management-KPIs
• qualitymanagement123.com/top-18-quality-management-job-descriptions
• qualitymanagement123.com/86-quality-management-interview-questions-and-answers
I. Contents of fda quality management system
==================
MasterControl and FDA Quality Standards
FDA approval is considered to be the final word in manufacturing products designed for human
use which is why companies across the globe are incorporating quality systems that are
consistent with FDA regulations. The MasterControl quality management system suite of
applications provides companies with the essential features that help in achieving and sustaining
FDA compliance.
The main emphasis of FDA quality standards is to educate companies in inventing consistent
means or embracing proven methods for incorporating quality in products from the very start of
the product development lifecycle. An efficient quality system addresses the needs of various
stakeholders which is why MasterControl provides companies with a web-based repository that
is accessible to authorized users from virtually anywhere. The online platform serves as a
consolidated portal for collaboration on new ideas and standard practices. Users are able to
discuss and finalize plans for enforcing quality in products from the start of the development
phase.
FDA quality standards emphasize the implementation of a quality management system (QMS)
that is customizable to fit into any company's framework and methodology. MasterControl
allows companies to build a QMS that can be tailored to meet any business requirements, taking
into account several factors such as the scope of business operations, complexity of processes,
and allocation of resources. This allows companies to align their quality processes with their
business model and develop products that are FDA compliant. With quality procedures in sync

2. with the overall business operations, it is inevitable that quality management principles will
converge across different departments, sectors, branches, and regions.
Meeting FDA Quality Standards with MasterControl
The holistic approach to quality management provided by the MasterControl software solution
suite creates a seamlessly integrated quality system that allows companies to easily attain FDA
compliance. Moreover, adherence with FDA quality standards also assures that the company is
also able to comply with CGMP and ISO standards. Our software ensures that a well built
quality management system is implemented that can ultimately reduce the number of rework and
recalls for defective or out-of-specification products while also upholding the company's
reputation in the marketplace.
While heavily regulated companies rely on many employees to achieve FDA quality compliance,
it is upper management that is primarily responsible for quality and compliance breaches. To
avoid the dreaded FDA 483 statement, the MasterControl suite of applications ensures that the
quality system requirements are successfully established and maintained.
Effective internal quality standards in conjunction with a proven and reliable QMS solution help
companies avoid non-compliance to FDA quality standards that lead to irrevocable consequences
such as fines ranging in the millions of dollars or lost manufacturing licenses. To avoid such
issues, upper management needs to establish quality and compliance safeguards by following the
established quality management plan and regularly communicating with quality management
representatives. In addition, the quality team must properly review and document the quality
maintained during production. Any issues pointed out during reviews must be dealt with
immediately with solutions being reflected in an updated quality policy. MasterControl cements
and simplifies these policies and procedures through use of technology enablers that enforce
FDA quality efforts. By solidifying a company's standard quality practices with FDA quality
measures MasterControl helps companies maintain compliance in their business while getting
products to market quickly and inexpensively.
==================
III. Quality management tools
1. Check sheet

3. 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

4. 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

5. 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

6. 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

7. 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]
III. Other topics related to Fda quality management system (pdf download)
quality management systems
quality management courses
quality management tools
iso 9001 quality management system
quality management process
quality management system example
quality system management
quality management techniques
quality management standards
quality management policy
quality management strategy
quality management books