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I. Contents of free quality management system software

==================
To be competitive globally, manufacturers must be able to produce high quality products quickly
and at the lowest possible cost. And in industries that are required to adhere to regulatory
standards such as those imposed by agencies such as the FDA or ISO, quality management
reaches an entirely new level of intricacy. The electronic quality management software systems
offered by MasterControl allow companies to eliminate paper-based quality processes and
drastically increase manufacturing efficiency while improving their ability to maintain
compliance with regulatory standards.
Quality Management Software Systems Are Key
A quality management software system that is automated and connects all departments is
essential for a regulated or ISO-compliant company. A QMS or a TQM (total quality
management) system can connect each phase in a product's development lifecycle with every
department in a company. This gives everyone an opportunity to provide feedback. Automated
routing, with escalation, ensures the rapid responses to inputs needed from other departments. By
building quality into products as opposed to forcing QA to bear the burden of the responsibility,
everyone (engineering, regulatory, QA, manufacturing, sales and marketing) wins.
How Can MasterControl's Quality Management Software System Benefit You?
With more than a decade of experience automating quality management processes in ISO
manufacturing and rigorous regulated environments like the FDA, MasterControl has developed

an integrated quality management software system that combines industry best practices with the
flexibility to meet every customer's unique needs.
The MasterControl's quality management software system consists of configurable, easy-to-use,
and connected applications for automating, streamlining, and effectively managing document
control, change control, training control, audits, corrective/preventive action (CAPA), customer
complaints, and other documents- and forms-based quality and business processes under a single
Web-based platform. Hundreds of companies worldwide rely on MasterControl to facilitate
compliance with FDA regulations (e.g., 21 CFR Parts 11, 210-211, 820, 606), and ISO quality
standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS16949).
The MasterControl quality management software system consists of the following integrated
applications:
Document Control
MasterControl Documents helps increase the quality unit's efficiency and effectiveness by
automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and
approval of all documents-based processes. It provides a single repository for all documentation,
making search and retrieval easy. MasterControl Documents, the core application in the
MasterControl quality management suite, integrates all quality processes such as change control,
customer complaints, corrective/preventive action, audits, etc., for a closed-loop solution.
Corrective and Preventive Action System
The MasterControl CAPA system interconnects different quality subsystems and tracks
incidents that can escalate into a corrective action. It includes a best-practice "8D" process to
guide the quality team through every step of CAPA implementation, from identification of the
problem through corrective action. A CAPA form can be launched directly from another form
(e.g., nonconformance or deviation report), automatically entering relevant data into the CAPA
form, reducing data entry and eliminating errors from manual transfer of information. Through
the Internet, customers, vendors, and others outside the company can submit customer complaint
or other forms that could lead to CAPA.
Change Control
MasterControl Change Control streamlines the entire change control procedure for faster
turnaround. It offers a best-practice form that incorporates priority level and prompts risk
assessment and classification of the change as low, medium, or high. Any high-level change
implies great impact on the product and is likely to require regulatory filing. Customizable
reports provide real-time status not only of change control tasks but of the entire quality system.
Training Management

MasterControl Training automates assignment and monitoring of training tasks and grading of
online exams. It allows sequencing of training courses, so after a prerequisite course is
completed, the next one is automatically launched. Provides group sign-off feature for verifying
training of large groups of employees. Training management can be integrated with the rest of
the quality system, so any change to a document or process that warrants new training will
automatically invoke training tasks upon approval of the change.
Nonconformance Automation Software
MasterControl Nonconformance is a robust quality management software system designed to
automate, manage, and streamline the process for identifying, evaluating, reviewing, and
handling of nonconforming materials, components, parts, and finished products. The solution's
best-practice form and five-step process connect all responsible personnel for effective and
timely disposition of a nonconformance. This solution offers the choice of maintaining a standalone nonconformance process for small-scale, localized incidents, or you may connect it to the
CAPA process for automatic escalation when the situation warrants. Training will automatically
invoke training tasks upon approval of the change.
Quality Audit Management
MasterControl Audit automates, streamlines, and effectively manages the audit process. It
provides advanced tracking capability, from scheduling and planning to execution and
completion. MasterControl offers best-practice forms for tracking basic audit information and
audit findings. It automates scheduling of all recurring audit-related activities and provides
advanced analytics and reporting capability, so managers get a real-time view of the audit
process.
Customer Complaints Software
MasterControl Customer Complaints streamlines the complaint-handling process and reduces
the lifecycle from submission to resolution. A simple, three-step process is incorporated in a preconfigured, multi-page form that starts with the processing of a customer complaint,
automatically moving to internal investigation, and culminating with a resolution of the issue.
MasterControl's advanced reporting capabilities increase management oversight and demonstrate
appropriate controls to regulatory agencies. MasterControl is Web-based, so customers can
submit complaints from virtually anywhere.
Forms-Based Processes Automation
The MasterControl Process quality management software system automates routing,
notification, escalation, and approval of any forms-based process for faster turnaround. This
solution offers best-practice features that prompt users with selected data to reduce data entry
and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or

PowerPoint can be converted to PDF as is, so users will see the same form and won't need new
training. A company may also improve existing forms or design new ones to suit its needs.
Electronic Submissions
MasterControl Submissions Gateway facilitates electronic delivery of FDA applications (such
as IND, NDA, and BLA) by providing control in assembling and tracking necessary
documentation. It provides appropriate templates to streamline the dossier-creation process.
MasterControl can be integrated with leading e-submission applications, connecting approved
documents and forms-based content with the dossier assembly process, to accelerate
submissions.
==================

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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