1. Definition quality management
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I. Contents of definition quality management
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The common quality management systems definition for the pharmaceutical industry stems from
key regulations that the FDA enforces such as 21 CFR Part 211.
Under this regulation, a quality management systems definition would necessarily cover the
concept of a quality control unit, which is responsible for overall quality management systems.
The quality control unit is primarily responsible for documentation (procedures, SOPs, policies,
etc.) and control of all documents that impact product quality and safety.
In addition to 21 CFR Part 211, the FDA guidance called “Pharmaceutical cGMPs for 21st
Century–A Risk-Based Approach” provides principles and standards that will help
pharmaceutical companies establish an organizational QMS definition. This guidance offers a
quality systems model and shows how manufacturers can comply fully with 21 CFR Part 211.
The ICH Q10, a harmonized guidance for the pharmaceutical industry, also provides a good
quality management systems definition by offering a model QMS based on ISO concepts and
principles on Good Manufacturing Practices.
Quality Management Systems: Definition for Medical Device Industry
For medical device companies, the Quality System Regulation (21 CFR 820) offers a solid basis
for a quality management systems definition. It is the primary FDA regulation for medical device
companies. In as much as it helps manufacturers create their own organizational QMS definition,
the regulation offers enough leeway for individual companies to define their priorities based on
the device they are manufacturing.

2. Most medical manufacturers also adhere to ISO 13485, which similarly provides a quality
management systems definition. The FDA has harmonized QSR with ISO standards, making
them complementary.
Both QSR and ISO 13485 require the establishment of a quality management system that
encompasses many quality processes, such as document control, training control, corrective
action and preventive action (CAPA), and audit management processes.
MasterControl’s Quality Management Systems Definition
MasterControl quality and compliance software was designed to meet the needs of life science
and other regulated companies. It is meant to facilitate compliance with GxP regulations (FDA,
MHRA, EMA, MHLW) and standards (ISO, European Union GMP). For MasterControl, a
quality management systems definition encompasses the following quality processes:
Document Control: Hundreds of regulated companies worldwide use MasterControl
Documents as the centerpiece of their quality management systems. MasterControl automates all
documents-based and forms-based processes. It also automates day-to-day tasks such as routing,
follow up, escalation, and approval of documents. It provides a centralized location for all
documents and records, making search and retrieval easy.
CAPA Management: CAPA management is essential to any QMS definition. MasterControl
CAPA automates, streamlines, and effectively manages the CAPA process. It provides best-
practice forms and workflows, including “8D” process, to guide every step of a CAPA
implementation.
Training Control: MasterControl Training automates distribution and monitoring of training
tasks and online grading of tests. This module has the capability to sequence training, so a trainee
who completes a prerequisite course will automatically get the next training. Effective training is
a necessary component of a compliant company’s quality management systems definition.
Audit Management: MasterControl Audit streamlines the audit process by automating all
recurring tasks, including scheduling of audits, sending out assignments, and tracking tasks. This
module provides best-practice forms for gathering and tracking basic information, as well as for
tracking audit findings. It provides robust tools for managing and conducting regular audits.
Risk Management: MasterControl Risk standardizes the process for collecting and managing
tasks pertaining to risk management. It automates review, approval, and execution of tasks.
MasterControl also features analytics and reporting tools for faster and effective risk analysis.
==================
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

4. 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

5. 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

6. 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

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]
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