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and effective. In particular, the FDA's Quality System Regulation (21 CFR 820) for medical
devices outlines what constitutes an effective quality system. Medical device and other FDAregulated companies were among the first to utilize online quality management software as the
platform for their online QMS.
The FDA's 21 CFR 211 requires pharmaceutical companies to establish a quality control unit,
whose major responsibility is to ensure quality in all facets of the manufacturing process. A
quality management system, whether it's manual or online, is the quality control unit's
responsibility. If a pharmaceutical company decides to use online quality management software,
then the unit typically spearheads the effort to purchase the system.
ISO Standards and Online Quality Management Software
ISO 13485 for medical device manufacturers and the ISO 9000 series for general manufacturers
emphasize the importance of an effective quality management system. Online quality
management software that exists in the market today is largely based on those ISO standards, in
addition to FDA and other regulations.
ISO 13485 requires the establishment of a QMS that covers quality and remedial procedures.
Similarly the ISO 9000 series requires the establishment of a QMS, including documentation of
quality processes. Manufacturers are increasingly switching from paper-based or hybrid systems
to online QMS.
MasterControl Online Quality Management Software and Regulated Companies
MasterControl's online quality management software is widely used in life science and other
regulated industries. Its enduring appeal lies in its fundamental characteristics - it is easy to use,
configurable, and all applications are built on a common web-based platform. Users attest that
the software is easy to implement and easy to validate.
MasterControl All Access offers a single solution for managing different quality processes
critical to compliance. It covers all essential components of any effective online QMS, including
document control, training management, CAPA, change control, BOM, and audit management.
For companies that prefer to use individual modules, consider the following MasterControl
modules:
MasterControl CAPA: This module automates and streamlines the CAPA process from
start to finish. It offers industry best-practice forms that help reduce error in data entry. It
gives users the capability to launch a CAPA form from another form, such as
nonconformance or deviation.
==================
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
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
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.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.
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]