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The solution to this problem is an integrated QMS system that combines quality, supplier,
training and document control together and acts like a portal, allowing you to funnel all quality
assurance events through one place.
Without an integrated quality management system (QMS), it's not uncommon to find
disconnected quality event management (QEM) tasks. A CAPA may be triggered by an OOS, an
NCR, audit findings, customer complaints, or a trend analysis. With manual systems, these
sources are disconnected, making data collection slow, incomplete, or worse, inaccurate. It is far
better to integrate the CAPA process throughout the entire organization.
Improving Quality in Your Organization with an Integrated QMS
With more than a decade of experience automating quality management processes in ISO
manufacturing and rigorous regulated environments like the FDA, MasterControl has developed
a fully configurable and integrated quality management software system that combines industry
best practices with the flexibility to meet every customer's unique needs. The software is
designed to help you improve quality throughout your entire organization.
MasterControl's integrated QMS 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).
Integrated QMS Resources
For more information about how implementing an integrated quality management system (QMS)
throughout your organization can improve your quality control, visit the MasterControl Resource
Center. Complimentary white papers, industry-specific literature, newsletters and other
downloads are available to help regulated companies improve their quality systems.
Contact MasterControl About Integrated Quality Management Software
Whether you want to learn more about integrated quality management systems or
MasterControl's innovative GxP solutions, the MasterControl team can answer your questions.
Call 800-825-9117 or contact MasterControl online.
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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:
2. Control chart
3. Pareto chart
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