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In this file, you can ref useful information about components of a quality management system
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Other useful material for components of a 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
The QMS solution should give your organization the ability to accelerate and automate
essential quality processes like CAPA, customer complaints, deviations, out-ofspecifications, change control, audits, non-conformance, and so forth.
The technology should provide the ability to automate documentation processes such as
document change, distribution, notification, and approval in order to accelerate
compliance and minimize the time it takes for products to get to market.
A system that is ready right out of the box is valuable, but it should also customizable
enough to fit your individual organizational needs.
A good quality management system must ensure that the integrity of regulatory
documentation and standard operating procedures (SOPs) can be maintained throughout a
documents lifecycle.
The QMS software should also offer the capability to route documents electronically
along pre-defined workflows for more efficient distribution, collaboration, and approvals.
Most companies doing business in regulatory environments require the following components of
quality management systems:
Accelerates compliance
Must facilitate compliance with stringent regulatory requirements such as 21 CFR Part 11
Supports standard databases used in life sciences and similarly regulated environments
Offers the capability to track forms by status or history (as in process, complete, etc.)
Maintains active links so users can review a completed process to see what event caused
or merged with another event
Integrates with existing document repositories and enterprise applications such as ERP,
LIMS, etc., without custom coding
Integrates forms with training control (i.e., any change to a document or process that calls
for new training should automatically trigger training tasks)
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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