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EtQ's
Risk Assessment Module Incorporates
Risk to the Quality System |
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FARMINGDALE,
NY (06-08-07): EtQ
has announced the release
of an integrated Risk Assessment
module, part of version
5 release of EtQ's Reliance
Quality Management System.
Risk management and risk
assessment are not new
to the quality and compliance
industry. In fact, risk
has been a prominent feature
in such standards as ISO
13485:2003, ISO 14971,
and more. As Quality Systems
evolve, the concept of
incorporating risk into
quality processes is becoming
more and more a necessity.
Recognizing this need,
EtQ has developed a stand-alone
module that allows users
to configure and integrate
risk-based assessment
tables within all of EtQ's
modules, or as an independent
risk event. From the EtQ
Risk Assessment module,
users can create risk
assessment templates,
with tables and charts
to identify severity,
frequency, or other risk-based
criteria. These templates
can be used for an independent
risk assessment event,
and can be linked to modules
within the EtQ Quality
Management System. The
result is an integrated
risk tool that calculates
the risk of quality events
at every step of the process,
thereby improving overall
quality, and reducing
recurrence of critical
events.
As an example, EtQ is able
to use the Risk Assessment
module with Corrective Action
and Preventive Action (CAPA)
to minimize the number of
CAPAs that enter a Quality
System.
This risk-based
filtering allows companies
to:
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Automatically
segregate and categorize
events at the source
module level (Complaints,
Audits, etc.) |
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Automatically identify
and display related
events |
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Initial assessment
to allow early closure
of non-critical events |
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Risk assessment
is calculated throughout
the process to guide
decision-making |
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Full investigation
with step-by-step
root cause analysis
to ensure overall
impact of events |
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Automatic lookup
and display of related
investigations and
CAPAs |
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Comprehensive CAPA
action and effectiveness
check plan with risk
mitigation history |
Using the Risk Assessment
module, companies can reduce
the number of CAPAs by filtering
out non-critical events
and investigating only those
events that have a critical
impact on the enterprise.
Each risk assessment event
incorporates risk mitigation
tracking, to ensure that
corrective and preventive
actions reduce the risk
to appropriate levels.
The Risk Assessment Module
furthers the concept of
continuous improvement
by allowing companies
to build risk portfolios
for individual products.
This allows the enterprise
to leverage previous risk
assessments, all the way
back to product design,
to quickly identify the
appropriate risk level
and resolution for quality
and compliance events.
EtQ's Risk Assessment
Module is just one of
over 20 integrated modules
available in the EtQ Quality
Management System, designed
to manage and measure
quality and compliance
processes and execute
organizational change.
About
EtQ, Inc.
EtQ is the leading Enterprise
Quality and Compliance Management
Software for identifying,
mitigating and preventing
high-risk events through
integration, automation
and collaboration. EtQ uses
best in class, integrated
modules and enterprise application
integration to manage and
measure quality and compliance
processes and execute organizational
change. Key modules within
the product include: Document
Control, CAPA (Corrective
and Preventive Action),
Audits, Complaint Handling,
Risk Management, Change
Management, Employee Training,
Nonconforming Materials,
Enterprise Reporting and
more than 20 additional
compliance-oriented modules.
With its world class flexible
workflow, collaborative
platform EtQ has developed
a unique niche to support
enterprises involved in
various compliance management
initiatives such as; cGxP
(FDA), ISO 13485, ISO 9000:2000,
ISO/TS 16949, ISO 14001,
AS 9001, TL 9000, OHSAS
18001, RoHS and similar
standards for compliance
and regulatory management.
EtQ has been providing compliance
solutions to a variety of
markets for over fifteen
years.
Contact: Tim Lozier
EtQ, Inc.
800.354.4476 ext. 19
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EtQ
is a registered trademark
of EtQ Management Consultants,
Inc. All other product,
company or organization
names are trademarks or
registered trademarks
of their respective owners.
This release is intended
for informational purposes
only. |
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