Press Release

EtQ's Risk Assessment Module Incorporates Risk to the Quality System

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:

  • Automatically segregate and categorize events at the source module level (Complaints, Audits, etc.)
  • Automatically identify and display related events
  • Initial assessment to allow early closure of non-critical events
  • Risk assessment is calculated throughout the process to guide decision-making
  • Full investigation with step-by-step root cause analysis to ensure overall impact of events
  • Automatic lookup and display of related investigations and CAPAs
  • 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

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), Audit Software, Complaint Handling, Risk Management, Change Management, Employee Training, Project Management, 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 9001:2008, ISO/TS 16949, ISO 14001, ISO 22000, AS 9001, TL 9000, OHSAS 18001, RoHS, Sarbanes-Oxley, HACCP, SQF and similar standards for compliance and regulatory management. EtQ has been providing compliance solutions to a variety of markets for over 15 years.

For more information about EtQ, please visit www.etq.com, or to schedule a virtual demo, contact EtQ Inc., at 800-354-4476 or 516-293-0949, or e-mail us at info@etq.com.

EtQ is a trademark of EtQ Management Consultants, Inc. All other product names and company names are trademarks or registered trademarks of their respective owners.

Press Contact:

Brenda Percy
bpercy@etq.com