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. Quality Management, Environmental Health and Safety (EHS) and Compliance Management systems evolve, the concept of incorporating risk assessment into quality processes is becoming more and more a necessity.
Recognizing this need, EtQ has developed a stand-alone risk assessment software utility, called the Risk Register. The Risk Register allows users to configure and integrate risk-based assessment tables within all of EtQ's modules, or as an independent risk event, and serves as a central repository for all risk items and controls. From the EtQ Risk Register, 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, EHS, and Compliance Management Software system. The result is an integrated risk assessment tool that calculates the risk of quality events at every step of the process, thereby improving overall quality, and reducing recurrence of critical events.
This risk-based filtering allows companies to:
- Automatically segregate and categorize events at the source module level (Complaints, Audits, etc.)
- Automatically identify and display risk assessment for related events
- Initial risk 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 Risk Based CAPA Software action and effectiveness check plan with risk mitigation history
Using the Risk Register, 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 Register 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, EHS and FDA Compliance events.