Effective evaluation and management of risk is the most effective means a company has of gauging compliance while minimizing costs. The trick, however, is implementing a cohesive risk management program that eliminates-rather than contributes to-system-wide uncertainty. Automated risk management programs allow companies to closely monitor critical events and better measure the effectiveness of corrective actions.
The main reason organizations are making the shift to electronic solutions for their risk management systems is because they need a central hub for all risk-related activities and documentation. Software solutions that automate risk management programs can give companies a complete and accurate picture of the risk landscape across product lines, business processes, and business units while also helping companies avoid reputation damage, recalls, or regulatory action that may come from ignoring risk factors.
In situations where assessments are performed but not standardized, risk evaluations will inevitably vary from one assessor to the next. Consequently, whether or not appropriate follow-up actions are taken will be dependent on the individual assessor, which means similar issues may end up being dealt with inconsistently. Implementing a consistent risk management program throughout the enterprise can help avoid such pitfalls.
If a risk system isn't cohesive, it may as well not even exist. When a single enterprise-level risk management program is in place to monitor and manage risk management activities, it guarantees that corporate risk tolerance thresholds are employed and followed organization-wide for all actions pertaining to risk management. Comprehensive and integrated risk management gives employees from different departments a uniform and efficient means of participating in risk assessment and mitigation activities. If you are considering automating your risk management, make sure that it offers all the built-in capabilities your organization will need, such as electronic workflows and electronic signatures for execution, review, and approvals and similar functionality. Also take into account the risk management program's ability to leverage a risk-based approach in multiple processes (i.e., CAPA, non-conforming material disposition, protocol development, supplier qualification, etc.)
Don't forget: streamlining processes and automating risk management sounds great on paper, but if you aren't able to implement effective changes and report on the resulting data it's like driving as fast as you can with your eyes closed. Any risk management program worth its salt must include adequate analytics reporting features that allow for comprehensive analysis of risk files and risk assessments. Risk processes that offer scheduled reporting capabilities and intelligent threshold rules are even more helpful (not to mention that they make the bosses happy by increasing management awareness of and visibility into risk-related activities).
For more information about risk management programs and the risk management software offered by MasterControl, contact a MasterControl representative or by calling 800-942-4000.
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