Are Risk Assessment Tools a Necessity in Regulatory Environments?
In Development of FDA-Regulated Medical Products, Elaine Whitmore eloquently points out the role of risk assessment in regulatory settings:
“Since being an apologist is in itself risky, in reality, risk analysis is a must for a manufacturer to be able to make an ethical and business call on whether a new device is safe enough to market. Although not expressly required for FDA approval for drugs and biologics, the principles of risk analysis techniques are applicable to these products, and are key elements in risk management strategies for drugs and biologics, as well as for medical devices.”
So, from this one can gather that in order to maintain regulatory compliance, manufacturers in life science industries must constantly be asking themselves these questions: 1) What could go wrong (or what went wrong) and what are the odds of such an issue reoccurring? And, 2) what are the possible consequences of those particular issues and what will be the magnitude of those negative outcomes?
The answers lie in an organization’s ability to accurately gauge the effectiveness of corrective measures and its efficiency in adequately monitoring critical events. This risk prescience, in turn, is dependent on the risk assessment tools an organization employs to obtain risk visibility across product lines, business processes, and business units. While such tools may not be officially mandated by regulatory bodies, they certainly prove that an organization has a compliance game plan and can prevent unnecessary obstacles to getting products to market.
Is an Automated Risk Assessment Tool Right for Your Organization?
Compare your own organization’s risk-based activities with the following benefits that could be provided by an automated risk assessment tool and ask yourself if your current system could benefit from automation:
- The system includes automatic triggers that initiate the performance of a risk analysis.
- backbone of the system is a methodology that establishes objective risk metrics that can be used as thresholds for decision making.
- The risk analysis tool provides customizable metrics that can match your organization’s individual needs. This results in consistent, objective, and defensible quality decisions.
- Since they are consistently executed and monitored with the same tool, risk processes never suffer from conflicting assessments and inconsistent analysis.
- Data is always easy to locate because the organization won’t have separate and disconnected risk-related data collection systems.
What Sets MasterControl’s Risk Solution Apart from the Competition?
While MasterControl’s risk assessment tool is popular because gives quality teams a straightforward, standardized means of performing reliable risk assessments, it distinguishes itself from competitors because it is useable right out of the box yet has the flexibility to be customized. It can be configured according to multiple risk types for evaluating different categories of operational risk.
Other features and benefits of the MasterControl risk assessment tool include:
- Best-Practice Process: MasterControl incorporates a user-friendly two-step process that guides users through procedures such as Risk Analysis Performance and Risk Analysis Approval.
- Best-Practice Forms: A pre-configured, multi-page form prompts users to collect and track all relevant data and guides them through the process while allowing responsible personnel to make decisions appropriately. The form is automatically routed to the appropriate personnel and can be escalated if it is not processed in a timely fashion.
- Analytics Reporting Tools: MasterControl’s built-in reporting tools come with a standard set of pre-configured reports that can be adjusted and customized by the end user. The risk assessment tool allows risk analyses to be analyzed according to source and other related parameters. These data-mining capabilities provide important insight into systemic quality issues and serve as yet another starting point for quality processes such as corrective and preventive actions (CAPA).
- Audit Trails and Electronic Signatures: MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy global regulatory requirements such as the FDA’s 21 CFR Part 11.
Because users need a single collection point for all risk-related activities pertinent to a given project, process, or supplier, MasterControl offers a risk assessment tool that effectively integrates risk assessments, documentation, and other risk management processes (FMEA, FTA, surveys, etc.). The criticality of comprehensive management oversight is also a central element of the MasterControl risk assessment software system and MasterControl’s best practice process, which fully incorporates risk mitigation and reassessment, is also highly beneficial to organizations that need the capacity to continually improve existing risk analysis processes.
Since risk assessments can be launched from any point within the MasterControl risk assessment tool, management can analyze hazards associated with any process or activity at any time. And, the solution’s standard methodology and approach to analytics simplifies management’s application of resources in the most risk-prone areas. Another added bonus for management is the scheduled reporting feature and intelligent threshold rules that increase risk awareness throughout the organization.
For More Details on Risk Assessment Tools
To get more detailed information on Risk Assessment Tools, feel free to contact a MasterControl representative.