If they are to run smoothly, quality processes are reliant on accurate and appropriate risk analysis. Whether it is the initiation of a CAPA or the reporting of a deviation or nonconformance, each process must start with the evaluation—and possible mitigation—of the immediate risks posed by particularly troublesome issues. Fortunately, systemic risks that may have severe long term repercussions can be exposed by automated risk analysis tools that efficiently track and provide analysis of recurring issues.
Is your organization able to precisely measure the effectiveness of corrective measures and adequately monitor critical events? How accurate is your overview of your company’s risk landscape across product lines, business processes, and/or business units? To answer those questions, first consider the risk analysis tools your organization utilizes and determine if they are efficient, connected, and standardized.
Ask yourself if your company is facing risk analysis challenges like these:
An automated risk assessment software system provides a single platform where all risk-related activities and documentation are united within a secure central repository that is easily accessible and used enterprise-wide.
So if the time has come for your company to implement an automated risk analysis tool, take the following factors into account:
What makes MasterControl’s risk analysis tool truly unique is its out-of-the-box functionality and flexibility. Users can utilize the system to configure multiple risk types for evaluating different categories of operational risk. MasterControl’s risk analysis tool gives quality teams a simple, standardized means of performing reliable risk assessments. Engineering and manufacturing groups can also use MasterControl to document and store risk assessment/mitigation documentation in product design and process areas. It also ensures that risk assessments launched from any point within the enterprise (e.g., a document, process, project, bill of materials, etc.) will be automatically connected to the appropriately related links within the MasterControl software system.
When it comes to efficient, secure, and compliant risk file management, the MasterControl risk analysis tool is unparalleled. The system offers a single collection point for all risk-related activities pertinent to a given project, process, or supplier to effectively integrate risk assessments, documentation, and other risk management processes (FMEA, FTA, surveys, etc.). And for companies doing business in regulatory environments, an added beneficial feature is that the system’s risk files may be routed for approval and electronically authorized in accordance with strict regulatory standards such as the FDA’s 21 CFR Part 11.
The importance of comprehensive management oversight is another core component of the MasterControl risk assessment software system. Since risk assessments can be launched from any point within the system, management has the ability to analyze hazards associated with any process or activity at any time. 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. In addition, the solution’s standard methodology and approach to analytics simplifies the application of resources in the most risk-prone areas. The system’s analytics reports allow for deep analysis of risk assessments and other risk-related files. A scheduled reporting feature and intelligent threshold rules also increase risk awareness throughout the organization. To put it simply, the main focus of the MasterControl risk analysis tool is to ensure that organizational risk tolerances are not exceeded.
To get more detailed information on risk analysis tools, feel free to contact a MasterControl representative.
Links zum Thema