Quality

Risk Analysis Tools

A consistent approach to assessing risk is critical to successful quality management.

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.

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Data Sheet: MasterControl Risk
White Paper: GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems
FAQ: Risk Management for Pharmaceutical Companies Under FDA's Q9 Guidance

Typical Risk Analysis Obstacles Your Company Might be Facing

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:

Actions taken—or not taken—are often challenged in internal or external audits or by employees. Without a formal risk analysis tool it can be difficult to defend the decisions that have been made.
In environments where risk assessments are performed but are not standardized, risk evaluations vary from one performer to the next. Whether an action on a quality issue is taken or not depends on the particular assessor, so similar issues end up being treated differently due to conflicting risk assessments and inconsistent risk analysis tools.
When manual risk analysis systems are in place, it is inevitable that the organization will wind up with separate and disconnected data collection systems. Take, for example, a risk analysis and its corresponding CAPA: if data pertaining to these quality events is compiled into repositories that aren’t connected, it is much more difficult to locate complete documentation later.

What an Automated Risk Analysis Tool Can Do For You

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:

Standardization and centralization are vital components of an effective risk analysis tool. All risk-related documentation needs to be contained within one secure repository. Just as importantly, a lack of standard risk analysis methodologies and assessments will unavoidably result in wasted resources throughout the enterprise. An automated feature-rich risk analysis tool with full search and scheduled reporting capabilities helps companies avoid severed connections and waste while providing easy access to risk assessment and mitigation activities and documentation.
Any worthwhile risk analysis tool should guarantee that corporate risk tolerance thresholds are consistently followed for all risk-oriented activities throughout the enterprise. If available, pre-configured best-practice forms as well as versatile calculation tools backed by a consistent risk methodology are also extremely beneficial.
An effective electronic risk analysis tool should offer employees from different departments an efficient and concise means of participating in risk assessment and mitigation activities. Specialized tools like electronic workflows and electronic signature functionality for execution, review, and approval of documentation are examples of some essentials to look for in a high-quality electronic risk analysis tool.

What Sets MasterControl’s Risk Analysis Tool Apart?

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.