Identify, classify, and document risks and root causes.

Risk Management Software

Risk management, FMEA, risk analysis, and HACCP in one software including root cause analysis, risk matrix, structure analysis, and function network. Use the comprehensive functions of the software Risk.Net in order to identify, evaluate, and document relevant risks and thereby fulfil key requirements of customers and regulating authorities. Whether ISO 9001, ISO 13485, GMP, IFS, or IATF 16949: Risk.Net is a risk management software solution that enables you to create and manage any type of standards-compliant risk analysis.

Advantages of the Risk Management Software

Risk Management Software Risk.Net
DIN EN ISO 14971 risk analysis methods (before/after matrix), FMEA evaluations, RPN/Pareto diagrams, risk matrices, and 3D signal light factors
  • Risk analyses via structure, function, and failure analysis
  • Confirmed suitability for the creation of AIAG / VDA compliant FMEAs
  • Risk analyses with Before / After Risk Matrix
  • Decision tree for establishing CCP, PRP, and oPRP in the context of HACCP
  • Determine priorities via risk matrices and 3D signal light factors
  • Root cause analysis with Ishikawa-Diagrams and 5-Why-Method
  • Guided linkage and auto-update of control plan and inspection plan
  • Integrated knowledge and revision management ensure traceability

Functions of the Risk Management Software

We all conduct risk analysis in our everyday lives. Every time we weigh up the probability of something happening and the resulting degree of severity, we are conducting risk analysis. Within the area of risk management, techniques such as FMEA, 3D signal light factors, HACCP, or ISO 14971 risk matrices are used in order to weigh up precisely these types of correlation between probability and severity, and to ascertain appropriate risk parameters. Whether automotive, medical technology, or food industry: in Risk.Net you have the best risk analysis methods of all sectors at your disposal, so that you can identify, analyze, and classify all risks and hazards.

FMEA Software Risk.Net
Sophisticated analysis tools or shed light onto actions and jobs

The Risk Management Software Risk.Net facilitates the application of all existing types of FMEA (construction, process, product, or system FMEA). The intuitive tree-structure enables even those users who have little experience in the area of risk analysis to start working with the program immediately. The integrated standards always ensure compliance with rules/regulations, and efficient work processes. A variety of standard form sheets such as, for instance, IATF 16949, VDA 86/96, or QS 9000 are already included. The program also allows you to freely design your own assessment classes for any type of risk evaluation and edit all reports to best suit your requirements. In the spirit of a holistic FMEA Software, Risk.Net furthermore enables the creation of FMEAs in accordance with the specifications of the FMEA manual as harmonized by AIAG and VDA - including the required 7 steps of an FMEA.

CAQ.Net®‘s individual software modules are completely interlinked. You can, for example, create the control plan directly from a completed risk analysis (FMEA) and subsequently create the inspection plan in the Quality Inspection Software Compact.Net. If a risk analysis (FMEA), control plan, or inspection plan changes, the parties responsible will be informed and can immediately recognize where action is needed using simple graphic tools. The changes can be synchronized via simple assistants and thus be adopted for the other entities.

AP classes in the risk management software Risk.Net
AP classes: High (H), Middle (M), and Low (L)

In addition to the direct link between risk analysis, control plan, and inspection plan, there is, true to the concept of PDCA, another control loop that can be used as input for risk analyses. The inspection plans from Compact.Net trigger process violations and complaints in the Complaint Management System REM.Net, and complaints from REM.Net, in turn, are used as a knowledge base for the creation and revision of risk analyses and FMEAs in Risk.Net. This ensures that improvements in quality and safety can be implemented continuously.

The Risk.Net Risk Management Software contains an ISO 22000 compliant HACCP Decision Tree. The user is thereby interactively guided through the 5 key questions that make up the question tree and need to be addressed for each product or product group, and every process-step where hazards are identified:

  • Are adequate actions for hazard control in place?
  • Are actions required?
  • Is the step necessary to eliminate the hazard?
  • Can the hazard increase at this step?
  • Does a further step eliminate the hazard?

Root-cause analysis in the risk management software Risk.Net
Application of Ishikawa diagrams and 5-Why method for root cause analysis

The software offers you numerous methods of cause and effect research, because experience shows that the immediate cause of a problem itself is generally the result of a variety of further causes, and each of these result from additional causes. Hence, you often need to dig very deep until you can uncover the actual root cause of a problem. The 5-Why Method and Ishikawa Diagrams, for instance, are two of the root-cause analysis methods that are available in the software.

Risk.Net allows you to easily refer back to previously implemented solutions, ideas, and actions. You can refer back to any point of your analysis in a structured manner and copy or add individual positions. The diverse functions for data exchange in the software are also fully in line with the idea of sophisticated knowledge management. You can, for example, exchange risk analyses / FMEAs / HACCPs across tenants and between different CAQ databases of different plants. This allows you to precisely apply your company‘s knowledge right where it is needed.

The Risk Management Software Risk.Net allows you to administrate any number of revision statuses of your risk analyses and thus provides you with seamless traceability and accountability with regard to product and system improvements – including all historical actions and previous events. Use the change tracking functions in the software in order to easily establish which person made what change when and on what workstation. The revision management section also contains a comprehensive restore function, which allows you to retrieve and reapply all previous versions of your risk analyses at any point in time.

Action management and due-date tracking in the risk management software Risk.Net

Use Risk.Net to specify actions or define activities and project steps directly in the clear tree-structure of your analysis. You can hereby not only define simple actions, but also directly include a whole host of additional information such as images, graphics, customer / supplier documents, or experiment results etc. The software allows you to define actions and responsibilities for due-dates and task executions and at the same time monitor your analysis costs and potential for savings. The integrated task management allows you to use powerful action tracking and escalation management functions in order to fully automatically monitor the process status of actions and send automated reminder e-mails. This means that no dates, actions, or events are forgotten, and you consistently have an eye on all analysis-relevant matters.

Standards-Compliance of the Risk Management Software

  • DIN EN ISO 9001:2015
  • DIN EN ISO 13485:2016
  • DIN EN ISO 14971:2020
  • ISO 22000:2018
  • FSSC 22000
  • ISO 31000
  • IATF 16949:2016
  • DIN EN ISO 12100
  • DIN EN 9100:2018
  • DIN EN ISO/IEC 17025:2018
  • FDA 21 CFR Part 820
  • FDA 21 CFR Part 11
  • GMP
  • IFS
  • More Regulations »

Risk Management FAQ

We all conduct risk analysis in our everyday lives. Every time we weigh up the probability of something happening and the resulting degree of severity, we are conducting risk analysis. If you leave the house when it is raining, the prospect of getting wet is very high. The degree of severity, however, is low. You’ll simply get wet. If you don’t put on your safety belt in the car, the probability of something happening is comparatively low. However, if something does happen, the severity of what may happen can be dramatic. Within the area of risk management, techniques such as FMEA, 3D signal light factors, HACCP, or ISO 14971 risk matrices are used in order to weigh up precisely these types of correlation between probability and severity, and to ascertain appropriate risk parameters.

FMEA (Failure Mode and Effects Analysis) is one of the most widely used types of risk analysis. It is a procedure within product development and operations management that assists you throughout the analysis of potential failure modes and provides a system for classification according to the severity and likelihood of failures. During the product development phase, FMEA helps identify and eliminate the causes of failures and put in place precise preventative actions. This means that subsequent control and failure costs within production processes or at customer level can be reduced significantly or prevented entirely.

In previous FMEAs, the respective risk was always determined on the basis of the known risk priority number (RPN) by multiplying the three factors significance (B), occurrence (A), and detection (E). In the course of the elaboration of IATF 16949 by AIAG and VDA, among other aspects, the Action Priority (AP) was designed as a replacement of the formerly predominant RPN. Compared to the RPN, the AP has three so-called “AP classes”: High (H), Middle (M), and Low (L). These new task priorities do not determine the level of risk, but instead prioritize the respective need for measures to reduce the risk. In Risk.Net, you can perform risk analyses using both the previously valid RPN and the Action Priority (AP).

Amongst other areas of application, the before / after risk matrix allows you to conduct effective and precise risk management in accordance with DIN EN ISO 14971. It allows you to schematically track the effectiveness of inspections or alterations of construction that have been carried out. By comparing before and after, you can easily track the effectiveness of the measures you have taken and prove their effectiveness at any time. If the frequency of an error in a product decreases after a change has been made, this will show up in the ‘after’ matrix.

The so-called Critical Control Points are key elements of HACCP, a risk management concept that is used in nearly all areas of the food industry. The Control Points are points along the production or handling chain that are of particular importance, as this is where food safety risks can be prevented, terminated, or lowered to an acceptable level. A HACCP “Decision Tree” is used in order to identify said CCPs. This type of risk analysis shows whether a point in a process is a CCP, whether an Operational Prerequisite Program (oPRP) should be applied there, or whether the point in the process indicates that the procedure or product needs to be altered.

The 5-Why-method, initially developed by Toyota, uses a simple yet effective question asking technique in order to find root causes. Repeatedly asking the question of “Why?” peels away individual causes bit by bit and eventually exposes the root cause of a problem.

The Ishikawa diagram allows you to consolidate all possible problem causes and interdependencies in a clearly structured fishbone diagram. The influencing variables are subdivided into primary and secondary causes which all point towards the main problem or potential for improvement.

Overview of Highlights
  • Efficient creation and management risk analyses
  • Standard-compliant FMEAs in accordance with e.g. ISO 9001, ISO 13485, IFS, and IATF 16949
  • FMEA according to AIAG & VDA including structure tree analysis and function net
  • Risk analysis in accordance with DIN EN ISO 14971 – including before/after matrix
  • HACCP with HACCP Decision Tree in order to establish CCP, PRP, oPRP
  • Application of Ishikawa Diagrams and 5-Why Method for root cause analysis
  • Data-output and analysis via risk matrices and 3D signal light factors
  • Implementation of construction, process, product, and system FMEA
  • Action management including efficient monitoring of responsibilities
  • Flexible creation and maintenance of family FMEAs and risk analyses
  • Fully integrated FMEA knowledge database with self-learning catalogues/libraries
  • Cross-modular PDCA circle of control
  • Free definition of any amount of risk analysis type and evaluation classes
  • Escalation management for action and due-date monitoring
  • Comprehensive revision management
  • Free definition of any amount of FMEA types and evaluation classes
  • Comprehensive risk management including risk analysis, risk evaluation, risk minimization, risk control, and risk monitoring
  • Clear definition of FMEA or risk analyses teams and persons responsible
  • Administration of discovery and preventative actions
  • Supports valid international standards and regulations
  • Integrated link to REM.Net and Compact.Net
  • Graphic display of RPNs via Pareto / RPN diagrams
  • Fully integrated standard forms (AIAG, VDA, QS 9000 etc.)
  • Data administration in clear tree-structure or directly in the FMEA form
  • Development of FMEA-specific cost-benefit analyses
  • Fully integrated FMEA knowledge database with self-learning catalogues/libraries
  • Text modules for unambiguous language rules and failure descriptions
  • Internal/external FMEA copy function
  • Direct access to applicable, implemented, and controlled QBD.Net documents
  • Freely definable attributes for all relevant entities
  • User-defined role concept and access rights management
  • Optimized for Citrix or Microsoft Terminal Server
  • Complete bidirectional integration into the CAQ.Net® system landscape
  • Multilingual applications & transaction data, incl. translation tool
  • Multi-tenant capability for cross-location and cross-database solutions
  • Complete history management via AuditTrail.Net
  • Integrated data exchange with peripheral systems via Connect.Net
  • And much more

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