The risk management software Risk.Net provides you with everything you require for conducting effective risk analyses and FMEAs. Use the clearly defined RPNs, Ishikawa diagrams, and expressive risk matrices of the software in order to easily fulfil key requirements of customers and regulating authorities.
- Efficient creation and management of FMEAs and risk analyses
- Standard-compliant FMEAs in accordance with ISO 9001, ISO 13485, IFS, and IATF 16949
- Action management including efficient monitoring of responsibilities
- Risk analysis in accordance with DIN EN ISO 14971 – including before/after matrix
- HACCP Decision Tree
- 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
- Flexible creation and maintenance of family FMEAs and analyses
- Fully integrated FMEA knowledge database with self-learning catalogues/libraries
- Cross-modular PDCA circle of control
- Free definition of any amount of FMEA types and evaluation classes
- Comprehensive revision management
- Escalation management for action and due-date monitoring
What is Risk Analysis?
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, so-called FMEAs 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.
Find, Evaluate, and Eliminate Failure Causes
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.
The software Risk.Net facilitates cost efficient and rapid access to all existing types of FMEA (construction, process, product, or system FMEA) as well as other methods of risk analysis. 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 – and the integrated standards always ensure compliance with rules/regulations, and efficient work processes. A variety of standard form sheets such as, for instance, VDA 86/96 or QS 9000 are already integrated. Of course, the program also allows you to freely design your own assessment classes for any type of risk evaluation.
Analysis, Assessment, and Evaluation
The application of Ishikawa diagrams and the 5-Why method provides the highest degree of flexibility in the search for potential failure causes. The software also includes DIN EN ISO 14971 risk analysis methods (before/after matrix), FMEA evaluations, RPN/Pareto diagrams, risk matrices, and 3D signal light factors. It thus provides an analysis and evaluation methods arsenal that is most probably second to none. Facilitating user-friendliness is a further focal point in Risk.Net. The well-structured display and easy usability of RPN-evaluations, for instance, means that you can open each of your individual actions from directly within your RPN graphic with the mere push of a button.
Good revision management facilitates clarity. Risk.Net therefore allows you to administrate any number of revision statuses of your risk analyses or FMEAs 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 of Risk.Net also contains a comprehensive restore function, which allows you to retrieve and reapply all previous versions of your FMEAs or risk analyses at any point in time.
Flexible Family FMEA
The software Risk.Net can do a lot more than simply administrate master FMEA or risk analysis templates. It allows you to freely combine the individual positions of all your analyses with one another – including all sub-entries (failures, failure consequences, causes, actions). If, for instance, you already have an analysis for a specific product or service, you can precisely select relevant positions from this analysis and include them in your new analysis. The multi-analysis management functions in Risk.Net enable you to do a lot more than restrictively deduct information from master templates – they provide absolute flexibility and innumerable failure position combinations throughout the creation of your analyses.
HACCP Decision Tree
The so-called Critical Control Points are key elements of HACCP. They 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 Risk.Net risk management module contains an ISO 22000 compliant HACCP decision tree in order to identify the aforementioned points. 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 risks are identified.
Fully Integrated Knowledge Database
Knowhow and experience are the true capital of your company. Safeguard the knowledge capital that you invested in your projects and 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 software thereby supports the intelligent and rapid creation, maintenance, and processing of your analysis during every step of the application.
Action Management and Due-Date Tracking
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.
In conjunction with JobControl.Net, you can 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.
Processes are generally versatile entities, and events and effects are seldom the outcome of just one cause. Risk.Net therefore grants you utmost flexibility in the depiction and visualization of your processes – without being limited by restrictive rules and regulations. Use the software to create freely structured failure and process trees that allow you to display even the minutest detail of your FMEA or analysis project. The easily usable tree structures furthermore enable you to access embedded or linked analyses and directly reference further applicable or related projects, positions, failures, and causes. If one failure cause or action is relevant for several processes, articles, or methods, or if a process improvement should be directly included in all related processes or products, then you can easily specify this via the intelligent tree structure.
The logic that is contained in your analyses is transferred to the mode that they are displayed in. This enables you to graphically depict processes or process interrelationships. It also means that you can specify that changes which are made to an action, failure, or cause should immediately apply to all further applicable elements. The software thereby gives you full and in-depth control of all your article, process, and system interrelationships. Thanks to the consistent process-orientation, even the smallest change to an improvement action can prompt an increase of the RPN factor of all linked elements. Use the references in Risk.Net in order to identify and highlight precisely the element of an analysis you need to optimize.
The PDCA Circle of Control
The individual modules of CAQ.Net® are all fully linked with one another. This fact is of particular importance within the framework of the PDCA circle (plan–do–check–act). The PDCA circle, also known as Deming Circle or Shewhart Cycle, can be understood as a four-phased problem solving process in which planning, execution, inspection, and reaction stand in close proximity to one another.
The realization of this circle of control in CAQ.Net® is best explained via the following example:
- Analyses you initially developed in Risk.Net are applied in Compact.Net inspection plans.
- The inspection plans that are created in Compact.Net in turn prompt complaints in REM.Net.
- The complaints in REM.Net are then used to compile a fresh knowledge base for creating and revising new analyses in Risk.Net.
- All of this ensures that improvements in the levels of quality and safety are continuously implemented.
Analysis and Documentation
RPNs, actions, efficiency reviews – Risk.Net turns your knowledge base into a precise and highly effective data processing system. You can immediately identify and document emphases and priorities with the sophisticated analysis tools or shed light onto actions and jobs. Of course, the software can display your FMEA or risk analysis on a variety of standard-compliant or custom-built forms at the push of a button and print these in whichever size you require them.