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Risk Management / FMEA

Risk Management / FMEA

The risk management software Risk.Net provides you with everything you require for conducting effective risk analyses such as FMEAs or according to HACCP. Use the comprehensive functions of the software in order to identify, evaluate, and document relevant risks and thereby fulfil key requirements of customers and regulating authorities.

  • 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

What is Risk Analysis?

FMEA Software: DIN EN ISO 14971 risk analysis methods
DIN EN ISO 14971 risk analysis methods (before/after matrix), FMEA evaluations, RPN/Pareto diagrams, risk matrices, and 3D signal light factors

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. Whether automotive, medical technology, or food industry: in Risk.Net you have the best methods of risk analysis of all sectors at your disposal, so that you can identify, analyse and classify all risks and dangers.

FMEA: Failure Mode and Effects Analysis

FMEA 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 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 – and 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.

Structure Tree Analysis

FMEA Software: Sophisticated analysis tools or shed light onto actions and jobs
Sophisticated analysis tools or shed light onto actions and jobs

Risk analyses usually also deal with the structures of products or processes. To identify these structures by means of structure tree analysis and to be able to visualize them accordingly is often the basis for a holistic risk analysis. Because only if you know the structures, you can identify the causes of errors within deeper lying structures or recognize possible consequences within higher lying structures. Risk.Net supports you with graphical tools to visualize and analyze the structures and to build up your risk analysis methodically based on the individual product or process structure.

Function Net

In addition to the structure tree analysis, the function net is another visualization method in Risk.Net that allows you to correctly assess and understand the interrelationships of risks. Here, the functions of individual structure elements are placed in relation to each other, because only if you understand the respective function you can recognize a possible fault. Risk.Net provides you with comprehensive graphical options for setting up and working with function nets.

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.

RPN and AP

FMEA Software: AP classes: High (H), Middle (M), and Low (L)
AP classes: High (H), Middle (M), and Low (L)

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 prioritise 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).

Before / After Risk Matrix

Amongst other areas of application, the before/after risk matrix in Risk.Net 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. Here’s an example: a wrongly fitted clamp causes a hose to leak. If inspections are introduced to ensure that the clamp is fitted correctly, then the risk parameter will decrease along with probability.

In addition to the medical technology industry, where this type of risk analysis is considered standard, the before/after risk matrix technique is now used in many other industries as well due to its high degree of expressiveness.

FMEA Software System

HACCP Decision Tree

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 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.

Root-Cause Analysis with the 5-Why Method

Risk.Net 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 need to often dig very deep until you can uncover the actual root cause of a problem.

The detection of causes and the correct designation of influence factors are the most important steps for effectively preventing negative effects. Two techniques that are available in Risk.Net to uncover the root cause of a problem are the 5-Why method and Ishikawa diagrams.

The 5-Why method, 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.

Root-Cause Analysis with the Ishikawa Diagram

FMEA Software: Ishikawa diagrams and 5-Why
Application of Ishikawa diagrams and 5-Why method for root cause analysis

The Ishikawa diagram works in a similar manner. It allows the user 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.

The individual arrows each stand for a contributing factor to a cause or improvement. These are then addressed step by step, thereby allowing valuable information to come to the fore. The analysis of the various influence factors via the Ishikawa diagram often reveals connections that no one would have thought of initially. With Risk.Net you get to use the most refined research tools that today’s quality management has to offer and efficiently shed light on the hidden causes of problems.

Control Plan & PDCA

CAQ.Net®‘s individual software modules are completely interlinked. You can, for example, create the control plan directly from a completed risk analyses (FMEAs) and subsequently create the inspection plan in 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 adopted for the other entities. 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 REM.Net, and complaints from REM.Net 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.

Fully Integrated Knowledge Database

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.

Revision Management

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 of Risk.Net 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

FMEA Software: Escalation management for action and due-date monitoring
Escalation management for action and due-date monitoring

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.

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Overview of Highlights

  • Efficient creation and management of FMEAs and risk analyses
  • Standard-compliant FMEAs in accordance with VDA, QS 9000, AIAG, 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
  • Comprehensive risk management including risk analysis, risk evaluation, risk minimization, risk control, and risk monitoring
  • Administration of discovery and preventative actions
  • Assessment of actions with regard to effectiveness and economical aspects
  • Integrated revision management in order to ensure traceability and facilitate change/history management
  • 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 (VDA 86, VDA 96, QS 9000 etc.)
  • Clear definition of FMEA or risk analyses teams and persons responsible
  • Data administration in clear tree-structure or directly in the FMEA form
  • Development of FMEA-specific cost-benefit analyses
  • Freely definable FMEA forms and reports via Form.Net
  • Text modules for unambiguous language rules and failure descriptions
  • Optimized for usage on Citrix or Microsoft Terminal-Server
  • Multi-lingual FMEAs and application/dynamic data – including translation tool
  • Multitenancy capable for cross-facility and cross-database solutions
  • Internal/external FMEA copy function
  • Direct access to applicable, implemented, and controlled QBD.Net documents
  • Creation and control of freely definable actions via JobControl.Net
  • Automatic e-mail notifications via JobControl.Net
  • Comprehensive history management via AuditTrail.Net
  • And much more


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