FMEA - Failure Mode and Effects Analysis Software

Explanation of terms

Risk priority number (RPN)
The risk priority number is calculated from B x A x E, where B = importance (or severity of error), A = probability of occurrence and E = probability of detection. All factors (B, A and E) are rated on a scale of 1 to 10. The risk priority number (RPN) can range from 1 to 1000. The higher the calculated risk priority number, the more likely it is that the error will have serious consequences and the probability of detection will be very low. In the automotive sector, the RPZ has been abolished according to VDA AIAG. It has been replaced by the risk matrix rank (RMR).

Risk Matrix Rank (RMR) and Traffic Light Factor
The risk matrix set is a kind of further development of the risk priority number or the simple risk assessment using the B x A risk matrix and consists of three individual matrices (BxA, BxE and ExA) and the risk matrix rank. Furthermore, visualisation is carried out using traffic light colours.

FMEDA
FMEDA stands for Failure Mode, Effects and Diagnostic Analysis. It is used to identify and analyse safety-critical components during development. It also determines the proportion of non-hazardous failures, SFF (Safe Failure Fraction), and the diagnostic coverage (DC) of a system. This is done in accordance with the requirements of IEC 61508 and ISO 26262. Ultimately, the process serves to make assemblies safer.

In addition to the general software criteria described in the previous sections, below you will find subject-specific criteria for evaluating FMEA software for error prevention.

Additional specific criteria and suggested questions for evaluating FMEA software for error prevention:

• Before making a software decision, conduct a thorough market research of potentially suitable solutions. Our tip: Use our free research service without any obligation. Large parts of the tender are taken over, potential solutions are presented in a structured way and the communication with the providers is documented!
• Check whether preparation, structure, function, measures, error analysis, optimisation and presentation can be clearly presented and are correct. Can they be carried out completely with the software solution?
• Are the assessment catalogues for significance, occurrence and discovery freely customisable? Can you supplement or adapt them with your specifications, assessments and evaluations?
• Is there requirements management? How are requirements handled and communicated? Are m to n links possible?
• Is it possible to output all forms, evaluations and results of the FMEA in HTML format? Is there a possibility to use a storable batch job for intranet applications?
• Is there a distinction between requirements, functions and characteristics? Are the characteristics available for system, design and process FMEA, and are product and process characteristics implemented correctly?
• Is the software also suitable for offline processing? This point is important if the FMEA moderator or moderators frequently work at different locations or from home.
• Check the languages available in the software. Are all the languages you need included, and what is their scope? Is the necessary technical vocabulary included? What are the translation options?
• Are there copy functions for sub-functions of FMEA? This allows you to efficiently transfer certain recurring sub-functions to new FMEA.
• If you wish to use ASIL (automotive safety integrity level), please clarify whether this is possible with the software.
• Is there a CAD interface? Can you import drawings directly from your CAD system?
• Are there suggestion lists for malfunctions? In other words, as the software is used more and more, can you draw on an extensive catalogue of relevant malfunctions, or define malfunction lists at the outset to ensure consistent usage?
• Check the software's filter, search and sort functions. For example, can you display the product or process FMEA with the highest risks with just a few clicks?
• Check whether the FMEA software has interfaces for, e.g., your quality management system, FuSi (functional safety), ERP or document management system.
• Are there basic FMEA templates that can be maintained centrally so that adjustments only need to be made once, if necessary, and can then serve as a basis for further FMEA analyses?
• Can inspection plans be created and inspection tasks defined and logged directly from the FMEA software? Are messages automatically generated and sent to those responsible when there have been changes to inspection plans?