> For the complete documentation index, see [llms.txt](https://docs.aligned.ch/aligned-elements-web-client-user-manual/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.aligned.ch/aligned-elements-web-client-user-manual/3.2.300.26398/risk-analysis/perform-a-fmea-risk-assessment.md). # Perform a FMEA Risk Assessment When performing an FMEA, three different document object types are involved. The central document object is the **Failure Mode** that contains and combines entered causes and effects into **Hazards** (which is the second document object type involved). **Hazards** generate a Risk Probability Number which grades how serious the danger of the hazard is. The Risk can be reduced by creating and assigning **Mitigations** to the Hazard. **Failure mode**, **Hazards,** and **Mitigations** are connected through traces visible in the Trace Explorer. A Failure Mode is generally an output from a specification; i.e., “what risks are involved in the requirement solution being specified in this way." However, it is also possible to create Failure modes as free standing objects or maybe more common from a Potential Hazard which acts as a placeholder for a Norm-reference. {% hint style="info" %} **Note!** Aligned Elements provide a large number of configuration option when it comes to risk management. These configuration options include naming conventions, risk parameter design, risk calculations and a large number of behaviors and UI settings. When Risk Assessment are discussed here we specify them as two major input types: * Preliminary Hazard Analysis (PHA) * Failuremode and Effect Analysis (FMEA) #### Preliminary Hazard Analysis The Hazardous Situation and Foreseeable sequence of Events are entered in the main item. In the Risk Table, one or more Harms (with their severities) can be added where each can be associated with one or more (Risk Control) Measures. Each row in th etable is represented by an (AE internal and technical) Probability Of Harm (POH) item. Per default, two risk parameters are applied: severity, associated with the Harm and probability. #### Failuremode and Effect Analysis Effects (and their impacts/severities) and Causes (and their likelihoods/probabilities) are defined in separate input controls in the FM UI and automatically combined/permutated in the risk table below. Each row in the risk table is represented by an (AE internal and technical) Hazard item which can be associated with zero, one or more Mitigation items. Per default, three risk parameters are applied: severity (or impact), associated with the Effect, probability (or likelhood) associated with the Cause and Visibility, associated with the combination of Cause and Effect. Note that these are primarilly two types of risk input modes (with associated UI behaviors) in Aligned Elements! To accomodate the large variability among customer risk assessments, the large number of configuration possibilities makes it is entierly possible to configure an FMEA using the PHA Input type or a PHA using the FMEA input type! These configuration possibilities can also be used to model: * Process Risk Assessments * Cyber Security Risk Assessments * Usability Risk Assessments * etc. {% endhint %} ## How to perform an FMEA risk assessment * Generate a Failure mode from e.g. a Specification or add a Failure mode like you add a regular Document Object. * In the Failure mode Document Object form, describe the Failure mode in the **title** which is usually a functional family that applies to the specification. E.g., for the specification "Create analyses of serum" you could have the failure mode "No result created." * Define one or more **effects** for the Failure mode and quantify their **severity** according to your company standards. * Define one or more **causes** for the Failure mode and quantify their **probability** according to your company standards. * As you see, each permutation of the listed causes and effects generates a hazard in the Risk table in the lower part of the form. * Define the **visibility** for the Hazard and quantify it according to your company standards. * The risk probability number (**RPN**) is calculated using a customized formula from the severity (from the effect), probability (from the cause), and visibility (from the combination of cause and effect). An acceptable RPN is displayed in green. However, if the RPN is higher than a pre-defined threshold (depends on your configuration), the number is displayed in red. Optionally you may also configure an intermediate level, ALARP (as low as reasonably possible), in which case the RPN would display itself in yellow. * For the generated hazards, you may add Mitigations with the intention to reduce the RPN to an acceptable level. * To assign a Mitigation, click on the **Add Row** button for the applicable hazard and select a Mitigation from the list. The Mitigation is traced from the Hazard which means that the Mitigation can be assigned to other Hazards in this or other Failure Modes. {% hint style="info" %} Note! Mitigations need to be defined prior to assigning them to hazards. {% endhint %} {% hint style="info" %} Note! To remove a Mitigation from a Hazard, click the **Remove Row** button at the end of the row for the applicable Hazard. {% endhint %} {% hint style="info" %} Note! To remove a Hazard from the Risk table, remove either the applicable Cause or Effect by clicking on **Remove** in the applicable row in the Effect or Cause table. {% endhint %} {% embed url="" %} --- # Agent Instructions This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. Learn more at gitbook.com. ## Querying This Documentation If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question. Perform an HTTP GET request on the current page URL with the `ask` query parameter: ``` GET https://docs.aligned.ch/aligned-elements-web-client-user-manual/3.2.300.26398/risk-analysis/perform-a-fmea-risk-assessment.md?ask= ``` The question should be specific, self-contained, and written in natural language. The response will contain a direct answer to the question and relevant excerpts and sources from the documentation. Use this mechanism when the answer is not explicitly present in the current page, you need clarification or additional context, or you want to retrieve related documentation sections.