FMEA Risk Management (ISO 14971) Tutorial


Orcanos FMEA Risk Management is ISO 14971 compliant and allows you to manage the complete process from hazard identification to risk mitigation. You can track risks, link them to mitigation and create a full traceability matrix. At the end – you can generate a risk management file to Word document, ready for submission.


This tutorial will assist you in the following:

  • Setup your risk management profile, according to your SOP
  • Build Risk Management File
  • Understand Risk e-Form
  • Trace risk to software and mechanical requirements for mitigation
  • Verify mitigation
  • Create filters and dashboards
  • Generate risk management file ready for submission


Before starting, it is recommended that you follow the Orcanos Quick Walk-through in order to learn the basics, and how to build document, add headings hierarchically, and add risk work items in the hierarchical document.

Setup your FMEA rules

Orcanos allows you to configure the risk management according to your SOP. In order to configure your risk management, follow this article: FMEA Settings

Configure Risk form

In case you wish to add/remove fields from risk e-Form, add tooltip to fields or add sections, you can do it using the Fields Layout section in Admin

Configure Risk status flow

In order to change your project status flow for risk, go to your project and select Process Flow tab


Select the project node and add a new Document

Select the new created document and add a new paragraph underneath

Select the newly created paragraph and add new risk


orcanos fmea risk management

Each risk has the following default tabs:


Contains the attribute (can be fully customized):

  • Name – short description of risk
  • Status – risk status flow. an example for risk workflow can be as such:

orcanos fmea

To see the risk status flow – click on the status flow viewer button, next to the status:


  • Condition – List of Single Fault, Incorrect Use, Normal Use
  • Assign To – Assignee
  • Category – list of categories according to the ISO 14971, such as Radiation, Intended Use, Biochemical, Electrical
  • Affected – Patient, Doctor, Operator, Environmental, Bystander, Service Personnel…
  • Control Type – which control is required (Labelling, By Design, Protective Measure, Training…)
  • Applicable Component – Related component

Attachments Tab

You can add relevant attachments, as evidence documents, etc

History Tab

Shows audit trail of risk history log

Discussion Tab

Manage team discussion over the risk item

Traceability Tab

Contains related items. Can be used for the followings:

  • Link risk to requirements for mitigation (see below)
  • Link risk to Complaint
  • Any other relations


Use the Traceability tab in order to manage relations to other work items.

You can add links from risk, or from mitigation items.

In case mitigation (requirement) exists:

  • Select risk item in your document
  • Select Traceability Tab
  • Click on the Add button (red button at the bottom right)

The Add a screen opens.


  • Select the project from which you want to add the mitigation
  • Select Work item (such as software requirement, hardware requirement)
  • Select predefined filter (how to filters)
  • Select link type “Risk Mitigation”
  • Source/Target – Important! Make risk as Target, so it would appear in Orcanos Full Traceability Matrix
  • Select risk/s from the list and click Save/ Save & Exist

In case mitigation doesn’t exist

Let’s assume we want to add a new software requirement for mitigation.

So, open the relevant project where the software requirements document is managed

Add new requirement

Select requirement traceability tab

  • Click on the Add button (red button at the bottom right)

The Add screen opens.

  • Select the project where risk exists
  • Select Risk work item
  • Select predefined filter (how to filters)
  • Select link type “Risk Mitigation”
  • Source/Target – Important! Make risk as Target, so it would appear in Orcanos Full Traceability Matrix
  • Select requirement/s from the list and click Save/ Save & Exist

Now traceability is created.


Now, we need to verify the mitigation. We will do it using Orcanos test management

You need to create a traceability between test case and the risk mitigation item (software requirement)

For your practice – use the Tracing Mode in Tree View in order to create this link


Use the execution set in order to build QA plan, and run the test which is related to the risk item.


There are several useful reports that allows you to track your risks

Add default panel and create the following panels:

Risk Before Mitigation panel, and Risk After Mitigation panel

orcanos fmea

Risk Full Traceability Matrix

orcanos risk management fmea


So, now you can generate the risk file. We are using “Export to Word Document” for that, along with dynamic filters. Click here to learn how to generate risk management file.

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