Overview

Safety Risks overview

Safety Risks turns risk management into work items you can query, link, and report on. Hazards, harms, and the risks themselves live in Jira alongside the requirements that control them, so the register stays current as the design moves instead of being rebuilt from a spreadsheet before each audit.

Rule on safety characteristics

Work through the characteristics the applicable standards ask about, and record for each one whether it applies to your product and what the evidence is.

Build the hazard and harm lists

Identify the hazards your product can present and the harms they can cause. Each harm carries the severity that every risk pointing at it inherits.

Assess risk from four angles

Hazard analysis, design FMEA, process FMEA, and use-related risk assessment run on the same work item, each with the fields its method needs.

Control, re-score, and sign off

Link risk controls to requirements so Design Control implements and verifies them, then score the residual risk and take it through a signed approval.

How the app is organized

Safety Risks is enabled per space. Once it is on, the space gets a Safety Risk page holding a table for each object you work with: Safety Characteristics, Hazards, Harms, and Risks, plus a Traceability tab that shows how each risk connects to the requirements controlling it.

The four tables are not four separate registers. A safety risk names the hazard it comes from and the harm it can cause, and it takes its severity from that harm. Building the hazard and harm lists first is what makes the risk assessment quick, and it is why the guides are ordered the way they are.

Where it meets the other apps

Design Control

A risk control is a requirement. You link each mitigation to a requirement with the category Risk Control, and Design Control then carries the implementation and the verification, so the proof that a control works is the same evidence the design record already holds.

Document Control

The register is evidence, not the file. Safety characteristics, hazard applicability, harms, and the risk register are each exported into a controlled document and approved there, and the risk management file references them.

The product lifecycle

Once a product leaves development, its lifecycle triggers the post-production activity that keeps the register accurate: complaints, field data, and design changes all reopen risks. Risk management does not stop at release.

Standards

The app follows the risk management process in ISO 14971:2019: identify hazards, estimate and evaluate the risk, apply controls, then check what those controls left behind. ISO 13485 requires risk management across product realization and points at ISO 14971 for how to do it, and the EU MDR and FDA 21 CFR Part 820 both expect a manufacturer to show that safety risk is managed across the product lifecycle.

Read Standards and compliance for what supporting a standard does and does not mean. The short version is that the app supports compliance and cannot deliver it on its own, because the procedures you write and the validation you run are yours.

New to the app? Read Key concepts first. The vocabulary is precise and the app uses it strictly: a hazard, a hazardous situation, and a harm are three different things, and the difference decides which field content goes in.