Manage hazards
A hazard is a potential source of harm, and it exists whether or not your product exposes anyone to it. The hazard list is where a risk assessment gets its coverage: every applicable hazard becomes one or more safety risks, so a hazard missed here is a risk never assessed.
What goes in each field
| Field | What goes in it |
|---|---|
| Description | The hazard itself. Usually already filled in when the item is cloned or imported. |
| Source | The standard or reference the hazard comes from, chosen from ISO 14971, ISO TR 24971, TIR 34971, TIR 57, and IEC 60601-1. |
| Evidence summary | Why the hazard applies to your product. |
| Justification | Why the hazard does not apply. Required before the item will move to Not applicable. |
| Evidence | Links to the controlled documents carrying the proof for either ruling. |
| Related design input | The design inputs that bear on this hazard, where they exist. |
| Safety characteristic | The characteristic this hazard relates to or affects. |
| Assignee | Who is working on this hazard. Not mandatory, worth setting anyway. |
Hazards use the same three statuses as safety characteristics and harms, described under Key concepts.
Create hazards
- Open the space where Safety Risks is enabled and go to the Safety Risk page.
- Open the Hazards table.
The Hazards tab, listing energy hazards by category and type, each ruled Applicable or Not applicable. - Click + New Hazard to add one by hand, fill in the Summary and Description, then click Create.
- To build the list in bulk, upload hazards from a CSV file, or clone them from the Standard & Regulations space.
Review a hazard and rule on it
- In the Hazards table, select the hazard.
- Read the Description and decide whether it applies to your product.
- Add any detail you have, such as the Source the hazard came from.
The Source field open on a hazard, offering ISO 14971, ISO TR 24971, TIR 34971, TIR 57, and IEC 60601-1. - If it applies, fill in the Evidence summary, use Evidence and Related design input to point at the proof, and move it to Applicable.
- If it does not apply, fill in the Justification, add Evidence where you have it, and move it to Not applicable.
Link a hazard to a safety characteristic
Where a hazard relates to a safety characteristic, or could affect one, connect the two through the link field on the hazard. The link is what lets you show that the characteristics you ruled applicable are the ones the hazard list actually covers.
Turn applicable hazards into safety risks
An applicable hazard is not yet an assessment. For each one, identify the risks it presents and create a safety risk for each, with the category Hazard. One hazard usually produces several risks, because a single hazard can reach a person by more than one sequence of events. See Analyze and score a safety risk.
Revise a hazard you have already ruled on
A hazard in Applicable or Not applicable is read-only. Move it to Outdated, change the applicability, evidence, or justification, then rule on it again.
Export hazard applicability to a controlled document
- In Confluence, open the Draft Documents space and create a document of type Hazard Applicability for your product.
- Complete the document, following the instructions written into the template.
- Take it through approval in Document Control.
- Link the approved document back to each hazard and its applicability.
When the list is complete
- Every applicable hazard is in the register.
- Every hazard has been reviewed and sits in the right status.
- Every evidence summary and justification is filled in.
- Hazard applicability has been approved in Document Control.