Labels for filtering, such as Patient Impact or Usability
Hazard (required)
The hazard itself, in a short line
Description / Effect
A short description, or the effect associated with the hazard
Harm (required)
The effect in the care setting, and the potential clinical impact or harm to the patient
The Hazard stage filled in, with the six stages across the top.
Suggest Hazards and Suggest Harm draft from your product description. To draft a whole hazard in plain English, use AI.
2
Add the causes
Add each cause in one of the three ways shown below: type a new one, link or copy an existing one, or copy in an AI suggestion.
1 Type a new cause and click Add. 2 Or link or copy an existing cause, filtering by product. 3 Suggest Causes offers AI suggestions.
A linked cause is one cause in several places, so editing or deleting it changes it everywhere.
3
Add the existing controls
For each cause, add the controls already in place, in the same three ways as causes.
1 Type a control and click Add. 2 Or link or copy one from Link or copy existing Controls to this Cause, using its filters. 3 Suggest Controls offers AI suggestions.
Attach evidence to each control now, or later from the Controls tab.
4
Set each control's details
For each control, set:
Field
Options
Responsibility
Manufacturer (you operate it) or Deploying Org (the deploying organisation operates it, so it’s a transferred control)
Control Type
The kind of control, chosen from a list
Control Status
Yours to define, for example Awaiting Evidence or Done
The control form, opened from an existing control. 1 Responsibility, 2 Control Type and 3 Control Status.
5
Score the initial risk
Rate the hazard with its existing controls in place (View Causes lists them). Set Severity and Likelihood with the sliders, or click a grid cell to set both. Initial Risk Justification is optional.The slider descriptions are cut short: Learn More gives Assuric’s full definitions, and Risk scales and thresholds has the matrix.
Likelihood and severity selected, the matching grid cell highlighted, and the Overall Rating filled in.
6
Add additional controls
Under each cause, add controls that bring the risk down further with New Additional Control. They take the same fields as existing controls.
1 Type an additional control under a cause and click Add. 2 Or link or copy an existing control from the panel.
7
Score the residual risk and set the status
Rate what remains with the additional controls in place (View Causes and Controls lists them), setting Severity and Likelihood as before.
From an Undesirable residual rating (3 on the default matrix), Residual Risk Justification becomes required. Confirm whether the risk is as low as reasonably practicable (ALARP) and give a risk-benefit justification, or the hazard won’t save.
