Causes, controls and evidence

The model behind the hazard log: how hazards, causes, controls and evidence link, the difference between copying and linking, and how to attach evidence to a control.

Quick summary

• A hazard has causes, each cause has controls, and evidence on a control supports every hazard using it.
• Editing or deleting a linked cause or control changes it everywhere it’s used, but a copy is independent.

The four objects

Object	What it is	Example
Hazard	Something about your product that could lead to harm	Patient contacted on the wrong number
Cause	A specific way the hazard could come about	Phone number entered incorrectly at registration
Control	Something you do that reduces the cause or its effect	Phone number format validation at entry
Evidence	Proof the control exists and works	Screenshot of the validation rule; training log

Evidence hangs off a control, not the hazard, so one piece of evidence supports every hazard where that control appears. Causes and controls go into a shared bank every hazard can draw from, whichever hazard you created them on.

A hazard expanded in the Hazard Log. 1 The hazard. 2 One of its causes. 3 One of that cause's controls. 4 The paperclip that opens the control's evidence.

Copy or link

Pulling a cause or control from the bank offers a copy icon and a link icon.

Copy

Takes the text only.

• Its controls and evidence don’t come with it.
• Editing it later affects only this hazard.

Use copy when this hazard’s version will diverge, with a different owner, evidence or scope.

Link

Connects to the original.

• Its mapped controls and their evidence come with it.
• Editing or deleting it anywhere affects it everywhere it appears.

Use link when it’s the same control doing the same job, which is the normal case.

A cause in the Link or copy existing Causes panel. 1 Copy takes the text only. 2 Link connects to the original.

To take a cause or control out of use without losing it, archive it.

Evidence

There are 2 routes to the same evidence pop-out, behind a control’s paperclip icon:

From the hazard log

Open the hazard, select the control, and click the paperclip icon.

From the Controls tab

Filter by Awaiting Evidence to see every control marked that way, then click the paperclip icon on each. The status is set by hand, so also scan the Evidence column: a control marked Done can still show (0).

The Controls tab, showing the controls for one product. Filter it by control status to find the ones still awaiting evidence.

Either way, you can add a file, a link, a note or a document already in Assuric.

• Choose an existing document where there is one, so the evidence links to it instead of uploading a copy.
• Document Version points at one specific version, so check the control still points to the current version after the document is re-approved.

The Control Evidence panel, opened from a control's paperclip. 1 New Evidence adds a Link, Upload, Note or Document Version. 2 Add from existing evidence library attaches one that already exists.

Related articles

Create a hazard

The end-to-end procedure, using the model above.

Manage hazards

Editing, archiving or deleting a shared item.