By Eric Shaver, PhD
This is the second in a multipart series on the design, presentation, and evaluation of safety information (warnings, precautions, and contraindications) in device labeling.
The research literature on safety information, specifically warnings, identifies four components (signal word, identification of the hazard, information on how to avoid the hazard, and consequences for failing to avoid the hazard) that typically are included when being developed.
Signal Word (and/or Safety Alert Symbol)
According to ANSI Z535.6 (2011), there are three signal words that can be used to identify safety information that addresses potentially hazardous situations that might negatively impact users. These signal words connote different degrees of hazard severity. They are:
- DANGER (indicates a hazardous situation which, if not avoided, will result in death or serious injury)
- WARNING (indicates a hazardous situation which, if not avoided, could result in death or serious injury)
- CAUTION (indicates a hazardous situation which, if not avoided, could result in minor or moderate injury)
A fourth signal word, NOTICE, should only be used for non-personal injury hazards, like property damage.
Often the signal words DANGER, WARNING, and CAUTION will be paired with a safety alert symbol (see the image below) to increase conspicuity of the safety information. The safety alert symbol should not be used with NOTICE.
There are human factors issues that should be considered with these products, however. They include:
Identification of the Hazard
Safety information should clearly identify the potential hazard(s) of the product. Doing so provides intended users with information that will help facilitate making an informed decision about how to safely interact with the device.
Information on How to Avoid the Hazard
Safety information should clearly identify what steps should be taken to prevent personal harm from occurring when using the device. Depending on the hazard complexity, this could be brief for simple concepts or require additional explanation for more complex concepts. Moreover, if it is known that potential users of the device have sufficient knowledge about the appropriate actions needed to avoid the hazard, it might not be necessary to include this content in the safety information.
Consequence for Failing to Avoid the Hazard
Safety information should clearly identify the potential consequences for failing to heed the message. Stating the consequence of a specific hazard may not be necessary if it can be readily inferred from the overall message of the safety information.
ANSI Z535.6. (2011). Product safety information in product manuals, instructions, and other collateral materials. Rosslyn, VA: National Electrical Manufacturers Association.