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Product Liability
Newsletter - December 2007
 
In this Issue...
A Human Factors Perspective on ANSI Z535.6
 
January 2, 2008
 

In the June 2007 edition of this newsletter, Marc Antonecchia introduced the newly published ANSI Z535.6 standard, which pertains to the formatting and design of product safety information in product accompanying or collateral materials. Given the wide scope of this new standard, the variety of products and media that might be affected is enormous. Examples range from automotive owner’s manuals to OTC drug inserts to single-sheet assembly instructions with children’s toys. Products may be governed by different regulatory agencies (e.g., EPA, FDA, NHTSA or the CPSC) with different approaches to requiring or evaluating safety information in collateral materials. With this broad scope in mind, the ANSI Z535.6 subcommittee intentionally provided a flexible framework of recommendations and formatting conventions. When compared to other ANSI Z535 standards, Z535.6 has far fewer “strictly required” elements and provides more advice and permission to use different formatting conventions.

As discussed in the Antonecchia article, this standard introduces new nomenclature to categorize four distinct types of safety messages: supplemental directives, grouped safety messages, section safety messages and embedded safety messages. The formatting requirements are different for each category of safety message. Additionally, there is flexibility in the formatting within a given category. As a result, two different documents can vary in terms of the formatting of identical safety messages and both can be in compliance with these new requirements. Flexibility in formatting is necessary for technical writers due to the broad scope of this standard and the variety of media it potentially addresses. However, this flexibility can lead to more difficulty for manufacturers, engineers and others in determining if a document is in compliance with the new standard.

This article will not attempt to summarize the new standard’s requirements or provide a “quick-and-dirty guide” to compliance. Rather, it will offer my perspective as a consultant in Human Factors Engineering on the implications of ANSI Z535.6 for manufacturers and the legal community. In addition to my professional experience in the development and evaluation of warnings and other safety communications for a variety of products and industries, I currently serve on the ANSI Z535 Executive Committee and participate in the ANSI Z535.6 subcommittee responsible for developing this new standard. The following are what I believe are the most frequently asked questions.

What’s the Point?

Although it has been asked in slightly different ways, most of my clients have wanted to know the intent of this new standard. The stated objective is to establish a uniform and consistent visual layout for safety messages in collateral materials for a wide variety of products. From the committee’s perspective, the primary rationale for developing the new standard was the lack of available guidance for manufacturers and other practitioners in preparing safety messages in owner’s manuals and other similar media. The committee wanted to provide “official” recommendations on how to apply the ANSI Z535 “style” of warnings to safety messages appearing in collateral materials.

Why Not Just Use Existing Standards for Warnings?

ANSI Z535.4, the American National Standard for Product Safety Signs and Labels, was never intended to apply to manuals and other collateral materials. This standard is limited in scope to on-product signs and labels. The Z535 committee has recognized the inherent differences in media such as on-product labels, barricade tape and owner’s manuals. As a result, the committee has elected to develop individual standards addressing the different modalities for communication of safety information. At the time this standard was developed, none of the existing Z535 standards were able to be expanded in a reasonable manner to include “collateral materials.”

Some time after ANSI Z535.4 was published, it became apparent to the Z535 national committee that attempts were being made to apply ANSI Z535.4 to collateral materials by practitioners as well as in litigation. Since Z535.4 was not developed for this purpose, it is ill-suited for application beyond on-product labels. Collateral materials differ considerably from on-product information in that collateral materials can vary significantly in terms of their purpose, content, format and length. Collateral materials typically contain more information than labels, while simultaneously integrating safety and non-safety information. They generally provide longer, more detailed safety messages and/or safety messages that are necessary but would be impractical for an on-product label. Also, unlike most on-product labels, collateral materials often address numerous hazards. They feature multiple safety messages over many pages that cannot be viewed simultaneously.

What If We’ve Already Applied Z535.4 to Our Collateral Materials?

In the past, some manufacturers or technical writers have tried to adapt the Z535.4 standard for use in their collateral materials. This was logical, in the absence of a directly applicable standard. However, since the publication of Z535.6 in late 2006, I would not recommend attempting to use ANSI Z535.4 in formatting these safety messages. In fact, I would encourage manufacturers to adopt the new Z535.6 guidelines during the next revision cycle. In terms of how much modification may be needed, a definitive answer can only be given on a case-by-case basis. Generally, manufacturers who have attempted to design their collateral materials in accordance with Z535.4 will likely need only minimal revision to conform to the new guidelines. This recommendation to revise collateral materials to comply with the new standard is limited to current production products. Existing collateral materials of products no longer in production, but still made available by the manufacturer, need not be revised. For example, owner’s manuals for a 2005 automobile in inventory or available online need not be updated.

Do We Really Need to Bother Complying With a Voluntary Standard?

If a company has invested the time, effort and resources to comply with Z535.4, they should already understand the importance in complying with Z535.6. Plaintiff attorneys and their expert witnesses will often, although mistakenly, use the Z535 series of standards as the “gold standard” in terms of designing an effective warning. It should be noted that the available human factors research does not support the conclusion that a warning must comply with ANSI Z535 to be effective. In fact, the Z535 committee “recognizes that safety information can also be effectively communicated using other graphical systems,” and that, in some cases, industry specific standards are more appropriate.

Despite the scientific research evidence contradicting their opinions, some expert witnesses have found success in litigation with their position that the Z535 standards are the benchmark a company must meet to have an effective warning and meet its duty to warn. In addition to satisfying some of the more common criticisms, there are additional advantages to compliance with ANSI Z535.6. All ANSI standards are consensus standards, meaning that the standards are developed by a collection of professionals from a wide variety of backgrounds, typically including academics, consultants, professional societies and individual manufacturers. Further, ANSI accredited committees are required to ensure due process in developing a consensus by eliciting public review and resolving any negative comments before publication. This diversity in opinions and input ensures that not only are the design guidelines based on sound theory and research, but that these standards will also be practical in their application.

As a result, designing safety information that complies with Z535.6 not only gives a company the position of meeting a nationally recognized and widely applied safety design standard, but by incorporating Z535.6, a manufacturer also benefits from the ANSI process.

When Must We Comply?

As mentioned previously, compliance with Z535.6, as with all of the Z535 series, is completely voluntary. The standard does not give an effective date for compliance. The Z535 series, including ANSI Z535.6, does provide a publication date: October 10, 2006. In my opinion, non-compliance is neither a safety deficiency nor a breach of the manufacturer’s continuing duty to warn. As such, there is no need to hastily revise all collateral materials in an attempt to be immediate, nor is there a need to send out replacement manuals for products already in consumers’ possession. The introduction of Z535.6 does not necessitate bringing collateral materials for out of production models in compliance with the new standard.

The publication of this new standard does present one distinct advantage for manufacturers: it provides a clear rationale and opportunity for manufacturers to conduct a comprehensive review and revision of the safety information in their collateral materials. The revisions could be completed and incorporated as a rolling change, when new printing is planned or required.

The Big Picture

ANSI Z535.6 is the first standard in the Z535 series designed specifically for manuals, instruction sheets and other collateral materials. The greater flexibility in the new standard is the underlying reason it can be applied to both a one-page insert as well as a 200-page manual. However, the greater freedom in design afforded by the new standard may also make it confusing for some practitioners in its application. It is clearly advantageous from both a safety and product liability prevention standpoint to comply with ANSI Z535.6. The publication of Z535.6 should also be looked upon as an opportunity for companies to undertake a comprehensive review of all collateral materials to incorporate necessary and important changes not only to formatting, but content as well.

For more information, email guest author Dr. Nathan Dorris at info@dorrisassociates.com.

About Our Guest Author:
Dr. Nathan Dorris is a Principal Consultant at Dorris and Associates, Inc., a leading provider of human factors, ergonomics and safety consulting services for over 25 years.