This document discusses developing effective warning information through a systematic 5-phase process: 1. Project planning to define scope, team, and resources. 2. Hazard identification and analysis to understand potential risks. 3. Warning development to determine topics, delivery methods, and create prototypes. 4. Warning evaluation through internal reviews and possible user testing. 5. Final approval and documentation to demonstrate due diligence and allow future consistency. Following this process helps maximize protection, resources, and consistency when determining safety warnings.

1. Product LiabiLity
Maximize Resources while Creating Consistency and Defensible Positions
Is Your Company Using
a Process to Develop
Warning Information?
By Eric F. Shaver and Curt C. Braun
users. Like many development efforts, the
quality of the warning information is deter-
mined by the process used to identify,
analyze and communicate about hazards.
Companies who do not use a systematic
warning information process might not
adequately inform users about a product’s
potential hazards. This article provides in-
house counsel and corporate legal exec-
utives with a basic understanding of the
warning information development process
so they can assist their clients with design
and development guidance. Armed with
a basic development process, counsel can
help their clients:
• Evaluate their current development
process.
• Assess the appropriateness of previously
developed warning information.
• Determine if further development is
needed to improve the conveyance of
product hazards.
Companies face difficult decisions when determining how to • Identify situations where warning infor-
warn users about potential hazards inherent in their products. mation experts should be consulted.
Although hundreds of research papers have been published Benefits
on the topic of warning information, few provide the guidance The warning information development
process can be readily applied from the
needed to create warning informa- genesis of a product to its obsolescence.
tion that protects companies and Along the way, companies can reap a vari-
n Eric F. Shaver, Ph.D. is a senior consultant at Benchmark Research & Safety, Inc. in Boise, Idaho. Curt C.
Braun, Ph.D. is the president and founder of Benchmark Research & Safety, Inc. in Moscow, Idaho. Bench-
mark is a human factors and ergonomics safety consulting firm specializing in the development and evalua-
tion of warning information. Dr. Shaver can be reached at eshaver@benchmarkrs.com.
64 In-House Defense Quarterly Summer 2007
n n © 2007 DRI. All rights reserved.

2. ety of benefits, including helping to pro- 4. Warning Evaluation mation, and if necessary, empirical test-
tect the company in cases of litigation and 5. Final Approval and Documentation ing. Determining which people to include
yielding increased returns on their invest- depends on the complexity of the product
ment (ROI). This process can: Phase 1: Project Planning and how well the hazards are understood
• Reduce the likelihood of product The project planning stage typically con- by the design team.
recalls. sists of three parts: defining the scope, Resource Requirements: Don’t ham-
• Demonstrate due diligence when com- assigning the people who will be part of the string the design team. Engage the design
panies face product safety or hazard lit- design team, and allocating the resources team early in the development process and
igation. Although litigation can never be necessary to perform the work. allocate the time and funds needed to com-
completely prevented, the use of a pro- plete the process. Regrettably, warning
cess can demonstrate reasonable care on n information often addresses design char-
behalf of the company. acteristics or flaws that could have been
• Focus the direction of the development All too often, warning eliminated early in the design process. All
process, thereby minimizing wasted too often, warning information is an after-
time and money. information is an afterthought thought rather than an integral part of the
• Provide a framework to develop sub- product development life cycle. Product
sequent warning information for other rather than an integral designers who appreciate the significance
products. First-time process develop- of safety and warning information on the
ment and implementation can be time part of the product product lifecycle can work more efficiently
consuming, but the potential for sub- from the beginning of the development
stantial savings exists when used repeat- development life cycle. process, thus avoiding costly redesigns and
edly with other company products. retooling.
• Create consistency across product lines. n
• Increase design team confidence in the Phase 2: Hazard Identification and Analysis
solutions selected to address hazards. Defining the Scope: Clearly identify- Hazard identification and analysis aims to
• Facilitate the development, presenta- ing the scope saves time and money and “know what was not previously known”
tion and tracking of all potential warn- increases the likelihood of finding potential about a product’s hazards. The design team
ing information. This benefit proves hazards. It is important that all aspects of a can use any number of formalized analysis
useful because a record can be main- product (e.g., primary product, accessories, techniques, including:
tained that specifies why certain warn- manuals, warnings, etc.) be included in the • Hazard Checklists
ing information was included and scope. Similarly, the scope should identify • Preliminary Hazard Analysis
others were not and the justifications typical uses and foreseeable misuses of the • Energy Flow/Barrier Analysis
for the decisions. product and its accessories. Finally, the • Fault Tree Analysis
The diversity of products available to scope should define the available methods • Failure Modes and Effects Analysis
users speaks to the variety of approaches to convey warning information to users. • Event Tree Analysis
manufacturers use when developing prod- Design Team Members: Having the right • Root Cause Analysis
ucts. The fact that companies design and people increases the ROI. Design team • Job Safety Analysis
create differently to meet the needs of their members might include individuals from • Critical Incident Technique
customers reduces the value of “cookie cut- all aspects of the company who affect the • Risk Assessment Matrices
ter” approaches to warning information product’s design, manufacturing, support, • Hierarchical Task Analysis
development. While this article provides an maintenance, marketing, documentation, These techniques are well documented
overall framework and guidance, it should etc. The goal is building a design team that and design teams can be trained in one or
not be considered a checklist for develop- can both identify hazards and respond to more techniques that are appropriate for a
ing warning information. This article cov- them. A typical design team might include given product. It is not likely that any sin-
ers a wide variety of domains; therefore, the design engineers (mechanical, electrical, gle technique will address all needs. Design
suggestions offered will not necessarily be chemical), human factors engineers/psy- teams should consider using multiple tech-
applicable to all situations. chologists, packaging engineers, techni- niques or combine components from mul-
cal writers, marketers, customer service, tiple techniques to get the best assessment
Warning Information regulatory affairs, trade association rep- of a product’s hazards. Given a list of fore-
Development Process resentatives and legal counsel. A company seeable hazards, design teams can assess
Overview might consider enlisting the assistance of the likelihood and severity that a particular
The warning information development professionals trained in the development hazard might produce injury, death, and/or
process typically consists of five phases: and communication of warning informa- property damage.
1. Project Planning tion. Their knowledge and expertise can Hazards can also be identified by other
2. Hazard Identification and Analysis greatly benefit the process by facilitating means when it is not necessary or practi-
3. Warning Development the rapid development of warning infor- cal to use formal techniques. Evaluating
In-House Defense Quarterly Summer 2007 65
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3. Product LiabiLity
similar existing products with known his- — Gender — Temporal (product user should see
tories is one way. Other examples include — Literacy (e.g., reading level, non- the warning information before expo-
researching and referring to applicable: native language users) sure to the hazard)
• Codes, regulations and standards — Personality traits (e.g., self-efficacy, — Spatial (locate where product user
• Competitor’s warning information locus of control, risk taking, need for will see it)
• Technical literature (e.g., journal arti- cognition) — Durability
cles, technical reports, and government — Product familiarity • Format
reports) — Hazard perception — Signal words
• Trade or industr y groups and • Hazard likelihood and severity — Text vs. symbols
publications — Color vs. black and white
• Safety organizations and associations n — List vs. prose
• Incident/accident data and reports — Font type and size
• Medical literature The warning development — Layout
• Warranty returns A warning prototype is created in the
• Customer service complaints phase consists of three last part of the warning development phase.
• Litigation claims Unfortunately, it is all too easy to view this
• Subject matter experts parts: identifying potential as the first rather than the last step in the
• Product users process. By focusing on the warning infor-
These sources can be helpful in provid- warning information topics, mation itself, design teams overlook how
ing a clearer picture about the potential the hazard might have been eliminated ear-
hazards of a product. determining how to deliver lier in the development process.
The “costs” (e.g., money, time, design There are several things to consider when
team expertise, etc.) associated with per- the warning information, developing initial prototypes. First, careful
forming one or more formal techniques consideration should be given to relevant
might limit the likelihood that they are per- and creating warning regulations and standards. Design teams
formed. Thus, it would be preferable to use might consider consulting the American
less formal techniques to identify and ana- information prototypes. National Standards Institute (ANSI) Z535
lyze potential hazards rather than to per- series of safety standards. Currently, there
form no analysis. Also, some techniques n are six standards in the ANSI Z535 series:
require greater levels of quantification than • Z535.1—Safety Color Code
are currently known for a product. Trying • “Open and obvious” hazards • Z535.2—Environmental and Facility
to “force” the use of inappropriate tech- • Regulations and standards Safety Signs
niques can lead to biased hazard severity • Space limitations • Z535.3—Criteria for Safety Symbols
and/or probability ratings, thus resulting • Cost of compliance • Z535.4—Product Safety Signs and Labels
in improper action being taking to address • Overwarning • Z535.5—Safety Tags and Barricade
the hazard(s). Ultimately, the decision of Defining these factors determines how Tapes (for Temporary Hazards)
which technique(s) to use will depend on the warning information might be deliv- • Z535.6—Product Safety Information
the design team and the product involved ered to users. Warning information can in Product Manuals, Instructions, and
in the process. Companies who are unsure be presented in one or more of the follow- Other Collateral Materials
which process to use are encouraged to ing methods: on-product labels and/or These standards focus on warning infor-
obtain the assistance of a warning infor- markings, hang tags, instruction and ser- mation format and provide some guidance
mation expert. vice manuals, product packaging, MSDS, regarding content and location.
signs, point-of-purchase materials, and Second, additional guidance can be
Phase 3: Warning Development advertising and promotional materials. gained from industry guidelines or recom-
The warning development phase consists Some factors to consider when determin- mendations. Some documents the design
of three parts: identifying potential warn- ing how to deliver the warning informa- team might consider referencing include:
ing information topics, determining how to tion include: • CPSC (2003, October). Manufacturer’s
deliver the warning information, and creat- • Content guide to developing consumer product
ing warning information prototypes. After — Warning components (hazard identi- instructions. Washington: Consumer
the hazards have been identified and ana- fication, how to avoid it, and the con- Product Safety Commission.
lyzed, it is possible to identify what warn- sequences for failing to comply) • FMC Corporation (1993). Product safety
ing information to consider for inclusion — Message length signs and label system. Santa Clara, CA:
in the prototypes. Some factors to consider — Message explicitness FMC Corporation.
include: — Space limitations • Lehto, M.R. (1992). Designing warning
• Characteristics of the target audience — Multilingual presentation signs and warning labels: Part 1—Guide-
— Age • Location lines for the practitioner. International
66 In-House Defense Quarterly Summer 2007
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4. Journal of Industrial Ergonomics, 10, necessary to complete all of the internal Phase 5: Final Approval
105–113. reviews for a product. Also, the design and Documentation
Design teams might also glean guidance team should consider using individuals in The design team is not finished until the
from the hundreds of research papers on the the company who are not familiar with the completed process has final approval and
topic of warning information. One source products to perform the comprehension, has been documented. The design team
an interested design team might reference legibility and readability reviews. should receive final approval from appro-
to gain a better overall understanding of When should warning information be priate company personnel. If necessary, the
warning information, including the history, empirically tested? Unfortunately, the design team can present the warning infor-
research findings, development methods, answer is not simple. Depending on the mation to appropriate regulatory agen-
regulations and litigation issues is: product, a design team might conclude cies for approval. It is important that the
• Wogalter, M.S. (2006). Handbook of that completion of the earlier development design team document the process used to
Warnings. Mahwah, New Jersey: Law- phases is sufficient. A design team might develop the warning information. A doc-
rence Erlbaum Associates. consider empirical testing when: umented process is easier to replicate in
Lastly, companies might want to con- • The product is marketed and sold to spe- the future. Additionally, the documents
sider enlisting outside warning informa- cial populations. can demonstrate that reasonable care was
tion experts to evaluate the prototypes and • The product is substantially different taken to identify and understand product
provide suggestions for improvement. A from anything currently in the stream hazards and develop warning information
qualified expert can help determine how to of commerce. that adequately communicated the hazards
convey the warning information in a man- • Symbols/pictorials/icons will be used to potential product users.
ner best understood by users. without text. Finally, the company might want to con-
• The warning information will be in- sider implementing a monitoring program.
Phase 4: Warning Evaluation cluded in a standard. This could include keeping track of changes
Prototypes should receive some type of Empirical testing provides no guaran- in regulations and standards, changes in
evaluation. There are two general types of tee that all users will notice, read and com- competitor’s warning information, new sci-
evaluations: internal reviews and empirical ply with the warning information. Also, entific findings regarding warning infor-
testing. Internal reviews can help to identify it does not eliminate the possibility of lit- mation, warranty returns, customer service
potential errors or problems that may have igation. The decision to test must arise complaints and litigation claims to identify
occurred during the process. There are sev- from the knowledge and experience of the when a periodic review of the product’s
eral types of internal reviews, including: design team, working in coordination with warning information might be necessary.
• Compliance —does the warning informa- legal counsel. At times like this, enlisting Such actions would demonstrate a good
tion conform to the appropriate regulations, the assistance of an expert experienced in faith effort on part of the company regard-
standards and company guidelines? the design and development of warning ing their duty to provide post-sale warning
• Comprehension —is the warning infor- information might be prudent. Warning information.
mation understandable? information experts can help determine
• Consistency —is there consistent use of if empirical testing is necessary, and if so, Final Thoughts
language (a) within the product’s system design and conduct the necessary tests. The use of a warning information devel-
of information and (b) with competitor’s If the design team has made the decision opment process can aid a company in the
products and the industry as a whole? that empirical testing is necessary, there design and development of new warning
• Content —does the warning informa- are several factors they should consider: information or when auditing previously
tion correctly identify the hazard, how • What type of test(s) will be used? developed warning information. Unfor-
to avoid it and the consequences for fail- • What research methods will be tunately, many companies are unaware
ing to comply (if not readily inferred)? employed? that a process exists for developing warn-
• Durability —will the medium hold up for • Will intended product users be tested? ing information and that there are warning
its intended location and use? • How will the company recruit information experts who can assist them in
• Legibility —is it possible to see and read participants? dealing with the challenges they may face.
the warning information from an appro- • Will the warning information as a whole Companies that successfully implement
priate distance? be tested or certain components (e.g., the process can maximize their time and
• Readability —is the intended user able text, symbols, signal words, color, etc.) money, create consistency across product
to understand and process the warning of it? lines, and potentially create a more defen-
information? • What criteria will be used to determine if sible position when litigation occurs.
It should be noted that it might not be the warning information is appropriate?
In-House Defense Quarterly n Summer 2007 n 67