Product LiabiLity

Maximize Resources while Creating Consistency and Defensible Positions

Is Your Company Using
a Proces...
ety of benefits, including helping to pro-      4. Warning Evaluation                            mation, and if necessary,...
Product LiabiLity

similar existing products with known his-         — Gender                                         — Te...
Journal of Industrial Ergonomics, 10,          necessary to complete all of the internal       Phase 5: Final Approval
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Warning Development Process Article


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Warning Development Process Article

  1. 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 64    In-House Defense Quarterly    Summer 2007 n n © 2007 DRI. All rights reserved.
  2. 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 n n
  3. 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 n n
  4. 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