Warning Information Development Process
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This document outlines Benchmark Research & Safety's warning information development process. It discusses the company's services, defines what constitutes a warning, and explains the benefits of a structured development process. This process involves 5 phases: 1) project planning, 2) hazard identification and analysis, 3) warning development, 4) warning evaluation, and 5) final approval and documentation. Each phase is described in 1-2 sentences with key considerations. The overall summary emphasizes Benchmark's systematic approach to warning design.
Warning Information Development Process
- 1. Warning Information Development Process Eric F. Shaver, Ph.D. November 4, 2011 1
- 2. Benchmark Research & Safety, Inc. Founded in 2000 Services & products we provide: • Product & occupational safety Warning information design, development, & evaluation Product liability litigation support Research design, development & analysis • Usability • Web application design & development • Program administration & contract monitoring • Training & education 2
- 3. What is a Warning? Warnings provide information about risks • Notification (facts) Nature of the hazard Instructions on how to avoid the hazard Consequences for failing to do so • Advice (judgments) What people ought to do Recommended course of action 3
- 4. Warnings & Product Safety Safety hierarchy • Design • Guard • Warn • Train Warnings are intended to contribute to product safety • Decreasing residual risk • Increasing tolerable risk Reasonably safe = residual risk < tolerable risk 4
- 5. Warning Considerations Why does it seem so easy to write a warning, but in actuality it’s quite difficult? Developing warnings is a balancing act • Trying to achieve many objectives • Working with limited resources • Choosing and implementing warning features So what is the solution? 5
- 6. Warning Information Development Process Phase 1: Project Planning Phase 2: Hazard Identification & Analysis Phase 3: Warning Development Phase 4: Warning Evaluation Phase 5: Final Approval & Documentation 6
- 7. Benefits Structured v. ad hoc process • Minimize time & money waste • Increased confidence in the warning information quality • Greater repeatability • Reduce likelihood of product recalls Legal concerns • Consistency across product lines • Maintain record of decisions • Deal with legal issues more efficiently and effectively 7
- 8. Project Planning Defining the scope Identify team members Resource allotment 8
- 9. Project Planning, cont. Defining the scope • Saves times and money • Identify affected products (including accessories) • “System of Information” On-product labels/markings Hang tags Instruction & service manuals Packaging MSDSs Signs Point-of-purchase materials Advertising & promotional materials 9
- 10. Project Planning, cont. Identify team members • Goal: identify & respond to hazards • Consider including: Design engineers (mechanical, electrical, chemical, etc.) Human factors engineers/psychologists Packaging engineers Technical writers Marketing Customer service Regulatory affairs Trade association representatives Legal counsel 10
- 11. Project Planning, cont. Resource allotment • Provide sufficient time & money • Engage early in the design process • Warnings are often an afterthought • Avoids costly redesigns 11
- 12. Hazard Identification & Analysis “Know what was not previously known” Two general ways – formal techniques & external sources Formal tools: • Hazard Checklists • Preliminary Hazard Analysis • Fault Tree Analysis • Failure Modes and Effects Analysis • Event Tree Analysis • Root Cause Analysis • Job Safety Analysis • Critical Incident Technique • Risk Assessment Matrices • Hierarchical Task Analysis 12
- 13. Hazard Identification & Analysis, cont. External sources of information • Codes, regulations, and standards • Competitor’s warnings information • Technical literature • Trade or industry groups & publications • Safety organizations & associations • Incident/accident data & reports • Medical literature • Warranty returns • Customer service complaints • Litigation claims • Subject matter experts • Product users 13
- 14. Hazard Identification & Analysis, cont. Unlikely any single method will address all needs Consider using multiple methods Formal techniques may not be necessary • Established products w/known histories Ultimately, decision lies with design team 14
- 15. Warning Development Three parts: • Identify potential topics • Determine delivery method • Prototype creation Two key questions • What do you want people to know? • How do you expect them to know it? 15
- 16. Warning Development, cont. Identify potential topics • Transform knowledge about hazards into possible topics Some hazards generate multiple topics Some topics address multiple hazards Not every hazard will lead to a warning topic • Why not provide a message about every topic? Space limitations Overwarning issues 16
- 17. Warning Development, cont. Identify potential topics, cont. • Characteristics of the target audience Age Gender Literacy (e.g., reading level, non-native language users, etc.) Personality traits (e.g., self-efficacy, locus of control, risk taking, etc.) Product familiarity Hazard perception • Hazard likelihood & severity • “Open and obvious” hazards • Regulations & standards • Space limitations • Cost of compliance • Spatial & temporal placement 17
- 18. Warning Development, cont. Determine delivery method • Content Warning components Message length Message explicitness Space limitations Multilingual presentation • Location Temporal (user should see before hazard exposure) Spatial (locate where product user will see it) Durability • Format Signal word Text v. symbols Color v. black & white List v. prose Font type & size Layout 18
- 19. Warning Development, cont. Determine delivery method, cont. • Presentation methods On-product labels/markings Hang tags Instruction & service manuals Packaging MSDSs Signs Point-of-purchase materials Advertising & promotional materials 19
- 20. Warning Development, cont. Prototype creation • Consult relevant regulations & standards • ANSI Z535 series: Z535.1 – Safety Color Code Z535.2 – Environmental and Facility Safety Signs Z535.3 – Criteria for Safety Symbols Z535.4 – Product Safety Signs and Labels Z535.5 – Safety Tags and Barricade Tapes (for Temporary Hazards) Z535.6 – Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials • Focuses on format w/ some content & location guidance 20
- 21. Warning Development, cont. Prototype creation, cont. • Reference documents CPSC (2003, October) – “Manufacturer’s guide to developing consumer product instructions” FMC Corporation (1993) – “Product safety signs and label system” Lehto (1992) – “Designing warnings signs and labels” Robinson (2009) – “Writing and designing manuals and warnings, 4th ed” • Consider using outside subject matter experts 21
- 22. Warning Evaluation Prototypes should receive some type of evaluation Two general types • Internal reviews Can help identify potential errors or problems • Empirical testing Some believe it’s a requirement No easy answer re: when empirical testing is needed 22
- 23. Warning Evaluation, cont. Internal reviews • Compliance - regulations, standards, & guideline compliance? • Comprehension - is it understandable? • Consistency – across products & industry? • Content - hazard, how to avoid it, & consequences • Durability • Legibility – can users see & read information? • Readability – can users understand & process info? 23
- 24. Warning Evaluation, cont. Empirical testing • When might a design team consider it: Marketed & sold to special populations Substantially different from other products on the market Symbols/pictorials used without text Warning information included in a standard • Provides no guarantee that user will notice, read, & comply 24
- 25. Research Findings Table 1: Rates of noticing, reading and complying with warnings reported in the literature Study % Noticed % Read % Complied Frantz & Rhoades (1993) 57 42 28 Frantz, et al. (2000) 98 -- 17 Friedmann (1998) 88 46 27 Gomer (1986) 100 -- 21 Hatem (1993) 87 -- 2 Otsubo (1988) 74 52 38 Shaver, et al. (2006) 90 47 10 Smith-Jackson & Durak (2000) 0 0 0 Strawbridge (1986) 91 77 37 25
- 26. Why is behavioral compliance so low? Several steps involved: • See it • Read it • Understand it • Accept it • Follow it The warning is only part of the puzzle 26
- 27. FAB Model Situation / Environment Product User Processing Decision Behavior Product / Task Making Warning 27
- 28. Warning Evaluation, cont. Empirical testing, cont. • Several considerations when What type of test(s) will be used? What research methods will be employed? Will intended product users be tested? How will the company recruit participants? Will the warning be tested as a whole or certain components? What acceptance criteria will be used? • Enlisting an outside consultant Decrease wasted time and money Guide process completion Determine if empirical testing is necessary Perform the empirical testing 28
- 29. Final Approval & Documentation Final approval • Company personnel • Regulatory agencies (if necessary) Documentation • Easier to replicate in the future • Demonstrates reasonable care May want to implement a monitoring program • Changes in regulations & standards • New scientific findings re: warning information • Warranty returns • Customer service complaints • Litigation claims 29
- 30. Contact Information For additional details, contact: • Eric F. Shaver, Ph.D. Senior Consultant Benchmark Research & Safety, Inc. eshaver@benchmarkrs.com 30