Bill Kitzes Product Safety Management

Kitzes on Safety

Unreasonable Risk

Originally published in the CCH Consumer Product Safety Guide, 2000.

We don’t live in a risk free society. Many of the products we use and activities we enjoy present some level of risk. Before distributing a product to the public, an evaluation is required to determine whether those risks are reasonable. Are consumers willing to take the risk (once fully informed) to enjoy the benefits? Debating these questions will be the central theme of this column. We’ll concentrate on reviewing safety regulations, including the reporting requirements and the recent proposal by the White House to increase compliance under the Consumer Product Safety Act. We’ll cover the defect reporting rules and Federal Motor Vehicle Safety Standards (FMVSS) published by the National Highway Traffic Safety Administration. Finally, we’ll explore specific product safety issues pertaining to sports and recreation equipment, children’s products, motor vehicles, power equipment, warning labels, hazardous substances and other products used in and around homes, schools and recreational areas.

The ten principles of product safety management described below provide a framework for manufacturers, distributors and retailers to determine whether an unreasonable risk exists, and the tools to evaluate whether technically feasible and economically practical safety measures will substantially reduce or eliminate injuries. These “system safety” procedures have been developed over the last 50 years, initiated by the writings of H.W. Heinrich in Industrial Accident Prevention: A Scientific Approach (1931), the Consumer Product Safety Commission’s Handbook and Standard for Manufacturing Safer Consumer Products (1975) and more recently the National Safety Council’s Product Safety Management Guidelines (1989, 1996). These core concepts provide a basic model for the reasonably prudent manufacturer, distributor and retailer to develop and market reasonably safe products.

1. Establish and observe a written Corporate Safety Policy

A written corporate safety policy is the ultimate responsibility of top management. The document is designed to detail executive commitment, both statutory and voluntary, to the concept of system safety; a before-the-fact management system designed to insure the production and distribution of reasonably safe products.

2. Create an independent safety review process

The role of the Corporate Safety Director is an advisory position, with authority to gather information across technical functions such as product design, engineering, epidemiology, human factors, communications and legal. Such data can then be related to top management independent of the production managers, whose primary responsibilities for “getting the product out the door” can divide his or her loyalties and compromise injury control.

3. Identify and evaluate the severity and foreseeability of product hazards

A hazard is the inherent capability of a product to do harm. It is most often the result of an energy transfer or release, with such transfer creating impact to the product user. Appropriate analysis must include a focus on whether the hazard is latent to the user while foreseeable to the producer and the impact on vulnerable populations groups, such as children, the elderly, and the disabled.

4. Conduct a design review assessing the risk of injury by considering the
hazards, the environment, and foreseeable use

A risk of injury is the opportunity for a specific set of conditions to create harm: Under what circumstances can the user be injured? An examination of the identified hazards, the environment in which it is intended to be used and foreseeable consumer use identified through surveys, focus groups, injury data, and other sources must be considered. Significant risks that can be substantially reduced or eliminated by technically feasible and economically practical safety means are by definition unreasonable.

5. First attempt to eliminate hazards. If not possible, then reduce the
opportunity for injury by guarding against the hazards

By completely eliminating a specific hazard, like removing the blade from a power mower, certain injuries cannot occur. But this is often not possible. That same power mower employing a steel blade rotating at over 200 mph can incorporate devices to shut down the blade when the operator releases the controls or gets up from the seat, and can provide guards to shield user access to the blades.

6. Warn users of product dangers and motivate them to avoid injury

In addition to other safety measures, product warnings and instructions can assist the user to avoid dangers, including those that remain after thorough attempts to eliminate or guard. Under the ANSI Z535 standard for Product Safety Signs and Labels, an explicit warning including a signal word, statement of the hazard, appropriate behavior and a description of the consequences of the danger are required. A pictorial illustrating the consequences is often effective to communicate the danger and motivate users to avoid injury.

7. Promote only the safe use of a product

Advertising and product promotion sometimes subtly and deceptively promote consumer misuse. Motorcycles promoting speeds up to 150 mph certainly encourage users to go fast, if not to the limit. Positive statements providing safe use instructions with sufficient frequency to influence behavior is necessary to reinforce safe activity. As early as 1975, the National Advertising Review Board published guidelines for safe marketing programs.

8. Maintain safety-related records during the useful life of the product

An effective product safety system requires records in sufficient detail to allow for timely detection of safety hazards and trends, and for tracing product defects in assembly, components and overall design. Records necessary to provide sufficient data for management decisions include safety-related product changes, test results, consumer complaints, product liability lawsuits, location of products within the distribution chain, government injury data, and engineering reports.

9. Continuously monitor the safety performance of the product in the
hands of users

Once a manufacturer/distributor has concluded that a product is reasonably safe based on pre-production review and analysis, the product is ready for distribution to users. Feedback from product users is critical to determining whether subsequent corrective action is necessary. Government injury data such as the CPSC’s National Electronic Injury Surveillance System (NEISS) is a primary resource for management safety data.

10. Promptly notify product users and institute recall procedures where
necessary to substantially reduce or eliminate injury

Upon discovery of a product defect or unreasonable risk after distribution to the public, immediate notification to both the government and consumers and quick steps to protect users from injury are critical. Efficient recall procedures can remove hazardous products from the stream of commerce. New Systems such as the CPSC’s Fast Track Program can initiate corrective action early without a finding of a substantial hazard by regulators.

Ultimately this column will explore how top management can develop a system to predict foreseeable uses, correct product defects and investigate accident reports to prevent injury to consumers. Over the next few columns, we will explore the Consumer Product Safety Commission’s reporting rules and identify ways to implement notice and recall campaigns quickly and effectively.