Product Safety Management
50 Years of Safety Research
Corporate Safety Policy
- Bass, Lewis, Products Liability: Design and Manufacturing Defects.
McGraw-Hill, Colorado. 1986, p. 292.
"Representatives from engineering, manufacturing, quality assurance, purchasing, sales, marketing, advertising, legal and insurance departments should serve on a central committee prepared to take specific action in the event that flawed products are being distributed to consumers.
- Blake, Roland P., ed., Industrial Safety. Prentice-Hall, New York.
1943, p. 65.
Management must provide leadership
"Under the circumstances, therefore, it is absolutely essential that top management as a whole, and the chief operating executive in particular, provide the same kind of leadership in accident prevention as they provide in the field of production. If the manager becomes convinced that accidents can and must be prevented, he will issue the necessary orders that are to be carried down through the organization; he will follow through to see that his orders are carried out; he will set a good example for safety..."
- Eads, George and Reuter, Peter, Designing Safer Products: Corporate
Responses to Product Liability Law and Regulation . The Rand Corporation
- The Institute for Civil Justice, Santa Monica, California. 1983, p.
xii.
"A lean product safety organization that has the ear of the CEO and a good working relationship at various levels of the firm is likely to be much more effective than a highly visible unit that establishes procedures but lacks either the resources to impose them or, even more disastrous, the support of the firm’s top officers when such support is necessary."
- Heinrich, H. W., Industrial Accident Prevention: A Scientific
Approach. McGraw-Hill, New York. 1931, p. 6.
"Fundamental Principles. -- This is a true composite picture of the situation in many progressive manufacturing concerns that have successfully applied modern accident-prevention methods in a businesslike way. It is given here because it exemplifies the use of the four principles of scientific accident prevention subsequently discussed in this book. These are:
1. Executive interest and support.
2. Cause-analysis
3. Selection and application of remedy.
4. Executive enforcement of corrective practice."
- Kolb, John and Ross, Steven S., Product Safety and Liability: A
Desk Reference. McGraw-Hill, New York. 1980, p. 91.
"The company official to whom product safety responsibility has been delegated should have immediately available copies of the firm’s safety policy, directories of responsible employees, recall procedures, and any additional material needed to react to an emergency situation or to routine requests for guidance from others within the company."
- Lux, William, "Engineering Considerations on Litigation Avoidance",
in Society of Automotive Engineers: Product Liability and Quality: SP-586.
Society of Automotive Engineers, Warrendale, Pennsylvania. 1984, p.
17.
"Such a product review team should consist of representatives from a broad spectrum of technologies and viewpoints -- engineering, design, test, safety experts, manufacturing people, inspection, materials experts, etc. This type of organization will provide a multi-focused wide variety of views in one consensus type effort. The viewpoints are varied, but the objective is well focused -- is the product safe and are there practical ways of making it safer?"
- National Safety Council, Accident Prevention Manual for Industrial
Operations, 4th ed. National Safety Council, Chicago. 1959, p. 2.1.
"Top management must take an active and interested part in the development and operation of the safety program."
- National Safety Council, Product Safety: Management Guidelines
National Safety Council, Chicago. 1989, p. 11-12
"The product safety program should have an important place within the organizational structure. The components of the program can include the policy statement, procedure manuals, safety committees, and a product safety coordinator... The objective of the policy statement is to communicate the company’s ideals and commitment to product safety to the employees."
- Roland, Harold E. and Moriarty, Brian, System Safety Engineering
and Management. John Wiley & Sons, New York. 1983, p. 34, 47.
"The system safety program is the most important element in implementing a system safety program after top management and the customer have made the commitment to develop a safe system. Implementation must be clearly detailed by the management document that will identify the safety tasks required to conduct the system safety program."
"Within a company the system safety manager should be on the immediate staff of the company’s program manager to insure that system safety engineering is accomplished for functions such as operational support, as well as design engineering. System safety functions best as a task group completely independent of the other supporting disciplines, such as reliability and maintainability ; the group should have access to design information."
Hazards / Functions
- Cushman, William H. and Rosenberg, Daniel J., Human Factors in
Product Design. Elsevier, Amsterdam. 1991, p. 36.
"Each task that has been tentatively allocated to the user should be examined in detail to determine the requirements for the user interface (e. g., displays, controls, and feedback) and whether users are capable of satisfying the task’s performance requirements. This procedure is usually referred to as task analysis. Tasks that are determined to be too difficult for the user must be simplified or performed by the product."
- Hammer, Willie, Product Safety Management and Engineering. Prentice-Hall,
Englewood Cliffs, New Jersey. 1980, p. 152.
"A predesign analysis determines those hazards that might be present in a product to be developed. It may be the basis for the preparation of specifications and criteria to be followed in design; it may indicate undesirable product characteristics, materials, and design practices to be avoided; it may determine safeguards to be provided; and it may tentatively establish tests to be undertaken to verify safety devices and safety-critical aspects of the product."
- Roland, Harold E. and Moriarty, Brian, System Safety Engineering
and Management. John Wiley & Sons, New York. 1983, p. 10, 187.
"Hazard Analysis is the heart of the system safety approach. An effective hazard analysis effort over the life cycle of a system is the spine on which all body components of a safety program are attached. Anticipating and controlling hazards at the design stages of an activity is the cornerstone of a system safety effort."
"A hazard may be defined as a potential for doing harm. The harm may take the form of injury, morbidity, or damage to equipment or other property. The word potential is important in the hazard definition. The system safety function can be defined in terms of a search for potentials to do harm. Having found the potentials, the system safety practitioner is expected to control them to an acceptable level through one of several means."
Forseeable Use
- Bass, Lewis, Product Liability: Design and Manufacturing Defects.
McGraw-Hill, Colorado. 1986, p. 39.
"The manufacturer is required to foresee how products are actually used even if these practices are not condoned or authorized."
- National Safety Council, Product Safety: Management Guidelines.
National Safety Council, Chicago. 1989, p. 43.
"Nevertheless, the manufacturer has a duty to make a product which is safe under normal use and under reasonably foreseeable misuse or to warn about substantial hazards that may result from normal user and reasonably foreseeable misuse."
- Organization for Economic Cooperation and Development, Product
Safety Measures to Protect Children. Organisation for Economic Cooperation
and Development, Paris. 1984, p. 8.
"It is widely accepted that consumer goods should be adequately safe when used for their intended purpose and also under conditions of foreseeable misuse of the kind which commonly occurs."
- Roland, Harold E. and Moriarty, Brian System Safety Engineering
and Management. John Wiley & Sons, New York. 1983, p. 9.
"The system safety concept, on the other hand, involves a planned, disciplined, systematically organized, and before-the-fact process characterized as the identify-analyze-control method of safety. The emphasis is placed upon an acceptable safety level designed into the system prior to actual production or operation of the system. The system safety discipline requires timely identification and evaluation of system hazards -- before losses occur."
- U. S. Consumer Product Safety Commission, Handbook and Standards
for Manufacturing Safer Consumer Products, June 1975. p. 35.
"Design review consists of:1) Identification and evaluation of potential safety hazards against pre-established criteria appropriate to the product. It is particularly important that these criteria include objective projections of the conditions under which the product is used, including recognition of the age levels and physical limitations of users, and contingencies that might occur as a result of misuse or abuse of the product. It is advisable that the criteria distinguish substantial safety hazards from product deficiencies that do not involve risks of injury or impairment of health."
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Weinstein, Alvin, Product Liability and the Reasonably Safe Product: A Guide for Management, Design, and Marketing. John Wiley & Sons, New York. 1978, p. 41, 140.
"It is crucial to distinguish between warnings and instructions. Instructions tell the consumer how to use the product effectively. Warnings inform the consumer of the dangers of improper use and tell how to guard against those dangers, if possible."
"...products must be designed for foreseeable use, not solely intended use. This means that, once the functional aspects of a product are designed, a subjective, analytical process must begin. This process must articulate the types of use and misuse a product can suffer in the hands of all who may come in contact with it. This process must anticipate the hazards and risks of injury that are likely to be encountered by the users. Once this is done, the product design must be reviewed and decisions made concerning which design alterations, warnings and instructions must be incorporated to minimize or eliminate the perceived risks of injury."
Risk Factors
- Bass, Lewis, Product Liability: Design and Manufacturing Defects.
McGraw-Hill, Colorado. 1986, p.35.
"The seller must design and manufacture a product anticipating the environment in which it will be used, the age and skill of the users, and expected modifications and misuses."
- Blixt, Charles A., "The Role of the Engineer in Product Liability
Litigation". in Society of Automotive Engineers: Product Liability
and Quality SP-586. Society of Automotive Engineers, Warrendale, Pennsylvania.
1984, p. 8.
"If a hazard exists, the designer then must determine what the risk of injury is... This is obviously affected by a variety of factors such as the intelligence of the user, his experience, the light or noise level at a given situation, the proximity of the individual to the hazard and the potential exposure to the hazard."
- Edwards, Alice, Product Standards and Labeling for Consumers.
The Ronald Press Co., New York 1940, p. 73.
"The dealer who acts with care and diligence, in seeing that the information is correct, in insisting that his sources furnish him with the necessary information, in conscientiously passing that information on to his customers in good faith, immediately places himself in a most favorable position so far as responsibility for wrongdoing is concerned."
- National Advertising Review Board (NARB), "Product Advertising
and Consumer Safety". Advertising Age Special Report, July 1, 1974.
"• Advertising can do more than it is now doing to safeguard the users of advertised products without impairing its ability to merchandise those products effectively.
• The number one problem is the "inadvertent safety error," the unsafe situation in which the product is presented rather than the claims made for the product itself.
• Advertisers and agencies do not always recognize that some consumers are particularly vulnerable to suggestion or have limited capacities for judging risk...
• Advertisers and agencies should establish within their organizations "safety in advertising review panels" charged with responding to the public interest in matters of product safety and responsible for compliance with the guidelines and philosophy of this report."
- National Safety Council, Product Safety: Management Guidelines.
National Safety Council, Chicago. 1989, p. 83.
"The company must also be able to verify that its sales personnel and dealers have been instructed to accurately describe the capabilities of the products they are selling or distributing. That is, the company should be able to prove that it has tried to avoid incurring undesired implied and/or expressed warranties. For example, sales personnel must be instructed not to exaggerate the capabilities of the company products."
"After a ‘reasonably’ safe product has been designed and manufactured, product complaints may be unnecessarily incurred by the manner in which the product is represented to customers and users."
- Organization for Economic Cooperation and Development, Safety of
Consumer Products: Policy and Legislation in OECD Member Countries.
Organisation for Economic Cooperation and Development, Paris. 1980,
p. 11.
"The potential hazard of a product is, therefore, first determined by the fact that it presents an unreasonable risk of injury when used for its intended purpose. Moreover, the risk of predictable misuse has also to be taken into account, in particular with regard to vulnerable consumer groups such as children."
- Organization for Economic Cooperation and Development, Product
Safety: Risk Management and Cost-Benefit Analysis. Organization for
Economic Cooperation and Development, Paris. 1983, p. 21.
"Evaluation of a risk relates not only to the nature and magnitude of the risk; it is also important to consider what population groups are particularly exposed (e.g., children, the elderly or the handicapped), how the consumer may foresee the risks and to what extent the mode of use -- or the time of use -- affects the injury."
- Weinstein, Alvin, Product Liability and the Reasonably Safe Product:
A Guide for Management, Design, and Marketing. John Wiley & Sons,
New York. 1978, p. 37, 137, 138, 141.
"The problem of product performance need not necessarily result from inadequate communication. The product itself may be the purveyor of false impressions about its performance abilities... The standards of performance may have to meet real life expectations determined by product use."
"First and foremost the manufacturer must assess the actual environment in which the product will be used. The manufacturer will not be permitted to define either by marketing techniques or ineffectively worded communication with the user, a use environment inconsistent with the real world. A product has a life of its own outside the walls of a design shop. A manufacturer must come to understand the real life of his product. Similarly, a manufacturer must know his user population, for they affect the scope and nature of product use."
"Equally important for the manufacturer should be concern about the marketing of products. A safe product may be made unsafe by creating unrealistic expectations in the mind of the user through advertising representations."
"Once these product use and user situations are posited, the next task is to identify the hazards that are likely to arise from the interactions of product use, environment and users."
Safety Measures
- Lowrance, William, Of Acceptable Risk: Science and the Determination
of Safety. W. Kaufmann, California. 1976, p. 138.
"Safeguarding actions are possible at every stage in the formative life of products, beginning with design and moving through certification or licensing, to manufacturing quality control, packaging and labeling, and on through advertising and marketing. And then products can be followed onto the market to monitor safety in use."
- National Safety Council, Accident Prevention Manual for Industrial
Operations, 5th ed.. National Safety Council, Chicago. 1964, p. 4.1.
"If all possibilities have been exhausted and the hazard is still not removed, then every effort should be made to enclose or guard the hazard at its source so that exposure to injury is controlled. In some cases, this measure can be just as effective as elimination of the hazard, but it is usually second best."
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National Safety Council, Product Safety: Management Guidelines. National Safety Council, Chicago. 1989, p. 29, 53.
"The first concept is the safety engineering hierarchy of priorities:
1) eliminate hazards
2) when hazards cannot be eliminated, provide feasible safeguards against them
3) provide warnings and personal protective equipment against remaining hazards."
"The product safety coordinator should, with the aid of engineering or other departments, if necessary, review all product communications and make sure that warning messages contained therein fulfill the following three requirements:
1) Warnings must clearly describe the possible consequences, especially personal injury, of not heeding the warning, when the consequence is not obvious.
2) Warnings must clearly and understandably inform the user what to do or not to do to avoid injury, when avoidance procedures are not obvious.
3) Warnings must identify all hazards that are not obvious." -
Weinstein, Alvin, Product Liability and the Reasonably Safe Product: A Guide for Management, Design, and Marketing. John Wiley & Sons, New York. 1978, p. 40, 138.
"Closely allied to the issue of unreasonable danger, and often determinative of it, are the warnings and instructions that accompany a product. A product may meet the most exacting production and design requirements and still be judged defective if the warnings and/or instructions are inadequate, because the danger level of the product can be substantially reduced by carefully worded warnings and instructions on product use and the possible consequences of misuse. Since warnings are relatively inexpensive and require no major redesigning of the product, the natural tendency of manufacturers is to warn against rather than redesign against a foreseeable danger. On the other hand, manufacturers may be reluctant to warn about all the foreseeable dangers for fear that such warnings will negatively affect the product’s marketability."
"Manufacturers should not, however, view warnings as a substitute for intelligent design decisions. Manufacturers, in deciding whether to design out a hazard or warn against it, should undertake the same risk -- utility balancing described for judging the adequacy of a given design."
"When a design alteration is not possible or feasible for reducing risk, then effective warnings may be the only way to market an acceptably safe product. Such warnings must not only alert the user of danger, but must also tell him, appropriately, how to avoid injury
Corrective Actions
- Bass, Lewis, Product Liability: Design and Manufacturing Defects.
McGraw-Hill, Colorado. 1986, p. 68, 346.
"A product that was not originally defective may be found defective because of a failure to warn of or correct hazards subsequent to sale. A manufacturer has a continuing duty to study tests and monitor developments in the particular field in which his or her product is used. The manufacturer must also apply sound judgment in analyzing the product and anticipating problems or dangers which may arise. Thus, a manufacturer may owe a duty to update a warning which, when given, was adequate, but by virtue of advancements and knowledge about the product, is now inadequate to disclose the new risk."
"Manufacturers must develop a traceability system whereby they can determine who the users of the equipment are and where the products are located... The manufacturer should maintain records that will permit an analysis of the potential recall magnitude."
- Carey, William R., "A Corporate Product Quality Assurance
Program". in Society of Automotive Engineers: Product Liability
and Quality SP-586. Society of Automotive Engineers, Warrendale, Pennsylvania.
1984, p. 30.
"The manufacturer has a continuing duty to users or consumers with respect to defects discovered after manufacturing."
- Dawson, John R. and Binder, Robert L., "How to Avoid (or Win)
Products Litigation". in Society of Automotive Engineers: Product
Liability and Quality SP-586. Society of Automotive Engineers, Warrendale,
Pennsylvania. 1984, p. 23.
"It also imposes an obligation to investigate problems discovered after a product already is in the field so that subsequent products are designed to avoid such problems."
- Kolb, John and Ross, Steven S., Product Safety and Liability: A
Desk Reference. McGraw-Hill, New York. 1980, p. 193.
"Organizing an effective product safety program requires more than formation of ‘internal’ monitoring agents such as the product safety review. It also requires the formation of agents to develop and report information back on your product."
- National Safety Council, Product Safety: Management Guidelines.
National Safety Council, Chicago. 1989, p. 105.
"Retention periods of records of tests, analyses, quality control procedures, lot numbers, serial numbers, and shipping procedures should take into consideration the life of the product plus a period to account for factors such as statutes of limitation. Generally speaking, if a company cannot accurately define the ‘life’ of its products, it should be theoretically prepared to consider retaining all product safety records in perpetuity."
- Organisation for Economic Cooperation and Development, Safety of
Consumer Products: Policy and Legislation in OECD member Countries.
Organisation for Economic Cooperation and Development, Paris. 1980,
p. 49.
"Once a hazard has been identified and confirmed, it is obviously important that all those who have purchased the defective product should be warned as quickly as possible."
- U. S. Consumer Product Safety Commission, Handbook and Standards
for Manufacturing Safer Consumer Products, June 1975. p. 38. Corrective
Action
"To prevent hazardous products from being delivered to consumers, it is necessary that manufacturers establish procedure to take prompt corrective action when appropriate. This action includes determination of hazard cause(s), prevention of their repetition, and removal of hazardous consumer products from production and distribution channels. Reporting procedures are necessary to keep executive management informed of product safety hazards and trends which might induce such hazards. Most importantly, arrangements must be provided for compliance with Section 15(b) of [the CPSA] to the effect that "Every manufacturer of a consumer product distributed in commerce, and every distributor and retailer of such product..." report to the CPSC products which contain "a defect which could create a substantial product hazard."
- Westinghouse Electric Corporation, Product Safety Label Handbook.
Westinghouse Printing Division, Trafford, Pennsylvania. 1985, p. 5.
Post-Sale Duty to Warn
"If a hazard is discovered after a product is sold, the manufacturer should consider informing product users or other appropriate persons about the risk. In some cases the product may have to be modified. In other cases it may be advisable to create a safety label."