Many of the aspects of Product Liability prevention (PLP) deal with other areas of the product development operation besides just safety design; Randall Goodden¹⁰ considers the following (and I heartily agree):

• Contracts & Agreements - what's your level of exposure?
• Product Design - Do you review the designs from a safety standpoint?
• Marketing / Advertising - What do you say and claim about the product
• Reliability Testing - Do you validate your claims?
• Document Control - Do you have a record that you've corrected past defects and a program to design against them?
• Warranties - Do you have them and understand what they are?
• Warning Labels & Instructions - Do they comply and are they correct?
• Records Retention - Do you save records to record your due diligence, design validations, safety justifications and activities?
• Supplier Selection - Do they have liability insurance and also follow good practices?
• Recall Procedures - Do you have them? Are you proactive to customers and regulatory agencies?
• Liability Incidents & Investigation - Are you proactive to customers and regulatory agencies?
• Litigation - Are you prepared for PLP?

Because your intended product may have a high litigious potential (e.g. medical devices, drugs, autos and large industrial processing machines), you might consider the need for a formal PLP (and PLP insurance) in addition to the product safety activities we've been stressing. This could be also be valuable as a focus for remedial actions during the product development and test program.

Also in force within the European Union is the European Defective Product Liability Directive (85/374/EEC), which introduced in the EU the principle of objective liability or 'liability without fault'. According to it:

"Any producer of a defective movable must compensate any damage caused to the physical well-being or property of individuals, independently whether or not there is negligence on the part of the producer."

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¹⁰ Randall Goodden is the author of Product Liability Prevention - A Strategic Guide (Quality Press, 2000) and Preventing & Handling Product Liability, (Marcel Dekker Publishers, 1995).