Product Design Risk Management- Checklists

July 9, 2013
Sejong University,Seoul

Sejong University,Seoul

When designing products, manufacturing companies need to be very detailed to avoid product liability litigation in the United States. Product planning is a very detailed process involving many departments and in some cases divisions of a company. As part of an overall plan to reduce risks of product liability litigation as well as class actions and government investigations raised by CPSC or FTC concerns, I recommend manufacturing companies develop a detailed design risk program or “DRP.” Such processes can minimize, reduce, or prevent liability when claims are brought and is part of a good LRM program. A checklist should be developed to cover such design risk  issues. Checklists are another handy tool to use when looking at processes and procedures to minimize legal liability.  I am a big fan of checklists as checklists can streamline the risk management process if used wisely.

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Product planning and design process considerations should normally include the following:

  • Written procedures for the design program, should include:
    • Design choices—consideration of alternative designs
    • Specifications—definition of specifications used in designing the product
    • Establishment of a design review committee
  • Establishment of written procedures for the development of specifications, which verify that specifications are accurately reflected in the designs.
  • Establishment of procedures for construction and testing and prototypes.
  • During the design: Evaluation and consideration of:
    • Determine types of people likely to be exposed to the product, consider unique risks to these groups
    • Tailor labeling and develop safety features to address the unique risks to the intended users
    • Risks of intended use—test and evaluate to determine what risks are presented if the product is used as intended; reduce these risks through design changes, safety features, and/or labeling

Of course many more items  can  be added to the DRP checklist to cover manufacturing concerns and new product development concerns including specifications for new product testing.  These items will be discussed in my upcoming blog post on new product development design considerations.

 

 

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