Here are a few items a company may be called upon to defend when a product's safety is at issue
Documentation of design choices/safer alternative designs
Ability of internal research and development to withstand scrutiny
Steps taken to ensure supply chain integrity
Reliability of component part manufacturers
Manufacturing quality controls on a global basis
Foreseeable misuse of the product
Marketing and distribution procedures
Ability to track and recall a product
Is there proposed or pending federal or state legislation which could impact the company?
Risk of counterfeit products/tampering
Internal document management, including e-mails
What strategic communications/crisis managements systems are in place?