Documents: Developing and Maintaining a Document Retention Policy
Product Safety: Monitoring Your Product to Identify Potential Hazards
Who should comprise the team? Product safety teams are typically composed of personnel from several key departments, such as from quality, regulatory, legal, operations, engineering, and customer service.
Is the inclusion of legal counsel appropriate? A company may include legal counsel on their team’s roster for the purpose of creating privilege. Before doing so, be sure to understand what sort of legal assistance creates privilege. Merely including an attorney on the team may not be enough to ensure that the team’s activities are privileged during litigation.
How often should the team convene? The team should meet regularly as determined by the frequency of customer complaints and adverse events. For some companies this may be monthly, for example, and for others is may be quarterly.
How should the team’s activities be documented? In order to ensure corporate accountability for the team’s findings and activities, require the team to report its findings to senior management.
Recalls: Taking Steps to Avoid Additional Injuries
Identify those parties that should be informed in the event of a recall. Procedures that describe how a company will conduct a recall usually identify the entities that the company must inform of the recall, such as suppliers and distributors. Also include on that list your insurance broker, who can offer suggestions about any insurance reporting requirements or implications for coverage.
Establish a path of legal review for all public documents. A company should require all communications to the public, including notices to the FDA and press releases, to undergo review by a products liability attorney. Too frequently, the only legal review these documents receive is to determine whether they meet FDA regulatory requirements. An attorney knowledgeable about products liability can assist with drafting the documents to ensure that they will not be problematic should a products liability lawsuit arise.
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Medmarc is a part of ProAssurance Group, a family of specialty liability insurance companies. The product material is for informational purposes only. In the event any of the information presented conflicts with the terms and conditions of any policy of insurance offered from ProAssurance, its subsidiaries, and its affiliates, the terms and conditions of the actual policy will apply.
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