Upon finding that 60 percent of products do not comply with new regulations, what is the regulatory professional's first step?

The first step for a regulatory professional upon discovering that a significant percentage of products do not comply with new regulations is to communicate with relevant internal departments. This action is critical as it facilitates a coordinated response to address compliance issues. Effective communication with various teams, such as product development, quality assurance, and legal, ensures that everyone is informed of the non-compliance issues and can collaboratively determine the root causes and potential solutions.

By engaging with these departments, the regulatory professional can gather insights into the specific reasons behind the non-compliance and work on developing strategies to bring the products into compliance. This step lays the groundwork for formulating an action plan that may include revising product specifications, changing manufacturing processes, or launching new training for staff.

While seeking advice from a trade association, preparing documentation, or requesting a waiver may also be relevant actions later in the process, they do not address the immediate need for internal collaboration and assessment of the current compliance status. Focusing on internal communication is essential for a thorough understanding of the situation and for formulating an effective response plan.