Meaning
Post market oversight ensures that the quality and safety of electronic products do not degrade after the initial approval is granted. Regulatory audit surveillance involves the random selection of units from the retail supply chain for independent laboratory testing. This process protects consumers by identifying products that no longer meet the required standards due to manufacturing changes or component substitutions.
Regular monitoring also serves to deter manufacturers from using unapproved parts in the production line.
Sampling Method
Selection of units is typically done without prior notice to the manufacturer to ensure a representative sample of the current production. During regulatory audit surveillance the agency might target specific product categories that have a history of non-compliance. The quantity of samples depends on the volume of the product in the market and the risk level of the technology.
Compliance Check
Laboratories re-evaluate the equipment against the same standards used during the initial certification process. A successful regulatory audit surveillance confirms that the product still adheres to the rules for electromagnetic interference and radio frequency exposure. Discrepancies between the original test data and the audit results are investigated thoroughly to find the root cause of the change.
Corrective Action
If a product fails the audit the manufacturer may be required to update the design or stop sales entirely. Findings from regulatory audit surveillance can lead to wider investigations into a company’s quality management system. Public notices are sometimes issued to inform consumers of any safety risks discovered during the surveillance.