Classification of Complaints

A classification method should be used identify the quality, safety and performance issues that pose a high risk to individual health and to public health, and therefore require the most immediate action to protect public health and safety. Complaints may include administrative/contractual complaints and technical complaints. As soon as it has been received a complaint should be classified by the manufacturer as part of the risk management file for the product. The degree of risk will determine the timeline for action, and who should be informed. The requirement for root cause analysis will remain, irrespective of the classification.

In general, most technical complaints will be considered as an adverse event and should be classified. However, not every complaint may need to be considered as an adverse event, and not every adverse event or potential adverse event may lead to a field safety corrective action.