Management of spontaneous reports remains one of the most important activities in postmarketing surveillance. Increasingly, spontaneous reporting data are publically available, particularly following the criticism from the European Ombudsman over data secrecy by the European Medicines Agency in August this year. New legislation in the EU could mean the number of reports may well increase and so it is timely to reflect on what is best practice for spontaneous case management based on guidance from sources such as the Council for International Organization of Medical Sciences (CIOMS) V Working Group, combined with the latest thinking on systems science. Experience from implementing and maintaining systems in other safety conscious sectors has revealed the overriding importance of the ‘human factor’ in ensuring compliance and managing this through organizational learning, team-working principles and communication. Spontaneous data are very heterogeneous, and it is critical to understand the various types of adverse events and how they differ from adverse reactions. There is a paucity of published data about how to implement effective spontaneous reporting processes. Based on what we understand about quality systems, there needs to be a documented sequence of activities to manage the information, mitigate variation and manage errors and other process-related risks. Close attention needs to be paid to training employees around first interactions with a reporter, as this first step is the most important step in capturing all relevant facts regarding a report and determining subsequent case quality. However, success depends on an organizational structure with defined roles and responsibilities and optimization of personnel interaction ideally through a competency framework. Both quantitative and qualitative tools and metrics are needed to manage process quality, which can be useful for audit. Technology should be automated for efficiency and consistency without crushing ingenuity and innovation. Disappointingly, although companies describe how they have improved process effectiveness, there has been no public benchmarking to enable other companies to examine what works and what does not. This means we have to resort to the principles of quality management and organizational science and adapt them according to the needs of an organization’s spontaneous reporting processes.