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If you are manage your records in the context within which had been looking created or captured, might unfortunately get a complicated classification system may never meet the requirements of your organisation or system users, let alone comply with ISO Standards.
Too often, when adverse events enter an organization’s Quality System, people are quick to read up a Corrective Action or Preventive Action (CAPA). No matter the adverse event, its severity or impact, a CAPA is opened up. Having a CAPA system high is highly valuable (and essential) a part of a good quality management system. However, if everything becomes a CAPA, a person create a bottleneck. Workers are so focused on working their CAPAs, they forgot complete anything if not. Essentially, people “freak out” the same as the sky were falling and open a CAPA.
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