When an Incident Is Not a Crisis: Management of Incidents and Nonconformities in Biobanking

<b><i>Introduction:</i></b> Incident reporting systems are vital tools for enhancing safety, quality, and continuous improvement in biomedical and health care environments, yet they remain underdeveloped within biobanking, a sector characterized by complexity, high reliability, and multidisciplinary operations. This article addresses the implementation of incident management (IM) and corrective action/preventive action (CAPA) frameworks in biobanks, with a focus on minor- to mid-level incidents and nonconformities. <b><i>Methods:</i></b> We conducted a structured literature review using PubMed, Google Scholar, and ResearchGate resources and distinctive keywords or keyword combinations. Relevant articles were screened across biomedical, laboratory safety, and high-reliability domains. In addition, case studies from the literature and operational experiences in biobanks were analyzed, focusing on frequent but underreported incidents. <b><i>Results:</i></b> Findings indicate that robust IM and CAPA adoption align with the level of quality management system (QMS) implementation. Case studies highlighted the role of psychosocial factors-such as psychological safety, trust, and nonpunitive reporting-in addition to technical processes like root cause analysis. Effective IM is demonstrated to require more than formal structures; it depends on fostering psychological safety and a trust-based "Restorative Just" culture. <b><i>Conclusion:</i></b> We provide the first synthesis of challenges, best practices, and cultural adaptations for IM in biobanking. For the first time, our article provides a thorough synthesis of current challenges, best practices, and cultural adaptations needed to handle incidents, and also a practical toolkit consisting of clear definitions, incident categories, and an implementation guideline to develop efficient nonconformity management in biobanking.