Failures are inevitable in any organization; however, it is important that organization performs a detailed investigation to identify the root cause for the reported non-compliance or failure in order to take an appropriate corrective action to avoid recurrence. Proactive organizations do not wait for the failure to be reported but take preventive action to improve the system. These organizations believe in identifying the potential non-conformity by performing quality risk assessment and taking appropriate preventive action to mitigate the risk and thus avoid the occurrence of non-compliance or failure. Proactive organization not only save money by avoiding these batch failures but also avoid potential questions / observations during regulatory audits. This proactive approach shall improve the quality metrics of the organization and reduce the frequency of regulatory audits as agency determines the audit frequency based on review of the quality metrics of the organizations.