Paper-based quality management systems are fairly common in mid-sized organizations. While such systems can successfully manage product and process quality, they significantly increase the risk of cGMP non-compliance at FDA-regulated organization.
Paper-based quality management systems are fairly common in mid-sized organizations. While such systems might be able to manage product and process quality, they significantly increase the risk of non-compliance in an organization. They also impede a manufacturer's ability to implement continuous improvement initiatives. Such paper-based systems also become a bottleneck for companies experiencing fast growth. This paper articulates various issues with paper-based quality management systems based on research with quality management executives at mid-sized companies.
An automated quality management system provides an organization with the tools to streamline the end-to-end quality management process. With automated change control, the quality managers have visibility into the status of any change request at the click of a mouse - who has reviewed the revised document, who is sitting on the approval request and needs to be prodded and who else needs to review it. As a result, review cycle time can drop by as much as 50% after the process is automated. Once approved, the new version automatically replaces the existing version of the document making change control a very smooth process. The out-of-spec problems, non-conformance issues and corrective actions are tracked automatically by the system. Users have 100% visibility into non-conformance issues that have not been resolved or corrective actions that are waiting to be implemented. An ability to look at all corrective actions for a process or a product in aggregate provides quality engineers an ability to trend and proactively identify potential issues and design preventive actions to address such issues before they surface. Dashboards and scorecards with up to-the-minute metrics with detailed drilldowns are available to key stakeholders. As a result, the overall cost of poor quality and cost of compliance reduces. Risk of non-compliance (and potential liabilities associated with it) is minimized.