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.
- Document Control: In a regulatory environment (or an ISO 9000 environment), document control is a fact of life. Any changes to a SOP need to go through a strict change-control process. In a paper-based environment, there is little visibility into the status of documents in the review cycle. Quality managers often have to walk from desk-to-desk to identify where a document is 'stuck' in the review cycle. As a result, the review cycles can be long and unpredictable. Manual document control procedures can also be more error-prone. Such issues may at times unknowingly compromise an organization's ability to comply with regulations or make it difficult to implement continuous improvement initiatives in a timely and predictable manner in an ISO 9000 environment.
- CAPA management: In a paper-based system, lack of a reliable closed loop control makes it difficult to ensure that the corrective actions were successfully implemented. As a result, adherence to standards can be unknowingly compromised. Without a clear visibility into the status of planned process changes, it is difficult for quality managers to implement continuous improvement initiatives in an ISO 9000 environment.
- Preventive Actions: Manufacturing organizations want to trend quality-related problems, proactively identify potential issues and take preventive actions to address such issues before they surface. Preventive actions can significantly reduce cost of poor quality in a manufacturing organization and can prevent potential problems that can cause non-compliance. However, quality managers in a paper-based environment cannot easily trend problems. Hence, they cannot deploy such an important quality management technique on a large scale.
- Metrics: The prevailing wisdom says what you can't measure, you can't improve. Paper-based systems make it very difficult for companies to collect and review key operating metrics in a timely manner. Our research with quality executives lead us to believe that in a paper-based environment, metrics are usually compiled with a huge manual effort (over 15% of a quality engineer's time) and distributed on a fortnightly or monthly basis with little drill-down capability for detailed causal analysis. Lack of metrics impedes their ability to react to quality-related issues in a timely manner, leading to high cost of poor quality and high cost of compliance.
- Cost of a paper environment: While paper-based systems may seem to cost less on the surface, there is a huge amount of hidden costs due to the enormous amount of time the organization spends to ensure document control, to chase down bottlenecks in document review and to ensure corrective actions were implemented in a timely manner. From our research, a quality engineer typically spends over 35% of their time on such activities - time that could be spent on higher value added activities for the organization. In addition, lack of ability to identify preventive actions on a large scale, inability to ensure all corrective actions are always implemented and poor visibility into quality-based metrics affects their ability to significantly reduce cost of poor quality or cost of compliance. As a result, the hidden cost of a paper-based quality system is very high.
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.