Corresponding QMS Solution—Corrective and Preventive Action (CAPA): In addition to determining root cause and investigation, the CAPA provides a method for recording and tracking any corrective actions taken, as well as verifying the effectiveness of the corrective action. Using quantitative risk assessment, an organization can conduct a risk assessment at the root cause phase, as well as at the effectiveness phase, to ensure that the corrective actions taken reduce recurrence risk to acceptable risk levels. An automated CAPA should have the ability to generate multiple report types throughout the process, including a CAPA history report that details the CAPA process from start to finish, as well as any other related records that are critical to the CAPA. This type of reporting is critical to the recall process and provides complete transparency when submitting information to the FDA.
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Explore This IssueFebruary/March 2010
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Corresponding QMS Solution—Centralized Reporting: Once the recall is executed, it is important to provide a comprehensive report. Through use of real-time, enterprise reporting tools, organizations can create status reports for each recall phase. This type of reporting provides visibility into the overall causes of the recall, offers a clear report for the FDA to review at each phase, and helps foster continuous improvement in identifying trends to prevent similar occurrences—or to execute a product or process change.
Reaping the Benefits
The QMS’s recall management system ensures that an organization is seamlessly guided through each step of the recall process. While familiar QMS functions such as document control, corrective action, complaints handling, and centralized reporting can be leveraged for recall management, there are other benefits.
Automation: Automating the recall management process helps mitigate the chance of human error while ensuring efficient task completion. Additionally, the QMS enables automation of various other business processes and workflows, such as employee training and internal audits. This is necessary because in a complex system, there are often many employees and many training materials. Timely completion of training cannot be achieved without the use of automated tools.
Flexibility: The ability of a system to adapt to business processes is of paramount importance. Too often, organizations must build their process around or adapt to a quality system. The use of an automated QMS will provide companies in the food and beverage industry with the ability to seamlessly change and improve along with their processes and enable them to adapt the system to their organization.
Visibility: The QMS provides visibility into data from multiple sources through robust integration layers as well as with intelligent business rules to enable collaboration across all areas of the enterprise. It also heightens visibility into business processes. For example, it provides visibility into supplier qualifications with a supplier rating and inspection tool. This is extremely beneficial for organizations in the food and beverage industry, because it allows them to rate their suppliers and, ultimately, ensure that they are using the best suppliers.
Integration: The QMS’s tools are able to “talk” to each other and are linked to other tools across the enterprise. This ability to interact with outside systems and to collaborate and coordinate across the business is critical to uncovering any gaps in processes. It also creates visibility from one operational area to the next.
Make the Recall Process Work
The recall process is time consuming and extremely complex. It must be thoroughly executed at every level to achieve the desired result—the effective retrieval of the defective product and a quick termination of the recall. Items left unaccounted for or parties not contacted will increase the recall length, raise costs, and decrease consumer confidence and brand equity. Adopting food safety standards and using automated recall management procedures will result in a total system for mitigating recall risk or enhancing the recall process if a recall is required.