Monitoring contract manufacturers and packagers for these same regulatory requirements also ensures the product that bears the name of the brand owner meets the quality standards of the brand. A proactive approach to risk-based audits at the facilities and to those products that have a higher risk of contamination can provide insight early on to the quality of their suppliers and proactively protect the brand reputation from high profile product recalls.
An integrated quality management framework can automate quality and workflow process into an enterprise pillar system that meets regulatory and corporate requirements for management of investigations, root cause analysis, Corrective and Preventative Actions (CAPA), and change control.
This allows these keys changes to be effectively processed and documented throughout the entire enterprise to ensure compliance and reduce ongoing errors in production, testing, packaging, and others key areas of the plant.
By implementing an enterprise quality management software solution, food manufacturers can create the preventative-control program set forth by the FSMA to:
• Centralize information that manages enterprise auditing to reduce costs and create efficiencies by sharing information between multiple audit groups;
• Provide transparency by tracking and managing resources inside and outside the facility for better business decisions; and
• Create greater efficiencies with critical issues and KPIs throughout the enterprise to help streamline current processes.
Under the FSMA, FDA has the power to enforce recalls and suspend factory operations without a court hearing. As a result, the FDA investigated and closed down the Sunland New Mexico plant, which was linked to the recent Salmonella outbreak in the U.S. Implementing a quality management framework can help all food and beverage companies avoid this outcome and ensure product quality and safety, protecting their brand and market share.
Kuchinski is the industry solution director at Sparta Systems. She can be reached at [email protected].
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