Quality And Safety Systems: Dissecting The Food Safety Modernization Act

With the passage of the Food Safety Modernization Act (FSMA), the FDA is expected to roll out a number of new regulations and guidances for the food industry. Many sections of the FSMA identify areas that food companies should reflect on now and prepare for by looking at technology. The following are all parts of the legislation that food manufacturers should keep in mind:

Section 101 – Inspection of Records–Records and documents are key factors in providing evidence for compliance, achieving accreditation and customer and regulatory authority trust. Documentation is an essential part of quality and relates to all aspects of Good Manufacturing Practices. Companies must have a good document framework or infrastructure. It is important for a company to get the documentation right in order to get the product and process right. The cost of poor quality documentation is hard to measure. But think of the time wasted through misinterpretation, searching for documents and data, recovering from errors, resubmitting to regulatory authorities, failing audits, etc.You need to whether or not all your activities are covered by good documentation and ensure they are current or up to date.

Section 103 – Hazard Analysis and Risk-Based Preventive Controls–Appropriate HACCP/risk plans, on-going monitoring or audits, proper corrective and preventive actions are all needed. Remember, HACCP implementation involves monitoring, verifying and validating of the daily work that is compliant with regulatory requirements in all stages all the time. In addition, companies need to learn to extend process management and HACCP out to the supply chain. By implementing an effective food safety and management system you can capture all your source errors, automate your Critical Control Points (CCP) threshold escalations and even prioritize them by risk. A closed-loop process capturing all activities, cause analysis, corrective actions and disposition/withdrawal with verification can reduce the possibilities of defects and miscommunication, certification jeopardy and regulatory actions, through enforced compliance. A system that enables a company to solve problems quickly today and help detect problems in the future is a powerful tool for performance monitoring and continuous improvement in the organization. Real-time data visibility of all critical CCP trends and operational metrics, ad hoc and scheduled reports, available at all operational levels, can help your organization make pro-active and informed decisions and allow management input, participation and understanding of continued effectiveness of system.

The FDA is expected to produce a guidance no later than nine months, and effective no later than 18 months, from January 2011, and will also include updates to guidances relating to fish and fisheries products hazards and controls. The clock is ticking to get prepared. Being unprepared can have a severe negative impact on an organization’s productivity and its ability to perform up to its potential, AND to be Compliant.

Section 105 – Standards for Produce Safety–Agricultural companies may have thought that the new FSMA might not have as much of an impact on them as to food manufacturers and processors. Although a proposed rule might not be available until 2012, getting started now on your quality, safety, hazard and risk-based preventive controls may boost your organization’s preparedness and your customers’ and consumers’ trust.

Section 201 – Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry–As the FDA adds more resources to its staff over the next few years, companies need to be prepared for the “initial” onslaught of inspections. Do you have a high-risk product? Have you had issues in the past? Any voluntary recalls? If you’ve answered yes to any of these questions, you’ll be on the FDA target list for their risk-based inspections. Although the FDA may be more focused on the prevention of contamination, don’t be surprised about the attention given to your records and documents – you had better review Section 101 and 103 again.

The FDA is going to be evaluating what the industry is doing and writing specific rules between now and by 2013. So, are you prepared? Six, twelve, eighteen, twenty-four months – it’s just around the corner. Perhaps this is a good time to load up your own plate with a Quality and Safety system that will keep you out of the news.

Last Week: Quality & Safety Systems: Focusing On Prevention

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